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Sample records for international multi-centre case-control

  1. Evaluation of the preliminary auditory profile test battery in an international multi-centre study

    NARCIS (Netherlands)

    van Esch, T.E.M.; Kollmeier, B.; Vormann, M.; Lijzenga, J.; Houtgast, T.; Hallgren, M.; Larsby, B.; Athalye, S.P.; Lutman, M.E.; Dreschler, W.A.

    2013-01-01

    Objective: This paper describes the composition and international multi-centre evaluation of a battery of tests termed the preliminary auditory profile. It includes measures of loudness perception, listening effort, speech perception, spectral and temporal resolution, spatial hearing, self-reported

  2. Evaluation of the preliminary auditory profile test battery in an international multi-centre study

    NARCIS (Netherlands)

    van Esch, Thamar E. M.; Kollmeier, Birger; Vormann, Matthias; Lyzenga, Johannes; Houtgast, Tammo; Hällgren, Mathias; Larsby, Birgitta; Athalye, Sheetal P.; Lutman, Mark E.; Dreschler, Wouter A.

    2013-01-01

    This paper describes the composition and international multi-centre evaluation of a battery of tests termed the preliminary auditory profile. It includes measures of loudness perception, listening effort, speech perception, spectral and temporal resolution, spatial hearing, self-reported disability

  3. European multi-centre case-control study on risk factors for rare cancers of unknown aetiology

    DEFF Research Database (Denmark)

    Lynge, Elsebeth; Afonso, Noemia; Kaerlev, Linda

    2005-01-01

    To search for occupational risk factors, we conducted a case-control study in nine European countries of cancers of the small intestine, male gall bladder, thymus, bone, male breast, melanoma of the eye, and mycosis fungoides. Recruitment was population based in Denmark, Latvia, France, Germany...... recruited 3374 population (61% interviewed) and 1284 colon cancer controls (86% interviewed). It was possible to undertake this complicated study across Europe, but we encountered three main problems. It was difficult to ensure complete case ascertainment, for population controls, we found a clear divide......, Italy, and Sweden, from hospital areas in Spain and Portugal, and from one United Kingdom (UK) hospital. We recruited 1457 cases (84% interviewed). Numbers identified corresponded to those in the EUROCIM database for Denmark, but were below those observed for France, Italy and Sweden in the database. We...

  4. Evaluation of the preliminary auditory profile test battery in an international multi-centre study.

    Science.gov (United States)

    van Esch, Thamar E M; Kollmeier, Birger; Vormann, Matthias; Lyzenga, Johannes; Houtgast, Tammo; Hällgren, Mathias; Larsby, Birgitta; Athalye, Sheetal P; Lutman, Mark E; Dreschler, Wouter A

    2013-05-01

    This paper describes the composition and international multi-centre evaluation of a battery of tests termed the preliminary auditory profile. It includes measures of loudness perception, listening effort, speech perception, spectral and temporal resolution, spatial hearing, self-reported disability and handicap, and cognition. Clinical applicability and comparability across different centres are investigated. Headphone tests were conducted in five centres divided over four countries. Effects of test-retest, ear, and centre were investigated. Results for normally-hearing (NH) and hearing-impaired (HI) listeners are presented. Thirty NH listeners aged 19-39 years, and 72 HI listeners aged 22-91 years with a broad range of hearing losses were included. Test-retest reliability was generally good and there were very few right/left ear effects. Results of all tests were comparable across centres for NH listeners after baseline correction to account for necessary differences between test materials. For HI listeners, results were comparable across centres for the language-independent tests. The auditory profile forms a clinical test battery that is applicable in four different languages. Even after baseline correction, differences between test materials have to be taken into account when interpreting results of language-dependent tests in HI listeners.

  5. I-MOVE multi-centre case control study 2010-11: overall and stratified estimates of influenza vaccine effectiveness in Europe.

    Science.gov (United States)

    Kissling, Esther; Valenciano, Marta; Cohen, Jean Marie; Oroszi, Beatrix; Barret, Anne-Sophie; Rizzo, Caterina; Stefanoff, Pawel; Nunes, Baltazar; Pitigoi, Daniela; Larrauri, Amparo; Daviaud, Isabelle; Horvath, Judit Krisztina; O'Donnell, Joan; Seyler, Thomas; Paradowska-Stankiewicz, Iwona Anna; Pechirra, Pedro; Ivanciuc, Alina Elena; Jiménez-Jorge, Silvia; Savulescu, Camelia; Ciancio, Bruno Christian; Moren, Alain

    2011-01-01

    In the third season of I-MOVE (Influenza Monitoring Vaccine Effectiveness in Europe), we undertook a multicentre case-control study based on sentinel practitioner surveillance networks in eight European Union (EU) member states to estimate 2010/11 influenza vaccine effectiveness (VE) against medically-attended influenza-like illness (ILI) laboratory-confirmed as influenza. Using systematic sampling, practitioners swabbed ILI/ARI patients within seven days of symptom onset. We compared influenza-positive to influenza laboratory-negative patients among those meeting the EU ILI case definition. A valid vaccination corresponded to > 14 days between receiving a dose of vaccine and symptom onset. We used multiple imputation with chained equations to estimate missing values. Using logistic regression with study as fixed effect we calculated influenza VE adjusting for potential confounders. We estimated influenza VE overall, by influenza type, age group and among the target group for vaccination. We included 2019 cases and 2391 controls in the analysis. Adjusted VE was 52% (95% CI 30-67) overall (N = 4410), 55% (95% CI 29-72) against A(H1N1) and 50% (95% CI 14-71) against influenza B. Adjusted VE against all influenza subtypes was 66% (95% CI 15-86), 41% (95% CI -3-66) and 60% (95% CI 17-81) among those aged 0-14, 15-59 and ≥60 respectively. Among target groups for vaccination (N = 1004), VE was 56% (95% CI 34-71) overall, 59% (95% CI 32-75) against A(H1N1) and 63% (95% CI 31-81) against influenza B. Results suggest moderate protection from 2010-11 trivalent influenza vaccines against medically-attended ILI laboratory-confirmed as influenza across Europe. Adjusted and stratified influenza VE estimates are possible with the large sample size of this multi-centre case-control. I-MOVE shows how a network can provide precise summary VE measures across Europe.

  6. I-MOVE multi-centre case control study 2010-11: overall and stratified estimates of influenza vaccine effectiveness in Europe.

    Directory of Open Access Journals (Sweden)

    Esther Kissling

    Full Text Available BACKGROUND: In the third season of I-MOVE (Influenza Monitoring Vaccine Effectiveness in Europe, we undertook a multicentre case-control study based on sentinel practitioner surveillance networks in eight European Union (EU member states to estimate 2010/11 influenza vaccine effectiveness (VE against medically-attended influenza-like illness (ILI laboratory-confirmed as influenza. METHODS: Using systematic sampling, practitioners swabbed ILI/ARI patients within seven days of symptom onset. We compared influenza-positive to influenza laboratory-negative patients among those meeting the EU ILI case definition. A valid vaccination corresponded to > 14 days between receiving a dose of vaccine and symptom onset. We used multiple imputation with chained equations to estimate missing values. Using logistic regression with study as fixed effect we calculated influenza VE adjusting for potential confounders. We estimated influenza VE overall, by influenza type, age group and among the target group for vaccination. RESULTS: We included 2019 cases and 2391 controls in the analysis. Adjusted VE was 52% (95% CI 30-67 overall (N = 4410, 55% (95% CI 29-72 against A(H1N1 and 50% (95% CI 14-71 against influenza B. Adjusted VE against all influenza subtypes was 66% (95% CI 15-86, 41% (95% CI -3-66 and 60% (95% CI 17-81 among those aged 0-14, 15-59 and ≥60 respectively. Among target groups for vaccination (N = 1004, VE was 56% (95% CI 34-71 overall, 59% (95% CI 32-75 against A(H1N1 and 63% (95% CI 31-81 against influenza B. CONCLUSIONS: Results suggest moderate protection from 2010-11 trivalent influenza vaccines against medically-attended ILI laboratory-confirmed as influenza across Europe. Adjusted and stratified influenza VE estimates are possible with the large sample size of this multi-centre case-control. I-MOVE shows how a network can provide precise summary VE measures across Europe.

  7. Retrospective exposure assessment and quality control in an international multi-centre case-control study

    DEFF Research Database (Denmark)

    Tinnerberg, H; Heikkilä, P; Huici-Montagud, A

    2003-01-01

    was higher among the original assessors (the assessor from the same country as the subject) than the average prevalence assessed by the other four in the quality control round. The original assessors classified more job situations as exposed than the others. Several reasons for this are plausible: real...... of the assessors, as Cohen's kappa and as overall proportion of the agreements. The reassessment of the exposures changed the exposure statuses significantly, when compared with the original cohort. Harmonization of the exposure criteria increased the conformity of the assessments. The prevalence of exposure...

  8. Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery

    Directory of Open Access Journals (Sweden)

    Bochenek Andrzej

    2011-09-01

    Full Text Available Abstract Background ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. Methods The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query and "dirty" (any incomplete, inconsistent or illegible data. The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent and time delay (in days between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India and "Developed" (Italy, UK, Austria and Australia. Results There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month. The time interval for the receipt of data was longer for "Developing" countries (median:37 days compared to "Developed" ones (median:11 days (p Conclusions In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality. Trial registration ISRCTN46552265

  9. Harmonizing national growth references for multi-centre surveys, drug monitoring and international postmarketing surveillance.

    Science.gov (United States)

    Hermanussen, M; Assmann, C; Wöhling, H; Zabransky, M

    2012-01-01

    National European growth references differ. We aimed to convert (harmonize) currently used charts into a single unified interchangeable LMS format for each European nation. Nine currently used national European growth references from Belgium (2009), France (1979), Poland (2001), Sweden (2002), Switzerland (1989), the UK (1990), Italy (2006) and Germany (1979 and 1997) were harmonized and compared with the international WHO child growth standards and WHO growth reference data for 5-19 years. European growth charts can be harmonized. The approach appears useful as height, and body mass index (BMI) is inappropriately represented by WHO references. European height references exhibit warping when plotted against the WHO reference. The French appears too short, the other Europeans too tall. Also, the BMI is not appropriately represented by the WHO references. Harmonizing references is a novel, convenient and cost-effective approach for converting historic and/or incomplete local or national growth reference charts into a unified interchangeable LMS format. Harmonizing facilitates producing growth references 'on demand', for limited regional purposes, for ethnically, socio-economically or politically defined minorities, but also for matching geographically different groups of children and adolescents for international growth and registry studies. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

  10. The Glioma International Case-Control Study

    DEFF Research Database (Denmark)

    Amirian, E. Susan; Armstrong, Georgina N; Zhou, Renke

    2016-01-01

    describe the Glioma International Case-Control (GICC) Study (recruitment, 2010-2013), a study being conducted by the Genetic Epidemiology of Glioma International Consortium that integrates data from multiple data collection sites, uses a common protocol and questionnaire, and includes biospecimen......Decades of research have established only a few etiological factors for glioma, which is a rare and highly fatal brain cancer. Common methodological challenges among glioma studies include small sample sizes, heterogeneity of tumor subtypes, and retrospective exposure assessment. Here, we briefly...... collection. To our knowledge, the GICC Study is the largest glioma study to date that includes collection of blood samples, which will allow for genetic analysis and interrogation of gene-environment interactions....

  11. Modifiable risk factors for scald injury in children under 5 years of age: A Multi-centre Case-Control Study.

    Science.gov (United States)

    Stewart, Jane; Benford, Penny; Wynn, Persephone; Watson, Michael Craig; Coupland, Carol; Deave, Toity; Hindmarch, Paul; Majsak-Newman, Gosia; Kendrick, Denise

    2016-12-01

    To determine the relationship between a range of modifiable risk factors and medically attended scalds in children under the age of 5 years. Multicentre matched case-control study in acute hospitals, minor injury units and GP practices in four study centres in England. Cases comprised 338 children under 5 presenting with a scald, and 1438 control participants matched on age, gender, date of event and study centre. Parents/caregivers completed questionnaires on safety practices, safety equipment use, home hazards and potential confounders. Odds ratios were estimated using conditional logistic regression. Parents of cases were significantly more likely than parents of controls to have left hot drinks within reach of their child (adjusted odds ratio (AOR) 2.33, 95%CI 1.63 to 3.31; population attributable fraction (PAF) 31%). They were more likely not to have taught children rules about climbing on kitchen objects (AOR 1.66, 95%CI 1.12 to 2.47; PAF 20%); what to do or not do when parents are cooking (AOR 1.95, 95%CI 1.33 to 2.85; PAF 26%); and about hot things in the kitchen (AOR 1.89, 95%CI 1.30 to 2.75; PAF 26%). Some scald injuries may be prevented by parents keeping hot drinks out of reach of children and by teaching children rules about not climbing on objects in the kitchen, what to do or not do whilst parents are cooking using the top of the cooker and about hot objects in the kitchen. Further studies, providing a more sophisticated exploration of the immediate antecedents of scalds are required to quantify associations between other hazards and behaviours and scalds in young children. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  12. Replication of EPHA1 and CD33 associations with late-onset Alzheimer's disease: a multi-centre case-control study

    Directory of Open Access Journals (Sweden)

    Barcikowska Maria

    2011-07-01

    Full Text Available Abstract Background A recently published genome-wide association study (GWAS of late-onset Alzheimer's disease (LOAD revealed genome-wide significant association of variants in or near MS4A4A, CD2AP, EPHA1 and CD33. Meta-analyses of this and a previously published GWAS revealed significant association at ABCA7 and MS4A, independent evidence for association of CD2AP, CD33 and EPHA1 and an opposing yet significant association of a variant near ARID5B. In this study, we genotyped five variants (in or near CD2AP, EPHA1, ARID5B, and CD33 in a large (2,634 LOAD, 4,201 controls, independent dataset comprising six case-control series from the USA and Europe. We performed meta-analyses of the association of these variants with LOAD and tested for association using logistic regression adjusted by age-at-diagnosis, gender, and APOE ε4 dosage. Results We found no significant evidence of series heterogeneity. Associations with LOAD were successfully replicated for EPHA1 (rs11767557; OR = 0.87, p = 5 × 10-4 and CD33 (rs3865444; OR = 0.92, p = 0.049, with odds ratios comparable to those previously reported. Although the two ARID5B variants (rs2588969 and rs494288 showed significant association with LOAD in meta-analysis of our dataset (p = 0.046 and 0.008, respectively, the associations did not survive adjustment for covariates (p = 0.30 and 0.11, respectively. We had insufficient evidence in our data to support the association of the CD2AP variant (rs9349407, p = 0.56. Conclusions Our data overwhelmingly support the association of EPHA1 and CD33 variants with LOAD risk: addition of our data to the results previously reported (total n > 42,000 increased the strength of evidence for these variants, providing impressive p-values of 2.1 × 10-15 (EPHA1 and 1.8 × 10-13 (CD33.

  13. The effects of a randomised multi-centre trial and international accreditation on availability and quality of clinical guidelines

    DEFF Research Database (Denmark)

    Juul, AB; Gluud, C; Wetterslev, J

    2005-01-01

    To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation.......To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation....

  14. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

    2015-01-01

    to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference...... to the original source....

  15. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

    2015-01-01

    to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference...

  16. Asymptomatic population reference values for three knee patient-reported outcomes measures: evaluation of an electronic data collection system and implications for future international, multi-centre cohort studies.

    Science.gov (United States)

    McLean, James M; Brumby-Rendell, Oscar; Lisle, Ryan; Brazier, Jacob; Dunn, Kieran; Gill, Tiffany; Hill, Catherine L; Mandziak, Daniel; Leith, Jordan

    2018-05-01

    The aim was to assess whether the Knee Society Score, Oxford Knee Score (OKS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) were comparable in asymptomatic, healthy, individuals of different age, gender and ethnicity, across two remote continents. The purpose of this study was to establish normal population values for these scores using an electronic data collection system. There is no difference in clinical knee scores in an asymptomatic population when comparing age, gender and ethnicity, across two remote continents. 312 Australian and 314 Canadian citizens, aged 18-94 years, with no active knee pain, injury or pathology in the ipsilateral knee corresponding to their dominant arm, were evaluated. A knee examination was performed and participants completed an electronically administered questionnaire covering the subjective components of the knee scores. The cohorts were age- and gender-matched. Chi-square tests, Fisher's exact test and Poisson regression models were used where appropriate, to investigate the association between knee scores, age, gender, ethnicity and nationality. There was a significant inverse relationship between age and all assessment tools. OKS recorded a significant difference between gender with females scoring on average 1% lower score. There was no significant difference between international cohorts when comparing all assessment tools. An electronic, multi-centre data collection system can be effectively utilized to assess remote international cohorts. Differences in gender, age, ethnicity and nationality should be taken into consideration when using knee scores to compare to pathological patient scores. This study has established an electronic, normal control group for future studies using the Knee society, Oxford, and KOOS knee scores. Diagnostic Level II.

  17. 77 FR 11136 - Proposed Collection; Comment Request; a Multi-Center International Hospital-Based Case-Control...

    Science.gov (United States)

    2012-02-24

    ... Request; a Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph... proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: A Multi-Center International Hospital- Based Case-Control Study of Lymphoma in...

  18. Authorship issues in multi-centre clinical trials: the importance of making an authorship contract.

    Science.gov (United States)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian; Vinther, Siri

    2015-02-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference to the original source.

  19. Multiple myeloma in Nigeria: a multi-centre epidemiological and ...

    African Journals Online (AJOL)

    Multiple myeloma in Nigeria: a multi-centre epidemiological and biomedical study. Nkiruka Nnonyelum Odunukwe, Jude Anazoeze Madu, Obigeli Eunice Nnodu, Titilola Stella Akingbola, Inyama Marcus Asuquo, Modupe Taiwo Balogun, Olufunto Olufela Kalejaiye, John Chinawaeze Aneke, Joseph Aondowase Orkuma, ...

  20. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

    2015-01-01

    Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for th...... to the original source....

  1. Reactive arthritis in relation to internal derangements of the temporomandibular joint: a case control study.

    Science.gov (United States)

    Lund, Bodil; Holmlund, Anders; Wretlind, Bengt; Jalal, Shah; Rosén, Annika

    2015-09-01

    The aim of this study was to find out if reactive arthritis was involved in the aetiology of chronic closed lock of the temporomandibular joint (TMJ) by looking for bacterial antigens in the synovial membrane of the TMJ, and by studying the antibody serology and carriage of human leucocyte antigen (HLA) B27 in patients with chronic closed lock. Patients with reciprocal clicking and healthy subjects acted as controls. We studied a total of 43 consecutive patients, 15 with chronic closed lock, 13 with reciprocal clicking, and 15 healthy controls with no internal derangements of the TMJ. Venous blood samples were collected from all subjects for measurement of concentrations of HLA tissue antigen and serology against Chlamydia trachomatis, Yersinia enterocolitica, Salmonella spp., Campylobacter jejuni, and Mycoplasma pneumoniae. Samples of synovial tissue from patients with closed lock and reciprocal clicking were obtained during discectomy and divided into two pieces, the first of which was tested by strand displacement amplification for the presence of C trachomatis, and the second of which was analysed for the presence of species-specific bacterial DNA using 16s rRNA pan-polymerase chain reaction (PCR). There were no significant differences between the groups in the incidence of antibodies against M pneumoniae, Salmonella spp. or Y enterocolitica. No patient had antibodies towards C trachomatis or C jejuni. We found no bacterial DNA in the synovial fluid from any patient. The HLA B27 antigen was present in 2/15 subjects in both the closed lock and control groups, and none in the reciprocal clicking group. In conclusion, reactive arthritis does not seem to be the mechanism of internal derangement of the TMJ. Copyright © 2015. Published by Elsevier Ltd.

  2. Hemodynamic characteristics of large unruptured internal carotid artery aneurysms prior to rupture: a case control study.

    Science.gov (United States)

    Liu, Jian; Fan, Jixing; Xiang, Jianping; Zhang, Ying; Yang, Xinjian

    2016-04-01

    Post-ruptured intracranial aneurysm geometry models have been widely used in computational fluid dynamic studies to assess hemodynamic parameters associated with aneurysm rupture. However, their results may not be valid due to the morphological changes of the aneurysm after rupture. Our aim was to identify the hemodynamic features of aneurysms prior to rupture in comparison with unruptured aneurysms. We retrospectively identified three large unruptured internal carotid artery (ICA) aneurysms (pre-ruptured group) with adequate image quality just before rupture. Matched with the same location and similar size, eight unruptured aneurysms (unruptured group) were selected as controls during the same time period. Flow simulations for these aneurysms were performed to compare differences in hemodynamics. Compared with unruptured aneurysms, pre-ruptured aneurysms had a significantly more irregular aneurysm shape, a higher aspect ratio, and lower aneurysm averaged wall shear stress (WSS) (p=0.024, p=0.048, and p=0.048, respectively). Although pre-ruptured aneurysms had a lower low WSS area and higher Oscillatory Shear Index, these were not statistically significant. For large unruptured ICA aneurysms, low WSS, higher aspect ratio, and irregular shape were indicators of fatal rupture. Early treatment for such lesions with flow diverter and coils may be the best therapeutic option. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  3. Digitoxin medication and cancer; case control and internal dose-response studies

    International Nuclear Information System (INIS)

    Haux, Johan; Klepp, Olbjørn; Spigset, Olav; Tretli, Steinar

    2001-01-01

    Digitoxin induces apoptosis in different human malignant cell lines in vitro. In this paper we investigated if patients taking digitoxin for cardiac disease have a different cancer incidence compared to the general population. Computer stored data on digitoxin concentrations in plasma from 9271 patients with cardiac disease were used to define a user population. Age and sex matched controls from the Norwegian Cancer Registry were used to calculate the number of expected cancer cases. The population on digitoxin showed a higher incidence of cancer compared to the control population. However, an additional analysis showed that the population on digitoxin had a general increased risk of cancer already, before the start on digitoxin. Leukemia/lymphoma were the cancer types which stood out with the highest risk in the digitoxin population before starting on digitoxin. This indicates that yet unknown risk factors exist for cardiovascular disease and lymphoproliferative cancer. An internal dose-response analysis revealed a relationship between high plasma concentration of digitoxin and a lower risk for leukemia/lymphoma and for cancer of the kidney/urinary tract. Morbidity and mortality are high in the population on digitoxin, due to high age and cardiac disease.These factors disturb efforts to isolate an eventual anticancer effect of digitoxin in this setting. Still, the results may indicate an anticancer effect of digitoxin for leukemia/lymphoma and kidney/urinary tract cancers. Prospective clinical cancer trials have to be done to find out if digitoxin and other cardiac glycosides are useful as anticancer agents

  4. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence

    NARCIS (Netherlands)

    Muller, U.C.; Asherson, P.; Banaschewski, T.; Buitelaar, J.K.; Ebstein, R.P.; Eisenberg, J.; Gill, M.; Manor, I.; Miranda, A.; Oades, R.D.; Roeyers, H.; Rothenberger, A.; Sergeant, J.A.; Sonuga-Barke, E.J.S.; Thompson, M.; Faraone, S.V.; Steinhausen, H.C.

    2011-01-01

    BACKGROUND: The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446

  5. Clinical effects of internal fixation for ulnar styloid fractures associated with distal radius fractures: A matched case-control study.

    Science.gov (United States)

    Sawada, Hideyoshi; Shinohara, Takaaki; Natsume, Tadahiro; Hirata, Hitoshi

    2016-11-01

    Ulnar styloid fractures are often associated with distal radius fractures. However, controversy exists regarding whether to treat ulnar styloid fractures. This study aimed to evaluate clinical effects of internal fixation for ulnar styloid fractures after distal radius fractures were treated with the volar locking plate system. We used prospectively collected data of distal radius fractures. 111 patients were enrolled in this study. A matched case-control study design was used. We selected patients who underwent fixation for ulnar styloid fractures (case group). Three control patients for each patient of the case group were matched on the basis of age, sex, and fracture type of distal radius fractures from among patients who did not undergo fixation for ulnar styloid fractures (control group). The case group included 16 patients (7 men, 9 women; mean age: 52.6 years; classification of ulnar styloid fractures: center, 3; base, 11; and proximal, 2). The control group included 48 patients (15 men, 33 women; mean age: 61.1 years; classification of ulnar styloid fractures: center, 10; base, 31; and proximal, 7). For radiographic examination, the volar tilt angle, radial inclination angle, and ulnar variance length were measured, and the union of ulnar styloid fractures was judged. For clinical examination, the range of motions, grip strength, Hand20 score, and Numeric Rating Scale score were evaluated. There was little correction loss for each radiological parameter of fracture reduction, and these parameters were not significantly different between the groups. The bone-healing rate of ulnar styloid fractures was significantly higher in the case group than in the control group, but the clinical results were not significantly different. We revealed that there was no need to fix ulnar styloid fractures when distal radius fractures were treated via open reduction and internal fixation with a volar locking plate system. Copyright © 2016 The Japanese Orthopaedic Association

  6. Low social interactions in eating disorder patients in childhood and adulthood: a multi-centre European case control study.

    Science.gov (United States)

    Krug, Isabel; Penelo, Eva; Fernandez-Aranda, Fernando; Anderluh, Marija; Bellodi, Laura; Cellini, Elena; di Bernardo, Milena; Granero, Roser; Karwautz, Andreas; Nacmias, Benedetta; Ricca, Valdo; Sorbi, Sandro; Tchanturia, Kate; Wagner, Gudrun; Collier, David; Treasure, Janet

    2013-01-01

    The objective of this article was to examine lifestyle behaviours in eating disorder (ED) patients and healthy controls. A total of 801 ED patients and 727 healthy controls from five European countries completed the questions related to lifestyle behaviours of the Cross-Cultural Questionnaire (CCQ). For children, the ED sample exhibited more solitary activities (rigorously doing homework [pfriends [p<0.05]) than the healthy control group and this continued in adulthood. There were minimal differences across ED sub-diagnoses and various cross-cultural differences emerged. Reduced social activities may be an important risk and maintaining factor for ED symptomatology.

  7. Who to handover: a case-control study of a novel scoring system to prioritise handover of internal medicine inpatients.

    Science.gov (United States)

    Bittman, Jesse; Tam, Penny; Little, Chris; Khan, Nadia

    2017-06-01

    Handover of patients between care providers is a critical event in patient care. There is, however, little evidence to guide the handover process, including determining which patients to handover. Compare the ability of gestalt-based handover with two structured scores, the modified early warning score (MEWS) and our novel iHAND clinical decision support system, to predict which patients will be assessed by a physician overnight. This case-control study included 90 inpatients, comprising 32 patients assessed overnight (cases) and 58 patients not assessed overnight (controls) at a teaching hospital in British Columbia, Canada (May 2012). Gestalt, MEWS and iHAND scores were analysed against patients seen overnight using logistic regression and receiver-operating characteristic (ROC) curves. Neither current gestalt-based handover practice (odds ratio (OR) 1.50, 95% CI 0.89 to 3.83) nor MEWS (OR 0.96, 95% CI 0.75 to 1.24, area under the ROC curve (AUC) 0.61, 95% CI 0.49 to 0.73) were significantly associated with need to be seen overnight. The iHAND score was associated with need to be seen (OR 1.93, 95% CI 1.24 to 3.02, AUC 0.70, 95% CI 0.60 to 0.81). The iHAND score had moderate ability to predict which patients required assessment overnight, while MEWS score and current gestalt approach correlated poorly, suggesting the iHAND score may help prioritisation of patients likely to be seen overnight for handover. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. A multi-centre clinical evaluation of reactive oxygen topical wound gel in 114 wounds.

    Science.gov (United States)

    Dryden, M; Dickinson, A; Brooks, J; Hudgell, L; Saeed, K; Cutting, K F

    2016-03-01

    This article reports the outcomes of the use of Surgihoney RO (SHRO), topical wound dressing in a multi-centre, international setting. The aims were to explore the clinical effects of SHRO, including a reduction in bacterial load and biofilm and improvement in healing in a variety of challenging non-healing and clinically infected wounds. This was a non-comparative evaluation, where both acute and chronic wounds with established delayed healing were treated with the dressing. Clinicians prospectively recorded wound improvement or deterioration, level of wound exudate, presence of pain, and presence of slough and necrosis. Analysis of this data provided information on clinical performance of the dressing. Semi-quantitative culture to assess bacterial bioburden was performed where possible. We recruited 104 patients, mean age 61 years old, with 114 wounds. The mean duration of wounds before treatment was 3.7 months and the mean duration of treatment was 25.7 days. During treatment 24 wounds (21%) healed and the remaining 90 (79%) wounds improved following application of the dressing. No deterioration in any wound was observed. A reduction in patient pain, level of wound exudate and in devitalised tissue were consistently reported. These positive improvements in wound progress were reflected in the wound cultures that showed a reduction in bacterial load in 39 out of the 40 swabs taken. There were two adverse events recorded: a stinging sensation following application of the dressing was experienced by 2 patients, and 2 elderly patients died of causes unrelated to the dressing or to the chronic wound. These patients' wounds and their response to SHRO have been included in the analysis. SHRO was well tolerated and shows great promise as an effective potent topical antimicrobial in the healing of challenging wounds. Matthew Dryden has become a shareholder in Matoke Holdings, the manufacturer of Surgihoney RO, since the completion of this study. Keith Cutting is a

  9. Low sodium diet and pregnancy-induced hypertension: a multi-centre randomised controlled trial

    NARCIS (Netherlands)

    Knuist, M.; Bonsel, G. J.; Zondervan, H. A.; Treffers, P. E.

    1998-01-01

    To examine the effectiveness of the standard policy in the Netherlands to prescribe a sodium restricted diet to prevent or to treat mild pregnancy-induced hypertension. Multi-centre randomised controlled trial between April 1992 and April 1994. Seven practices of independent midwives and one

  10. Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.

    NARCIS (Netherlands)

    Halder, Marlies; Depraetere, Hilde; Delannois, Frédérique; Akkermans, Arnoud; Behr-Gross, Marie-Emmanuelle; Bruysters, Martijn; Dierick, Jean-François; Jungbäck, Carmen; Kross, Imke; Metz, Bernard; Pennings, Jeroen; Rigsby, Peter; Riou, Patrice; Balks, Elisabeth; Dobly, Alexandre; Leroy, Odile; Stirling, Catrina

    2018-01-01

    Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation

  11. Proposal for the standardisation of multi-centre trials in nuclear medicine imaging

    DEFF Research Database (Denmark)

    Dickson, John Caddell; Tossici-Bolt, Livia; Sera, Terez

    2012-01-01

    Multi-centre trials are an important part of proving the efficacy of procedures, drugs and interventions. Imaging components in such trials are becoming increasingly common; however, without sufficient control measures the usefulness of these data can be compromised. This paper describes a framew...

  12. Significance of internal mammary lymph nodes in patients after mastectomy with tissue-expander reconstruction: a case-control study

    International Nuclear Information System (INIS)

    Kaewlai, R.; Digumarthy, S.R.; Smith, B.L.; Corben, A.D.; Austen, W.G.; Shepard, J.-A.O.; Sharma, A.

    2010-01-01

    Aim: To retrospectively assess the frequency of internal mammary lymph nodes (IMNs) in patients after mastectomy and tissue-expander reconstruction. Materials and methods: Statistical analysis was performed for all available data in patients with mastectomy and tissue-expander reconstruction from 2004-2007 (study group). The data were compared with that of a control population with mastectomy who did not have reconstruction (control group). Patients with recurrent breast cancers, previous breast reconstruction, surgeries performed at outside hospitals, no available pre- or postoperative computed tomography (CT) or magnetic resonance imaging (MRI) data, or inadequate imaging follow-up were excluded. Results: There were eight patients in the study group (median age 50.5 years, seven breast cancers), and eight patients in the control group (median age 52 years, seven breast cancers). No patients had IMNs on their preoperative imaging examinations. New IMNs were present in postoperative imaging in seven of eight patients (7/8, 87.5%) in the study group. All of them were stable or decreased in size on subsequent imaging examinations. None of the patients in the control group had IMNs (0/8). Conclusion: IMNs are common on imaging after mastectomy and tissue-expander placement. The IMNs decreased or remained stable on follow-up imaging and may represent reactive nodes.

  13. Building a Multi-centre Clinical Research Facilitation Network: The ARC Experience

    Directory of Open Access Journals (Sweden)

    Ian Nicholson

    2017-06-01

    Full Text Available Introduction: In order to practice evidence-based veterinary medicine, good quality clinical evidence needs to be produced, in order that it can be apprasied systematically by the EBVM network, and used by vets. There is very little good-quality veterinary evidence for most of the veterinary procedures carried out every day across the world. Very few, if any, individuals have all the necessary qualities (case-load, time, research expertise, financial support to be able to systematically produce good-quality, and relevant, clinical research on their own, in a timely manner. The Association for Veterinary Soft Tissue Surgery (AVSTS www.avsts.org.uk is an affiliate group with the British Small Animal Veterinary Association (BSAVA, and functions as a clinical network of like-minded individuals. In 2013 AVSTS sought to create a role for itself in facilitating the production (by its members of multi-centre clinical research of relevance to its members.Materials and methods: Members of AVSTS were asked to join the AVSTS Research Cooperative (ARC, with a veterinary epidemiologist and an experienced multi-centre veterinary clinical researcher (to help with study design and statistical planning, and the Animal Health Trust clinical research ethics committee. An email list was established, and a page was set up on the AVSTS website, to allow information to be disseminated. The AVSTS spring and autumn meetings were used as a regular forum by ARC, to discuss its direction, to generate interest, to create and promote specific studies (in order to widen participation amongst different centres, and to update members about previous studies.Results: Membership of ARC has grown to 224 people, although the epidemiologist left. One multi-centre study has been published, two have been presented and await publication, one has been accepted for presentation, two other studies are gathering data at present, and further studies are in the pipeline. There has been

  14. Approach to derive doses for case-control studies of lung cancer and leukaemia among workers internally exposed to uranium and plutonium

    International Nuclear Information System (INIS)

    Thierry-Chef, Isabelle; Berard, Philippe; Bingham, Derek; Blanchardon, Eric; Challeton-de Vathaire, Cecile; Birchall, Alan; Puncher, Matthew; Bull, Richard; Hurtgen, Christian; Riddell, Tony; Vrijheid, Martine; Cardis, Elisabeth

    2008-01-01

    Case-control studies are currently conducted in 3 European countries (Belgium, France and the United Kingdom) to estimate the risk of lung cancer and leukaemia in relation to internal exposure to uranium and plutonium amongst workers in the nuclear industry. The project requires calculating doses absorbed by the lung and the bone marrow for many hundreds of cases and controls internally exposed. In order to establish a common approach to dose reconstruction, a detailed dosimetry protocol and a database of individual exposure were set up and will be presented. The dose reconstruction relies heavily on bioassay data, which are usually urine analysis, extending back over 50 years in some cases. Inevitably, data obtained over such a time span are of variable quality. It is important to review the monitoring practices at the various laboratories and to assess the reliability of these data in order to estimate possible biases as well as random uncertainties. Another key step in the reconstruction process is to decide upon the likely intake regimes consistent with the data. Generally, chronic intakes will be assumed and acute intakes will be added only when their existence is supported by operational data. Biokinetic models are used both to calculate intakes from bioassay data and to convert intakes to doses. The ICRP publication 66 respiratory tract model will be used along with the latest systemic models described by ICRP. These will be supplemented by the Leggett 2005 model for plutonium. These various models will be implemented by the code IMBA-Expert. Since it is essential to obtain central estimates for the doses, a particular problem is encountered with datasets consisting only of values below the limit of detection. For these cases Bayesian statistics will be employed using a non-informative prior probability distribution. (author)

  15. Ethical issues: the multi-centre low-risk ethics/governance review process and AMOSS.

    Science.gov (United States)

    Vaughan, Geraldine; Pollock, Wendy; Peek, Michael J; Knight, Marian; Ellwood, David; Homer, Caroline S; Pulver, Lisa Jackson; McLintock, Claire; Ho, Maria T; Sullivan, Elizabeth A

    2012-04-01

    The Australasian Maternity Outcomes Surveillance System (AMOSS) conducts surveillance and research of rare and serious conditions in pregnancy. This multi-centre population health study is considered low risk with minimal ethical impact. To describe the ethics/governance review pathway undertaken by AMOSS. Prospective, descriptive study during 2009-2011 of the governance/ethical review processes required to gain approval for Australian and New Zealand (ANZ) maternity units with more than 50 births per year (n = 303) to participate in AMOSS. Review processes ranged from a single application for 24 NZ sites, a single application for eligible hospitals in two Australian states, full Health Research Ethics Committee (HREC) applications for individual hospitals, through simple letters of support. As of September 2011, 46 full/expedited ethics applications, 131 site governance applications and 136 letters of support requests were made over 33 months, involving an estimated 3261 hours by AMOSS staff/investigators, and an associated resource burden by participating sites, to obtain approval to receive nonidentifiable data from 291 hospitals. The AMOSS research system provides an important resource to enhance knowledge of conditions that cause rare and serious maternal morbidity. Yet the highly variable ethical approval processes required to implement this study have been excessively repetitive and burdensome. This process jeopardises timely, efficient research project implementation, without corresponding benefits to research participants. The resource burden to establish research governance for AMOSS confirms the urgent need for the Harmonisation of Multi-centre Ethical Review (HoMER) to further streamline ethics/governance review processes for multi-centre research. © 2011 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2011 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  16. Comprehensive comparing percutaneous endoscopic lumbar discectomy with posterior lumbar internal fixation for treatment of adjacent segment lumbar disc prolapse with stable retrolisthesis: A retrospective case-control study.

    Science.gov (United States)

    Sun, Yapeng; Zhang, Wei; Qie, Suhui; Zhang, Nan; Ding, Wenyuan; Shen, Yong

    2017-07-01

    The study was to comprehensively compare the postoperative outcome and imaging parameter characters in a short/middle period between the percutaneous endoscopic lumbar discectomy (PELD) and the internal fixation of bone graft fusion (the most common form is posterior lumbar interbody fusion [PLIF]) for the treatment of adjacent segment lumbar disc prolapse with stable retrolisthesis after a previous lumbar internal fixation surgery.In this retrospective case-control study, we collected the medical records from 11 patients who received PELD operation (defined as PELD group) for and from 13 patients who received the internal fixation of bone graft fusion of lumbar posterior vertebral lamina decompression (defined as control group) for the treatment of the lumbar disc prolapse combined with stable retrolisthesis at Department of Spine Surgery, the Third Hospital of Hebei Medical University (Shijiazhuang, China) from May 2010 to December 2015. The operation time, the bleeding volume of perioperation, and the rehabilitation days of postoperation were compared between 2 groups. Before and after surgery at different time points, ODI, VAS index, and imaging parameters (including Taillard index, inter-vertebral height, sagittal dislocation, and forward bending angle of lumbar vertebrae) were compared.The average operation time, the blooding volume, and the rehabilitation days of postoperation were significantly less in PELD than in control group. The ODI and VAS index in PELD group showed a significantly immediate improving on the same day after the surgery. However, Taillard index, intervertebral height, sagittal dislocation in control group showed an immediate improving after surgery, but no changes in PELD group till 12-month after surgery. The forward bending angle of lumbar vertebrae was significantly increased and decreased in PELD and in control group, respectively.PELD operation was superior in terms of operation time, bleeding volume, recovery period, and financial

  17. Approaching a Scientific Consensus on the Association between Allergies and Glioma Risk: A Report from the Glioma International Case-Control Study.

    Science.gov (United States)

    Amirian, E Susan; Zhou, Renke; Wrensch, Margaret R; Olson, Sara H; Scheurer, Michael E; Il'yasova, Dora; Lachance, Daniel; Armstrong, Georgina N; McCoy, Lucie S; Lau, Ching C; Claus, Elizabeth B; Barnholtz-Sloan, Jill S; Schildkraut, Joellen; Ali-Osman, Francis; Sadetzki, Siegal; Johansen, Christoffer; Houlston, Richard S; Jenkins, Robert B; Bernstein, Jonine L; Merrell, Ryan T; Davis, Faith G; Lai, Rose; Shete, Sanjay; Amos, Christopher I; Melin, Beatrice S; Bondy, Melissa L

    2016-02-01

    Several previous studies have found inverse associations between glioma susceptibility and a history of allergies or other atopic conditions. Some evidence indicates that respiratory allergies are likely to be particularly relevant with regard to glioma risk. Using data from the Glioma International Case-Control Study (GICC), we examined the effects of respiratory allergies and other atopic conditions on glioma risk. The GICC contains detailed information on history of atopic conditions for 4,533 cases and 4,171 controls, recruited from 14 study sites across five countries. Using two-stage random-effects restricted maximum likelihood modeling to calculate meta-analysis ORs, we examined the associations between glioma and allergy status, respiratory allergy status, asthma, and eczema. Having a history of respiratory allergies was associated with an approximately 30% lower glioma risk, compared with not having respiratory allergies (mOR, 0.72; 95% confidence interval, 0.58-0.90). This association was similar when restricting to high-grade glioma cases. Asthma and eczema were also significantly protective against glioma. A substantial amount of data on the inverse association between atopic conditions and glioma has accumulated, and findings from the GICC study further strengthen the existing evidence that the relationship between atopy and glioma is unlikely to be coincidental. As the literature approaches a consensus on the impact of allergies in glioma risk, future research can begin to shift focus to what the underlying biologic mechanism behind this association may be, which could, in turn, yield new opportunities for immunotherapy or cancer prevention. ©2016 American Association for Cancer Research.

  18. Harmonization process and reliability assessment of anthropometric measurements in the elderly EXERNET multi-centre study.

    Science.gov (United States)

    Gómez-Cabello, Alba; Vicente-Rodríguez, Germán; Albers, Ulrike; Mata, Esmeralda; Rodriguez-Marroyo, Jose A; Olivares, Pedro R; Gusi, Narcis; Villa, Gerardo; Aznar, Susana; Gonzalez-Gross, Marcela; Casajús, Jose A; Ara, Ignacio

    2012-01-01

    The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain) participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. For height, intra-rater technical errors of measurement (TEMs) were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population.

  19. Harmonization Process and Reliability Assessment of Anthropometric Measurements in the Elderly EXERNET Multi-Centre Study

    Science.gov (United States)

    Gómez-Cabello, Alba; Vicente-Rodríguez, Germán; Albers, Ulrike; Mata, Esmeralda; Rodriguez-Marroyo, Jose A.; Olivares, Pedro R.; Gusi, Narcis; Villa, Gerardo; Aznar, Susana; Gonzalez-Gross, Marcela; Casajús, Jose A.; Ara, Ignacio

    2012-01-01

    Background The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. Purpose To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. Materials and Methods A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain) participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. Results For height, intra-rater technical errors of measurement (TEMs) were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. Conclusion The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population. PMID:22860013

  20. The role of dosimetry audit in lung SBRT multi-centre clinical trials.

    Science.gov (United States)

    Clark, Catharine H; Hurkmans, Coen W; Kry, Stephen F

    2017-12-01

    Stereotactic Body Radiotherapy (SBRT) in the lung is a challenging technique which requires high quality clinical trials to answer the un-resolved clinical questions. Quality assurance of these clinical trials not only ensures the safety of the treatment of the participating patients but also minimises the variation in treatment, thus allowing the lowest number of patient treatments to answer the trial question. This review addresses the role of dosimetry audits in the quality assurance process and considers what can be done to ensure the highest accuracy of dose calculation and delivery and it's assessment in multi-centre trials. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  1. Obstetric risk indicators for labour dystocia in nulliparous women: a multi-centre cohort study

    DEFF Research Database (Denmark)

    Kjaergaard, H.; Olsen, J.; Ottesen, Bent Smedegaard

    2008-01-01

    for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. METHODS: A multi-centre population based cohort study with prospectively collected data from 2810...... nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR) and 95% confidence intervals (CI) are given. RESULTS...... fetal head-to-cervix contact (1.83, 1.31-2.56). The use of epidural analgesia (5.65, 4.33-7.38) was also associated with dystocia. CONCLUSION: Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia...

  2. A multi-centre dosimetry audit on advanced radiotherapy in lung as part of the Isotoxic IMRT study

    Directory of Open Access Journals (Sweden)

    Yat Tsang

    2017-10-01

    Conclusion: This multi-centre dosimetry audit of complex IMRT/VMAT delivery provides confidence in the accuracy of modern planning and delivery systems in inhomogeneous tissues. The findings from this study can be used as a reference for future dosimetry audits.

  3. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence.

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

    Abstract Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 unselected siblings. The aim was to describe and analyse questionnaire data and IQ measures from all probands and siblings. In particular, to investigate the influence of age, gender, family status (proband vs. sibling), informant, and centres on sample homogeneity in psychopathological measures. Methods Conners\\' Questionnaires, Strengths and Difficulties Questionnaires, and Wechsler Intelligence Scores were used to describe the phenotype of the sample. Data were analysed by use of robust statistical multi-way procedures. Results Besides main effects of age, gender, informant, and centre, there were considerable interaction effects on questionnaire data. The larger differences between probands and siblings at home than at school may reflect contrast effects in the parents. Furthermore, there were marked gender by status effects on the ADHD symptom ratings with girls scoring one standard deviation higher than boys in the proband sample but lower than boys in the siblings sample. The multi-centre design is another important source of heterogeneity, particularly in the interaction with the family status. To a large extent the centres differed from each other with regard to differences between proband and sibling scores. Conclusions When ADHD probands are diagnosed by use of fixed symptom counts, the severity of the disorder in the proband sample may markedly differ between boys and girls and across age, particularly in samples with a large age range. A multi-centre design carries the risk of considerable phenotypic differences between centres and, consequently, of additional heterogeneity of the sample even if standardized diagnostic procedures are used. These

  4. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

    Full Text Available Abstract Background The International Multi-centre ADHD Genetics (IMAGE project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 unselected siblings. The aim was to describe and analyse questionnaire data and IQ measures from all probands and siblings. In particular, to investigate the influence of age, gender, family status (proband vs. sibling, informant, and centres on sample homogeneity in psychopathological measures. Methods Conners' Questionnaires, Strengths and Difficulties Questionnaires, and Wechsler Intelligence Scores were used to describe the phenotype of the sample. Data were analysed by use of robust statistical multi-way procedures. Results Besides main effects of age, gender, informant, and centre, there were considerable interaction effects on questionnaire data. The larger differences between probands and siblings at home than at school may reflect contrast effects in the parents. Furthermore, there were marked gender by status effects on the ADHD symptom ratings with girls scoring one standard deviation higher than boys in the proband sample but lower than boys in the siblings sample. The multi-centre design is another important source of heterogeneity, particularly in the interaction with the family status. To a large extent the centres differed from each other with regard to differences between proband and sibling scores. Conclusions When ADHD probands are diagnosed by use of fixed symptom counts, the severity of the disorder in the proband sample may markedly differ between boys and girls and across age, particularly in samples with a large age range. A multi-centre design carries the risk of considerable phenotypic differences between centres and, consequently, of additional heterogeneity of the sample even if standardized diagnostic procedures are

  5. Ulcer, gastric surgery and pancreatic cancer risk: an analysis from the International Pancreatic Cancer Case-Control Consortium (PanC4).

    Science.gov (United States)

    Bosetti, C; Lucenteforte, E; Bracci, P M; Negri, E; Neale, R E; Risch, H A; Olson, S H; Gallinger, S; Miller, A B; Bueno-de-Mesquita, H B; Talamini, R; Polesel, J; Ghadirian, P; Baghurst, P A; Zatonski, W; Fontham, E; Holly, E A; Gao, Y T; Yu, H; Kurtz, R C; Cotterchio, M; Maisonneuve, P; Zeegers, M P; Duell, E J; Boffetta, P; La Vecchia, C

    2013-11-01

    Peptic ulcer and its treatments have been associated to pancreatic cancer risk, although the evidence is inconsistent. We pooled 10 case-control studies within the Pancreatic Cancer Case-control Consortium (PanC4), including 4717 pancreatic cancer cases and 9374 controls, and estimated summary odds ratios (OR) using multivariable logistic regression models. The OR for pancreatic cancer was 1.10 [95% confidence interval (CI) 0.98-1.23] for history of ulcer (OR = 1.08 for gastric and 0.97 for duodenal ulcer). The association was stronger for a diagnosis within 2 years before cancer diagnosis (OR = 2.43 for peptic, 1.75 for gastric, and 1.98 for duodenal ulcer). The OR was 1.53 (95% CI 1.15-2.03) for history of gastrectomy; however, the excess risk was limited to a gastrectomy within 2 years before cancer diagnosis (OR = 6.18, 95% CI 1.82-20.96), while no significant increased risk was observed for longer time since gastrectomy. No associations were observed for pharmacological treatments for ulcer, such as antacids, H2-receptor antagonists, or proton-pump inhibitors. This uniquely large collaborative study does not support the hypothesis that peptic ulcer and its treatment materially affect pancreatic cancer risk. The increased risk for short-term history of ulcer and gastrectomy suggests that any such association is due to increased cancer surveillance.

  6. Evidence - competence - discourse: the theoretical framework of the multi-centre clinical ethics support project METAP.

    Science.gov (United States)

    Reiter-Theil, Stella; Mertz, Marcel; Schürmann, Jan; Stingelin Giles, Nicola; Meyer-Zehnder, Barbara

    2011-09-01

    In this paper we assume that 'theory' is important for Clinical Ethics Support Services (CESS). We will argue that the underlying implicit theory should be reflected. Moreover, we suggest that the theoretical components on which any clinical ethics support (CES) relies should be explicitly articulated in order to enhance the quality of CES. A theoretical framework appropriate for CES will be necessarily complex and should include ethical (both descriptive and normative), metaethical and organizational components. The various forms of CES that exist in North-America and in Europe show their underlying theory more or less explicitly, with most of them referring to some kind of theoretical components including 'how-to' questions (methodology), organizational issues (implementation), problem analysis (phenomenology or typology of problems), and related ethical issues such as end-of-life decisions (major ethical topics). In order to illustrate and explain the theoretical framework that we are suggesting for our own CES project METAP, we will outline this project which has been established in a multi-centre context in several healthcare institutions. We conceptualize three 'pillars' as the major components of our theoretical framework: (1) evidence, (2) competence, and (3) discourse. As a whole, the framework is aimed at developing a foundation of our CES project METAP. We conclude that this specific integration of theoretical components is a promising model for the fruitful further development of CES. © 2011 Blackwell Publishing Ltd.

  7. Current management of intracerebral haemorrhage in China: a national, multi-centre, hospital register study

    Directory of Open Access Journals (Sweden)

    Heeley Emma L

    2011-01-01

    Full Text Available Abstract Background We aimed to examine current practice of the management and secondary prevention of intracerebral haemorrhage (ICH in China where the disease is more common than in Western populations. Methods Data on baseline characteristics, management in-hospital and post-stroke, and outcome of ICH patients are from the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment study, a multi-centre, prospective, 62 hospital registry in China during 2006-07. Results Nearly all ICH patients (n = 1572 received an intravenous haemodiluting agent such as mannitol (96% or a neuroprotectant (72%, and there was high use of intravenous traditional Chinese medicine (TCM (42%. Neurosurgery was undertaken in 137 (9% patients; being overweight, having a low Glasgow Coma Scale (GCS score on admission, and Total Anterior Circulation Syndrome (TACS clinical pattern on admission, were the only baseline factors associated with this intervention in multivariate analyses. Neurosurgery was associated with nearly three times higher risk of death/disability at 3 months post-stroke (odd ratio [OR] 2.60, p Conclusions The management of ICH in China is characterised by high rates of use of intravenous haemodiluting agents, neuroprotectants, and TCM, and of antihypertensives for secondary prevention. The controversial efficacy of these therapies, coupled with the current lack of treatments of proven benefit, is a call for action for more outcomes based research in ICH.

  8. The tryptophan hydroxylase 1 (TPH1) gene, schizophrenia susceptibility, and suicidal behavior: a multi-centre case-control study and meta-analysis

    DEFF Research Database (Denmark)

    Saetre, Peter; Lundmark, Per; Wang, August

    2010-01-01

    associated with schizophrenia. The minor allele (A) of this polymorphism (A218C) is also more frequent in patients who have attempted suicide and individuals who died by suicide, than in healthy control individuals. In an attempt to replicate previous findings, five single nucleotide polymorphisms (SNPs...... affected individuals having attempted suicide at least once and patients with no history of suicide attempts (P = 0.84). A systematic literature review and meta-analysis support the A218C polymorphism as a susceptibility locus for schizophrenia (odds ratio 1.17, 95% confidence interval 1....../A779 locus increases the susceptibility of schizophrenia in Caucasian and Asian populations. In addition, the data at hand suggest that the locus contributes to the liability of psychiatric disorders characterized by elevated suicidal rates, rather than affecting suicidal behavior of individuals...

  9. The tryptophan hydroxylase 1 (TPH1) gene, schizophrenia susceptibility, and suicidal behavior: a multi-centre case-control study and meta-analysis

    DEFF Research Database (Denmark)

    Saetre, Peter; Lundmark, Per; Wang, August

    2010-01-01

    affected individuals having attempted suicide at least once and patients with no history of suicide attempts (P = 0.84). A systematic literature review and meta-analysis support the A218C polymorphism as a susceptibility locus for schizophrenia (odds ratio 1.17, 95% confidence interval 1....../A779 locus increases the susceptibility of schizophrenia in Caucasian and Asian populations. In addition, the data at hand suggest that the locus contributes to the liability of psychiatric disorders characterized by elevated suicidal rates, rather than affecting suicidal behavior of individuals...

  10. Multi-centre audit of VMAT planning and pre-treatment verification.

    Science.gov (United States)

    Jurado-Bruggeman, Diego; Hernández, Victor; Sáez, Jordi; Navarro, David; Pino, Francisco; Martínez, Tatiana; Alayrach, Maria-Elena; Ailleres, Norbert; Melero, Alejandro; Jornet, Núria

    2017-08-01

    We performed a multi-centre intercomparison of VMAT dose planning and pre-treatment verification. The aims were to analyse the dose plans in terms of dosimetric quality and deliverability, and to validate whether in-house pre-treatment verification results agreed with those of an external audit. The nine participating centres encompassed different machines, equipment, and methodologies. Two mock cases (prostate and head and neck) were planned using one and two arcs. A plan quality index was defined to compare the plans and different complexity indices were calculated to check their deliverability. We compared gamma index pass rates using the centre's equipment and methodology to those of an external audit (global 3D gamma, absolute dose differences, 10% of maximum dose threshold). Log-file analysis was performed to look for delivery errors. All centres fulfilled the dosimetric goals but plan quality and delivery complexity were heterogeneous and uncorrelated, depending on the manufacturer and the planner's methodology. Pre-treatment verifications results were within tolerance in all cases for gamma 3%-3mm evaluation. Nevertheless, differences between the external audit and in-house measurements arose due to different equipment or methodology, especially for 2%-2mm criteria with differences up to 20%. No correlation was found between complexity indices and verification results amongst centres. All plans fulfilled dosimetric constraints, but plan quality and complexity did not correlate and were strongly dependent on the planner and the vendor. In-house measurements cannot completely replace external audits for credentialing. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Development of a Multi-Centre Clinical Trial Data Archiving and Analysis Platform for Functional Imaging

    Science.gov (United States)

    Driscoll, Brandon; Jaffray, David; Coolens, Catherine

    2014-03-01

    Purpose: To provide clinicians & researchers participating in multi-centre clinical trials with a central repository for large volume dynamic imaging data as well as a set of tools for providing end-to-end testing and image analysis standards of practice. Methods: There are three main pieces to the data archiving and analysis system; the PACS server, the data analysis computer(s) and the high-speed networks that connect them. Each clinical trial is anonymized using a customizable anonymizer and is stored on a PACS only accessible by AE title access control. The remote analysis station consists of a single virtual machine per trial running on a powerful PC supporting multiple simultaneous instances. Imaging data management and analysis is performed within ClearCanvas Workstation® using custom designed plug-ins for kinetic modelling (The DCE-Tool®), quality assurance (The DCE-QA Tool) and RECIST. Results: A framework has been set up currently serving seven clinical trials spanning five hospitals with three more trials to be added over the next six months. After initial rapid image transfer (+ 2 MB/s), all data analysis is done server side making it robust and rapid. This has provided the ability to perform computationally expensive operations such as voxel-wise kinetic modelling on very large data archives (+20 GB/50k images/patient) remotely with minimal end-user hardware. Conclusions: This system is currently in its proof of concept stage but has been used successfully to send and analyze data from remote hospitals. Next steps will involve scaling up the system with a more powerful PACS and multiple high powered analysis machines as well as adding real-time review capabilities.

  12. Development of a Multi-Centre Clinical Trial Data Archiving and Analysis Platform for Functional Imaging

    International Nuclear Information System (INIS)

    Driscoll, Brandon; Jaffray, David; Coolens, Catherine

    2014-01-01

    Purpose: To provide clinicians and researchers participating in multi-centre clinical trials with a central repository for large volume dynamic imaging data as well as a set of tools for providing end-to-end testing and image analysis standards of practice. Methods: There are three main pieces to the data archiving and analysis system; the PACS server, the data analysis computer(s) and the high-speed networks that connect them. Each clinical trial is anonymized using a customizable anonymizer and is stored on a PACS only accessible by AE title access control. The remote analysis station consists of a single virtual machine per trial running on a powerful PC supporting multiple simultaneous instances. Imaging data management and analysis is performed within ClearCanvas Workstation® using custom designed plug-ins for kinetic modelling (The DCE-Tool®), quality assurance (The DCE-QA Tool) and RECIST. Results: A framework has been set up currently serving seven clinical trials spanning five hospitals with three more trials to be added over the next six months. After initial rapid image transfer (+ 2 MB/s), all data analysis is done server side making it robust and rapid. This has provided the ability to perform computationally expensive operations such as voxel-wise kinetic modelling on very large data archives (+20 GB/50k images/patient) remotely with minimal end-user hardware. Conclusions: This system is currently in its proof of concept stage but has been used successfully to send and analyze data from remote hospitals. Next steps will involve scaling up the system with a more powerful PACS and multiple high powered analysis machines as well as adding real-time review capabilities.

  13. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

    Science.gov (United States)

    2014-01-01

    Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

  14. Quantification of FDG PET studies using standardised uptake values in multi-centre trials: effects of image reconstruction, resolution and ROI definition parameters

    NARCIS (Netherlands)

    Westerterp, Marinke; Pruim, Jan; Oyen, Wim; Hoekstra, Otto; Paans, Anne; Visser, Eric; van Lanschot, Jan; Sloof, Gerrit; Boellaard, Ronald

    2007-01-01

    PURPOSE: Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multi-centre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of

  15. Quantification of FDG PET studies using standardised uptake values in multi-centre trials: effects of image reconstruction, resolution and ROI definition parameters.

    NARCIS (Netherlands)

    Westerterp, M.; Pruim, J.; Oyen, W.J.G.; Hoekstra, O.; Paans, A.; Visser, E.P.; Lanschot, J.J. van; Sloof, G.; Boellaard, R.

    2007-01-01

    PURPOSE: Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multi-centre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of

  16. Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women.

    Science.gov (United States)

    Spitzer, W. O.; Lewis, M. A.; Heinemann, L. A.; Thorogood, M.; MacRae, K. D.

    1996-01-01

    OBJECTIVE--To test whether use of combined oral contraceptives containing third generation progestogens is associated with altered risk of venous thromboembolism. DESIGN--Matched case-control study. SETTING--10 centres in Germany and United Kingdom. SUBJECTS--Cases were 471 women aged 16-44 who had a venous thromboembolism. Controls were 1772 women (at least 3 controls per case) unaffected by venous thromboembolism who were matched with corresponding case for age and for hospital or community setting. MAIN OUTCOME MEASURES--Odds ratios derived with stratified analyses and unconditional logistic regression to adjust for potential confounding variables. RESULTS--Odds ratios (95% confidence intervals) for venous thromboembolism were: for any oral contraceptives versus no use, 4.0 (3.1 to 5.3); for second generation products (low dose ethinyl-oestradiol, no gestodene or desogestrel) versus no use, 3.2 (2.3 to 4.3); for third generation products (low dose ethinyloestradiol, gestodene or desogestrel) versus no use, 4.8 (3.4 to 6.7); for third generation products versus second generation products, 1.5 (1.1 to 2.1); for products containing gestodene versus second generation products, 1.5 (1.0 to 2.2); and for products containing desogestrel versus second generation products, 1.5 (1.1 to 2.2). Probability of death due to venous thromboembolism for women using third generation products is about 20 per million users per year, for women using second generation products it is about 14 per million users per year, and for non-users it is five per million per year. CONCLUSIONS--Risk of venous thromboembolism was slightly increased in users of third generation oral contraceptives compared with users of second generation products. PMID:8555935

  17. [Case-control study on effects of external fixation combined with limited internal fixation for the treatment of Pilon fractures of Rüedi-Allgower type III].

    Science.gov (United States)

    Duan, Da-Peng; You, Wu-Lin; Ji, Le; Zhang, Yong-Tao; Dang, Xiao-Qian; Wang, Kun-Zheng

    2014-01-01

    To analyze the effects of three surgical operations in the treatment of Pilon fracture of Rüedi-Allgower type III, and put forward the best therapeutic method. The clinical data of 33 patients with Pilon fracture who received surgical operations (plaster immobilization group, 10 cases; distal tibia anatomical plate group, 11 cases; external fixation with limited internal fixation group, 12 cases) from October 2009 to January 2012 were analyzed. There were 5 males and 5 females, ranging in age from 24 to 61 years in the plaster immobilization group. There were 7 males and 4 females, ranging in age from 21 to 64 years in the distal tibia anatomical plate group. There were 7 males and 5 females, ranging in age from 23 to 67 years in the external fixation with limited internal fixation group. The Ankle X-ray of Pilon fracture after operation, ankle score, early and late complications were collected. Bourne system was used to evaluate ankle joint function. After 8 months to 3 years follow-up, it was found that three kinds of treatment had significant differences in the outcomes and complications (P external fixation with limited internal fixation group got the best results. The number of anatomic reduction cases in the external fixation with limited internal fixation group (7 cases) and the distal tibia anatomical plate group (8 cases) was more than the plaster immobilization group (2 cases). According to the ankle score, 8 patients got an excellent result, 3 good and 1 poor in the limited internal fixation group ,which was better than those of distal tibia anatomical plate group (5 excellent, 4 good and 2 poor) and the plaster immobilization group (3 excellent, 4 good and 3 poor). The number of early and late complications in the external fixation with limited internal fixation group was more than those in the plaster immobilization group and the distal tibia anatomical plate group (Pexternal fixation with limited internal fixation in the treatment of Pilon fracture

  18. Acute myocardial infarction and combined oral contraceptives: results of an international multicentre case-control study. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception.

    Science.gov (United States)

    1997-04-26

    The association between oral contraceptive (OC) use and acute myocardial infarction (AMI) was established in studies from northern Europe and the USA, which took place during the 1960s and 1970s. Few data are available to quantify the risk worldwide of AMI associated with use of OCs introduced since those early studies. This hospital-based case-control study examined the association between a first AMI and current OC use in women from Africa, Asia, Europe, and Latin America (21 centres). Cases were women aged 20-44 years who had definite or possible AMI (classified by history, electrocardiographic, and cardiac-enzyme criteria), who were admitted to hospital, and who survived for at least 24 h. Up to three hospital controls matched by 5-year age-band were recruited for each of the 368 cases (941 controls). All participants were interviewed while in hospital with the same questionnaire, which included information on medical and personal history, lifetime contraceptive use, and blood-pressure screening before the most recent episode of OC use. Odds ratios compared the risk of AMI in current OC users and in non-users (past users and never-users combined). The overall odds ratio for AMI was 5.01 (95% CI 2.54-9.90) in Europe and 4.78 (2.52-9.07) in the non-European (developing) countries; however, these risk estimates reflect the frequent coexistence of other risk factors among OC users who have AMI. Very few AMIs were identified among women who had no cardiovascular risk factors and who reported that their blood pressure had been checked before OC use; odds ratios associated with OC use in such women were not increased in either Europe or the developing countries. Among OC users who smoked ten or more cigarettes per day, the odds ratios in Europe and in the developing countries were over 20. Similarly, among OC users with a history of hypertension (during pregnancy or at any other time), odds ratios were at least ten in both groups of countries. No consistent

  19. [Case-control study on T-shaped locking internal fixation and external fixation for the treatment of dorsal Barton's fracture].

    Science.gov (United States)

    Chen, Huan-qing; Wen, Xi-le; Li, Yang-ming; Wen, Cong-you

    2015-06-01

    To compare clinical effect of T-shaped locking internal fixation and external fixation in treating dorsal Barton's fracture,and investigate selective strategy of internal fixation. From January 2008 to January 2013, 100 patients with dorsal Barton's fracture were randomly divided into two groups. In treatment group, there were 30 males and 20 females with an average age of (33.8±3.6) years old;30 cases were type B, 20 cases were type C;and treated with T-shaped locking internal fixation. In control group, there were 32 male and 18 females with an average age of (32.9±3.4) years old; 29 cases were type B, 21 cases were type C; and treated with external fixation. Volar tilt, ulnar deviation and radial height at 3 months after operation were detected and compared between two groups. Mechara functional evaluation were used to evaluate postoperative clinical effects. Clinical cure time, postoperative complications,joint mobility and function score were recorded and compared between two groups. In treatment group,volar tilt was (11.9±2.7)°, ulnar deviation was (20.8+ 2.9)°,and radial height was (10.9±1.8) mm; while volar tilt was (9.1±1.6)°, ulnar deviation was (17.1±2.9)°, and radial height was (8.1±1.5) mm in control group. Treatment group was better than control group in volar tilt, ulnar deviation and radial height. Clinical cure time in treatment group was(12.0±2.3) weeks, shorter than control group (18.0±4.1) weeks. The incidence of complications in treatment group was lower than control group. According to Mehara functional evaluation,20 cases got excellent results, 25 good, 3 moderate and 2 poor in treatment group; 16 cases got excellent results, 14 good, 10 moderate and 10 poor in control group. Treatment group was better than control group in clinical effects. T-shaped locking internal fixation with postoperative functional exercise for the treatment of dorsal Barton's fracture fits for biomechanics demands,and has advantages of stable fixation

  20. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns.

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

    Abstract Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit\\/hyperactivity disorder (ADHD-CT) and 1446 \\'unselected\\' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres) and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities). A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS) interview and the DSM-IV items of the Conners\\' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands) were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband\\/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive

  1. Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings.

    Science.gov (United States)

    Dickson, Sylvia; Logan, Janet; Hagen, Suzanne; Stark, Diane; Glazener, Cathryn; McDonald, Alison M; McPherson, Gladys

    2013-11-15

    Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient's preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and

  2. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

    Full Text Available Abstract Background The International Multi-centre ADHD Genetics (IMAGE project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit/hyperactivity disorder (ADHD-CT and 1446 'unselected' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities. A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS interview and the DSM-IV items of the Conners' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive

  3. Fast neutrons in the treatment of head and neck cancers: the results of a multi-centre randomly controlled trial

    International Nuclear Information System (INIS)

    Duncan, W.; Arnott, S.J.; Orr, J.A.; Kerr, G.R.; Schmitt, G.

    1984-01-01

    The results are presented of a multi-centre randomly controlled trial of fast neutron irradiation and mega-voltage X-rays in the treatment of patients with locally advanced squamous cell carcinoma of the head and neck region. No significant difference was observed in local tumour control rates. Salvage surgery was performed in a similar number of patients in the two groups. Late morbidity was also similar in the two treatment groups. Patients in a subgroup with cancer of the larynx treated by photons had a significantly better survival than those in the neutron treated group. (Auth.)

  4. ZOOM or Non-ZOOM? Assessing Spinal Cord Diffusion Tensor Imaging Protocols for Multi-Centre Studies.

    Directory of Open Access Journals (Sweden)

    Rebecca S Samson

    Full Text Available The purpose of this study was to develop and evaluate two spinal cord (SC diffusion tensor imaging (DTI protocols, implemented at multiple sites (using scanners from two different manufacturers, one available on any clinical scanner, and one using more advanced options currently available in the research setting, and to use an automated processing method for unbiased quantification. DTI parameters are sensitive to changes in the diseased SC. However, imaging the cord can be technically challenging due to various factors including its small size, patient-related and physiological motion, and field inhomogeneities. Rapid acquisition sequences such as Echo Planar Imaging (EPI are desirable but may suffer from image distortions. We present a multi-centre comparison of two acquisition protocols implemented on scanners from two different vendors (Siemens and Philips, one using a reduced field-of-view (rFOV EPI sequence, and one only using options available on standard clinical scanners such as outer volume suppression (OVS. Automatic analysis was performed with the Spinal Cord Toolbox for unbiased and reproducible quantification of DTI metrics in the white matter. Images acquired using the rFOV sequence appear less distorted than those acquired using OVS alone. SC DTI parameter values obtained using both sequences at all sites were consistent with previous measurements made at 3T. For the same scanner manufacturer, DTI parameter inter-site SDs were smaller for the rFOV sequence compared to the OVS sequence. The higher inter-site reproducibility (for the same manufacturer and acquisition details, i.e. ZOOM data acquired at the two Philips sites of rFOV compared to the OVS sequence supports the idea that making research options such as rFOV more widely available would improve accuracy of measurements obtained in multi-centre clinical trials. Future multi-centre studies should also aim to match the rFOV technique and signal-to-noise ratios in all

  5. Preservation of the smooth muscular internal (vesical) sphincter and of the proximal urethra for the early recovery of urinary continence after retropubic radical prostatectomy: a prospective case-control study.

    Science.gov (United States)

    Brunocilla, Eugenio; Schiavina, Riccardo; Pultrone, Cristian Vincenzo; Borghesi, Marco; Rossi, Martina; Cevenini, Matteo; Martorana, Giuseppe

    2014-02-01

    To evaluate the influence of preservation of the muscular internal sphincter and proximal urethra on continence recovery after radical prostatectomy. This was a prospective single-center, case-control study. A total of 40 consecutive patients with organ-confined prostate cancer were submitted to radical prostatectomy with the preservation of the muscular internal sphincter and the proximal urethra (group 1), and their outcomes were compared with those of 40 patients submitted to a standard procedure (group 2). Continence rates were assessed using a self-administrated questionnaire at 3, 7 and 30 days, and 3 and 12 months after removal of the catheter. Group 1 had a faster recovery of early continence than group 2 at day 3 (45% vs 22%; P = 0.029) and at day 7 (75% vs 50%; P = 0.018). Considering the number of pads, group 1 had a faster recovery of continence at 3, 7 and 30 days, and also had less incidence of severe incontinence. There was no statistically significant difference in terms of continence at 3 and 12 months among the two groups. Multivariate logistic regression analysis showed that surgical technique and young age were significantly associated with earlier time to continence at 3 and 7 days. The two groups had no significant differences in terms of surgical margins. Our modified technique of radical retropubic prostatectomy with preservation of the smooth muscular internal sphincter, as well as of the proximal urethra during bladder neck dissection, results in a significantly increased urinary continence at 3, 7 and 30 days after catheter removal, with a minor incidence of severe incontinence. The technique is also oncologically safe, and it does not increase the operative duration of the procedure. © 2013 The Japanese Urological Association.

  6. Adherence to MRI protocol consensus guidelines in multiple sclerosis: an Australian multi-centre study

    International Nuclear Information System (INIS)

    Curley, Michael; Josey, Lawrence; Lucas, Robyn; Dear, Keith; Taylor, Bruce V.; Coulthard, Alan; Ausimmune Investigator Group

    2012-01-01

    Multiple sclerosis (MS) is a debilitating disease that causes significant morbidity within a young demographic. Diagnostic guidelines for MS have evolved, and imaging has played an increasingly important role in diagnosis over the last two decades. For imaging to contribute to diagnosis in a meaningful way, it must be reproducible. Consensus guidelines for MRI in MS exist to define correct sequence type and imaging technique, but it is not clear to what extent they are followed. This study reviewed MRI studies performed on Australian individuals presenting with a first clinical diagnosis of central nervous system demyelination (FCD) for adherence to published guidelines and discussed practical implementation of MS guidelines in light of recent updates. The Ausimmune study was a prospective case control study of Australian participants presenting with FCD from 2003 to 2006. Baseline cranial and spinal cord MRI studies of 226 case participants from four separate Australian regions were reviewed. MRI sequences were classified according to anatomical location, slice plane, tissue weighting and use of gadolinium-containing contrast media. Results were compared with the 2003 Consortium of Multiple Sclerosis Centres MRI protocol for the diagnosis of MS. The composition of core cranial MRI sequences performed varied across the 226 scans. Of the studies, 91% included sagittal fluid attenuated inversion recovery (FLAIR) sequences. Cranial axial T2-weighted, axial FLAIR and axial proton density-weighted sequences were performed in 88%, 60% and 16% (respectively) of scans. Only 25% of the studies included a T1-weighted contrast-enhanced sequence. Concordance with the guidelines in all sequences was very low (2). Only a small number of MRI investigations performed included all of the sequences stipulated by consensus guidelines. This is likely due to poor awareness in the imaging community of the guidelines and the rationale behind certain sequences. Radiologists with a sub

  7. Clinical efficacy and safety of IV ferric carboxymaltose (FCM) treatment of RLS: a multi-centred, placebo-controlled preliminary clinical trial.

    Science.gov (United States)

    Allen, Richard P; Adler, Charles H; Du, Wei; Butcher, Angelia; Bregman, David B; Earley, Christopher J

    2011-10-01

    Intravenous (IV) iron has been used as a treatment to reduce Restless Legs Syndrome (RLS) symptoms, but two double-blinded trials of a frequently prescribed IV iron formulation, iron sucrose, failed to show lasting efficacy. This study evaluates efficacy and safety of a new IV iron formulation (ferric carboxymaltose, FCM) with molecular properties that may make iron more available for uptake to the brain than iron sucrose does. In this 28-day, multi-centre, randomised, placebo-controlled trial 46 RLS patients were discontinued from all RLS treatment. Twenty-four received 500 mg FCM in two doses 5 days apart and 22 received a matching placebo. At day 28, those on placebo were given a single 1000 mg IV FCM and those not responding to initial treatment were given a third dose of 500 mg FCM. Patients were followed up for 24 weeks or until needing added RLS treatment. FCM significantly improved primary and secondary outcomes compared to placebo: International Restless Legs Syndrome study group severity scale (IRLS) average (SD) decrease of 8.9 (8.52) versus 4.0 (6.11), p=0.040; Clinical Global Inventory of Change (CGI-1) very much or much improved 48.3% versus 14.3%, p=0.004. Quality of life was also significantly improved. Of the 24 with initial iron treatment 45% responded and 29% remitted (IRLS ≤ 10) at day 28, and 25% continued free of other RLS medications at 24 weeks after treatment. The single 1000 mg dose on day 28 produced the same degree of treatment response as the divided dose, but the added 500 mg dose for those not responding to the initial treatment showed little benefit. There were no significant adverse events. IV FCM provided a safe and effective treatment for RLS that lasted for at least 24 weeks for some patients. Larger studies are needed to confirm these results. Copyright © 2011 Elsevier B.V. All rights reserved.

  8. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Benítez Mència

    2008-05-01

    Full Text Available Abstract Background Influenza vaccines are recommended for administration by the intramuscular route. However, many physicians use the subcutaneous route for patients receiving an oral anticoagulant because this route is thought to induce fewer hemorrhagic side effects. Our aim is to assess the safety of intramuscular administration of influenza vaccine in patients on oral anticoagulation therapy. Methods Design: Randomised, controlled, single blinded, multi-centre clinical trial. Setting: 4 primary care practices in Barcelona, Spain. Participants: 229 patients on oral anticoagulation therapy eligible for influenza vaccine during the 2003–2004 season. Interventions: intramuscular administration of influenza vaccine in the experimental group (129 patients compared to subcutaneous administration in the control group (100 patients. Primary outcome: change in the circumference of the arm at the site of injection at 24 hours. Secondary outcomes: appearance of local reactions and pain at 24 hours and at 10 days; change in INR (International Normalized Ratio at 24 hours and at 10 days. Analysis was by intention to treat using the 95% confidence intervals of the proportions or mean differences. Results Baseline variables in the two groups were similar. No major side effects or major haemorrhage during the follow-up period were reported. No significant differences were observed in the primary outcome between the two groups. The appearance of local adverse reactions was more frequent in the subcutaneous administration group (37,4% vs. 17,4%, 95% confidence interval of the difference 8,2% to 31,8%. Conclusion This study shows that the intramuscular administration route of influenza vaccine in patients on anticoagulant therapy does not have more side effects than the subcutaneous administration route. Registration number NCT00137579 at clinicaltrials.gov

  9. Governance approval for multisite, non-interventional research: what can Harmonisation of Multi-Centre Ethical Review learn from the New South Wales experience?

    Science.gov (United States)

    Vajdic, C M; Meagher, N S; Hicks, S C; Faedo, M; Ward, R L; Pearson, S-A

    2012-02-01

    In 2007, New South Wales Health mandated the separation of ethical and scientific review from research governance at all New South Wales public health sites based on their distinction in the National Health and Medical Research Council National Statement. This separation allowed for single-site ethical review of multicentre studies. To investigate the time taken for governance approval of multicentre studies through the site-specific approval (SSA) process. A retrospective audit of the SSA process for five non-interventional studies proposed by a university cancer research unit. The median total governance approval time for all submissions (n= 28) was 12 weeks (range 2.5-64); median time from starting the SSA to submission was 8 weeks (range 1-48) and median time for governance approval was 5 weeks (range 0.3-40). Approval times were shorter for public compared to private institutions. Reasons for delays in finalising submissions for approval were the absence of institutional governance officers, lack of clarity regarding signatories, the need to identify a principal investigator employed by the institution, and lack of recognition of ethical approval by private institutions. The need to develop legal agreements between the university and hospital was the main reason for lengthy delays in obtaining approval. The advantages of a harmonised single ethical review process were undermined by the coexistence of a fragmented, complex and lengthy governance approval process. This experience has implications for the success of the national Harmonisation of Multi-Centre Ethical Review (HoMER) model. A harmonised and fully supported national approach to research governance should be developed contemporaneously with HoMER. © 2011 The Authors. Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

  10. Relating functional changes during hand movement to clinical parameters in patients with multiple sclerosis in a multi-centre fMRI study

    NARCIS (Netherlands)

    Wegner, C.; Filippi, M.; Korteweg, T.; Beckmann, C.; Ciccarelli, O.; De Stefano, N.; Enzinger, C.; Fazekas, F.; Agosta, F.; Gass, A.; Hirsch, J.; Johansen-Berg, H.; Kappos, L.; Barkhof, F.; Polman, C.H.; Mancini, L.; Manfredonia, F.; Marino, S.; Miller, D. H.; Montalban, X.; Palace, J.; Rocca, M.; Ropele, S.; Rovira, A.; Smith, S.; Thompson, A.; Thornton, J.; Yousry, T.; Matthews, P.M.

    2008-01-01

    We performed a prospective multi-centre study using functional magnetic resonance imaging (fMRI) to better characterize the relationships between clinical expression and brain function in patients with multiple sclerosis (MS) at eight European sites (56 MS patients and 60 age-matched, healthy

  11. KidsBrainIT: A New Multi-centre, Multi-disciplinary, Multi-national Paediatric Brain Monitoring Collaboration.

    Science.gov (United States)

    Lo, T; Piper, I; Depreitere, B; Meyfroidt, G; Poca, M; Sahuquillo, J; Durduran, T; Enblad, P; Nilsson, P; Ragauskas, A; Kiening, K; Morris, K; Agbeko, R; Levin, R; Weitz, J; Park, C; Davis, P

    2018-01-01

    Validated optimal cerebral perfusion pressure (CPP) treatment thresholds in children do not exist. To improve the intensive care unit (ICU) management of the paediatric traumatic brain injury (TBI) population, we are forming a new paediatric multi-centre collaboration to recruit standardised ICU data for running and reporting upon models for assessing autoregulation and optimal CCP (CPPopt). We are adapting the adult BrainIT group's approach to develop a new Paediatric Brain Monitoring and Information Technology Group (KidsBrainIT), which will include a repository to store prospectively collected high-resolution physiological, clinical, and outcome data. In the first phase of this project there are 7 UK Paediatric Intensive Care Units, 1 Spanish, 1 Belgium, and 1 Romanian Centre interested in participating. In subsequent phases, we plan to open recruitment to other centres both within Europe, US and abroad. We are collaborating with the Leuven Group and plan to use their LAx (low-frequency autoregulation index), DATACAR (dynamic adaptive target of active cerebral autoregulation), CPPopt and visualisation methodologies. We also plan to use the continuous diffuse optical monitoring and tomography technology developed in Barcelona as an acute surrogate end-point for optimising brain perfusion. This technology allows non-invasive continuous monitoring of deep tissue perfusion and oxygenation in adults but its clinical application in infants and children with TBI has not been studied previously. We report on the current status of setting up this new collaboration and also on pilot analyses in two centres which are the basis of our rationale for the need for a prospective validation study of CPPopt in children. Specifically, we demonstrated that CPPopt varied with time for each patient during their paediatric intensive care unit (PICU) stay, and the median overall CPPopt levels for children aged 2-6 years, 7-11 years and 12-16 years were 68.83, 68.09, and 72.17 mm

  12. An international multi-centre prospective study on the efficacy of an intraarticular polyacrylamide hydrogel in horses with osteoarthritis

    DEFF Research Database (Denmark)

    Tnibar, Aziz; Schougaard, Hans; Camitz, Linus

    2015-01-01

    Background: Polyacrylamide hydrogel (PAAG) was evaluated recently to treat osteoarthritis (OA) in horses with highly encouraging results; however no long term field-study was done to explore its clinical efficacy and lasting effect. The objective of this study was to evaluate the efficacy of PAAG...

  13. Recruiting ENT and Audiology patients into pharmaceutical trials: evaluating the multi-centre experience in the UK and USA.

    Science.gov (United States)

    Sanchez, Victoria A; Hall, Deborah A; Millar, Bonnie; Escabi, Celia D; Sharman, Alice; Watson, Jeannette; Thasma, Sornaraja; Harris, Peter

    2018-01-21

    Recruiting into clinical trials on time and on target is a major challenge and yet often goes unreported. This study evaluated the adjustment to procedures, recruitment and screening methods in two multi-centre pharmaceutical randomised controlled trials (RCTs) for hearing-related problems in adults. Recruitment monitoring and subsequent adjustment of various study procedures (e.g. eligibility criteria, increasing recruiting sites and recruitment methods) are reported. Participants were recruited through eight overarching methods: trial registration, posters/flyers, print publications, Internet, social media, radio, databases and referrals. The efficiency of the recruitment was measured by determining the number of people: (1) eligible for screening as a percentage of those who underwent telephone pre-screening and (2) randomised as a percentage of those screened. A total of 584 participants completed the pre-screening steps, 491 screened and 169 participants were randomised. Both RCTs completed adjustments to the participant eligibility, added new study sites and additional recruitment methods. No single recruitment method was efficient enough to serve as the only route to enrolment. A diverse portfolio of methods, continuous monitoring, mitigation strategy and adequate resourcing were essential for achieving our recruitment goals.

  14. Psychological and psychosocial functioning of children with burn scarring using cosmetic camouflage: a multi-centre prospective randomised controlled trial.

    Science.gov (United States)

    Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

    2014-02-01

    Burns leave patients with long-term physical scarring. Children with scarring are required to face challenges of reintegration into their community, including acceptance of an altered appearance and acceptance by others. This can be difficult given society's preoccupation with physical appearance. Limited research exists investigating validity of cosmetic camouflage as a psychosocial intervention for children with scarring. This study investigated whether using cosmetic camouflage (Microskin™) had a positive impact on health-related quality of life, self-concept and psychopathology for children and adolescents (8-17 years) with burn scarring. A prospective multi-centre randomised controlled trial was conducted across Australian and New Zealand paediatric hospitals. 63 participants (49 females, mean age 12.7 ± 2.1 years) were enrolled. Data points were baseline (Time 1) and at 8 weeks (Time 2) using reliable and valid psychometric measures. Findings indicate there were significant improvements in socialisation, school and appearance scales on the Paediatric Quality of Life Inventory and psychopathology scores particularly peer problems decreased. However self-concept remained stable from baseline throughout intervention use. Cosmetic camouflage appears to have a positive impact on quality of life particularly socialisation. Cosmetic camouflage is a valid tool to assist children with scarring to actively participate socially within their communities. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  15. Does Cataract Surgery Alleviate Poverty? Evidence from a Multi-Centre Intervention Study Conducted in Kenya, the Philippines and Bangladesh

    Science.gov (United States)

    Kuper, Hannah; Polack, Sarah; Mathenge, Wanjiku; Eusebio, Cristina; Wadud, Zakia; Rashid, Mamunur; Foster, Allen

    2010-01-01

    Background Poverty and blindness are believed to be intimately linked, but empirical data supporting this purported relationship are sparse. The objective of this study is to assess whether there is a reduction in poverty after cataract surgery among visually impaired cases. Methodology/Principal Findings A multi-centre intervention study was conducted in three countries (Kenya, Philippines, Bangladesh). Poverty data (household per capita expenditure – PCE, asset ownership and self-rated wealth) were collected from cases aged ≥50 years who were visually impaired due to cataract (visual acuityassets and self-rated wealth. By follow-up PCE had increased significantly among operated cases in each of the three settings to the level of controls (Kenya: $30 versus £36 p = 0.49, Bangladesh: $23 vs $23 p = 0.20, Philippines: $45 vs $36 p = 0.68). There were smaller increases in self-rated wealth and no changes in assets. Changes in PCE were apparent in different socio-demographic and ocular groups. The largest PCE increases were apparent among the cases that were poorest at baseline. Conclusions/Significance This study showed that cataract surgery can contribute to poverty alleviation, particularly among the most vulnerable members of society. This study highlights the need for increased provision of cataract surgery to poor people and shows that a focus on blindness may help to alleviate poverty and achieve the Millennium Development Goals. PMID:21085697

  16. Balance exercise for persons with multiple sclerosis using Wii games: a randomised, controlled multi-centre study.

    Science.gov (United States)

    Nilsagård, Ylva E; Forsberg, Anette S; von Koch, Lena

    2013-02-01

    The use of interactive video games is expanding within rehabilitation. The evidence base is, however, limited. Our aim was to evaluate the effects of a Nintendo Wii Fit® balance exercise programme on balance function and walking ability in people with multiple sclerosis (MS). A multi-centre, randomised, controlled single-blinded trial with random allocation to exercise or no exercise. The exercise group participated in a programme of 12 supervised 30-min sessions of balance exercises using Wii games, twice a week for 6-7 weeks. Primary outcome was the Timed Up and Go test (TUG). In total, 84 participants were enrolled; four were lost to follow-up. After the intervention, there were no statistically significant differences between groups but effect sizes for the TUG, TUGcognitive and, the Dynamic Gait Index (DGI) were moderate and small for all other measures. Statistically significant improvements within the exercise group were present for all measures (large to moderate effect sizes) except in walking speed and balance confidence. The non-exercise group showed statistically significant improvements for the Four Square Step Test and the DGI. In comparison with no intervention, a programme of supervised balance exercise using Nintendo Wii Fit® did not render statistically significant differences, but presented moderate effect sizes for several measures of balance performance.

  17. Creating probabilistic maps of the face network in the adolescent brain: A multi-centre functional MRI study

    International Nuclear Information System (INIS)

    Tahmasebi, Amir M.; Mareckova, Klara; Artiges, Eric; Martinot, Jean-Luc; Banaschewski, Tobias; Barker, Gareth J.; Loth, Eva; Schumann, Gunter; Bruehl, Ruediger; Ittermann, Bernd; Buchel, Christian; Conrod, Patricia J.; Flor, Herta; Strohle, Andreas; Garavan, Hugh; Gallinat, Jurgen; Heinz, Andreas; Poline, Jean-Baptiste; Rietschel, Marcella; Smolka, Michael N.; Paus, Tomas

    2012-01-01

    Large-scale magnetic resonance (MR) studies of the human brain offer unique opportunities for identifying genetic and environmental factors shaping the human brain. Here, we describe a dataset collected in the context of a multi-centre study of the adolescent brain, namely the IMAGEN Study. We focus on one of the functional paradigms included in the project to probe the brain network underlying processing of ambiguous and angry faces. Using functional MR (fMRI) data collected in 1,110 adolescents, we constructed probabilistic maps of the neural network engaged consistently while viewing the ambiguous or angry faces; 21 brain regions responding to faces with high probability were identified. We were also able to address several methodological issues, including the minimal sample size yielding a stable location of a test region, namely the fusiform face area (FFA), as well as the effect of acquisition site (eight sites) and scanner (four manufacturers) on the location and magnitude of the fMRI response to faces in the FFA. Finally, we provided a comparison between male and female adolescents in terms of the effect sizes of sex differences in brain response to the ambiguous and angry faces in the 21 regions of interest. Overall, we found a stronger neural response to the ambiguous faces in several cortical regions, including the fusiform face area, in female (vs. male) adolescents, and a slightly stronger response to the angry faces in the amygdala of male (vs. female) adolescents. (authors)

  18. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

    Directory of Open Access Journals (Sweden)

    Fayers Peter

    2010-09-01

    Full Text Available Abstract Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis. Aim 1 To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2 To determine patient health outcomes over time and principle cost drivers [Study Phase 2]. The study objectives are as follows. 1 To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1 in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2 To conduct patient focus group discussions at each of these (Phase 1 to determine care received. 3 To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2. 4 To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2. 5 To undertake document

  19. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  20. Virtual patients design and its effect on clinical reasoning and student experience: a protocol for a randomised factorial multi-centre study.

    Science.gov (United States)

    Bateman, James; Allen, Maggie E; Kidd, Jane; Parsons, Nick; Davies, David

    2012-08-01

    Virtual Patients (VPs) are web-based representations of realistic clinical cases. They are proposed as being an optimal method for teaching clinical reasoning skills. International standards exist which define precisely what constitutes a VP. There are multiple design possibilities for VPs, however there is little formal evidence to support individual design features. The purpose of this trial is to explore the effect of two different potentially important design features on clinical reasoning skills and the student experience. These are the branching case pathways (present or absent) and structured clinical reasoning feedback (present or absent). This is a multi-centre randomised 2 x 2 factorial design study evaluating two independent variables of VP design, branching (present or absent), and structured clinical reasoning feedback (present or absent).The study will be carried out in medical student volunteers in one year group from three university medical schools in the United Kingdom, Warwick, Keele and Birmingham. There are four core musculoskeletal topics. Each case can be designed in four different ways, equating to 16 VPs required for the research. Students will be randomised to four groups, completing the four VP topics in the same order, but with each group exposed to a different VP design sequentially. All students will be exposed to the four designs. Primary outcomes are performance for each case design in a standardized fifteen item clinical reasoning assessment, integrated into each VP, which is identical for each topic. Additionally a 15-item self-reported evaluation is completed for each VP, based on a widely used EViP tool. Student patterns of use of the VPs will be recorded.In one centre, formative clinical and examination performance will be recorded, along with a self reported pre and post-intervention reasoning score, the DTI. Our power calculations indicate a sample size of 112 is required for both primary outcomes. This trial will provide

  1. Outcomes following combined intramedullary nail and plate fixation for complex tibia fractures: A multi-centre study.

    Science.gov (United States)

    Yoon, Richard S; Bible, Jesse; Marcus, Matthew S; Donegan, Derek J; Bergmann, Karl A; Siebler, Justin C; Mir, Hassan R; Liporace, Frank A

    2015-01-01

    Concomitant plate fixation as an adjunct to intramedullary nailing (IMN) of proximal third tibia fractures is a proven technique. Benefits include its role as a minimally invasive reduction aid, allowing for minimal soft tissue disruption. Expanding its indications as adjunct fixation to IMN throughout the tibia, we aimed to study outcomes in a multi-centre initiative. From May 1999 to March 2010, a total of 1302 operatively treated tibial fractures (including plateau and pilon fractures) with complete medical records were identified for review. Of these, 376 cases were treated via IMN, of which 30 cases were treated via combined IMN and plating, meeting inclusion criteria. Primary outcome was union rates, time to union, and complication rates. Secondary outcomes included mean alignment from the immediate postoperative period to the time of final follow-up. Twenty-seven out of 30 patients were available for follow-up. Twenty-five (93%) achieved bony union; the remaining two patients, sustained Type IIIA and B injuries respectively, went onto non-union secondary to deep infection and required multiple re-operations before achieving ultimate union. Mean time at final follow-up was 20 ± 10 months, 96% were ambulatory at full weight bearing status with no malunions. No significant changes in alignment in either the coronal or sagittal planes were noted at time of final follow-up. Combined IMN and plate fixation is a reliable tool not only in the treatment of fractures of the proximal tibia, but also for those fractures in the diaphysis and segmental fractures with proximal and/or distal metadiaphyseal extension with consistent ability to maintain high union rates and maintained alignment. However, longer-term follow-up and prospective trials will be necessary before coming to a definitive conclusion. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. Recommended dairy product intake modulates circulating fatty acid profile in healthy adults: a multi-centre cross-over study.

    Science.gov (United States)

    Abdullah, Mohammad M H; Cyr, Audrey; Lépine, Marie-Claude; Labonté, Marie-Ève; Couture, Patrick; Jones, Peter J H; Lamarche, Benoît

    2015-02-14

    Dairy products are rich sources of an array of fatty acids (FA) that have been shown individually and in certain clusters to exert varying effects on cardiovascular health, for which the circulating lipid profile is a powerful biomarker. Whether the profile of these FA is reflected in blood upon short terms of intake, possibly contributing to the lipid-related health impacts of dairy products, remains to be fully established. The objectives of the present study were to assess a recommended dairy product consumption in relation to circulating FA and lipid profiles, and to evaluate certain FA in dairy fat as potential biomarkers of intake. In a free-living, multi-centre, cross-over design, 124 healthy individuals consumed 3 servings/d of commercial dairy (DAIRY; 1% fat milk, 1·5% fat yogurt and 34% fat cheese) or energy-equivalent control (CONTROL; fruit and vegetable juice, cashews and a cookie) products for 4 weeks each, separated by a 4-week washout period. Plasma FA and serum lipid profiles were assessed by standard methods at the end of each dietary phase. After 4 weeks of intake, plasma levels of FA pentadecanoic acid (15 : 0) and heptadecanoic acid (17 : 0) were higher (0·26 v. 0·22% and 0·42 v. 0·39% of the total identified FA, respectively) after the DAIRY phase than after the CONTROL phase (Pcholesterol levels after the DAIRY phase compared with the CONTROL phase (+0·08 mmol/l; P= 0·04). In conclusion, intake of 3 servings/d of conventional dairy products may modify certain circulating FA and lipid profiles within 4 weeks, where 15 : 0 and 17 : 0 may be potential short-term biomarkers of intake.

  3. [Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Galicia].

    Science.gov (United States)

    Pato-Pato, A; Midaglia, L; Costa-Arpin, E; Rodriguez-Regal, A; Puy-Nunez, A; Rodriguez-Rodriguez, M; Lopez-Real, A; Llaneza-Gonzalez, M A; Garcia-Estevez, D A; Moreno-Carretero, M J; Escriche-Jaime, D; Aguado-Valcarcel, M L; Munoz, D; Prieto, J M; Lorenzo-Gonzalez, J R; Amigo-Jorrin, M C

    2016-09-05

    The effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) have been proven in clinical trials. Yet, due to their limitations, it is important to know how it behaves under everyday clinical practice conditions. Hence, the aim of this study is to evaluate the effectiveness and safety of fingolimod after 12 months' usage in clinical practice in Galicia. We conducted a retrospective, multi-centre study (n = 8) of patients with RRMS who were treated with one or more doses of fingolimod, 0.5 mg/day. Effectiveness was assessed -annualised relapse rate (ARR), changes in the score on the Expanded Disability Status Scale (EDSS), percentage of patients free from relapses, free from progression of disability and free from activity in resonance- for the total number of patients and according to previous treatment. Safety was assessed based on the percentage of patients who withdrew and presented adverse side effects. After 12 months' use, fingolimod reduced the ARR by 87% (1.7 to 0.23; p < 0.0001) and, consequently, 81% of patients were free from relapses. The score was reduced by 9%. In all, 91% of patients were free from progression of disability and 72% were free from resonance activity. No signs of disease activity were found in 43% of the patients. Most of the benefits of fingolimod differed depending on previous treatment. About a third of the patients reported adverse side effects, but only 2% of them withdrew for this reason. In clinical practice, most of the results on the effectiveness of the clinical trials conducted with fingolimod were observed during the first 12 months of treatment. A better safety profile was observed than that reported in the clinical trials.

  4. Short video interventions to reduce mental health stigma: a multi-centre randomised controlled trial in nursing high schools.

    Science.gov (United States)

    Winkler, Petr; Janoušková, Miroslava; Kožený, Jiří; Pasz, Jiří; Mladá, Karolína; Weissová, Aneta; Tušková, Eva; Evans-Lacko, Sara

    2017-12-01

    We aimed to assess whether short video interventions could reduce stigma among nursing students. A multi-centre, randomised controlled trial was conducted. Participating schools were randomly selected and randomly assigned to receive: (1) an informational leaflet, (2) a short video intervention or (3) a seminar involving direct contact with a service user. The Community Attitudes towards Mental Illness (CAMI) and Reported and Intended Behaviour Scale (RIBS) were selected as primary outcome measures. SPANOVA models were built and Cohen's d calculated to assess the overall effects in each of the trial arms. Compared to the baseline, effect sizes immediately after the intervention were small in the flyer arm (CAMI: d = 0.25; RIBS: d = 0.07), medium in the seminar arm (CAMI: d = 0.61; RIBS: d = 0.58), and medium in the video arm (CAMI: d = 0.49 RIBS: d = 0.26; n = 237). Effect sizes at the follow-up were vanishing in the flyer arm (CAMI: d = 0.05; RIBS: d = 0.04), medium in the seminar arm (CAMI: d = 0.43; RIBS: d = 0.26; n = 254), and small in the video arm (CAMI: d = 0.22 RIBS: d = 0.21; n = 237). Seminar had the strongest and relatively stable effect on students' attitudes and intended behaviour, but the effect of short video interventions was also considerable and stable over time. Since short effective video interventions are relatively cheap, conveniently accessible and easy to disseminate globally, we recommend them for further research and development.

  5. The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial

    DEFF Research Database (Denmark)

    Lindholt, J S; Gottschalksen, B; Johannesen, N

    2011-01-01

    To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study.......To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study....

  6. Does cataract surgery alleviate poverty? Evidence from a multi-centre intervention study conducted in Kenya, the Philippines and Bangladesh.

    Directory of Open Access Journals (Sweden)

    Hannah Kuper

    Full Text Available BACKGROUND: Poverty and blindness are believed to be intimately linked, but empirical data supporting this purported relationship are sparse. The objective of this study is to assess whether there is a reduction in poverty after cataract surgery among visually impaired cases. METHODOLOGY/PRINCIPAL FINDINGS: A multi-centre intervention study was conducted in three countries (Kenya, Philippines, Bangladesh. Poverty data (household per capita expenditure--PCE, asset ownership and self-rated wealth were collected from cases aged ≥50 years who were visually impaired due to cataract (visual acuity<6/24 in the better eye and age-sex matched controls with normal vision. Cases were offered free/subsidised cataract surgery. Approximately one year later participants were re-interviewed about poverty. 466 cases and 436 controls were examined at both baseline and follow-up (Follow up rate: 78% for cases, 81% for controls, of which 263 cases had undergone cataract surgery ("operated cases". At baseline, operated cases were poorer compared to controls in terms of PCE (Kenya: $22 versus £35 p = 0.02, Bangladesh: $16 vs $24 p = 0.004, Philippines: $24 vs 32 p = 0.0007, assets and self-rated wealth. By follow-up PCE had increased significantly among operated cases in each of the three settings to the level of controls (Kenya: $30 versus £36 p = 0.49, Bangladesh: $23 vs $23 p = 0.20, Philippines: $45 vs $36 p = 0.68. There were smaller increases in self-rated wealth and no changes in assets. Changes in PCE were apparent in different socio-demographic and ocular groups. The largest PCE increases were apparent among the cases that were poorest at baseline. CONCLUSIONS/SIGNIFICANCE: This study showed that cataract surgery can contribute to poverty alleviation, particularly among the most vulnerable members of society. This study highlights the need for increased provision of cataract surgery to poor people and shows that a focus on blindness may help to alleviate

  7. Pilates based core stability training in ambulant individuals with multiple sclerosis: protocol for a multi-centre randomised controlled trial.

    Science.gov (United States)

    Freeman, Jennifer; Fox, Esther; Gear, Margaret; Hough, Alan

    2012-04-05

    People with Multiple Sclerosis (MS) frequently experience balance and mobility impairments, including reduced trunk stability. Pilates-based core stability training, which is aimed at improving control of the body's stabilising muscles, is popular as a form of exercise with people with MS and therapists. A replicated single case series study facilitated by the Therapists in MS Group in the United Kingdom (UK) provides preliminary evidence that this approach can improve balance and mobility in ambulant people with MS; further evidence is needed to substantiate these findings to ensure that limited time, energy, finances and resources are used to best effect.This study builds upon the pilot work undertaken in the case series study by implementing a powered randomised controlled study, with the aims of: 1 Establishing the effectiveness of core stability training; 2 Comparing core stability training with standardised physiotherapy exercise; 3 Exploring underlying mechanisms of change associated with this intervention This is a multi-centre, double blind, block randomised, controlled trial. Eligible participants will be recruited from 4 UK centres. Participants will be randomly allocated to one of three groups: Pilates based core stability training, standardised physiotherapy exercise or contract-relax relaxation sessions (placebo control). All will receive face to face training sessions over a 12 week period; together with a 15 minute daily home programme. All will be assessed by a blinded assessor before training, at the end of the 12 week programme and at 4 week follow-up. The primary outcome measure is the 10 metre timed walk. Secondary outcome measures are the MS walking Scale (MSWS-12), the Functional Reach (forwards and lateral), a 10 point Numerical Rating Scale to determine "Difficulty in carrying a drink when walking", and the Activities-specific Balance Confidence (ABC) Scale. In addition, ultrasound imaging of the abdominal muscles will be performed before

  8. Pilates based core stability training in ambulant individuals with multiple sclerosis: protocol for a multi-centre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Jennifer

    2012-04-01

    Full Text Available Abstract Background People with Multiple Sclerosis (MS frequently experience balance and mobility impairments, including reduced trunk stability. Pilates-based core stability training, which is aimed at improving control of the body's stabilising muscles, is popular as a form of exercise with people with MS and therapists. A replicated single case series study facilitated by the Therapists in MS Group in the United Kingdom (UK provides preliminary evidence that this approach can improve balance and mobility in ambulant people with MS; further evidence is needed to substantiate these findings to ensure that limited time, energy, finances and resources are used to best effect. This study builds upon the pilot work undertaken in the case series study by implementing a powered randomised controlled study, with the aims of: 1 Establishing the effectiveness of core stability training 2 Comparing core stability training with standardised physiotherapy exercise 3 Exploring underlying mechanisms of change associated with this intervention Methods This is a multi-centre, double blind, block randomised, controlled trial. Eligible participants will be recruited from 4 UK centres. Participants will be randomly allocated to one of three groups: Pilates based core stability training, standardised physiotherapy exercise or contract-relax relaxation sessions (placebo control. All will receive face to face training sessions over a 12 week period; together with a 15 minute daily home programme. All will be assessed by a blinded assessor before training, at the end of the 12 week programme and at 4 week follow-up. The primary outcome measure is the 10 metre timed walk. Secondary outcome measures are the MS walking Scale (MSWS-12, the Functional Reach (forwards and lateral, a 10 point Numerical Rating Scale to determine "Difficulty in carrying a drink when walking", and the Activities-specific Balance Confidence (ABC Scale. In addition, ultrasound imaging of the

  9. Effectiveness of a hospital-based work support intervention for female cancer patients - a multi-centre randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Sietske J Tamminga

    Full Text Available OBJECTIVE: One key aspect of cancer survivorship is return-to-work. Unfortunately, many cancer survivors face problems upon their return-to-work. For that reason, we developed a hospital-based work support intervention aimed at enhancing return-to-work. We studied effectiveness of the intervention compared to usual care for female cancer patients in a multi-centre randomised controlled trial. METHODS: Breast and gynaecological cancer patients who were treated with curative intent and had paid work were randomised to the intervention group (n = 65 or control group (n = 68. The intervention involved patient education and support at the hospital and improvement of communication between treating and occupational physicians. In addition, we asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan. Outcomes at 12 months of follow-up included rate and time until return-to-work (full or partial, quality of life, work ability, work functioning, and lost productivity costs. Time until return-to-work was analyzed with Kaplan-Meier survival analysis. RESULTS: Return-to-work rates were 86% and 83% (p = 0.6 for the intervention group and control group when excluding 8 patients who died or with a life expectancy of months at follow-up. Median time from initial sick leave to partial return-to-work was 194 days (range 14-435 versus 192 days (range 82-465 (p = 0.90 with a hazard ratio of 1.03 (95% CI 0.64-1.6. Quality of life and work ability improved statistically over time but did not differ statistically between groups. Work functioning and costs did not differ statistically between groups. CONCLUSION: The intervention was easily implemented into usual psycho-oncological care and showed high return-to-work rates. We failed to show any differences between groups on return-to-work outcomes and quality of life scores. Further research is needed to study which

  10. Calibration test of PET scanners in a multi-centre clinical trial on breast cancer therapy monitoring using 18F-FLT.

    Directory of Open Access Journals (Sweden)

    Francis Bouchet

    Full Text Available A multi-centre trial using PET requires the analysis of images acquired on different systems We designed a multi-centre trial to estimate the value of 18F-FLT-PET to predict response to neoadjuvant chemotherapy in patients with newly diagnosed breast cancer. A calibration check of each PET-CT and of its peripheral devices was performed to evaluate the reliability of the results.11 centres were investigated. Dose calibrators were assessed by repeated measurements of a 68Ge certified source. The differences between the clocks associated with the dose calibrators and inherent to the PET systems were registered. The calibration of PET-CT was assessed with an homogeneous cylindrical phantom by comparing the activities per unit of volume calculated from the dose calibrator measurements with that measured on 15 Regions of Interest (ROIs drawn on 15 consecutive slices of reconstructed filtered back-projection (FBP images. Both repeatability of activity concentration based upon the 15 ROIs (ANOVA-test and its accuracy were evaluated.There was no significant difference for dose calibrator measurements (median of difference -0.04%; min = -4.65%; max = +5.63%. Mismatches between the clocks were less than 2 min in all sites and thus did not require any correction, regarding the half life of 18F. For all the PET systems, ANOVA revealed no significant difference between the activity concentrations estimated from the 15 ROIs (median of difference -0.69%; min = -9.97%; max = +9.60%.No major difference between the 11 centres with respect to calibration and cross-calibration was observed. The reliability of our 18F-FLT multi-centre clinical trial was therefore confirmed from the physical point of view. This type of procedure may be useful for any clinical trial involving different PET systems.

  11. Combinatorial detection of autoreactive CD8+T cells with HLA-A2 multimers: a multi-centre study by the Immunology of Diabetes Society T Cell Workshop.

    Science.gov (United States)

    James, Eddie A; Abreu, Joana R F; McGinty, John W; Odegard, Jared M; Fillié, Yvonne E; Hocter, Claire N; Culina, Slobodan; Ladell, Kristin; Price, David A; Alkanani, Aimon; Rihanek, Marynette; Fitzgerald-Miller, Lisa; Skowera, Ania; Speake, Cate; Gottlieb, Peter; Davidson, Howard W; Wong, F Susan; Roep, Bart; Mallone, Roberto

    2018-03-01

    Validated biomarkers are needed to monitor the effects of immune intervention in individuals with type 1 diabetes. Despite their importance, few options exist for monitoring antigen-specific T cells. Previous reports described a combinatorial approach that enables the simultaneous detection and quantification of multiple islet-specific CD8 + T cell populations. Here, we set out to evaluate the performance of a combinatorial HLA-A2 multimer assay in a multi-centre setting. The combinatorial HLA-A2 multimer assay was applied in five participating centres using centralised reagents and blinded replicate samples. In preliminary experiments, samples from healthy donors were analysed using recall antigen multimers. In subsequent experiments, samples from healthy donors and individuals with type 1 diabetes were analysed using beta cell antigen and recall antigen multimers. The combinatorial assay was successfully implemented in each participating centre, with CVs between replicate samples that indicated good reproducibility for viral epitopes (mean %CV = 33.8). For beta cell epitopes, the assay was very effective in a single-centre setting (mean %CV = 18.4), but showed sixfold greater variability across multi-centre replicates (mean %CV = 119). In general, beta cell antigen-specific CD8 + T cells were detected more commonly in individuals with type 1 diabetes than in healthy donors. Furthermore, CD8 + T cells recognising HLA-A2-restricted insulin and glutamate decarboxylase epitopes were found to occur at higher frequencies in individuals with type 1 diabetes than in healthy donors. Our results suggest that, although combinatorial multimer assays are challenging, they can be implemented in multiple laboratories, providing relevant T cell frequency measurements. Assay reproducibility was notably higher in the single-centre setting, suggesting that biomarker analysis of clinical trial samples would be most successful when assays are performed in a single laboratory

  12. [Renal insufficiency and clinical outcomes in patients with acute coronary syndrome undergoing percutaneous coronary intervention: a multi-centre study].

    Science.gov (United States)

    Huo, Yong; Ho, Wa

    2007-12-18

    To investigate the association of renal insufficiency and clinical outcomes in patients with acute coronary syndrome(ACS). The study was a multi-centre register study including 3,589 ACS patients coming from 39 centers across China who had received percutaneous coronary intervention(PCI) prior to 1st February, 2007. Estimated glomerular filtration rate (eGFR) was calculated for all patients using the 4-variable MDRD equation with the serum creatinine obtained before angiography. The association between renal insufficiency and clinical outcomes and the presence of in-hospital death and bleeding was studied by Fisher's exact test. Multi-variable analysis on the risk factors of in-hospital bleeding was done by logistic regression test. The mean age of the study population was (61.74+/-11.37) years (ranging from 23 years to 92 years)and 76.5% (2,746/3,589) of the population was male. Only 90 patients (2.51%) were known to have chronic kidney disease at the time of admission and 144 patients(4.01%) had serum creatinine levels above 133 micromol/L. However, after the evaluation of renal status by the MDRD equation, 2,250 patients (63.1%)showed a reduction in eGFR of less than 90 mL/min, of whom, 472 (13.1%) even reached the level of moderate renal insufficiency (eGFRchronic total occlusion lesions(CTO) and eight (0.22%) needed shift to coronary artery bypass grafting (CABG) after angiography. Both the presence of CTO lesions and CABG were proved to be associated with decrease of renal function through Fisher's exact test (P= 0.005 8 and 0.041, respectively). The in-hospital mortality rate was 0.47%(17/3 589) which was associated with the degree of renal insufficiency (P=0.001 3). A total of 75 patients(2.09%) of in-hospital bleeding were recorded with 26 patients(0.72%) diagnosed as major bleeding events. 92% (69/75) of the bleeding events occurred after PCI. Bleeding was found to be associated with the degree of renal insufficiency in every type of antithrombotic

  13. Case-Control Study of Writer's Cramp

    Science.gov (United States)

    Roze, E.; Soumare, A.; Pironneau, I.; Sangla, S.; de Cock, V. Cochen; Teixeira, A.; Astorquiza, A.; Bonnet, C.; Bleton, J. P.; Vidailhet, M.; Elbaz, A.

    2009-01-01

    Task-specific focal dystonias are thought to be due to a combination of individual vulnerability and environmental factors. There are no case-control studies of risk factors for writer's cramp. We undertook a case-control study of 104 consecutive patients and matched controls to identify risk factors for the condition. We collected detailed data…

  14. Influence of the workplace on physical activity and cardiometabolic health: Results of the multi-centre cross-sectional Champlain Nurses' study.

    Science.gov (United States)

    Reed, Jennifer L; Prince, Stephanie A; Pipe, Andrew L; Attallah, Suzanne; Adamo, Kristi B; Tulloch, Heather E; Manuel, Douglas; Mullen, Kerri-Anne; Fodor, George; Reid, Robert D

    2018-02-13

    Nurses are the largest professional group within the health care workforce, and their work is perceived as being physically demanding. Regular physical activity helps to prevent or ameliorate cardiometabolic conditions (e.g. cardiovascular disease, diabetes). It is not known whether Canadian nurses are meeting current physical activity guidelines. To assess the influence of the workplace on the physical activity and cardiometabolic health of nurses from hospitals in the Champlain region of Ontario, Canada. A multi-centre, cross-sectional study. Hospitals in the Champlain Local Health Integration Network of Ontario. Nurses wore an ActiGraph accelerometer to objectively assess levels of moderate-to-vigorous intensity physical activity measured in minutes/day in bouts ≥10 min. All completed the Perceived Workplace Environment (PWE) scale and International Physical Activity Questionnaire (IPAQ). Height, body mass, waist circumference, blood pressure and heart rate were measured, and body mass index (BMI) was determined. Each nurse's 5-year cardiovascular risk was calculated using the Harvard Score. A total of 410 nurses (94% female; mean ± SD: age = 43 ± 12 years) from 14 hospitals participated. Nurses spent an average of 96 ± 100 min/week in bouts ≥10 min of moderate-to-vigorous intensity physical activity; 23% of nurses met recommended physical activity guidelines. Nurses working 8- vs. 12-h shifts (16 ± 16 vs. 10 ± 11 min/day, p = 0.026), fixed vs. rotating shifts (15 ± 15 vs. 12 ± 13 min/day, p = 0.012) and casual vs. full-time (29 ± 17 vs. 13 ± 15 min/day, p physical activity in bouts ≥10 min. The average PWE score was 2.4 ± 0.9, with no association between PWE scores and moderate-to-vigorous intensity physical activity in bouts ≥10 min (p > 0.05). Nurses working 8-h shifts, fixed shifts and in urban hospitals reported better PWE scores (p physical activity guidelines

  15. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol.

    Science.gov (United States)

    Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Vale, Luke; Norrie, John; Kinsella, John; Cook, Jonathan; Brittenden, Julie; Grant, Adrian

    2010-04-16

    Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial registration number - ISRCTN32188676.

  16. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

    Directory of Open Access Journals (Sweden)

    Norrie John

    2010-04-01

    Full Text Available Abstract Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676

  17. Case-control studies in neurosurgery.

    Science.gov (United States)

    Nesvick, Cody L; Thompson, Clinton J; Boop, Frederick A; Klimo, Paul

    2014-08-01

    Observational studies, such as cohort and case-control studies, are valuable instruments in evidence-based medicine. Case-control studies, in particular, are becoming increasingly popular in the neurosurgical literature due to their low cost and relative ease of execution; however, no one has yet systematically assessed these types of studies for quality in methodology and reporting. The authors performed a literature search using PubMed/MEDLINE to identify all studies that explicitly identified themselves as "case-control" and were published in the JNS Publishing Group journals (Journal of Neurosurgery, Journal of Neurosurgery: Pediatrics, Journal of Neurosurgery: Spine, and Neurosurgical Focus) or Neurosurgery. Each paper was evaluated for 22 descriptive variables and then categorized as having either met or missed the basic definition of a case-control study. All studies that evaluated risk factors for a well-defined outcome were considered true case-control studies. The authors sought to identify key features or phrases that were or were not predictive of a true case-control study. Those papers that satisfied the definition were further evaluated using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist. The search detected 67 papers that met the inclusion criteria, of which 32 (48%) represented true case-control studies. The frequency of true case-control studies has not changed with time. Use of odds ratios (ORs) and logistic regression (LR) analysis were strong positive predictors of true case-control studies (for odds ratios, OR 15.33 and 95% CI 4.52-51.97; for logistic regression analysis, OR 8.77 and 95% CI 2.69-28.56). Conversely, negative predictors included focus on a procedure/intervention (OR 0.35, 95% CI 0.13-0.998) and use of the word "outcome" in the Results section (OR 0.23, 95% CI 0.082-0.65). After exclusion of nested case-control studies, the negative correlation between focus on a procedure

  18. A large multi-centre European study validates high-sensitivity C-reactive protein (hsCRP) as a clinical biomarker for the diagnosis of diabetes subtypes

    DEFF Research Database (Denmark)

    Thanabalasingham, G.; Shah, N.; Vaxillaire, M.

    2011-01-01

    An accurate molecular diagnosis of diabetes subtype confers clinical benefits; however, many individuals with monogenic diabetes remain undiagnosed. Biomarkers could help to prioritise patients for genetic investigation. We recently demonstrated that high-sensitivity C-reactive protein (hs......CRP) levels are lower in UK patients with hepatocyte nuclear factor 1 alpha (HNF1A)-MODY than in other diabetes subtypes. In this large multi-centre study we aimed to assess the clinical validity of hsCRP as a diagnostic biomarker, examine the genotype-phenotype relationship and compare different hsCRP assays....... High-sensitivity CRP levels were analysed in individuals with HNF1A-MODY (n = 457), glucokinase (GCK)-MODY (n = 404), hepatocyte nuclear factor 4 alpha (HNF4A)-MODY (n = 54) and type 2 diabetes (n = 582) from seven European centres. Three common assays for hsCRP analysis were evaluated. We excluded 121...

  19. Compliance with clothing regulations and traffic flow in the operating room: a multi-centre study of staff discipline during surgical procedures.

    Science.gov (United States)

    Loison, G; Troughton, R; Raymond, F; Lepelletier, D; Lucet, J-C; Avril, C; Birgand, G

    2017-07-01

    This multi-centre study assessed operating room (OR) staff compliance with clothing regulations and traffic flow during surgical procedures. Of 1615 surgical attires audited, 56% respected the eight clothing measures. Lack of compliance was mainly due to inappropriate wearing of jewellery (26%) and head coverage (25%). In 212 procedures observed, a median of five people [interquartile range (IQR) 4-6] were present at the time of incision. The median frequency of entries to/exits from the OR was 10.6/h (IQR 6-29) (range 0-93). Reasons for entries to/exits from the OR were mainly to obtain materials required in the OR (N=364, 44.5%). ORs with low compliance with clothing regulations tended to have higher traffic flows, although the difference was not significant (P=0.12). Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  20. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

    Science.gov (United States)

    Boden, Ianthe; Browning, Laura; Skinner, Elizabeth H; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K; Denehy, Linda

    2015-12-15

    Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and

  1. The outcome of a multi-centre feasibility study of online adaptive radiotherapy for muscle-invasive bladder cancer TROG 10.01 BOLART

    International Nuclear Information System (INIS)

    Foroudi, Farshad; Pham, Daniel; Rolfo, Aldo; Bressel, Mathias; Tang, Colin I.; Tan, Alex; Turner, Sandra; Hruby, George; Williams, Stephen; Hayne, Dickon; Lehman, Margot; Skala, Marketa; Jose, Chakiath C.; Gogna, Kumar; Kron, Tomas

    2014-01-01

    Purpose: To assess whether online adaptive radiotherapy for bladder cancer is feasible across multiple Radiation Oncology departments using different imaging, delivery and recording technology. Materials and methods: A multi-centre feasibility study of online adaptive radiotherapy, using a choice of three “plan of the day”, was conducted at 12 departments. Patients with muscle-invasive bladder cancer were included. Departments were activated if part of the pilot study or after a site-credentialing visit. There was real time review of the first two cases from each department. Results: 54 patients were recruited, with 50 proceeding to radiotherapy. There were 43 males and 7 females with a mean age of 78 years. The tumour stages treated included T1 (1 patient), T2 (35), T3 (10) and T4 (4). One patient died of an unrelated cause during radiotherapy. The three adaptive plans were created before the 10th fraction in all cases. In 8 (16%) of the patients, a conventional plan using a ‘standard’ CTV to PTV margin of 1.5 cm was used for one or more fractions where the pre-treatment bladder CTV was larger than any of the three adaptive plans. The bladder CTV extended beyond the PTV on post treatment imaging in 9 (18%) of the 49 patients. Conclusions: From a technical perspective an online adaptive radiotherapy technique can be instituted in a multi-centre setting. However, without further bladder filling control or imaging, a CTV to PTV margin of 7 mm is insufficient

  2. Struggling doctors in specialist training: a case control study

    DEFF Research Database (Denmark)

    O'Neill, Lotte; Norberg, Karen; Thomsen, Maria

    ), or transferred (i.e. had unplanned changes in place of training/ward due to failure to thrive or due to inadequate development of competences), or dropped out (i.e. were dismissed from, had resigned from, or changed their speciality). Controls were a random sample of doctors in the source population, who were......Abstract summary The aim of this cummulative incidence case-control study was to examine: if struggling trainees in medical specialist training (cases) tended to struggle already in medical school or not compared to non-struggling controls, and which performance indicators during medical school...... seemed to predict struggling in postgraduate education if any. The study design is rooted in epidemiological methodology. Struggling doctors in specialist training: a case-control study. It has been reported in the international literature, that around 3-10% of doctors in post-garduate specialist...

  3. [Case control study on therapeutic effects of dynamic external fixtor combined with limited internal fixation and cross K-wires fixation for the treatment of Pilon fractures of the proximal interphalangeal joint].

    Science.gov (United States)

    Miao, Dao-yi; Yang, Guo-jing; Zhang, Ling-zhou; Wu, Jian-wei

    2015-10-01

    To compare the clinical effects and safety of dynamic external fixtor combined with limited internal fixation and cross K-wires fixation for the treatment of close Pilon fractures of the proximal interphalangeal joint. From June 2012 to June 2014, totally 41 patients (45 fingers) with close interphalangeal joint Pilon fracture were treated by dynamic external fixtor combined with limited internal fixation or cross K-wires fixation, and all the patients were followed up. In the dynamic external fixtor combined with limited internal fixation group (group A), there were 21 patients with 22 fingers, including 12 males and 9 females, with an average of (30.6±5.6) years old. In the cross K-wires fixation group (group B), there were 20 patients with 23 fingers, including 11 males and 9 females, with an average of (30.1±5.3) years old. Regular re-examination of X-ray was performed to evaluate the active range of joint motion, fracture healing time, infection rate and postoperative joint motion pain. According to the evaluation criteria of upper extremity function issued by the Hand Surgery Society of Chinese Medical Association, the excellent and good cases of group A was up to 19 and 13 for group B. The evaluation results has significant differences (Z=2.558, P=0.011). The excellent and good rate of group A was obviously higher than that of group B. The average bone union time of group A was (7.9±2.1) weeks, and (8.1±2.3) weeks for group B. There was no significant difference on the mean healing time (t=-0.304, P=0.762). The infection fingers of group A was 5, and 1 for group B. The difference between the results was statistically significant (χ2=3.287, Pexternal fixtor combined with limited internal fixation is a reliable and effective method to treat Pilon fractures of the proximal interphalangeal joint. It allows early postoperative functional rehabilitation and restores the joint function.

  4. Harmonisation of multi-centre real-time reverse-transcribed PCR results of a candidate prognostic marker in breast cancer: an EU-FP6 supported study of members of the EORTC - PathoBiology Group.

    NARCIS (Netherlands)

    Span, P.N.; Sieuwerts, A.M.; Heuvel, J.J.T.M.; Spyratos, F.; Duffy, M.J.; Eppenberger-Castori, S.; Vacher, S.; O'Brien, K.; McKiernan, E.; Pierce, A.; Vuaroqueaux, V.; Foekens, J.A.; Sweep, C.G.J.; Martens, J.W.

    2009-01-01

    AIM: Assessment of intra- and inter-laboratory variation in multi-centre real-time reverse-transcribed PCR (qRT-PCR)-based mRNA quantification of a prognostic marker in breast cancer using external quality assurance (EQA). METHODS: A questionnaire on the methodologies used and EQA calibrators were

  5. Critical Care Health Informatics Collaborative (CCHIC): Data, tools and methods for reproducible research: A multi-centre UK intensive care database.

    Science.gov (United States)

    Harris, Steve; Shi, Sinan; Brealey, David; MacCallum, Niall S; Denaxas, Spiros; Perez-Suarez, David; Ercole, Ari; Watkinson, Peter; Jones, Andrew; Ashworth, Simon; Beale, Richard; Young, Duncan; Brett, Stephen; Singer, Mervyn

    2018-04-01

    To build and curate a linkable multi-centre database of high resolution longitudinal electronic health records (EHR) from adult Intensive Care Units (ICU). To develop a set of open-source tools to make these data 'research ready' while protecting patient's privacy with a particular focus on anonymisation. We developed a scalable EHR processing pipeline for extracting, linking, normalising and curating and anonymising EHR data. Patient and public involvement was sought from the outset, and approval to hold these data was granted by the NHS Health Research Authority's Confidentiality Advisory Group (CAG). The data are held in a certified Data Safe Haven. We followed sustainable software development principles throughout, and defined and populated a common data model that links to other clinical areas. Longitudinal EHR data were loaded into the CCHIC database from eleven adult ICUs at 5 UK teaching hospitals. From January 2014 to January 2017, this amounted to 21,930 and admissions (18,074 unique patients). Typical admissions have 70 data-items pertaining to admission and discharge, and a median of 1030 (IQR 481-2335) time-varying measures. Training datasets were made available through virtual machine images emulating the data processing environment. An open source R package, cleanEHR, was developed and released that transforms the data into a square table readily analysable by most statistical packages. A simple language agnostic configuration file will allow the user to select and clean variables, and impute missing data. An audit trail makes clear the provenance of the data at all times. Making health care data available for research is problematic. CCHIC is a unique multi-centre longitudinal and linkable resource that prioritises patient privacy through the highest standards of data security, but also provides tools to clean, organise, and anonymise the data. We believe the development of such tools are essential if we are to meet the twin requirements of

  6. Quantification of FDG PET studies using standardised uptake values in multi-centre trials: effects of image reconstruction, resolution and ROI definition parameters.

    Science.gov (United States)

    Westerterp, Marinke; Pruim, Jan; Oyen, Wim; Hoekstra, Otto; Paans, Anne; Visser, Eric; van Lanschot, Jan; Sloof, Gerrit; Boellaard, Ronald

    2007-03-01

    Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multi-centre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of different scanners, image reconstruction and data analysis software. In this study we evaluated whether SUVs, obtained at three different institutes, may be directly compared after calibration and correction for inter-institute differences. First, an anthropomorphic thorax phantom containing variously sized spheres and activities, simulating tumours, was scanned and processed in each institute to evaluate differences in scanner calibration. Secondly, effects of image reconstruction and ROI method on recovery coefficients were studied. Next, SUVs were derived for tumours in 23 subjects. Of these 23 patients, four and ten were scanned in two institutes on an HR+ PET scanner and nine were scanned in one institute on an ECAT EXACT PET scanner. All phantom and clinical data were reconstructed using iterative reconstruction with various iterations, with both measured (MAC) and segmented attenuation correction (SAC) and at various image resolutions. Activity concentrations (AC) or SUVs were derived using various ROI isocontours. Phantom data revealed differences in SUV quantification of up to 30%. After application-specific calibration, recovery coefficients obtained in each institute were equal to within 15%. Varying the ROI isocontour value resulted in a predictable change in SUV (or AC) for both phantom and clinical data. Variation of image resolution resulted in a predictable change in SUV quantification for large spheres/tumours (>5 cc) only. For smaller tumours (<2 cc), differences of up to 40% were found between high (7 mm) and low (10 mm) resolution images. Similar differences occurred when data were reconstructed with a small number of iterations. Finally, no significant

  7. Design and performance of a multi-centre randomised controlled trial and economic evaluation of joint tele-consultations [ISRCTN54264250

    Directory of Open Access Journals (Sweden)

    Thompson Simon

    2002-01-01

    Full Text Available Abstract Background Appropriate information flow is crucial to the care of patients, particularly at the interface between primary and secondary care. Communication problems can result from inadequate organisation and training, There is a major expectation that information and communication technologies may offer solutions, but little reliable evidence. This paper reports the design and performance of a multi-centre randomised controlled trial (RCT, unparalleled in telemedicine research in either scale or range of outcomes. The study investigated the effectiveness and cost implications in rural and inner-city settings of using videoconferencing to perform joint tele-consultations as an alternative to general practitioner referral to the hospital specialist in the outpatient clinic. Methods Joint tele-consultation services were established in both the Royal Free Hampstead NHS Trust in inner London, and the Royal Shrewsbury Hospitals Trust, in Shropshire. All the patients who gave consent to participate were randomised either to joint tele-consultation or to a routine outpatients appointment. The principal outcome measures included the frequency of decision by the specialist to offer a follow-up outpatient appointment, patient satisfaction (Ware Specific Questionnaire, wellbeing (SF12 and enablement (PEI, numbers of tests, investigations, procedures and treatments. Results A total of 134 general practitioners operating from 29 practices participated in the trial, referring a total of 3170 patients to 20 specialists in ENT medicine, general medicine (including endocrinology, and rheumatology, gastroenterology, orthopaedics, neurology and urology. Of these, 2094 patients consented to participate in the study and were correctly randomised. There was a 91% response rate to the initial assessment questionnaires, and analysis showed equivalence for all key characteristics between the treatment and control groups. Conclusion We have designed and

  8. Prevention of heel pressure ulcers among older patients--from ambulance care to hospital discharge: A multi-centre randomized controlled trial.

    Science.gov (United States)

    Bååth, Carina; Engström, Maria; Gunningberg, Lena; Muntlin Athlin, Åsa

    2016-05-01

    The aim was to investigate the effect of an early intervention, a heel suspension device boot, on the incidence of heel pressure ulcers among older patients (aged 70+). Pressure ulcers are a global healthcare issue; furthermore, the heel is an exposed location. Research indicates that preventive nursing interventions starting during the ambulance care and used across the acute care delivery chain are seldom used. A multi-centre randomized control study design was used. Five ambulance stations, two emergency departments and 16 wards at two Swedish hospitals participated. Altogether, 183 patients were transferred by ambulance to the emergency department and were thereafter admitted to one of the participating wards. Significantly fewer patients in the intervention group (n=15 of 103; 14.6%) than the control group (n=24 of 80; 30%) developed heel pressure ulcers during their hospital stay (p=0.017). Pressure ulcer prevention should start early in the acute care delivery chain to increase patient safety. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. A multi-centre, prospective, clinical in-market evaluation to assess the performance of Opsite™ Post-Op Visible dressings.

    LENUS (Irish Health Repository)

    O'Brien, Gillian

    2010-10-01

    The aim of this study was to assess the performance of Opsite™ Post-Op Visible as a post-surgical dressing in a typical clinical setting. In this multi-centre clinical evaluation, patients who underwent clean surgery were treated with Opsite Post-Op Visible dressing. Duration of dressing wear, visibility through the dressing and ability to handle exudate were assessed and the product was rated in comparison with those normally used. A total of 64 patients were recruited. Mean wear time was 4·5 days. Exudate management was rated very good or good at 96% of assessments. Visibility of the incision site was rated as very good or good at 72%, and as acceptable at 24%, of assessments. Patient comfort was rated very comfortable (63%) or comfortable (37%) at all assessments. Dressings were generally rated as satisfactory or exceeding expectations with clinicians stating that the Opsite Post-Op Visible dressing was better than the dressing they routinely used for 92% of patients. Opsite Post-Op Visible dressing is an innovative dressing combining good visibility with exudate management and patient comfort. It was found to have adequate wear time, visibility and exudate management properties making it suitable for use on a variety of surgical incision sites.

  10. Three-in-one protocol reduces mortality of patients with haemodynamically unstable pelvic fractures-a five year multi-centred review in Hong Kong.

    Science.gov (United States)

    Cheng, Mina; Lee, Kin-Yan; Chang, Annice-M L; Ho, Hiu-Fai; Chan, Lily-P S; Lee, Kin-Bong; Kwok, Philip-C H; Lee, Alexander-C W; Wong, Kevin-Y K; Kam, Chak-Wah; Leung, Gilberto-K K; Wong, John-K S; Cheung, Nai-Kwong; Yeung, Janice-H H; Tang, Ning; Choi, Shing-Hing; Lau, Tak-Wing; Wong, Heidi-H T; Leung, Ming

    2018-02-27

    The mortality rate in patients with haemodynamically unstable pelvic fractures is as high as 40-60%. Despite the new advances in trauma care which are in phase in trauma centres in Hong Kong, the management of haemodynamically unstable pelvic fracture is still heterogeneous. The aim of this study is to review the results of management of haemodynamically unstable pelvic fracture patients in Hong Kong over a five year period. This is a retrospective multi-centred cohort study of patients with haemodynamic and mechanically unstable pelvic fractures from 1 January 2010 to 31 December 2014. The primary outcome investigated is mortality of patients (including overall, 30-day, 7-day and 24-hour mortalities). Implementation of three-in-one pelvic damage control protocol was identified to be a significant independent predictive factor for overall, 30-day, seven-day and 24-hour mortalities. The overall in-hospital and 30-day mortality rates for patients managed with three-in-one protocol was 12.5%, while it was 11% for seven day mortality and 6% for 24 hour mortality. There were no significant differences in demographic characteristics, physiological measurements, types of pelvic fracture, severity and mechanism of injury between patients managed with or without three-in-one protocol. Implementation of the multidisciplinary three-in-one pelvic damage control protocol reduces mortality and therefore should be highly recommended. The results are convincing as it has eliminated the limitations of our previous single-centred trial.

  11. A complexity analysis of the Gauss-Bessel quadrature as applied to the evaluation of multi-centre integrals over STFs

    International Nuclear Information System (INIS)

    Bouferguene, Ahmed; Safouhi, Hassan

    2006-01-01

    In a previous work (Bouferguene 2005 J. Phys. A: Math. Gen. 38 3923), we have shown that in the framework of the Gaussian integral transform, multi-centre integrals over Slater type functions can be evaluated to an acceptable accuracy using a tailored Gauss quadrature in which the weight function has the form W(σ, τ; z) = z ν exp(-σz - τ/z). To be considered a solution worth implementing within a software for routine use in ab initio molecular simulations, the method must also prove to be at least as efficient as those methods previously published in the literature. Two major results are provided in this paper. Firstly, an improvement of the procedure used to generate the roots and weights of the Gauss-Bessel quadrature is proposed. Secondly, a computational cost analysis of the present method and the SD-bar (Safouhi 2001 J. Phys. A: Math. Gen. 34 2801) based approach are compared, hence proving the equivalence of the two from a complexity point of view

  12. Relating functional changes during hand movement to clinical parameters in patients with multiple sclerosis in a multi-centre fMRI study.

    Science.gov (United States)

    Wegner, C; Filippi, M; Korteweg, T; Beckmann, C; Ciccarelli, O; De Stefano, N; Enzinger, C; Fazekas, F; Agosta, F; Gass, A; Hirsch, J; Johansen-Berg, H; Kappos, L; Barkhof, F; Polman, C; Mancini, L; Manfredonia, F; Marino, S; Miller, D H; Montalban, X; Palace, J; Rocca, M; Ropele, S; Rovira, A; Smith, S; Thompson, A; Thornton, J; Yousry, T; Matthews, P M

    2008-02-01

    We performed a prospective multi-centre study using functional magnetic resonance imaging (fMRI) to better characterize the relationships between clinical expression and brain function in patients with multiple sclerosis (MS) at eight European sites (56 MS patients and 60 age-matched, healthy controls). Patients showed greater task-related activation bilaterally in brain regions including the pre- and post-central, inferior and superior frontal, cingulate and superior temporal gyri and insula (P < 0.05, all statistics corrected for multiple comparisons). Both patients and healthy controls showed greater brain activation with increasing age in the ipsilateral pre-central and inferior frontal gyri (P < 0.05). Patients, but not controls, showed greater brain activation in the anterior cingulate gyrus and the bilateral ventral striatum (P < 0.05) with less hand dexterity. An interaction between functional activation changes in MS and age was found. This large fMRI study over a broadly selected MS patient population confirms that movement for patients demands significantly greater cognitive 'resource allocation' and suggests age-related differences in brain responses to the disease. These observations add to evidence that brain functional responses (including potentially adaptive brain plasticity) contribute to modulation of clinical expression of MS pathology and demonstrate the feasibility of a multi-site functional MRI study of MS.

  13. Prefecture-wide multi-centre radiation dose survey as a useful tool for CT dose optimisation: report of Gunma radiation dose study.

    Science.gov (United States)

    Fukushima, Yasuhiro; Taketomi-Takahashi, Ayako; Nakajima, Takahito; Tsushima, Yoshito

    2015-12-01

    The aim of this study was to verify the usefulness for the dose optimisation of setting a diagnostic reference level (DRL) based on the results of a prefecture-wide multi-centre radiation dose survey and providing data feedback. All hospitals/clinics in the authors' prefecture with computed tomography (CT) scanners were requested to report data. The first survey was done in July 2011, and the results of dose-length products (DLPs) for each CT scanner were fed back to all hospitals/clinics, with DRL set from all the data. One year later, a second survey was done in the same manner. The medians of DLP in the upper abdomen, whole body and coronary CT in 2012 were significantly smaller than those of the 2011 survey. The interquartile ranges of DLP in the head, chest, pelvis and coronary CT were also smaller in 2012. Radiation dose survey with data feedback may be helpful for CT dose optimisation. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  14. Gadobutrol-enhanced moving-table magnetic resonance angiography in patients with peripheral vascular disease: a prospective, multi-centre blinded comparison with digital subtraction angiography

    Energy Technology Data Exchange (ETDEWEB)

    Hentsch, Annette [Schering AG, Berlin (Germany); Aschauer, Manuela A.; Ebner, Franz [Department of Magnetic Resonance, University of Graz, Graz (Austria); Balzer, Joern O.; Davis, Kirsten [Department of Diagnostic and Interventional Radiology, University of Frankfurt/Main, Frankfurt/Main (Germany); Brossmann, Joachim; Schaefer, Fritz K.W. [Department of Diagnostic Radiology, University of Kiel, Kiel (Germany); Busch, Hans P. [Krankenhaus der Barmherzigen Brueder, Trier (Germany); Douek, Philippe [Department of Diagnostic Radiology, University of Lyon (France); Engelshoven, Jos M.A. van; Leiner, Tim [Department of Radiology, Cardiovascular Research Institute, University of Maastricht, Maastricht (Netherlands); Gregor, Michaela; Reimer, Peter [Department of Radiology, Staedtisches Klinikum, Karlsruhe (Germany); Kersting, Christian [Department of Diagnostic Radiology, University of Muenster, Muenster (Germany); Knuesel, Patrick R. [Institute of Diagnostic Radiology, University Hospital Zurich, MRI Center, Zurich (Switzerland); Leen, Edward [Department of X-ray, Glasgow Royal Infirmary, Glasgow (United Kingdom); Loewe, Christian; Thurnher, Siegfried A. [Section of Angiography and Interventional Radiology, Department of Radiology' ' University of Vienna, Vienna (Austria); McPherson, Simon [Department of Radiology, University of Leeds, Leeds (United Kingdom); Taupitz, Matthias [Department of Radiology, Humboldt University of Berlin (Charite), Berlin (Germany); Tombach, Bernd; Wegener, Robin; Weishaupt, Dominik; Meaney, James F.M.

    2003-09-01

    The purpose of this study was to compare moving-table three-dimensional contrast-enhanced magnetic resonance angiography (CE MRA), using 1.0-mol gadobutrol, with intra-arterial digital subtraction angiography (i.a. DSA) for evaluation of pelvic and peripheral arteries in patients with peripheral arterial occlusive disease. A total of 203 patients were examined in a prospective, multi-centre study at 1.0/1.5 T. Ten vessel segments of one leg were evaluated on-site and by three independent blinded reviewers off-site. One hundred eighty-two patients were evaluable in blinded reading. For pelvis and thigh, there was statistically significant diagnostic agreement between CE MRA and i.a. DSA on-site (94%) and off-site (86-88%). Overall, for detection of clinically significant stenoses, 93% sensitivity and 90% specificity were achieved in on-site evaluation, with 71-76 and 87-93% off-site; for detection of occlusion, sensitivity and specificity on-site were 91 and 97%, with 75-82 and 94-98% off-site. Evaluation was more sensitive on-site than off-site for detection of stenoses and occlusion, whereas specificity was similar. The CE MRA with 1.0-mol gadobutrol gave results comparable to those of i.a. DSA for the larger arteries of pelvis and thigh. Results for calf arteries were compromised by spatial resolution and technical limitations. (orig.)

  15. Multi-centre evaluation of accuracy and reproducibility of planar and SPECT image quantification. An IAEA phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Zimmermann, Brian E. [National Institute of Standards and Technology, Gaithersburg, MD (United States); Grosev, Darko [Univ. Hospital Centre Zagreb (Croatia); Buvat, Irene [Service Hospitalier Frederic Joliot, Paris (France); and others

    2017-08-01

    Accurate quantitation of activity provides the basis for internal dosimetry of targeted radionuclide therapies. This study investigated quantitative imaging capabilities at sites with a variety of experience and equipment and assessed levels of errors in activity quantitation in Single-Photon Emission Computed Tomography (SPECT) and planar imaging. Participants from 9 countries took part in a comparison in which planar, SPECT and SPECT with X ray computed tomography (SPECT-CT) imaging were used to quantify activities of four epoxy-filled cylinders containing {sup 133}Ba, which was chosen as a surrogate for {sup 131}I. The sources, with nominal volumes of 2, 4, 6 and 23 mL, were calibrated for {sup 133}Ba activity by the National Institute of Standards and Technology, but the activity was initially unknown to the participants. Imaging was performed in a cylindrical phantom filled with water. Two trials were carried out in which the participants first estimated the activities using their local standard protocols, and then repeated the measurements using a standardized acquisition and analysis protocol. Finally, processing of the imaging data from the second trial was repeated by a single centre using a fixed protocol. In the first trial, the activities were underestimated by about 15% with planar imaging. SPECT with Chang's first order attenuation correction (Chang-AC) and SPECT-CT overestimated the activity by about 10%. The second trial showed moderate improvements in accuracy and variability. Planar imaging was subject to methodological errors, e.g., in the use of a transmission scan for attenuation correction. The use of Chang-AC was subject to variability from the definition of phantom contours. The project demonstrated the need for training and standardized protocols to achieve good levels of quantitative accuracy and precision in a multicentre setting. Absolute quantification of simple objects with no background was possible with the strictest protocol to

  16. Multi-centre evaluation of accuracy and reproducibility of planar and SPECT image quantification: An IAEA phantom study.

    Science.gov (United States)

    Zimmerman, Brian E; Grošev, Darko; Buvat, Irène; Coca Pérez, Marco A; Frey, Eric C; Green, Alan; Krisanachinda, Anchali; Lassmann, Michael; Ljungberg, Michael; Pozzo, Lorena; Quadir, Kamila Afroj; Terán Gretter, Mariella A; Van Staden, Johann; Poli, Gian Luca

    2017-06-01

    Accurate quantitation of activity provides the basis for internal dosimetry of targeted radionuclide therapies. This study investigated quantitative imaging capabilities at sites with a variety of experience and equipment and assessed levels of errors in activity quantitation in Single-Photon Emission Computed Tomography (SPECT) and planar imaging. Participants from 9 countries took part in a comparison in which planar, SPECT and SPECT with X ray computed tomography (SPECT-CT) imaging were used to quantify activities of four epoxy-filled cylinders containing 133 Ba, which was chosen as a surrogate for 131 I. The sources, with nominal volumes of 2, 4, 6 and 23mL, were calibrated for 133 Ba activity by the National Institute of Standards and Technology, but the activity was initially unknown to the participants. Imaging was performed in a cylindrical phantom filled with water. Two trials were carried out in which the participants first estimated the activities using their local standard protocols, and then repeated the measurements using a standardized acquisition and analysis protocol. Finally, processing of the imaging data from the second trial was repeated by a single centre using a fixed protocol. In the first trial, the activities were underestimated by about 15% with planar imaging. SPECT with Chang's first order attenuation correction (Chang-AC) and SPECT-CT overestimated the activity by about 10%. The second trial showed moderate improvements in accuracy and variability. Planar imaging was subject to methodological errors, e.g., in the use of a transmission scan for attenuation correction. The use of Chang-AC was subject to variability from the definition of phantom contours. The project demonstrated the need for training and standardized protocols to achieve good levels of quantitative accuracy and precision in a multicentre setting. Absolute quantification of simple objects with no background was possible with the strictest protocol to about 6% with planar

  17. Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study

    Directory of Open Access Journals (Sweden)

    Grant Adrian M

    2006-12-01

    Full Text Available Abstract Background Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS. Methods In-depth semi-structured telephone interviews were conducted in 2003–04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. Results The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. Conclusion This study highlights complex financial aspects of planning and conducting trials, especially where multiple

  18. Use of antibiotics and the prevalence of antibiotic-associated diarrhoea in patients with spinal cord injuries : An international, multi-centre study

    NARCIS (Netherlands)

    Wong, S.; Santullo, P.; Hirani, S. P.; Kumar, N.; Chowdhury, J. R.; Garcia-Forcada, A.; Recio, M.; Paz, F.; Zobina, I.; Kolli, S.; Kiekens, C.; Draulans, N.; Roels, E.; Martens-Bijlsma, J.; O'Driscoll, J.; Jamous, A.; Saif, M.

    2017-01-01

    Background: Little is known about the use of antibiotics and the extent of antibiotic-associated diarrhoea (AAD) in patients with spinal cord injuries (SCIs). Aims: To record the use of antibiotics, establish the prevalence of AAD and Clostridium difficile infection (CDI), and assess if there was

  19. Percutaneous Isolated Hepatic Perfusion as a Treatment for Isolated Hepatic Metastases of Uveal Melanoma: Patient Outcome and Safety in a Multi-centre Study.

    Science.gov (United States)

    Vogl, Thomas J; Koch, Silvia A; Lotz, Gösta; Gebauer, Bernhard; Willinek, Winfried; Engelke, Christoph; Brüning, Roland; Zeile, Martin; Wacker, Frank; Vogel, Arndt; Radeleff, Boris; Scholtz, Jan-Erik

    2017-06-01

    Percutaneous isolated hepatic perfusion (PIHP) with Melphalan has been developed as a treatment for patients with isolated hepatic metastases of uveal melanoma. We discuss patient outcome and safety in a retrospective multi-centre study. Between 2012 and 2016 18 patients with un-resectable isolated hepatic metastases of uveal melanoma received single or repeated PIHP with Melphalan (n = 35) at seven sites. Progression-free time, overall survival time (OS) and tumour response by means of RECIST 1.1 criteria were evaluated. Peri- and post-procedural adverse events (AE) were registered. Patients' life quality was assessed using four-point scale questionnaires. Of 18 patients, initial PIHP treatment resulted in partial response (PR) in eight, stable disease (SD) in seven and progressive disease (PD) in three cases. Nine patients underwent second PIHP with PR in eight cases and PD in one case. Six patients were evaluated after third PIHP with PR in five patients and SD in one patient. Two patients received fourth PIHP with PD in both cases. Median OS was 9.6 months (range 1.6-41.0 months). Median progression-free survival time was 12.4 months (range 0.9-41.0 months) with 1-year survival of 44%. Most common post-procedural AE grade 3 and 4 were temporary leukopenia (n = 11) and thrombocytopenia (n = 8). Patients' self-assessments showed good ratings for overall health and quality of life with only slight changes after PIHP, and a high degree of satisfaction with PIHP treatment. PIHP with Melphalan proved to be a relatively safe, minimal-invasive and repeatable treatment for patients with non-resectable hepatic metastases of uveal melanoma.

  20. A randomised, double-blind, multi-centre trial comparing vasopressin and adrenaline in patients with cardiac arrest presenting to or in the Emergency Department.

    Science.gov (United States)

    Ong, Marcus Eng Hock; Tiah, Ling; Leong, Benjamin Sieu-Hon; Tan, Elaine Ching Ching; Ong, Victor Yeok Kein; Tan, Elizabeth Ai Theng; Poh, Bee Yen; Pek, Pin Pin; Chen, Yuming

    2012-08-01

    To compare vasopressin and adrenaline in the treatment of patients with cardiac arrest presenting to or in the Emergency Department (ED). A randomised, double-blind, multi-centre, parallel-design clinical trial in four adult hospitals. Eligible cardiac arrest patients (confirmed by the absence of pulse, unresponsiveness and apnea) aged >16 (aged>21 for one hospital) were randomly assigned to intravenous adrenaline (1mg) or vasopressin (40 IU) at ED. Patients with traumatic cardiac arrest or contraindication for cardiopulmonary resuscitation (CPR) were excluded. Patients received additional open label doses of adrenaline as per current guidelines. Primary outcome was survival to hospital discharge (defined as participant discharged alive or survival to 30 days post-arrest). The study recruited 727 participants (adrenaline = 353; vasopressin = 374). Baseline characteristics of the two groups were comparable. Eight participants (2.3%) from adrenaline and 11 (2.9%) from vasopressin group survived to hospital discharge with no significant difference between groups (p = 0.27, RR = 1.72, 95% CI = 0.65-4.51). After adjustment for race, medical history, bystander CPR and prior adrenaline given, more participants survived to hospital admission with vasopressin (22.2%) than with adrenaline (16.7%) (p = 0.05, RR = 1.43, 95% CI = 1.02-2.04). Sub-group analysis suggested improved outcomes for vasopressin in participants with prolonged arrest times. Combination of vasopressin and adrenaline did not improve long term survival but seemed to improve survival to admission in patients with prolonged cardiac arrest. Further studies on the effect of vasopressin combined with therapeutic hypothermia on patients with prolonged cardiac arrest are needed. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  1. Percutaneous Isolated Hepatic Perfusion as a Treatment for Isolated Hepatic Metastases of Uveal Melanoma: Patient Outcome and Safety in a Multi-centre Study

    International Nuclear Information System (INIS)

    Vogl, Thomas J.; Koch, Silvia A.; Lotz, Gösta; Gebauer, Bernhard; Willinek, Winfried; Engelke, Christoph; Brüning, Roland; Zeile, Martin; Wacker, Frank; Vogel, Arndt; Radeleff, Boris; Scholtz, Jan-Erik

    2017-01-01

    PurposePercutaneous isolated hepatic perfusion (PIHP) with Melphalan has been developed as a treatment for patients with isolated hepatic metastases of uveal melanoma. We discuss patient outcome and safety in a retrospective multi-centre study.Materials and MethodsBetween 2012 and 2016 18 patients with un-resectable isolated hepatic metastases of uveal melanoma received single or repeated PIHP with Melphalan (n = 35) at seven sites. Progression-free time, overall survival time (OS) and tumour response by means of RECIST 1.1 criteria were evaluated. Peri- and post-procedural adverse events (AE) were registered. Patients’ life quality was assessed using four-point scale questionnaires.ResultsOf 18 patients, initial PIHP treatment resulted in partial response (PR) in eight, stable disease (SD) in seven and progressive disease (PD) in three cases. Nine patients underwent second PIHP with PR in eight cases and PD in one case. Six patients were evaluated after third PIHP with PR in five patients and SD in one patient. Two patients received fourth PIHP with PD in both cases. Median OS was 9.6 months (range 1.6–41.0 months). Median progression-free survival time was 12.4 months (range 0.9–41.0 months) with 1-year survival of 44%. Most common post-procedural AE grade 3 and 4 were temporary leukopenia (n = 11) and thrombocytopenia (n = 8). Patients’ self-assessments showed good ratings for overall health and quality of life with only slight changes after PIHP, and a high degree of satisfaction with PIHP treatment.ConclusionPIHP with Melphalan proved to be a relatively safe, minimal-invasive and repeatable treatment for patients with non-resectable hepatic metastases of uveal melanoma.

  2. Percutaneous Isolated Hepatic Perfusion as a Treatment for Isolated Hepatic Metastases of Uveal Melanoma: Patient Outcome and Safety in a Multi-centre Study

    Energy Technology Data Exchange (ETDEWEB)

    Vogl, Thomas J., E-mail: t.vogl@em.uni-frankfurt.de; Koch, Silvia A., E-mail: silvia.koch@web.de [University Hospital Frankfurt, Department of Diagnostic and Interventional Radiology (Germany); Lotz, Gösta, E-mail: goesta.lotz@kgu.de [University Hospital Frankfurt, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy (Germany); Gebauer, Bernhard, E-mail: bernhard.gebauer@charite.de [Universitätsmedizin Berlin, Department of Diagnostic and Interventional Radiology, Campus Charité Mitte (Germany); Willinek, Winfried, E-mail: w.willinek@bk-trier.de [Brüderkrankenhaus Trier, Department of Diagnostic and Interventional Radiology (Germany); Engelke, Christoph, E-mail: engelke@ekweende.de [Evangelisches Krankenhaus Göttingen-Weende gGmbH, Department of Diagnostic and Interventional Radiology (Germany); Brüning, Roland, E-mail: r.bruening@asklepios.com; Zeile, Martin, E-mail: m.zeile@asklepios.com [Asklepios Klinik Barmbek, Department of Diagnostic and Interventional Radiology (Germany); Wacker, Frank, E-mail: wacker.frank@mh-hannover.de [Medizinische Hochschule Hannover, Department of Diagnostic and Interventional Radiology (Germany); Vogel, Arndt, E-mail: vogel.arndt@mh-hannover.de [Medizinische Hochschule Hannover, Department of Gastroenterology, Hepatology and Endocrinology (Germany); Radeleff, Boris, E-mail: boris.radeleff@med.uni-heidelberg.de [Heidelberg University Hospital, Department of Diagnostic and Interventional Radiology (Germany); Scholtz, Jan-Erik, E-mail: janerikscholtz@gmail.com [University Hospital Frankfurt, Department of Diagnostic and Interventional Radiology (Germany)

    2017-06-15

    PurposePercutaneous isolated hepatic perfusion (PIHP) with Melphalan has been developed as a treatment for patients with isolated hepatic metastases of uveal melanoma. We discuss patient outcome and safety in a retrospective multi-centre study.Materials and MethodsBetween 2012 and 2016 18 patients with un-resectable isolated hepatic metastases of uveal melanoma received single or repeated PIHP with Melphalan (n = 35) at seven sites. Progression-free time, overall survival time (OS) and tumour response by means of RECIST 1.1 criteria were evaluated. Peri- and post-procedural adverse events (AE) were registered. Patients’ life quality was assessed using four-point scale questionnaires.ResultsOf 18 patients, initial PIHP treatment resulted in partial response (PR) in eight, stable disease (SD) in seven and progressive disease (PD) in three cases. Nine patients underwent second PIHP with PR in eight cases and PD in one case. Six patients were evaluated after third PIHP with PR in five patients and SD in one patient. Two patients received fourth PIHP with PD in both cases. Median OS was 9.6 months (range 1.6–41.0 months). Median progression-free survival time was 12.4 months (range 0.9–41.0 months) with 1-year survival of 44%. Most common post-procedural AE grade 3 and 4 were temporary leukopenia (n = 11) and thrombocytopenia (n = 8). Patients’ self-assessments showed good ratings for overall health and quality of life with only slight changes after PIHP, and a high degree of satisfaction with PIHP treatment.ConclusionPIHP with Melphalan proved to be a relatively safe, minimal-invasive and repeatable treatment for patients with non-resectable hepatic metastases of uveal melanoma.

  3. One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.

    Science.gov (United States)

    Thomas, Peter W; Thomas, Sarah; Kersten, Paula; Jones, Rosemary; Slingsby, Vicky; Nock, Alison; Davies Smith, Angela; Baker, Roger; Galvin, Kathleen T; Hillier, Charles

    2014-05-19

    Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The aim was to evaluate the effectiveness at 1-year follow-up of a manualised group-based programme ('FACETS') for managing MS-fatigue. One-year follow-up of a pragmatic multi-centre randomised controlled trial. People with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcome measures were fatigue severity (Global Fatigue Severity subscale of the Fatigue Assessment Instrument), self-efficacy (MS-Fatigue Self-Efficacy) and disease-specific quality of life (MS Impact Scale). Between May 2008 and November 2009, 164 participants were randomised. Primary outcome data were available at 1 year for 131 (80%). The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted, with a slight reduction in standardised effect sizes (SES) (-0.29, p = 0.06 and 0.34, p = 0.09, respectively). There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months (SES -0.24, p = 0.046). No adverse events were reported. Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1 year with additional improvements in MS impact. The FACETS programme provides modest long-term benefits to people with MS-fatigue. ISRCTN76517470.

  4. Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

    Science.gov (United States)

    Beukes, Eldré W; Baguley, David M; Allen, Peter M; Manchaiah, Vinaya; Andersson, Gerhard

    2017-04-21

    Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. ClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

  5. Radiological and pathological findings of interval cancers in a multi-centre, randomized, controlled trial of mammographic screening in women from age 40-41 years

    Energy Technology Data Exchange (ETDEWEB)

    Evans, A.J. [Breast Institute, Nottingham City Hospital, Nottingham (United Kingdom)]. E-mail: andrew.evans@nuh.nhs.uk; Kutt, E. [Avon Breast Cancer Screening Unit, Central Health Clinic, Tower Hill, Bristol, Avon (United Kingdom); Record, C. [Breast Screening Service, Stoke Mandeville Hospital, Aylesbury (United Kingdom); Waller, M. [Cancer Screening Evaluation Unit, Institute of Cancer Research, London (United Kingdom); Bobrow, L. [Histopathology, Addenbrookes Hospital, Cambridge (United Kingdom); Moss, S. [Cancer Screening Evaluation Unit, Institute of Cancer Research, London (United Kingdom)

    2007-04-15

    Aim: The aim of this study was to analyse the radiographic findings of the screening mammograms of women with interval cancer who participated in a multi-centre, randomized, controlled trial of mammographic screening in women from age 40-48 years. Materials and methods: The screening and diagnostic mammograms of 208 women with interval cancers were reviewed. Abnormalities were classified as malignant, subtle and non-specific. Results: Eighty-seven (42%) of women had true, 66 (32%) occult and 55 (26%) false-negative interval cancers. The features most frequently missed or misinterpreted were granular microcalcification (38%), asymmetric density (27%) and distortion (22%). Thirty-seven percent of abnormal previous screens were classified as malignant, 39% subtle change and 21% as non-specific. Granular calcifications were significantly more common on the diagnostic mammograms of false-negative interval cancers than those of true interval cancers (28 versus 14%, p = 0.04). Occult interval cancers were more likely to be <10 mm and <15 mm in invasive pathological size than other interval cancers (p = 0.03 and 0.005, respectively). True interval cancers were more likely to be histologically grade 3 than other interval cancers (p = 0.04). Women who developed true and false-negative interval cancers had similar background patterns, but women with occult cancers had a higher proportion of dense patterns (p < 0.05). Conclusion: Interval cancers in a young screening population have a high proportion of occult lesions that are small and occur in dense background patterns. The proportion of interval cancers that are false negative is similar that seen in older populations and granular microcalcification is the commonest missed mammographic feature.

  6. A multi-centre, blinded, randomised, placebo-controlled, laboratory-based study of MQX-503, a novel topical gel formulation of nitroglycerine, in patients with Raynaud phenomenon.

    Science.gov (United States)

    Hummers, Laura K; Dugowson, Carin E; Dechow, Frederick J; Wise, Robert A; Gregory, Jeffrey; Michalek, Joel; Yenokyan, Gayane; McGready, John; Wigley, Fredrick M

    2013-12-01

    MQX-503 is a novel nitroglycerine preparation designed to absorb quickly and allow local vasodilatation in the skin. We examined the efficacy and tolerability of this medication in Raynaud phenomenon (RP) in a laboratory-based study. In this multi-centre, double-blind, randomised, placebo-controlled, cross-over study, subjects were treated with 0.5% or 1.25% nitroglycerine or placebo gel. Subjects received each dose twice in a randomised order. Each study session consisted of baseline laser Doppler measurements, study gel application and 5 min of cold chamber exposure (-20°C). Blood flow (BF) was measured at the end of exposure and for the next 120 min at set intervals. Other outcome measures included achievement of baseline BF; the time to achieve 50% and 70% baseline skin temperature (ST); and pain, tingling and numbness scores. 37 subjects completed 214 treatment periods. Time to achieve baseline BF was significantly shorter in the two treated groups (HR=1.77 and 2.02 for 0.5% and 1.25% vs placebo, respectively). The proportion of subjects achieving baseline BF was 45.8% for placebo, 66.2% for 0.5% and 69% for 1.25% (p=0.01 and p=0.002 for 0.5% and 1.25% vs placebo, respectively). No meaningful differences were seen in ST or pain/numbness/tingling scores. Treatment was well tolerated with no serious adverse events. Treatment with MQX-503 caused a significant improvement in skin BF compared with placebo. Data from this proof of concept study suggest benefit of MQX-503 in subjects with RP.

  7. ASAP ECMO: Antibiotic, Sedative and Analgesic Pharmacokinetics during Extracorporeal Membrane Oxygenation: a multi-centre study to optimise drug therapy during ECMO

    Directory of Open Access Journals (Sweden)

    Shekar Kiran

    2012-11-01

    Full Text Available Abstract Background Given the expanding scope of extracorporeal membrane oxygenation (ECMO and its variable impact on drug pharmacokinetics as observed in neonatal studies, it is imperative that the effects of the device on the drugs commonly prescribed in the intensive care unit (ICU are further investigated. Currently, there are no data to confirm the appropriateness of standard drug dosing in adult patients on ECMO. Ineffective drug regimens in these critically ill patients can seriously worsen patient outcomes. This study was designed to describe the pharmacokinetics of the commonly used antibiotic, analgesic and sedative drugs in adult patients receiving ECMO. Methods/Design This is a multi-centre, open-label, descriptive pharmacokinetic (PK study. Eligible patients will be adults treated with ECMO for severe cardiac and/or respiratory failure at five Intensive Care Units in Australia and New Zealand. Patients will receive the study drugs as part of their routine management. Blood samples will be taken from indwelling catheters to investigate plasma concentrations of several antibiotics (ceftriaxone, meropenem, vancomycin, ciprofloxacin, gentamicin, piperacillin-tazobactum, ticarcillin-clavulunate, linezolid, fluconazole, voriconazole, caspofungin, oseltamivir, sedatives and analgesics (midazolam, morphine, fentanyl, propofol, dexmedetomidine, thiopentone. The PK of each drug will be characterised to determine the variability of PK in these patients and to develop dosing guidelines for prescription during ECMO. Discussion The evidence-based dosing algorithms generated from this analysis can be evaluated in later clinical studies. This knowledge is vitally important for optimising pharmacotherapy in these most severely ill patients to maximise the opportunity for therapeutic success and minimise the risk of therapeutic failure. Trial registration ACTRN12612000559819

  8. Radiological and pathological findings of interval cancers in a multi-centre, randomized, controlled trial of mammographic screening in women from age 40-41 years

    International Nuclear Information System (INIS)

    Evans, A.J.; Kutt, E.; Record, C.; Waller, M.; Bobrow, L.; Moss, S.

    2007-01-01

    Aim: The aim of this study was to analyse the radiographic findings of the screening mammograms of women with interval cancer who participated in a multi-centre, randomized, controlled trial of mammographic screening in women from age 40-48 years. Materials and methods: The screening and diagnostic mammograms of 208 women with interval cancers were reviewed. Abnormalities were classified as malignant, subtle and non-specific. Results: Eighty-seven (42%) of women had true, 66 (32%) occult and 55 (26%) false-negative interval cancers. The features most frequently missed or misinterpreted were granular microcalcification (38%), asymmetric density (27%) and distortion (22%). Thirty-seven percent of abnormal previous screens were classified as malignant, 39% subtle change and 21% as non-specific. Granular calcifications were significantly more common on the diagnostic mammograms of false-negative interval cancers than those of true interval cancers (28 versus 14%, p = 0.04). Occult interval cancers were more likely to be <10 mm and <15 mm in invasive pathological size than other interval cancers (p = 0.03 and 0.005, respectively). True interval cancers were more likely to be histologically grade 3 than other interval cancers (p = 0.04). Women who developed true and false-negative interval cancers had similar background patterns, but women with occult cancers had a higher proportion of dense patterns (p < 0.05). Conclusion: Interval cancers in a young screening population have a high proportion of occult lesions that are small and occur in dense background patterns. The proportion of interval cancers that are false negative is similar that seen in older populations and granular microcalcification is the commonest missed mammographic feature

  9. Determinants of self-monitoring of blood glucose in patients with Type 1 diabetes: a multi-centre study in Brazil.

    Science.gov (United States)

    Gomes, M B; Tannus, L R M; Cobas, R A; Matheus, A S M; Dualib, P; Zucatti, A T; Cani, C; Guedes, A D; Santos, F M; Sepulveda, J; Tolentino, M; Façanha, M C; Faria, A C R A; Lavigne, S; Montenegro, A P; Rodacki, M; de Fatima Guedes, M; Szundy, R; Cordeiro, M M; Santos, P T S; Negrato, C A

    2013-10-01

    The aim of this study was to determine the relationship between the daily frequency of self-monitoring of blood glucose and glycaemic control, demographic and socio-economic status in patients with Type 1 diabetes under routine clinical care in Brazil. This was a cross-sectional, multi-centre study conducted between December 2008 and December 2010 in 28 public clinics in 20 Brazilian cities. The data were obtained from 3176 patients, aged 22 ± 11.8 years, of whom 56.3% were female and 57.4% were Caucasian. The mean time since diabetes diagnosis was 11.7 ± 8.1 years. The prevalence of self-monitoring of blood glucose was 88.5%. There was a significant increase in self-monitoring frequency associated with female gender, lower ages, more intensive diabetes management and higher socio-economic status. A correlation between HbA(1c) levels and the daily frequency of self-monitoring was observed (r(s) = -0.13; P = 0.001). The mean HbA1c levels were related to the daily frequency of self-monitoring (P self-monitoring more than four times daily (9.2, 11.2, 10.2,15.2 and 15% for one, two, three, four, five or more self-monitoring tests daily, respectively; P self-monitoring tests daily, with more frequent testing reported by females, younger patients, those on intensive insulin regimens and of higher socio-economic status. No additional benefit was found in patients who performed self-monitoring more than four times daily. The diabetes care team must improve patients' education regarding self-monitoring of blood glucose and its benefits. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

  10. Oxygen titration after resuscitation from out-of-hospital cardiac arrest: a multi-centre, randomised controlled pilot study (the EXACT pilot trial).

    Science.gov (United States)

    Bray, Janet E; Hein, Cindy; Smith, Karen; Stephenson, Michael; Grantham, Hugh; Finn, Judith; Stub, Dion; Cameron, Peter

    2018-04-20

    Recent studies suggest the administration of 100% oxygen to hyperoxic levels following return-of-spontaneous-circulation (ROSC) post-cardiac arrest may be harmful. However, the feasibility and safety of oxygen titration in the prehospital setting is unknown. We conducted a multi-centre, phase-2 study testing whether prehospital titration of oxygen results in an equivalent number of patients arriving at hospital with oxygen saturations SpO2 ≥ 94%. We enrolled unconscious adults with: sustained ROSC; initial shockable rhythm; an advanced airway; and an SpO2 ≥ 95%. Initially (Sept 2015-March 2016) patients were randomised 1:1 to either 2 litres/minute (L/min) oxygen (titrated) or >10 L/min oxygen (control) via a bag-valve reservoir. However, one site experienced a high number of desaturations (SpO2 titrated arm and this arm was changed (April 2016) to an initial reduction of oxygen to 4 L/min then, if tolerated, to 2 L/min, and the desaturation limit was decreased to titrated (n = 37: 2L/min = 20 and 2-4 L/min = 17) oxygen or control (n = 24). Patients allocated to titrated oxygen were more likely to desaturate compared to controls ((SpO2 titrated: 90% vs. control: 100%) and all patients had a SpO2 ≥ 90%. One patient (control) re-arrested. Survival to hospital discharge was similar. Oxygen titration post-ROSC is feasible in the prehospital environment, but incremental titration commencing at 4L/min oxygen flow may be needed to maintain an oxygen saturation >90% (NCT02499042). Copyright © 2018. Published by Elsevier B.V.

  11. The impact of PET-CT in suspected recurrent ovarian cancer: A prospective multi-centre study as part of the Australian PET Data Collection Project.

    Science.gov (United States)

    Fulham, M J; Carter, J; Baldey, A; Hicks, R J; Ramshaw, J E; Gibson, M

    2009-03-01

    To assess the impact of FDG PET-CT on the management of patients with suspected recurrent ovarian cancer and to determine the incremental information provided by PET-CT. This was a prospective, multi-centre, cohort study. Ninety women (mean age 59.9 years; age range 35-85 years) with a previous history of treated epithelial ovarian carcinoma and suspected recurrence based on elevated CA-125, anatomical imaging or clinical symptoms were studied with FDG PET-CT across two States. Referring doctors were asked to specify a management plan pre-PET, if management was altered after PET-CT and, the impact (rated - none, low, medium, high) of PET-CT on patient management. The pre-PET management plan could include radiotherapy, chemotherapy, surgery, and 'other' including observation. Patients were followed at 6 and 12 months and clinical status, evidence of recurrence and progression were recorded. Patients were referred by 34 individual specialists. At least 168 additional sites of disease in 61 patients (68%), not identified by conventional imaging were identified by PET-CT. In 77% the additional lesions were located below the diaphragm and most were nodal or peritoneal. PET-CT affected management in 60% (49% high, 11% medium impact). Patients where more disease was detected with PET-CT were more likely to progress in the following 12 months. For women with previously treated ovarian carcinoma with recurrent disease, PET-CT can: a) alter management in close to 60% of patients, b) detect more sites of disease than abdominal and pelvic CT, c) is superior in the detection of nodal, peritoneal and subcapsular liver disease and d) offers the opportunity for technology replacement in this setting.

  12. Associations between community-based physiotherapy for musculoskeletal injury and health related quality of life (EQ-5D): a multi-centre retrospective analysis.

    Science.gov (United States)

    Caplan, Nick; Robson, H; Robson, A; Barry, G; Wilkes, G

    2017-10-25

    Community-based musculoskeletal physiotherapy is used to improve function and health related quality of life (HRQoL). The purpose of this retrospective, multi-centre observational study was to determine the association between community-based physiotherapy management for musculoskeletal disorders and changes in HRQoL. Four thousand one hundred twelve patients' data were included in the study. Patients were included if they received a single period of treatment for a musculoskeletal injury or disorder. Patients were only included if they were being treated for a single morbidity. Patients received standard physiotherapy appropriate to their specific disorder, which could include health education/advice, exercise therapy, manual therapy, taping, soft tissue techniques, electrotherapy and/or acupuncture. Health related quality of life was assessed using the EQ-5D index. EQ-5D improved by 0.203 across all patients (d = 1.10). When grouped by anatomical site of symptom, the largest increases in EQ-5D was in foot pain (0.233; d = 1.29) and lumbar pain (0.231; d = 1.13). Improvements in EQ-5D greater than the minimum clinically important difference (MCID) were seen in 68.4% of all patients. The highest proportion of patients with positive responses to treatment were in ankle pain (74.2%) and thoracic pain (73.4%). The hand (40.5%), elbow (34.7%), and hip (33.9%) showed the greatest proportion of patients that did not respond to treatment. Community-based musculoskeletal physiotherapy is associated with improved health related quality of life. A randomised controlled trial is needed to determine any causal relationship between community-based physiotherapy and health related quality of life improvements.

  13. Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial

    International Nuclear Information System (INIS)

    McNeely, Margaret L.; Campbell, Kristin L.; Webster, Marc; Kuusk, Urve; Tracey, Karen; Mackey, John

    2016-01-01

    Lymphedema is a prevalent long-term effect of breast cancer treatment that is associated with reduced quality of life. More recent observational data suggest that the addition of night-time compression to day-time use of a compression garment results in better long-term control of arm lymphedema. The primary objectives of the randomized controlled phase of the trial are to determine the efficacy of night-time compression on arm lymphedema volume maintenance and quality of life in breast cancer survivors who have completed intensive reduction treatment for their lymphedema. The study will be a parallel 3-arm, multi-centre randomized fast-track trial. A total of 120 women with breast cancer related lymphedema will be recruited from 3 centres in Canada and randomized to group 1: Day-time compression garment alone or Group 2: Day-time compression garment + night-time compression bandaging or Group 3: Day-time compression garment + use of a night-time compression system garment. The duration of the primary intervention period will be 12 weeks. The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal observational design. The primary outcome variables: differences from baseline to week 12 in arm volume and quality of life (Lymphoedema Functioning, Disability and Health Questionnaire: Lymph-ICF). Secondary outcomes include bioimpedance analysis, sleep disturbance and self-efficacy. All measurements are standardized and will be performed prior to randomization, and at weeks 6, 12, 18 and 24. The use of night-time compression as a self-management strategy for chronic breast cancer related lymphedema is seen as an innovative approach to improve long-term control over the condition. This trial aims to advance the knowledge on self-management strategies for lymphedema

  14. Vorinostat in refractory soft tissue sarcomas - Results of a multi-centre phase II trial of the German Soft Tissue Sarcoma and Bone Tumour Working Group (AIO).

    Science.gov (United States)

    Schmitt, Thomas; Mayer-Steinacker, Regine; Mayer, Frank; Grünwald, Viktor; Schütte, Jochen; Hartmann, Jörg T; Kasper, Bernd; Hüsing, Johannes; Hajda, Jacek; Ottawa, Gregor; Mechtersheimer, Gunhild; Mikus, Gerd; Burhenne, Jürgen; Lehmann, Lorenz; Heilig, Christoph E; Ho, Anthony D; Egerer, Gerlinde

    2016-09-01

    New treatment options for patients with metastatic Soft Tissue Sarcoma are urgently needed. Preclinical studies suggested activity of vorinostat, a histone deacetylase inhibitor. A multi-centre, open-label, non-randomised phase II trial to investigate the efficacy and safety of vorinostat in patients with locally advanced or metastatic Soft Tissue Sarcoma failing 1st-line anthracycline-based chemotherapy was initiated. Patients were treated with vorinostat 400 mg po qd for 28 d followed by a treatment-free period of 7 d, representing a treatment cycle of 5 weeks. Restaging was performed every three cycles or at clinical progression. Between 06/10 and 09/13, 40 Soft Tissue Sarcoma patients were treated with vorinostat at seven participating centres. Patients had received 1 (n=8, 20%), 2 (n=10, 25%) or ≥3 (n=22, 55%) previous lines of chemotherapy. Best response after three cycles of treatment was stable disease (n=9, 23%). Median progression-free survival and overall survival were 3.2 and 12.3 months, respectively. Six patients showed long-lasting disease stabilisation for up to ten cycles. Statistical analyses failed to identify baseline predictive markers in this subgroup. Major toxicities (grade ≥III) included haematological toxicity (n=6, 15%) gastrointestinal disorders (n=5, 13%), fatigue (n=4, 10%), musculoskeletal pain (n=4, 10%), and pneumonia (n=2, 5%). In a heavily pre-treated patient population, objective response to vorinostat was low. However, a small subgroup of patients had long-lasting disease stabilisation. Further studies aiming to identify predictive markers for treatment response as well as exploration of combination regimens are warranted. NCT00918489 (ClinicalTrials.gov) EudraCT-number: 2008-008513-19. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Sheard, Laura; O'Hara, Jane; Armitage, Gerry; Wright, John; Cocks, Kim; McEachan, Rosemary; Watt, Ian; Lawton, Rebecca

    2014-10-29

    Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection

  16. Efficacy and safety of artemisinin-naphthoquine versus dihydroartemisinin-piperaquine in adult patients with uncomplicated malaria: a multi-centre study in Indonesia

    Directory of Open Access Journals (Sweden)

    Tjitra Emiliana

    2012-06-01

    Full Text Available Abstract Background A practical and simple regimen for all malaria species is needed towards malaria elimination in Indonesia. It is worth to compare the efficacy and safety of a single dose of artemisinin-naphthoquine (AN with a three-day regimen of dihydroartemisinin-piperaquine (DHP, the existing programme drug, in adults with uncomplicated symptomatic malaria. Methods This is a phase III, randomized, open label using sealed envelopes, multi-centre, comparative study between a single dose of AN and a three-day dose of DHP in Jayapura and Maumere. The modified WHO inclusion and exclusion criteria for efficacy study were used in this trial. A total of 401 eligible adult malaria subjects were hospitalized for three days and randomly treated with AN four tablets single dose on day 0 or DHP three to four tablets single daily dose for three days, and followed for 42 days for physical examination, thick and thin smears microscopy, and other necessary tests. The efficacy of drug was assessed by polymerase chain reaction (PCR uncorrected and corrected. Results There were 153 Plasmodium falciparum, 158 Plasmodium vivax and 90 P. falciparum/P. vivax malaria. Mean of fever clearance times were similar, 13.0 ± 10.3 hours in AN and 11.3 ± 7.3 hours in DHP groups. The mean of parasite clearance times were longer in AN compared with DHP (28.0 ± 11.7 hours vs 25.5 ± 12.2 hours, p = 0.04. There were only 12 PCR-corrected P. falciparum late treatment failures: seven in AN and five in DHP groups. The PCR uncorrected and corrected on day −42 of adequate clinical and parasitological responses for treatment of any malaria were 93.7% (95% Cl: 90.3–97.2 and 96.3% (95% Cl: 93.6–99.0 in AN, 96.3% (95% Cl: 93.5–99.0 and 97.3% (95% Cl: 95.0–99.6 in DHP groups. Few and mild adverse events were reported. All the abnormal haematology and blood chemistry values had no clinical abnormality. Conclusion AN and DHP are confirmed very effective

  17. Implementation of preventive strength training in residential geriatric care: a multi-centre study protocol with one year of interventions on multiple levels.

    Science.gov (United States)

    Brach, Michael; Nieder, Frank; Nieder, Ulrike; Mechling, Heinz

    2009-11-24

    There is scientific evidence that preventive physical exercise is effective even in high age. In contrast, there are few opportunities of preventive exercise for highly aged people endangered by or actually in need of care. For example, they would not be able to easily go to training facilities; standard exercises may be too intensive and therefore be harmful to them; orientation disorders like dementia would exacerbate individuals and groups in following instructions and keeping exercises going. In order to develop appropriate interventions, these and other issues were assigned to different levels: the individual-social level (ISL), the organisational-institutional level (OIL) and the political-cultural level (PCL). Consequently, this conceptional framework was utilised for development, implementation and evaluation of a new strength and balance exercise programme for old people endangered by or actually in need of daily care. The present paper contains the development of this programme labeled "fit for 100", and a study protocol of an interventional single-arm multi-centre trial. The intervention consisted of (a) two group training sessions every week over one year, mainly resistance exercises, accompanied by sensorimotor and communicative group exercises and games (ISL), (b) a sustainable implementation concept, starting new groups by instructors belonging to the project, followed by training and supervision of local staff, who stepwise take over the group (OIL), (c) informing and convincing activities in professional, administrative and governmental contexts, public relation activities, and establishing an advisory council with renowned experts and public figures (PCL). Participating institutions of geriatric care were selected through several steps of quality criteria assessment. Primary outcome measures were continuous documentation of individual participation (ISL), number of groups continued without external financial support (at the end of the project, and

  18. Induction of labour versus expectant management for nulliparous women over 35 years of age: a multi-centre prospective, randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Kate F

    2012-12-01

    Full Text Available Abstract Background British women are increasingly delaying childbirth. The proportion giving birth over the age of 35 rose from 12% in 1996 to 20% in 2006. Women over this age are at a higher risk of perinatal death, and antepartum stillbirth accounts for 61% of all such deaths. Women over 40 years old have a similar stillbirth risk at 39 weeks as women who are between 25 and 29 years old have at 41 weeks. Many obstetricians respond to this by suggesting labour induction at term to forestall some of the risk. In a national survey of obstetricians 37% already induce women aged 40–44 years. A substantial minority of parents support such a policy, but others do not on the grounds that it might increase the risk of Caesarean section. However trials of induction in other high-risk scenarios have not shown any increase in Caesarean sections, rather the reverse. If induction for women over 35 did not increase Caesareans, or even reduced them, it would plausibly improve perinatal outcome and be an acceptable intervention. We therefore plan to perform a trial to test the effect of such an induction policy on Caesarean section rates. This trial is funded by the NHS Research for Patient Benefit (RfPB Programme. Design The 35/39 trial is a multi-centre, prospective, randomised controlled trial. It is being run in twenty UK centres and we aim to recruit 630 nulliparous women (315 per group aged over 35 years of age, over two years. Women will be randomly allocated to one of two groups: Induction of labour between 390/7 and 396/7 weeks gestation. Expectant management i.e. awaiting spontaneous onset of labour unless a situation develops necessitating either induction of labour or Caesarean Section. The primary purpose of this trial is to establish what effect a policy of induction of labour at 39 weeks for nulliparous women of advanced maternal age has on the rate of Caesarean section deliveries. The secondary aim is to act as a pilot study for a trial to

  19. Implementation of preventive strength training in residential geriatric care: a multi-centre study protocol with one year of interventions on multiple levels

    Directory of Open Access Journals (Sweden)

    Nieder Ulrike

    2009-11-01

    Full Text Available Abstract Background There is scientific evidence that preventive physical exercise is effective even in high age. In contrast, there are few opportunities of preventive exercise for highly aged people endangered by or actually in need of care. For example, they would not be able to easily go to training facilities; standard exercises may be too intensive and therefore be harmful to them; orientation disorders like dementia would exacerbate individuals and groups in following instructions and keeping exercises going. In order to develop appropriate interventions, these and other issues were assigned to different levels: the individual-social level (ISL, the organisational-institutional level (OIL and the political-cultural level (PCL. Consequently, this conceptional framework was utilised for development, implementation and evaluation of a new strength and balance exercise programme for old people endangered by or actually in need of daily care. The present paper contains the development of this programme labeled "fit for 100", and a study protocol of an interventional single-arm multi-centre trial. Methods The intervention consisted of (a two group training sessions every week over one year, mainly resistance exercises, accompanied by sensorimotor and communicative group exercises and games (ISL, (b a sustainable implementation concept, starting new groups by instructors belonging to the project, followed by training and supervision of local staff, who stepwise take over the group (OIL, (c informing and convincing activities in professional, administrative and governmental contexts, public relation activities, and establishing an advisory council with renowned experts and public figures (PCL. Participating institutions of geriatric care were selected through several steps of quality criteria assessment. Primary outcome measures were continuous documentation of individual participation (ISL, number of groups continued without external financial

  20. Implementation of preventive strength training in residential geriatric care: a multi-centre study protocol with one year of interventions on multiple levels

    Science.gov (United States)

    2009-01-01

    Background There is scientific evidence that preventive physical exercise is effective even in high age. In contrast, there are few opportunities of preventive exercise for highly aged people endangered by or actually in need of care. For example, they would not be able to easily go to training facilities; standard exercises may be too intensive and therefore be harmful to them; orientation disorders like dementia would exacerbate individuals and groups in following instructions and keeping exercises going. In order to develop appropriate interventions, these and other issues were assigned to different levels: the individual-social level (ISL), the organisational-institutional level (OIL) and the political-cultural level (PCL). Consequently, this conceptional framework was utilised for development, implementation and evaluation of a new strength and balance exercise programme for old people endangered by or actually in need of daily care. The present paper contains the development of this programme labeled "fit for 100", and a study protocol of an interventional single-arm multi-centre trial. Methods The intervention consisted of (a) two group training sessions every week over one year, mainly resistance exercises, accompanied by sensorimotor and communicative group exercises and games (ISL), (b) a sustainable implementation concept, starting new groups by instructors belonging to the project, followed by training and supervision of local staff, who stepwise take over the group (OIL), (c) informing and convincing activities in professional, administrative and governmental contexts, public relation activities, and establishing an advisory council with renowned experts and public figures (PCL). Participating institutions of geriatric care were selected through several steps of quality criteria assessment. Primary outcome measures were continuous documentation of individual participation (ISL), number of groups continued without external financial support (at the end

  1. Estimating glomerular filtration rate by serum creatinine or/and cystatin C equations: An analysis of multi-centre Chinese subjects.

    Science.gov (United States)

    Ye, Xiaoshuang; Liu, Xun; Song, Dan; Zhang, Xiaoxuan; Zhu, Bei; Wei, Lu; Pei, Xiaohua; Wu, Jianqing; Lou, Tanqi; Zhao, Weihong

    2016-05-01

    Various equations based on serum creatinine or/and cystatin C, required further validation in a Chinese population. We compared the performance of six Chinese equations (Mascr, Peiscr, Macys, Fengcys, Mascr-cys and Fengscr-cys) with the CKD-EPI equations in multi-centre Chinese subjects and evaluated their applicability in clinical practice. A total of 1522 adult patients from four different hospitals of China were enrolled in the study. (99m) Tc-DTPA renal dynamic imaging was used as the reference GFR (rGFR), and serum creatinine and cystatin C were measured by standardized assays. An optimal score system was implemented in the study. The average rGFR of recruited subjects was 67.30±28.89 mL/min per 1.73m(2) . All estimated GFR (eGFR) correlated well with rGFR. In accordance with Bland-Altman analysis, the Fengscr-cys equations achieved optimal overall performance (score 14 vs 0-6), with least bias (median difference, -0.57 mL/min per 1.73m(2) ; median absolute difference, 8.83 mL/min per 1.73m(2) ), best precision (17.99 mL/min per 1.73m(2) ), highest accuracy (percentage of eGFR within 15%, 30% and 50% of the rGFR (P15 , P30 and P50 ; 49.7%, 78.7% and 91.8%, respectively); root-mean-square-error (RMSE, 16.28)). The Fengcys equation, a typical cystatin C based equation, was another well-behaved formula with an impressive performance. The Ma equations performed much poorer than the CKD-EPI equations. Consistent results can be observed in the GFR- /age- and sex-specific subgroups, while none equation yielded ideal accuracy in GFR<60 mL/min per 1.73 m(2) subgroup. The Fengscr-cys equation appeared to achieve the best performance for GFR estimation in overall Chinese adult patients. However, further research is warranted to improve the accuracy of available equations in GFR less than 60 mL/min per 1.73 m(2) individuals. © 2015 Asian Pacific Society of Nephrology.

  2. Vitrectomy with or without encircling band for pseudophakic retinal detachment: a multi-centre, three-arm, randomised clinical trial. VIPER Study Report No. 1--design and enrolment.

    Science.gov (United States)

    Mazinani, B; Baumgarten, S; Schiller, P; Agostini, H; Helbig, H; Limburg, E; Hellmich, M; Walter, P

    2016-03-01

    Scleral buckling is currently used in addition to vitrectomy for the treatment of pseudophakic retinal detachment (PRD) to better support the vitreous base and better visualisation of the periphery. The aims of this study are to evaluate (1) whether the combination of 20 G vitrectomy and scleral buckling is superior to 20 G vitrectomy alone (control) (confirmatory), and (2) whether transconjunctival 23/25 G vitrectomy is non-inferior to 20 G vitrectomy (both without scleral buckling) regarding operation success (exploratory). The VIPER (Vitrectomy Plus Encircling Band Vs. Vitrectomy Alone For The Treatment Of Pseudophakic Retinal Detachment) study is an unmasked, multi-centre, three-arm randomised trial. Patients with PRD were eligible, excluding complicated retinal detachment or otherwise severe ophthalmologic impairment. Patients were randomised to one of three interventions: 20 G vitrectomy alone (control C), combination of 20 G vitrectomy and circumferential scleral buckling (experimental treatment E1) or 23/25 G vitrectomy alone (experimental treatment E2). The primary endpoint is the absence of any indication for a retina re-attaching procedure during 6 months of follow-up. Secondary endpoints include best corrected visual acuity, retina re-attaching procedures, complications and adverse events. From June 2011 to August 2013, 257 patients were enrolled in the study. The internet randomisation service assigned 100 patients each to the treatment arms C and E1, and 57 patients to treatment E2. The imbalance is due to the fact that several retinal surgeons did not qualify for performing E2. The random assignment was stratified and balanced (ie, 1:1 or 1:1:1 ratio) by surgeon. The described study represents a methodologically rigorous protocol evaluating the benefits of three different vitrectomy approaches to PRD. The projected results will help to establish their overall efficacy and will permit conclusions regarding their relative value. DRKS

  3. Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).

    Science.gov (United States)

    Naughton, Felix; Cooper, Sue; Foster, Katharine; Emery, Joanne; Leonardi-Bee, Jo; Sutton, Stephen; Jones, Matthew; Ussher, Michael; Whitemore, Rachel; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim

    2017-07-01

    To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Sixteen antenatal clinics in England. Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were smoked at least one daily cigarette (> 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

  4. Quality of out-of-hospital palliative emergency care depends on the expertise of the emergency medical team--a prospective multi-centre analysis.

    Science.gov (United States)

    Wiese, Christoph H R; Bartels, Utz E; Marczynska, Karolina; Ruppert, David; Graf, Bernhard M; Hanekop, Gerd G

    2009-12-01

    The number of palliative care patients who live at home and have non-curable life-threatening diseases is increasing. This is largely a result of modern palliative care techniques (e.g. specialised out-of-hospital palliative medical care services), changes in healthcare policy and the availability of home care services. Accordingly, pre-hospital emergency physicians today are more likely to be involved in out-of-hospital emergency treatment of palliative care patients with advanced disease. In a prospective multi-centre study, we analysed all palliative emergency care calls during a 24-month period across four emergency services in Germany. Participating pre-hospital emergency physicians were rated according to their expertise in emergency and palliative care as follows--group 1: pre-hospital emergency physicians with high experience in emergency and palliative medical care, group 2: pre-hospital emergency physicians with high experience in emergency medical care but less experience in palliative medical care and group 3: pre-hospital emergency physicians with low experience in palliative and emergency medical care. During the period of interest, the centres received 361 emergency calls requiring a response to palliative care patients (2.8% of all 12,996 emergency calls). Ten percent of all patients were treated by group 1; 42% were treated by group 2 and 47% were treated by group 3. There was a statistically significant difference in the treatment of palliative care patients (e.g. transfer to hospital, symptom control, end-of-life decision) as a result of the level of expertise of the investigated pre-hospital emergency physicians (pmedical treatment of palliative care patients depends on the expertise in palliative medical care of the pre-hospital emergency physicians who respond to the call. In our investigation, best out-of-hospital palliative medical care was given by pre-hospital emergency physicians who had significant expertise in palliative and emergency

  5. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Logan Pip A

    2012-06-01

    Full Text Available Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries, satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect, age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence

  6. Laryngeal sarcoidosis: a case-control study.

    Science.gov (United States)

    Duchemann, Boris; Lavolé, Armelle; Naccache, Jean-Marc; Nunes, Hilario; Benzakin, Sylvain; Lefevre, Marine; Kambouchner, Marianne; Périé, Sophie; Valeyre, Dominique; Cadranel, Jacques

    2014-10-20

    We undertook a study on a series of laryngeal sarcoidosis (LS), a very rare and often threatening localization to better specify laryngeal manifestations, sarcoidosis clinical expression and long-term follow-up. This was a retrospective case-control study. All LS patients from two French centers were included and compared to sarcoidosis patients without laryngeal localization with two controls for one patient. Twelve consecutive LS patients were recruited between 1993 and 2011. LS revealed sarcoidosis in eight cases (67%). The most common symptoms were hoarseness (77%), inspiratory dyspnea (38%) and dysphagia (38%). Epidemiological characterisics were not different. Extrapulmonary localizations were significantly more common in LS patients than in controls (92% vs. 54%, p=0.02), particularly lupus pernio (25% vs. 0%, p=0.03) and nasosinusal involvement (83% vs. 4%, p<0.01) while thoracic involvement was less frequent (58% vs 100%, p < 0.01). Treatment rates were higher in the LS group (92% vs. 58%, p=0.04), and treatment duration was longer (median: 81 vs. 13 months, p=0.04), with frequent long-term treatment (67%, N=8/12). Two patients underwent surgery. One patient needed temporary tracheostomy during the course of the disease; Remission rates were lower in LS patients (9% vs. 58% at 2 years p<0.01). Eventually, there was no death nor definitive tracheotomy. LS is a rare condition that is often associated to other loco-regional localizations. LS are often difficult to manage. Survival is good but may require a medico-surgical approach.

  7. REMCARE: Pragmatic Multi-Centre Randomised Trial of Reminiscence Groups for People with Dementia and their Family Carers: Effectiveness and Economic Analysis.

    Directory of Open Access Journals (Sweden)

    Robert T Woods

    Full Text Available Joint reminiscence groups, involving people with dementia and family carers together, are popular, but the evidence-base is limited. This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care.This multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group. A restricted dynamic method of randomisation was used, with an overall allocation ratio of 1:1, restricted to ensure viable sized intervention groups. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (primary end-point, usually in the person's home. Participants were recruited in eight centres, mainly through NHS Memory Clinics and NHS community mental health teams. Included participants were community resident people with mild to moderate dementia (DSM-IV, who had a relative or other care-giver in regular contact, to act as informant and willing and able to participate in intervention. 71% carers were spouses. 488 people with dementia (mean age 77.5were randomised: 268 intervention, 220 control; 350 dyads completed the study (206 intervention, 144 control. The intervention evaluated was joint reminiscence groups (with up to 12 dyads weekly for twelve weeks; monthly maintenance sessions for further seven months. Sessions followed a published treatment manual and were held in a variety of community settings. Two trained facilitators in each centre were supported by volunteers. Primary outcome measures were self-reported quality of life for the person with dementia (QoL-AD, psychological distress for the carer (General Health Questionnaire, GHQ-28. Secondary outcome measures included: autobiographical memory and activities of daily living for the person with dementia; carer stress for the carer; mood, relationship quality and service use and costs for both.The intention to treat analysis (ANCOVA identified no

  8. The case-control design in veterinary sciences: A survey.

    Science.gov (United States)

    Cullen, Jonah N; Sargeant, Jan M; Makielski, Kelly M; O'Connor, Annette M

    2016-11-01

    The case-control study design is deceptively simple. However, many design considerations influence the estimated effect measure. An investigation of case-control studies in the human health literature suggested that some of these considerations are not described in reports of case-control studies. Our hypothesis was that the majority of veterinary studies labeled as case-controls would be incident density designs, and many would not interpret the effect measure obtained from those studies as the rate ratio rather than the odds ratio. Reference databases were searched for author-designated case-control studies. A survey of 100 randomly selected studies was conducted to examine the different design options described and estimated effect measures. Of the 100 author-identified case-control studies, 83 assessed an exposure-outcome association and, of those, only 54 (65.1%) sampled the study population based on an outcome and would thus be considered case-control designs. Twelve studies were incidence density designs but none used this terminology. Of the studies that reported an odds ratio as the effect measure, none reported on additional considerations that would have enabled a more interpretable result. This survey indicated many case-control-labeled studies were not case-control designs and among case-control studies, key design aspects were not often described. The absence of information about study design elements and underlying assumptions in case-control studies limits the ability to establish the effect measured by the study and the evidentiary value of the study might be underestimated. Copyright © 2016 Elsevier B.V. All rights reserved.

  9. Inpatient pediatric consultation-liaison: a case-controlled study.

    Science.gov (United States)

    Carter, Bryan D; Kronenberger, William G; Baker, Janet; Grimes, Laurie M; Crabtree, Valerie M; Smith, Courtney; McGraw, Kelly

    2003-09-01

    To conduct a prospective case-controlled study of pediatric inpatients referred for consultation in a tertiary care children's medical center. Referrals (n = 104) were matched with nonreferrals (n = 104) for age (4 to 18 years), gender, and illness type/severity and completed parent- and self-report (dependent on age) behavioral rating scales to assess for adjustment/functioning. Nurses completed in-hospital ratings of behavioral/adjustment difficulties. Goal attainment and satisfaction ratings were obtained from the referring physicians, parents/guardians, and the consultant. Referrals exhibited more behavior/adjustment/coping difficulties than nonreferrals by parent, nurse, and self report. Frequently employed interventions included coping-strategies intervention, cognitive and behavioral therapies, and case management. Referring physician and consultant ratings of goal attainment were high, as were physician ratings of satisfaction and parent/guardian ratings of overall helpfulness. Pediatric inpatients referred by their physicians had significantly more internalizing and externalizing disturbances than their nonreferred hospitalized peers. Many of the behavioral and adjustment problems that lead to in-hospital consultation referral were evident in global behavior difficulties prior to hospitalization. Referring pediatricians, parents/guardians, and consultants rate the outcome as benefiting the patients via assisting in the overall management of their health concerns, coping, and adjustment.

  10. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder--study protocol of the randomised, multi-centre controlled SOSTA--net trial.

    Science.gov (United States)

    Freitag, Christine M; Cholemkery, Hannah; Elsuni, Leyla; Kroeger, Anne K; Bender, Stephan; Kunz, Cornelia Ursula; Kieser, Meinhard

    2013-01-07

    Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA-FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. The SOSTA - net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. ISRCTN94863788--SOSTA--net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

  11. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

    Directory of Open Access Journals (Sweden)

    Freitag Christine M

    2013-01-01

    Full Text Available Abstract Background Group-based social skills training (SST has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD. To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS compared to treatment as usual (TAU. It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

  12. Influence of quality of care and individual patient characteristics on quality of life and return to work in survivors of the acute respiratory distress syndrome: protocol for a prospective, observational, multi-centre patient cohort study (DACAPO).

    Science.gov (United States)

    Brandstetter, Susanne; Dodoo-Schittko, Frank; Blecha, Sebastian; Sebök, Philipp; Thomann-Hackner, Kathrin; Quintel, Michael; Weber-Carstens, Steffen; Bein, Thomas; Apfelbacher, Christian

    2015-12-17

    Health-related quality of life (HRQoL) and return to work are important outcomes in critical care medicine, reaching beyond mortality. Little is known on factors predictive of HRQoL and return to work in critical illness, including the acute respiratory distress syndrome (ARDS), and no evidence exists on the role of quality of care (QoC) for outcomes in survivors of ARDS. It is the aim of the DACAPO study ("Surviving ARDS: the influence of QoC and individual patient characteristics on quality of life") to investigate the role of QoC and individual patient characteristics on quality of life and return to work. A prospective, observational, multi-centre patient cohort study will be performed in Germany, using hospitals from the "ARDS Network Germany" as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyse a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. QoC will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (HRQoL and return to work) will be assessed by self-report questionnaires. Further data collection includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of QoC and individual patient characteristics on outcomes, taking the cluster structure of the data into account. By obtaining comprehensive data at patient and hospital level using a prospective multi-centre design, the DACAPO-study is the first study investigating the influence of QoC on individual outcomes of ARDS survivors.

  13. Reducing selection bias in case-control studies from rare disease registries

    Directory of Open Access Journals (Sweden)

    Mistry Pramod K

    2011-09-01

    Full Text Available Abstract Background In clinical research of rare diseases, where small patient numbers and disease heterogeneity limit study design options, registries are a valuable resource for demographic and outcome information. However, in contrast to prospective, randomized clinical trials, the observational design of registries is prone to introduce selection bias and negatively impact the validity of data analyses. The objective of the study was to demonstrate the utility of case-control matching and the risk-set method in order to control bias in data from a rare disease registry. Data from the International Collaborative Gaucher Group (ICGG Gaucher Registry were used as an example. Methods A case-control matching analysis using the risk-set method was conducted to identify two groups of patients with type 1 Gaucher disease in the ICGG Gaucher Registry: patients with avascular osteonecrosis (AVN and those without AVN. The frequency distributions of gender, decade of birth, treatment status, and splenectomy status were presented for cases and controls before and after matching. Odds ratios (and 95% confidence intervals were calculated for each variable before and after matching. Results The application of case-control matching methodology results in cohorts of cases (i.e., patients with AVN and controls (i.e., patients without AVN who have comparable distributions for four common parameters used in subject selection: gender, year of birth (age, treatment status, and splenectomy status. Matching resulted in odds ratios of approximately 1.00, indicating no bias. Conclusions We demonstrated bias in case-control selection in subjects from a prototype rare disease registry and used case-control matching to minimize this bias. Therefore, this approach appears useful to study cohorts of heterogeneous patients in rare disease registries.

  14. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    DEFF Research Database (Denmark)

    O'Donnell, M; Serpault, Damien Xavier; Diener, C

    2010-01-01

    Stroke is a major global health problem. It is the third leading cause of death and the leading cause of adult disability. INTERHEART, a global case-control study of acute myocardial infarction in 52 countries (29,972 participants), identified nine modifiable risk factors that accounted for >90......-income countries is inadequate, where a very large burden of stroke occurs. Accordingly, a similar epidemiological study is required for stroke, to inform effective population-based strategies to reduce the risk of stroke. Methods: INTERSTROKE is an international, multicenter case-control study. Cases are patients...... years). A questionnaire (cases and controls) is used to acquire information on known and proposed risk factors for stroke. Cardiovascular (e.g. blood pressure) and anthropometric (e.g. waist-to-hip ratio) measurements are obtained at the time of interview. Nonfasting blood samples and random urine...

  15. Bridging case-control studies and randomized trials

    Directory of Open Access Journals (Sweden)

    Rosendaal Frits R

    2001-05-01

    Full Text Available Abstract Randomized trials and observational studies, such as case-control studies, are often seen as opposing approaches. However, in many instances results obtained by different designs may complement each other. For instance, case-control studies on aetiology of disease may help to give the direction of future trials. In this commentary, the author discusses the purpose of randomization and observation, and under which conditions one design may be preferred to another. Randomization is useful to combat 'confounding by indication', and is therefore the design of choice for most therapeutic trials. When this confounding is not an issue, as in studies of genetic risk factors or side-effects, then case-control studies are preferred.

  16. Perinatal mortality and associated risk factors: a case control study ...

    African Journals Online (AJOL)

    BACKGROUND: Perinatal mortality is reported to be five times higher in developing than in developed nations. Little is known about the commonly associated risk factors for perinatal mortality in Southern Nations National Regional State of Ethiopia. METHODS: A case control study for perinatal mortality was conducted in ...

  17. Drug and alcohol crash risk : a case-control study.

    Science.gov (United States)

    2016-12-01

    This study used a case-control design to estimate the risk of crashes involving drivers using drugs, alcohol or both. Data was collected in Virginia Beach, Virginia, for 20 months. The study obtained biological measures on more than 3,000 crash...

  18. Case-control matching: effects, misconceptions, and recommendations.

    Science.gov (United States)

    Mansournia, Mohammad Ali; Jewell, Nicholas Patrick; Greenland, Sander

    2018-01-01

    Misconceptions about the impact of case-control matching remain common. We discuss several subtle problems associated with matched case-control studies that do not arise or are minor in matched cohort studies: (1) matching, even for non-confounders, can create selection bias; (2) matching distorts dose-response relations between matching variables and the outcome; (3) unbiased estimation requires accounting for the actual matching protocol as well as for any residual confounding effects; (4) for efficiency, identically matched groups should be collapsed; (5) matching may harm precision and power; (6) matched analyses may suffer from sparse-data bias, even when using basic sparse-data methods. These problems support advice to limit case-control matching to a few strong well-measured confounders, which would devolve to no matching if no such confounders are measured. On the positive side, odds ratio modification by matched variables can be assessed in matched case-control studies without further data, and when one knows either the distribution of the matching factors or their relation to the outcome in the source population, one can estimate and study patterns in absolute rates. Throughout, we emphasize distinctions from the more intuitive impacts of cohort matching.

  19. Determinants of podoconiosis, a case control study | Feleke ...

    African Journals Online (AJOL)

    Background: Podoconiosis is a non-filarial swelling of lower extremity endemic in tropical regions, North America and India. The etiology and pathophysiology of the disease remain unknown. The objective of this study was to identify the determinants of Podoconiosis. Methods: Unmatched case control study design was ...

  20. Aetiology of handball injuries : a case-control study

    NARCIS (Netherlands)

    Dirx, M.; Bouter, L. M.; de Geus, G. H.

    This article presents the results of a case-control study regarding the background to handball injuries among players of 12 years and older. Data were collected by means of a written questionnaire on the nature, location and direct causes of the injuries as well as information on risk factors.

  1. Using cumulative sums of martingale residuals for model checking in nested case-control studies.

    Science.gov (United States)

    Borgan, Ørnulf; Zhang, Ying

    2015-09-01

    Standard use of Cox regression requires collection of covariate information for all individuals in a cohort even when only a small fraction of them experiences the event of interest (fail). This may be very expensive for large cohorts. Further in biomarker studies, it will imply a waste of valuable biological material that one may want to save for future studies. A nested case-control study offers a useful alternative. For this design, covariate information is only needed for the failing individuals (cases) and a sample of controls selected from the cases' at-risk sets. Methods based on martingale residuals are useful for checking the fit of Cox's regression model for cohort data. But similar methods have so far not been developed for nested case-control data. In this article, it is described how one may define martingale residuals for nested case-control data, and it is shown how plots and tests based on cumulative sums of martingale residuals may be used to check model fit. The plots and tests may be obtained using available software. © 2015, The International Biometric Society.

  2. Population versus hospital controls for case-control studies on cancers in Chinese hospitals

    Directory of Open Access Journals (Sweden)

    Li Lin

    2011-12-01

    Full Text Available Abstract Background Correct control selection is crucial to the internal validity of case-control studies. Little information exists on differences between population and hospital controls in case-control studies on cancers in Chinese hospital setting. Methods We conducted three parallel case-control studies on leukemia, breast and colorectal cancers in China between 2009 and 2010, using population and hospital controls to separately match 540 incident cases by age, gender and residency at a 1:1 ratio. Demographic and lifestyle factors were measured using a validated questionnaire in face-to-face interview. Odds ratios (ORs and 95% confidence intervals (CIs were obtained using conditional logistic regression analyses. Results The two control groups had closely similar exposure distributions of 15 out of 16 factors, with the only exception being that hospital controls were less likely to have a BMI ≥ 25 (OR = 0.71, 95% CI: 0.54, 0.93. For exposure of green tea drinking, the adjusted ORs (95% CIs comparing green tealeaves intake ≥ 1000 grams annually with non-drinkers were 0.51 (0.31, 0.83 and 0.21 (0.27, 0.74 for three cancers combined, 0.06 (0.01, 0.61 and 0.07 (0.01, 0.47 for breast cancer, 0.52 (0.29, 0.94 and 0.45 (0.25, 0.82 for colorectal cancer, 0.65 (0.08, 5.63 and 0.57 (0.07, 4.79 for leukemia using hospital and population controls respectively. Conclusions The study found that hospital controls were comparable with population controls for most demographic characteristics and lifestyle factors measured, but there was a slight difference between the two control groups. Hospital outpatients provide a satisfactory control group in hospital-based case-control study in the Chinese hospital setting.

  3. Population versus hospital controls for case-control studies on cancers in Chinese hospitals.

    Science.gov (United States)

    Li, Lin; Zhang, Min; Holman, D'Arcy

    2011-12-15

    Correct control selection is crucial to the internal validity of case-control studies. Little information exists on differences between population and hospital controls in case-control studies on cancers in Chinese hospital setting. We conducted three parallel case-control studies on leukemia, breast and colorectal cancers in China between 2009 and 2010, using population and hospital controls to separately match 540 incident cases by age, gender and residency at a 1:1 ratio. Demographic and lifestyle factors were measured using a validated questionnaire in face-to-face interview. Odds ratios (ORs) and 95% confidence intervals (CIs) were obtained using conditional logistic regression analyses. The two control groups had closely similar exposure distributions of 15 out of 16 factors, with the only exception being that hospital controls were less likely to have a BMI ≥ 25 (OR = 0.71, 95% CI: 0.54, 0.93). For exposure of green tea drinking, the adjusted ORs (95% CIs) comparing green tealeaves intake ≥ 1000 grams annually with non-drinkers were 0.51 (0.31, 0.83) and 0.21 (0.27, 0.74) for three cancers combined, 0.06 (0.01, 0.61) and 0.07 (0.01, 0.47) for breast cancer, 0.52 (0.29, 0.94) and 0.45 (0.25, 0.82) for colorectal cancer, 0.65 (0.08, 5.63) and 0.57 (0.07, 4.79) for leukemia using hospital and population controls respectively. The study found that hospital controls were comparable with population controls for most demographic characteristics and lifestyle factors measured, but there was a slight difference between the two control groups. Hospital outpatients provide a satisfactory control group in hospital-based case-control study in the Chinese hospital setting.

  4. Study protocol: SPARCLE – a multi-centre European study of the relationship of environment to participation and quality of life in children with cerebral palsy

    Directory of Open Access Journals (Sweden)

    Colver Allan

    2006-04-01

    Full Text Available Abstract Background SPARCLE is a nine-centre European epidemiological research study examining the relationship of participation and quality of life to impairment and environment (physical, social and attitudinal in 8–12 year old children with cerebral palsy. Concepts are adopted from the International Classification of Functioning, Disability and Health which bridges the medical and social models of disability. Methods/Design A cross sectional study of children with cerebral palsy sampled from total population databases in 9 European regions. Children were visited by research associates in each country who had been trained together. The main instruments used were KIDSCREEN, Life-H, Strength and Difficulties Questionnaire, Parenting Stress Index. A measure of environment was developed within the study. All instruments were translated according to international guidelines. The potential for bias due to non response and missing data will be examined. After initial analysis using multivariate regression of how the data captured by each instrument relate to impairment and socio-economic characteristics, relationships between the latent traits captured by the instruments will then be analysed using structural equation modelling. Discussion This study is original in its methods by directly engaging children themselves, ensuring those with learning or communication difficulty are not excluded, and by studying in quantitative terms the crucial outcomes of participation and quality of life. Specification and publication of this protocol prior to analysis, which is not common in epidemiology but well established for randomised controlled trials and systematic reviews, should avoid the pitfalls of data dredging and post hoc analyses.

  5. Effect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trial.

    Science.gov (United States)

    Brorson, Stig; Olsen, Bo Sanderhoff; Frich, Lars Henrik; Jensen, Steen Lund; Johannsen, Hans Viggo; Sørensen, Anne Kathrine; Hrobjartsson, Asbjørn

    2009-07-08

    Fractures of the proximal humerus are common injuries and account for 4-5 percent of all fractures, second only to hip and wrist fractures. The incidence is positively correlated with age and osteoporosis, and is likely to increase. Displaced four-part fractures are among the most severe injuries, accounting for 2-10 percent of proximal humeral fractures. The optimal intervention is disputed. Two previous randomised trials were very small and involved a noticeable risk of bias, and systematic reviews consequently conclude that there is inadequate basis for evidence-based treatment decisions. We aim to compare the effect of osteosynthesis with angle-stable plate with non-surgical management, and the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management. We will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two-year period. We plan to include 162 patients. A central randomisation unit will allocate patients. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy regardless of treatment allocation. Patients will be followed at least one year. The primary outcomes will be the overall score on the Constant Disability Scale, and its pain subscale, measured at 12 months. A blinded physiotherapist will carry out the assessments. Other secondary outcomes are Oxford Shoulder Score, and general health status (Short Form-36).

  6. Effect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Johannsen Hans

    2009-07-01

    Full Text Available Abstract Background Fractures of the proximal humerus are common injuries and account for 4–5 percent of all fractures, second only to hip and wrist fractures. The incidence is positively correlated with age and osteoporosis, and is likely to increase. Displaced four-part fractures are among the most severe injuries, accounting for 2–10 percent of proximal humeral fractures. The optimal intervention is disputed. Two previous randomised trials were very small and involved a noticeable risk of bias, and systematic reviews consequently conclude that there is inadequate basis for evidence-based treatment decisions. We aim to compare the effect of osteosynthesis with angle-stable plate with non-surgical management, and the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management. Methods/Design We will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two-year period. We plan to include 162 patients. A central randomisation unit will allocate patients. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy regardless of treatment allocation. Patients will be followed at least one year. The primary outcomes will be the overall score on the Constant Disability Scale, and its pain subscale, measured at 12 months. A blinded physiotherapist will carry out the assessments. Other secondary outcomes are Oxford Shoulder Score, and general health status (Short Form-36.

  7. Efficacy and safety of rasagiline as an adjunct to levodopa treatment in Chinese patients with Parkinson's disease: a randomized, double-blind, parallel-controlled, multi-centre trial.

    Science.gov (United States)

    Zhang, Lina; Zhang, Zhiqin; Chen, Yangmei; Qin, Xinyue; Zhou, Huadong; Zhang, Chaodong; Sun, Hongbin; Tang, Ronghua; Zheng, Jinou; Yi, Lin; Deng, Liying; Li, Jinfang

    2013-08-01

    Rasagiline mesylate is a highly potent, selective and irreversible monoamine oxidase type B (MAOB) inhibitor and is effective as monotherapy or adjunct to levodopa for patients with Parkinson's disease (PD). However, few studies have evaluated the efficacy and safety of rasagiline in the Chinese population. This study was designed to investigate the safety and efficacy of rasagiline as adjunctive therapy to levodopa treatment in Chinese PD patients. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial conducted over a 12-wk period that enrolled 244 PD patients with motor fluctuations. Participants were randomly assigned to oral rasagiline mesylate (1 mg) or placebo, once daily. Altogether, 219 patients completed the trial. Rasagiline showed significantly greater efficacy compared with placebo. During the treatment period, the primary efficacy variable--mean adjusted total daily off time--decreased from baseline by 1.7 h in patients treated with 1.0 mg/d rasagiline compared to placebo (p rasagiline treatment. Rasagiline was well tolerated. This study demonstrated that rasagiline mesylate is effective and well tolerated as an adjunct to levodopa treatment in Chinese PD patients with fluctuations.

  8. DALI: Defining Antibiotic Levels in Intensive care unit patients: a multi-centre point of prevalence study to determine whether contemporary antibiotic dosing for critically ill patients is therapeutic.

    Science.gov (United States)

    Roberts, Jason A; De Waele, Jan J; Dimopoulos, George; Koulenti, Despoina; Martin, Claude; Montravers, Philippe; Rello, Jordi; Rhodes, Andrew; Starr, Therese; Wallis, Steven C; Lipman, Jeffrey

    2012-07-06

    The clinical effects of varying pharmacokinetic exposures of antibiotics (antibacterials and antifungals) on outcome in infected critically ill patients are poorly described. A large-scale multi-centre study (DALI Study) is currently underway describing the clinical outcomes of patients achieving pre-defined antibiotic exposures. This report describes the protocol. DALI will recruit over 500 patients administered a wide range of either beta-lactam or glycopeptide antibiotics or triazole or echinocandin antifungals in a pharmacokinetic point-prevalence study. It is anticipated that over 60 European intensive care units (ICUs) will participate. The primary aim will be to determine whether contemporary antibiotic dosing for critically ill patients achieves plasma concentrations associated with maximal activity. Secondary aims will compare antibiotic pharmacokinetic exposures with patient outcome and will describe the population pharmacokinetics of the antibiotics included. Various subgroup analyses will be conducted to determine patient groups that may be at risk of very low or very high concentrations of antibiotics. The DALI study should inform clinicians of the potential clinical advantages of achieving certain antibiotic pharmacokinetic exposures in infected critically ill patients.

  9. Multi-centre observational study of transplacental transmission of influenza antibodies following vaccination with AS03(A)-adjuvanted H1N1 2009 vaccine.

    Science.gov (United States)

    Puleston, Richard; Bugg, George; Hoschler, Katja; Konje, Justin; Thornton, James; Stephenson, Iain; Myles, Puja; Enstone, Joanne; Augustine, Glenda; Davis, Yvette; Zambon, Maria; Nicholson, Karl; Nguyen-Van-Tam, Jonathan

    2013-01-01

    Illness and death from influenza increase during pregnancy. In the United Kingdom pregnant women were targeted in a national programme for vaccination during the H1N1 2009-10 pandemic. In this study, pregnant women were recruited in labour from November 9, 2009 to March 10, 2010. Pandemic vaccination status was determined. Venous cord blood collected at delivery was evaluated for transplacental transfer of antibodies by measurement of haemagglutination inhibition and microneutralization titres. Samples were collected from 77 vaccinated and 27 unvaccinated women. Seroprotection (HI titre ≥1:40) was detected in 58 (75.3%, 95% CI 64.2-84.4) cord blood samples from vaccinated women and 5 (18.5%, 95% CI 6.3-38.1) from unvaccinated women (Pcases for at least 16 weeks. Immunization of pregnant women with AS03(A)-adjuvanted vaccine is followed by transplacental transfer of passive immunity at titres consistent with clinical protection in three-quarters of new-born infants. The findings support national and international pandemic H1N1 2009 recommendations for immunization during pregnancy.

  10. Violence against Women and Gastroschisis: A Case-Control Study

    OpenAIRE

    Ortega-Garc?a, Juan Antonio; Soldin, Offie P.; S?nchez-Sauco, Miguel Felipe; C?novas-Conesa, Alicia; Gomar?z-Pe?alver, Virtudes; Jaimes-Vega, Diana Carolina; Perales, Joseph E.; C?rceles-Alvarez, Alberto; Mart?nez-Ros, Maria Teresa; Ruiz, Daniel

    2013-01-01

    Background: Gastroschisis, a birth defect characterized by herniated fetal abdominal wall, occurs more commonly in infants born to teenage and young mothers. Ischemia of the vascular vitelline vessels is the likely mechanism of pathogenesis. Given that chronic stress and violence against women are risk factors for cardiovascular disease we explored whether these may represent risk factors for gastroschisis, when they occur during pregnancy. A case-control study was conducted, with 15 incident...

  11. Risk factors for gonorrhoea: case-control study.

    OpenAIRE

    Bjekić, M; Vlajinac, H; Sipetić, S; Marinković, J

    1997-01-01

    OBJECTIVE: To define risk factors for gonococcal infection. METHODS: A case-control study comparing 200 gonorrhoea cases with 400 patients with non-gonococcal genitourinary infections and 400 patients with various skin diseases, all of them attending City Department for Skin and Venereal Diseases In Belgrade (Yugoslavia) from October 1993 to December 1994. RESULTS: According to multivariate logistic regression analysis the following factors were significantly related to gonorrhoea in men: edu...

  12. Anxiety during pregnancy and preeclampsia: a case - control study

    OpenAIRE

    Masoumeh Kordi; Azra Vahed; Fariborz Rezaee Talab; Seyed Reza Mazloum; Marzieh Lotfalizadeh

    2017-01-01

    Introduction:  Preeclampsia is the common and dangerous complication of pregnancy with unknown reason. Multiple causes such as depression, psychological and physical stress may be involved in its development. This study was performed to determine the relationship between anxiety during pregnancy and the incidence of preeclampsia. Methods: This case-control study was conducted on 150 pregnant women with preeclampsia and 150 healthy pregnant women referred to health centers and academic hospita...

  13. Test-retest and interobserver reliability of quantitative sensory testing according to the protocol of the German Research Network on Neuropathic Pain (DFNS): a multi-centre study.

    Science.gov (United States)

    Geber, Christian; Klein, Thomas; Azad, Shahnaz; Birklein, Frank; Gierthmühlen, Janne; Huge, Volker; Lauchart, Meike; Nitzsche, Dorothee; Stengel, Maike; Valet, Michael; Baron, Ralf; Maier, Christoph; Tölle, Thomas; Treede, Rolf-Detlef

    2011-03-01

    Quantitative sensory testing (QST) is an instrument to assess positive and negative sensory signs, helping to identify mechanisms underlying pathologic pain conditions. In this study, we evaluated the test-retest reliability (TR-R) and the interobserver reliability (IO-R) of QST in patients with sensory disturbances of different etiologies. In 4 centres, 60 patients (37 male and 23 female, 56.4±1.9years) with lesions or diseases of the somatosensory system were included. QST comprised 13 parameters including detection and pain thresholds for thermal and mechanical stimuli. QST was performed in the clinically most affected test area and a less or unaffected control area in a morning and an afternoon session on 2 consecutive days by examiner pairs (4 QSTs/patient). For both, TR-R and IO-R, there were high correlations (r=0.80-0.93) at the affected test area, except for wind-up ratio (TR-R: r=0.67; IO-R: r=0.56) and paradoxical heat sensations (TR-R: r=0.35; IO-R: r=0.44). Mean IO-R (r=0.83, 31% unexplained variance) was slightly lower than TR-R (r=0.86, 26% unexplained variance, Ptest area (TR-R: r=0.86; IO-R: r=0.83) than in the control area (TR-R: r=0.79; IO-R: r=0.71, each Ptest-retest and interobserver reliability within 2days. With standardized training, observer bias is much lower than random variance. Quantitative sensory testing performed by trained examiners is a valuable diagnostic instrument with good interobserver and test-retest reliability for use in patients with sensory disturbances of different etiologies to help identify mechanisms of neuropathic and non-neuropathic pain. Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  14. Assessment of global phase uncertainty in case-control studies

    Directory of Open Access Journals (Sweden)

    van Houwelingen Hans C

    2009-09-01

    Full Text Available Abstract Background In haplotype-based candidate gene studies a problem is that the genotype data are unphased, which results in haplotype ambiguity. The measure 1 quantifies haplotype predictability from genotype data. It is computed for each individual haplotype, and for a measure of global relative efficiency a minimum value is suggested. Alternatively, we developed methods directly based on the information content of haplotype frequency estimates to obtain global relative efficiency measures: and based on A- and D-optimality, respectively. All three methods are designed for single populations; they can be applied in cases only, controls only or the whole data. Therefore they are not necessarily optimal for haplotype testing in case-control studies. Results A new global relative efficiency measure was derived to maximize power of a simple test statistic that compares haplotype frequencies in cases and controls. Application to real data showed that our proposed method gave a clear and summarizing measure for the case-control study conducted. Additionally this measure might be used for selection of individuals, who have the highest potential for improving power by resolving phase ambiguity. Conclusion Instead of using relative efficiency measure for cases only, controls only or their combined data, we link uncertainty measure to case-control studies directly. Hence, our global efficiency measure might be useful to assess whether data are informative or have enough power for estimation of a specific haplotype risk.

  15. Empathy among undergraduate medical students: A multi-centre cross-sectional comparison of students beginning and approaching the end of their course.

    Science.gov (United States)

    Quince, Thelma A; Kinnersley, Paul; Hales, Jonathan; da Silva, Ana; Moriarty, Helen; Thiemann, Pia; Hyde, Sarah; Brimicombe, James; Wood, Diana; Barclay, Matthew; Benson, John

    2016-03-15

    Although a core element in patient care the trajectory of empathy during undergraduate medical education remains unclear. Empathy is generally regarded as comprising an affective capacity: the ability to be sensitive to and concerned for, another and a cognitive capacity: the ability to understand and appreciate the other person's perspective. The authors investigated whether final year undergraduate students recorded lower levels of empathy than their first year counterparts, and whether male and female students differed in this respect. Between September 2013 and June 2014 an online questionnaire survey was administered to 15 UK, and 2 international medical schools. Participating schools provided both 5-6 year standard courses and 4 year accelerated graduate entry courses. The survey incorporated the Jefferson Scale of Empathy-Student Version (JSE-S) and Davis's Interpersonal Reactivity Index (IRI), both widely used to measure medical student empathy. Participation was voluntary. Chi squared tests were used to test for differences in biographical characteristics of student groups. Multiple linear regression analyses, in which predictor variables were year of course (first/final); sex; type of course and broad socio-economic group were used to compare empathy scores. Five medical schools (4 in the UK, 1 in New Zealand) achieved average response rates of 55 % (n = 652) among students starting their course and 48 % (n = 487) among final year students. These schools formed the High Response Rate Group. The remaining 12 medical schools recorded lower response rates of 24.0 % and 15.2 % among first and final year students respectively. These schools formed the Lower Response Rate Group. For both male and female students in both groups of schools no significant differences in any empathy scores were found between students starting and approaching the end of their course. Gender was found to significantly predict empathy scores, with females scoring higher

  16. Success of a weight loss plan for overweight dogs: The results of an international weight loss study

    OpenAIRE

    Flanagan, John; Bissot, Thomas; Hours, Marie-Anne; Moreno, Bernabe; Feugier, Alexandre; German, Alexander J.

    2017-01-01

    Introduction Obesity is a global concern in dogs with an increasing prevalence, and effective weight loss solutions are required that work in different geographical regions. The main objective was to conduct an international, multi-centre, weight loss trial to determine the efficacy of a dietary weight loss intervention in obese pet dogs. Methods A 3-month prospective observational cohort study of weight loss in 926 overweight dogs was conducted at 340 veterinary practices in 27 countries. Co...

  17. Comparison of haemodialysis patients and non-haemodialysis patients with respect to clinical characteristics and 3-year clinical outcomes after sirolimus-eluting stent implantation: insights from the Japan multi-centre post-marketing surveillance registry.

    Science.gov (United States)

    Otsuka, Yoritaka; Ishiwata, Sugao; Inada, Tsukasa; Kanno, Hiroyuki; Kyo, Eisho; Hayashi, Yasuhiko; Fujita, Hiroshi; Michishita, Ichiro

    2011-04-01

    Long-term outcomes after sirolimus-eluting stent (SES) implantation in haemodialysis (HD) patients have remained controversial. We investigated the impact of HD on outcomes after SES implantation. We analysed the data on 2050 patients who underwent SES implantation in a multi-centre prospective registry in Japan. Three-year clinical outcomes were compared between the HD group (n = 106) and the non-haemodialysis (NH) group (n = 1944). At the 3-year clinical follow-up, the rates of unadjusted cardiac mortality (HD: 16.3 vs. NH: 2.3%) and target-lesion revascularization (TLR) (HD: 19.4 vs. NH: 6.6%) were significantly higher in the HD group than the NH group (P 2.0 vs. NH: 0.7%) did not reach statistical significance. Using Cox's proportional-hazard models with propensity score adjustment for baseline differences, the HD group had higher risks of TLR [HD: 16.3 vs. NH: 6.1%; hazard ratio, 2.83; 95% confidence interval (CI): 1.62-4.93, P = 0.0003] and cardiac death (HD: 12.3 vs. NH: 2.3%; hazard ratio, 5.51; 95% CI: 2.58-11.78, P < 0.0001). The consistent results of analyses, whether unadjusted or adjusted for other baseline clinical and procedural differences, identify HD as an independent risk factor for cardiac death and TLR. Percutaneous coronary intervention with SES in HD patients has a higher incidence of repeat revascularization and mortality compared with those in NH patients. Haemodialysis appears to be strongly associated with mortality and repeat revascularization even after SES implantation.

  18. Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study.

    Science.gov (United States)

    Meissner, H O; Mscisz, A; Reich-Bilinska, H; Kapczynski, W; Mrozikiewicz, P; Bobkiewicz-Kozlowska, T; Kedzia, B; Lowicka, A; Barchia, I

    2006-12-01

    This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (PMaca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) - hence, reducing dependence on hormone therapy programs.

  19. The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial.

    Science.gov (United States)

    Lindholt, J S; Gottschalksen, B; Johannesen, N; Dueholm, D; Ravn, H; Christensen, E D; Viddal, B; Flørenes, T; Pedersen, G; Rasmussen, M; Carstensen, M; Grøndal, N; Fasting, H

    2011-05-01

    To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study. Eleven Scandinavian centres enrolled 569 patients with chronic functional or critical lower limb ischaemia who were scheduled to undergo femoro-femoral bypass or femoro-poplitaeal bypass. The patients were randomised 1:1 stratified by centre. Patency was assessed by duplex ultrasound scanning. A total of 546 patients (96%) completed the study with adequate follow-up. Perioperative bleeding was, on average, 370 ml with PTFE grafts and 399 ml with Heparin-bonded PTFE grafts (p = 0.32). Overall, primary patency after 1 year was 86.4% for Hb-PTFE grafts and 79.9% for PTFE grafts (OR = 0.627, 95% CI: 0.398; 0.989, p = 0.043). Secondary patency was 88% in Hb-PTFE grafts and 81% in PTFE grafts (OR = 0.569 (0.353; 0.917, p = 0.020)). Subgroup analyses revealed that significant reduction in risk (50%) was observed when Hb-PTFE was used for femoro-poplitaeal bypass (OR = 0.515 (0.281; 0.944, p = 0.030)), and a significant reduction in risk (50%) was observed with Hb-PTFE in cases with critical ischaemia (OR = 0.490 (0.249; 0.962, p = 0.036)). The Hb-PTFE graft significantly reduced the overall risk of primary graft failure by 37%. Risk reduction was 50% in femoro-poplitaeal bypass cases and in cases with critical ischaemia. Copyright © 2011. Published by Elsevier Ltd.

  20. Recruiting Hard-to-Reach Subjects for Exercise Interventions: A Multi-Centre and Multi-Stage Approach Targeting General Practitioners and Their Community-Dwelling and Mobility-Limited Patients

    Directory of Open Access Journals (Sweden)

    Michael Brach

    2013-12-01

    Full Text Available The general practitioner (GP’s practice appears to be an ideal venue for recruiting community-dwelling older adults with limited mobility. This study (Current Controlled Trials ISRCTN17727272 aimed at evaluating the recruiting process used for a multi-centre exercise intervention (HOMEfit. Each of six steps resulted in an absolute number of patients (N1–N6. Sex and age (for N4–N6 and reasons for dropping out were assessed. Patient database screening (N1–N3 at 15 GP practices yielded N1 = 5,990 patients aged 70 and above who had visited their GP within the past 6 months, N2 = 5,467 after exclusion of institutionalised patients, N3 = 1,545 patients eligible. Using a pre-defined limitation algorithm in order to conserve the practices’ resources resulted in N4 = 1,214 patients (80.3 ± 5.6 years, 68% female, who were then officially invited to the final assessment of eligibility at the GP’s practice. N5 = 434 patients (79.5 ± 5.4 years, 69% female attended the practice screening (n = 13 of whom had not received an official invitation. Finally, N6 = 209 (79.8 ± 5.2 years, 74% female were randomised after they were judged eligible and had given their written informed consent to participate in the randomised controlled trial (overall recruitment rate: 4.4%. The general strategy of utilising a GP’s practice to recruit the target group proved beneficial. The data and experiences presented here can help planners of future exercise-intervention studies.

  1. Study Protocol. IDUS -- Instrumental delivery & ultrasound. A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-09-13

    AbstractBackgroundInstrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice.Methods\\/DesignA multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha.DiscussionIt is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries.Trial registrationCurrent Controlled Trials ISRCTN72230496

  2. Risk factors associated with lipomyelomeningocele: a case-control study.

    Science.gov (United States)

    Esmaeili, Arash; Hanaei, Sara; Fadakar, Kaveh; Dadkhah, Sahar; Arjipour, Mahdi; Habibi, Zohreh; Nejat, Farideh; El Khashab, Mostafa

    2013-01-01

    In general, it seems that both genetic and environmental factors play important roles in the induction of neural tube defects. Lipomyelomeningocele (LipoMMC) is a rather common type of closed neural tube defect, but only limited studies have investigated the potential risk factors of this anomaly. Therefore, the purpose of this case-control study was to investigate the risk factors involved in LipoMMC formation. Various risk factors were evaluated in 35 children between 1 month and 10 years of age with LipoMMC in a hospital-based case-control study. The 2 control arms consisted of 35 children with myelomeningocele (MMC group) and 35 children with congenital anomalies other than central nervous system problems (control group). All groups were matched for age and visited the same hospital. A structured questionnaire was used for the collection of all data, including the mothers' weight and height during pregnancy, education, reproductive history, previous abortions, and socioeconomic status, as well as the parents' consanguinity and family history of the same anomalies. Univariate analysis of the children with LipoMMC compared to the control group showed that the use of periconceptional folic acid supplementation was significantly lower in the MMC and LipoMMC groups compared to the control group. In addition, comparison of the MMC and control groups revealed statistically significant differences regarding the use of folic acid and maternal obesity. In multivariate analysis, use of folic acid in the periconceptional period and during the first trimester was an independent risk factor for LipoMMC and MMC. Furthermore, maternal obesity was a significantly positive risk factor for MMC. The probable risk factors for LipoMMC were investigated in this case-control study. Consumption of folic acid in the periconceptional period and during the first trimester is an independent protective factor against LipoMMC. It seems that larger studies are needed to examine other possible

  3. Struggling doctors in specialist training: a case control study

    DEFF Research Database (Denmark)

    O'Neill, Lotte; Norberg, Karen; Thomsen, Maria

    not identified as cases in the case extraction period. We aimed at a case-control ratio of 1:4 and intend to match on graduation year. Ten different performance measures relating to medical school admission, first year performance and overall program performances will be examined, such as: pre-university exam...... in medical school, and program completion time. At the present we have identified 90 cases and 343 controls. We expect the study to be completed in the spring of 2014. To the best of our knowledge, nobody has examined this particular question before, though a few studies have examined the relationships...

  4. Delirium markers in older fallers: a case-control study.

    Science.gov (United States)

    Doherty, Kelly; Archambault, Elizabeth; Kelly, Brittany; Rudolph, James L

    2014-01-01

    When a hospitalized older patient falls or develops delirium, there are significant consequences for the patient and the health care system. Assessments of inattention and altered consciousness, markers for delirium, were analyzed to determine if they were also associated with falls. This retrospective case-control study from a regional tertiary Veterans Affairs referral center identified falls and delirium risk factors from quality databases from 2010 to 2012. Older fallers with complete delirium risk assessments prior to falling were identified. As a control, non-fallers were matched at a 3:1 ratio. Admission risk factors that were compared in fallers and non-fallers included altered consciousness, cognitive performance, attention, sensory deficits, and dehydration. Odds ratio (OR) was reported (95% confidence interval [CI]). After identifying 67 fallers, the control population (n=201) was matched on age (74.4±9.8 years) and ward (83.6% medical; 16.4% intensive care unit). Inattention as assessed by the Months of the Year Backward test was more common in fallers (67.2% versus 50.8%, OR=2.0; 95% CI: 1.1-3.7). Fallers tended to have altered consciousness prior to falling (28.4% versus 12.4%, OR=2.8; 95% CI: 1.3-5.8). In this case-control study, alterations in consciousness and inattention, assessed prior to falling, were more common in patients who fell. Brief assessments of consciousness and attention should be considered for inclusion in fall prediction.

  5. International

    International Nuclear Information System (INIS)

    Anon.

    1997-01-01

    This rubric reports on 10 short notes about international economical facts about nuclear power: Electricite de France (EdF) and its assistance and management contracts with Eastern Europe countries (Poland, Hungary, Bulgaria); Transnuclear Inc. company (a 100% Cogema daughter company) acquired the US Vectra Technologies company; the construction of the Khumo nuclear power plant in Northern Korea plays in favour of the reconciliation between Northern and Southern Korea; the delivery of two VVER 1000 Russian reactors to China; the enforcement of the cooperation agreement between Euratom and Argentina; Japan requested for the financing of a Russian fast breeder reactor; Russia has planned to sell a floating barge-type nuclear power plant to Indonesia; the control of the Swedish reactor vessels of Sydkraft AB company committed to Tractebel (Belgium); the renewal of the nuclear cooperation agreement between Swiss and USA; the call for bids from the Turkish TEAS electric power company for the building of the Akkuyu nuclear power plant answered by three candidates: Atomic Energy of Canada Limited (AECL), Westinghouse (US) and the French-German NPI company. (J.S.)

  6. Variation in dentofacial morphology and occlusion in juvenile idiopathic arthritis subjects: a case-control study.

    Science.gov (United States)

    Hu, Yuqian; Billiau, An D; Verdonck, An; Wouters, Carine; Carels, Carine

    2009-02-01

    Juvenile idiopathic arthritis (JIA) can severely disturb facial growth and affect occlusal development. In this case-control study, facial, functional, and occlusal characteristics of 100 JIA patients (35 males and 65 females; age range: 1.7-19.4 years) comprising all subtypes classified according to the revised classification criteria of the International League of Associations for Rheumatology (ILAR) were studied. They were compared with a mixed orthodontic control group (n=32; 12 males and 20 females) and with a Class II division 1 malocclusion group (n=19; eight males and 11 females). The JIA patients and controls were evaluated using clinical assessment, dental pantomograms, lateral cephalograms (LCGs), and dental casts. Compared with the age- and gender-matched mixed orthodontic controls, JIA patients showed a significantly greater prevalence of anterior open bites (AOBs; Pplane (Pplane, the gonial and the interincisal angles, or total face height. From this case-control study, it can be concluded that although JIA patients share occlusal characteristics with non-JIA patients with a Class II division 1 malocclusion, they are different with regard to the prevalence of condylar lesions and AOBs, as well as SNA and SNB angles and LAFH.

  7. The use of the bootstrap in the analysis of case-control studies with missing data

    DEFF Research Database (Denmark)

    Siersma, Volkert Dirk; Johansen, Christoffer

    2004-01-01

    nonparametric bootstrap, bootstrap confidence intervals, missing values, multiple imputation, matched case-control study......nonparametric bootstrap, bootstrap confidence intervals, missing values, multiple imputation, matched case-control study...

  8. A case-control study of Alzheimer's disease in Australia.

    Science.gov (United States)

    Broe, G A; Henderson, A S; Creasey, H; McCusker, E; Korten, A E; Jorm, A F; Longley, W; Anthony, J C

    1990-11-01

    We conducted a case-control study of clinically diagnosed Alzheimer's disease (AD) on 170 cases aged 52 to 96 years, and 170 controls matched for age, sex and, where possible, the general practice of origin. Trained lay interviewers naive to the hypotheses and to the clinical status of the elderly person carried out risk-factor interviews with informants. Significant odds ratios were found for 4 variables: a history of either dementia, probable AD, or Down's syndrome in a 1st-degree relative, and underactivity as a behavioral trait in both the recent and more distant past. Previously reported or suggested associations not confirmed by this study include head injury, starvation, thyroid disease, analgesic abuse, antacid use (aluminum exposure), alcohol abuse, smoking, and being left-handed.

  9. Leptospira Exposure and Gardeners: A Case-Control Seroprevalence Study

    Science.gov (United States)

    Alvarado-Esquivel, Cosme; Hernandez-Tinoco, Jesus; Sanchez-Anguiano, Luis Francisco; Ramos-Nevarez, Agar; Cerrillo-Soto, Sandra Margarita; Guido-Arreola, Carlos Alberto

    2016-01-01

    Background Leptospira can be found in soil. However, it is unclear whether occupational exposure to soil may represent a risk for Leptospira infection in humans. Therefore, we sought to determine the association of Leptospira IgG seroprevalence with the occupation of gardener, and to determine the epidemiological characteristics of gardeners associated with Leptospira exposure. Methods We performed a case-control study in 168 gardeners and 168 age- and gender-matched control subjects without gardening occupation in Durango City, Mexico. The seroprevalence of anti-Leptospira IgG antibodies in cases and controls was determined using an enzyme immunoassay. Bivariate and multivariate analyses were used to assess the association of Leptospira exposure and the characteristics of the gardeners. Results Anti-Leptospira IgG antibodies were found in 10 (6%) of 168 gardeners and in 15 (8.9%) of 168 control subjects (odds ratio (OR): 0.64; 95% confidence interval (CI): 0.28 - 1.48; P = 0.40). Multivariate analysis showed that Leptospira seropositivity was positively associated with female gender (OR: 5.82; 95% CI: 1.11 - 30.46; P = 0.03), and negatively associated with eating while working (OR: 0.21; 95% CI: 0.05 - 0.87; P = 0.03). In addition, multivariate analysis showed that high anti-Leptospira levels were associated with consumption of boar meat (OR: 28.00; 95% CI: 1.20 - 648.80; P = 0.03). Conclusions This is the first case-control study of Leptospira exposure in gardeners. Results do not support an association of Leptospira exposure with the occupation of gardener. However, further studies to confirm the lack of this association are needed. The potential role of consumption of boar meat in Leptospira infection deserves further investigation. PMID:26668679

  10. Pilot case-control study of paediatric falls from windows.

    Science.gov (United States)

    Johnston, Brian D; Quistberg, D Alexander; Shandro, Jamie R; Partridge, Rebecca L; Song, Hyun Rae; Ebel, Beth E

    2011-12-01

    Unintentional falls from windows are an important cause of paediatric morbidity. There have been no controlled studies to identify modifiable environmental risk factors for window falls in young children. The authors have piloted a case-control study to test procedures for case identification, subject enrolment, and environmental data collection. Case windows were identified when a child 0-9 years old presented for care after a fall from that window. Control windows were identified (1) from the child's home and (2) from the home of an age- and gender-matched child seeking care for an injury diagnosis not related to a window fall. Study staff visited enrolled homes to collect window measurements and conduct window screen performance tests. The authors enrolled and collected data on 18 case windows, 18 in-home controls, and 14 matched community controls. Six potential community controls were contacted for every one enrolled. Families who completed the home visit viewed study procedures positively. Case windows were more likely than community controls to be horizontal sliders (100% vs 50%), to have deeper sills (6.28 vs 4.31 inches), to be higher above the exterior surface (183 vs 82 inches), and to have screens that failed below a threshold derived from the static pressure of a 3-year-old leaning against the mesh (60.0% vs 16.7%). Case windows varied very little from in-home controls. Case-control methodology can be used to study risk factors for paediatric falls from windows. Recruitment of community controls is challenging but essential, because in-home controls tend to be over-matched on important variables. A home visit allows direct measurement of window type, height, sill depth, and screen performance. These variables should all be investigated in subsequent, larger studies covering major housing markets.

  11. Functional Impairment in Adult Sleepwalkers: A Case-Control Study

    Science.gov (United States)

    Lopez, Regis; Jaussent, Isabelle; Scholz, Sabine; Bayard, Sophie; Montplaisir, Jacques; Dauvilliers, Yves

    2013-01-01

    Study Objectives: To investigate the restorative quality of sleep and daytime functioning in sleepwalking adult patients in comparison with controls. Design: Prospective case-control study. Setting: Data were collected at the Sleep Disorders Center, Hôpital-Gui-de Chauliac, Montpellier, France between June 2007 and January 2011. Participants: There were 140 adult sleepwalkers (100 (median age 30 y, 55% male) in whom primary SW was diagnosed) who underwent 1 night of video polysomnography. All patients participated in a standardized clinical interview and completed a battery of questionnaires to assess clinical characteristics of parasomnia, daytime sleepiness, fatigue, insomnia, depressive and anxiety symptoms, and health-related quality of life. Results were compared with those of 100 sex- and age-matched normal controls. Interventions: N/A. Measurements and Results: Of the sleepwalkers, 22.3% presented with daily episodes and 43.5% presented with weekly episodes. Median age at sleepwalking onset was 9 y. Familial history of sleepwalking was reported in 56.6% of sleepwalkers and violent sleep related behaviors in 57.9%, including injuries requiring medical care for at least one episode in 17%. Significant associations were found between sleepwalking and daytime sleepiness, fatigue, insomnia, depressive and anxiety symptoms, and altered quality of life. Early-onset sleepwalkers had higher frequency of violent behaviors and injuries. Sleepwalkers with violent behaviors had higher frequency of sleep terrors and triggering factors, with greater alteration in health-related quality of life. Conclusion: Adult sleepwalking is a potentially serious condition that may induce violent behaviors, self-injury or injury to bed partners, sleep disruption, excessive daytime sleepiness, fatigue, and psychological distress, all of which affect health-related quality of life. Citation: Lopez R; Jaussent I; Scholz S; Bayard S; Montplaisir J; Dauvilliers Y. Functional impairment in

  12. Hospital visitors as controls in case-control studies

    Directory of Open Access Journals (Sweden)

    Gulnar Azevedo S Mendonça

    2001-10-01

    Full Text Available OBJECTIVE: Selecting controls is one of the most difficult tasks in the design of case-control studies. Hospital controls may be inadequate and random controls drawn from the base population may be unavailable. The aim was to assess the use of hospital visitors as controls in a case-control study on the association of organochlorinated compounds and other risk factors for breast cancer conducted in the main hospital of the "Instituto Nacional de Câncer" -- INCA (National Cancer Institute in Rio de Janeiro (Brazil. METHODS: The study included 177 incident cases and 377 controls recruited among female visitors. Three different models of control group composition were compared: Model 1, with all selected visitors; Model 2, excluding women visiting relatives with breast cancer; and Model 3, excluding all women visiting relatives with any type of cancer. Odds ratios (OR and 95% confidence intervals were calculated to test the associations. RESULTS: Age-adjusted OR for breast cancer associated with risk factors other than family history of cancer, except smoking and breast size, were similar in the three models. Regarding family history of all cancers, except for breast cancer, there was a decreased risk in Models 1 and 2, while in Model 3 there was an increased risk, but not statistically significant. Family history of breast cancer was a risk factor in Models 2 and 3, but no association was found in Model 1. In multivariate analysis a significant risk of breast cancer was found when there was a family history of breast cancer in Models 2 and 3 but not in Model 1. CONCLUSIONS: These results indicate that while investigating risk factors unrelated to family history of cancer, the use of hospital visitors as controls may be a valid and feasible alternative.

  13. Functional impairment in adult sleepwalkers: a case-control study.

    Science.gov (United States)

    Lopez, Regis; Jaussent, Isabelle; Scholz, Sabine; Bayard, Sophie; Montplaisir, Jacques; Dauvilliers, Yves

    2013-03-01

    To investigate the restorative quality of sleep and daytime functioning in sleepwalking adult patients in comparison with controls. Prospective case-control study. Data were collected at the Sleep Disorders Center, Hôpital-Gui-de Chauliac, Montpellier, France between June 2007 and January 2011. There were 140 adult sleepwalkers (100 (median age 30 y, 55% male) in whom primary SW was diagnosed) who underwent 1 night of video polysomnography. All patients participated in a standardized clinical interview and completed a battery of questionnaires to assess clinical characteristics of parasomnia, daytime sleepiness, fatigue, insomnia, depressive and anxiety symptoms, and health-related quality of life. Results were compared with those of 100 sex- and age-matched normal controls. N/A. Of the sleepwalkers, 22.3% presented with daily episodes and 43.5% presented with weekly episodes. Median age at sleepwalking onset was 9 y. Familial history of sleepwalking was reported in 56.6% of sleepwalkers and violent sleep related behaviors in 57.9%, including injuries requiring medical care for at least one episode in 17%. Significant associations were found between sleepwalking and daytime sleepiness, fatigue, insomnia, depressive and anxiety symptoms, and altered quality of life. Early-onset sleepwalkers had higher frequency of violent behaviors and injuries. Sleepwalkers with violent behaviors had higher frequency of sleep terrors and triggering factors, with greater alteration in health-related quality of life. Adult sleepwalking is a potentially serious condition that may induce violent behaviors, self-injury or injury to bed partners, sleep disruption, excessive daytime sleepiness, fatigue, and psychological distress, all of which affect health-related quality of life. Lopez R; Jaussent I; Scholz S; Bayard S; Montplaisir J; Dauvilliers Y. Functional impairment in adult sleepwalkers: a case-control study. SLEEP 2013;36(3):345-351.

  14. Anger management for people with mild to moderate learning disabilities: Study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff

    Directory of Open Access Journals (Sweden)

    Nuttall Jacqueline

    2011-02-01

    Full Text Available Abstract Background Cognitive behaviour therapy (CBT is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited evidence base for the use of CBT with this client group. Anger treatment is the one area where there exists a reasonable number of small controlled trials. This study will evaluate the effectiveness of a manualized 12-week CBT intervention for anger. The intervention will be delivered by staff working in the day services that the participants attend, following training to act as 'lay therapists' by a Clinical Psychologist, who will also provide supervision. Methods/Design This is a multi-centre cluster randomized controlled trial of a group intervention versus a 'support as usual' waiting-list control group, with randomization at the level of the group. Outcomes will be assessed at the end of the intervention and again 6-months later. After completion of the 6-month follow-up assessments, the intervention will also be delivered to the waiting-list groups. The study will include a range of anger/aggression and mental health measures, some of which will be completed by service users and also by their day service key-workers and by home carers. Qualitative data will be collected to assess the impact of the intervention on participants, lay therapists, and services, and the study will also include a service-utilization cost and consequences analysis. Discussion This will be the first trial to investigate formally how effectively staff working in services providing day activities for people with learning disabilities are able to use a therapy manual to deliver a CBT based anger management intervention, following brief training by a Clinical Psychologist. The demonstration that service staff can successfully deliver anger management to people with learning disabilities, by widening the pool of potential therapists, would have

  15. A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Harrison, Eleanor F; Haines, Rachel H; Cowdell, Fiona; Sach, Tracey H; Dean, Taraneh; Pollock, Ian; Burrows, Nigel P; Buckley, Hannah; Batchelor, Jonathan; Williams, Hywel C; Lawton, Sandra; Brown, Sara J; Bradshaw, Lucy E; Ahmed, Amina; Montgomery, Alan A; Mitchell, Eleanor J; Thomas, Kim S

    2015-09-02

    Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that 'silk therapeutic garments plus standard eczema care' is superior to 'standard care alone' for children with moderate to severe eczema. Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months' duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners. Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child's age ( 5 years), and concealed using a secure web-based system. The sequence of treatment allocations will remain concealed until

  16. Prescription errors in Brazilian hospitals: a multi-centre exploratory survey Erros de prescrição em hospitais brasileiros: um estudo exploratório multicêntrico

    Directory of Open Access Journals (Sweden)

    Adriana Inocenti Miasso

    2009-02-01

    Full Text Available In Brazil, millions of prescriptions do not follow the legal requirements necessary to guarantee the correct dispensing and administration of medication. This multi-centre exploratory study aimed to analyze the appropriateness of prescriptions at four Brazilian hospitals and to identify possible errors caused by inadequacies. The sample consisted of 864 prescriptions obtained at hospital medical clinics in January 2003. Data was collected by three nurse researchers during one week using a standard data sheet that included items about: the type of prescription; legibility; completeness; use of abbreviations; existence of changes and erasures. There were statistically significant differences between incomplete electronic prescriptions at hospital A, and handwritten ones from hospitals C (Ç2 = 12.703 and p No Brasil, milhões de prescrições não apresentam os requisitos legais necessários para garantir a correta dispensação e administração dos medicamentos. Este estudo multicêntrico exploratório objetivou analisar a adequação das prescrições em quatro hospitais brasileiros e identificar eventuais erros causados pelas inadequações. A amostra consistiu de 864 prescrições obtidas nas clínicas médicas dos hospitais em janeiro de 2003. Os dados foram coletados por três enfermeiras durante uma semana através de instrumento estruturado com variáveis sobre: tipo de prescrição; legibilidade; completude; presença de abreviações, alterações e rasuras. Houve diferenças estatisticamente significativas entre prescrição eletrônica no hospital A e manuscritas nos C (Ç2 = 12,703 e p < 0,001 e D (Ç2 = 14,074 e p < 0,001. Abreviações foram usadas em mais de 80% das receitas nos hospitais B, C e D. Alterações foram encontradas em prescrições de todos os hospitais, com níveis mais elevados no B (35,2% e A (25,3%. Este estudo identificou uma série de pontos vulneráveis na fase prescrição dos sistemas de medicação dos

  17. Cancer Trials Ireland (ICORG) 06-34: A multi-centre clinical trial using three-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer.

    Science.gov (United States)

    McDermott, Ronan L; Armstrong, John G; Thirion, Pierre; Dunne, Mary; Finn, Marie; Small, Cormac; Byrne, Mary; O'Shea, Carmel; O'Sullivan, Lydia; Shannon, Aoife; Kelly, Emma; Hacking, Dayle J

    2018-03-13

    Cancer Trials Ireland (ICORG) 06-34: A multi-centre clinical trial using three-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer. NCT01176487. Trials of radiation therapy for the palliation of intra-thoracic symptoms from locally advanced non-small cell lung cancer (NSCLC) have concentrated on optimising fractionation and dose schedules. In these trials, the rates of oesophagitis induced by this "palliative" therapy have been unacceptably high. In contrast, this non-randomised, single-arm trial was designed to assess if more technically advanced treatment techniques would result in equivalent symptom relief and reduce the side-effect of symptomatic oesophagitis. Thirty-five evaluable patients with symptomatic locally advanced or metastatic NSCLC were treated using a three-dimensional conformal technique (3-DCRT) and standardised dose regimens of 39 Gy in 13 fractions, 20 Gy in 5 fractions or 17 Gy in 2 fractions. Treatment plans sought to minimise oesophageal dose. Oesophagitis was recorded during treatment, at two weeks, one month and three months following radiation therapy and 3-6 monthly thereafter. Mean dose to the irradiated oesophagus was calculated for all treatment plans. Five patients (14%) had experienced grade 2 oesophagitis or dysphagia or both during treatment and 2 other patients had these side effects at the 2-week follow-up. At follow-up of one month after therapy, there was no grade two or higher oesophagitis or dysphagia reported. 22 patients were eligible for assessment of late toxicity. Five of these patients reported oesophagitis or dysphagia (one had grade 3 dysphagia, two had grade 2 oesophagitis, one of whom also had grade 2 dysphagia). Quality of Life (QoL) data at baseline and at 1-month follow up were available for 20 patients. At 1-month post radiation therapy, these patients had slightly less trouble taking a short walk, less shortness of breath, did not feel as weak, had

  18. The effect of an education programme (MEDIAS 2 BSC) of non-intensive insulin treatment regimens for people with Type 2 diabetes: a randomized, multi-centre trial.

    Science.gov (United States)

    Hermanns, N; Ehrmann, D; Schall, S; Maier, B; Haak, T; Kulzer, B

    2017-08-01

    A self-management oriented education programme (MEDIAS 2 BSC) for people with Type 2 diabetes who are on a non-intensive insulin treatment regimen was developed. In a randomized, multi-centre trial, the effect of MEDIAS 2 BSC was compared with an established education programme that acted as a control group. The primary outcome was the impact of MEDIAS 2 BSC on glycaemic control. Secondary outcomes included the incidence of severe hypoglycaemia, hypoglycaemia unawareness, diabetes-related distress, diabetes knowledge, quality of life and self-care behaviour. In total, 182 participants were randomized to the control group or MEDIAS 2 BSC [median age 64.0 (interquartile range 58.0-68.5) vs. 63.5 (57.0-70.0) years; HbA 1c 62.8 ± 12.7 mmol/mol vs. 63.7 ± 14.0 mmol/mol; 7.9% ± 1.2% vs. 8.0% ± 1.3%]. After a 6-month follow-up, there was a mean decrease in HbA 1c of 3.5 mmol/mol (0.32%) in the control group and 6.7 mmol/mol (0.61%) in MEDIAS 2 BSC. After adjusting for baseline differences and study centre, the mean difference between the groups was -3.3 mmol/mol [95% confidence interval (CI) -0.54 to -5.90 mmol/mol] [-0.30% (95% CI -0.05 to -0.54)] in favour of MEDIAS 2 BSC (P = 0.018). There were no increases in severe hypoglycaemia or hypoglycaemia unawareness. The education programmes had no significant effects on psychosocial outcome variables. MEDIAS 2 BSC was more effective in lowering HbA 1c than the control condition. MEDIAS 2 BSC is a safe educational tool that improves glycaemic control without increasing the risk for hypoglycaemia. (Clinical Trials Registry No; NCT 02748239). © 2017 Diabetes UK.

  19. Case-control study on infant mortality in Southern Brazil

    Directory of Open Access Journals (Sweden)

    Mendes Karina Giane

    2006-01-01

    Full Text Available OBJECTIVE: To identify risk factors associated with infant mortality and, more specifically, with neonatal mortality. METHODS: A case-control study was carried out in the municipality of Caxias do Sul, Southern Brazil. Characteristics of prenatal care and causes of mortality were assessed for all live births in the 2001-2002 period with a completed live-birth certificate and whose mothers lived in the municipality. Cases were defined as all deaths within the first year of life. As controls, there were selected the two children born immediately after each case in the same hospital, who were of the same sex, and did not die within their first year of life. Multivariate analysis was performed using conditional logistic regression. RESULTS: There was a reduction in infant mortality, the greatest reduction was observed in the post-neonatal period. The variables gestational age (<36 weeks, birth weight (<2,500 g, and 5-minute Apgar (<6 remained in the final model of the multivariate analysis, after adjustment. CONCLUSIONS: Perinatal conditions comprise almost the totality of neonatal deaths, and the majority of deaths occur at delivery. The challenge for reducing infant mortality rate in the city is to reduce the mortality by perinatal conditions in the neonatal period.

  20. Weighing the causal pies in case-control studies.

    Science.gov (United States)

    Liao, Shu-Fen; Lee, Wen-Chung

    2010-07-01

    Epidemiologists are familiar with the concepts of Rothman's causal pies. Using real data the Hoffman study showed recently how to calculate the "proportion of diseased subjects who develop the disease due to classes of sufficient causes" (PDCs). The PDC is actually an attributable-fraction index. It may be specific to a particular risk factor profile but it does not correspond to any given class of causal pies. In this study, we show how to estimate the "causal-pie weights" (CPWs), so that each and every class of causal pies has one and only one CPW attached to it. To conform to Rothman's model, we apply a non-negative linear odds model to constrain all the odds ratios (ORs) to be equal to or greater than one, and the interactions between them to be additive or superadditive. Based on these constrained ORs, we calculate the population attributable fractions, and then the CPWs. We used a published case-control data to show the methodology. The CPWs succinctly quantify the relative importance of different classes of causal pies. The proposed method helps to clarify the multi-factorial and complex interactive effects in disease causation. It also provides important information for designing an efficient public health intervention strategy. 2010 Elsevier Inc. All rights reserved.

  1. Violence against women and gastroschisis: a case-control study.

    Science.gov (United States)

    Ortega-García, Juan Antonio; Soldin, Offie P; Sánchez-Sauco, Miguel Felipe; Cánovas-Conesa, Alicia; Gomaríz-Peñalver, Virtudes; Jaimes-Vega, Diana Carolina; Perales, Joseph E; Cárceles-Alvarez, Alberto; Martínez-Ros, Maria Teresa; Ruiz, Daniel

    2013-10-17

    Gastroschisis, a birth defect characterized by herniated fetal abdominal wall, occurs more commonly in infants born to teenage and young mothers. Ischemia of the vascular vitelline vessels is the likely mechanism of pathogenesis. Given that chronic stress and violence against women are risk factors for cardiovascular disease we explored whether these may represent risk factors for gastroschisis, when they occur during pregnancy. A case-control study was conducted, with 15 incident cases of children born with gastroschisis in the Region of Murcia, Spain, from December 2007 to June 2013. Forty concurrent controls were recruited at gestation weeks 20-24 or post-partum. All mothers of cases and controls completed a comprehensive, in-person, 'green sheet' questionnaire on environmental exposures. Mothers of children with gastroschisis were younger, smoked more cigarettes per week relative to controls, were exposed to higher amounts of illegal drugs, and suffered from domestic violence more frequently than the controls. Multivariable logistic regression analysis highlights periconceptional 'gender-related violence' (OR: 16.6, 95% CI 2.7 to 101.7) and younger maternal age (OR 1.1, 95% CI 1.0-1.3). Violence against pregnant women is associated with birth defects, and should be studied in more depth as a cause-effect teratogenic. Psychosocial risk factors, including gender-based violence, are important for insuring the health and safety of the pregnant mother and the fetus.

  2. REPRODUCTIVE FACTORS AND COLORECTAL CANCER RISK. Case - control study.

    Directory of Open Access Journals (Sweden)

    Adriana Ruseva

    2015-02-01

    Full Text Available Colorectal cancer is one of the most common cancers worldwide. The role of the female sex hormones in the etiology of the disease is very intriguing. Reproductive factors are surrogate measure of lifetime exposition to the sex hormones. Purpose: Our aim is to investigate the association between the reproductive factors and colorectal carcinoma risk. Materials and methods: We include 234 Bulgarian women in our study – 117 cases with colorectal cancer and the same number of healthy controls. Cases are divided into three groups according to the localization of the tumor. We conduct case-control study, using questionnaires about reproductive factors. We use the following statistical methods – descriptive, variational analysis, binary logistic regression. Results: We observed that only the age at menopause is associated with colorectal cancer risk, and this factor has strongest protective effect in the proximal colon (95% CI - 0,051-0,781, OR – 0,200, p – 0,021. Conclusion: Analyzing our data we observed that among Bulgarian women the only reproductive factor that show association with the risk of colorectal cancer is the age at menopause.

  3. Association between diabetes and tuberculosis: case-control study

    Directory of Open Access Journals (Sweden)

    Susan Martins Pereira

    Full Text Available ABSTRACT OBJECTIVE To test the association between diabetes and tuberculosis. METHODS It is a case-control study, matched by age and sex. We included 323 new cases of tuberculosis with positive results for bacilloscopy. The controls were 323 respiratory symptomatic patients with negative bacilloscopy, from the same health services, such as: ambulatory cases from three referral hospitals and six basic health units responsible for the notifications of new cases of tuberculosis in Salvador, Bahia. Data collection occurred between 2008 and 2010. The instruments used were structured interview, including clinical data, capillary blood glucose (during fasting or postprandial, and the CAGE questionnaire for screening of abusive consumption of alcohol. Descriptive, exploratory, and multivariate analysis was performed using conditional logistic regression. RESULTS The average age of the cases was 38.5 (SD = 14.2 years and of the controls, 38.5 (SD = 14.3 years. Among cases and controls, most subjects (61% were male. In univariate analysis we found association between the occurrence of diabetes and tuberculosis (OR = 2.37; 95%CI 1.04–5.42, which remained statistically significant after adjustment for potential confounders (OR = 3.12; 95%CI 1.12–7.94. CONCLUSIONS The association between diabetes and tuberculosis can hinder the control of tuberculosis, contributing to the maintainance of the disease burden. The situation demands increasing early detection of diabetes among people with tuberculosis, in an attempt to improve disease control strategies.

  4. Case-control study of a gastroschisis cluster in Nevada.

    Science.gov (United States)

    Elliott, Leslie; Loomis, Dana; Lottritz, Lisa; Slotnick, Robert Nathan; Oki, Earle; Todd, Randall

    2009-11-01

    To identify potential risk factors associated with a sudden increase in gastroschisis cases in northern Nevada. Case-control study. Medical centers and a pregnancy care center in Reno, Nevada. Participants (n = 14) were women who gave birth to infants with gastroschisis at either of the 2 medical centers in Reno, Nevada, from April 5, 2007, through April 4, 2008. Controls (n = 57) were selected from the same pregnancy center providing perinatal care to the cases and were matched 4:1 to the case mothers by maternal date of birth within 1 year. Environmental exposures and illnesses during pregnancy. Association of gastroschisis with illnesses, medications, or environmental exposures. Gastroschisis was associated with the use of methamphetamine (odds ratio [OR], 7.15; 95% confidence interval [CI], 1.35-37.99) or any vasoconstrictive recreational drug (methamphetamine, amphetamine, cocaine, ecstasy) (OR, 4.46; 95% CI, 1.21-16.44) before pregnancy. When we limited self-reported illnesses to those occurring during the first trimester of pregnancy, chest colds (OR, 16.77; 95% CI, 1.88-150.27) and sore throats (OR, 12.72; 95% CI, 1.32-122.52) were associated with gastroschisis. These findings add strength to the hypothesis that use of methamphetamine and related drugs is a risk factor for gastroschisis and raise questions about the risks associated with infections.

  5. Violence against Women and Gastroschisis: A Case-Control Study

    Directory of Open Access Journals (Sweden)

    Daniel Ruiz

    2013-10-01

    Full Text Available Background: Gastroschisis, a birth defect characterized by herniated fetal abdominal wall, occurs more commonly in infants born to teenage and young mothers. Ischemia of the vascular vitelline vessels is the likely mechanism of pathogenesis. Given that chronic stress and violence against women are risk factors for cardiovascular disease we explored whether these may represent risk factors for gastroschisis, when they occur during pregnancy. A case-control study was conducted, with 15 incident cases of children born with gastroschisis in the Region of Murcia, Spain, from December 2007 to June 2013. Forty concurrent controls were recruited at gestation weeks 20–24 or post-partum. All mothers of cases and controls completed a comprehensive, in-person, ‘green sheet’ questionnaire on environmental exposures. Results: Mothers of children with gastroschisis were younger, smoked more cigarettes per week relative to controls, were exposed to higher amounts of illegal drugs, and suffered from domestic violence more frequently than the controls. Multivariable logistic regression analysis highlights periconceptional ‘gender-related violence’ (OR: 16.6, 95% CI 2.7 to 101.7 and younger maternal age (OR 1.1, 95% CI 1.0–1.3. Conclusions: Violence against pregnant women is associated with birth defects, and should be studied in more depth as a cause-effect teratogenic. Psychosocial risk factors, including gender-based violence, are important for insuring the health and safety of the pregnant mother and the fetus.

  6. Risk Factors For Ectopic Pregnancy : A Case Control Study

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    Deshmukh J.S

    1999-01-01

    Full Text Available Research question: Which are the risk factors for ectopic pregnancy . Objective: To study the strength of association between hypothesised risk factors and ectopic pregnancy. Study design: Unmatched case- control study. Setting: Government Medical College, Hospital, Nagpur. Participants: 133 cases of ectopic pregnancy and equal number of controls (non pregnant women admitted to study hospital. Study variables : Pelvic inflammatory diseases, sexually transmitted diseases, IUD use at conception , past use of IUD, prior ectopic pregnancy, OC pills use at the time of conception, past use of OC pills, induced abortion, spontaneous abortion, infertility and pelvic and abdominal surgery. Statistical analysis: Odds ratios & their 95% CI, Pearson’s chi square test, unconditional logistic regression analysis and population attributable risk proportion. Results : Use of IUD at conception, prior ectopic pregnancy , pelvic inflammatory disease, sexually transmitted diseases, infertility, OC pills use at the time of conception, past use of IUD and induced abortion were found to be significantly associated with ectopic pregnancy. Conclusion: Identification of these risk factors for etopic pregnancy shall help in early detection and appropriate management in an individual case and it may help in devising a comprehensive preventive strategy for ectopic pregnancy

  7. Hypothyroidism among SLE patients: Case-control study.

    Science.gov (United States)

    Watad, Abdulla; Mahroum, Naim; Whitby, Aaron; Gertel, Smadar; Comaneshter, Doron; Cohen, Arnon D; Amital, Howard

    2016-05-01

    The prevalence of hypothyroidism in SLE patients varies considerably and early reports were mainly based on small cohorts. To investigate the association between SLE and hypothyroidism. Patients with SLE were compared with age and sex-matched controls regarding the proportion of hypothyroidism in a case-control study. Chi-square and t-tests were used for univariate analysis and a logistic regression model was used for multivariate analysis. The study was performed utilizing the medical database of Clalit Health Services. The study included 5018 patients with SLE and 25,090 age and sex-matched controls. The proportion of hypothyroidism in patients with SLE was increased compared with the prevalence in controls (15.58% and 5.75%, respectively, Phypothyroidism (odds ratio 2.644, 95% confidence interval 2.405-2.908). Patients with SLE have a greater proportion of hypothyroidism than matched controls. Therefore, physicians treating patients with SLE should be aware of the possibility of thyroid dysfunction. Copyright © 2016 Elsevier B.V. All rights reserved.

  8. A case-control study of visual acuity in onychocryptosis.

    LENUS (Irish Health Repository)

    Hogan, Aisling M

    2012-02-01

    BACKGROUND: There are many theories surrounding the etiology of ingrown toenails (IGTN). Few factors have been formally assessed, but it is widely accepted that a poor nail cutting technique has a causative role. AIM: To investigate the hypothesis that decreased visual acuity may lead to inadequate nail cutting and the formation of IGTN. METHODS: A prospective case-control study was performed. Near and distance visual acuity were tested on a population with IGTN (n = 19) and compared with that of an age- and sex-matched control cohort (n = 24) who underwent epidermal cyst excision in the same tertiary referral center. Comparisons of visual acuity were made between groups by Mann-Whitney U-test. Differences were taken to be significant if P < 0.05. Institutional Review Board approval was sought and granted. RESULTS: No significant difference in visual acuity (near or distance) was demonstrated between patients with IGTN and the control group (P = 0.33). CONCLUSION: Visual acuity does not appear to play a significant role in the development of IGTN.

  9. Abortion and breast cancer: case-control study.

    Science.gov (United States)

    Ilic, Milena; Vlajinac, Hristina; Marinkovic, Jelena; Sipetic-Grujicic, Sandra

    2013-01-01

    The aim of the present study was to examine if certain aspects of a woman's experience of abortion might be associated with the risk of breast cancer. The case-control study was conducted in Kragujevac (Serbia) during the period 2004-2005. The case group (191 women) consisted of patients with newly diagnosed first primary breast cancer, which was histologically confirmed. The control group (191 women), individually matched by age (± 2 years), hospital admittance and place of residence (rural/urban) to the respective cases, was selected from female patients admitted for other diseases. The analysis was restricted to parous women (168 cases and 171 controls). Breast cancer risk was reduced among women who had a history of any abortion (adjusted OR, 0.46; 95% CI, 0.24-0.88). The protective effect was found for both induced abortion (adjusted OR, 0.47; 95% CI, 0.25-0.90) and spontaneous abortion (adjusted OR, 0.31; 95% CI, 0.10-0.98). It seems that these associations did not depend on the number of abortions, age at first abortion, or gestational age at first aborted pregnancy. Our study suggests that even short pregnancies ending in abortion add to the protection against breast cancer.

  10. Potential risk factors for diabetic neuropathy: a case control study

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    Nooraei Mahdi

    2005-12-01

    Full Text Available Abstract Background Diabetes mellitus type II afflicts at least 2 million people in Iran. Neuropathy is one of the most common complications of diabetes and lowers the patient's quality of life. Since neuropathy often leads to ulceration and amputation, we have tried to elucidate the factors that can affect its progression. Methods In this case-control study, 110 diabetic patients were selected from the Shariati Hospital diabetes clinic. Michigan Neuropathic Diabetic Scoring (MNDS was used to differentiate cases from controls. The diagnosis of neuropathy was confirmed by nerve conduction studies (nerve conduction velocity and electromyography. The multiple factors compared between the two groups included consumption of angiotensin converting enzyme inhibitors (ACEI, blood pressure, serum lipid level, sex, smoking, method of diabetes control and its quality. Results Statistically significant relationships were found between neuropathy and age, gender, quality of diabetes control and duration of disease (P values in the order: 0.04, 0.04, Conclusion In this study, hyperglycemia was the only modifiable risk factor for diabetic neuropathy. Glycemic control reduces the incidence of neuropathy, slows its progression and improves the diabetic patient's quality of life. More attention must be paid to elderly male diabetic patients with poor diabetes control with regard to regular foot examinations and more practical education.

  11. Case-control study of leukemia and diagnostic radiation exposure

    International Nuclear Information System (INIS)

    Yuasa, Hidemichi; Hamajima, Nobuyuki; Ueda, Ryuzo

    1997-01-01

    A case-control study of leukemia and diagnostic X-ray exposure was conducted by a multi-institution co-operative study group. The subjects were 134 patients with acute myelogenous leukemia, 57 with chronic myelogenous leukemia, 56 with acute lymphocytic leukemia and 50 with myelodysplasia syndrome, who were between 15 and 79 years old, and diagnosed at one of 27 hospitals between September 1993 and August 1995. The controls were 479 first-visit patients seen at eight of these 27 hospitals. History of diagnostic X-ray tests between 1982 and 1991 was determined by an anonymous self-administered questionnaire. The total relative dose of radiation exposure was calculated by summing the products of given weights and frequencies of each test. The relative risk was 0.83 (95% confidence interval (C.I.), 0.58-1.19) for relative dose of 10-30 (equivalent to 4-11 times of UGI series), 0.76 (0.48-1.20) for relative dose of 30 or more (more than 12 times of UGI series), when compared with relative dose of 0-10 (0-3 times of UGI series). Analysis according to type of leukemia revealed that only acute myelogenous leukemia had an estimated relative risk above unity (1.08, 95%, C.I. 0.69-1.69, for relative dose 10-30). This study did not support the hypothesis that diagnostic X-ray tests increases leukemia risk. (author)

  12. Anxiety during pregnancy and preeclampsia: a case - control study

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    Masoumeh Kordi

    2017-01-01

    Full Text Available Introduction:  Preeclampsia is the common and dangerous complication of pregnancy with unknown reason. Multiple causes such as depression, psychological and physical stress may be involved in its development. This study was performed to determine the relationship between anxiety during pregnancy and the incidence of preeclampsia. Methods: This case-control study was conducted on 150 pregnant women with preeclampsia and 150 healthy pregnant women referred to health centers and academic hospitals of Mashhad in 2014. The diagnosis of preeclampsia was made by systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg accompanied with urinary protein excretion more than 300 mg per 24 hours. The cutoff point for the presence of anxiety was the score of ≥8; the score of 8-9 was mild anxiety and the score of 20 was very severe anxiety. Data collection tools included the form of demographic characteristics, clinical and laboratory signs of preeclampsia, and depression, anxiety, and stress scale (DASS 21. Data were analyzed using SPSS software (version 16 and independent t-test, Mann-Whitney, Chi-square, and logistic regressions model. P Results: We found significant relationship between anxiety and preeclampsia (P

  13. The Misconception of Case-Control Studies in the Plastic Surgery Literature: A Literature Audit.

    Science.gov (United States)

    Hatchell, Alexandra C; Farrokhyar, Forough; Choi, Matthew

    2017-06-01

    Case-control study designs are commonly used. However, many published case-control studies are not true case-controls and are in fact mislabeled. The purpose of this study was to identify all case-control studies published in the top three plastic surgery journals over the past 10 years, assess which were truly case-control studies, clarify the actual design of the articles, and address common misconceptions. MEDLINE, Embase, and Web of Science databases were searched for case-control studies in the three highest-impact factor plastic surgery journals (2005 to 2015). Two independent reviewers screened the resulting titles, abstracts, and methods, if applicable, to identify articles labeled as case-control studies. These articles were appraised and classified as true case-control studies or non-case-control studies. The authors found 28 articles labeled as case-control studies. However, only six of these articles (21 percent) were truly case-control designs. Of the 22 incorrectly labeled studies, one (5 percent) was a randomized controlled trial, three (14 percent) were nonrandomized trials, two (9 percent) were prospective comparative cohort designs, 14 (64 percent) were retrospective comparative cohort designs, and two (9 percent) were cross-sectional designs. The mislabeling was worse in recent years, despite increases in evidence-based medicine awareness. The majority of published case-control studies are not in fact case-control studies. This misunderstanding is worsening with time. Most of these studies are actually comparative cohort designs. However, some studies are truly clinical trials and thus a higher level of evidence than originally proposed.

  14. Sexual Dysfunction in Breast Cancer: A Case-Control Study

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    Mandana Ebrahimi

    2015-02-01

    Full Text Available Background: Sexual dysfunction in breast cancer patients is considered as a common and distressing problem. Considering the increasing number of breast cancer survivors living for longer periods of time with the disease and the importance of their quality of life, we conducted the present study to compare the sexual functioning in breast cancer patients with their healthy counterparts.Methods: In this case-control study, breast cancer patients who completed their treatment protocol and were followed up for at least six months were included. The controls were healthy women with normal clinical breast examinations. All subjects filled-in the Persian version of Female Sexual Function Index questionnaire.Results: A total of 165 subjects including 71 breast cancer patients and 94 healthy women were studied. The frequency of sexual dysfunction in cases and controls was 52.6% and 47.4%, respectively (P = 0.09. There were no significant differences between the two groups regarding domain scores, except for vaginal lubrication (P = 0.045. Logistic regression analysis indicated that significant determinants of sexual dysfunction in breast cancer group was patients' age (OR = 4.0, 95%CI: 1.3 – 11.5, P = 0.01 and age of the spouse (OR= 9.8, 95% CI: 1.8-51.9, P= 0.007, while in controls, only emotional relationship with the husband was the significant predictive factor (OR = 6.3, 95%CI: 1.9 – 20.5, P = 0.002.Conclusions: Our findings indicated that sexual dysfunction is prevalent in Iranian women regardless of their physical health status. The frequency of vaginal dryness in breast cancer patients was significantly higher than controls. Age of the patient and the spouse (>40 were the only significant predictors of sexual dysfunction among women with breast cancer. Preventive strategies, sexual education and access to effective treatment should be planned in supportive care of breast cancer patients.

  15. Sensory impairments and wrist fractures: A case-control study

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    Bergthora Baldursdottir

    2017-12-01

    Full Text Available Objectives: To investigate vestibular function, foot sensation, postural control and functional abilities, and to evaluate whether these variables are associated with fall-related wrist fracture. Methods: A case-control study was conducted with 98 subjects, age range 50–75 years, who had sustained a fall-related wrist fracture. Forty-eight sex-, age- and physical activity-matched individuals, with no previous history of wrist fracture, served as controls. Measurements included: head-shake test (HST, tuning fork, biothesiometer, Semmes-Weinstein monofilaments (MF, Sensory Organization Test (SOT, Five-Times-Sit-to-Stand Test (FTSTS, 10-m walk test (10MWT, Activities-specific Balance Confidence (ABC, and the Dizziness Handicap Inventory (DHI scales. Logistic regression models were used to determine associations of variables with a fall-related wrist fracture. Results: Vestibular asymmetry was apparent in 82% of wrist fracture subjects and 63% of controls (p = 0.012. Plantar pressure sensation (p <0.001, SOT composite scores (p < 0.001, 10MWT (p <0.001, FTSTS (p <0.001, ABC (p <0.001 and DHI (p <0.005 were significantly poorer among cases than controls. A positive HST (odds ratio (OR 5.424; p = 0.008 and monofilament sensation (OR 3.886; p = 0.014 showed the strongest associations with having a fall-related wrist fracture. Conclusion: Asymmetrical vestibular function and reduced plantar pressure sensation are associated with fall-related wrist fractures among the ageing population. These factors are potential targets for future interventions.

  16. Case-control study of fetal microchimerism and breast cancer.

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    Vijayakrishna K Gadi

    2008-03-01

    Full Text Available Prior pregnancy is known to protect against development of breast cancer. Recent studies have demonstrated that pregnancy has the capacity to establish small numbers of immunologically active fetal-derived cells in the mother, a phenomenon known as fetal microchimerism (FMc. We asked whether presence of FMc, routinely acquired during pregnancy, is a protective factor for breast cancer.DNA extracts from peripheral blood specimens were obtained from a population-based case-control study of risk factors for breast cancer in women 21 to 45 years old. Specimens were tested with quantitative PCR for presence and concentrations of male DNA presumed to derive from prior pregnancies with a male fetus. Odds ratios (OR and 95% confidence intervals (CI were estimated with consideration of multiple established reproductive and environmental risk factors for breast cancer. FMc results were generated on 99 parous women, 54 with primary invasive breast cancer and 45 general population controls. FMc prevalence was 56% (25/45 and 26% (14/54 in controls and cases, respectively. Women harboring FMc were less likely to have had breast cancer (OR = 0.29, 95% CI 0.11-0.83; p = 0.02, adjusting for age, number of children, birth of a son, history of miscarriage, and total DNA tested. In addition, FMc concentrations were higher in controls versus cases (p = 0.01. Median concentrations were 2 (0-78 and 0 (0-374 fetal genomes/10(6 maternal genomes in controls and cases, respectively.Results suggest that the enigma of why some parous women are not afforded protection from breast cancer by pregnancy might in part be explained by differences in FMc. Mechanistic studies of FMc-derived protection against breast cancer are warranted.

  17. Androgens and hyperemesis gravidarum: a case-control study.

    Science.gov (United States)

    Helseth, Ragnhild; Ravlo, Merethe; Carlsen, Sven M; Vanky, E Eszter

    2014-04-01

    The pathogenesis of hyperemesis gravidarum (HG) is probably multifactorial, involving several hormones. Androgen concentrations are reported to correlate positively with emesis gravidarum. Hypothesizing a continuum between emesis gravidarum and HG, we investigated androgen concentrations in women with HG. In a case-control study, 32 women hospitalized for HG were compared with 29 control women scheduled for elective surgical abortion. Control women were matched for age, gestational length, body mass index (BMI) and parity. Patient characteristics and concentrations of dehydroepiandrosterone sulphate (DHEAS), androstenedione, testosterone, sex hormone binding globulin (SHBG), free testosterone index (FTI), androstanediol glucuronide (ADG), progesterone, TSH, free T3 and T4, beta-hCG, ferritin, insulin, estradiol and estriol were compared using Mann-Whitney tests and multivariate linear regression analyses. Women with HG had higher concentrations of ADG (8.49±4.19 vs. 6.19±1.77pmol/L; p=0.015), estradiol (2.39±1.36 vs. 1.60±9.30nmol/L; p=0.009) and ferritin (186±138 vs. 117±94pmol/L; p=0.040) compared with control women. Androstenedione (5.34±2.82 vs. 6.86±2.67; p=0.004) and insulin (63.7±35.0 vs. 75.3±25.8; p=0.050) concentrations were lower in women with HG. DHEAS, testosterone, FTI, SHBG, estriol, progesterone, beta-hCG, TSH, free T3 and free T4 concentrations did not differ between the groups. In multivariate regression analyses HG was associated with high concentrations of ADG (p=0.026) and low concentrations of androstenedione (p=0.018). Steroid hormone homeostasis may be altered in women with HG. HG may be associated with high ADG and low androstenedione concentrations. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  18. Personality profile in essential tremor: A case-control study

    Science.gov (United States)

    Thenganatt, Mary Ann; Louis, Elan D.

    2012-01-01

    Background Neuropsychiatric findings described in essential tremor (ET) include depression and anxiety. There may be personality features as well; in 2004, we demonstrated higher harm avoidance (HA) scores in ET patients than controls. We now (1) determined whether this finding could be replicated in a new sample of cases and controls, and (2) analyzed HA sub-scores (HA1–HA4) to further understand case-control differences. Design/Methods 60 ET cases and 35 controls were evaluated using the Tridimensional Personality Questionnaire (TPQ), which assesses three domains of personality: HA, novelty seeking (NS), and reward dependence (RD). Results Total HA and total NS scores were marginally higher in cases than controls (14.8 ± 7.6 vs. 12.4 ± 5.3, p = 0.09) and (13.8 ± 5.4 vs. 11.8 ± 4.9, p = 0.09), respectively. When adjusted for age and gender, cases and controls differed with respect to total HA score (p = 0.03) but not total NS score (p = 0.10). Further analysis of HA subscores demonstrated that HA1 (anticipatory worry and pessimism) and HA4 (fatigability and asthenia) were most robustly elevated in cases vs. controls (p = 0.04 and p = 0.01, respectively). Conclusions This study suggests that ET cases have a personality profile characterized by a greater HA, with certain domains of HA most affected. It is unclear whether this personality profile is pre-morbid or is a co-morbid feature of the illness, nor it is known whether the greater tendency towards HA in ET lessens receptivity to deep brain stimulation surgery and other therapies. PMID:22703869

  19. Cooking with biomass stoves and tuberculosis: a case control study.

    Science.gov (United States)

    Pérez-Padilla, R; Pérez-Guzmán, C; Báez-Saldaña, R; Torres-Cruz, A

    2001-05-01

    To search for an association between tuberculosis and use of biomass stoves found recently in a cross sectional study. In a case-control study based in a chest referral hospital, the cases were 288 patients with active smear-positive or culture-positive tuberculosis, and the controls were 545 patients with ear nose and throat ailments with no evidence of chest disease studied at the same time as the cases. Exposure to present or previous biomass smoke by history of cooking with traditional wood stoves was assessed by positive or negative response. Exposure to biomass smoke was significantly higher in cases than in controls. Crude odds ratios for tuberculosis and biomass smoke exposure were 5.2 (95%CI 3.1-8.9) for current exposure, 3.4 (95%CI 2.4-5.0) for past or present exposure and 1.8 (95%CI 1.1-3.0) for past exposure. The association was observed only for patients living in Metropolitan Mexico City and urban or suburban areas in the center of Mexico providing most cases and controls. For rural areas, the power of the study was low and the origin of the patients heterogeneous. Odds ratio for Mexico City Metropolitan area and the center of Mexico was 2.4 (95%CI 1.04-5.6), adjusted for age, sex, level of education, crowding, smoking, socio-economic level, zone of residence and state of birth. In the same model smoking had an OR of 1.5 (95%CI 1.0-2.3) for tuberculosis. Our results support a causal role of current domestic biomass smoke exposure in tuberculosis.

  20. Risk factors for syphilis in women: case-control study

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    Vilma Costa de Macêdo

    2017-08-01

    Full Text Available ABSTRACT OBJECTIVE To determine the sociodemographic, behavioral, and health care factors related to the occurrence of syphilis in women treated at public maternity hospitals. METHODS This is a case-control study (239 cases and 322 controls with women admitted to seven maternity hospitals in the municipality of Recife, Brazil, from July 2013 to July 2014. Eligible women were recruited after the result of the VDRL (Venereal Disease Research Laboratory under any titration. The selection of cases and controls was based on the result of the serology for syphilis using ELISA (enzyme-linked immunosorbent assay. The independent variables were grouped into: sociodemographic, behavioral, clinical and obstetric history, and health care in prenatal care and maternity hospital. Information was obtained by interview, during hospitalization, with the application of a questionnaire. Odds ratios and 95% confidence intervals were estimated using logistic regression to identify the predicting factors of the variable to be explained. RESULTS The logistic regression analysis identified as determinant factors for gestational syphilis: education level of incomplete basic education or illiterate (OR = 2.02, lack of access to telephone (OR = 2.4, catholic religion (OR = 1.70 , four or more pregnancies (OR = 2.2, three or more sexual partners in the last year (OR = 3.1, use of illicit drugs before the age of 18 (OR = 3.0, and use of illicit drugs by the current partner (OR = 1.7. Only one to three prenatal appointments (OR = 3.5 and a previous history of sexually transmitted infection (OR = 9.7 were also identified as determinant factors. CONCLUSIONS Sociodemographic, behavioral, and health care factors are associated with the occurrence of syphilis in women and should be taken into account in the elaboration of universal strategies aimed at the prevention and control of syphilis, but with a focus on situations of greater vulnerability.

  1. Behavioral Problems in Iranian Epileptic Children; A Case Control Study

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    Maryam Aludari

    2017-12-01

    Full Text Available Background Epilepsy is among the most common neurological disorders in childhood, prevalence of which is increasing. Unpredictable and chronic nature of the disease affects physical, social and mental functions of the children and their family. This study was aimed to compare behavioral problems in epileptic children group versus healthy control group. Materials and Methods This study is a case-control one conducted from January 2013 to June 2016 in Tehran, Iran. The epileptic children in age of 7-10 years old that were diagnosed by neurologist referred to the researcher for further process. Their parents were provided with Child Behavior Checklist (CBCL to be completed. For matching by age and gender, the healthy group was sampled after the epilepsy group. Multivariate Analysis of Variance was used for statistical analysis. Results In this study 94 children with epilepsy and 83 healthy children in age of 7-10 years old were studied. The results indicated that there were significantly higher behavioral problems in the children with epilepsy than in control group in nine categories of seclusiveness, physical complaints, anxiety and depression, social problems, thought problems, attention problems, delinquent behaviors, aggressive behaviors, and other problems. Comparison of two generalized and partial epilepsy groups indicated that there was a significant difference only in attention problems (p = 0.024. Conclusion The present study indicates that the children with epilepsy have more behavioral problems as compared to control group. Therefore, educational and psychological interventions are necessary for supporting desirable psychosocial growth and development of such children.

  2. Case-control analysis of paternal age and trisomic anomalies.

    Science.gov (United States)

    De Souza, E; Morris, J K

    2010-11-01

    To determine whether older paternal age increases the risk of fathering a pregnancy with Patau (trisomy 13), Edwards (trisomy 18), Klinefelter (XXY) or XYY syndrome. Case-control: cases with each of these syndromes were matched to four controls with Down syndrome from within the same congenital anomaly register and with maternal age within 6 months. Data from 22 EUROCAT congenital anomaly registers in 12 European countries. Diagnoses with observed or (for terminations) predicted year of birth from 1980 to 2005, comprising live births, fetal deaths with gestational age ≥ 20 weeks and terminations after prenatal diagnosis of the anomaly. Data include 374 cases of Patau syndrome, 929 of Edwards syndrome, 295 of Klinefelter syndrome, 28 of XYY syndrome and 5627 controls with Down syndrome. Odds ratio (OR) associated with a 10-year increase in paternal age for each anomaly was estimated using conditional logistic regression. Results were adjusted to take account of the estimated association of paternal age with Down syndrome (1.11; 95% CI 1.01 to 1.23). The OR for Patau syndrome was 1.10 (95% CI 0.83 to 1.45); for Edwards syndrome, 1.15 (0.96 to 1.38); for Klinefelter syndrome, 1.35 (1.02 to 1.79); and for XYY syndrome, 1.99 (0.75 to 5.26). There was a statistically significant increase in the odds of Klinefelter syndrome with increasing paternal age. The larger positive associations of Klinefelter and XYY syndromes with paternal age compared with Patau and Edwards syndromes are consistent with the greater percentage of these sex chromosome anomalies being of paternal origin.

  3. At-Risk Phenotype of Neurofibromatose-1 Patients: A Multicentre Case-Control Study

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    Ferkal Salah

    2011-07-01

    Full Text Available Abstract Objectives To assess associations between subcutaneous neurofibromas (SC-NFs and internal neurofibromas in patients with neurofibromatosis type 1 (NF-1 and to determine whether the association between SC-NFs and peripheral neuropathy was ascribable to internal neurofibromas. Patients and methods Prospective multicentre case-control study. Between 2005 and 2008, 110 NF-1 adults having two or more SC-NFs were individually matched for age, sex and hospital with 110 controls who had no SC-NF. Patients underwent standardized MRI of the spinal cord, nerve roots and sciatic nerves and an electrophysiological study. Analyses used adjusted multinomial logistic regression (ORa to estimate the risk of the presence of internal neurofibromas or peripheral neuropathies associated with patients presented 2 to 9 SC-NFs, at least 10 SC-NFs as compared to patients without any (referential category. Results Cases had a mean age of 41 (± 13 years; 85 (80% had two to nine SC-NFs and 21 (19% at least ten SC-NFs. SC-NFs were more strongly associated with internal neurofibromas in patients with ten or more SC-NFs than in patients with fewer NF-SCs (e.g., sciatic nerve, aOR = 29.1 [8.5 to 100] vs. 4.3 [2.1 to 9.0]. The association with SC-NFs was stronger for diffuse, intradural, and > 3 cm internal neurofibromas than with other internal neurofibromas. Axonal neuropathy with slowed conduction velocities (SCV was more strongly associated with having at least ten SC-NFs (aOR = 29.9, 5.5 to 162.3 than with having fewer SC-NFs (aOR = 4.4, 0.9 to 22.0. Bivariate analyses showed that the association between axonal neuropathy with SCV and sciatic neurofibromas was mediated by the association between SC-NFs and sciatic neurofibromas. Conclusion The at-risk phenotype of NF-1 patients (i.e. NF-1 patients with SC-NFs is ascribable to associations linking SC-NFs to internal neurofibromas at risk for malignant transformation and to axonal neuropathies with slowed

  4. Association between diabetes and tuberculosis: case-control study.

    Science.gov (United States)

    Pereira, Susan Martins; Araújo, Gleide Santos de; Santos, Carlos Antônio de Souza Teles; Oliveira, Maeli Gomes de; Barreto, Maurício Lima

    2016-12-22

    To test the association between diabetes and tuberculosis. It is a case-control study, matched by age and sex. We included 323 new cases of tuberculosis with positive results for bacilloscopy. The controls were 323 respiratory symptomatic patients with negative bacilloscopy, from the same health services, such as: ambulatory cases from three referral hospitals and six basic health units responsible for the notifications of new cases of tuberculosis in Salvador, Bahia. Data collection occurred between 2008 and 2010. The instruments used were structured interview, including clinical data, capillary blood glucose (during fasting or postprandial), and the CAGE questionnaire for screening of abusive consumption of alcohol. Descriptive, exploratory, and multivariate analysis was performed using conditional logistic regression. The average age of the cases was 38.5 (SD = 14.2) years and of the controls, 38.5 (SD = 14.3) years. Among cases and controls, most subjects (61%) were male. In univariate analysis we found association between the occurrence of diabetes and tuberculosis (OR = 2.37; 95%CI 1.04-5.42), which remained statistically significant after adjustment for potential confounders (OR = 3.12; 95%CI 1.12-7.94). The association between diabetes and tuberculosis can hinder the control of tuberculosis, contributing to the maintainance of the disease burden. The situation demands increasing early detection of diabetes among people with tuberculosis, in an attempt to improve disease control strategies. Testar a associação entre diabetes e tuberculose. Trata-se de estudo caso-controle, pareado por idade e sexo. Foram incluídos 323 casos novos de tuberculose com resultados positivos à baciloscopia. Os controles foram 323 sintomáticos respiratórios com baciloscopia negativa, oriundos dos mesmos serviços de saúde dos casos: ambulatórios de três hospitais de referência e seis unidades básicas de saúde responsáveis pelas notificações dos casos novos de

  5. Risk Factors Of Low Birth Weight; Case-Control Study

    Directory of Open Access Journals (Sweden)

    Özgür Önal

    2017-06-01

    Full Text Available Low birth weight (LBW (defined as a birth weight of less than 2500 grams is associated with fetal and neonatal morbidity and mortality, impaired cognitive development, and the advent of chronic diseases in later life. The global incidence of LBW is around 15,5%. The aim of this study was to identify risk factors for low birthweight in the centre of Denizli province. A case-control study was carried out and mothers of 295 newborns with birthweight between 1500-2499 g (cases and 302 newborns with birthweight between 2500-4000 g (controls were analyzed. The questionnare was applied to women using face to face technics between July,2009 and June,2010 . The questionnare included birth weight and birth lenght of newborn, the date of last pregnacy and type of last delivery, profile of mother, anthropometric measures, life styles, habits, addictions, sociodemographic and socioeconomic characteristics of mother and father of newborn. Analysis included frequency and percent distributions, means, standart deviations. In group comparisions for categorical variable, chi square test and odds ratio (OR was used. Logistic regression model was performed for some selected risk factors. P<0.05 was considered statistically significant. Statistical Package for Social Sciences (SPSS program, Version 10 was used for data entry and analysis. When backward logistic regression model was performed for some selected factors in relation to low birth weight, there was a positive relationship between multiple pregnancy [OR(95%CI 18.50 (8.54, 40.39], BMI lower than 20 kg/m2 of mother before pregnancy andemployment status [OR(95%CI 1.98 (1.23, 3.19], weight gain of 7 kg and under during pregnanacy [OR(95%CI 2.49 (1.56, 3.96], a history of giving birth to low birth weight infant [OR(95%CI 3.44 (1.69, 7.02], first- degree and second- degree relative’s histories of giving birth to low birth weight infant [OR(95%CI 4.28 (2.61, 6.94], X- ray exposure in the three months before and

  6. Homocyst(e)ine and cardiovascular disease: a systematic review of the evidence with special emphasis on case-control studies and nested case-control studies.

    Science.gov (United States)

    Ford, Earl S; Smith, S Jay; Stroup, Donna F; Steinberg, Karen K; Mueller, Patricia W; Thacker, Stephen B

    2002-02-01

    Elevated concentrations of homocyst(e)ine are thought to increase the risk of vascular diseases including coronary heart disease and cerebrovascular disease. We searched MEDLINE (1966-1999), EMBASE (1974-1999), SciSearch (1974- 1999), and Dissertation Abstracts (1999) for articles and theses about homocyst(e)ine concentration and coronary heart disease and cerebrovascular disease. We included 57 publications (3 cohort studies, 12 nested case-control studies, 42 case-control studies) that reported results on 5518 people with coronary heart disease (11,068 control subjects) and 1817 people with cerebrovascular disease (4787 control subjects) in our analysis. For coronary heart disease, the summary odds ratios (OR) for a 5-micromol/l increase in homocyst(e)ine concentration were 1.06 (95% CI : 0.99-1.13) for 2 publications of cohort studies, 1.23 (95% CI : 1.07-1.41) for 10 publications of nested case-control studies, and 1.70 (95% CI : 1.50-1.93) for 26 publications of case-control studies. For cerebrovascular disease, the summary OR for a 5-micromol/l increase in homocyst(e)ine concentration were 1.10 (95% CI : 0.94-1.28) for 2 publications of cohort studies, 1.58 (95% CI : 1.35-1.85) for 5 publications of nested case-control studies, and 2.16 (95% CI : 1.65-2.82) for 17 publications of case-control studies. Prospective studies offer weaker support than case-control studies for an association between homocyst(e)ine concentration and cardiovascular disease. Although other lines of evidence support a role for homocyst(e)ine in the pathogenesis of cardiovascular disease, more information from prospective epidemiological studies or clinical trials is needed to clarify this role.

  7. Impact of waning acquired immunity and asymptomatic infections on case-control studies for enteric pathogens

    NARCIS (Netherlands)

    Havelaar, Arie H; Swart, Arno

    2016-01-01

    Case-control studies of outbreaks and of sporadic cases of infectious diseases may provide a biased estimate of the infection rate ratio, due to selecting controls that are not at risk of disease. We use a dynamic mathematical model to explore biases introduced in results drawn from case-control

  8. Risk factors for syphilis in women: case-control study.

    Science.gov (United States)

    Macêdo, Vilma Costa de; Lira, Pedro Israel Cabral de; Frias, Paulo Germano de; Romaguera, Luciana Maria Delgado; Caires, Silvana de Fátima Ferreira; Ximenes, Ricardo Arraes de Alencar

    2017-08-17

    To determine the sociodemographic, behavioral, and health care factors related to the occurrence of syphilis in women treated at public maternity hospitals. This is a case-control study (239 cases and 322 controls) with women admitted to seven maternity hospitals in the municipality of Recife, Brazil, from July 2013 to July 2014. Eligible women were recruited after the result of the VDRL (Venereal Disease Research Laboratory) under any titration. The selection of cases and controls was based on the result of the serology for syphilis using ELISA (enzyme-linked immunosorbent assay). The independent variables were grouped into: sociodemographic, behavioral, clinical and obstetric history, and health care in prenatal care and maternity hospital. Information was obtained by interview, during hospitalization, with the application of a questionnaire. Odds ratios and 95% confidence intervals were estimated using logistic regression to identify the predicting factors of the variable to be explained. The logistic regression analysis identified as determinant factors for gestational syphilis: education level of incomplete basic education or illiterate (OR = 2.02), lack of access to telephone (OR = 2.4), catholic religion (OR = 1.70 ), four or more pregnancies (OR = 2.2), three or more sexual partners in the last year (OR = 3.1), use of illicit drugs before the age of 18 (OR = 3.0), and use of illicit drugs by the current partner (OR = 1.7). Only one to three prenatal appointments (OR = 3.5) and a previous history of sexually transmitted infection (OR = 9.7) were also identified as determinant factors. Sociodemographic, behavioral, and health care factors are associated with the occurrence of syphilis in women and should be taken into account in the elaboration of universal strategies aimed at the prevention and control of syphilis, but with a focus on situations of greater vulnerability. Determinar os fatores sociodemográficos, comportamentais e de assistência à sa

  9. Lower urinary tract symptoms and falls in older women: a case control study.

    Science.gov (United States)

    Edwards, Rhodri; Hunter, Kathleen; Wagg, Adrian

    2015-03-01

    To examine the distribution of lower urinary tract symptoms (LUTS) in women >65y old presenting to the emergency department following a fall or fall related injury. A prospective, case controlled postal questionnaire study. University Teaching Hospital, London, UK. The distribution of LUTS were assessed using the International Consultation on Incontinence Modular Questionnaire for female lower urinary tract symptoms. Data were analysed using descriptive statistics to determine whether there was a difference in the distribution of LUTS between women presenting with a fall or non-fall related health problem. The proportion of women who attributed their fall to lower urinary tract symptoms was also assessed. No difference in the distribution of LUTS was found between older women presenting with a fall and those without. Only 6.5% of women presenting with falls attributed their fall to antecedent LUTS. No relationship between falls and urgency or urgency incontinence was found in a cohort of older women presenting to the emergency department having fallen. A temporal association between falls and LUTS was observed in only a minority of falls. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  10. Risk factors for basal cell carcinoma in a southern Brazilian population: a case-control study.

    Science.gov (United States)

    Gon, Airton; Minelli, Lorivaldo

    2011-10-01

    Basal cell carcinoma (BCC) is the most common cancer to occur in Caucasian populations, and its incidence is increasing. Despite its frequency, there is a paucity of data on risk factors for BCC in some regions. This study investigated the association between pigmentary characteristics, distinctive patterns of solar exposure, habits and lifestyle, and risk for BCC among patients attending a dermatology center in a region in southern Brazil. We conducted a hospital-based, case-control study that included 127 case patients with histologically confirmed BCC and 280 cancer-free control subjects with other dermatologic conditions, observed between January 2006 and December 2007. The study was conducted using a questionnaire and physical examination by a dermatologist. Relative risks were estimated using exposure odds ratios generated by cross-tabulation and logistic regression models. Risk for BCC was associated with family history of skin cancer, Fitzpatrick skin type I, and the presence of actinic keratoses, solar lentigines, leukoderma, and elastosis romboidalis nuchae. No effect was found for different patterns of solar exposure, eye, hair or skin color, exposure to non-solar ultraviolet radiation (UVR), or lifestyle-related habits such as sunscreen use and cigarette smoking. The results of this study suggest that skin type and family history of skin cancer may be important in establishing risk for developing BCC. Additionally, the detection by clinical examination of skin markers related to UVR action is important in establishing which patients are more likely to develop BCC. © 2011 The International Society of Dermatology.

  11. Leukemia risk among U.S. white male coal miners. A case-control study.

    Science.gov (United States)

    Gilman, P A; Ames, R G; McCawley, M A

    1985-09-01

    The relevance of occupational exposure to electrical and magnetic fields (EMF) in the etiology of leukemia has been raised in several studies. Underground coal miners represent an occupational group with situationally determined EMF exposure, as high-voltage power distribution lines are strung overhead in the mines and converters and step-down transformers provide power to mining equipment. Risk in occupational exposure to EMF was examined in a case-control study of 40 leukemia decedents and 160 control subjects who died of causes other than cancer or accident and who were matched on age at death. The control subjects were selected from a group of 6,066 persons whose deaths were reported in four National Institute for Occupational Safety and Health cohort mortality follow-up studies. Based on these data, 25 or more years of underground mining, a surrogate of EMF exposure, was found to pose a statistically significant risk for leukemia (International Classification of Diseases [ICD] codes 204 through 207, eighth revision), myelogenous leukemia (ICD 205), and chronic lymphocytic leukemia (CLL) (ICD 204.1). Accumulative exposure to chemical agents probably poses a risk for acute myelogenous leukemia, although this relationship fell short of being statistically significant. Although CLL has not previously been attributed to environmental agents, these data suggest a possible CLL risk from prolonged exposure to EMF.

  12. Advantages of the nested case-control design in diagnostic research

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    Hoes Arno W

    2008-07-01

    Full Text Available Abstract Background Despite its benefits, it is uncommon to apply the nested case-control design in diagnostic research. We aim to show advantages of this design for diagnostic accuracy studies. Methods We used data from a full cross-sectional diagnostic study comprising a cohort of 1295 consecutive patients who were selected on their suspicion of having deep vein thrombosis (DVT. We draw nested case-control samples from the full study population with case:control ratios of 1:1, 1:2, 1:3 and 1:4 (per ratio 100 samples were taken. We calculated diagnostic accuracy estimates for two tests that are used to detect DVT in clinical practice. Results Estimates of diagnostic accuracy in the nested case-control samples were very similar to those in the full study population. For example, for each case:control ratio, the positive predictive value of the D-dimer test was 0.30 in the full study population and 0.30 in the nested case-control samples (median of the 100 samples. As expected, variability of the estimates decreased with increasing sample size. Conclusion Our findings support the view that the nested case-control study is a valid and efficient design for diagnostic studies and should also be (reappraised in current guidelines on diagnostic accuracy research.

  13. Analgesics use and ESRD in younger age: a case-control study

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    Moehner Sabine

    2007-12-01

    Full Text Available Abstract Background An ad hoc peer-review committee was jointly appointed by Drug Authorities and Industry in Germany, Austria and Switzerland in 1999/2000 to review the evidence for a causal relation between phenacetin-free analgesics and nephropathy. The committee found the evidence as inconclusive and requested a new case-control study of adequate design. Methods We performed a population-based case-control study with incident cases of end-stage renal disease (ESRD under the age of 50 years and four age and sex-matched neighborhood controls in 170 dialysis centers (153 in Germany, and 17 in Austria from January 1, 2001 to December 31, 2004. Data on lifetime medical history, risk factors, treatment, job exposure and intake of analgesics were obtained in a standardized face-to-face interview using memory aids to enhance accuracy. Study design, study performance, analysis plan, and study report were approved by an independent international advisory committee and by the Drug Authorities involved. Unconditional logistic regression analyses were performed. Results The analysis included 907 cases and 3,622 controls who had never used phenacetin-containing analgesics in their lifetime. The use of high cumulative lifetime dose (3rd tertile of analgesics in the period up to five years before dialysis was not associated with later ESRD. Adjusted odds ratios with 95% confidence intervals were 0.8 (0.7 – 1.0 and 1.0 (0.8 – 1.3 for ever- compared with no or low use and high use compared with low use, respectively. The same results were found for all analgesics and for mono-, and combination preparations with and without caffeine. No increased risk was shown in analyses stratifying for dose and duration. Dose-response analyses showed that analgesic use was not associated with an increased risk for ESRD up to 3.5 kg cumulative lifetime dose (98 % of the cases with ESRD. While the large subgroup of users with a lifetime dose up to 0.5 kg (278 cases and

  14. A case control study of breast cancer risk and exposure to injectable ...

    African Journals Online (AJOL)

    A case control study of breast cancer risk and exposure to injectable progestogen contraceptives. R. Bailie, J Katzenellenbogen, M. Hoffman, G Schierhout, H Truter, D Dent, A Gudgeon, J van Zyl, L Rosenberg, S Shapiro ...

  15. Spironolactone and risk of upper gastrointestinal events: population based case-control study

    NARCIS (Netherlands)

    K.M.C. Verhamme (Katia); G. Mosis (Georgio); B.H.Ch. Stricker (Bruno); M.C.J.M. Sturkenboom (Miriam); J.P. Dieleman (Jeanne)

    2006-01-01

    textabstractOBJECTIVE: To confirm and quantify any association between spironolactone and upper gastrointestinal bleeding and ulcers. DESIGN: Population based case-control study. SETTING: A primary care information database in the Netherlands. PARTICIPANTS: All people on the

  16. Implant failure and history of failed endodontic treatment: A retrospective case-control study

    OpenAIRE

    Chatzopoulos, Georgios S.; Wolff, Larry F.

    2017-01-01

    Background Residual bacterial biofilm and/or bacteria in planktonic form may be survived in the bone following an extraction of an infected tooth that was endodontically treated unsuccessfully Failed endodontic treatment may be associated with failure of implants to osseointegrate in the same sites. Therefore, the aim of this retrospective case-control study is to examine the risk of implant failure in previous failed endodontic sites. Material and Methods This retrospective case-control stud...

  17. Neuropsychiatric manifestation of celiac disease: A case-control study in North India

    Directory of Open Access Journals (Sweden)

    Mahendra Nimel

    2016-01-01

    Full Text Available Background: Celiac disease (CD is an immune-mediated disease dependent on gluten. Prevalence of CD is about 1% and beside gastrointestinal complaints, neuropsychiatric symptoms may represent an atypical feature of CD. Some studies suggest that a gluten-free diet is effective in treating them. Settings and Design: This case-control study of 49 cases was done during the period of January to March 2013. Aim: To know the spectrum of psychiatric manifestations and cognitive functions in children with CD. Materials and Methods: We took 49 diagnosed cases of CD (based on the demonstration of IgA tissue transglutaminase antibodies and duodenal biopsy and compared with demographically matched control group (n = 50 on Seguin Form Board Test for cognitive functions and Behavioral Summarized Evaluation-Revised scale for assessment of psychiatric and behavior disturbances. All possible psychiatric diagnosis was made on the basis of International Statistical Classification of Disease and Related Health Problems-Tenth Revision criteria. Statistical Analysis: Statistical analyses were done by using Chi-square test and two-tailed P-values. Results: Neuropsychiatric manifestations were seen in 29% of cases as against 4% of controls which was statistically significant (P=0.001. Only four cases and 1 control fount to be mild mental retardation (P = 0.16. Autism, dyslexia, developmental delay, disruptive behavior disorder, and tic disorder present in cases were not found. Conclusion: Clinical manifestations of CD vary from typical malabsorption syndrome to neuropsychiatric manifestations. Those psychiatric patients who are not responding to standard pharmacological modalities, a diagnosis of CD should be taken into consideration. Only behavioral problem can be the sole clinical manifestation of CD.

  18. Nutritional and behavioral determinants of adolescent obesity: a case-control study in Sri Lanka.

    Science.gov (United States)

    Rathnayake, Kumari M; Roopasingam, Tharrmini; Wickramasighe, V P

    2014-12-17

    Global prevalence of adolescent obesity is rising at an alarming rate leading to increase risk of adult obesity. Obesity in adolescence is postulated to have a significant impact on both physical and psychological health of an individual. The study aim was to identify nutritional and behavioral risk factors associated with obesity among adolescent Sri Lankan school girls. In this case-control study, age and ethnicity matched 100 cases (BMI-for-age above +2SD) and 100 controls (BMI-for-age between -2SD to +1 SD) adolescent girls between 14 to 18 years of age were recruited. Predicted risk factors of obesity were assessed through an interviewer administrated questionnaire. A three day diet diary and long version of international physical activity questionnaire were used to assess daily energy intake and energy expenditure from physical activity, respectively. The significant differences in mean values were evaluated using paired t-test. Multivariable logistic regression analysis was performed to assess the risk factors associated with obesity. Obese girls had significantly higher BMI (31.3, 20.2 kgm-2 p  2 hours/ day (2.96, 1.33-6.61), energy intake (3.97, 3.19-16.36), significantly increased the risk of obesity, whereas increased physical activity (4.34, 1.33-14.14) decreased the risk. Irregular menstruation (4.34, 1.33-14.14) was noted among the obese. Socioeconomic and behavior factors are major determinants of adolescent obesity in Sri Lanka. There is an urgent need to implement awareness as well as behavior modification programmes targeting adolescents, parents and schools to control childhood and adolescent obesity.

  19. Effectiveness of malaria control interventions in Madagascar: a nationwide case-control survey.

    Science.gov (United States)

    Kesteman, Thomas; Randrianarivelojosia, Milijaona; Raharimanga, Vaomalala; Randrianasolo, Laurence; Piola, Patrice; Rogier, Christophe

    2016-02-11

    Madagascar, as other malaria endemic countries, depends mainly on international funding for the implementation of malaria control interventions (MCI). As these funds no longer increase, policy makers need to know whether these MCI actually provide the expected protection. This study aimed at measuring the effectiveness of MCI deployed in all transmission patterns of Madagascar in 2012-2013 against the occurrence of clinical malaria cases. From September 2012 to August 2013, patients consulting for non-complicated malaria in 31 sentinel health centres (SHC) were asked to answer a short questionnaire about long-lasting insecticidal nets (LLIN) use, indoor residual spraying (IRS) in the household and intermittent preventive treatment of pregnant women (IPTp) intake. Controls were healthy all-ages individuals sampled from a concurrent cross-sectional survey conducted in areas surrounding the SHC. Cases and controls were retained in the database if they were resident of the same communes. The association between Plasmodium infection and exposure to MCI was calculated by multivariate multilevel models, and the protective effectiveness (PE) of an intervention was defined as 1 minus the odds ratio of this association. Data about 841 cases (out of 6760 cases observed in SHC) and 8284 controls was collected. The regular use of LLIN provided a significant 51 % PE (95 % CI [16-71]) in multivariate analysis, excluding in one transmission pattern where PE was -11 % (95 % CI [-251 to 65]) in univariate analysis. The PE of IRS was 51 % (95 % CI [31-65]), and the PE of exposure to both regular use of LLIN and IRS was 72 % (95 % CI [28-89]) in multivariate analyses. Vector control interventions avoided yearly over 100,000 clinical cases of malaria in Madagascar. The maternal PE of IPTp was 73 %. In Madagascar, LLIN and IRS had good PE against clinical malaria. These results may apply to other countries with similar transmission profiles, but such case-control surveys could be

  20. Case-control study evaluating competing risk factors for angioedema in a high-risk population.

    Science.gov (United States)

    Kamil, Rebecca J; Jerschow, Elina; Loftus, Patricia A; Tan, Melin; Fried, Marvin P; Smith, Richard V; Foster, David; Ow, Thomas J

    2016-08-01

    Black race is a risk factor for angioedema. The primary aim was to examine the relationship between race-ethnicity and risk factors for angioedema. Using a retrospective case-control study design, data was extracted with the Clinical Looking Glass utility, a data collection and management tool that captures data from electronic medical record systems within the Montefiore Healthcare System. Cases were emergency department (ED) visits with primary or secondary International Classification of Diseases, Ninth Revision, code diagnoses of angioedema in adults aged ≥ 18 years from January 2008 to December 2013 at three Montefiore centers in Bronx, New York. Controls were a random sampling of adult ED visits during the same period. In primary analyses, angiotensin-converting enzyme inhibitor (ACE-I) and black race were evaluated for synergy. The influence of different risk factors in the development of angioedema was evaluated using logistic regression models. Finally, race-ethnicity was further explored by evaluating for effect modification by stratification of models by race-ethnicity categories. There were 1,247 cases and 6,500 controls randomly selected from a larger control pool. ACE-I use (odds ratio [OR] 3.70, 95% confidence interval [CI] 2.98, 4.60), hypertension (OR 1.88, 95% CI 1.55, 2.29), and black race (OR 2.25, 95% CI 1.86, 2.72) were the strongest risk factors. ACE-I use and black race were not synergistic (OR 1.10, 95% CI 0.80, 1.51). Race-ethnicity was an effect modifier for certain risk factors. Race-ethnicity acts as an effect modifier for particular angioedema risk factors. The two strongest risk factors, ACE-I use and black race, were not synergistic. 3b. Laryngoscope, 126:1823-1830, 2016. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

  1. Severe Sepsis in Severely Malnourished Young Bangladeshi Children with Pneumonia: A Retrospective Case Control Study.

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    Mohammod Jobayer Chisti

    Full Text Available In developing countries, there is no published report on predicting factors of severe sepsis in severely acute malnourished (SAM children having pneumonia and impact of fluid resuscitation in such children. Thus, we aimed to identify predicting factors for severe sepsis and assess the outcome of fluid resuscitation of such children.In this retrospective case-control study SAM children aged 0-59 months, admitted to the Intensive Care Unit (ICU of the Dhaka Hospital of the International Centre for Diarrhoeal Disease Research, Bangladesh from April 2011 through July 2012 with history of cough or difficult breathing and radiologic pneumonia, who were assessed for severe sepsis at admission constituted the study population. We compared the pneumonic SAM children with severe sepsis (cases = 50 with those without severe sepsis (controls = 354. Severe sepsis was defined with objective clinical criteria and managed with fluid resuscitation, in addition to antibiotic and other supportive therapy, following the standard hospital guideline, which is very similar to the WHO guideline.The case-fatality-rate was significantly higher among the cases than the controls (40% vs. 4%; p<0.001. In logistic regression analysis after adjusting for potential confounders, lack of BCG vaccination, drowsiness, abdominal distension, acute kidney injury, and metabolic acidosis at admission remained as independent predicting factors for severe sepsis in pneumonic SAM children (p<0.05 for all comparisons.We noted a much higher case fatality among under-five SAM children with pneumonia and severe sepsis who required fluid resuscitation in addition to standard antibiotic and other supportive therapy compared to those without severe sepsis. Independent risk factors and outcome of the management of severe sepsis in our study children highlight the importance for defining optimal fluid resuscitation therapy aiming at reducing the case fatality in such children.

  2. Use of antidepressants and association with elective termination of pregnancy: population based case-control study.

    Science.gov (United States)

    Kieler, H; Malm, H; Artama, M; Engeland, A; Furu, K; Gissler, M; Nørgaard, M; Stephansson, O; Valdimarsdottir, U; Zoega, H; Haglund, B

    2015-11-01

    To assess whether the use of selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, mirtazapine, venlafaxine or other antidepressants is associated with late elective termination of pregnancy. Case-control study using data from national registers. Denmark, Finland, and Norway during the period 1996-2007. A total of 14,902 women were included as cases and 148,929 women were included as controls. Cases were women with elective termination of pregnancy at 12-23 weeks of gestation. Controls continued their pregnancy and were matched with cases on key factors. Association between antidepressant use during pregnancy and elective termination of pregnancy at 12-23 weeks of gestation for fetal anomalies, or for maternal ill health or socio-economic disadvantage. At least one prescription of antidepressants was filled by 3.7% of the cases and 2.2% of the controls. Use of any type of antidepressant was associated with elective termination of pregnancy for maternal ill health or socio-economic disadvantage (odds ratio, OR 2.3; 95% confidence interval, 95% CI 2.0-2.5). Elective termination of pregnancy for fetal anomalies was associated with the use of mirtazapine (OR 2.2, 95% CI 1.1-4.5). There was no association between the use of any of the other antidepressants and elective termination of pregnancy for fetal anomalies. The use of any type of antidepressants was associated with elective termination of pregnancy at 12-23 weeks for maternal ill health or socio-economic disadvantage, but not with terminations for fetal anomalies. Further studies need to confirm the findings concerning mirtazapine and termination of pregnancy for fetal anomalies. © 2014 The Authors. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

  3. Hyperemesis gravidarum and maternal cancer risk, a Scandinavian nested case-control study.

    Science.gov (United States)

    Vandraas, Kathrine F; Grjibovski, Andrej M; Støer, Nathalie C; Troisi, Rebecca; Stephansson, Olof; Ording, Anne Gulbech; Vangen, Siri; Grotmol, Tom; Vikanes, Åse V

    2015-09-01

    Reproductive factors have been shown to influence cancer risk. Several pathological conditions during pregnancy have also been associated with subsequent altered cancer risk in the mother. Hyperemesis gravidarum (hyperemesis) is an early pregnancy condition characterized by severe nausea and vomiting resulting in weight loss and metabolic disturbances. Studies have reported associations between hyperemesis and cancer, but results are inconsistent. In this nested case-control study we linked the population-based medical birth registries and cancer registries in Norway, Sweden and Denmark in order to examine overall cancer risk and risk of specific cancer types in women with a history of hyperemesis, using conditional logistic regression. In total, 168,501 cases of cancer in addition to up to 10 cancer-free controls per case were randomly sampled, matched on year of birth and birth registry (n = 1,721,626). Hyperemesis was defined through the International Classification of Diseases. Analyses were adjusted for potential confounders. Hyperemesis was inversely associated with overall cancer risk with adjusted relative risk (aRR) of 0.93 (95% CI: 0.88-0.99), with cancer in the lungs (aRR: 0.60, 95% CI: 0.44-0.81), cervix (aRR: 0.66, 95% CI: 0.49-0.91) and rectum (aRR: 0.48, 95% CI: 0.29-0.78). Thyroid cancer was positively associated with hyperemesis (aRR 1.45, 95% CI: 1.06-1.99) and risk increased with more than one hyperemetic pregnancy (aRR 1.80, 95% CI: 1.23-2.63). Hormonal factors, in particular human chorionic gonadotropin, are likely to be involved in mediating these effects. This study is the first to systematically address these associations and provides valuable knowledge on potential long-term consequences of hyperemesis. © 2015 UICC.

  4. A case-control study of correlates of severe acute maternal morbidity in Kabul, Afghanistan.

    Science.gov (United States)

    Todd, Catherine S; Mansoor, Ghulam Farooq; Haider, Sadia; Hashimy, Pashtoon; Mustafavi, Nazifa; Nasir, Abdul; Miller, Suellen

    2015-08-01

    To identify correlates of severe acute maternal morbidity (SAMM) in Kabul, Afghanistan. The present case-control study enrolled postpartum couples at four public maternity hospitals between September 2007 and December 2009. Eligibility was determined by: spousal consent; SAMM criteria from chart review for cases; and matching by age, parity, and time since previous delivery for controls (uncomplicated deliveries). Staff administered questionnaires to women and their husbands separately. SAMM correlates were analyzed with conditional logistic regression in models including (proximate) and excluding (distal) care factors. Among 285 case and 285 control couples, the most frequent SAMM diagnoses were obstructed labor (104 [36.5%]) and hemorrhage requiring transfusion (102 [35.8%]). In both models, SAMM was associated with the husband having more than one wife (distal: adjusted odds ratio [aOR] 48.6, 95% CI 5.4-436.5; proximate: 141.8, 3.5-5819.0), prior stillbirth(s) (distal: 16.2, 6.1-42.9; proximate: 8.0, 2.9-22.4), and complications in a prior pregnancy (distal: 5.4, 95% CI 2.5-12.1; proximate: 7.1, 2.5-20.4). In the proximate model, SAMM was associated with visiting another facility before hospitalization (aOR 7.5, 95% CI 3.1-17.9), male-reported planned home delivery (5.5, 1.5-20.0), and provider-determined care-seeking (4.8, 1.6-14.9). Planned home delivery and referral to multiple facilities or by providers are factors associated with SAMM that are potentially amenable to intervention in Afghanistan. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  5. Psychiatric disorders in male prisoners who made near-lethal suicide attempts: case-control study.

    Science.gov (United States)

    Rivlin, Adrienne; Hawton, Keith; Marzano, Lisa; Fazel, Seena

    2010-10-01

    Although male prisoners are five times more likely to die by suicide than men of a similar age in the general population, the contribution of psychiatric disorders is not known. To investigate the association of psychiatric disorders with near-lethal suicide attempts in male prisoners. A matched case-control study of 60 male prisoners who made near-lethal suicide attempts (cases) and 60 prisoners who had never carried out near-lethal suicide attempts in prison (controls) was conducted. Psychiatric disorders were identified with the Mini International Neuropsychiatric Interview (MINI), and information on sociodemographic characteristics and criminal history was gathered using a semi-structured interview. Psychiatric disorders were present in all cases and 62% of controls. Most current psychiatric disorders were associated with near-lethal suicide attempts, including major depression (odds ratio (OR) = 42.0, 95% CI 5.8-305), psychosis (OR = 15.0, 95% CI 2.0-113), anxiety disorders (OR = 6.0, 95% CI 2.3-15.5) and drug misuse (OR = 2.9, 95% CI 1.3-6.4). Lifetime psychiatric disorders associated with near-lethal attempts included recurrent depression and psychoses. Although cases were more likely than controls to meet criteria for antisocial personality disorder, the difference was not statistically significant. Comorbidity was also significantly more common among cases than controls for both current and lifetime disorders. In male prisoners, psychiatric disorders, especially depression, psychosis, anxiety and drug misuse, are associated with near-lethal suicide attempts, and hence probably with suicide.

  6. A retrospective matched case-control study on medical costs of refractory migraine in Taiwan.

    Science.gov (United States)

    Tang, Chao-Hsiun; Chen, Yong-Chen; Ng, Kwong; Wang, Shuu-Jiun

    2013-03-01

    Migraine is associated with a significant economic burden in Western countries. However, there is limited information regarding the impact of the cost of migraine in Asia. To quantify and compare the direct medical costs of refractory migraine (RM) and other migraine, using health insurance claims data in Taiwan. A retrospective matched case-control study was conducted utilizing data from the Taiwan National Health Insurance Research Database. RM cases were defined as patients with at least 1 neurological outpatient visit with a primary or secondary International Classification of Diseases, Ninth Revision, Clinical Modification code of 346.11 (common migraine with intractable migraine, so stated), diagnosed by certified neurologists in medical centers during 2007-2008. The first control group was the non-migraineurs matched with cases at a 4:1 ratio by age, gender, urbanization level of the residence, and income. The second control group was patients with other migraine types (346.00, 346.10, 346.20, 346.80, and 346.90) matched with cases at a 4:1 ratio by age, gender, and hospital setting. Medical utilization and costs within 365 days after the index visit date were assessed using a 2-part model. The exchange rate for US $1 was NT $32.50. Patients with RM had significantly higher total medical costs compared with non-migraineurs (NT $57,932 [US $1783] vs. NT $26,817 [US $825]; P Taipei Veterans General Hospital, a medical center in Taiwan) in 2007. Of these patients, 88 (90%) fulfilled the Silberstein-Lipton criteria for chronic migraine, i.e., >15 headache days per month and presence of a history of migraine. Refractory migraineurs in Taiwan had significantly higher medical costs than either non-migraineurs or those with other migraine diagnoses. © 2013 American Headache Society.

  7. Radiation exposure and central nervous system cancers: A case-control study among workers at two nuclear facilities

    International Nuclear Information System (INIS)

    Carpenter, A.V.; Flanders, W.D.; Frome, E.L.; Crawford-Brown, D.J.; Fry, S.A.

    1987-03-01

    A nested case-control study was conducted among workers employed between 1943 and 1977 at two nuclear facilities to investigate the possible association of primary malignant neoplasms of the central nervous system (CNS) with occupational exposure to ionizing radiation from external and internal sources. Eighty-nine white male and female workers, who according to the information on death certificates dies of primary CNS cancers, were identified as cases. Four matched controls were selected for each case. External radiation exposure data were available from film badge readings for individual workers, whereas radiation dose to lung from internally deposited radionuclides, mainly uranium, was estimated from area and personnel monitoring data and was used in analyses in lieu of the dose to the brain. Matched sets were included in the analyses only if information was available for the case and at least one of the corresponding controls. Thus, the analyses of external radiation included 27 cases and 90 matched controls, and 47 cases and 120 matched controls were analyzed for the effects of radiation from internally deposited uranium. No association was observed between deaths fron CNS cancers and occupational exposure to ionizing radiation from external or internal sources. However, due to the small number of monitored subjects and low doses, a weak association could not be ruled out. 43 refs., 1 fig., 15 tabs

  8. Allium vegetable intake and gastric cancer: a case-control study and meta-analysis.

    Science.gov (United States)

    Turati, Federica; Pelucchi, Claudio; Guercio, Valentina; La Vecchia, Carlo; Galeone, Carlotta

    2015-01-01

    To provide new epidemiological data and summarize evidence on the association between allium vegetable intake and gastric cancer risk. Data were from an Italian case-control study including 230 cases and 547 controls. Odds ratios were derived using multiple logistic regression. We combined results from all published studies using random-effect models. In our case-control study, the odds ratios were 0.59 (95% confidence interval, CI, 0.25-1.41) for ≥2 portions of onion per week, 0.69 (95% CI, 0.41-1.15) for high garlic intake, and 0.70 (95% CI, 0.39-1.28) for frequent use of both onion and garlic. Besides our study, 22 case-control and four cohort studies were included in the meta-analyses (>10 000 cases). The pooled relative risks for the highest versus lowest intake category were 0.78 (95% CI, 0.67-0.91) for allium vegetables (ten case-control and four cohort studies), 0.60 (95% CI, 0.47-0.76) for garlic (12 case-control studies), and 0.55 (95% CI, 0.41-0.73) for onion (13 case-control studies). The pooled relative risk for high allium vegetable intake from the four cohorts was 1.02 (95% CI, 0.88-1.18). High allium vegetable consumption is likely to reduce gastric cancer risk. This evidence is derived mainly from case-control studies. Further data from large cohorts are desirable for conclusive confirmation. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  9. Predictive factors of adrenal insufficiency in patients admitted to acute medical wards: a case control study

    Directory of Open Access Journals (Sweden)

    Oboni Jean-Baptiste

    2013-01-01

    Full Text Available Abstract Background Adrenal insufficiency is a rare and potentially lethal disease if untreated. Several clinical signs and biological markers are associated with glucocorticoid failure but the importance of these factors for diagnosing adrenal insufficiency is not known. In this study, we aimed to assess the prevalence of and the factors associated with adrenal insufficiency among patients admitted to an acute internal medicine ward. Methods Retrospective, case-control study including all patients with high-dose (250 μg ACTH-stimulation tests for suspected adrenal insufficiency performed between 2008 and 2010 in an acute internal medicine ward (n = 281. Cortisol values Results 32 patients (11.4% presented adrenal insufficiency; the others served as controls. Among all clinical and biological parameters studied, history of glucocorticoid withdrawal was the only independent factor significantly associated with patients with adrenal insufficiency (Odds Ratio: 6.71, 95% CI: 3.08 –14.62. Using a logistic regression, a model with four significant and independent variable was obtained, regrouping history of glucocorticoid withdrawal (OR 7.38, 95% CI [3.18 ; 17.11], p-value p-value 0.044, eosinophilia (OR 17.6, 95% CI [1.02; 302.3], p-value 0.048 and hyperkalemia (OR 2.41, 95% CI [0.87; 6.69], p-value 0.092. The AROC (95% CI was 0.75 (0.70; 0.80 for this model, with 6.3 (0.8 – 20.8 for sensitivity and 99.2 (97.1 – 99.9 for specificity. Conclusions 11.4% of patients with suspected adrenal insufficient admitted to acute medical ward actually do present with adrenal insufficiency, defined by an abnormal response to high-dose (250 μg ACTH-stimulation test. A history of glucocorticoid withdrawal was the strongest factor predicting the potential adrenal failure. The combination of a history of glucocorticoid withdrawal, nausea, eosinophilia and hyperkaliemia might be of interest to suspect adrenal insufficiency.

  10. Unresolved attachment and agency in women victims of intimate partner violence: A case-control study.

    Science.gov (United States)

    Pallini, Susanna; Alfani, Agnese; Marech, Lucrezia; Laghi, Fiorenzo

    2017-06-01

    Women victims of IPV are more likely insecurely attached and have experienced childhood abuse, which according to the attachment theory is deeply related to disorganized attachment. This case-control study was performed with the aim to compare the attachment status and the defensive processing patterns of women victims of IPV (cases) with women with no experiences of IPV (controls). Cases were 16 women with an age range from 26 years to 51 years. The control group included 16 women with an age range from 26 years to 59 years. Women's states of mind in regard to attachment were evaluated with the Adult Attachment Projective Picture System, which allows classifying attachment status and defensive mechanisms. Compared with control group, most IPV women resulted having an unresolved attachment status and describing characters less capable to draw upon internal resources, that is, internalized secure base, and less capable to act than controls. Women victims of IPV used significantly more words referring danger and failed protection than controls. The results evidenced the strong effectiveness of the AAP on analysing the psychological attitudes of women victims of IPV. The dramatic events lived by the women victims of IPV are so dominant in their minds that they invade their stories. This could represent a clue of emotional dysregulation. The use of AAP improves the understanding of the agency of self and of the specific levels of trauma experienced by IPV victims, on clarifying their frightening/frightened dynamic, typical of the disorganized attachment relationship, which undermines their activity of mentalization. The therapist will assume the stance of a secure base and then both promoting exploration and contrasting impotence, humiliation, and subordination that IPV women have experienced. This therapeutic interpersonal context will be functional to reach two different but related therapeutic goals: (1) to facilitate the rebuilding of agency (through an

  11. A Note on Penalized Regression Spline Estimation in the Secondary Analysis of Case-Control Data

    KAUST Repository

    Gazioglu, Suzan

    2013-05-25

    Primary analysis of case-control studies focuses on the relationship between disease (D) and a set of covariates of interest (Y, X). A secondary application of the case-control study, often invoked in modern genetic epidemiologic association studies, is to investigate the interrelationship between the covariates themselves. The task is complicated due to the case-control sampling, and to avoid the biased sampling that arises from the design, it is typical to use the control data only. In this paper, we develop penalized regression spline methodology that uses all the data, and improves precision of estimation compared to using only the controls. A simulation study and an empirical example are used to illustrate the methodology.

  12. Maximum likelihood estimation for Cox's regression model under nested case-control sampling

    DEFF Research Database (Denmark)

    Scheike, Thomas; Juul, Anders

    2004-01-01

    -like growth factor I was associated with ischemic heart disease. The study was based on a population of 3784 Danes and 231 cases of ischemic heart disease where controls were matched on age and gender. We illustrate the use of the MLE for these data and show how the maximum likelihood framework can be used......Nested case-control sampling is designed to reduce the costs of large cohort studies. It is important to estimate the parameters of interest as efficiently as possible. We present a new maximum likelihood estimator (MLE) for nested case-control sampling in the context of Cox's proportional hazards...... model. The MLE is computed by the EM-algorithm, which is easy to implement in the proportional hazards setting. Standard errors are estimated by a numerical profile likelihood approach based on EM aided differentiation. The work was motivated by a nested case-control study that hypothesized that insulin...

  13. Time to recurrence is a significant predictor of cancer-specific survival after recurrence in patients with recurrent renal cell carcinoma--results from a comprehensive multi-centre database (CORONA/SATURN-Project).

    Science.gov (United States)

    Brookman-May, Sabine D; May, Matthias; Shariat, Shahrokh F; Novara, Giacomo; Zigeuner, Richard; Cindolo, Luca; De Cobelli, Ottavio; De Nunzio, Cosimo; Pahernik, Sascha; Wirth, Manfred P; Longo, Nicola; Simonato, Alchiede; Serni, Sergio; Siracusano, Salvatore; Volpe, Alessandro; Morgia, Giuseppe; Bertini, Roberto; Dalpiaz, Orietta; Stief, Christian; Ficarra, Vincenzo

    2013-11-01

    To assess the prognostic impact of time to recurrence (TTR) on cancer-specific survival (CSS) after recurrence in patients with renal cell carcinoma (RCC) undergoing radical nephrectomy or nephron-sparing surgery. To analyse differences in clinical and histopathological criteria between patients with early and late recurrence. Of 13,107 patients with RCC from an international multicentre database, 1712 patients developed recurrence in the follow-up (FU), at a median (interquartile range) of 50.1 (25-106) months. In all, 1402 patients had recurrence at ≤5 years (Group A) and 310 patients beyond this time (Group B). Differences in clinical and histopathological variables between patients with early and late recurrence were analysed. The influence of TTR and further variables on CSS after recurrence was assessed by Cox regression analysis. Male gender, advanced age, tumour diameter and stage, Fuhrman grade 3-4, lymphovascular invasion (LVI), and pN + stage were significantly more frequent in patients with early recurrence, who had a significantly reduced 3-year CSS of 30% compared with patients in Group B (41%; P = 0.001). Age, gender, tumour histology, pT stage, and continuous TTR (hazard ratio 0.99, P = 0.006; monthly interval) independently predicted CSS. By inclusion of dichotomised TTR in the multivariable model, a significant influence of this variable on CSS was present until 48 months after surgery, but not beyond this time. Advanced age, male gender, larger tumour diameters, LVI, Fuhrman grade 3-4, pN + stage, and advanced tumour stages are associated with early recurrence. Up to 4 years from surgery, a shorter TTR independently predicts a reduced CSS after recurrence. © 2013 The Authors. BJU International © 2013 BJU International.

  14. Travel-related health risks in moderately and severely immunocompromised patients: a case-control study.

    Science.gov (United States)

    Dekkiche, Souad; de Vallière, Serge; D'Acremont, Valérie; Genton, Blaise

    2016-03-01

    The number of immunocompromised persons travelling to tropical countries is increasing. The hypothesis is that this population is at increased risk of travel-related health problems but there are few data to support it. The objective was to assess the risk of travel-related health problems in immunocompromised persons when compared with the general population of travellers. A retrospective matched case-control study was performed. Cases were moderately or severely immunocompromised persons travelling to tropical countries and controls were non-immunocompromised persons, matched for demographic and travel characteristics. All participants responded to a phone questionnaire, asking them about any health problem they may have encountered while travelling or during the month following their return. The primary outcome was the incidence of a significant clinical event defined as repatriation, hospitalization during the travel or during the month following the return if due to a travel-related health problem and medical consultations during the trip. One hundred and sixteen moderately or severely immunocompromised cases [HIV infection (15), active cancer (25), splenectomized (20), solid organ transplant recipients (4) and use of systemic immunosuppressive medication (52)] and 116 controls were included. Incidence rates of significant clinical events were higher in immunocompromised travellers (9/116, 7.8%) than in controls (2/116, 1.7%) [OR = 4.8 , 95% CI 1.01-22.70; P = 0.048]. Most cases were related to infectious diseases (5/9, 55.5%), others were pulmonary embolism (2/9, 22%), inflammatory disease and trauma (1/9, 11.1% each). There was no significant difference between the two groups regarding common health problems. Moderately and severely immunocompromised travellers are at increased risk of developing a serious health problem during or after a trip in a tropical country. They should be well informed about the specific risks they are particularly prone to

  15. Association between selective serotonin reuptake inhibitors and upper gastrointestinal bleeding: population based case-control study

    Science.gov (United States)

    de Abajo, Francisco José; Rodríguez, Luis Alberto García; Montero, Dolores

    1999-01-01

    Objective To examine the association between selective serotonin reuptake inhibitors and risk of upper gastrointestinal bleeding. Design Population based case-control study. Setting General practices included in the UK general practice research database. Subjects 1651 incident cases of upper gastrointestinal bleeding and 248 cases of ulcer perforation among patients aged 40 to 79 years between April 1993 and September 1997, and 10 000 controls matched for age, sex, and year that the case was identified. Interventions Review of computer profiles for all potential cases, and an internal validation study to confirm the accuracy of the diagnosis on the basis of the computerised information. Main outcome measures Current use of selective serotonin reuptake inhibitors or other antidepressants within 30 days before the index date. Results Current exposure to selective serotonin reuptake inhibitors was identified in 3.1% (52 of 1651) of patients with upper gastrointestinal bleeding but only 1.0% (95 of 10 000) of controls, giving an adjusted rate ratio of 3.0 (95% confidence interval 2.1 to 4.4). This effect measure was not modified by sex, age, dose, or treatment duration. A crude incidence of 1 case per 8000 prescriptions was estimated. A small association was found with non-selective serotonin reuptake inhibitors (relative risk 1.4, 1.1 to 1.9) but not with antidepressants lacking this inhibitory effect. None of the groups of antidepressants was associated with ulcer perforation. The concurrent use of selective serotonin reuptake inhibitors with non-steroidal anti-inflammatory drugs increased the risk of upper gastrointestinal bleeding beyond the sum of their independent effects (15.6, 6.6 to 36.6). A smaller interaction was also found between selective serotonin reuptake inhibitors and low dose aspirin (7.2, 3.1 to 17.1). Conclusions Selective serotonin reuptake inhibitors increase the risk of upper gastrointestinal bleeding. The absolute effect is, however

  16. Parenteral exposure to pesticides and occurence of congenital malformations: hospital-based case-control study.

    Science.gov (United States)

    Ueker, Marly Eliane; Silva, Vivianne Monteiro; Moi, Gisele Pedroso; Pignati, Wanderley Antonio; Mattos, Ines Echenique; Silva, Ageo Mário Cândido

    2016-08-12

    Most fetal defects are associated with genetic and environmental causes, among them, exposure of pregnant women to intensive pesticide use. Agribusiness is the economic basis of the state of Mato Grosso, the largest consumer of pesticides of all Brazilian states. The objective of this study was to investigate the association between past parental exposure to pesticides and the occurrence of congenital malformations in children in Mato Grosso, Brazil. This hospital-based case-control study was conducted in Cuiabá, the capital of Mato Grosso, from March to October 2011. Data was collected in all public, private, and health plan referral hospitals that provide care for pregnant women in the state of Mato Grosso and were situated in Cuiabá. Cases were children under 5 years of age with congenital malformations classified in Chapter XVIII of the International Classification of Diseases-10 and controls were children within the same age range, without congenital malformations, treated at the same hospitals. Malformation-related data was obtained from the patients' medical records. Socioeconomic data and information about parental exposure to pesticides were obtained in an interview with the mother using a standardized questionnaire. We conducted multivariate logistic regression to assess the relation between parent report of past pesticide use and congenital malformations. We also assessed effect modification to verify whether low maternal education level modified the association between exposure and our outcome. We observed positive effect modification of the association of paternal past exposure to pesticide and congenital malformation in the offspring by maternal education for mothers with low educational level (OR = 8.40, 95 % CI 2.17-32.52), father's work related to farming (OR = 4.65, 95 % CI 1.03-20.98) and paternal past exposure to pesticides (OR = 4.15, 95 % CI 1.24-13.66). These findings provide further evidence that paternal exposure to

  17. Risk of metabolic syndrome among children living in metropolitan Kuala Lumpur: A case control study

    Directory of Open Access Journals (Sweden)

    Ismail Mohd N

    2011-05-01

    Full Text Available Abstract Background With the increasing prevalence of childhood obesity, the metabolic syndrome has been studied among children in many countries but not in Malaysia. Hence, this study aimed to compare metabolic risk factors between overweight/obese and normal weight children and to determine the influence of gender and ethnicity on the metabolic syndrome among school children aged 9-12 years in Kuala Lumpur and its metropolitan suburbs. Methods A case control study was conducted among 402 children, comprising 193 normal-weight and 209 overweight/obese. Weight, height, waist circumference (WC and body composition were measured, and WHO (2007 growth reference was used to categorise children into the two weight groups. Blood pressure (BP was taken, and blood was drawn after an overnight fast to determine fasting blood glucose (FBG and full lipid profile, including triglycerides (TG, high-density lipoprotein cholesterol (HDL-C, low-density lipoprotein cholesterol (LDL-C and total cholesterol (TC. International Diabetes Federation (2007 criteria for children were used to identify metabolic syndrome. Results Participants comprised 60.9% (n = 245 Malay, 30.9% (n = 124 Chinese and 8.2% (n = 33 Indian. Overweight/obese children showed significantly poorer biochemical profile, higher body fat percentage and anthropometric characteristics compared to the normal-weight group. Among the metabolic risk factors, WC ≥90th percentile was found to have the highest odds (OR = 189.0; 95%CI 70.8, 504.8, followed by HDL-C≤1.03 mmol/L (OR = 5.0; 95%CI 2.4, 11.1 and high BP (OR = 4.2; 95%CI 1.3, 18.7. Metabolic syndrome was found in 5.3% of the overweight/obese children but none of the normal-weight children (p Conclusions We conclude that being overweight or obese poses a greater risk of developing the metabolic syndrome among children. Indian ethnicity is at higher risk compared to their counterparts of the same age. Hence, primary intervention strategies are

  18. Severe war-related trauma and personality pathology: a case-control study.

    Science.gov (United States)

    Munjiza, Jasna; Britvic, Dolores; Radman, Maja; Crawford, Mike J

    2017-03-21

    Exposure to war-related trauma has long been recognised to have an adverse effect on mental health. We attempted to investigate whether people who have clinically significant personality-related problems 15 years after a war are more likely to have been exposed to severe war-related trauma than those who do not have significant personality difficulties. A case -control study was conducted in southern Croatia, fifteen years after the 1991-1995 war. We recruited 268 participants: 182 cases who scored positively on the International Personality Disorder Examination scale (IPDE), and 86 controls who were IPDE negative. Severity of war-related trauma was assessed according to the 17 items on the Harvard Trauma Questionnaire (HTQ) trauma event scale, which were considered to be of severe (catastrophic) nature based on the ICD-10 description of catastrophic trauma and the opinion of trauma experts. All participants also completed measures of mental health (depression, anxiety and PTSD), social functioning and current substance misuse. Cases (IPDE positive) were eight times more likely to report exposure to severe war-related trauma than controls. This association increased after adjustments for demographic factors (OR = 10.1, 95% CI 5.0 to 20.4). The types of severe trauma most frequently reported were either the participants'own life being in direct danger or witnessing extreme violence inflicted on others or the result of violence towards others (murder, torture, seeing burned or disfigured bodies). Prevalences of depression, anxiety and PTSD were high among IPDE positive participants 15 years after exposure to war trauma. Their level of interpersonal dysfunction was considerably higher than that in controls (OR = 10.39, 95% CI 3.51 to 30.75). Alcohol consumption in cases was significantly higher with a mean of 14.24 units per week (sd = 11.03) when compared to controls whose mean number of alcohol units was 9.24 (sd = 7.25), t (73) = 2.16, p

  19. The prognostic value of pimonidazole and tumour pO2 in human cervix carcinomas after radiation therapy: a prospective international multi-center study

    DEFF Research Database (Denmark)

    Nordsmark, Marianne; Loncaster, Julie; Aquino-Parsons, Christina

    2006-01-01

    BACKGROUND AND PURPOSE: Hypoxia adversely affects treatment outcome in human uterine cervical cancer. Here, we present the results of a prospective international multi-centre study evaluating the prognostic value of pre-treatment tumour oxygen partial pressure (pO(2)) and the hypoxia marker pimon...... pimonidazole (pimo). MATERIALS AND METHODS: One hundred and twenty-seven patients with primary cervix cancer were entered. Pre-treatment tumour pO(2) measurements were obtained, and reported by the median tumour pO(2), the fraction of pO(2) values...

  20. A case control study of breast cancer risk and exposure to injectable ...

    African Journals Online (AJOL)

    breast cancer. Design. A population-based case-control study of breast cancer risk in relation to the use of IPes among coloured and black women. Setting. The Western Cape ... tertiary care hospitals in the Western Cape are recruited. Controls are a .... are obtained to confirm the diagnosis for all cases and to determine ...

  1. Multiple sclerosis and exposure to house pets during childhood and adolescence : a case-control study

    NARCIS (Netherlands)

    De Keyser, J; Zwanikken, C

    1997-01-01

    Multiple sclerosis (MS) might be triggered by an infectious agent early in life. In a case-control study, we compared exposure to household pets for the age periods 0-5, 6-10, 11-15 and 16-20 years in 100 patients with MS and 100 controls. Exposure to household dogs between the ages of 0-10 years

  2. Predictors for failure of vacuum-assisted vaginal delivery: a case-control study

    NARCIS (Netherlands)

    Verhoeven, Corine J.; Nuij, Chelly; Janssen-Rolf, Christel R. M.; Schuit, Ewoud; Bais, Joke M. J.; Oei, S. Guid; Mol, Ben Willem J.

    2016-01-01

    To identify potential predictors for failed vacuum-assisted delivery. Retrospective case-control study conducted in two perinatal centers in the Netherlands. Cases were women who underwent a failed vacuum-assisted delivery between 1997 and 2011. A failed vacuum extraction was defined as a delivery

  3. Predictors for failure of vacuum-assisted vaginal delivery : A case-control study

    NARCIS (Netherlands)

    Verhoeven, Corine J M; Nuij, Chelly; Janssen-Rolf, Christel R M; Schuit, Ewoud|info:eu-repo/dai/nl/341652385; Bais, Joke M J; Oei, S. Guid; Mol, Ben Willem J

    2016-01-01

    Objective To identify potential predictors for failed vacuum-assisted delivery. Study design Retrospective case-control study conducted in two perinatal centers in the Netherlands. Cases were women who underwent a failed vacuum-assisted delivery between 1997 and 2011. A failed vacuum extraction was

  4. Anorexia nervosa versus bulimia nervosa : differences based on retrospective correlates in a case-control study

    NARCIS (Netherlands)

    Machado, Barbara C.; Goncalves, Sonia F.; Martins, Carla; Brandao, Isabel; Roma-Torres, Antonio; Hoek, Hans W.; Machado, Paulo P.

    This study is the result of two Portuguese case-control studies that examined the replication of retrospective correlates and preceding life events in anorexia nervosa (AN) and bulimia nervosa (BN) development. This study aims to identify retrospective correlates that distinguish AN and BN A

  5. Risk factors for Creutzfeldt-Jakob disease: a reanalysis of case-control studies.

    NARCIS (Netherlands)

    D.P.W.M. Wientjens (Dorothee); Z. Davanipour; K. Kondo; W.B. Matthews; R.G. Will (Robert); C.M. van Duijn (Cornelia); A. Hofman (Albert)

    1996-01-01

    textabstractTo review the evidence for risk factors of Creutzfeldt-Jakob disease (CJD), we pooled and reanalyzed the raw data of three case-control studies. The pooled data set comprised 178 patients and 333 control subjects. The strength of association between CJD and putative risk factors was

  6. Power for genetic association study of human longevity using the case-control design

    DEFF Research Database (Denmark)

    Tan, Qihua; Zhao, Jing Hua; Zhang, Dongfeng

    2008-01-01

    The efficiency of the popular case-control design in gene-longevity association studies needs to be verified because, different from a binary trait, longevity represents only the extreme end of the continuous life span distribution without a clear cutoff for defining the phenotype. In this paper...

  7. Prevalence and Case-Control Study of Cerebral Malaria in Limbe of ...

    African Journals Online (AJOL)

    West Cameroon. ... Lois E Ikome, Kenneth JN Ndamukong, Helen Kimbi ... Data were obtained using a questionnaire administered to 650 people aged between 6 months and 70 years, and by a case-control study on 90 people (30 cases and 60 ...

  8. Psychosocial and Psychiatric Factors Associated with Adolescent Suicide: A Case-Control Psychological Autopsy Study

    Science.gov (United States)

    Portzky, Gwendolyn; Audenaert, Kurt; van Heeringen, Kees

    2009-01-01

    This study aimed at the investigation of psychosocial and psychiatric risk factors of adolescent suicide by means of a case-control psychological autopsy study. Relatives and other informants of 19 suicide victims and 19 matched psychiatric controls were interviewed by means of a semi-structured interview schedule. Psychiatric controls included…

  9. Combinations of SNP genotypes from the Wellcome Trust Case Control Study of bipolar patients

    DEFF Research Database (Denmark)

    Mellerup, Erling; Jørgensen, Martin Balslev; Dam, Henrik

    2018-01-01

    Objectives: Combinations of genetic variants are the basis for polygenic disorders. We examined combinations of SNP genotypes taken from the 446 729 SNPs in The Wellcome Trust Case Control Study of bipolar patients. Methods: Parallel computing by graphics processing units, cloud computing, and data...

  10. A case control study of breast cancer risk and exposure to injectable ...

    African Journals Online (AJOL)

    breast cancer. Design. A population-based case-control study of breast cancer risk in relation to the use of IPes among coloured and black women. Setting. The Western Cape, including the Cape metropole and surrounding rural areas. Study subjects. All coloured and black women with newly diagnosed breast cancer, ...

  11. High prevalence of eating disorders in narcolepsy with cataplexy: a case-control study

    NARCIS (Netherlands)

    Droogleever Fortuyn, H.A.; Swinkels, S.H.N.; Buitelaar, J.K.; Renier, W.O.; Furer, J.W.; Rijnders, C.A.T.; Hodiamont, P.P.G.; Overeem, S.

    2008-01-01

    Study Objectives: To study the prevalence of and symptoms of eating disorders in patients with narcolepsy. Design: We performed a case-control study comparing symptoms of eating disorders in patients with narcolepsy versus healthy population controls, using the Schedules for Clinical Assessment

  12. High prevalence of eating disorders in narcolepsy with cataplexy: a case-control study.

    NARCIS (Netherlands)

    Droogleever Fortuyn, H.A.; Swinkels, S.H.N.; Buitelaar, J.K.; Renier, W.O.; Furer, J.W.; Rijnders, C.A.T.; Hodiamont, P.P.G.; Overeem, S.

    2008-01-01

    STUDY OBJECTIVES: To study the prevalence of and symptoms of eating disorders in patients with narcolepsy. DESIGN: We performed a case-control study comparing symptoms of eating disorders in patients with narcolepsy versus healthy population controls, using the Schedules for Clinical Assessment in

  13. Microbial Characteristics of Peri-Implantitis : A Case-Control Study

    NARCIS (Netherlands)

    de Waal, Y C M; Eijsbouts, H V L C; Winkel, E G; van Winkelhoff, A J

    BACKGROUND: Aim of this case-control study was to compare oral microbiological characteristics of subjects with healthy peri-implant conditions and subjects with peri-implantitis and to explore the influence of various patient-related and implant-related factors on the microbiological

  14. Excess relative risk as an effect measure in case-control studies of rare diseases.

    Directory of Open Access Journals (Sweden)

    Wen-Chung Lee

    Full Text Available Epidemiologists often use ratio-type indices (rate ratio, risk ratio and odds ratio to quantify the association between exposure and disease. By comparison, less attention has been paid to effect measures on a difference scale (excess rate or excess risk. The excess relative risk (ERR used primarily by radiation epidemiologists is of peculiar interest here, in that it involves both difference and ratio operations. The ERR index (but not the difference-type indices is estimable in case-control studies. Using the theory of sufficient component cause model, the author shows that when there is no mechanistic interaction (no synergism in the sufficient cause sense between the exposure under study and the stratifying variable, the ERR index (but not the ratio-type indices in a rare-disease case-control setting should remain constant across strata and can therefore be regarded as a common effect parameter. By exploiting this homogeneity property, the related attributable fraction indices can also be estimated with greater precision. The author demonstrates the methodology (SAS codes provided using a case-control dataset, and shows that ERR preserves the logical properties of the ratio-type indices. In light of the many desirable properties of the ERR index, the author advocates its use as an effect measure in case-control studies of rare diseases.

  15. Medical and environmental risk factors for sporadic frontotemporal dementia: a retrospective case-control study

    NARCIS (Netherlands)

    S.M. Rosso (Sonia); E.J. Landweer; M. Houterman; C.M. van Duijn (Cornelia); J.C. van Swieten (John); L. Donker Kaat (Laura)

    2003-01-01

    textabstractA retrospective case-control study was carried out on 80 patients with sporadic frontotemporal dementia and 124 age, sex, and surrogate informant matched controls with respect to various medical and environmental risk factors. Head trauma was associated with an odds ratio of 3.3 (95%

  16. Human papillomavirus infection, cervical dysplasia and invasive cervical cancer in Honduras: a case-control study.

    NARCIS (Netherlands)

    Ferrera, A.B.; Velema, J.P.; Figueroa, M.; Bulnes, R.; Toro, L.A.; Claros, J.M.; Barahona, O. de; Melchers, W.J.G.

    1999-01-01

    A substantial body of evidence has confirmed human papillomavirus (HPV) infection as the central etiological agents in human cervical carcinogenesis. In Honduras, cervical cancer is the most common cancer among women, with a high annual incidence. We conducted a population-based, case-control study

  17. The relationship between parenting, family interaction and childhood dental caries: a case-control study

    NARCIS (Netherlands)

    de Jong-Lenters, M.; Duijster, D.; Bruist, M.A.; Thijssen, J.; de Ruiter, C.

    2014-01-01

    The aim of this case-control study was to explore the relationship between parenting practices, parent-child interaction and childhood dental caries, using a sample of 5-8-year old children from the Netherlands. Cases were defined as children with four or more decayed, missing or filled teeth and

  18. Placental histology in spontaneous and indicated preterm birth: A case control study

    NARCIS (Netherlands)

    Nijman, Tobias A. J.; van Vliet, Elvira O. G.; Benders, Manon J. N.; Mol, Ben Willem J.; Franx, Arie; Nikkels, Peter G. J.; Oudijk, Martijn A.

    2016-01-01

    Placental pathology is an important contributor in preterm birth, both spontaneous and indicated. The aim of this study was to describe and compare placental histological features of spontaneous preterm birth versus indicated preterm birth. A case control study was performed at the University

  19. Placental histology in spontaneous and indicated preterm birth : A case control study

    NARCIS (Netherlands)

    Nijman, Tobias A J; van Vliet, Elvira O G; Benders, Manon J N; Mol, Ben Willem J; Franx, Arie; Nikkels, Peter G J; Oudijk, Martijn A

    2016-01-01

    INTRODUCTION: Placental pathology is an important contributor in preterm birth, both spontaneous and indicated. The aim of this study was to describe and compare placental histological features of spontaneous preterm birth versus indicated preterm birth. METHODS: A case control study was performed

  20. Gout, not induced by diuretics? A case-control study from primary care.

    NARCIS (Netherlands)

    Janssens, H.; Lisdonk, E.H. van de; Janssen, M.; Hoogen, H.J.M. van den; Verbeek, A.L.M.

    2006-01-01

    BACKGROUND: It is taken for granted that diuretics may induce gout, but there is a general lack of evidence on this topic. OBJECTIVES: To determine the incidence of gout in patients who use diuretics, taking into account concurrent hypertension and cardiovascular diseases. METHODS: A case-control

  1. Nutritional Status of Children with Autism Spectrum Disorders (ASDs): A Case-Control Study

    Science.gov (United States)

    Marí-Bauset, Salvador; Llopis-González, Agustín; Zazpe-García, Itziar; Marí-Sanchis, Amelia; Morales-Suárez-Varela, María

    2015-01-01

    Children with autism spectrum disorder (ASD) have problems of food selectivity, implying risks of nutritional deficiencies. The aim was to compare intakes of macro and micronutrients and body mass index in ASD and typically developing (TD) children. In a case--control study, 3-day food diaries and anthropometric measurements were completed for ASD…

  2. National Case-Control Study of Homicide Offending and Methamphetamine Use

    Science.gov (United States)

    Stretesky, Paul B.

    2009-01-01

    The purpose of this study is to examine the relationship between methamphetamine use and homicide. To carry out this study, data from the National Household Survey on Drug Abuse and Survey of Inmates in State and Federal Correctional Facilities were combined to create a case-control design. The main exposure measure is methamphetamine use and the…

  3. Robust estimation for homoscedastic regression in the secondary analysis of case-control data

    KAUST Repository

    Wei, Jiawei

    2012-12-04

    Primary analysis of case-control studies focuses on the relationship between disease D and a set of covariates of interest (Y, X). A secondary application of the case-control study, which is often invoked in modern genetic epidemiologic association studies, is to investigate the interrelationship between the covariates themselves. The task is complicated owing to the case-control sampling, where the regression of Y on X is different from what it is in the population. Previous work has assumed a parametric distribution for Y given X and derived semiparametric efficient estimation and inference without any distributional assumptions about X. We take up the issue of estimation of a regression function when Y given X follows a homoscedastic regression model, but otherwise the distribution of Y is unspecified. The semiparametric efficient approaches can be used to construct semiparametric efficient estimates, but they suffer from a lack of robustness to the assumed model for Y given X. We take an entirely different approach. We show how to estimate the regression parameters consistently even if the assumed model for Y given X is incorrect, and thus the estimates are model robust. For this we make the assumption that the disease rate is known or well estimated. The assumption can be dropped when the disease is rare, which is typically so for most case-control studies, and the estimation algorithm simplifies. Simulations and empirical examples are used to illustrate the approach.

  4. Differences in treatment approach between Dutch paediatric dentists and general practitioners, a case control study

    NARCIS (Netherlands)

    Kuin, D.; Veerkamp, J.S.J.

    2012-01-01

    AIM: This case control study was to assess whether paediatric dentists perform significantly more diagnostic, preventive and curative care in a clinical setting then do general dental practitioners. METHODS: 16 paediatric dentists were approached and a matching control group of 16 general dental

  5. Intrauterine exposure to carbamazepine and specific congenital malformations : systematic review and case-control study

    NARCIS (Netherlands)

    Jentink, Janneke; Dolk, Helen; Loane, Maria A.; Morris, Joan K.; Wellesley, Diana; Garne, Ester; de Jong-van den Berg, Lolkje

    2010-01-01

    Objective To identify specific major congenital malformations associated with use of carbamazepine in the first trimester of pregnancy. Design A review of all published cohort studies to identify key indications and a population based case-control study to test these indications. Setting Review of

  6. Agreement between oral contraceptive users and prescribers: implications for case-control studies

    NARCIS (Netherlands)

    F.E. van Leeuwen; C.M. van Duijn (Cornelia); M.H. Camps; B.A. Kempers; M.F. Mentjens; H.B. Mulder; E.G. Schouten (Evert); R.M.L. Zwijsen; M.A. Rookus (Matti)

    1992-01-01

    textabstractCase-control studies examining the effects of oral contraceptives (OC) are prone to misclassification bias due to errors in assessment of OC use. Concern about inaccurate exposure histories has increased since current studies require women to recall OC use over prolonged periods of time.

  7. Body image in cancer survivors : a systematic review of case-control studies

    NARCIS (Netherlands)

    Lehmann, Vicky; Hagedoorn, Mariët; Tuinman, Marrit A

    2014-01-01

    PURPOSE: There is common consensus that cancer and its treatment can impair the body, but combined evidence of the previous literature in cancer survivors is missing. Therefore, we reviewed body image in cancer survivors and focused on case-control studies, in order to draw conclusions as to whether

  8. Body image in cancer survivors : a systematic review of case-control studies

    NARCIS (Netherlands)

    Lehmann, Vicky; Hagedoorn, Mariet; Tuinman, Marrit A.

    2015-01-01

    There is common consensus that cancer and its treatment can impair the body, but combined evidence of the previous literature in cancer survivors is missing. Therefore, we reviewed body image in cancer survivors and focused on case-control studies, in order to draw conclusions as to whether body

  9. Case-Control Genome-Wide Association Study of Attention-Deficit/Hyperactivity Disorder

    Science.gov (United States)

    Neale, Benjamin M.; Medland, Sarah; Ripke, Stephan; Anney, Richard J. L.; Asherson, Philip; Buitelaar, Jan; Franke, Barbara; Gill, Michael; Kent, Lindsey; Holmans, Peter; Middleton, Frank; Thapar, Anita; Lesch, Klaus-Peter; Faraone, Stephen V.; Daly, Mark; Nguyen, Thuy Trang; Schafer, Helmut; Steinhausen, Hans-Christoph; Reif, Andreas; Renner, Tobias J.; Romanos, Marcel; Romanos, Jasmin; Warnke, Andreas; Walitza, Susanne; Freitag, Christine; Meyer, Jobst; Palmason, Haukur; Rothenberger, Aribert; Hawi, Ziarih; Sergeant, Joseph; Roeyers, Herbert; Mick, Eric; Biederman, Joseph

    2010-01-01

    Objective: Although twin and family studies have shown attention-deficit/hyperactivity disorder (ADHD) to be highly heritable, genetic variants influencing the trait at a genome-wide significant level have yet to be identified. Thus additional genome-wide association studies (GWAS) are needed. Method: We used case-control analyses of 896 cases…

  10. Macrosomia: a case-control study of risk factors and outcome | Anya ...

    African Journals Online (AJOL)

    Background: Macrosomia is associated with increased risk of maternal and perinatal morbidity. The aim of this study was to identify risk factors and assess impact of macrosomia on maternal and perinatal outcome. Methods: A five-year retrospective case-control study was undertaken at a referral centre. Macrosomia was ...

  11. Behavioural Comorbidity in Tanzanian Children with Epilepsy: A Community-Based Case-Control Study

    Science.gov (United States)

    Burton, Kathryn; Rogathe, Jane; Hunter, Ewan; Burton, Matthew; Swai, Mark; Todd, Jim; Neville, Brian; Walker, Richard; Newton, Charles

    2011-01-01

    Aim: The aim of this study was to define the prevalence of and risk factors for behavioural disorders in children with epilepsy from a rural district of Tanzania by conducting a community-based case-control study. Method: One hundred and twelve children aged 6 to 14 years (55 males, 57 females; median age 12y) with active epilepsy (at least two…

  12. Case-Control Study Of Risk Factors For Breast Cancer In Nigerian ...

    African Journals Online (AJOL)

    Objective: To evaluate the risk factors for breast cancer among women in Midwestern and Southeastern Nigeria. Design: A case control study. Setting: University of Benin Teaching hospital, Benin City and University of Port Harcourt Teaching Hospital, Port Harcourt in Nigeria. Subjects: Fifty one women with diagnosis of ...

  13. The relationship between parenting, family interaction and childhood dental caries: A case-control study

    NARCIS (Netherlands)

    Jong-Lenters, M. de; Duijster, D.; Bruist, M.A.; Thijssen, J.; Ruiter, C. de

    2014-01-01

    The aim of this case-control study was to explore the relationship between parenting practices, parent-child interaction and childhood dental caries, using a sample of 5-8-year old children from the Netherlands. Cases were defined as children with four or more decayed, missing or filled teeth and

  14. Risk factors for abdominal wound dehiscence in children: A case-control study

    NARCIS (Netherlands)

    G.H. van Ramshorst (Gabrielle); N.E. Salu (Nathalie); N.M.A. Bax (Klaas); W.C.J. Hop (Wim); E. van Heurn (Ernst); D.C. Aronson (Daniel); J.F. Lange (Johan)

    2009-01-01

    textabstractBackground: In the limited literature concerning abdominal wound dehiscence after laparotomy in children, reported incidences range between 0.2-1.2% with associated mortality rates of 8-45%. The goal of this retrospective case-control study was to identify major risk factors for

  15. Risk Factors for Abdominal Wound Dehiscence in Children: A Case-Control Study

    NARCIS (Netherlands)

    van Ramshorst, Gabriëlle H.; Salu, Nathalie E.; Bax, Nikolaas M. A.; Hop, Wim C. J.; van Heurn, Ernst; Aronson, Daniel C.; Lange, Johan F.

    2009-01-01

    In the limited literature concerning abdominal wound dehiscence after laparotomy in children, reported incidences range between 0.2-1.2% with associated mortality rates of 8-45%. The goal of this retrospective case-control study was to identify major risk factors for abdominal wound dehiscence in

  16. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    DEFF Research Database (Denmark)

    O'Donnell, M; Serpault, Damien Xavier; Diener, C

    2010-01-01

    Stroke is a major global health problem. It is the third leading cause of death and the leading cause of adult disability. INTERHEART, a global case-control study of acute myocardial infarction in 52 countries (29,972 participants), identified nine modifiable risk factors that accounted for >90% ...

  17. Risk of tinnitus in patients with sleep apnea: A nationwide, population-based, case-control study.

    Science.gov (United States)

    Koo, Malcolm; Hwang, Juen-Haur

    2017-09-01

    To investigate the risk of tinnitus in patients with sleep disturbance or sleep apnea. Case control study. We identified 21,798 middle-aged and elderly patients with otolaryngologist-diagnosed tinnitus between January 1, 2000, and December 31, 2012, from the Longitudinal Health Insurance Database 2000 of the Taiwan National Health Insurance Research Database. A total of 108,990 controls were also identified from the same database based on frequency-matching on 10-year age interval, sex, and year of index date of the cases. Diagnoses of sleep disturbance (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] codes 780.50, 780.52, 307.4) and sleep apnea (ICD-9-CM codes 780.51, 780.53, 780.57) in the cases and controls prior to the index date were assessed. The risks of tinnitus in patients with sleep disturbance and sleep apnea were separately evaluated with multivariate logistic regression analyses. The mean age of the total 130,788 patients was 59.8 years, and 47% of them were males. The risk of tinnitus was higher in patients with sleep disturbance compared to those without the condition (adjusted odds ratio [OR] = 1.13, 95% confidence interval [CI] [95% CI] = 1.11-1.17), and the risk of tinnitus was higher in patients with sleep apnea compared to those without the condition (adjusted OR = 1.36, 95% CI = 1.16-1.60). In this population-based, case-control study, the risk of tinnitus was found to be significantly higher among middle-aged and elderly Taiwanese patients with sleep disturbances, especially with sleep apnea. 3b. Laryngoscope, 127:2171-2175, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

  18. High mammographic breast density predicts locoregional recurrence after modified radical mastectomy for invasive breast cancer: a case-control study.

    Science.gov (United States)

    Huang, Yu-Sen; Chen, Jenny Ling-Yu; Huang, Chiun-Sheng; Kuo, Sung-Hsin; Jaw, Fu-Shan; Tseng, Yao-Hui; Ko, Wei-Chun; Chang, Yeun-Chung

    2016-12-01

    We aimed to evaluate the influence of mammographic breast density at diagnosis on the risk of cancer recurrence and survival outcomes in patients with invasive breast cancer after modified radical mastectomy. This case-control study included 121 case-control pairs of women diagnosed with invasive breast cancer between 2004 and 2009, and who had undergone modified radical mastectomy and had mammographic breast density measured before or at diagnosis. Women with known locoregional recurrence or distant metastasis were matched by pathological disease stage, age, and year of diagnosis to women without recurrence. Locoregional recurrence was defined as recurrence in the ipsilateral chest wall, or axillary, internal mammary, or supraclavicular nodes. The median follow-up duration was 84.0 months for case patients and 92.9 months for control patients. Patients with heterogeneously dense (50-75% density) and extremely dense (>75% density) breasts had an increased risk of locoregional recurrence (hazard ratios 3.1 and 5.7, 95% confidence intervals 1.1-9.8 and 1.2-34.9, p = 0.043 and 0.048, respectively) than did women with less dense breasts. Positive margins after surgery also increased the risk of locoregional recurrence (hazard ratio 3.3, 95% confidence interval 1.3-8.3, p = 0.010). Multivariate analysis that included dense breasts (>50% density), positive margin, no adjuvant radiotherapy, and no adjuvant chemotherapy revealed that dense breasts were significant factors for predicting locoregional recurrence risk (hazard ratio 3.6, 95% confidence interval 1.2-11.1, p = 0.025). Our results demonstrate that dense breast tissue (>50% density) increased the risk of locoregional recurrence after modified radical mastectomy in patients with invasive breast cancer. Additional prospective studies are necessary to validate these findings. The study is retrospectively registered with ClinicalTrials.gov, number NCT02771665 , on May 11, 2016.

  19. Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls.

    Science.gov (United States)

    Verani, Jennifer R; Baqui, Abdullah H; Broome, Claire V; Cherian, Thomas; Cohen, Cheryl; Farrar, Jennifer L; Feikin, Daniel R; Groome, Michelle J; Hajjeh, Rana A; Johnson, Hope L; Madhi, Shabir A; Mulholland, Kim; O'Brien, Katherine L; Parashar, Umesh D; Patel, Manish M; Rodrigues, Laura C; Santosham, Mathuram; Scott, J Anthony; Smith, Peter G; Sommerfelt, Halvor; Tate, Jacqueline E; Victor, J Chris; Whitney, Cynthia G; Zaidi, Anita K; Zell, Elizabeth R

    2017-06-05

    Case-control studies are commonly used to evaluate effectiveness of licensed vaccines after deployment in public health programs. Such studies can provide policy-relevant data on vaccine performance under 'real world' conditions, contributing to the evidence base to support and sustain introduction of new vaccines. However, case-control studies do not measure the impact of vaccine introduction on disease at a population level, and are subject to bias and confounding, which may lead to inaccurate results that can misinform policy decisions. In 2012, a group of experts met to review recent experience with case-control studies evaluating the effectiveness of several vaccines; here we summarize the recommendations of that group regarding best practices for planning, design and enrollment of cases and controls. Rigorous planning and preparation should focus on understanding the study context including healthcare-seeking and vaccination practices. Case-control vaccine effectiveness studies are best carried out soon after vaccine introduction because high coverage creates strong potential for confounding. Endpoints specific to the vaccine target are preferable to non-specific clinical syndromes since the proportion of non-specific outcomes preventable through vaccination may vary over time and place, leading to potentially confusing results. Controls should be representative of the source population from which cases arise, and are generally recruited from the community or health facilities where cases are enrolled. Matching of controls to cases for potential confounding factors is commonly used, although should be reserved for a limited number of key variables believed to be linked to both vaccination and disease. Case-control vaccine effectiveness studies can provide information useful to guide policy decisions and vaccine development, however rigorous preparation and design is essential. Published by Elsevier Ltd.

  20. Matched case-control studies: a review of reported statistical methodology

    Directory of Open Access Journals (Sweden)

    Niven DJ

    2012-04-01

    Full Text Available Daniel J Niven1, Luc R Berthiaume2, Gordon H Fick1, Kevin B Laupland11Department of Critical Care Medicine, Peter Lougheed Centre, Calgary, 2Department of Community Health Sciences, University of Calgary, Calgary, Alberta, CanadaBackground: Case-control studies are a common and efficient means of studying rare diseases or illnesses with long latency periods. Matching of cases and controls is frequently employed to control the effects of known potential confounding variables. The analysis of matched data requires specific statistical methods.Methods: The objective of this study was to determine the proportion of published, peer reviewed matched case-control studies that used statistical methods appropriate for matched data. Using a comprehensive set of search criteria we identified 37 matched case-control studies for detailed analysis.Results: Among these 37 articles, only 16 studies were analyzed with proper statistical techniques (43%. Studies that were properly analyzed were more likely to have included case patients with cancer and cardiovascular disease compared to those that did not use proper statistics (10/16 or 63%, versus 5/21 or 24%, P = 0.02. They were also more likely to have matched multiple controls for each case (14/16 or 88%, versus 13/21 or 62%, P = 0.08. In addition, studies with properly analyzed data were more likely to have been published in a journal with an impact factor listed in the top 100 according to the Journal Citation Reports index (12/16 or 69%, versus 1/21 or 5%, P ≤ 0.0001.Conclusion: The findings of this study raise concern that the majority of matched case-control studies report results that are derived from improper statistical analyses. This may lead to errors in estimating the relationship between a disease and exposure, as well as the incorrect adaptation of emerging medical literature.Keywords: case-control, matched, dependent data, statistics

  1. Adaptation of Chain Event Graphs for use with Case-Control Studies in Epidemiology.

    Science.gov (United States)

    Keeble, Claire; Thwaites, Peter Adam; Barber, Stuart; Law, Graham Richard; Baxter, Paul David

    2017-09-26

    Case-control studies are used in epidemiology to try to uncover the causes of diseases, but are a retrospective study design known to suffer from non-participation and recall bias, which may explain their decreased popularity in recent years. Traditional analyses report usually only the odds ratio for given exposures and the binary disease status. Chain event graphs are a graphical representation of a statistical model derived from event trees which have been developed in artificial intelligence and statistics, and only recently introduced to the epidemiology literature. They are a modern Bayesian technique which enable prior knowledge to be incorporated into the data analysis using the agglomerative hierarchical clustering algorithm, used to form a suitable chain event graph. Additionally, they can account for missing data and be used to explore missingness mechanisms. Here we adapt the chain event graph framework to suit scenarios often encountered in case-control studies, to strengthen this study design which is time and financially efficient. We demonstrate eight adaptations to the graphs, which consist of two suitable for full case-control study analysis, four which can be used in interim analyses to explore biases, and two which aim to improve the ease and accuracy of analyses. The adaptations are illustrated with complete, reproducible, fully-interpreted examples, including the event tree and chain event graph. Chain event graphs are used here for the first time to summarise non-participation, data collection techniques, data reliability, and disease severity in case-control studies. We demonstrate how these features of a case-control study can be incorporated into the analysis to provide further insight, which can help to identify potential biases and lead to more accurate study results.

  2. [Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection].

    Science.gov (United States)

    Xiao, Ying; Zhao, Yubin; Xie, Yanming

    2011-10-01

    The nested case-control study design (or the case-control in a cohort study) is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.

  3. Community-level antibiotic access and use (ABACUS in low- and middle-income countries: Finding targets for social interventions to improve appropriate antimicrobial use – an observational multi-centre study [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Heiman F.L. Wertheim

    2017-07-01

    Full Text Available In many low- and middle-income countries (LMICs, a poor link between antibiotic policies and practices exists. Numerous contextual factors may influence the degree of antibiotic access, appropriateness of antibiotic provision, and actual use in communities. Therefore, improving appropriateness of antibiotic use in different communities in LMICs probably requires interventions tailored to the setting of interest, accounting for cultural context. Here we present the ABACUS study (AntiBiotic ACcess and USe, which employs a unique approach and infrastructure, enabling quantitative validation, contextualization of determinants, and cross-continent comparisons of antibiotic access and use. The community infrastructure for this study is the INDEPTH-Network (International Network for the Demographic Evaluation of Populations and Their Health in Developing Countries, which facilitates health and population research through an established health and demographic surveillance system. After an initial round of formative qualitative research with community members and antibiotic suppliers in three African and three Asian countries, household surveys will assess the appropriateness of antibiotic access, provision and use. Results from this sample will be validated against a systematically conducted inventory of suppliers. All potential antibiotic suppliers will be mapped and characterized. Subsequently, their supply of antibiotics to the community will be measured through customer exit interviews, which tend to be more reliable than bulk purchase or sales data. Discrepancies identified between reported and observed antibiotic practices will be investigated in further qualitative interviews. Amartya Sen’s Capability Approach will be employed to identify the conversion factors that determine whether or not, and the extent to which appropriate provision of antibiotics may lead to appropriate access and use of antibiotics. Currently, the study is ongoing and

  4. Occupation and risk of glioma, meningioma and acoustic neuroma: results from a German case-control study (interphone study group, Germany)

    DEFF Research Database (Denmark)

    Samkange-Zeeb, F; Schlehofer, B; Schüz, J

    2010-01-01

    /electronic and transport, and the risk of glioma, meningioma and acoustic neuroma. METHODS: In a population-based case-control study involving a total of 844 cases and 1688 controls conducted from 2000 to 2003, detailed information on life-long job histories was collected during personal interviews and used to create job...... calendars for each participant. Job title, job activity, job number, and the starting and ending dates of the activity were recorded for all activities with duration of at least 1 year. Reported occupational activities were coded according to the International Standard Classification of Occupations 1988...

  5. Multiple sclerosis and dental amalgam: case-control study in Ferrara, Italy.

    Science.gov (United States)

    Casetta, I; Invernizzi, M; Granieri, E

    2001-05-01

    Dental amalgam fillings containing mercury have been suggested as a possible risk factor for multiple sclerosis (MS). In the context of a wider program of investigation into environmental risk factors and MS, we conducted a case-control comparison to investigate the alleged association between MS, dental caries, and amalgam fillings. We included 132 MS patients with onset during the last 16 years and 423 controls, matched to cases for sex, age and residence. Data were collected by a personal interview conducted by trained doctors. Cases and controls gave informed consent. Although we report a trend toward a higher number of dental fillings in cases than controls, odds ratios for subjects with exposures of different duration and with different numbers of amalgam fillings were not statistically significant. This case-control study failed to demonstrate an association between either the number of dental amalgam fillings or the duration of exposure to mercury amalgam and MS. Copyright 2001 S. Karger AG, Basel

  6. Impulse control disorders in Parkinson disease: a multicenter case--control study.

    Science.gov (United States)

    Voon, Valerie; Sohr, Mandy; Lang, Anthony E; Potenza, Marc N; Siderowf, Andrew D; Whetteckey, Jacqueline; Weintraub, Daniel; Wunderlich, Glen R; Stacy, Mark

    2011-06-01

    To assess factors associated with impulse control disorders (ICDs) in Parkinson disease (PD) using a multicenter case--control design. Patients enrolled in the DOMINION study, a multicenter study assessing the cross-sectional frequency of ICDs in PD, were eligible to participate in the case--control study. PD patients with and without an ICD (n = 282 each) (compulsive gambling, buying, sexual behavior, and eating) were matched individually on age, gender, and dopamine agonist treatment. Subjects were assessed with a comprehensive neurological, psychiatric, and cognitive assessment battery. ICD patients reported more functional impairment (p compulsive symptoms (p cognitive impairments, including affective and anxiety symptoms, as well as elevated obsessionality, novelty seeking, and impulsivity. These results highlight the importance of assessing multiple mental health domains in individuals with PD and ICDs, and suggest possible pathophysiological mechanisms and risk indicators for these disorders. Copyright © 2011 American Neurological Association.

  7. Recall bias in a case-control surveillance system on the use of medicine during pregnancy

    DEFF Research Database (Denmark)

    Rockenbauer, M.; Olsen, Jørn; Czeizel, A.E.

    2001-01-01

    It is important to study possible teratogenic effects of drugs used during pregnancy. Many studies of this type rely upon case-control designs in which drug intake is recalled by the mothers after having given birth. Recall bias in this situation may lead to spurious associations. We looked...... for indicators of recall bias by comparing self-reported drug intake with medically notified intake for specific diseases in the Hungarian Case-Control Surveillance System of Congenital Abnormalities, which includes 22,865 cases with congenital abnormalities and 39,151 controls. Recall error was present......, especially for drugs used for a short time period. Furthermore, the timing of drug intake was reported slightly closer to the time of interview for cases compared than for controls. Severe or visible congenital abnormalities did not appear to be more conducive to recall bias than other abnormalities under...

  8. Circulating folate levels and colorectal adenoma: a case-control study and a meta-analysis.

    Science.gov (United States)

    Park, Yeong Mi; Youn, Jiyoung; Cho, Chang Ho; Kim, Sung Hi; Lee, Jung Eun

    2017-10-01

    The relationship between folate and colorectal neoplasia remains controversial. We examined the association between serum folate concentrations and colorectal adenomas in a case-control study of Korean adults and conducted a meta-analysis. Our case-control study included 113 pairs of case and control who underwent colonoscopy and provided blood samples. We used multivariable conditional logistic regression models to obtain the odds ratios and 95% confidence interval (CIs). For meta-analysis, we identified the relevant studies by searching the PubMed database up to February 2017, included our case-control study and combined the study-specific relative risks (RRs) using a random-effects model. In this case-control study, we included 58 men and 55 women with colorectal adenomas and sex and fasting status matched the controls. We did not find any significant association between the serum folate levels and colorectal adenomas in either men or women. For meta-analysis, a total of eleven studies were included in our analysis and classified into two groups; polyp clearance group (PC) for the studies that included participants who underwent endoscopies and had their polyps removed at baseline; and no polyp clearance group (NPC) for the studies that included participants whose histories of endoscopies were unknown or who underwent their first endoscopies. Four PC (1,311 cases and 1,672 non-cases) and eight NPC studies (3,501 cases and 11,347 non-cases) were included. The combined RRs (95% CIs) comparing the bottom with the top categories of circulating folate levels were 1.07 (0.97-1.18) for the NPC group but 1.45 (1.16-1.74) for the PC group. Low circulating folate levels were associated with new adenoma formation.

  9. Telomere length and ischaemic stroke in women: a nested case-control study.

    Science.gov (United States)

    Schürks, M; Prescott, J; Dushkes, R; De Vivo, I; Rexrode, K M

    2013-07-01

    Telomere shortening has been implicated in cardiovascular disease (CVD). However, prospective data on the association between relative telomere length (RTL) and ischaemic stroke are scarce and inconclusive. We used a nested case-control design among women participating in the prospective Nurses' Health Study. Participants provided blood samples in 1990 and were followed till 2006. Women with confirmed incident ischaemic stroke were matched to controls by age, smoking, postmenopausal status and postmenopausal hormone use. Quantitative polymerase chain reaction was used to determine RTL in genomic DNA extracted from peripheral blood leukocytes. Conditional logistic regression was used to determine the risk of ischaemic stroke associated with RTL, using RTL quartiles and as dichotomous according to the median. Data on RTL were available from 504 case-control pairs. Results did not suggest an association between RTL and ischaemic stroke. The odds ratio (OR) for ischaemic stroke was 0.82 [95% confidence interval (CI) 0.52-1.32] comparing lowest with the highest RTL quartile and 0.90 (95% CI 0.65-1.24) comparing RTL below the median with RTL above the median. Associations were unchanged after additional adjustment for cardiovascular risk factors. Further analyses suggested an association between RTL and fatal ischaemic stroke (54 case-control pairs; lowest versus highest quartile OR = 1.99, 95%CI 0.26-14.9); however, results were statistically insignificant. In this large nested case-control study among women RTL was not associated with ischaemic stroke. In light of the varying study results in the literature on the association between telomere length and stroke, additional research is warranted. © 2013 The Author(s) European Journal of Neurology © 2013 EFNS.

  10. Juvenile Perpetrators of Homicides and Attempted Homicides – A Case Control Study

    OpenAIRE

    Britvić, Dolores; Urlić, Ivan; Definis-Gojanović, Marija

    2006-01-01

    The aim of this study was to explore the influence of certain aspects of family dynamics, as well as some behavior and psychological development disorders on the occurrence of homicides and attempted homicides among juveniles in the Split Dalmatian County over a period of 10 years (1989–1998). A retrospective case-control study was performed to compare juvenile murderers and attempted murderers with minors who committed other offences, i.e. property crimes. The subjects were paired according ...

  11. Patterned genital injury in cases of rape - A case-control study

    DEFF Research Database (Denmark)

    Astrup, Birgitte Schmidt; Ravn, Pernille; Thomsen, Jørgen Lange

    2013-01-01

    A pattern of genital injury that separates trauma seen in sexual assault cases from trauma seen following consensual sexual intercourse has been a matter of debate. This study aimed at clarifying the question by eliminating as many confounders as possible in a prospective, case-control setup...... for detection of genital lesions using the three most commonly used techniques is provided. These results will aid in the interpretation of findings seen when examining sexual assault victims....

  12. Dietary patterns and risk of colorectal cancer in Tehran Province: a case?control study

    OpenAIRE

    Safari, Akram; Shariff, Zalilah Mohd; Kandiah, Mirnalini; Rashidkhani, Bahram; Fereidooni, Foroozandeh

    2013-01-01

    Background Colorectal cancer is the third and fourth leading cause of cancer incidence and mortality among men and women, respectively in Iran. However, the role of dietary factors that could contribute to this high cancer incidence remains unclear. The aim of this study was to determine major dietary patterns and its relationship with colorectal cancer. Methods This case?control study was conducted in four hospitals in Tehran city of Iran. A total of 71 patients (35 men and 36 women, aged 40...

  13. Dietary calcium intake and the risk of colorectal cancer: a case control study

    OpenAIRE

    Han, Changwoo; Shin, Aesun; Lee, Jeonghee; Lee, Jeeyoo; Park, Ji Won; Oh, Jae Hwan; Kim, Jeongseon

    2015-01-01

    Background High intake of dietary calcium has been thought to be a protective factor against colorectal cancer. To explore the dose-response relationship in the associations between dietary calcium intake and colorectal cancer risk by cancer location, we conducted a case-control study among Korean population, whose dietary calcium intake levels are relatively low. Methods The colorectal cancer cases and controls were recruited from the National Cancer Center in Korea between August 2010 and A...

  14. Cardiovascular and metabolic syndrome risk among men with and without erectile dysfunction: case-control study

    OpenAIRE

    Zambon, João Paulo; Mendonça, Rafaela Rosalba de; Wroclawski, Marcelo Langer; Karam Junior, Amir; Santos, Raul D.; Carvalho, José Antonio Maluf de; Wroclawski, Eric Roger

    2010-01-01

    CONTEXT AND OBJECTIVE: Erectile dysfunction has been associated with cardiovascular diseases. The aim here was to evaluate cardiovascular risk through the Framingham Risk Score (FRS) criteria, C-reactive protein (CRP) assays and presence of metabolic syndrome (MS) in men with and without erectile dysfunction diagnosed within a healthcare program. DESIGN AND SETTING: A retrospective case-control study was conducted. The patients were selected from a healthcare program at the Hospital Israelita...

  15. Rheumatoid Arthritis - Neuropsychology, Depression and Anxiety. A case - control study -120 Portuguese Female subjects.

    OpenAIRE

    Luis Maia

    2012-01-01

    Objectives: Impact of Rheumatoid Arthritis in cognitive functions has not been well acknowledged in Portugal. With this original article we intended to elucidate this problem in this specific country. Methods: We measured the results of 60 Rheumatoid Arthritis female patients (study group), comparing every patient in a case control paired plan (years in school and age), with control subjects (n = 60, in a total of 120 subjects). All participants were evaluated with Paced Auditory Selective At...

  16. Risk factors for candidemia in cancer patients: a case-control study.

    OpenAIRE

    Karabinis, A; Hill, C; Leclercq, B; Tancrède, C; Baume, D; Andremont, A

    1988-01-01

    Risk factors for candidemia were analyzed in a case-control study of 30 cancer patients with candidemia and 58 controls. In a univariate analysis, previous surgery, neutropenia, central catheterization, chemotherapy, specific antibiotic treatments, and peripheral cultures positive for Candida spp. were associated with a significantly increased risk of candidemia. In a multivariate logistic model, the significant risk factors for candidemia were positive peripheral cultures for Candida spp. (P...

  17. Depression, Anxiety, Stress and Hyperemesis Gravidarum: Temporal and Case Controlled Correlates

    OpenAIRE

    Tan, Peng Chiong; Zaidi, Syeda Nureena; Azmi, Noor; Omar, Siti Zawiah; Khong, Su Yen

    2014-01-01

    OBJECTIVE: To evaluate the temporal and case-controlled correlations of anxiety, depression and stress with hyperemesis gravidarum. STUDY DESIGN: We performed a longitudinal cohort study of women with hyperemesis gravidarum using the Depression, Anxiety and Stress Scale (DASS-21) to evaluate psychological distress at hospitalization and in the third trimester of pregnancy (from 28 weeks gestation). Third pregnancy trimester controls were recruited from routine antenatal clinic attendees who w...

  18. Implant failure and history of failed endodontic treatment: A retrospective case-control study.

    Science.gov (United States)

    Chatzopoulos, Georgios S; Wolff, Larry F

    2017-11-01

    Residual bacterial biofilm and/or bacteria in planktonic form may be survived in the bone following an extraction of an infected tooth that was endodontically treated unsuccessfully Failed endodontic treatment may be associated with failure of implants to osseointegrate in the same sites. Therefore, the aim of this retrospective case-control study is to examine the risk of implant failure in previous failed endodontic sites. This retrospective case-control study is based on 94 dental records of implants placed at the University of Minnesota School of Dentistry. Dental records of patients who received an implant in sites with previously failed endodontic therapy in the dental school were identified from the electronic database, while control subjects were obtained from the same pool of patients with the requirement to have received an implant in a site that was not endodontically treated. The mean age of the population was 62.89±14.17 years with 57.4% of the sample being females and 42.6% of them being males. In regards to the socio-economic status and dental insurance, 84.0% of this population was classified as low socio-economic status and 68.1% had dental insurance. Tobacco use was self-reported by 9.6% and hypercholesterolemia was the most prevalent systemic medical condition. Dental implant failure was identified in two of the included records (2.1%), both of which were placed in sites with a history of failed endodontic treatment. Within the limitations of this retrospective case-control study, further investigation with a larger population group into implant failure of sites that previously had unsuccessful endodontic treatment would be warranted. Implant failure may be associated with a history of failed endodontic treatment. Key words: Implantology, endodontics, osseointegration, treatment outcome, case-control study.

  19. Method for mapping population-based case-control studies: an application using generalized additive models

    Directory of Open Access Journals (Sweden)

    Aschengrau Ann

    2006-06-01

    Full Text Available Abstract Background Mapping spatial distributions of disease occurrence and risk can serve as a useful tool for identifying exposures of public health concern. Disease registry data are often mapped by town or county of diagnosis and contain limited data on covariates. These maps often possess poor spatial resolution, the potential for spatial confounding, and the inability to consider latency. Population-based case-control studies can provide detailed information on residential history and covariates. Results Generalized additive models (GAMs provide a useful framework for mapping point-based epidemiologic data. Smoothing on location while controlling for covariates produces adjusted maps. We generate maps of odds ratios using the entire study area as a reference. We smooth using a locally weighted regression smoother (loess, a method that combines the advantages of nearest neighbor and kernel methods. We choose an optimal degree of smoothing by minimizing Akaike's Information Criterion. We use a deviance-based test to assess the overall importance of location in the model and pointwise permutation tests to locate regions of significantly increased or decreased risk. The method is illustrated with synthetic data and data from a population-based case-control study, using S-Plus and ArcView software. Conclusion Our goal is to develop practical methods for mapping population-based case-control and cohort studies. The method described here performs well for our synthetic data, reproducing important features of the data and adequately controlling the covariate. When applied to the population-based case-control data set, the method suggests spatial confounding and identifies statistically significant areas of increased and decreased odds ratios.

  20. Risk factors for noma disease: a 6-year, prospective, matched case-control study in Niger

    OpenAIRE

    Baratti, Denise; Gayet-Ageron, Angèle; Hugonnet, Stéphane; Francois, Patrice; Pittet Cuenod, Brigitte Maud; Huyghe, Antoine; Bornand, Jacques-Etienne; Gervaix, Alain; Montandon, Denys; Schrenzel, Jacques; Mombelli, Andrea; Pittet, Didier

    2013-01-01

    Background: Noma is a poorly studied disease that leads to severe facial tissue destruction in children in developing countries, but the cause remains unknown. We aimed to identify the epidemiological and microbiological risk factors associated with noma disease. Methods: We did a prospective, matched, case-control study in Niger between Aug 1, 2001, and Oct 31, 2006, in children younger than 12 years to assess risk factors for acute noma. All acute noma cases were included and four contro...

  1. Risk factors for severe hand foot mouth disease in Singapore: a case control study

    OpenAIRE

    Chew, So-Phia; Chong, Shu-Ling; Barbier, Sylvaine; Matthew, Aji; Lee, Jan Hau; Chan, Yoke Hwee

    2015-01-01

    Background Hand foot mouth disease (HFMD) is a common childhood infection that can potentially lead to serious complications. The aim of this study is to identify risk factors of acquiring severe HFMD in our population. Methods We performed a case control study using patients admitted to our hospital from August 2004 to July 2014. Cases were patients with severe HFMD disease while controls were age-matched patients obtained from the same year, in a 2:1 ratio. Data comprising demographic chara...

  2. Risk Factors for Abdominal Wound Dehiscence in Children: A Case-Control Study

    OpenAIRE

    van Ramshorst, Gabri?lle H.; Salu, Nathalie E.; Bax, Nikolaas M. A.; Hop, Wim C. J.; van Heurn, Ernst; Aronson, Daniel C.; Lange, Johan F.

    2009-01-01

    Background In the limited literature concerning abdominal wound dehiscence after laparotomy in children, reported incidences range between 0.2?1.2% with associated mortality rates of 8?45%. The goal of this retrospective case-control study was to identify major risk factors for abdominal wound dehiscence in the pediatric population. Methods Patients younger than aged 18?years who developed abdominal wound dehiscence in three pediatric surgical centers during the period 1985?2005 were identifi...

  3. A random forest approach to the detection of epistatic interactions in case-control studies.

    Science.gov (United States)

    Jiang, Rui; Tang, Wanwan; Wu, Xuebing; Fu, Wenhui

    2009-01-30

    The key roles of epistatic interactions between multiple genetic variants in the pathogenesis of complex diseases notwithstanding, the detection of such interactions remains a great challenge in genome-wide association studies. Although some existing multi-locus approaches have shown their successes in small-scale case-control data, the "combination explosion" course prohibits their applications to genome-wide analysis. It is therefore indispensable to develop new methods that are able to reduce the search space for epistatic interactions from an astronomic number of all possible combinations of genetic variants to a manageable set of candidates. We studied case-control data from the viewpoint of binary classification. More precisely, we treated single nucleotide polymorphism (SNP) markers as categorical features and adopted the random forest to discriminate cases against controls. On the basis of the gini importance given by the random forest, we designed a sliding window sequential forward feature selection (SWSFS) algorithm to select a small set of candidate SNPs that could minimize the classification error and then statistically tested up to three-way interactions of the candidates. We compared this approach with three existing methods on three simulated disease models and showed that our approach is comparable to, sometimes more powerful than, the other methods. We applied our approach to a genome-wide case-control dataset for Age-related Macular Degeneration (AMD) and successfully identified two SNPs that were reported to be associated with this disease. Besides existing pure statistical approaches, we demonstrated the feasibility of incorporating machine learning methods into genome-wide case-control studies. The gini importance offers yet another measure for the associations between SNPs and complex diseases, thereby complementing existing statistical measures to facilitate the identification of epistatic interactions and the understanding of epistasis in

  4. A Survey on Some of the Effective Factors in Premature Birth: A Case-Control Study

    OpenAIRE

    Nader Esmailnasab; Hossein Amirian; Batoul Eskandai; Mina Zarei

    2015-01-01

    Background and objectives : Preterm birth (birth that occurs before the 37th week of pregnancy) is the major factor affecting a child's health and survival. Compared with term infants, these infants are at higher risk of mortality and incidence of health problems. The aim of this study was to identify risk factors associated with preterm birth. Material and Methods : A case-control study was conducted in Hamadan Fatemieh hospital, Iran, between 23rd October 2011 and 21st June 2012. Convenie...

  5. Isoflavone and Soyfood Intake and Colorectal Cancer Risk: A Case-Control Study in Korea

    OpenAIRE

    Shin, Aesun; Lee, Jeonghee; Lee, Jeeyoo; Park, Moon Sung; Park, Ji Won; Park, Sung Chan; Oh, Jae Hwan; Kim, Jeongseon

    2015-01-01

    We aimed to assess the relationship between dietary soyfood and isoflavone intake and colorectal cancer risk in a case-control study. A total of 901 colorectal cancer cases and 2669 controls were recruited at the National Cancer Center, Korea. A semi-quantitative food frequency questionnaire was used to assess the usual dietary habits, and the isoflavone intake level was estimated from five soyfood items. A high intake of total soy products, legumes, and sprouts was associated with a reduced ...

  6. Soy consumption and risk of COPD and respiratory symptoms: a case-control study in Japan

    OpenAIRE

    Hirayama, Fumi; Lee, Andy H; Binns, Colin W; Zhao, Yun; Hiramatsu, Tetsuo; Tanikawa, Yoshimasa; Nishimura, Koichi; Taniguchi, Hiroyuki

    2009-01-01

    Abstract Background To investigate the relationship between soy consumption, COPD risk and the prevalence of respiratory symptoms, a case-control study was conducted in Japan. Methods A total of 278 eligible patients (244 men and 34 women), aged 50–75 years with COPD diagnosed within the past four years, were referred by respiratory physicians, while 340 controls (272 men and 68 women) were recruited from the community. All participants underwent spirometric measurements of respiratory functi...

  7. Taurodontism in children with hypodontia and supernumerary teeth: a case control study.

    Science.gov (United States)

    Kan, Wayne Y W; Seow, W Kim; Holcombe, Trevor

    2010-01-01

    The aim of the present investigation was to compare the prevalence of taurodontism in the permanent mandibular first molars of nonsyndromic children with hypodontia and supernumerary teeth with age- and gender-matched controls. The crown-body root ratios of the permanent first molars were determined from orthopantomograms of 83 children with hypodontia (> or =1 missing teeth) and 37 children with supernumerary teeth (> or =1 extra teeth) compared with normal case controls. In children with hypodontia, only girls showed a significantly higher tendency for taurodontism compared to case controls (P=.003), while boys with hypodontia showed a similar prevalence of taurodontism as controls (P=.83). Children with multiple missing teeth were significantly more susceptible to taurodontism than children with a single missing tooth (P=.004). By contrast, the prevalence of taurodontism in children with supernumerary teeth was not significantly different from that of controls. Compared to normal case controls, children with nonsyndromic hypodontia are more likely to show taurodontism of the permanent first molar teeth whereas children with nonsyndromic supernumerary teeth are not.

  8. Unconditional or Conditional Logistic Regression Model for Age-Matched Case-Control Data?

    Science.gov (United States)

    Kuo, Chia-Ling; Duan, Yinghui; Grady, James

    2018-01-01

    Matching on demographic variables is commonly used in case-control studies to adjust for confounding at the design stage. There is a presumption that matched data need to be analyzed by matched methods. Conditional logistic regression has become a standard for matched case-control data to tackle the sparse data problem. The sparse data problem, however, may not be a concern for loose-matching data when the matching between cases and controls is not unique, and one case can be matched to other controls without substantially changing the association. Data matched on a few demographic variables are clearly loose-matching data, and we hypothesize that unconditional logistic regression is a proper method to perform. To address the hypothesis, we compare unconditional and conditional logistic regression models by precision in estimates and hypothesis testing using simulated matched case-control data. Our results support our hypothesis; however, the unconditional model is not as robust as the conditional model to the matching distortion that the matching process not only makes cases and controls similar for matching variables but also for the exposure status. When the study design involves other complex features or the computational burden is high, matching in loose-matching data can be ignored for negligible loss in testing and estimation if the distributions of matching variables are not extremely different between cases and controls.

  9. Laryngospasm during emergency department ketamine sedation: a case-control study.

    Science.gov (United States)

    Green, Steven M; Roback, Mark G; Krauss, Baruch

    2010-11-01

    The objective of this study was to assess predictors of emergency department (ED) ketamine-associated laryngospasm using case-control techniques. We performed a matched case-control analysis of a sample of 8282 ED ketamine sedations (including 22 occurrences of laryngospasm) assembled from 32 prior published series. We sequentially studied the association of each of 7 clinical variables with laryngospasm by assigning 4 controls to each case while matching for the remaining 6 variables. We then used univariate statistics and conditional logistic regression to analyze the matched sets. We found no statistical association of age, dose, oropharyngeal procedure, underlying physical illness, route, or coadministered anticholinergics with laryngospasm. Coadministered benzodiazepines showed a borderline association in the multivariate but not univariate analysis that was considered anomalous. This case-control analysis of the largest available sample of ED ketamine-associated laryngospasm did not demonstrate evidence of association with age, dose, or other clinical factors. Such laryngospasm seems to be idiosyncratic, and accordingly, clinicians administering ketamine must be prepared for its rapid identification and management. Given no evidence that they decrease the risk of laryngospasm, coadministered anticholinergics seem unnecessary.

  10. Impact of waning acquired immunity and asymptomatic infections on case-control studies for enteric pathogens.

    Science.gov (United States)

    Havelaar, Arie H; Swart, Arno

    2016-12-01

    Case-control studies of outbreaks and of sporadic cases of infectious diseases may provide a biased estimate of the infection rate ratio, due to selecting controls that are not at risk of disease. We use a dynamic mathematical model to explore biases introduced in results drawn from case-control studies of enteric pathogens by waning and boosting of immunity, and by asymptomatic infections, using Campylobacter jejuni as an example. Individuals in the population are either susceptible (at risk of infection and disease), fully protected (not at risk of either) or partially protected (at risk of infection but not of disease). The force of infection is a function of the exposure frequency and the exposure dose. We show that the observed disease odds ratios are indeed strongly biased towards the null, i.e. much lower than the infection rate ratio, and furthermore even not proportional to it. The bias could theoretically be controlled by sampling controls only from the reservoir of susceptible individuals. The population at risk is in a dynamic equilibrium, and cannot be identified as those who are not and have never experienced disease. Individual-level samples to measure protective immunity would be required, complicating the design, cost and execution of case-control studies. Copyright © 2016 The Author(s). Published by Elsevier B.V. All rights reserved.

  11. Severe maternal sepsis in the UK, 2011-2012: a national case-control study.

    Directory of Open Access Journals (Sweden)

    Colleen D Acosta

    2014-07-01

    Full Text Available In light of increasing rates and severity of sepsis worldwide, this study aimed to estimate the incidence of, and describe the causative organisms, sources of infection, and risk factors for, severe maternal sepsis in the UK.A prospective case-control study included 365 confirmed cases of severe maternal sepsis and 757 controls from all UK obstetrician-led maternity units from June 1, 2011, to May 31, 2012. Incidence of severe sepsis was 4.7 (95% CI 4.2-5.2 per 10,000 maternities; 71 (19.5% women developed septic shock; and five (1.4% women died. Genital tract infection (31.0% and the organism Escherichia coli (21.1% were most common. Women had significantly increased adjusted odds ratios (aORs of severe sepsis if they were black or other ethnic minority (aOR = 1.82; 95% CI 1.82-2.51, were primiparous (aOR = 1.60; 95% CI 1.17-2.20, had a pre-existing medical problem (aOR = 1.40; 95% CI 1.01-1.94, had febrile illness or were taking antibiotics in the 2 wk prior to presentation (aOR = 12.07; 95% CI 8.11-17.97, or had an operative vaginal delivery (aOR = 2.49; 95% CI 1.32-4.70, pre-labour cesarean (aOR = 3.83; 95% CI 2.24-6.56, or cesarean after labour onset (aOR = 8.06; 95% CI 4.65-13.97. Median time between delivery and sepsis was 3 d (interquartile range = 1-7 d. Multiple pregnancy (aOR = 5.75; 95% CI 1.54-21.45 and infection with group A streptococcus (aOR = 4.84; 2.17-10.78 were associated with progression to septic shock; for 16 (50% women with a group A streptococcal infection there was <2 h-and for 24 (75% women, <9 h-between the first sign of systemic inflammatory response syndrome and a diagnosis of severe sepsis. A limitation of this study was the proportion of women with sepsis without an identified organism or infection source (16.4%.For each maternal sepsis death, approximately 50 women have life-threatening morbidity from sepsis. Follow-up to ensure infection is eradicated is important. The

  12. Adult attention-deficit hyperactivity disorder, risky behaviors, and motorcycle injuries: a case-control study

    Directory of Open Access Journals (Sweden)

    Sadeghi-Bazargani H

    2015-08-01

    Full Text Available Homayoun Sadeghi-Bazargani,1,2 Leili Abedi,3 Minoo Mahini,4 Shahrokh Amiri,5 Davoud Khorasani-Zavareh6 1Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; 2World Health Organization Collaborating Center on Safe Community Promotion, Stockholm, Sweden; 3Department of Statistics and Epidemiology, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, 4Department of Counseling, Aras International Campus, University of Tehran, Jolfa, 5Research Center of Psychiatry and Behavioral Sciences, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, 6Social Determinants of Health Research Center, Urmia University of Medical Sciences, Urmia, Iran Background: The aim of this study was to assess the association of motorcycle traffic injuries with motorcycle riding behavior and subtypes of attention-deficit hyperactivity disorder (ADHD while controlling for individual correlates of motorcycle traffic injuries.Methods: A case-control study was carried out in 298 patients with motorcycle trauma along with 151 control patients admitted to the Shohada and Imam Reza university hospitals as the two referral specialty centers in the East Azarbyjan Province of Iran in 2013. The Persian version of the Motorcycle Riding Behavior Questionnaire and the Persian version of Conner’s Adult ADHD Rating Scales (the self-report short version were used to assess riding behavior and screen for adult ADHD, respectively. The scale has four subscales, comprising subscale A (inattention, subscale B (hyperactivity, impulsivity, subscale C (A + C, and subscale D (ADHD index. The statistical analysis was done using Stata version 11.Results: All subjects were male and aged 13–79 years. Approximately 54% of the participants were married and 13% had academic education. Approximately 18% of the motorcycle riders stated that their motorcycle riding was only for fun purposes. More than two thirds of the participants did not

  13. Quantifying the impact of selection bias caused by nonparticipation in a case-control study of mobile phone use

    DEFF Research Database (Denmark)

    Vrijheid, Martine; Richardson, Lesley; Armstrong, Bruce K

    2009-01-01

    To quantitatively assess the impact of selection bias caused by nonparticipation in a multinational case-control study of mobile phone use and brain tumor.......To quantitatively assess the impact of selection bias caused by nonparticipation in a multinational case-control study of mobile phone use and brain tumor....

  14. Effectiveness and cost-effectiveness of transmural collaborative care with consultation letter (TCCCL) and duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: design of a randomized placebo-controlled multi-Centre trial: TCC:PAINDIP.

    Science.gov (United States)

    de Heer, Eric W; Dekker, Jack; van Eck van der Sluijs, Jonna F; Beekman, Aartjan Tf; van Marwijk, Harm Wj; Holwerda, Tjalling J; Bet, Pierre M; Roth, Joost; Hakkaart-Van Roijen, Leona; Ringoir, Lianne; Kat, Fiona; van der Feltz-Cornelis, Christina M

    2013-05-24

    The comorbidity of pain and depression is associated with high disease burden for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression in such cases is low, but evolving. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, like collaborative care, is promising. However, treatment of chronic pain conditions in depressive patients has, so far, received limited attention in research. Cost effectiveness of an integrated approach of pain in depressed patients has not been studied. This study is a placebo controlled double blind, three armed randomized multi centre trial. Patients with (sub)chronic pain and a depressive disorder are randomized to either a) collaborative care with duloxetine, b) collaborative care with placebo or c) duloxetine alone. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures (PHQ-9 score). Data on depression, anxiety, mental and physical health, medication adherence, medication tolerability, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. This study enables us to show the value of a closely monitored integrated treatment model above usual pharmacological treatment. Furthermore, a comparison with a placebo arm enables us to evaluate effectiveness of duloxetine in this population in a real life setting. Also, this study will provide evidence-based treatments and tools for their implementation in practice. This will facilitate generalization and implementation of results of this study. Moreover, patients included in this study are screened for pain symptoms, differentiating between nociceptive

  15. Colorectal cancer and its association with the metabolic syndrome: a Malaysian multi-centric case-control study.

    Science.gov (United States)

    Ulaganathan, V; Kandiah, M; Zalilah, M S; Faizal, J A; Fijeraid, H; Normayah, K; Gooi, B H; Othman, R

    2012-01-01

    Colorectal cancer (CRC) and the metabolic syndrome (MetS) are both on the rise in Malaysia. A multi-centric case-control study was conducted from December 2009 to January 2011 to determine any relationship between the two. Patients with confirmed CRC based on colonoscopy findings and cancer free controls from five local hospitals were assessed for MetS according to the International Diabetes Federation (IDF) definition. Each index case was matched for age, gender and ethnicity with two controls (140: 280). MetS among cases was highly prevalent (70.7%), especially among women (68.7%). MetS as an entity increased CRC risk by almost three fold independently (OR=2.61, 95%CI=1.53-4.47). In men MetS increased the risk of CRC by two fold (OR=2.01, 95%CI, 1.43-4.56), demonstrating an increasing trend in risk with the number of Mets components observed. This study provides evidence for a positive association between the metabolic syndrome and colorectal cancer. A prospective study on the Malaysian population is a high priority to confirm these findings.

  16. Chlamydia trachomatis and invasive cervical cancer: a pooled analysis of the IARC multicentric case-control study.

    Science.gov (United States)

    Smith, Jennifer S; Bosetti, Cristina; Muñoz, Nubia; Herrero, Rolando; Bosch, F Xavier; Eluf-Neto, José; Meijer, Chris J L M; Van Den Brule, Adriaan J C; Franceschi, Silvia; Peeling, Rosanna W

    2004-09-01

    To determine whether Chlamydia trachomatis infection is consistently associated with an increased risk of invasive cervical carcinoma (ICC) after accounting for the strong effect of human papillomavirus (HPV) infection, a case-control study of 1,238 cases of ICC and 1,100 control women from 7 countries was carried out (hospital-based studies in Thailand, the Philippines, Morocco, Peru, Brazil and population-based studies in Colombia and Spain, all coordinated by the International Agency for Research on Cancer, Lyon, France). C. trachomatis serum antibody detection was made by means of a microfluorescence assay. Among HPV DNA-positive cases and controls, the risk of squamous cell ICC was elevated in C. trachomatis seropositive women (OR = 1.8; 95% CI = 1.2-2.7) after adjustment for age, center, oral contraceptive use, history of Pap smears, number of full-term pregnancies and herpes simplex virus 2 seropositivity. The effect of C. trachomatis seropositivity on squamous cell ICC risk increased with increasing C. trachomatis antibody titers and was higher in women under 55 years of age. C. trachomatis antibodies were not associated with adeno- or adenosquamous cell carcinoma (OR = 1.0; 95% CI = 0.53-1.9) in HPV DNA-positive women. An association of C. trachomatis with squamous cell ICC was found among all cases and control women with or without adjustment for HPV. Copyright 2004 Wiley-Liss, Inc.

  17. Differences between homicide and filicide offenders; results of a nationwide register-based case-control study

    Directory of Open Access Journals (Sweden)

    Eronen Markku

    2009-05-01

    Full Text Available Abstract Background Filicide, the killing of one's child, is an extraordinary form of homicide. It has commonly been associated with suicide and parental psychiatric illness. In the research on filicide, nationwide studies with comparison groups, specific perpetrator subgroups, and assessment of possible risk factors have been called for. The purpose of the current study was to provide all that. Methods In this nationwide register-based case-control study all filicide offenders who were in a forensic psychiatric examination in Finland 1995–2004 were examined and compared with an age- and gender matched control group of homicide offenders. The assessed variables were psychosocial history, index offence, and psychiatric variables as well as psychopathy using the PCL-R. Results Filicide offenders were not significantly more often diagnosed with psychotic disorders than the controls but they had attempted suicide at the crime scene significantly more often. Filicide offenders had alcohol abuse/dependence and antisocial personality less often than the controls. Filicide offenders scored significantly lower on psychopathy than the controls. Within the group of filicide offenders, the psychopathy items with relatively higher scores were lack of remorse or guilt, shallow affect, callous/lack of empathy, poor behavioral controls, and failure to accept responsibility. Conclusion Since filicide offenders did not seem significantly more mentally disordered than the other homicide offenders, psychiatry alone cannot be held responsible for the prevention of filicide. Extensive international studies are needed to replicate our findings and provide more specific knowledge in order to enhance prevention.

  18. Self-reported health and satisfaction of patients with chronic diseases who meditate: a case-control study.

    Science.gov (United States)

    Lauche, Romy; Langhorst, Jost; Paul, Anna; Dobos, Gustav; Cramer, Holger

    2014-11-01

    While many clinical trials suggest that meditation is effective in reducing disease-related symptoms and increasing quality of life in diseased samples, subjective health benefits associated with the use of meditation under naturalistic conditions have not yet been investigated. The aim of this study was to investigate the differences in quality of life, mental health, and satisfaction in patients with chronic diseases who regularly use meditation versus those who do not. The study applied a case-control design. Patients with chronic diseases who regularly used meditation were selected from a larger observational trial and compared to matched control patients who did not meditate regularly. They were compared in terms of their reported quality of life (SF-36 questionnaire), mental health (Hospital Anxiety and Depression Scale), life and health satisfaction (Questionnaire for Life Satisfaction), and medication usage as well as health locus of control (German version of the Multidimensional Health Locus of Control Scale). A total of 115 meditators and 115 controls were compared. Cases showed higher quality of life on the bodily pain subscale, higher internal and less external health locus of control, and higher life satisfaction than controls. No group differences were found for general health perception, most other aspects of quality of life, anxiety, depression, and medication use and health satisfaction. Regular practice of meditation was not clearly associated with better health perception in chronically diseased patients. However, those who regularly used meditation reported better pain-related quality of life and are more satisfied with their life.

  19. Chronic osteomyelitis correlates with increased risk of acute pancreatitis in a case-control study in Taiwan.

    Science.gov (United States)

    Lai, Shih-Wei; Lai, Hsueh-Chou; Lin, Cheng-Li; Liao, Kuan-Fu; Tseng, Chun-Hung

    2015-07-01

    The objective of this study was to examine the relationship between chronic osteomyelitis and acute pancreatitis in Taiwan. This was a population-based case-control study utilizing the database of the Taiwan National Health Insurance Program. We identified 7678 cases aged 20-84 with newly diagnosed acute pancreatitis during the period of 1998 to 2011. From the same database, 30,712 subjects without diagnosis of acute pancreatitis were selected as controls. The cases and controls were matched with sex, age and index year of diagnosing acute pancreatitis. The odds ratio with 95% confidence interval of acute pancreatitis associated with chronic osteomyelitis was examined by the multivariable unconditional logistic regression analysis. After adjustment for multiple confounders, the multivariable analysis showed that the adjusted odds ratio of acute pancreatitis was 1.93 for subjects with chronic osteomyelitis (95% confidence interval 1.01, 3.69), when compared with subjects without chronic osteomyelitis. Chronic osteomyelitis correlates with increased risk of acute pancreatitis. Patients with chronic osteomyelitis should be carefully monitored about the risk of acute pancreatitis. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  20. A case-control study on alcohol and psychiatric disorders as risk factors for drug abuse pattern

    Directory of Open Access Journals (Sweden)

    Lopes Claudia S.

    2002-01-01

    Full Text Available We evaluated alcohol and psychiatric disorders as risk factors for the pattern of drug abuse/dependence in a matched case-control study (370 adults. Cases (drug abusers and controls were selected in the community using the snowball technique and matched by sex, age, and friendship. Information was gathered using the "Composite International Diagnostic Interview" (CIDI. Three patterns of drug abuse/dependence were evaluated: any drug abuse/dependence, only cannabis, and cocaine and other drugs. Logistic conditional regression showed that alcohol dependence was strongly associated with pattern of drug abuse/dependence. Thus, compared to the "no drug abuse group", the odds ratio for association with diagnosis of abuse/dependence on cocaine and other drugs was 10.2 (95% CI: 4.9-21.2, whereas for abuse/dependence on cannabis only, the odds ratio was 1.0. For affective disorders, the odds ratio was 2.0 (95% CI: 1.10-3.64 for the group that received a diagnosis of abuse/dependence on cocaine and other drugs, whereas no association was found for those with abuse/dependence on cannabis only. In conclusion, there is not a homogeneous group of "drug users", and the role of risk factors depends on the drug use pattern.

  1. A case-control study on alcohol and psychiatric disorders as risk factors for drug abuse pattern

    Directory of Open Access Journals (Sweden)

    Claudia S. Lopes

    Full Text Available We evaluated alcohol and psychiatric disorders as risk factors for the pattern of drug abuse/dependence in a matched case-control study (370 adults. Cases (drug abusers and controls were selected in the community using the snowball technique and matched by sex, age, and friendship. Information was gathered using the "Composite International Diagnostic Interview" (CIDI. Three patterns of drug abuse/dependence were evaluated: any drug abuse/dependence, only cannabis, and cocaine and other drugs. Logistic conditional regression showed that alcohol dependence was strongly associated with pattern of drug abuse/dependence. Thus, compared to the "no drug abuse group", the odds ratio for association with diagnosis of abuse/dependence on cocaine and other drugs was 10.2 (95% CI: 4.9-21.2, whereas for abuse/dependence on cannabis only, the odds ratio was 1.0. For affective disorders, the odds ratio was 2.0 (95% CI: 1.10-3.64 for the group that received a diagnosis of abuse/dependence on cocaine and other drugs, whereas no association was found for those with abuse/dependence on cannabis only. In conclusion, there is not a homogeneous group of "drug users", and the role of risk factors depends on the drug use pattern.

  2. International Case-Control Study of Adult Brain, Head and Neck Tumours: Results of the Feasibility Study (invited paper)

    International Nuclear Information System (INIS)

    Cardis, E.; Kilkenny, M.

    1999-01-01

    The objectives of the feasibility study were to collect and analyse the information necessary to assess the feasibility of a multi-centric study of adult head and neck tumours (including brain tumours) and mobile telephones. Information was obtained on the availability and accessibility of records from companies, the prevalence of mobile telephone use over time and the expected number of tumour cases in the proposed study regions. The conclusion is that it is feasible to develop a study of the relation between mobile telephone use and brain cancer risk. The feasibility of a study of the relation between radiofrequency exposure and cancer risk is, however, unclear at present. It is unknown whether a sufficiently accurate and precise RF exposure gradient can be derived to classify adequately each subject in the proposed study. A study of the relation between mobile telephone use and risk of salivary gland tumours and acoustic neurinomas is probably feasible, but more information is required about the logistic difficulties of ascertaining these cases in the study regions. Two subcommittees have been formed to develop the exposure measurement and epidemiological aspect of the study. (author)

  3. Acoustic neuroma risk in relation to mobile telephone use: Results of the INTERPHONE international case-control study

    DEFF Research Database (Denmark)

    Berg-Beckhoff, Gabi

    2011-01-01

    exposure at five years before the reference date were also done to allow for a possible longer latent period. Results: The odds ratio (OR) of acoustic neuroma with ever having been a regular mobile phone user was 0.85 (95% confidence interval 0.69-1.04). The OR for ≥10 years after first regular mobile.......88-1.97); there were, however, implausible values of reported use in those with ≥1640h of accumulated mobile phone use. With censoring at 5 years before the reference date the OR for ≥10 years after first regular mobile phone use was 0.83 (0.58-1.19) and for ≥1640h of cumulative call time it was 2.79 (1...... was conducted in 13 countries using a common protocol. Past mobile phone use was assessed by personal interview. In the primary analysis, exposure time was censored at one year before the reference date (date of diagnosis for cases and date of diagnosis of the matched case for controls); analyses censoring...

  4. Validation of protein carbonyl measurement: A multi-centre study

    Directory of Open Access Journals (Sweden)

    Edyta Augustyniak

    2015-04-01

    Full Text Available Protein carbonyls are widely analysed as a measure of protein oxidation. Several different methods exist for their determination. A previous study had described orders of magnitude variance that existed when protein carbonyls were analysed in a single laboratory by ELISA using different commercial kits. We have further explored the potential causes of variance in carbonyl analysis in a ring study. A soluble protein fraction was prepared from rat liver and exposed to 0, 5 and 15 min of UV irradiation. Lyophilised preparations were distributed to six different laboratories that routinely undertook protein carbonyl analysis across Europe. ELISA and Western blotting techniques detected an increase in protein carbonyl formation between 0 and 5 min of UV irradiation irrespective of method used. After irradiation for 15 min, less oxidation was detected by half of the laboratories than after 5 min irradiation. Three of the four ELISA carbonyl results fell within 95% confidence intervals. Likely errors in calculating absolute carbonyl values may be attributed to differences in standardisation. Out of up to 88 proteins identified as containing carbonyl groups after tryptic cleavage of irradiated and control liver proteins, only seven were common in all three liver preparations. Lysine and arginine residues modified by carbonyls are likely to be resistant to tryptic proteolysis. Use of a cocktail of proteases may increase the recovery of oxidised peptides. In conclusion, standardisation is critical for carbonyl analysis and heavily oxidised proteins may not be effectively analysed by any existing technique.

  5. Peptic Ulcer Disease in Bangladesh: A Multi-centre Study.

    Science.gov (United States)

    Ghosh, C K; Khan, M R; Alam, F; Shil, B C; Kabir, M S; Mahmuduzzaman, M; Das, S C; Masud, H; Roy, P K

    2017-01-01

    The incidence of peptic ulcer has steadily declined through out the world. This decreasing trend is also noticeable in this subcontinent. The point prevalence of peptic ulcer (PUD) in Bangladesh was around 15% in eighties. The aim of this study was to see the present prevalence of peptic ulcer at endoscopy and to identify changing trends in the occurrence of peptic ulcer in Bangladesh. This retrospective analysis of the endoscopic records of multiple tertiary referral centres of Dhaka city were done from January 2012 to July 2013. A total of 5608 subjects were the study samples. We included those patients having peptic ulcer in the form of duodenal ulcer, benign gastric ulcer including pre-pyloric ulcer and gastric outlet obstruction due to peptic ulcer. Duodenal ulcer and benign gastric ulcer were found in 415(7.4%) and 184(3.28%) patients respectively and gastric outlet obstruction due to peptic ulcer was found in 23(0.40%) patients.

  6. Pregnancy, chimerism and lupus nephritis: a multi-centre study.

    NARCIS (Netherlands)

    Kremer Hovinga, I.C.; Koopmans, M.; Grootscholten, C.; Wal, A.M. van der; Bijl, M. van der; Derksen, R.H.W.M.; Voskuyl, A.E.; Heer, E. de; Bruijn, J.A.; Berden, J.H.M.; Bajema, I.M.

    2008-01-01

    Chimerism occurs twice as often in the kidneys of women with lupus nephritis as in normal kidneys and may be involved in the pathogenesis of systemic lupus erythematosus. Pregnancy is considered the most important source of chimerism, but the exact relationship between pregnancy, the persistence of

  7. Pregnancy, chimerism and lupus nephritis : a multi-centre study

    NARCIS (Netherlands)

    Hovinga, I. C. L. Kremer; Koopmans, M.; Grootscholten, C.; van der Wal, A. M.; Bijl, M.; Derksen, R. H. W. M.; Voslcuyl, A. E.; de Heer, E.; Bruijn, J. A.; Berden, J. H. M.; Rajema, I. M.

    2008-01-01

    Chimerism occurs twice as often in the kidneys of women with lupus nephritis as in normal kidneys and may he involved in the pathogenesis of systemic lupus erythematosus. Pregnancy is considered the most important source of chimerism, but the exact relationship between pregnancy, the persistence of

  8. Multi-centre, multi-database studies with common protocols

    DEFF Research Database (Denmark)

    Klungel, Olaf H.; Kurz, Xavier; de Groot, Mark C.H.

    2016-01-01

    Purpose: To assess the impact of a variety of methodological parameters on the association between six drug classes and five key adverse events in multiple databases. Methods: The selection of Drug-Adverse Event pairs was based on public health impact, regulatory relevance, and the possibility to...

  9. Brotizolam and chronic insomnia: a multi-centre study.

    Science.gov (United States)

    Fritz-Osner, A; Arias-Ortiz, J L; Dorantes, J F; Rabago-Sánchez, J; Rodríguez-Tenorio, A; Sánchez-Martinez, J

    1983-01-01

    A double-blind, crossover study was carried out on the acceptability of three doses of brotizolam (0.125, 0.25 and 0.5 mg) in chronic insomniacs aged between 21 and 75 years (33 men: 42 women). Patients reported a shorter time to fall asleep and less nocturnal awakenings. Improvement in sleep was evident during the first week of the study when each patient received 0.25 mg. There were no dose-related side-effects, and on withdrawal from the medication there was no evidence of disturbed sleep which would have suggested a rebound effect.

  10. Prescription errors in psychiatry - a multi-centre study.

    Science.gov (United States)

    Stubbs, Jean; Haw, Camilla; Taylor, David

    2006-07-01

    Medication errors are an important cause of patient morbidity and mortality, of which there have been few reports in psychiatry, especially in the UK. Our aim was to examine the nature, frequency and potential severity of prescribing errors in UK mental health units in a prospective, 1 week survey of errors detected by pharmacy staff in nine NHS trusts. Pharmacists checked 22036 prescription items. In total, 523 errors meeting the study definition were detected (2.4% of prescription items checked). Prescription writing errors (77.4%) were most common, while decision-making errors accounted for 22.6% of errors. In 280 (53.5%) cases the prescribed drug had been administered before the error was detected. Most errors were of doubtful or minor importance but 22 (4.3%) were deemed likely to result in serious adverse effects or death. The error detection rate varied fourfold between trusts. Prescribing errors are fairly common in psychiatry. A small proportion of errors have the potential for serious harm. Pharmacy staff have an important role to play in their management.

  11. Association between microcephaly, Zika virus infection, and other risk factors in Brazil: final report of a case-control study.

    Science.gov (United States)

    de Araújo, Thalia Velho Barreto; Ximenes, Ricardo Arraes de Alencar; Miranda-Filho, Demócrito de Barros; Souza, Wayner Vieira; Montarroyos, Ulisses Ramos; de Melo, Ana Paula Lopes; Valongueiro, Sandra; de Albuquerque, Maria de Fátima Pessoa Militão; Braga, Cynthia; Filho, Sinval Pinto Brandão; Cordeiro, Marli Tenório; Vazquez, Enrique; Cruz, Danielle di Cavalcanti Souza; Henriques, Claudio Maierovitch Pessanha; Bezerra, Luciana Caroline Albuquerque; Castanha, Priscila Mayrelle da Silva; Dhalia, Rafael; Marques-Júnior, Ernesto Torres Azevedo; Martelli, Celina Maria Turchi; Rodrigues, Laura Cunha

    2018-03-01

    A Zika virus epidemic emerged in northeast Brazil in 2015 and was followed by a striking increase in congenital microcephaly cases, triggering a declaration of an international public health emergency. This is the final report of the first case-control study evaluating the potential causes of microcephaly: congenital Zika virus infection, vaccines, and larvicides. The published preliminary report suggested a strong association between microcephaly and congenital Zika virus infection. We did a case-control study in eight public maternity hospitals in Recife, Brazil. Cases were neonates born with microcephaly, defined as a head circumference of 2 SD below the mean. Two controls without microcephaly were matched to each case by expected date of delivery and area of residence. We tested the serum of cases and controls and the CSF of cases for detection of Zika virus genomes with quantitative RT-PCR and for detection of IgM antibodies with capture-IgM ELISA. We also tested maternal serum with plaque reduction neutralisation assays for Zika and dengue viruses. We estimated matched crude and adjusted odds ratios with exact conditional logistic regression to determine the association between microcephaly and Zika virus infection. We screened neonates born between Jan 15 and Nov 30, 2016, and prospectively recruited 91 cases and 173 controls. In 32 (35%) cases, congenital Zika virus infection was confirmed by laboratory tests and no controls had confirmed Zika virus infections. 69 (83%) of 83 cases with known birthweight were small for gestational age, compared with eight (5%) of 173 controls. The overall matched odds ratio was 73·1 (95% CI 13·0-∞) for microcephaly and Zika virus infection after adjustments. Neither vaccination during pregnancy or use of the larvicide pyriproxyfen was associated with microcephaly. Results of laboratory tests for Zika virus and brain imaging results were available for 79 (87%) cases; within these cases, ten were positive for Zika virus

  12. Racial and ethnic differences in the risk of postpartum venous thromboembolism: a population-based, case-control study.

    Science.gov (United States)

    Blondon, M; Harrington, L B; Righini, M; Boehlen, F; Bounameaux, H; Smith, N L

    2014-12-01

    Venous thromboembolism (VTE) is a major contributor of maternal morbidity and mortality. Whether maternal race/ethnicity is associated with the risk of postpartum VTE remains unclear. We conducted a population-based, case-control study in Washington State, from 1987 through 2011. Cases comprised all women with selected International Classification of Diseases, Ninth Edition, Clinical Modification codes for hospitalized VTE within 3 months post-delivery. Controls were randomly selected postpartum women who did not experience a VTE. Characteristics of women and their deliveries were abstracted from birth certificates. Using logistic regression models, we compared the risk of postpartum VTE in black, Asian, and Hispanic women with that in non-Hispanic white women, after adjustment for maternal characteristics (age, body mass index, parity, education), pregnancy complications, and delivery methods. Our study comprised 688 cases and 10 246 controls. Among controls, the mean age and body mass index were 27.5 years and 26.3 kg m(-2) , respectively. Compared with white women, black and Asian women had a greater and lower risk of postpartum VTE (adjusted odds ratio [OR] 1.50, 95% confidence interval [CI] 1.10-2.04 and OR 0.67, 95%CI 0.48-0.94, respectively). A lower risk was present in Hispanic women (adjusted OR 0.80, 95% CI 0.61-1.06) but was not statistically significant. In subgroup analyses, we observed an increased risk for black compared with white women among women who delivered via cesarean section (OR 2.03, 95% CI 1.34-3.07) but not among vaginal deliveries (OR 1.03, 95% CI 0.61-1.74). Maternal race/ethnicity is associated with the risk of postpartum VTE, independently of other risk factors, and should be considered when assessing the use of thromboprophylaxis after delivery. © 2014 International Society on Thrombosis and Haemostasis.

  13. Case-control geographic clustering for residential histories accounting for risk factors and covariates

    Directory of Open Access Journals (Sweden)

    Goovaerts Pierre

    2006-08-01

    Full Text Available Abstract Background Methods for analyzing space-time variation in risk in case-control studies typically ignore residential mobility. We develop an approach for analyzing case-control data for mobile individuals and apply it to study bladder cancer in 11 counties in southeastern Michigan. At this time data collection is incomplete and no inferences should be drawn – we analyze these data to demonstrate the novel methods. Global, local and focused clustering of residential histories for 219 cases and 437 controls is quantified using time-dependent nearest neighbor relationships. Business address histories for 268 industries that release known or suspected bladder cancer carcinogens are analyzed. A logistic model accounting for smoking, gender, age, race and education specifies the probability of being a case, and is incorporated into the cluster randomization procedures. Sensitivity of clustering to definition of the proximity metric is assessed for 1 to 75 k nearest neighbors. Results Global clustering is partly explained by the covariates but remains statistically significant at 12 of the 14 levels of k considered. After accounting for the covariates 26 Local clusters are found in Lapeer, Ingham, Oakland and Jackson counties, with the clusters in Ingham and Oakland counties appearing in 1950 and persisting to the present. Statistically significant focused clusters are found about the business address histories of 22 industries located in Oakland (19 clusters, Ingham (2 and Jackson (1 counties. Clusters in central and southeastern Oakland County appear in the 1930's and persist to the present day. Conclusion These methods provide a systematic approach for evaluating a series of increasingly realistic alternative hypotheses regarding the sources of excess risk. So long as selection of cases and controls is population-based and not geographically biased, these tools can provide insights into geographic risk factors that were not specifically

  14. Association between smoking habits and acne vulgaris. A case-control study

    Directory of Open Access Journals (Sweden)

    Alice Mannocci

    2012-09-01

    Full Text Available

    Background: acne vulgaris, is one of the most common skin disorder. Previous studies about the role of smoke in the pathogenesis of acne reported contradictory results. The aim of this study was to conduct a case-control study investigating the relationship between tobacco smoking and acne.

    Methods: a case-control study was performed during the period September 2009 - February 2010. A questionnaire was administrated to each participant, to assess the association acne - smoke. Cases were outpatients of the Dermatologic Ambulatory of the “Fiorini” Hospital, Sapienza University of Rome (Italy. Controls were age and gender-matched to the cases. The ratio cases-controls was 1:2. A univariate and a multiple logistic regression analysis were conducted; Odds Ratio (OR and the relative 95% confidence interval (95%CI were assessed. The statistical significance was set at p < 0.05.

    Results: crude OR for the association acne - smoke was 7.26 (IC=2.27-23.18; adjusted OR for sex and age was 5.47 (IC=1.67-17.97. Of 93 cases, 6 had a severe grade of acne (6.5%, 19 had an intermediate grade of acne (20.4%, and 68 had a mild grade of acne (73.1%. No one of the smokers had a severe grade of acne, one had an intermediate grade of acne and 11 had mild acne; these differences are not statistically significant.

    Conclusions: the association between acne and smoke shows an increased risk (OR=7.26 with a statistically significant CI. Moreover, people ≥ 18 years of age have twice the risk compared to persons < 18 years of age (OR=2.31.

  15. Effectiveness of reactive oral cholera vaccination in rural Haiti: a case-control study

    Science.gov (United States)

    Ivers, Louise C; Hilaire, Isabelle J; Teng, Jessica E; Almazor, Charles P; Jerome, J Gregory; Ternier, Ralph; Boncy, Jacques; Buteau, Josiane; Murray, Megan B; Harris, Jason B; Franke, Molly F

    2015-01-01

    Background Between April and June 2012, a reactive cholera vaccination campaign was conducted in Haiti using an oral inactivated bivalent whole-cell vaccine (BivWC). Methods We conducted a case-control study to estimate field effectiveness of the vaccine. Cases had acute watery diarrhea, sought treatment at one of three participating cholera treatment units from October 24, 2012 through March 9, 2014, and had a stool sample positive for cholera by culture. For each case, four controls (individuals who did not seek treatment for acute watery diarrhea) were matched by location of residence, calendar time, and age. We also conducted a bias-indicator case-control study to assess the likelihood of bias in the vaccine effectiveness (VE) study. Findings During the study period, 114 eligible individuals presented with acute watery diarrhea and were enrolled. 47 were analyzed as cases in the VE case-control study and 42 as cases in the bias-indicator study. In multivariable analyses, VE was 63% [95% confidence interval (CI): 8%–85%] by self-reported vaccination and 58% [95% CI: 13%–80%] for verified vaccination. Neither self-reported nor verified vaccination was significantly associated with non-cholera diarrhea (VE: 18% [95% CI: −208%–−78%] by self-report and −21% [95%CI: −238%–57%] for verified vaccination). Interpretation BivWC oral cholera vaccine was effective in protecting against cholera in Haiti during the study period –from 4 through 24 months after vaccination. Vaccination is an important component of epidemic cholera control efforts. Funding National Institutes of Health, Delivering Oral Vaccines Effectively project, Department of Global Health and Social Medicine at Harvard Medical School. PMID:25701994

  16. A case-control study: occupational cooking and the risk of uveal melanoma

    Directory of Open Access Journals (Sweden)

    Marr Anja

    2010-10-01

    Full Text Available Abstract Background A European-wide population based case-control study (European rare cancer study undertaken in nine European countries examined risk factors for uveal melanoma. They found a positive association between cooks and the risk of uveal melanoma. In our study we examine whether cooks or people who worked in cook related jobs have an increased uveal melanoma risk. Methods We conducted a case-control study during 2002 and 2005. Overall, 1653 eligible subjects (age range: 20-74 years, living in Germany participated. Interviews were conducted with 459 incident uveal melanoma cases, 827 population controls, 180 ophthalmologist controls and 187 sibling controls. Data on occupational exposure were obtained from a self-administered postal questionnaire and a computer-assisted telephone interview. We used conditional logistic regression to estimate odds ratios adjusting for the matching factors. Results Overall, we did not observe an increased risk of uveal melanoma among people who worked as cooks or who worked in cook related jobs. When we restricted the source population of our study to the population of the Federal State of Northrhine-Westphalia, we observed an increased risk among subjects who were categorized as cooks in the cases-control analysis. Conclusion Our results are in conflict with former results of the European rare cancer study. Considering the rarity of the disease laboratory in vitro studies of human uveal melanoma cell lines should be done to analyze potential exposure risk factors like radiation from microwaves, strong light from incandescent ovens, or infrared radiation.

  17. Exposure to antiepileptic drugs and the risk of hip fracture: a case-control study

    DEFF Research Database (Denmark)

    Tsiropoulos, Ioannis; Andersen, Morten; Nymark, Tine

    2008-01-01

    with a hip fracture during the period 1996-2004. Controls (n = 27,575) were frequency matched by age and gender. Information on use of AEDs, other drugs, and hospital contacts was available from local registers. Odds ratios (ORs) with 95% confidence intervals (CI) for hip fracture were estimated......PURPOSE: To investigate whether the use of antiepileptic drugs (AEDs) increases the risk of hip fracture. METHODS: We performed a case-control study using data from the Funen County (population 2004: 475,000) hip fracture register. Cases (n = 7,557) were all patients admitted to county hospitals...

  18. HPV and cofactors for invasive cervical cancer in Morocco: a multicentre case-control study

    OpenAIRE

    Berraho, Mohamed; Amarti-Riffi, Afaf; El-Mzibri, Mohammed; Bezad, Rachid; Benjaafar, Noureddine; Benideer, Abdelatif; Matar, Noureddine; Qmichou, Zinab; Abda, Naima; Attaleb, Mohammed; Znati, Kaoutar; El Fatemi, Hind; Bendahhou, Karima; Obtel, Majdouline; Filali Adib, Abdelhai

    2017-01-01

    Background Limited national information is available in Morocco on the prevalence and distribution of HPV-sub-types of cervical cancer and the role of other risk factors. The aim was to determine the frequency of HPV-sub-types of cervical cancer in Morocco and investigate risk factors for this disease. Methods Between November 2009 and April 2012 a multicentre case-control study was carried out. A total of 144 cases of cervical cancer and 288 age-matched controls were included. Odds-ratios an...

  19. Multilocus Heterozygosity and Coronary Heart Disease: Nested Case-Control Studies in Men and Women

    DEFF Research Database (Denmark)

    Mukamal, Kenneth J.; Jensen, Majken K.; Pers, Tune Hannes

    2015-01-01

    genome scans in parallel case-control studies of coronary heart disease (CHD) nested in the Health Professionals Follow-up Study and Nurses' Health Study. We examined ∼ 700,000 single nucleotide polymorphisms (SNPs) in 435 men with incident CHD and 878 matched controls and 435 women with incident CHD...... to risk of CHD in either men or women (adjusted odds ratios per 2000 heterozygous SNPs 1.01 [95% confidence interval, 0.91-1.13] in women and 0.94 [0.84-1.06] in men). We also found no consistent associations of genome-wide heterozygosity with levels of lipids, inflammatory markers, adhesion molecules...

  20. Risk factors for femicide-suicide in abusive relationships: results from a multisite case control study.

    Science.gov (United States)

    Koziol-McLain, Jane; Webster, Daniel; McFarlane, Judith; Block, Carolyn Rebecca; Ulrich, Yvonne; Glass, Nancy; Campbell, Jacquelyn C

    2006-02-01

    The killing of women by men who then take their own lives (femicide-suicide) is the most common form of homicide-suicide. This study identified femicide-suicide risk factors in an 11-city case-control study of femicide in the United States. Perpetrator, victim, relationship, and incident characteristics were analyzed for femicide-suicide cases (n = 67) and controls (n = 356, women living in the community with nonfatal physical abuse) using logistic regression modeling. Two risk factors emerged that were unique to femicide-suicides cases compared to overall femicide risk analyses: prior perpetrator suicide threats and victims having ever been married to the perpetrator.

  1. On estimation of linear transformation models with nested case-control sampling.

    Science.gov (United States)

    Lu, Wenbin; Liu, Mengling

    2012-01-01

    Nested case-control (NCC) sampling is widely used in large epidemiological cohort studies for its cost effectiveness, but its data analysis primarily relies on the Cox proportional hazards model. In this paper, we consider a family of linear transformation models for analyzing NCC data and propose an inverse selection probability weighted estimating equation method for inference. Consistency and asymptotic normality of our estimators for regression coefficients are established. We show that the asymptotic variance has a closed analytic form and can be easily estimated. Numerical studies are conducted to support the theory and an application to the Wilms' Tumor Study is also given to illustrate the methodology.

  2. Cor pulmonale and silicosis: a necropsy based case-control study.

    Science.gov (United States)

    Murray, J; Reid, G; Kielkowski, D; de Beer, M

    1993-01-01

    The presence of cor pulmonale at death in relation to other factors such as emphysema, silicosis, and thromboembolism was analysed in a case-control study of 732 South African gold miners. Marked emphysema was the highest risk factor with an odds ratio of 21.32 (95% confidence interval (95% CI) 5.02-90.7), then extensive silicosis (OR 4.95, 95% CI 2.92-8.38) and thromboembolic disease (OR 1.92, 95% CI 1.37-2.69). Age and smoking were not significant predictors of cor pulmonale. PMID:8329320

  3. Patient outcomes from lung cancer and diabetes mellitus: a matched case-control study.

    Science.gov (United States)

    Karlin, Nina J; Amin, Shailja B; Buras, Matthew R; Kosiorek, Heidi E; Verona, Patricia M; Cook, Curtiss B

    2018-01-01

    This case-control study examined the impact of diabetes mellitus (DM) on survival in lung cancer patients and lung cancer on glycemic control in DM. Patients with a new lung cancer diagnosis and DM (n = 124) were matched to 124 lung cancer patients without DM. Laboratory results and DM and cancer therapies were obtained from electronic records. Five-year overall survival for lung cancer patients with and without DM was 20 versus 29% (p = .12). Glycemic control among DM patients did not change significantly with time. DM does not cause adverse impact on lung cancer survival. Lung cancer does not affect glycemic control.

  4. Female Sexual Victimization Predicts Psychosis: A Case-Control Study Based on the Danish Registry System

    DEFF Research Database (Denmark)

    Elklit, A.; Shevlin, Mark

    2011-01-01

    Objective: An increasing research literature has identified a statistical association between trauma exposure and psychosis. Methodological limitations, primarily relating to failures to establish the temporal ordering of events and relying on retrospective self-reports, have made the argument...... for a causal association difficult to establish. Method: A case-control study was conducted based on data from the Danish Civil Registration System and the Danish Psychiatric Central Register. All female visitors to a rape center during the index year (2003) were matched with controls based on age and area...

  5. Challenges in Recruiting Aging Women Holocaust Survivors to a Case Control Study of Breast Cancer.

    Science.gov (United States)

    Vin-Raviv, Neomi; Dekel, Rachel; Barchana, Micha; Linn, Shai; Keinan-Boker, Lital

    2015-01-01

    Older adults are underrepresented in medical research for many reasons, including recruitment difficulties. Recruitment of older adults for research studies is often a time-consuming process and can be more challenging when the study involves older adults with unique exposures to traumatic events and from minority groups. The current article provides a brief overview of (a) challenges encountered while recruiting aging women Holocaust survivors for a case control study and (b) strategies used for meeting those challenges. The case group comprised women Holocaust survivors who were recently diagnosed with breast cancer and the control group comprised healthy women from a Holocaust-survivor community in Israel. Copyright 2015, SLACK Incorporated.

  6. Leptospira Exposure and Patients with Liver Diseases: A Case-Control Seroprevalence Study

    Science.gov (United States)

    Alvarado-Esquivel, Cosme; Sánchez-Anguiano, Luis Francisco; Hernández-Tinoco, Jesús; Ramos-Nevárez, Agar; Margarita Cerrillo-Soto, Sandra; Alberto Guido-Arreola, Carlos

    2016-01-01

    The seroepidemiology of Leptospira infection in patients suffering from liver disease has been poorly studied. Information about risk factors associated with infection in liver disease patients may help in the optimal planning of preventive measures. We sought to determine the association of Leptospira IgG seroprevalence and patients with liver diseases, and to determine the characteristics of the patients with Leptospira exposure. We performed a case-control study of 75 patients suffering from liver diseases and 150 age- and gender-matched control subjects. Diagnoses of liver disease included liver cirrhosis, steatosis, chronic hepatitis, acute hepatitis, and amoebic liver abscess. Sera of participants were analyzed for the presence of anti- Leptospira IgG antibodies using a commercially available enzyme immunoassay. Anti-Leptospira IgG antibodies were found in 17 (22.7%) of 75 patients and in 15 (10.0%) of 150 control subjects (OR = 2.32; 95% CI: 1.09-4.94; P=0.03). This is the first age- and gender-matched case control study about Leptospira seroprevalence in patients with liver diseases. Results indicate that Leptospira infection is associated with chronic and acute liver diseases. Results warrants for additional studies on the role of Leptospira exposure in chronic liver disease. PMID:27493589

  7. Serum Taurine and Stroke Risk in Women: A Prospective, Nested Case-Control Study.

    Science.gov (United States)

    Wu, Fen; Koenig, Karen L; Zeleniuch-Jacquotte, Anne; Jonas, Saran; Afanasyeva, Yelena; Wójcik, Oktawia P; Costa, Max; Chen, Yu

    2016-01-01

    Taurine (2-aminoethanesulfonic acid), a conditionally essential sulfur-containing amino acid, is mainly obtained from diet in humans. Experimental studies have shown that taurine's main biological actions include bile salt conjugation, blood pressure regulation, anti-oxidation, and anti-inflammation. We conducted a prospective case-control study nested in the New York University Women's Health Study, a cohort study involving 14,274 women enrolled since 1985. Taurine was measured in pre-diagnostic serum samples of 241 stroke cases and 479 matched controls. There was no statistically significant association between serum taurine and stroke risk in the overall study population. The adjusted ORs for stroke were 1.0 (reference), 0.87 (95% CI, 0.59-1.28), and 1.03 (95% CI, 0.69-1.54) in increasing tertiles of taurine (64.3-126.6, 126.7-152.9, and 153.0-308.5 nmol/mL, respectively). A significant inverse association between serum taurine and stroke risk was observed among never smokers, with an adjusted OR of 0.66 (95% CI, 0.37-1.18) and 0.50 (95% CI, 0.26-0.94) for the second and third tertile, respectively (p for trend = 0.01), but not among past or current smokers (p for interaction taurine and stroke risk, although a protective effect was observed in never smokers, which requires further investigation. Taurine, Stroke, Epidemiology, Prospective, Case-control study, NYUWHS.

  8. Association between bullous pemphigoid and neurologic diseases: a case-control study.

    Science.gov (United States)

    Casas-de-la-Asunción, E; Ruano-Ruiz, J; Rodríguez-Martín, A M; Vélez García-Nieto, A; Moreno-Giménez, J C

    2014-11-01

    In the past 10 years, bullous pemphigoid has been associated with other comorbidities and neurologic and psychiatric conditions in particular. Case series, small case-control studies, and large population-based studies in different Asian populations, mainland Europe, and the United Kingdom have confirmed this association. However, no data are available for the Spanish population. This was an observational, retrospective, case-control study with 1:2 matching. Fifty-four patients with bullous pemphigoid were selected. We compared the percentage of patients in each group with concurrent neurologic conditions, ischemic heart disease, diabetes, chronic obstructive pulmonary disease, and solid tumors using univariate logistic regression. An association model was constructed with conditional multiple logistic regression. The case group had a significantly higher percentage of patients with cerebrovascular accident and/or transient ischemic attack (odds ratio [OR], 3.06; 95% CI, 1.19-7.87], dementia (OR, 5.52; 95% CI, 2.19-13.93), and Parkinson disease (OR, 5; 95% CI, 1.57-15.94). A significantly higher percentage of cases had neurologic conditions (OR, 6.34; 95% CI, 2.89-13.91). Dementia and Parkinson disease were independently associated with bullous pemphigoid in the multivariate analysis. Patients with bullous pemphigoid have a higher frequency of neurologic conditions. Copyright © 2013 Elsevier España, S.L.U. and AEDV. All rights reserved.

  9. A Case-Control Study of Risk Factors for Salivary Gland Cancer in Canada

    Directory of Open Access Journals (Sweden)

    Sai Yi Pan

    2017-01-01

    Full Text Available Aim. To assess the effect of various lifestyle risk factors on the risk of salivary gland cancer in Canada using data from a population-based case-control study. Methods. Data from a population-based case-control study of 132 incident cases of salivary gland cancer and 3076 population controls were collected through self-administered questionnaire and analysed using unconditional logistic regression. Results. Four or more servings/week of processed meat product was associated with an adjusted odds ratio (OR and corresponding 95% confidence interval (CI of 1.62 (1.02–2.58. Nonsignificantly increased ORs were also related to obesity, >7 drinks/week of alcohol consumption, and occupational exposure to radiation. Furthermore, nonsignificantly decreased ORs were found to be associated with high education level (>12 years (OR=0.65, high consumption of spinach/squash (OR=0.62 and all vegetables/vegetable juices (OR=0.75, and >30 sessions/month of recreational physical activity (OR=0.78. Conclusions. This study suggests positive associations with consumption of processed meat, smoking, obesity, alcohol drinking, and occupational exposure to radiation as well as negative associations with higher education, consumption of spinach/squash, and physical activity, which suggest a role of lifestyle factors in the etiology of salivary gland cancer. However, these findings were based on small number of cases and were nonsignificant. Further larger studies are warranted to confirm our findings.

  10. PedGenie: meta genetic association testing in mixed family and case-control designs

    Directory of Open Access Journals (Sweden)

    Allen-Brady Kristina

    2007-11-01

    Full Text Available Abstract Background- PedGenie software, introduced in 2006, includes genetic association testing of cases and controls that may be independent or related (nuclear families or extended pedigrees or mixtures thereof using Monte Carlo significance testing. Our aim is to demonstrate that PedGenie, a unique and flexible analysis tool freely available in Genie 2.4 software, is significantly enhanced by incorporating meta statistics for detecting genetic association with disease using data across multiple study groups. Methods- Meta statistics (chi-squared tests, odds ratios, and confidence intervals were calculated using formal Cochran-Mantel-Haenszel techniques. Simulated data from unrelated individuals and individuals in families were used to illustrate meta tests and their empirically-derived p-values and confidence intervals are accurate, precise, and for independent designs match those provided by standard statistical software. Results- PedGenie yields accurate Monte Carlo p-values for meta analysis of data across multiple studies, based on validation testing using pedigree, nuclear family, and case-control data simulated under both the null and alternative hypotheses of a genotype-phenotype association. Conclusion- PedGenie allows valid combined analysis of data from mixtures of pedigree-based and case-control resources. Added meta capabilities provide new avenues for association analysis, including pedigree resources from large consortia and multi-center studies.

  11. Case-control study on uveal melanoma (RIFA: rational and design

    Directory of Open Access Journals (Sweden)

    Schmidt-Pokrzywniak Andrea

    2004-08-01

    Full Text Available Abstract Background Although a rare disease, uveal melanoma is the most common primary intraocular malignancy in adults, with an incidence rate of up to 1.0 per 100,000 persons per year in Europe. Only a few consistent risk factors have been identified for this disease. We present the study design of an ongoing incident case-control study on uveal melanoma (acronym: RIFA study that focuses on radiofrequency radiation as transmitted by radio sets and wireless telephones, occupational risk factors, phenotypical characteristics, and UV radiation. Methods/Design We conduct a case-control study to identify the role of different exposures in the development of uveal melanoma. The cases of uveal melanoma were identified at the Division of Ophthalmology, University of Essen, a referral centre for tumours of the eye. We recruit three control groups: population controls, controls sampled from those ophthalmologists who referred cases to the Division of Ophthalmology, University of Duisburg-Essen, and sibling controls. For each case the controls are matched on sex and age (five year groups, except for sibling controls. The data are collected from the study participants by short self-administered questionnaire and by telephone interview. During and at the end of the field phase, the data are quality-checked. To estimate the effect of exposures on uveal melanoma risk, we will use conditional logistic regression that accounts for the matching factors and allows to control for potential confounding.

  12. Bridging ImmunoGenomic Data Analysis Workflow Gaps (BIGDAWG): An integrated case-control analysis pipeline.

    Science.gov (United States)

    Pappas, Derek J; Marin, Wesley; Hollenbach, Jill A; Mack, Steven J

    2016-03-01

    Bridging ImmunoGenomic Data-Analysis Workflow Gaps (BIGDAWG) is an integrated data-analysis pipeline designed for the standardized analysis of highly-polymorphic genetic data, specifically for the HLA and KIR genetic systems. Most modern genetic analysis programs are designed for the analysis of single nucleotide polymorphisms, but the highly polymorphic nature of HLA and KIR data require specialized methods of data analysis. BIGDAWG performs case-control data analyses of highly polymorphic genotype data characteristic of the HLA and KIR loci. BIGDAWG performs tests for Hardy-Weinberg equilibrium, calculates allele frequencies and bins low-frequency alleles for k×2 and 2×2 chi-squared tests, and calculates odds ratios, confidence intervals and p-values for each allele. When multi-locus genotype data are available, BIGDAWG estimates user-specified haplotypes and performs the same binning and statistical calculations for each haplotype. For the HLA loci, BIGDAWG performs the same analyses at the individual amino-acid level. Finally, BIGDAWG generates figures and tables for each of these comparisons. BIGDAWG obviates the error-prone reformatting needed to traffic data between multiple programs, and streamlines and standardizes the data-analysis process for case-control studies of highly polymorphic data. BIGDAWG has been implemented as the bigdawg R package and as a free web application at bigdawg.immunogenomics.org. Copyright © 2015 American Society for Histocompatibility and Immunogenetics. Published by Elsevier Inc. All rights reserved.

  13. Shrinkage Estimators for Robust and Efficient Inference in Haplotype-Based Case-Control Studies

    KAUST Repository

    Chen, Yi-Hau

    2009-03-01

    Case-control association studies often aim to investigate the role of genes and gene-environment interactions in terms of the underlying haplotypes (i.e., the combinations of alleles at multiple genetic loci along chromosomal regions). The goal of this article is to develop robust but efficient approaches to the estimation of disease odds-ratio parameters associated with haplotypes and haplotype-environment interactions. We consider "shrinkage" estimation techniques that can adaptively relax the model assumptions of Hardy-Weinberg-Equilibrium and gene-environment independence required by recently proposed efficient "retrospective" methods. Our proposal involves first development of a novel retrospective approach to the analysis of case-control data, one that is robust to the nature of the gene-environment distribution in the underlying population. Next, it involves shrinkage of the robust retrospective estimator toward a more precise, but model-dependent, retrospective estimator using novel empirical Bayes and penalized regression techniques. Methods for variance estimation are proposed based on asymptotic theories. Simulations and two data examples illustrate both the robustness and efficiency of the proposed methods.

  14. Anorexia nervosa versus bulimia nervosa: differences based on retrospective correlates in a case-control study.

    Science.gov (United States)

    Machado, Bárbara C; Gonçalves, Sónia F; Martins, Carla; Brandão, Isabel; Roma-Torres, António; Hoek, Hans W; Machado, Paulo P

    2016-06-01

    This study is the result of two Portuguese case-control studies that examined the replication of retrospective correlates and preceding life events in anorexia nervosa (AN) and bulimia nervosa (BN) development. This study aims to identify retrospective correlates that distinguish AN and BN METHOD: A case-control design was used to compare a group of women who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for AN (N = 98) and BN (N = 79) with healthy controls (N = 86) and with other psychiatric disorders (N = 68). Each control group was matched with AN patients regarding age and parental social categories. Risk factors were assessed by interviewing each person with the Oxford Risk Factor Interview. Compared to AN, women with BN reported significantly higher rates of paternal high expectations, excessive family importance placed on fitness/keeping in shape, and negative consequences due to adolescent overweight and adolescent objective overweight. Overweight during adolescence emerged as the most relevant retrospective correlate in the distinction between BN and AN participants. Family expectations and the importance placed on keeping in shape were also significant retrospective correlates in the BN group.

  15. Human papillomaviruses in colorectal cancers: A case-control study in western patients.

    Science.gov (United States)

    Vuitton, Lucine; Jaillet, Carine; Jacquin, Elise; Monnien, Franck; Heberle, Marine; Mihai, Maria I; Lassabe, Catherine; Raffoul, Johnny; Puyraveau, Marc; Lakkis, Zaher; Lamfichekh, Najib; Picard, Alain; Prétet, Jean-Luc; Mougin, Christiane; Valmary-Degano, Séverine

    2017-04-01

    Colorectal cancer (CRC) is one of the most common cancers. As in other cancer locations, the involvement of human papillomaviruses (HPV) has been suggested but remains highly debated with wide differences among reported prevalence of HPV infection in CRCs. To determine the actual prevalence of high risk HPV16 and 18 in a large case-control study. CRC specimens were used for analysis of both tumor and distant healthy tissue. As a non-malignant control group, samples from sigmoid diverticulosis resections were studied. Detection of HPV16 and HPV18 DNA was performed using a real time polymerase chain reaction (qPCR). Ten percent of tumor samples were also randomly subjected to a complete HPV genotyping using the INNO-LiPA technique. 467 samples were analyzed: 217 tumor samples from 210 CRCs, 210 distant healthy tissue samples, and 40 sigmoid samples. HPV18 DNA was never amplified and HPV16 was amplified only three times in tumor tissues with viral loads under or at the limit of quantification. New extraction from the same tumor blocks for these samples revealed no HPV with qPCR and INNO-Lipa assays. With adequate procedures and reliable techniques, no HPV was detected in the largest case-control study so far, bringing more evidence on the absence of involvement of HPV in CRCs. Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  16. 77 FR 56854 - Submission for OMB Review; Comment Request: A Multi-Center International Hospital-Based Case...

    Science.gov (United States)

    2012-09-14

    ...; Comment Request: A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (Asia... the Office of Management and Budget (OMB) a request to review and approve the information collection... Multi-Center International Hospital- Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) (OMB...

  17. Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2009-01-01

    BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  18. Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

    BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  19. How to improve walking, balance and social participation following stroke: a comparison of the long term effects of two walking aids--canes and an orthosis TheraTogs--on the recovery of gait following acute stroke. A study protocol for a multi-centre, single blind, randomised control trial

    Directory of Open Access Journals (Sweden)

    Maguire Clare

    2012-03-01

    Full Text Available Abstract Background Annually, some 9000 people in Switzerland suffer a first time stroke. Of these 60% are left with moderate to severe walking disability. Evidence shows that rehabilitation techniques which emphasise activity of the hemiplegic side increase ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" (a corset with elasticated strapping significantly increases hemiplegic muscle activity during gait. The aim of the present study is to investigate the long term effects on the recovery of gait, balance and social participation of gait rehabilitation with TheraTogs compared to gait rehabilitation with a cane following first time acute stroke. Methods/Design Multi-centre, single blind, randomised trial with 120 patients after first stroke. When subjects have reached Functional Ambulation Category 3 they will be randomly allocated into TheraTogs or cane group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardised procedure. Cane walking held at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with only the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented. The intervention will continue for five weeks or until patients have reached Functional Ambulation category 5. Outcome measures will be assessed the day before begin of intervention, the day after completion, 3 months, 6 months and 2 years. Primary outcome: Timed "up and go" test, secondary outcomes: peak surface EMG of gluteus maximus and gluteus medius, activation patterns of hemiplegic leg musculature, temporo-spatial gait parameters, hemiplegic hip kinematics in the frontal and sagittal planes, dynamic balance, daily activity measured by accelerometry, Stroke Impact Scale

  20. A comparison of the clinical effectiveness and cost of specialised individually delivered parent training for preschool attention-deficit/hyperactivity disorder and a generic, group-based programme: a multi-centre, randomised controlled trial of the New Forest Parenting Programme versus Incredible Years.

    Science.gov (United States)

    Sonuga-Barke, Edmund J S; Barton, Joanne; Daley, David; Hutchings, Judy; Maishman, Tom; Raftery, James; Stanton, Louise; Laver-Bradbury, Cathy; Chorozoglou, Maria; Coghill, David; Little, Louisa; Ruddock, Martin; Radford, Mike; Yao, Guiqing Lily; Lee, Louise; Gould, Lisa; Shipway, Lisa; Markomichali, Pavlina; McGuirk, James; Lowe, Michelle; Perez, Elvira; Lockwood, Joanna; Thompson, Margaret J J

    2017-10-30

    The objective of this study is to compare the efficacy and cost of specialised individually delivered parent training (PT) for preschool children with attention-deficit/hyperactivity disorder (ADHD) against generic group-based PT and treatment as usual (TAU). This is a multi-centre three-arm, parallel group randomised controlled trial conducted in National Health Service Trusts. The participants included in this study were preschool children (33-54 months) fulfilling ADHD research diagnostic criteria. New Forest Parenting Programme (NFPP)-12-week individual, home-delivered ADHD PT programme; Incredible Years (IY)-12-week group-based, PT programme initially designed for children with behaviour problems were the interventions. Primary outcome-Parent ratings of child's ADHD symptoms (Swanson, Nolan & Pelham Questionnaire-SNAP-IV). Secondary outcomes-teacher ratings (SNAP-IV) and direct observations of ADHD symptoms and parent/teacher ratings of conduct problems. NFPP, IY and TAU outcomes were measured at baseline (T1) and post treatment (T2). NFPP and IY outcomes only were measured 6 months post treatment (T3). Researchers, but not therapists or parents, were blind to treatment allocation. Analysis employed mixed effect regression models (multiple imputations). Intervention and other costs were estimated using standardized approaches. NFPP and IY did not differ on parent-rated SNAP-IV, ADHD combined symptoms [mean difference - 0.009 95% CI (- 0.191, 0.173), p = 0.921] or any other measure. Small, non-significant, benefits of NFPP over TAU were seen for parent-rated SNAP-IV, ADHD combined symptoms [- 0.189 95% CI (- 0.380, 0.003), p = 0.053]. NFPP significantly reduced parent-rated conduct problems compared to TAU across scales (p values IY over TAU were seen for parent-rated SNAP, ADHD symptoms [- 0.16 95% CI (- 0.37, 0.04), p = 0.121] or parent-rated conduct problems (p > 0.05). The cost per family of providing NFPP in the trial was significantly

  1. Study Protocol. ECSSIT – Elective Caesarean Section Syntocinon® Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon® 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section

    Directory of Open Access Journals (Sweden)

    Montgomery Alan A

    2009-08-01

    Full Text Available Abstract Background Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4–10 minutes therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. Methods and design A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml. A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. Discussion It is both important and timely that we evaluate the optimal approach to the management

  2. Study Protocol. ECSSIT – Elective Caesarean Section Syntocinon® Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon®) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section

    Science.gov (United States)

    Murphy, Deirdre J; Carey, Michael; Montgomery, Alan A; Sheehan, Sharon R

    2009-01-01

    Background Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4–10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. Methods and design A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. Discussion It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  3. A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Abbott, Penelope; Gunasekera, Hasantha; Leach, Amanda Jane; Askew, Deborah; Walsh, Robyn; Kong, Kelvin; Girosi, Federico; Bond, Chelsea; Morris, Peter; Lujic, Sanja; Hu, Wendy; Usherwood, Tim; Tyson, Sissy; Spurling, Geoffrey; Douglas, Markeeta; Schubert, Kira; Chapman, Shavaun; Siddiqui, Nadeem; Murray, Reeion; Rabbitt, Keitha; Porykali, Bobby; Woodall, Cheryl; Newman, Tina; Reath, Jennifer

    2016-03-03

    Treatment guidelines recommend watchful waiting for children older than 2 years with acute otitis media (AOM) without perforation, unless they are at high risk of complications. The high prevalence of chronic suppurative otitis media (CSOM) in remote Aboriginal and Torres Strait Islander communities leads these children to be classified as high risk. Urban Aboriginal and Torres Strait Islander children are at lower risk of complications, but evidence to support the subsequent recommendation for watchful waiting in this population is lacking. This non-inferiority multi-centre randomised controlled trial will determine whether watchful waiting is non-inferior to immediate antibiotics for urban Aboriginal and Torres Strait Islander children with AOM without perforation. Children aged 2 - 16 years with AOM who are considered at low risk for complications will be recruited from six participating urban primary health care services across Australia. We will obtain informed consent from each participant or their guardian. The primary outcome is clinical resolution on day 7 (no pain, no fever of at least 38 °C, no bulging eardrum and no complications of AOM such as perforation or mastoiditis) as assessed by general practitioners or nurse practitioners. Participants and outcome assessors will not be blinded to treatment. With a sample size of 198 children in each arm, we have 80 % power to detect a non-inferiority margin of up to 10 % at a significance level of 5 %, assuming clinical improvement of at least 80 % in both groups. Allowing for a 20 % dropout rate, we aim to recruit 495 children. We will analyse both by intention-to-treat and per protocol. We will assess the cost- effectiveness of watchful waiting compared to immediate antibiotic prescription. We will also report on the implementation of the trial from the perspectives of parents/carers, health professionals and researchers. The trial will provide evidence for the safety and effectiveness of watchful waiting

  4. Safety and immunogenicity of H1/IC31®, an adjuvanted TB subunit vaccine, in HIV-infected adults with CD4+ lymphocyte counts greater than 350 cells/mm3: a phase II, multi-centre, double-blind, randomized, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Klaus Reither

    Full Text Available Novel tuberculosis vaccines should be safe, immunogenic, and effective in various population groups, including HIV-infected individuals. In this phase II multi-centre, double-blind, placebo-controlled trial, the safety and immunogenicity of the novel H1/IC31 vaccine, a fusion protein of Ag85B-ESAT-6 (H1 formulated with the adjuvant IC31, was evaluated in HIV-infected adults.HIV-infected adults with CD4+ T cell counts >350/mm3 and without evidence of active tuberculosis were enrolled and followed until day 182. H1/IC31 vaccine or placebo was randomly allocated in a 5:1 ratio. The vaccine was administered intramuscularly at day 0 and 56. Safety assessment was based on medical history, clinical examinations, and blood and urine testing. Immunogenicity was determined by a short-term whole blood intracellular cytokine staining assay.47 of the 48 randomised participants completed both vaccinations. In total, 459 mild or moderate and 2 severe adverse events were reported. There were three serious adverse events in two vaccinees classified as not related to the investigational product. Local injection site reactions were more common in H1/IC31 versus placebo recipients (65.0% vs. 12.5%, p = 0.015. Solicited systemic and unsolicited adverse events were similar by study arm. The baseline CD4+ T cell count and HIV viral load were similar by study arm and remained constant over time. The H1/IC31 vaccine induced a persistent Th1-immune response with predominately TNF-α and IL-2 co-expressing CD4+ T cells, as well as polyfunctional IFN-γ, TNF-α and IL-2 expressing CD4+ T cells.H1/IC31 was well tolerated and safe in HIV-infected adults with a CD4+ Lymphocyte count greater than 350 cells/mm3. The vaccine did not have an effect on CD4+ T cell count or HIV-1 viral load. H1/IC31 induced a specific and durable Th1 immune response.Pan African Clinical Trials Registry (PACTR PACTR201105000289276.

  5. Chronic obstructive pulmonary disease as a cardiovascular risk factor: results of a case-control study (CONSISTE study

    Directory of Open Access Journals (Sweden)

    Falola M

    2013-02-01

    Full Text Available Michael FalolaDepartment of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, USAI read with interest the article "Chronic obstructive pulmonary disease as a cardiovascular risk factor. Results of a case-control study (CONSISTE study" by de Lucas-Ramos et al.1 In my opinion, the study did not use case-control design, despite its title.View original paper by de Lucas-Ramos and colleagues.

  6. Potential Psychosocial Risk Factors for Chronic TMD: Descriptive Data and Empirically Identified Domains from the OPPERA Case-Control Study

    OpenAIRE

    Fillingim, Roger B.; Ohrbach, Richard; Greenspan, Joel D.; Knott, Charles; Dubner, Ronald; Bair, Eric; Baraian, Cristina; Slade, Gary D.; Maixner, William

    2011-01-01

    Case-control studies have consistently associated psychosocial factors with chronic pain in general, and with temporomandibular disorders (TMD) specifically. Moreover, a handful of prospective studies suggest that pre-existing psychosocial characteristics represent risk factors for new onset TMD. The current study presents psychosocial findings from the baseline case-control study of the Orofacial Pain Prospective Evaluation and Risk Assessment (OPPERA) cooperative agreement. For this study, ...

  7. A retrospective likelihood approach for efficient integration of multiple omics factors in case-control association studies.

    Science.gov (United States)

    Balliu, Brunilda; Tsonaka, Roula; Boehringer, Stefan; Houwing-Duistermaat, Jeanine

    2015-03-01

    Integrative omics, the joint analysis of outcome and multiple types of omics data, such as genomics, epigenomics, and transcriptomics data, constitute a promising approach for powerful and biologically relevant association studies. These studies often employ a case-control design, and often include nonomics covariates, such as age and gender, that may modify the underlying omics risk factors. An open question is how to best integrate multiple omics and nonomics information to maximize statistical power in case-control studies that ascertain individuals based on the phenotype. Recent work on integrative omics have used prospective approaches, modeling case-control status conditional on omics, and nonomics risk factors. Compared to univariate approaches, jointly analyzing multiple risk factors with a prospective approach increases power in nonascertained cohorts. However, these prospective approaches often lose power in case-control studies. In this article, we propose a novel statistical method for integrating multiple omics and nonomics factors in case-control association studies. Our method is based on a retrospective likelihood function that models the joint distribution of omics and nonomics factors conditional on case-control status. The new method provides accurate control of Type I error rate and has increased efficiency over prospective approaches in both simulated and real data. © 2015 Wiley Periodicals, Inc.

  8. Investigation of a staphylococcal food poisoning outbreak combining case-control, traditional typing and whole genome sequencing methods, Luxembourg, June 2014.

    Science.gov (United States)

    Mossong, Joël; Decruyenaere, Frédéric; Moris, Gilbert; Ragimbeau, Catherine; Olinger, Christophe M; Johler, Sophia; Perrin, Monique; Hau, Patrick; Weicherding, Pierre

    2015-01-01

    In June 2014, a staphylococcal food poisoning outbreak occurred at an international equine sports event in Luxembourg requiring the hospitalisation of 31 persons. We conducted a microbiological investigation of patients and buffet items, a case-control study and a carriage study of catering staff. Isolates of Staphylococcus aureus from patients, food and catering staff were characterised and compared using traditional typing methods and whole genome sequencing. Genotypically identical strains (sequence type ST8, spa-type t024, MLVA-type 4698, enterotoxin A FRI100) were isolated in 10 patients, shiitake mushrooms, cured ham, and in three members of staff. The case-control study strongly suggested pasta salad with pesto as the vehicle of infection (pfood item could not be tested, because there were no leftovers. Additional enterotoxigenic strains genetically unrelated to the outbreak strain were found in four members of staff. Non-enterotoxigenic strains with livestock-associated sequence type ST398 were isolated from three food items and two members of staff. The main cause of the outbreak is likely to have been not maintaining the cold chain after food preparation. Whole genome sequencing resulted in phylogenetic clustering which concurred with traditional typing while simultaneously characterising virulence and resistance traits.

  9. A review of the data quality and comparability of case-control studies of low-level exposure to benzene in the petroleum industry.

    Science.gov (United States)

    Miller, B G; Fransman, W; Heederik, D; Hurley, J F; Kromhout, H; Fitzsimons, E

    2010-01-01

    Published case-control studies of risks of leukaemia following low exposures to benzene in the distribution of petroleum (gasoline) have not all identified the same level of risk, but the studies have had differences in cohort inclusion, case determination and availability of occupational and lifestyle data. We reviewed the quality and comparability of the data from three (of four) studies. Through site visits, discussions with the investigators and reading study reports, we reviewed and audited the methods used for selecting cases and controls, for estimating individual exposures and for analysing and interpreting the data. Case-control comparisons of exposures were examined using customized graphs. We found that there were no issues of subject selection, methods or general data quality that were likely to have distorted their internal comparisons; we could not check in detail whether the metric for exposure assessments was the same across the studies; the exposure assessments for the Australian study required the least backward estimation, and the Canadian, which also had fewest cases, the most; evidence of an increased risk at higher exposures in Australia was convincing. The findings are consistent with some effect of benzene at higher lifetime exposures. A proposed pooled analysis should improve quantification of any exposure-response relationship.

  10. Qat use and esophageal cancer in Ethiopia: A pilot case-control study.

    Directory of Open Access Journals (Sweden)

    Maria E Leon

    Full Text Available Qat (Catha edulis chewing is reported to induce lesions in the buccal mucosa, irritation of the esophagus, and esophageal reflux. Case series suggest a possible etiological role in oral and esophageal cancers. This pilot study aimed to generate preliminary estimates of the magnitude and direction of the association between qat use and esophageal cancer (EC risk and to inform the logistics required to conduct a multi-center case-control study.Between May 2012 and May 2013, 73 EC cases (including 12 gastro-esophageal junction cases and 133 controls matched individually on sex, age, and residence were enrolled at two endoscopy clinics and a cancer treatment hospital in Addis Ababa. A face-to-face structured questionnaire was administered. Qat use was defined as ever having chewed qat once a week or more frequently for at least one year. Odds ratios were calculated using conditional logistic regression.Only 8% of cases resided in Addis Ababa. Qat use was more frequent in cases (36% than in controls (26%. A 2-fold elevation in EC risk was observed in ever qat chewers compared with never users in unadjusted conditional logistic regression (OR = 2.12; 95% CI = 0.94, 4.74, an association that disappeared after adjusting for differences in tobacco use, consumption of alcohol and green vegetables, education level, and religion (OR = 0.95; 0.22, 4.22. Among never tobacco users, however, a non-significant increase in EC risk was suggested in ever qat users also after adjustment. Increases in EC risk were observed with ever tobacco use, alcohol consumption, low consumption of green vegetables, a salty diet, illiteracy, and among Muslims; the four latter associations were significant.This pilot study generated EC risk estimates in association with a habit practiced by millions of people and never before studied in a case-control design. Results must be interpreted cautiously in light of possible selection bias, with some demographics such as education level

  11. RECONSTRUCTION OF RADIATION DOSES IN A CASE-CONTROL STUDY OF THYROID CANCER FOLLOWING THE CHERNOBYL ACCIDENT

    Science.gov (United States)

    Drozdovitch, Vladimir; Khrouch, Valeri; Maceika, Evaldas; Zvonova, Irina; Vlasov, Oleg; Bratilova, Angelica; Gavrilin, Yury; Goulko, Guennadi; Hoshi, Masaharu; Kesminiene, Ausrele; Shinkarev, Sergey; Tenet, Vanessa; Cardis, Elisabeth; Bouville, Andre

    2010-01-01

    A population-based case-control study of thyroid cancer was carried out in contaminated regions of Belarus and Russia among persons who were exposed during childhood and adolescence to fallout from the Chernobyl accident. For each study subject, individual thyroid doses were reconstructed for the following pathways of exposure: (1) intake of 131I via inhalation and ingestion; (2) intake of short-lived radioiodines (132I, 133I, and 135I) and radiotelluriums (131mTe, 132Te) via inhalation and ingestion; (3) external dose from radionuclides deposited on the ground; and (4) ingestion of 134Cs and 137Cs. A series of intercomparison exercises validated the models used for reconstruction of average doses to populations of specific age groups as well as of individual doses. Median thyroid doses from all factors for study subjects were estimated to be 0.37 and 0.034 Gy in Belarus and Russia, respectively. The highest individual thyroid doses among the subjects were 10.2 Gy in Belarus and 5.3 Gy in Russia. Iodine-131 intake was the main pathway for thyroid exposure. Estimated doses from short-lived radioiodines and radiotelluriums ranged up to 0.53 Gy. Reconstructed individual thyroid doses from external exposure ranged up to 0.1 Gy, while those from internal exposure due to ingested cesium did not exceed 0.05 Gy. The uncertainty of the reconstructed individual thyroid doses, characterized by the geometric standard deviation, varies from 1.7 to 4.0 with a median of 2.2. PMID:20539120

  12. A population-based case-control study on social factors and risk of testicular germ cell tumours.

    Science.gov (United States)

    Schmeisser, Nils; Conway, David I; Stang, Andreas; Jahn, Ingeborg; Stegmaier, Christa; Baumgardt-Elms, Cornelia; Jöckel, Karl-Heinz; Behrens, Thomas; Ahrens, Wolfgang

    2013-09-20

    Incidence rates for testicular cancer have risen over the last few decades. Findings of an association between the risk of testicular cancer and social factors are controversial. The association of testicular cancer and different indicators of social factors were examined in this study. Case-control study. Population-based multicentre study in four German regions (city states Bremen and Hamburg, the Saarland region and the city of Essen). The study included 797 control participants and 266 participants newly diagnosed with testicular cancer of which 167 cases were classified as seminoma and 99 as non-seminoma. The age of study participants ranged from 15 to 69 years. Social position was classified by educational attainment level, posteducational training, occupational sectors according to Erikson-Goldthorpe-Portocarrero (EGP) and the socioeconomic status (SES) on the basis of the International SocioEconomic Index of occupational status (ISEI). ORs and corresponding 95% CIs (95% CIs) were calculated for the whole study sample and for seminoma and non-seminoma separately. Testicular cancer risk was modestly increased among participants with an apprenticeship (OR=1.7 (95% CI 1.0 to 2.8)) or a university degree (OR=1.6 (95% CI 0.9 to 2.8)) relative to those whose education was limited to school. Analysis of occupational sectors revealed an excess risk for farmers and farm-related occupations. No clear trend was observed for the analyses according to the ISEI-scale. Social factors based on occupational measures were not a risk factor for testicular cancer in this study. The elevated risk in farmers and farm-related occupations warrants further research including analysis of occupational exposures.

  13. Diagnostic profile characteristics of cancer patients with frequent consultations in primary care before diagnosis: a case-control study.

    Science.gov (United States)

    Ewing, Marcela; Naredi, Peter; Zhang, Chenyang; Månsson, Jörgen

    2018-03-13

    Many patients with common cancers are late diagnosed. Identify consultation profiles and clinical features in patients with the seven most common cancers, who had consulted a general practitioner (GP) frequently before their cancer diagnosis. A case-control study was conducted in Region Västra Götaland, Sweden. A total of 2570 patients, diagnosed in 2011 with prostate, breast, colorectal, lung, gynaecological and skin cancers including malignant melanoma, and 9424 controls were selected from the Swedish Cancer Register and a regional health care database. Diagnostic codes [International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10)] from primary care for patients with ≥4 GP consultations registered in the year before cancer diagnosis were collected. Likelihood ratios (LRs) were calculated for variables associated with the different cancers. Fifty-six percent of the patients had consulted a GP four or more times in the year before cancer diagnosis. Alarm symptoms or signs represented 60% of the codes with the highest LR, but only 40% of the 10 most prevalent codes. Breast lump had the highest LR, 11.9 [95% confidence interval (CI) 8.0-17.8]; abnormalities of plasma proteins had an LR of 5.0 (95% CI 3.0-8.2) and abnormal serum enzyme levels had an LR of 4.6 (95% CI 3.6-5.9). Early clinical features associated with cancer had been registered already at the first two GP consultations. One out of six clinical features associated with cancer were presented by cancer patients with four or more pre-referral consultations already at the two first consultations. These early clinical features that were focal and had benign characteristics might have been missed diagnostic opportunities.

  14. Screening for impulse control symptoms in patients with de novo Parkinson disease: a case-control study.

    Science.gov (United States)

    Weintraub, Daniel; Papay, Kimberly; Siderowf, Andrew

    2013-01-08

    To determine the frequency and correlates of impulse control and related behavior symptoms in patients with de novo, untreated Parkinson disease (PD) and healthy controls (HCs). The Parkinson's Progression Markers Initiative is an international, multisite, case-control clinical study conducted at 21 academic movement disorders centers. Participants were recently diagnosed, untreated PD patients (n = 168) and HCs (n = 143). The outcome measures were presence of current impulse control and related behavior symptoms based on recommended cutoff points for the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP)-Short Form. There were 311 participants with complete QUIP data. Frequencies of impulse control and related behavior symptoms for patients with PD vs HCs were as follows: gambling (1.2% vs. 0.7%), buying (3.0% vs. 2.1%), sexual behavior (4.2% vs. 3.5%), eating (7.1% vs. 10.5%), punding (4.8% vs. 2.1%), hobbyism (5.4% vs. 11.9%), walkabout (0.6% vs. 0.7%), and any impulse control or related behavior (18.5% vs. 20.3%). In multivariable models, a diagnosis of PD was not associated with symptoms of any impulse control or related behavior (p ≥ 0.10 in all cases). PD itself does not seem to confer an increased risk for development of impulse control or related behavior symptoms, which further reinforces the reported association between PD medications and impulse control disorders in PD. Given that approximately 20% of patients with newly diagnosed PD report some impulse control or related behavior symptoms, long-term follow-up is needed to determine whether such patients are at increased risk for impulse control disorder development once PD medications are initiated.

  15. Human chorionic gonadotropin, fetal sex and risk of hypertensive disorders of pregnancy: A nested case-control study.

    Science.gov (United States)

    Zheng, Qizhen; Deng, Yuqing; Zhong, Shilin; Shi, Yu

    2016-01-01

    To assess whether human chorionic gonadotropin (HCG) and fetal sex are two independent risk factors for hypertensive pregnancy in the early second-trimester of pregnancy. This was a retrospective nested case-control study based on a cohort of 2521 singleton pregnancies, among whom we recruited 98 hypertensive pregnancies (subdivided into severe preeclampsia, n=34; mild preeclampsia, n=29 and gestational hypertension, n=35) and 196 normotensive pregnancies. Maternal serum HCG levels were measured at 15-20 weeks of gestation and fetal sex was determined from the neonatal record. Mann-Whitney U and chi-square tests were performed to assess differences of HCG levels and fetal sex between groups. Logistic regressions were performed to evaluate the effect of HCG and fetal sex on hypertensive pregnancy. There were 35 male and 63 female fetuses in the hypertensive group, and 102 male and 94 female fetuses in the normotensive group (p=0.008). HCG (MoM) levels were significantly higher in only severe preeclamptic pregnancies (n=34) (p=0.013). There were no significant differences of the HCG (MoM) levels between male and female fetuses in each sub-group. aOR for increased maternal HCG levels and female fetus were 2.4 (95% CI: 1.434-3.954) and 2.9 (95% CI: 1.227-6.661) respectively in severe preeclamptic pregnancies compared with normotensive pregnancies. There is a female preponderance in hypertensive pregnancies. Increased HCG levels and female fetus are two independent risk factors for severe preeclampsia in the early second-trimester of pregnancy. Copyright © 2016 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.

  16. Effect of vascular burden as measured by vascular indexes upon vascular dementia: a matched case-control study

    Directory of Open Access Journals (Sweden)

    Takahashi PY

    2012-01-01

    Full Text Available Paul Y Takahashi, Casey R Caldwell, Paul V TargonskiPrimary Care Internal Medicine, Mayo Clinic, Rochester MN, USABackground: Vascular dementia (VaD is a challenging illness that affects the lives of older adults and caregivers. It is unclear how multiple vascular risk factor exposures (polyvascular disease affect VaD.Purpose: To determine the relationship between multiple vascular risk exposures, as counted on an index in cases with VaD, compared with healthy age-/gender-matched controls.Methods: This was a matched case-control study of subjects living in Olmsted County, MN with documented VaD. Controls were selected by gender and age within 3 years from those who did not have dementia. The exposures included a total index (eleven exposure factors added together, along with indexes for cerebrovascular disease (two exposures, cardiovascular disease (four exposures, vascular disease (three exposures, and lifestyle (two exposures. Analysis used matched conditional univariable logistic regression for each index.Results: A total of 1736 potential subjects were identified, and 205 subjects were diagnosed with VaD. There was a significant association of the total score index with an odds ratio of 1.45 (95% confidence interval 1.21–1.74. The cerebrovascular index was also associated with VaD with an odds ratio of 12.18 (95% confidence interval 6.29–23.61. The cardiovascular and vascular indexes were also associated with VaD status. The lifestyle index was not associated with VaD.Conclusion: The cumulative role of multiple vascular risk factors or diseases increased the risk of VaD, as noted by the total vascular index. The lifestyle index did not reveal any significant differences. Further work is required for evaluation of these indexes.Keywords: polyvascular disease, elderly, vascular dementia

  17. Dental Caries and Developmental Defects of Enamel in the Primary Dentition of Preterm Infants: Case-Control Observational Study.

    Science.gov (United States)

    Schüler, Ina Manuela; Haberstroh, Stefanie; Dawczynski, Kristin; Lehmann, Thomas; Heinrich-Weltzien, Roswitha

    2018-01-01

    Assessment of dental health in the primary dentition of preterm infants (PTI) including investigation of mother- and infant-related risk factors in a case-control study design. One hundred twenty-eight infants aged 3-4 years were included. Sixty-four PTI (27 males) were randomly selected from the preterm registry of the Jena University Hospital. As a control group served 64 full-term infants (FTI) recruited from the Department of Paediatric Dentistry, matched for age and sex. Dental examinations were provided by one dentist under standard clinical conditions. Caries was scored using the International Caries Detection and Assessment System (ICDAS II) and the DMFT, gingival health using the Periodontal Screening Index, and developmental defects of enamel using the DDE index. Mother- and infant-related factors were collected via a questionnaire and from medical records. The caries prevalence was 50.0% (ICDAS II >0) in PTI and 12.5% (ICDAS II >0) in FTI. The caries experience was higher in PTI (DMFT 1.0 ± 3.1) than in FTI (DMFT 0.3 ± 1.0). PTI had a higher risk of caries (OR 7.0), initial lesions (OR 6.2), DDE (OR 7.5), and gingivitis (OR 6.5) than FTI. The highest risk occurred in PTI with an extremely low birth weight (risk of DDE was present when mothers suffered from illness during pregnancy (OR 3.9). A higher risk of caries was revealed in infants with respiratory syndrome (OR 6.2) or when their mothers had a lower socioeconomic status (OR 6.3). PTI had less healthy teeth than FTI and are at a higher risk for DDE, caries, and gingivitis. The poorer dental health in PTI is associated with a low birth weight, a low socioeconomic status, and mothers' illness during pregnancy. © 2017 S. Karger AG, Basel.

  18. Association between omeprazole use and Clostridium difficile infection among hospitalized patients: A case-control study of the Saudi population.

    Science.gov (United States)

    Al Otaibi, Hazza; Ahmed, Anwar E; Alammari, Maha

    2017-01-01

    Background: While few international studies have assessed the association between omeprazole use and the risk of Clostridium difficile infection (CDI), research into this is lacking in Saudi Arabia and the Middle East region. The aim of this study was to determine whether exposure to omeprazole is associated with the risk of Clostridium difficile infection in a sample of hospitalized Saudi patients. Methodology: A retrospective matched case-control study was conducted at the King Abdulaziz Medical City in Riyadh, Saudi Arabia, from 1 August 2010 through 31 July 2015. The analysis included a total of 200 patients: 100 CDI cases and 100 matched controls. Results: The majority (60%, 120 out of 200) of patients had received proton pump inhibitors (PPIs), and a minority (18.5%, 37 out of 200) had received omeprazole. The PPI use was insignificantly higher in CDI cases than in controls. However, the use of omeprazole was significantly higher in CDI cases compared with controls. Specifically, patients receiving omeprazole were two times more likely to develop CDI compared with controls (aOR = 2.1, 95% confidence interval (CI) = (1.007-4.437)). After adjusting for potential predictors of CDI, watery diarrhea (aOR = 59.1, 95% CI = 19.831-175.974) and abdominal pain (aOR = 7.5, 95% CI = 2.184-25.445) were found to be independent predictors of CDI. Conclusions: The data suggests that PPIs were commonly used in patients admitted to King Abdulaziz Medical City in Riyadh: six out of ten patients received PPIs. The findings support a possible association between the use of omeprazole and a high risk of CDI. To confirm causality, the link between omeprazole and CDI should be assessed in a large interventional study.

  19. Factors associated with postmenopausal osteoporosis: a case-control study of Belgrade women.

    Science.gov (United States)

    Grgurevic, Anita; Gledovic, Zorana; Vujasinovic-Stupar, Nada

    2010-07-01

    The aim of this study was to investigate factors related to osteoporosis in postmenopausal women in Belgrade. A case-control study was conducted during 2006-2007. The study group consisted of 100 newly diagnosed osteoporosis patients and 100 age-matched controls (± 2 years). The inclusion criteria for the case group were newly diagnosed osteoporosis confirmed by dual-energy X-ray absorptiometry of the lumbar spine and being menopausal (at least 2 years of amenorrhea). The inclusion criteria for the control group were postmenopausal women with confirmed normal bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry. All study participants were interviewed using a structured questionnaire. Univariate and multivariate logistic regression analyses were used. The following factors were significantly independently related to osteoporosis: low body weight (P menopause at age osteoporosis.

  20. Foods and risk of bladder cancer: a case-control study in Uruguay.

    Science.gov (United States)

    Balbi, J C; Larrinaga, M T; De Stefani, E; Mendilaharsu, M; Ronco, A L; Boffetta, P; Brennan, P

    2001-10-01

    A case-control study on 144 cases of transitional cell bladder carcinoma and 576 hospitalized controls was conducted in Montevideo, Uruguay. Barbecued meat, salted meat and fried eggs were associated with significant increased risks of bladder cancer (odds ratio (OR) for high intake of salted meat 4.04, 95% confidence interval (CI) 2.24-7.27). On the other hand, all fruits, cooked vegetables, potatoes and cheese were associated with inverse associations (OR for high consumption of potatoes 0.38, 95% CI 0.23-0.64). The associations with salted and barbecued meat suggest that the way of preserving or cooking meat play a role in bladder carcinogenesis. More precisely, N-nitroso compounds and heterocyclic amines could be involved in this process.

  1. A population-based case-control teratologic study of ampicillin treatment during pregnancy

    DEFF Research Database (Denmark)

    Czeizel, A.E.; Rockenbauer, M.; Sørensen, Henrik Toft

    2001-01-01

    Objective: This was a study of the association between ampicillin treatment during pregnancy and prevalence of different congenital abnormalities. Study Design: The paired analysis of case patients with congenital abnormalities and matched population control subjects was performed in the population......-based Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. Of 38,151 pregnant women who had babies without any defects (population control group), 2632 (6.9%) had been treated with ampicillin. Of 22,865 pregnant women who had offspring with congenital abnormalities (case patients......), 1643 (7.2%) had been treated with ampicillin (crude odds ratio, 1.0; 95% confidence interval, 0.7-1.2). Of 812 mothers who were delivered of babies affected by Down syndrome (patient control subjects), 61 (7.5%) had ampicillin treatment, and these were also compared with the case group. Results...

  2. Bioactive prolactin levels and risk of breast cancer: a nested case-control study

    Science.gov (United States)

    Tworoger, Shelley S.; Rice, Megan S.; Rosner, Bernard A.; Feeney, Yvonne B; Clevenger, Charles V.; Hankinson, Susan E.

    2014-01-01

    Background Prolactin is a lactogenic hormone associated with breast cancer risk in prospective studies, which used immunoassays. The immunoassay captures multiple isoforms and may not fully reflect the biological activity of prolactin relevant to breast carcinogenesis. Methods We considered plasma bioactive prolactin levels measured by the Nb2 lymphoma cell bioassay, which is sensitive to the somatolactogenic activity of prolactin and growth hormone, within a nested case-control study of invasive breast cancer in the Nurses’ Health Studies (NHS/NHSII). We also considered associations with breast cancer risk factors. Results We had bioassay measures on 1329 cases and 1329 controls. Bioassay levels were inversely associated with parity (4+ vs. 0 children=−18%, p=0.01), body mass index (30+ vs. prolactin levels measured by bioassay and by immunoassay with both breast cancer risk factors and risk. Impact Future work examining risk prediction model of breast cancer can use the immunoassay to accurately characterize risk. PMID:25315962

  3. Predictors of Nursing Staff Voluntary Termination in Nursing Homes: A Case-Control Study.

    Science.gov (United States)

    Zhang, Yuan; Punnett, Laura; Gore, Rebecca

    2017-08-01

    Workforce instability in the long-term care sector has raised wide attention about nursing staff turnover. Most attention has been devoted to understanding the relationship between facility's characteristics and organizational turnover. This case-control study examined the contribution of work characteristics to individual staff turnover. Surveys were collected with nursing staff in 18 for-profit nursing homes on up to five occasions between 2006 and 2012. A list of nursing staff voluntarily terminating jobs was provided by the company. Cases and controls (628 of each) were selected from survey respondents by matching on age, job category, and survey occasion. Multiple predictor conditional logistic regression models showed that evening shift work (hazards ratio [HR] = 2.00, p 8 hr (HR = 1.42, p voluntary termination. This study provides different perspectives of nursing staff voluntary termination in nursing homes. Future qualitative research would be valuable to explore and understand nursing staff turnover in the health care industry.

  4. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    DEFF Research Database (Denmark)

    O'Donnell, M; Serpault, Damien Xavier; Diener, C

    2010-01-01

    Stroke is a major global health problem. It is the third leading cause of death and the leading cause of adult disability. INTERHEART, a global case-control study of acute myocardial infarction in 52 countries (29,972 participants), identified nine modifiable risk factors that accounted for >90......% of population-attributable risk. However, traditional risk factors (e.g. hypertension, cholesterol) appear to exert contrasting risks for stroke compared with coronary heart disease, and the etiology of stroke is far more heterogeneous. In addition, our knowledge of risk factors for stroke in low...... years). A questionnaire (cases and controls) is used to acquire information on known and proposed risk factors for stroke. Cardiovascular (e.g. blood pressure) and anthropometric (e.g. waist-to-hip ratio) measurements are obtained at the time of interview. Nonfasting blood samples and random urine...

  5. [Multicenter case-control study of the relationship between smoking and bladder cancer in China].

    Science.gov (United States)

    Dai, Qi-Shan; He, Hui-Chan; Cai, Chao; Chen, Jia-Hong; Han, Zhao-Dong; Qin, Guo-Qiang; Liang, Yu-Xiang; Zhong, Wei-de

    2011-09-13

    To explore the relationship between smoking and bladder cancer in China. A multicenter case-control study was conducted from September 2005 to June 2008. A total of 432 bladder cancer patients, matched with 392 control cases, received a questionnaire including the type of exposure (active vs. passive smoking), the age of beginning and/or quitting smoking, smoking amount and time and depth of smoke inhalation. Both active smoking and passive smoking increased the incidence of bladder cancer (P Smoke amount and time were significantly correlated with bladder cancer risk (P smoking did not affect the bladder cancer risk (P > 0.05). Inhaling smoke into mouth or throat was also a risk factor for bladder cancer (P smoking and bladder cancer. Active and passive smoking, smoke amount and time, and the depth of smoke inhalation are risk factors for bladder cancer. The best way of preventing bladder cancer is never smoking.

  6. Impact of urate level on cardiovascular risk in allopurinol treated patients. A nested case control study

    DEFF Research Database (Denmark)

    Larsen, Kasper Søltoft; Pottegård, Anton; Lindegaard, H. M.

    2015-01-01

    is required to reduce cardiovascular risk is not known. Objectives: We sought to investigate the effect of achieving target plasma urate with allopurinol on cardiovascular outcomes in a case control study nested within long-term users of allopurinol. Methods: We identified all long-term users of allopurinol......Background: Gout gives rise to increased risk of adverse cardiovascular outcomes. Gout attacks can be effectively prevented with urate lowering drugs such as allopurinol, and allopurinol further potentially reduces the cardiovascular risk. Whether treatment to a target level of uric acid...... in Funen County, Denmark. Among these, we identified all cases of cardiovascular events (Antiplatelet trialist's Collaboration composite endpoint) and sampled 4 controls to each case from the same population. The cases and controls were compared with respect to whether they reached a urate target below 0...

  7. Colon cancer controls versus population controls in case-control studies of occupational risk factors

    DEFF Research Database (Denmark)

    Kaerlev, Linda; Lynge, Elsebeth; Sabroe, Svend

    2004-01-01

    . METHODS: The study was conducted from 1995 to 1997. Incident colon cancer controls (N = 428) aged 35-69 years with a histological verified diagnosis and population controls (N = 583) were selected. Altogether 254 (59%) of the colon cancer controls and 320 (55%) of the population controls were interviewed...... about occupational, medical and life style conditions. RESULTS: No statistical significant difference for educational level, medical history or smoking status was seen between the two control groups. There was evidence of a higher alcohol intake, less frequent work as a farmer and less exposure......BACKGROUND: Since updated population registers do not exist in many countries it is often difficult to sample valid population controls from the study base to a case-control study. Use of patient controls is an alternative option if the exposure experience under study for these patients...

  8. Risk Factors for Inhibitor Formation in Hemophilia: A Prevalent Case-Control Study

    Science.gov (United States)

    Ragni, Margaret V.; Ojeifo, Oluseyi; Feng, Jinong; Yan, Jin; Hill, Kathleen A.; Sommer, Steve S.; Trucco, Massimo N.; Brambilla, Donald J.

    2009-01-01

    Background Inhibitor formation is a major complication of hemophilia treatment. Aim In a prevalent case-control study, we evaluated blood product exposure, genotype, and HLA type on hemophilia A inhibitor formation. Methods Product exposure was extracted from medical records. Genotype was determined on stored DNA samples by detection of virtually all mutations-SSCP (DOVAM-S) and subcycling PCR. HLA typing was performed by PCR amplification and exonuclease-released fluorescence. Results Cases experienced higher intensity factor, 455 vs. 200 U per exposure, p0.100. Genotype was not associated with race. Time to immune tolerance was shorter for titers 0.50. Conclusions Inhibitor formation is associated with high intensity product exposure, CNS bleeding, African-American race, and low frequency of missense mutations. The ideal time to initiate prophylaxis to reduce CNS bleeding and inhibitor formation will require prospective studies. PMID:19563499

  9. Incidence of basilar invagination in patients with tonsillar herniation ? a case control craniometrical study

    Directory of Open Access Journals (Sweden)

    Andrei F Joaquim

    2014-09-01

    Full Text Available A retrospective case-control study based on craniometrical evaluation was performed to evaluate the incidence of basilar invagination (BI. Patients with symptomatic tonsillar herniation treated surgically had craniometrical parameters evaluated based on CT scan reconstructions before surgery. BI was diagnosed when the tip of the odontoid trespassed the Chamberlain’s line in three different thresholds found in the literature: 2, 5 or 6.6 mm. In the surgical group (SU, the mean distance of the tip of the odontoid process above the Chamberlain’s line was 12 mm versus 1.2 mm in the control (CO group (p<0.0001. The number of patients with BI according to the threshold used (2, 5 or 6.6 mm in the SU group was respectively 19 (95%, 16 (80% and 15 (75% and in the CO group it was 15 (37%, 4 (10% and 2 (5%.

  10. Tobacco chewing and risk of gastric cancer: a case-control study in Yemen.

    Science.gov (United States)

    Al-Qadasi, F A; Shah, S A; Ghazi, H F

    2017-01-23

    This study aimed to assess the risk factors for gastric cancer in Yemen. A hospital-based case-control study of 70 cases and 140 controls was carried out in Sana'a city between May and October 2014. A structured questionnaire was used to collect information through direct interview. Living in rural areas, tobacco chewing and drinking untreated water were significant risk factors for gastric cancer. Frequent consumption of chicken, cheese, milk, starchy vegetables, cucumber, carrots, leeks, sweet pepper, fruit drinks, legumes and olive oil were associated significantly with decreased risk of gastric cancer. Multiple logistic regression analysis showed that chewing tobacco and frequent consumption of white bread were associated with increased risk of gastric cancer, whereas frequent consumption of chicken, cooked potatoes and fruit drinks had an inverse association. Risk of gastric cancer can be prevented by health education and increasing community awareness.

  11. A case-controlled study of altered visual art production in Alzheimer's and FTLD.

    Science.gov (United States)

    Rankin, Katherine P; Liu, Anli A; Howard, Sara; Slama, Hilary; Hou, Craig E; Shuster, Karen; Miller, Bruce L

    2007-03-01

    To characterize dementia-induced changes in visual art production. Although case studies show altered visual artistic production in some patients with neurodegenerative disease, no case-controlled studies have quantified this phenomenon across groups of patients. Forty-nine subjects [18 Alzheimer disease, 9 frontotemporal dementia (FTD), 9 semantic dementia (SD), 15 healthy older controls (NC)] underwent formal neuropsychologic testing of visuospatial, perceptual, and creative functioning, and produced 4 drawings. Subjective elements of drawings were rated by an expert panel that was blind to diagnosis. Despite equal performance on standard visuospatial tests, dementia groups produced distinct patterns of artistic features that were significantly different from NCs. FTDs used more disordered composition and less active mark-making (Pvisual art.

  12. Prolonged outbreak of Serratia marcescens in Tartu University Hospital: a case-control study.

    Science.gov (United States)

    Adamson, Vivika; Mitt, Piret; Pisarev, Heti; Metsvaht, Tuuli; Telling, Kaidi; Naaber, Paul; Maimets, Matti

    2012-10-31

    The aim of our study was to investigate and control an outbreak and identify risk factors for colonization and infection with Serratia marcescens in two departments in Tartu University Hospital. The retrospective case-control study was conducted from July 2005 to December 2006. Molecular typing by pulsed field gel electrophoresis was used to confirm the relatedness of Serratia marcescens strains. Samples from the environment and from the hands of personnel were cultured. The outbreak involved 210 patients, 61 (29%) developed an infection, among them 16 were invasive infections. Multivariate analysis identified gestational age, arterial catheter use and antibiotic treatment as independent risk factors for colonization and infection with Serratia marcescens. Molecular typing was performed on 83 Serratia marcescens strains, 81 of them were identical and 2 strains were different. Given the occasionally severe consequences of Serratia marcescens in infants, early implementation of aggressive infection control measures involving patients and mothers as well as the personnel is of utmost importance.

  13. Gut microbiota diversity and T1DM onset: Preliminary data of a case-control study

    Directory of Open Access Journals (Sweden)

    Deborah Traversi

    2017-12-01

    Full Text Available Type-1 diabetes incidence is increasing during the last decades. Recently, a role of microbiota alteration is proposed as pre-diabetic and diabetic risk factor. A bicentric case-control study is in progress in Northern Italy. Here preliminary results are shown. The microbiome clusterization showed a division between cases and controls even if fingerprint profiles are heterogenic. Methanobrevibacter smithii is highly present only in few patients. The diversity index and the microorganism sequenced in cases and controls, seems to be quite dissimilar. The conclusive results could show a significant predictive value for the bio-indicators evaluated. Keywords: Type 1 diabetes mellitus, Microbiota, Children, Methanobrevibacter smithii, qRT-PCR

  14. Myocardial infarction and oral contraceptives, a retrospective case control study in England and Scotland ('MICA' Study).

    Science.gov (United States)

    Dunn, N R; Thorogood, M; de Caestecker, L; Mann, R D

    1997-07-01

    Recent studies have shown that modern (third generation), oral contraceptives (OC) are associated with an increased incidence of venous thromboembolic disease compared to older (second generation), OC. It is not known, however, whether this association is also true for arterial thrombosis, in particular myocardial infarction. In fact, it has been suggested that third generation OC may even be protective against myocardial infarction (MI), compared to second generation OC. The protocol for a multicentre case-control study, involving the whole of England and Scotland, is described. Cases will be female patients aged 16-44 years, who suffered an MI between 1.10.93 and 1.10.95. Controls will be drawn from the community, using the GP list, to which the case belonged. Odds ratios will be calculated primarily to compare current users of third generation OC with current users of second generation OC. Copyright 1997 John Wiley & Sons, Ltd.

  15. Autoimmune disease and risk for Parkinson disease A population-based case-control study

    DEFF Research Database (Denmark)

    Rugbjerg, K.; Friis, S.; Ritz, B.

    2009-01-01

    Objective: Inflammatory mediators are increased in autoimmune diseases and may activate microglia and might cause an inflammatory state and degeneration of dopaminergic neurons in the brain. Thus, we evaluated whether having an autoimmune disease increases the risk for developing Parkinson disease...... (PD). Methods: A population based case-control study was conducted in Denmark of 13,695 patients with a primary diagnosis of PD recorded in the Danish National Hospital Register during the period 1986-2006. Each case was matched on year of birth and sex to 5 population controls selected at random from...... do not support the hypothesis that autoimmune diseases increase the risk for Parkinson disease. The decreased risk observed among patients with rheumatoid arthritis might be explained by underdiagnosis of movement disorders such as Parkinson disease in this patient group or by a protective effect...

  16. Colon cancer controls versus population controls in case-control studies of occupational risk factors

    DEFF Research Database (Denmark)

    Kaerlev, Linda; Lynge, Elsebeth; Sabroe, Svend

    2004-01-01

    are interchangeable with the experience for population controls. Patient controls may even be preferable from population controls under certain conditions. In this study we examine if colon cancer patients can serve as surrogates for proper population controls in case-control studies of occupational risk factors....... METHODS: The study was conducted from 1995 to 1997. Incident colon cancer controls (N = 428) aged 35-69 years with a histological verified diagnosis and population controls (N = 583) were selected. Altogether 254 (59%) of the colon cancer controls and 320 (55%) of the population controls were interviewed...... to pesticides among colon cancer controls. CONCLUSIONS: Use of colon cancer controls may provide valid exposure estimates in studies of many occupational risk factors for cancer, but not for studies on exposure related to farming....

  17. A case-control study of risk factors for bovine cysticercosis in Danish cattle herds

    DEFF Research Database (Denmark)

    Calvo Artavia, Francisco Fernando; Nielsen, Liza Rosenbaum; Dahl, J.

    2013-01-01

    Bovine cysticercosis (BC) is a zoonotic, parasitic infection in cattle. Under the current EU meat inspection regulation, every single carcass from all bovines above 6 weeks of age is examined for BC. This method is costly and makes more sense in countries with higher number of BC-infected animals...... than in countries with few lightly infected cases per year. The aim of the present case-control study was to quantify associations between potential herd-level risk factors and BC in Danish cattle herds. Risk factors can be used in the design of a risk-based meat inspection system targeted towards...... the animals with the highest risk of BC. Cases (n = 77) included herds that hosted at least one animal diagnosed with BC at meat inspection, from 2006 to 2010. Control herds (n = 231) consisted of randomly selected herds that had not hosted any animals diagnosed with BC between 2004 and 2010. The answers from...

  18. Mallory Weiss syndrome is not associated with hiatal hernia: a matched case-control study.

    Science.gov (United States)

    Corral, Juan E; Keihanian, Tara; Kröner, Paul T; Dauer, Ryan; Lukens, Frank J; Sussman, Daniel A

    2017-04-01

    Hiatal hernia is considered to be a predisposing factor to develop Mallory-Weiss Syndrome (MWS). No large case-control studies verifying this hypothesis have been conducted. We reviewed all esophagogastroduodenoscopies with findings of MWS (n = 2342) in a national database and compared with age and gender-matched controls (n = 9368). Demographics, endoscopic characteristics and presence of a hiatal hernia were compared between both groups. Average age was 56.7 ± 18.6 years, and 72.4% were male. Hiatal hernia was more common in controls, and no significant difference was seen in a multivariate analysis. Dynamic changes inducing mucosal tension are more relevant determinants to develop MWS than gastro-esophageal junction location alone.

  19. Case-control study of possible causative factors in mycosis fungoides

    Energy Technology Data Exchange (ETDEWEB)

    Tuyp, E.; Burgoyne, A.; Aitchison, T.; MacKie, R.

    1987-02-01

    A detailed case control study was carried out on 53 patients (33 males and 20 females) with histologically proven mycosis fungoides and on an age- and sex-matched control population. Possible causative factors investigated included occupation, recreation, and exposure to petrochemicals, pesticides, insecticides, and potential carcinogens. Exposure to plants of the Compositae family, tanning history, and chronic sun exposure were also investigated, as were smoking history, drug ingestion history, and other skin disease. Personal and family histories of other malignancies were also investigated. The only statistically significant difference to emerge was that the patients with mycosis fungoides had significantly more family history of atopic dermatitis. In view of the absence of any significant difference between patients and controls with regard to personal history of atopic dermatitis, this difference may be the result of multiple statistical testing rather than a phenomenon of true biological significance.

  20. A case control study: White-collar defendants compared with defendants charged with other nonviolent theft.

    Science.gov (United States)

    Poortinga, Ernest; Lemmen, Craig; Jibson, Michael D

    2006-01-01

    We examined the clinical, criminal, and sociodemographic characteristics of all white-collar crime defendants referred to the evaluation unit of a state center for forensic psychiatry. With 29,310 evaluations in a 12-year period, we found 70 defendants charged with embezzlement, 3 with health care fraud, and no other white-collar defendants (based on the eight crimes widely accepted as white-collar offenses). In a case-control study design, the 70 embezzlement cases were compared with 73 defendants charged with other forms of nonviolent theft. White-collar defendants were found to have a higher likelihood of white race (adjusted odds ratio (adj. OR) = 4.51), more years of education (adj. OR = 3471), and a lower likelihood of substance abuse (adj. OR = .28) than control defendants. Logistic regression modeling showed that the variance in the relationship between unipolar depression and white-collar crime was more economically accounted for by education, race, and substance abuse.

  1. Cardiovascular drugs and the risk of suicide: a nested case-control study

    DEFF Research Database (Denmark)

    Callréus, Torbjörn; Agerskov Andersen, Ulla; Hallas, Jesper

    2007-01-01

    OBJECTIVE: During the past 30 years, various cardiovascular drugs have been implicated as causes of depression or suicide. Although the evidence for causal relationships has generally been conflicting, both beta-blockers and angiotensin-converting-enzyme inhibitors (ACE-inhibitors) have been...... related to depression. Lipid-lowering therapies and calcium-channel blockers have also been linked to an increased risk of suicide. In this study, we investigated the possible association between the use of cardiovascular drugs and suicide using population-based register data. METHODS: We performed...... a nested case-control study in the county of Funen, Denmark, that consisted of 743 cases of completed suicide identified in a Death Registry for the period 1991-1998 and 14,860 age- and sex-matched controls. Information on previous drug use was retrieved from prescription data and the association between...

  2. Psychopathology and Suicide among Quebec Physicians: A Nested Case Control Study

    Directory of Open Access Journals (Sweden)

    Pierre Gagné

    2011-01-01

    Full Text Available Objective. To describe a psychiatric profile and characteristics of physicians who killed themselves in Quebec between 1992 and 2009. Method. The cases of 36 physicians (7 females and 29 males and 36 nonphysicians who committed suicide were matched for age and gender and examined in a nested case control design. All subjects were judged as definite suicide by the Quebec Coroner Head Office. Consensus regarding DSM-IV diagnoses was established by two forensic psychiatrists. Results. Rates of all Axis I diagnoses were 83% for physicians and 91% for nonphysicians at the time of suicide. Major depressive disorders were the most frequently observed pathology in both groups (61% and 56%, resp.. Conclusions. Physicians and nonphysicians who committed suicide in Quebec suffered from the same type of psychiatric disorder at the time of killing themselves. The findings advocate strongly for more efficient suicide prevention measures including early detection and treatment of mood disorders for the physicians.

  3. Normal endothelial function in patients with mild-to-moderate psoriasis: a case-control study

    DEFF Research Database (Denmark)

    Jensen, Peter R; Zachariae, Claus; Hansen, Peter

    2011-01-01

    -dependent and technically demanding ultrasound measurement of brachial artery flow-mediated vasodilation. Therefore, we decided to measure endothelial function and other cardiovascular risk factors in patients with mild-to-moderate psoriasis (n = 30) and controls (n = 30) using a newer and relatively operator......Evidence is increasing that severe psoriasis is an independent cardiovascular risk factor. Results from case-control studies of endothelial dysfunction, a marker of early atherosclerosis, in patients with moderate-to-severe psoriasis have been conflicting and were conducted with operator...... blood pressures, and plasma levels of triglycerides, very-low-density lipoprotein cholesterol and glycated glucose, compared with controls. This indicates that even mild-to-moderate psoriasis may be regarded as a systemic inflammatory disease, and that an increased risk of cardiovascular morbidity may...

  4. Nutritional variables and work-related accidents: a case-control study.

    Science.gov (United States)

    de Medeiros, M A T; Zangirolani, Lia Thieme Oikawa; Cordeiro, Ricardo Carlos; da Costa, Proença Rossana Pacheco; Diez-Garcia, Rosa Wanda

    2014-01-01

    Nutritional aspects are important for the prevention of diseases and disorders, and few studies have focused on the relationship between risk of work injury and nutritional variables. This study aimed to verify whether nutritional variables constitute risk factors for work-related accidents. 1,422 industrial workers (600 cases plus 822 controls). A case-control study was carried out in an industrial city in south-east Brazil. A multiple logistic regression model was adjusted using work-related accidents as the response variable and nutritional variables as predictors. The associations were assessed by Odds Ratio (OR), with a p-value work-related accidents were (a) attending formal education for an above average number of years (OR=0.91, pwork-related accidents. This indicates the need, during the formulation of policies for these kinds of government benefits, to include nutrition aspects in order to minimize work-related accidents risks.

  5. A case control study on the lung cancer risk factors in north of Iran.

    Science.gov (United States)

    Karimzadeh, Laleh; Koohdani, Fariba; Siassi, Fereydoon; Mahmoudi, Mahmoud; Moslemi, Dariush; Shokrzadeh, Mohammad; Safari, Farid

    2011-01-01

    In this case control study, the risk factors of lung cancer was assessed in the north of Iran. Two groups were matched for gender and age (+/- 5 years). Data were collected from 40 cases and 40 controls attending to hospitals. A public information questionnaire was used for data collection. Incidence odds ratios (OR) and corresponding 95% confidence intervals calculated using logistic regression analyses. Results showed that in adjusted odd ratio positive family history of cancer (OR = 0/19, 95% CI: 0/04-0/8) was associated with a reduction, and consumption of baked bread in traditional oven (OR = 22/6, 95% CI: 1/9-270), was associated with increase in lung cancer risk. Based on the results, smoking was not correlated with lung cancer. In conclusion, the data offers consumption of traditional oven-baked bread may enhance the risk of lung cancer but positive family history of cancer may reduce it.

  6. Maternal Abortion History and the Risk of Congenital Heart Defects. A Case-Control Study.

    Science.gov (United States)

    Li, Na-Na; Chen, Xin-Lin; Liu, Zhen; Li, Xiao-Hong; Deng, Ying; Zhu, Jun

    2015-01-01

    To explore the association between maternal abortion history and congenital heart defect (CHD) risk in subsequent pregnancies. A multihospital-based case-control study was conducted. The cases included 370 women whose fetuses were diagnosed with CHDs. The controls were 413 women with fetuses without an apparent malformation in the same hospital. All of the participants were investigated by trained interviewers. Univariate analysis was performed, followed by multivariate logistic regression analysis to calculate odds ratio and 95% confidence interval to evaluate the risk of maternal abortion history on CHD risk. There were no statistically significant positive associations between maternal abortion (induced abortion and spontaneous abortion) occurrence and the risk of CHDs. There were no statistically significant positive associations between the number of maternal abortions (induced and spontaneous) and the risk of congenital heart defects. Maternal abortion history may not be associated with fetal CHDs.

  7. Role of calcium deficiency in development of nutritional rickets in Indian children: a case control study.

    Science.gov (United States)

    Aggarwal, Varun; Seth, Anju; Aneja, Satinder; Sharma, Bhawna; Sonkar, Pitamber; Singh, Satveer; Marwaha, Raman K

    2012-10-01

    Nutritional rickets is usually attributed to vitamin D deficiency. Studies from some tropical countries have postulated low dietary intake of calcium as the cause of nutritional rickets. Both vitamin D and dietary calcium deficiency are highly prevalent in India. Information on their relative contribution in the development of rickets in Indian children is limited. The aim was to study the role of calcium and vitamin D deficiency in causation of nutritional rickets in young Indian children. In a case-control study, 67 children with nutritional rickets and 68 age- and sex-matched healthy controls were compared for demographic factors, nutritional status, sun exposure (UV score), dietary calcium and phytate intake (for subjects not breast-fed at presentation), and biochemical parameters [serum calcium, inorganic phosphate, alkaline phosphatase, 25-hydroxyvitamin D (25OHD), and PTH]. Mean intake of calcium (204±129 vs. 453±234 mg/d; Pnutrition status.

  8. Case-control study of intracranial meningiomas in women in Los Angeles County, California

    International Nuclear Information System (INIS)

    Preston-Martin, S.; Paganini-Hill, A.; Henderson, B.E.; Pike, M.C.; Wood, C.

    1980-01-01

    A case-control study was conducted among women in Los Angeles County to investigate possible causes of intracranial meningiomas. Questionnaires sought information from patients and from a neighbor of each one on characteristics and past experiences that might be associated with the development of this disease. Information was obtained on 188 matched patient-neighbor pairs. Three primary factors appeared to be associated with meningioma occurrence: 1) a history of head trauma (odds ratio = 2.0, p = 0.01), 2) consumption of certain cured meats (odds ratio = 2.8, p = less than 0.01), and 3) exposure to medical and dental diagnostic X-rays to the head. For diagnostic X-rays, the strongest association was with early exposure (less than 20 yr old) to full-mouth dental X-ray series

  9. Breast cancer and smoking, vodka drinking and dietary habits. A case-control study.

    Science.gov (United States)

    Pawlega, J

    1992-01-01

    The relationship between cigarette smoking, vodka drinking and consumption of 44 food items typical of the Polish diet were analysed in a case-control study in Cracow, Poland, among 127 cases of breast cancer and 250 controls randomly selected from the general population. Cigarette smoking was not significantly influencing the breast cancer risk. Compared with never-drinkers, the habit of vodka drinking 20 years earlier significantly increased breast cancer risk in women below 50 years of age (multivariate OR was 4.4 with 95% CI 1.6-12.4). Frequent consumption of boiled vegetables 20 years earlier (greater than 3 times per week) was associated with a decreased risk of breast cancer in women aged 50 years and more (multivariate OR was 0.4 with 95% CI 0.2-0.8).

  10. Sleep problems and suicide attempts among adolescents: a case-control study.

    Science.gov (United States)

    Koyawala, Neel; Stevens, Jack; McBee-Strayer, Sandra M; Cannon, Elizabeth A; Bridge, Jeffrey A

    2015-01-01

    This study used a case-control design to compare sleep disturbances in 40 adolescents who attempted suicide with 40 never-suicidal adolescents. Using hierarchical logistic regression analyses, we found that self-reported nighttime awakenings were significantly associated with attempted suicide, after controlling for antidepressant use, antipsychotic use, affective problems, and being bullied. In a separate regression analysis, the parent-reported total sleep problems score also predicted suicide attempt status, controlling for key covariates. No associations were found between suicide attempts and other distinct sleep problems, including falling asleep at bedtime, sleeping a lot during the day, trouble waking up in the morning, sleep duration, and parent-reported nightmares. Clinicians should be aware of sleep problems as potential risk factors for suicide attempts for adolescents.

  11. Systemic inflammation in acute intermittent porphyria: a case-control study.

    Science.gov (United States)

    Storjord, E; Dahl, J A; Landsem, A; Fure, H; Ludviksen, J K; Goldbeck-Wood, S; Karlsen, B O; Berg, K S; Mollnes, T E; W Nielsen, E; Brekke, O-L

    2017-03-01

    This study aimed to examine whether acute intermittent porphyria (AIP) is associated with systemic inflammation and whether the inflammation correlates with disease activity. A case-control study with 50 AIP cases and age-, sex- and place of residence-matched controls was performed. Plasma cytokines, insulin and C-peptide were analysed after an overnight fast using multiplex assay. Long pentraxin-3 (PTX3) and complement activation products (C3bc and TCC) were analysed using enzyme-linked immunosorbent assay (ELISA). Urine porphobilinogen ratio (U-PBG, µmol/mmol creatinine), haematological and biochemical tests were performed using routine methods. Questionnaires were used to register AIP symptoms, medication and other diseases. All 27 cytokines, chemokines and growth factors investigated were increased significantly in symptomatic AIP cases compared with controls (P inflammation. Decreased C-peptide levels in symptomatic AIP cases indicate that reduced insulin release is associated with enhanced disease activity and reduced kidney function. © 2016 British Society for Immunology.

  12. Case-control study of gadodiamide-related nephrogenic systemic fibrosis

    DEFF Research Database (Denmark)

    Marckmann, Peter; Skov, Lone; Rossen, Kristian

    2007-01-01

    .02). CONCLUSIONS: Increasing cumulative gadodiamide exposure, high-dose epoietin-beta treatment, and higher serum concentrations of ionized calcium and phosphate increase the risk of gadodiamide-related nephrogenic systemic fibrosis in renal failure patients. Severe cases seem to develop primarily among patients......BACKGROUND: Nephrogenic systemic fibrosis may be caused by gadolinium (Gd)-containing magnetic resonance imaging contrast agents. Most reported cases were associated with one particular agent, gadodiamide. Yet, unidentified cofactors might explain why only a minority of renal failure patients...... exposed to gadodiamide develop nephrogenic systemic fibrosis. METHODS: We conducted a case-control study of 19 histologically verified cases and 19 sex- and age-matched controls. All subjects had chronic renal failure when exposed to gadodiamide. Clinical, biochemical and pharmacological data were...

  13. Characterization of the polysensitized patient: a matched case-control study

    DEFF Research Database (Denmark)

    Carlsen, Berit Christina; Andersen, Klaus Ejner; Menné, Torkil

    2009-01-01

    for polysensitization, including atopic eczema. METHODS: A questionnaire case-control study of 562 polysensitized and 1124 single/double-sensitized individuals was performed. RESULTS: The results show that 45% of polysensitized and 31% of single/double-sensitized patients had or had had atopic eczema, and atopic eczema...... was identified as a risk factor for polysensitization. Patients with leg ulcer constituted only a minor part of the polysensitized group and leg ulcers were not identified as a risk factor for polysensitization in this study. The influence of contact allergies on duration and course of disease diverged between...... predispose to contact allergy. Therefore, it is of interest to consider atopic eczema and contact allergies, especially in patients with multiple allergies. OBJECTIVE: To characterize polysensitized patients regarding occurrence, duration and course of dermatitis, and examine potential risk factors...

  14. Association between colonic diverticulosis and bowel symptoms: A case-control study of 1629 Asian patients.

    Science.gov (United States)

    Nagata, Naoyoshi; Niikura, Ryota; Aoki, Tomonori; Shimbo, Takuro; Sekine, Katsunori; Okubo, Hidetaka; Watanabe, Kazuhiro; Sakurai, Toshiyuki; Yokoi, Chizu; Yanase, Mikio; Akiyama, Junichi; Uemura, Naomi

    2015-08-01

    It remains unclear whether diverticulosis, absent inflammation, is responsible for chronic bowel symptoms. We examined the association between bowel symptoms and asymptomatic diverticulosis. This case-control study included 543 patients with diverticulosis and 1086 age and sex-matched controls (1:2) without diverticulosis on screening colonoscopy. Eleven symptoms (abdominal discomfort, hunger discomfort, borborygmus, abdominal distension, flatus, constipation, diarrhea, loose stools, hard stools, fecal urgency, and incomplete evacuation) were evaluated using a gastrointestinal symptoms rating scale (GSRS) at baseline and second questionnaire. Associations between diverticulosis and symptoms were estimated using odds ratios (ORs) and 95 confidence interval (CI). In multivariate analysis, constipation (OR, 0.85 [0.78-0.93]) and hard stools (OR, 0.86 [0.78-0.94]) were negatively associated with diverticulosis. The other nine symptoms showed no association with diverticulosis. Diverticulosis was negatively associated with constipation (OR, 0.93 [0.74-0.93]), hard stools (OR, 0.85 [0.76-0.96]), and incomplete evacuation (OR, 0.88 [0.79-0.99]) in males, and positively associated with diarrhea (OR, 1.39 [1.14-1.69]) and loose stools (OR, 1.28 [1.05-1.55]) in females. No bowel symptoms were positively associated with any of right-sided, left-sided, or bilateral diverticulosis. Test-retest reliability of GSRS (mean interval, 4.4 months) was moderate (Mean Kappa, 0.568) in males and good (Mean Kappa, 0.652) in females. This large, colonoscopy-based, case-control study demonstrated that neither constipation nor hard stools were associated with an increased risk of diverticulosis, regardless of diverticulum location. In females, but not males, diarrhea and loose stools were positively associated with diverticulosis. Long-term test-retest reliability suggested that these symptoms remain consistent over a given period. © 2015 Journal of Gastroenterology and Hepatology

  15. Reduced Risk of Barrett's Esophagus in Statin Users: Case-Control Study and Meta-Analysis.

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    Beales, Ian L P; Dearman, Leanne; Vardi, Inna; Loke, Yoon

    2016-01-01

    Use of statins has been associated with a reduced incidence of esophageal adenocarcinoma in population-based studies. However there are few studies examining statin use and the development of Barrett's esophagus. The purpose of this study was to examine the association between statin use and the presence of Barrett's esophagus in patients having their first gastroscopy. We have performed a case-control study comparing statin use between patients with, and without, an incident diagnosis of non-dysplastic Barrett's esophagus. Male Barrett's cases (134) were compared to 268 male age-matched controls in each of two control groups (erosive gastro-esophageal reflux and dyspepsia without significant upper gastrointestinal disease). Risk factor and drug exposure were established using standardised interviews. Logistic regression was used to compare statin exposure and correct for confounding factors. We performed a meta-analysis pooling our results with three other case-control studies. Regular statin use was associated with a significantly lower incidence of Barrett's esophagus compared to the combined control groups [adjusted OR 0.62 (95 % confidence intervals 0.37-0.93)]. This effect was more marked in combined statin plus aspirin users [adjusted OR 0.43 (95 % CI 0.21-0.89)]. The inverse association between statin or statin plus aspirin use and risk of Barrett's was significantly greater with longer duration of use. Meta-analysis of pooled data (1098 Barrett's, 2085 controls) showed that statin use was significantly associated with a reduced risk of Barrett's esophagus [pooled adjusted OR 0.63 (95 % CI 0.51-0.77)]. Statin use is associated with a reduced incidence of a new diagnosis of Barrett's esophagus.

  16. Clinical features of adolescents with deliberate self-harm: A case control study in Lisbon, Portugal

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    Diogo F Guerreiro

    2009-11-01

    Full Text Available Diogo F Guerreiro, Ema L Neves, Rita Navarro, Raquel Mendes, Ana Prioste, Diana Ribeiro, Tiago Lila, António Neves, Mónica Salgado, Nazaré Santos, Daniel SampaioYouth Suicide Study Group (NES, The Hospital Santa Maria, Psychiatry Department, Lisbon Faculty of Medicine, PortugalAbstract: Deliberate self-harm (DSH among adolescents is a high-risk condition for suicide. The aim of the present study is to describe the characteristic clinical features of adolescents with DSH according to our local context (Lisbon, Portugal, using easily available information from clinical settings. A case control study was constructed from a sample of 100 adolescents (aged 12 to 21 years. The sample was divided into two groups: adolescents with and without DSH. Case files were examined and data was completed by clinical interviews. Demographic, psychosocial, and psychopathological data were assessed and compared. Ninety-eight subjects completed the protocol. The DSH group was associated with the following: suicidal ideation or suicidal behavior as consultation motive, emergency room referral, previous follow-up attempts, suicidal ideation, psychosocial difficulties, or lack of therapeutic goals. There was a nonsignificant trend towards diagnosis of depression in the DSH group. These results reflect our clinical practice with adolescents and add data about teenagers who self-harm to the literature. Prevention and early recognition of DSH (and frequently associated depression in adolescents are essential and could be life-saving measures. An integrated approach, which takes into account psychosocial difficulties, family dysfunction, and negative expectations, seems to be of great importance.Keywords: deliberate self-harm, suicide, adolescents, suicide risk, case control

  17. Dietary food groups intake and cooking methods associations with pancreatic cancer: a case-control study.

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    Ghorbani, Zeinab; Hekmatdoost, Azita; Zinab, Hassan Eini; Farrokhzad, Solmaz; Rahimi, Roya; Malekzadeh, Reza; Pourshams, Akram

    2015-05-01

    The role of dietary habits in the etiology of pancreatic cancer (PC) has not yet been well elucidated. The aim of the present study was to examine the association of the frequency of different food groups' intake and their cooking methods with PC risk based on a well-designed case-control study. A case-control study including 307 PC patients and 322 controls referred to four tertiary endosonography centers was conducted from January 2011 to January 2014 to compare the frequency intake of different food items and their cooking methods between cases and controls. After adjustment for gender, age, body mass index, years of education, diabetes and alcohol history, smoking status, and opium use, a significant direct relationship was observed between PC risk and intake frequency (time/week) of bread (OR = 1.50; 95 % CI 1.05-2.13; p-value 0.024), rice (OR = 2.10; 95 % CI 1.15-3.82; p for trend 0.034), and red meat (OR = 2.25; 95 % CI 1.22-4.14; p for trend 0.033) (time/day), when comparing the highest category of intake frequency with the lowest, while increasing frequency of fish consumption was associated with a lower risk of PC (OR = 0.93; 95 % CI0.59-1.47; p for trend 0.009). Increasing consumption of barbecuing red meat and deep fried vegetables was associated with 67 % and 70 % increased risk of PC (p-value 0.025 and 0.006, respectively). Our results indicate that increased frequency of intake of bread, rice, and red meat (especially barbecued) and deep fried vegetables can aggregate PC risk, while increased frequency of fish consumption can protect against PC. However, more studies are still needed.

  18. High Seroprevalence of Leptospira Exposure in Meat Workers in Northern Mexico: A Case-Control Study

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    Alvarado-Esquivel, Cosme; Hernandez-Tinoco, Jesus; Sanchez-Anguiano, Luis Francisco; Ramos-Nevarez, Agar; Cerrillo-Soto, Sandra Margarita; Saenz-Soto, Leandro; Martinez-Ramirez, Lucio

    2016-01-01

    Background The seroepidemiology of Leptospira infection in workers occupationally exposed to raw meat has been poorly studied. This work aimed to determine the association between Leptospira exposure and the occupation of meat worker, and to determine the seroprevalence association with socio-demographic, work, clinical and behavioral characteristics of the meat workers studied. Methods We performed a case-control study in 124 meat workers and 124 age- and gender-matched control subjects in Durango City, Mexico. Sera of cases and controls were analyzed for anti-Leptospira IgG antibodies using a commercially available enzyme immunoassay. Data of meat workers were obtained with the aid of a questionnaire. The association of Leptospira exposure with the characteristics of meat workers was analyzed by bivariate and multivariate analyses. Results Anti-Leptospira IgG antibodies were found in 22 (17.7%) of 124 meat workers and in eight (6.5%) of 124 controls (OR = 3.12; 95% CI: 1.33 - 7.33; P = 0.006). Seroprevalence of Leptospira infection was similar between male butchers (17.6%) and female butchers (18.2%) (P = 1.00). Multivariate analysis of socio-demographic, work and behavioral variables showed that Leptospira exposure was associated with duration in the activity, rural residence, and consumption of snake meat and unwashed raw fruits. Conclusions This is the first case-control study of the association of Leptospira exposure with the occupation of meat worker. Results indicate that meat workers represent a risk group for Leptospira exposure. Risk factors for Leptospira exposure found in this study may help in the design of optimal preventive measures against Leptospira infection. PMID:26858797

  19. Case-control analysis of the health and nutrition of orphan schoolchildren in Ethiopia.

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    Hall, Andrew; Tuffrey, Veronica; Kassa, Tamiru; Demissie, Tsegaye; Degefie, Tedbabe; Lee, Seung

    2010-03-01

    To undertake a case-control analysis of the health, nutrition and caring practices of orphans enrolled in primary schools in Ethiopia. Pupils of both sexes aged 7-17 who were randomly selected from Grades 3 and 4 of primary school during a national survey of schoolchildren in Ethiopia and who were classified as an orphan were matched by age, sex and school with non-orphans. Logistic regression was used to compare children in terms of indicators of anthropometric and nutritional status, chronic infections, personal hygiene, diet, caring practices and self-reported sensory disability. Of the 7752 children in the national survey, 1283 (16.9%) had lost either both parents or one parent. Of these orphans, 1048 were uniquely pair matched for the case-control analysis. About 60% of orphans had lost their father, and about 20% each had lost their mother or both parents. Orphans had better anthropometric measurements and indices than non-orphans, although the differences were small, and they were less likely to have a goitre (OR = 0.68, P = 0.011). There were no differences in the odds of infections. Orphans were less likely than non-orphans to have eaten breakfast or fruit and vegetables on the previous day and were more likely to report having trouble seeing and hearing. Orphans were slight better nourished than non-orphans, but this could have been a result of asystematic bias in underestimating the age of orphans. The indicators suggested that orphans were less well cared for than non-orphans, but the differences were small.

  20. Alcohol and Difficulty Conceiving in the SUN Cohort: A Nested Case-Control Study

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    Cristina Lopez-del Burgo

    2015-07-01

    Full Text Available The role of alcohol on fertility remains unclear. We aimed to investigate the association between alcohol and specific alcoholic beverages consumption and the risk of difficulty getting pregnant. We used a case-control study nested within the Seguimiento Universidad de Navarra (SUN cohort, a prospective, dynamic and multipurpose cohort of 21,705 Spanish university graduates, followed biennially with mailed questionnaires. We identified 686 case-control pairs, matched for age and time in the cohort. Cases were women reporting difficulty getting pregnant. Controls did not consult due to difficulty conceiving and had at least one child during follow-up. After adjustment for potential confounders, we found no association between self-reported difficulty getting pregnant and the number of alcoholic beverages consumed per week, (Odds Ratio [OR] > 5 drinks/week vs. none = 1.04, 95% Confidence Interval [CI] = 0.72–1.51. No association between types of alcoholic beverage and difficulty conceiving (OR > 5 drinks of wine/week vs. none = 1.16, 95% CI = 0.72–1.88; OR > 5 drinks of beer/week vs. none = 1.06, 95% CI = 0.82–1.37; OR > 5 drinks of spirits/week vs. none = 1.24, 95% CI = 0.84–1.64 was observed. In conclusion, we found no association between alcohol intake and risk of consulting a physician due to difficulty conceiving. More studies are needed to clearly elucidate the effects of alcohol intake on women’s fertility. In the meantime, recommendations about alcohol intake to couples trying to conceive have to be given cautiously.

  1. Bovine Viral Diarrhoea Virus (BVDV) in Dairy Cattle: A Matched Case-Control Study.

    Science.gov (United States)

    Machado, G; Egocheaga, R M F; Hein, H E; Miranda, I C S; Neto, W S; Almeida, L L; Canal, C W; Stein, M C; Corbellini, L G

    2016-02-01

    Bovine viral diarrhoea virus (BVDV) causes one of the most important diseases of cattle in terms of economic costs and welfare. The aims were to estimate herd prevalence and to investigate the factors associated with antibodies in bulk tank milk (BTM) in dairy herds through a matched case-control study. To estimate herd prevalence, BTM samples were randomly selected (n = 314) from a population (N = 1604). The true prevalence of BVDV was 24.3% (CI 95% = 20.1-29.3%). For the case-control study, BVDV antibody-positive herds (high antibody titres) were classified as cases (n = 21) and matched (n = 63) by milk production with herds presenting low antibody titres (ratio of 1 : 3). Three multivariable models were built: 1) full model, holding all 21 variables, and two models divided according to empirical knowledge and similarity among variables; 2) animal factor model; and 3) biosecurity model. The full model (model 1) identified: age as a culling criteria (OR = 0.10; CI 95% = 0.02-0.39; P animals (OR = 0.14; CI 95% = 0.01-0.26; P = 0.02). The biosecurity model revealed a significant association with the use of natural mating (OR = 9.03; CI 95% = 2.14-38.03; P animals (OR = 0.06; CI 95% = 0.05-0.83; P = 0.03); years providing milk for the same industry (OR = 0.94; CI 95% = 0.91-0.97; P = 0.02); and direct contact over fences among cattle of neighbouring farms (OR = 5.78; CI 95% = 1.41-23.67; P = 0.04). We recommend the application of grouping predictors as a good choice for model building because it could lead to a better understanding of disease-exposure associations. © 2014 Blackwell Verlag GmbH.

  2. Serum Taurine and Stroke Risk in Women: A Prospective, Nested Case-Control Study

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    Wu, Fen; Koenig, Karen L.; Zeleniuch-Jacquotte, Anne; Jonas, Saran; Afanasyeva, Yelena; Wójcik, Oktawia P.; Costa, Max; Chen, Yu

    2016-01-01

    Background Taurine (2-aminoethanesulfonic acid), a conditionally essential sulfur-containing amino acid, is mainly obtained from diet in humans. Experimental studies have shown that taurine’s main biological actions include bile salt conjugation, blood pressure regulation, anti-oxidation, and anti-inflammation. Methods We conducted a prospective case-control study nested in the New York University Women’s Health Study, a cohort study involving 14,274 women enrolled since 1985. Taurine was measured in pre-diagnostic serum samples of 241 stroke cases and 479 matched controls. Results There was no statistically significant association between serum taurine and stroke risk in the overall study population. The adjusted ORs for stroke were 1.0 (reference), 0.87 (95% CI, 0.59–1.28), and 1.03 (95% CI, 0.69–1.54) in increasing tertiles of taurine (64.3–126.6, 126.7–152.9, and 153.0–308.5 nmol/mL, respectively). A significant inverse association between serum taurine and stroke risk was observed among never smokers, with an adjusted OR of 0.66 (95% CI, 0.37–1.18) and 0.50 (95% CI, 0.26–0.94) for the second and third tertile, respectively (p for trend = 0.01), but not among past or current smokers (p for interaction taurine and stroke risk, although a protective effect was observed in never smokers, which requires further investigation. Taurine, Stroke, Epidemiology, Prospective, Case-control study, NYUWHS. PMID:26866594

  3. Vitamin D Status and Risk of Breast Cancer in Iranian Women: A Case-Control Study.

    Science.gov (United States)

    Jamshidinaeini, Yasaman; Akbari, Mohammad Esmaeil; Abdollahi, Morteza; Ajami, Marjan; Davoodi, Sayed Hossein

    2016-01-01

    Considering the rising incidence of breast cancer and high prevalence of vitamin D deficiency in Iran, this case-control study aimed to investigate the relationship between serum concentration and intake of vitamin D and risk of breast cancer. A total of 135 incident breast cancer cases at the Cancer Research Center of Shahid Beheshti University of Medical Sciences were matched with 135 controls by age and menopausal status. A validated and reliable 168-item food frequency questionnaire was completed by participant interviews. To determine the vitamin D content of foods we used the U.S. Department of Agriculture (USDA) nutrient database. To analyze the food frequency questionnaires we used the data collected in the Iranian Household Food Pattern Study, conducted by the National Nutrition and Food Technology Research Institute and the Iranian Ministry of Agriculture. Five-milliliter blood samples were collected to measure serum 25-hydroxyvitamin D (25(OH)D) using an enzyme-linked immunosorbent assay method. Women in the fourth quartile of serum 25(OH)D level had 3 times lower risk of developing breast cancer compared to those in the first quartile. In the adjusted model the inverse relationship remained significant (odds ratio [OR] = 0.269; 95% confidence interval [CI], 0.122-0.593). In the stratified model by menopausal status the inverse association was only seen in premenopausal women (OR = 0.25; 95% CI, 0.094-0.687). Dietary intake of vitamin D was inversely associated with risk of breast cancer (OR fourth quartile [Q4] vs first quartile [Q1] = 0.39; 95% CI, 0.196-0.784; p = 0.008). After adjusting for the confounding factors, this inverse association remained significant. Results from this case-control study support the protective effect of higher serum concentration of 25(OH)D against breast cancer. Moreover, dietary but not total intake of vitamin D was associated with decreased risk of breast cancer.

  4. Selective Serotonin Reuptake Inhibitors and Gastrointestinal Bleeding: A Case-Control Study

    Science.gov (United States)

    Carvajal, Alfonso; Ortega, Sara; Del Olmo, Lourdes; Vidal, Xavier; Aguirre, Carmelo; Ruiz, Borja; Conforti, Anita; Leone, Roberto; López-Vázquez, Paula; Figueiras, Adolfo; Ibáñez, Luisa

    2011-01-01

    Background Selective serotonin reuptake inhibitors (SSRIs) have been associated with upper gastrointestinal (GI) bleeding. Given their worldwide use, even small risks account for a large number of cases. This study has been conducted with carefully collected information to further investigate the relationship between SSRIs and upper GI bleeding. Methods We conducted a case-control study in hospitals in Spain and in Italy. Cases were patients aged ≥18 years with a primary diagnosis of acute upper GI bleeding diagnosed by endoscopy; three controls were matched by sex, age, date of admission (within 3 months) and hospital among patients who were admitted for elective surgery for non-painful disorders. Exposures to SSRIs, other antidepressants and other drugs were defined as any use of these drugs in the 7 days before the day on which upper gastrointestinal bleeding started (index day). Results 581 cases of upper GI bleeding and 1358 controls were considered eligible for the study; no differences in age or sex distribution were observed between cases and controls after matching. Overall, 4.0% of the cases and 3.3% of controls used an SSRI antidepressant in the week before the index day. No significant risk of upper GI bleeding was encountered for SSRI antidepressants (adjusted odds ratio, 1.06, 95% CI, 0.57–1.96) or for whichever other grouping of antidepressants. Conclusions The results of this case-control study showed no significant increase in upper GI bleeding with SSRIs and provide good evidence that the magnitude of any increase in risk is not greater than 2. PMID:21625637

  5. Use of oral cholera vaccines in an outbreak in Vietnam: a case control study.

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    Dang Duc Anh

    Full Text Available BACKGROUND: Killed oral cholera vaccines (OCVs are available but not used routinely for cholera control except in Vietnam, which produces its own vaccine. In 2007-2008, unprecedented cholera outbreaks occurred in the capital, Hanoi, prompting immunization in two districts. In an outbreak investigation, we assessed the effectiveness of killed OCV use after a cholera outbreak began. METHODOLOGY/PRINCIPAL FINDINGS: From 16 to 28 January 2008, vaccination campaigns with the Vietnamese killed OCV were held in two districts of Hanoi. No cholera cases were detected from 5 February to 4 March 2008, after which cases were again identified. Beginning 8 April 2008, residents of four districts of Hanoi admitted to one of five hospitals for acute diarrhea with onset after 5 March 2008 were recruited for a matched, hospital-based, case-control outbreak investigation. Cases were matched by hospital, admission date, district, gender, and age to controls admitted for non-diarrheal conditions. Subjects from the two vaccinated districts were evaluated to determine vaccine effectiveness. 54 case-control pairs from the vaccinated districts were included in the analysis. There were 8 (15% and 16 (30% vaccine recipients among cases and controls, respectively. The vaccine was 76% protective against cholera in this setting (95% CI 5% to 94%, P = 0.042 after adjusting for intake of dog meat or raw vegetables and not drinking boiled or bottled water most of the time. CONCLUSIONS/SIGNIFICANCE: This is the first study to explore the effectiveness of the reactive use of killed OCVs during a cholera outbreak. Our findings suggest that killed OCVs may have a role in controlling cholera outbreaks.

  6. [Case control trial on putative factors antagonising the successful project course of MD thesis projects].

    Science.gov (United States)

    Scharfenberg, J; Schaper, K; Krummenauer, F

    2015-05-01

    Award of the degree MD has special relevance in Germany since the underlying research project can be started during the qualification for admission to doctoral training. This leads to a large number of thesis projects with a not always sufficiently pronounced enthusiasm and thus poor chances of success. Accordingly a case control study was undertaken in the Department of Human Medicine, Witten/Herdecke University to investigate reported drop-outs of thesis projects. In autumn 2012 all students in the clinical phases of human medicine education were surveyed using a self-conceived questionnaire on previously initiated or terminated thesis projects, "terminated" is defined as the unsuccessful ending of a project after working for at least 3 months. Individually reported thesis terminations were evaluated using defined items in a 4-stage Likert scale regarding thesis plan and project, subsequently, graduate students who successfully completed a project received the same questionnaire. The items possibly corresponding to process determinants were averaged to a total of 7 dimensions prior to the analysis; the resulting scores were normalised in value ranges 0.0 to 1.0 (1.0 = optimal project situation) whereby individual items could be included in several scores. By means of 5 items a primary endpoint from the faculty's perspective on "compliance with formal procedures" was aggregated; by means of a two-sided Wilcoxon test at the 5 % level students with unsuccessful and successful courses were compared along the corresponding scores. 181 of 276 students from 7 study semesters participated in the screening; details of 17 terminations and 23 currently successful courses could be evaluated in the case control study. For significant differences (p thesis projects to the responsible committees. A weakness is the low number of evaluable self-reported drop-outs as well as the overall moderate response rate. Georg Thieme Verlag KG Stuttgart · New York.

  7. Selective serotonin reuptake inhibitors and gastrointestinal bleeding: a case-control study.

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    Alfonso Carvajal

    Full Text Available BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs have been associated with upper gastrointestinal (GI bleeding. Given their worldwide use, even small risks account for a large number of cases. This study has been conducted with carefully collected information to further investigate the relationship between SSRIs and upper GI bleeding. METHODS: We conducted a case-control study in hospitals in Spain and in Italy. Cases were patients aged ≥18 years with a primary diagnosis of acute upper GI bleeding diagnosed by endoscopy; three controls were matched by sex, age, date of admission (within 3 months and hospital among patients who were admitted for elective surgery for non-painful disorders. Exposures to SSRIs, other antidepressants and other drugs were defined as any use of these drugs in the 7 days before the day on which upper gastrointestinal bleeding started (index day. RESULTS: 581 cases of upper GI bleeding and 1358 controls were considered eligible for the study; no differences in age or sex distribution were observed between cases and controls after matching. Overall, 4.0% of the cases and 3.3% of controls used an SSRI antidepressant in the week before the index day. No significant risk of upper GI bleeding was encountered for SSRI antidepressants (adjusted odds ratio, 1.06, 95% CI, 0.57-1.96 or for whichever other grouping of antidepressants. CONCLUSIONS: The results of this case-control study showed no significant increase in upper GI bleeding with SSRIs and provide good evidence that the magnitude of any increase in risk is not greater than 2.

  8. Intrauterine device use and the risk of pre-eclampsia: a case-control study.

    Science.gov (United States)

    Parker, S E; Jick, S S; Werler, M M

    2016-04-01

    To determine the association between intrauterine device (IUD) use, timing of removal prior to pregnancy, and the risk of pre-eclampsia. A case-control study within the Clinical Practice Research Datalink, UK. Medical record database in the UK. Cases of pre-eclampsia (n = 2744) were identified among pregnancies resulting in singleton deliveries from 1993 to 2010. Four controls, or pregnancies unaffected by pre-eclampsia, were matched to each case on maternal age, general practice, and year of delivery. Data on IUD use were obtained from patient records. The odds ratios (ORs) for the association between IUD and pre-eclampsia were adjusted for covariates identified a priori, and analyses were stratified by BMI and number of prior deliveries. Odds ratios (95% confidence intervals, 95% CIs) of pre-eclampsia in pregnancies among women with a history of IUD use, compared with women without a history of IUD use. Prior IUD use was associated with a reduced risk of pre-eclampsia (OR 0.76; 95% CI 0.58-0.98). The timing of removal in relation to the start of pregnancy showed an inverse association, with shorter intervals associated with a larger decrease in risk of pre-eclampsia. IUD removal within a year prior to pregnancy had an OR of 0.68 (95% CI 0.46-1.00). Among women with a prior delivery, the association between IUD use and pre-eclampsia was null. Intrauterine device use is associated with a small decreased risk of pre-eclampsia, specifically if removed within the year prior to conception. A case-control study of pregnancies in the UK suggests a reduced risk of pre-eclampsia for former IUD users. © 2015 Royal College of Obstetricians and Gynaecologists.

  9. Association between protozoa in sputum and asthma: a case-control study.

    Science.gov (United States)

    van Woerden, Hugo C; Ratier-Cruz, Adriana; Aleshinloye, Olabode B; Martinez-Giron, Rafael; Gregory, Clive; Matthews, Ian P

    2011-06-01

    Atypical infectious agents have been proposed as potential contributors to asthma. A novel set of morphological and staining criteria permit the identification of flagellated protozoa in sputum. This case-control study was designed to use this novel method and to assess: (1) are protozoa more common in asthmatics than in non-asthmatics; (2) is the presence of protozoa associated with the use of steroid inhalers; and (3) is the presence of protozoa associated with living in damp housing? Induced sputum samples were collected from asthma patients and local non-atopic, non-smoking controls. Questionnaires assessed asthma severity and housing conditions. Sputum was examined for flagellated protozoa using a previously described staining technique. 96 participants were recruited for this study; 54 asthma patients and 42 controls, age range 21-62 years, 70% female participants. Limiting results to those who were clearly positive or negative for flagellated protozoa, 66.7% (20/30) of asthmatics and 30.8% (4/13) of controls had protozoa (p = 0.046). Among the asthma patients, prevalence of protozoa was not significantly different between those who had (10/18), and those who had not (10/12), used steroid inhaler in the preceding two weeks (p = 0.11). Similarly, the prevalence of protozoa was not significantly different between those who did (6/11) and those who did not (18/32), live in damp homes (p = 0.92). This case-control study demonstrates an association between flagellated protozoa in sputum and asthma. It is now necessary to confirm and characterise the protozoa using genetic techniques based on 18S ribosomal RNA. Once tis is established it would be worthwhile to determine if asthma symptoms improve when treated by anti-protozoal agents. Copyright © 2010 Elsevier Ltd. All rights reserved.

  10. Anticholinergic Medication Use and Risk of Pneumonia in Elderly Adults: A Nested Case-Control Study.

    Science.gov (United States)

    Chatterjee, Satabdi; Carnahan, Ryan M; Chen, Hua; Holmes, Holly M; Johnson, Michael L; Aparasu, Rajender R

    2016-02-01

    To examine the risk of community-acquired pneumonia (CAP) associated with the use of anticholinergic medications in elderly adults. Nested case-control study. A regional Medicare Advantage healthcare plan (2009-2010). Participants were Medicare Advantage Plan enrollees aged 65 and older with at least one inpatient and one outpatient claim with no history of CAP between January 1 and June 30, 2009. Cases were identified as enrollees with an incident diagnosis of CAP, between July 1, 2009, and December 31, 2010 (n = 291). Four age- and sex-matched controls (n = 1,164) were identified per case using incidence density sampling. Anticholinergic prescription 30 days preceding the event date was the primary exposure. Anticholinergic exposure was defined based on the Anticholinergic Drug Scale (ADS). A conditional logistic regression model stratified on matched case-control sets was used, with exposure to a Level 1, 2, or 3 anticholinergic on the ADS as the main independent variable; CAP as the main outcome variable; and risk factors for CAP as additional explanatory variables. After controlling for risk factors, overall use of anticholinergic medications was significantly associated with risk of pneumonia (odds ratio (OR) = 1.65, 95% confidence interval (CI) = 1.20-2.28). The risk of pneumonia remained significant across the different exposure periods, although use of higher-level (ADS Level 2 or 3) anticholinergics was not associated with pneumonia risk (OR = 1.16, 95% CI = 0.70-1.96). Overall use of anticholinergic medications, but not higher-level drugs, was associated with greater risk of CAP compared to no use after controlling for other factors. More research is needed to better understand the role of potent anticholinergic medications on pneumonia risk in elderly adults. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  11. Salivirus in Children and Its Association with Childhood Acute Gastroenteritis: A Paired Case-Control Study.

    Science.gov (United States)

    Yu, Jie-Mei; Ao, Yuan-Yun; Liu, Na; Li, Li-Li; Duan, Zhao-Jun

    2015-01-01

    Salivirus was recently discovered in children with gastroenteritis and in sewage. Though a causative role for salivirus in childhood gastroenteritis was suggested in the previous study, the relationship between salivirus and acute gastroenteritis has not yet been clearly clarified. The sewage strain reported by Ng, although represented by incomplete genome sequencing data, was distinct from previously reported saliviruses, and had not previously been detected in humans. A case-control study examining 461 paired stool samples from children with diarrhea and healthy controls (1:1) was conducted in this study. Also, common diarrheal viruses were detected and complete genome of a salivirus was determined. Results showed that salivirus was detected in 16 (3.5%) and 13 (2.8%) of the case and control samples, respectively; no differences in detection rates (p=0.571) or mean values of viral loads (p=0.400) were observed between the groups. Multivariate Cox regression revealed no association between salivirus and gastroenteritis (p=0.774). The data also demonstrated that salivirus infection did not exacerbate clinical symptoms of gastroenteritis in children. Furthermore, complete genome sequence of a salivirus recovered from the feces of a child with diarrhea (i.e., SaliV-FHB) shared a 99% nucleotide identity with the sewage strain. In conclusion, a paired case-control study did not support a causative role for salivirus strains detected in this study with pediatric gastroenteritis. This study also demonstrated that all known saliviruses can be detected in the feces of children with or without gastroenteritis.

  12. Risk factors for mortality in ventilator-associated tracheobronchitis: a case-control study

    Science.gov (United States)

    Pontes, Leonilda Giani; de Menezes, Fernando Gatti; Gonçalves, Priscila; Toniolo, Alexandra do Rosário; Silva, Claudia Vallone; Kawagoe, Julia Yaeko; dos Santos, Camila Marques; Castagna, Helena Maria Fernandes; Martino, Marinês Dalla Valle; Corrêa, Luci

    2017-01-01

    ABSTRACT Objective To describe the microbiological characteristics and to assess the risk factors for mortality of ventilator-associated tracheobronchitis in a case-control study of intensive care patients. Methods This case-control study was conducted over a 6-year period in a 40-bed medical-surgical intensive care unit in a tertiary care, private hospital in São Paulo, Brazil. Case patients were identified using the Nosocomial Infection Control Committee database. For the analysis of risk factors, matched control subjects were selected from the same institution at a 1:8.8 ratio, between January 2006 and December 2011. Results A total of 40 episodes of ventilator-associated tracheobronchitis were evaluated in 40 patients in the intensive care unit, and 354 intensive care patients who did not experience tracheobronchitis were included as the Control Group. During the 6-year study period, a total of 42 organisms were identified (polymicrobial infections were 5%) and 88.2% of all the microorganisms identified were Gram-negative. Using a logistic regression model, we found the following independent risk factors for mortality in ventilator-associated tracheobronchitis patients: Acute Physiology and Chronic Health Evaluation I score (odds ratio 1.18 per unit of score; 95%CI: 1.05-1.38; p=0.01), and duration of mechanical ventilation (odds ratio 1.09 per day of mechanical ventilation; 95%CI: 1.03-1.17; p=0.004). Conclusion Our study provided insight into the risk factors for mortality and microbiological characteristics of ventilator-associated tracheobronchitis. PMID:28444091

  13. Risk factors of post-traumatic stress disorder (PTSD) after Wenchuan earthquake: a case control study.

    Science.gov (United States)

    Cheng, Yongzhong; Wang, Fang; Wen, Jin; Shi, Yingkang

    2014-01-01

    Few clues were found in the literature about the independent risk factors for PTSD among earthquake survivors in Sichuan province three years after the 2008 earthquake. Ours was the first case-control study with matching factors of age and distance from the epicenter among survivors age 16 years or older, three years after the catastrophe. To identify independent risk factors for PTSD among earthquake survivors. We performed a population-based matched case-control study. The cases were drawn from earthquake areas three years after the Wenchuan earthquake, including 113 cases who met positive criteria for PTSD symptoms according to the PCL-C (PTSD Checklist-Civilian Version) score and 452 controls who did not meet the criteria. Cases and controls were matched individually by birth year (+ three years) and the town they lived in when the earthquake occurred. Independent risk factors for PTSD symptoms included two-week disease prevalence (odds ratio [OR],1.92; 95% confidence interval [CI],1.18-3.13), witnessing someone being killed in the earthquake (OR, 2.04;95%CI, 1.17-3.58), having no regular income after the earthquake (OR, 0.52; 95%CI, 0.28-0.98), receiving mental health support only one time after the earthquake (OR, 2.43; 95%CI, 1.09-5.42) and lower social support (lower PSSS score) (OR, 0.95; 95%CI, 0.93-0.97). Earthquake experience, suffering from physical illnesses, lack of stable income, and lower social support were associated with PTSD symptoms.

  14. Dental x-rays and the risk of thyroid cancer: A case-control study

    International Nuclear Information System (INIS)

    Memon, Anjum; Godward, Sara; Williams, Dillwyn; Siddique, Iqbal; Al-Saleh, Khalid

    2010-01-01

    The thyroid gland is highly susceptible to radiation carcinogenesis and exposure to high-dose ionising radiation is the only established cause of thyroid cancer. Dental radiography, a common source of low-dose diagnostic radiation exposure in the general population, is often overlooked as a radiation hazard to the gland and may be associated with the risk of thyroid cancer. An increased risk of thyroid cancer has been reported in dentists, dental assistants, and x-ray workers; and exposure to dental x-rays has been associated with an increased risk of meningiomas and salivary tumours. Methods. To examine whether exposure to dental x-rays was associated with the risk of thyroid cancer, we conducted a population-based case-control interview study among 313 patients with thyroid cancer and a similar number of individually matched (year of birth ± three years, gender, nationality, district of residence) control subjects in Kuwait. Results. Conditional logistic regression analysis, adjusted for other upper-body x-rays, showed that exposure to dental x-rays was significantly associated with an increased risk of thyroid cancer (odds ratio = 2.1, 95% confidence interval: 1.4, 3.1) (p=0.001) with a dose-response pattern (p for trend <0.0001). The association did not vary appreciably by age, gender, nationality, level of education, or parity. Discussion. These findings, based on self-report by cases/controls, provide some support to the hypothesis that exposure to dental x-rays, particularly multiple exposures, may be associated with an increased risk of thyroid cancer; and warrant further study in settings where historical dental x-ray records may be available.

  15. Nasal Airway Microbiota Profile and Severe Bronchiolitis in Infants: A Case-control Study.

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    Hasegawa, Kohei; Linnemann, Rachel W; Mansbach, Jonathan M; Ajami, Nadim J; Espinola, Janice A; Petrosino, Joseph F; Piedra, Pedro A; Stevenson, Michelle D; Sullivan, Ashley F; Thompson, Amy D; Camargo, Carlos A

    2017-11-01

    Little is known about the relationship of airway microbiota with bronchiolitis in infants. We aimed to identify nasal airway microbiota profiles and to determine their association with the likelihood of bronchiolitis in infants. A case-control study was conducted. As a part of a multicenter prospective study, we collected nasal airway samples from 40 infants hospitalized with bronchiolitis. We concurrently enrolled 110 age-matched healthy controls. By applying 16S ribosomal RNA gene sequencing and an unbiased clustering approach to these 150 nasal samples, we identified microbiota profiles and determined the association of microbiota profiles with likelihood of bronchiolitis. Overall, the median age was 3 months and 56% were male. Unbiased clustering of airway microbiota identified 4 distinct profiles: Moraxella-dominant profile (37%), Corynebacterium/Dolosigranulum-dominant profile (27%), Staphylococcus-dominant profile (15%) and mixed profile (20%). Proportion of bronchiolitis was lowest in infants with Moraxella-dominant profile (14%) and highest in those with Staphylococcus-dominant profile (57%), corresponding to an odds ratio of 7.80 (95% confidence interval, 2.64-24.9; P profile and greater likelihood of bronchiolitis persisted (odds ratio for comparison with Moraxella-dominant profile, 5.16; 95% confidence interval, 1.26-22.9; P = 0.03). By contrast, Corynebacterium/Dolosigranulum-dominant profile group had low proportion of infants with bronchiolitis (17%); the likelihood of bronchiolitis in this group did not significantly differ from those with Moraxella-dominant profile in both unadjusted and adjusted analyses. In this case-control study, we identified 4 distinct nasal airway microbiota profiles in infants. Moraxella-dominant and Corynebacterium/Dolosigranulum-dominant profiles were associated with low likelihood of bronchiolitis, while Staphylococcus-dominant profile was associated with high likelihood of bronchiolitis.

  16. Case-control study of radon and lung cancer in New Jersey

    International Nuclear Information System (INIS)

    Wilcox, H. B.; Al-Zoughool, M.; Garner, M. J.; Jiang, H.; Klotz, J. B.; Krewski, D.; Nicholson, W. J.; Schoenberg, J. B.; Villeneuve, P. J.; Zielinski, J. M.

    2008-01-01

    Radon is known to cause lung cancer in humans; however, there remain uncertainties about the effects associated with residential exposures. This case-control study of residential radon and lung cancer was conducted in five counties in New Jersey and involved 561 cases and 740 controls. A yearlong α-track detector measurement of radon was completed for ∼93% of all residences lived in at the time of interview (a total of 2063). While the odds ratios (ORs) for whole data were suggestive of an increased risk for exposures >75 Bq m -3 , these associations were not statistically significant. The adjusted excess OR (EOR) per 100 Bq m -3 was -0.13 (95% CI: -0.30 to 0.44) for males, 0.29 (95% CI: -0.12 to 1.70) for females and 0.05 (95% CI: -0.14 to 0.56) for all subjects combined. An analysis of radon effects by histological type of lung cancer showed that the OR was strongest for small/oat cell carcinomas in both males and females. There was no statistical heterogeneity of radon effects by demographic factors (age at disease occurrence, education level and type of respondent). Analysis by categories of smoking status, frequency or duration did not modify the risk estimates of radon on lung cancer. The findings of this study are consistent with an earlier population-based study of radon and lung cancer among New Jersey women, and with the North American pooling of case control radon seven studies, including the previous New Jersey study. Several uncertainties regarding radon measurements and assumptions of exposure history may have resulted in underestimation of a true exposure-response relationship. (authors)

  17. Medical illness, medication use and suicide in seniors: a population-based case-control study.

    Science.gov (United States)

    Voaklander, D C; Rowe, B H; Dryden, D M; Pahal, J; Saar, P; Kelly, K D

    2008-02-01

    Suicide among seniors is a significant health problem in north America, particularly for men in whom the rates rise steadily after 50 years of age. The goal of this study was to examine elder suicides identified from a large population-based database using case-control methods to determine disease and medication factors related to suicide. A population-based 1 : 5 case-control study was conducted comparing seniors aged 66 years and older who had died by suicide with age and sex-matched controls. Case data were obtained through British Columbia (BC) Vital Statistics, whereas controls were randomly selected from the BC Health Insurance Registry. Cases and controls were linked to the provincial PharmaCare database to determine medication use and the provincial Physician Claims and Inpatient Hospitalization databases to determine co-morbidity. Between 1993 and 2002 a total of 602 seniors died by suicide in BC giving an annual rate of 13.2 per 100,000. Firearms were the most common mechanism (28%), followed by hanging/suffocation (25%), self-poisoning (21%), and jumping from height (7%). In the adjusted logistic model, variables related to suicide included: lower socioeconomic status, depression/psychosis, neurosis, stroke, cancer, liver disease, parasuicide, benzodiazepine use, narcotic pain killer use and diuretic use. There was an elevated risk for those prescribed inappropriate benzodiazepines and for those using strong narcotic pain killers. This study is consistent with previous studies that have identified a relationship between medical or psychiatric co-morbidity and suicide in seniors. In addition, new and potentially useful information confirms that certain types and dosages of benzodiazepines are harmful to seniors and their use should be avoided.

  18. Correlation of Tourette syndrome and allergic disease: nationwide population-based case-control study.

    Science.gov (United States)

    Chang, Yu-Tzu; Li, Yu-Fen; Muo, Chih-Hsin; Chen, Shih-Chieh; Chin, Zheng-Nan; Kuo, Huang-Tsung; Lin, Hung-Chih; Sung, Fung-Chang; Tsai, Chang-Hai; Chou, I-Ching

    2011-01-01

    Linkage between allergy and increased immune response activation in Tourette syndrome (TS) has been reported. We performed a matched case-control study to evaluate correlation between allergic diseases and TS. Data in this case-control study were from the Taiwan National Health Insurance Research Database. The sample comprised 845 2- to 18-year-old patients with newly diagnosed TS in 2003–2007 and 3378 controls frequency matched with cases on age, sex, and urbanization level. Unconditional logistic regression estimated odds ratios (ORs) and 95% confidence intervals (CIs) of the association between allergic disease (e.g., allergic rhinitis, atopic dermatitis, asthma, and allergic conjunctivitis), the number of allergic comorbidities, and TS. The majority (76.0%) of incident TS cases were boys; the 4 allergic diseases strongly correlated with higher risk of TS. In a model simultaneously considering all 4 allergic diseases, subjects with allergic rhinitis showed double the risk of TS (adjusted OR = 2.18, 95%CI 1.83–2.59; p < 0.0001); adjusted ORs were 1.82, 1.61, and 1.33, respectively, for asthma (95% CI 1.47–2.24; p < 0.0001), dermatitis (95%CI 1.32–1.95; p < 0.0001), and allergic conjunctivitis (95% CI 1.13–1.57; p < 0.001). Risk increased with number of comorbidities (p < 0.0001); this association was positively modified by age (p < 0.0001). Our data showed significant correlation between allergic diseases and TS. Risk also increased with number of allergic comorbidities and with age. Further studies on the mechanism of neuroimmunology of TS are required.

  19. Exposure to statins and risk of common cancers: a series of nested case-control studies

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    Coupland Carol

    2011-09-01

    Full Text Available 1 Abstract Background Many studies and meta-analyses have investigated the effects of statins on cancer incidence but without showing consistent effects. Methods A series of nested case-control studies was conducted covering 574 UK general practices within the QResearch database. Cases were patients with primary cancers diagnosed between 1998 and 2008. The associations between statin use and risk of ten site-specific cancers were estimated with conditional logistic regression adjusted for co-morbidities, smoking status, socio-economic status, and use of non-steroidal anti-inflammatory drugs, cyclo-oxygenase-2 inhibitors and aspirin. Results 88125 cases and 362254 matched controls were analysed. The adjusted odds ratio for any statin use and cancer at any site were 1.01 (95%CI 0.99 to 1.04. For haematological malignancies there was a significant reduced risk associated with any statin use (odds ratio 0.78, 95%CI 0.71 to 0.86. Prolonged (more than 4 years use of statins was associated with a significantly increased risk of colorectal cancer (odds ratio 1.23, 95%CI 1.10 to 1.38, bladder cancer (odds ratio 1.29, 95%CI 1.08 to 1.54 and lung cancer (odds ratio 1.18, 95%CI 1.05 to 1.34. There were no significant associations with any other cancers. Conclusion In this large population-based case-control study, prolonged use of statins was not associated with an increased risk of cancer at any of the most common sites except for colorectal cancer, bladder cancer and lung cancer, while there was a reduced risk of haematological malignancies.

  20. Poison prevention practices and medically attended poisoning in young children: multicentre case-control study.

    Science.gov (United States)

    Kendrick, Denise; Majsak-Newman, Gosia; Benford, Penny; Coupland, Carol; Timblin, Clare; Hayes, Mike; Goodenough, Trudy; Hawkins, Adrian; Reading, Richard

    2017-04-01

    Childhood poisonings are common, placing a substantial burden on health services. Case-control studies have found inconsistent evidence about modifiable risk factors for poisonings among children aged 0-4 years. This study quantifies associations between poison prevention practices and medically attended poisonings in children aged 0-4 years. Multicentre case-control study conducted at hospitals, minor injury units and family practices from four study centres in England between 2010 and 2013. Participants comprised 567 children presenting with unintentional poisoning occurring at home and 2320 community control participants matched on age, sex, date of event and study centre. Parents/caregivers provided data on safety practices, safety equipment use, home hazards and potential confounders by means of self-completion questionnaires. Data were analysed using conditional logistic regression. Compared with community controls, parents of poisoned children were significantly more likely not to store medicines out of reach (adjusted OR (AOR) 1.59; 95% CI 1.21 to 2.09; population attributable fraction (PAF) 15%), not to store medicines safely (locked or out of reach (AOR 1.83; 95% CI 1.38 to 2.42; PAF 16%) and not to have put all medicines (AOR 2.11; 95% CI 1.54 to 2.90; PAF 20%) or household products (AOR 1.79, 95% CI 1.29 to 2.48; PAF 11%) away immediately after use. Not storing medicines out of reach or locked away and not putting medicines and household products away immediately after use increased the odds of secondary care attended poisonings in children aged 0-4 years. If associations are causal, implementing these poison prevention practices could each prevent between 11% and 20% of poisonings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  1. Results of case-control studies support the association between contact lens use and Acanthamoeba keratitis

    Directory of Open Access Journals (Sweden)

    Pacella E

    2013-05-01

    Full Text Available Elena Pacella,1 Giuseppe La Torre,2 Maria De Giusti,2 Chiara Brillante,1 Anna Maria Lombardi,2 Gianpaolo Smaldone,1 Tommaso Lenzi,1 Fernanda Pacella11Department of Sense Organs, Faculty of Medicine and Dentistry, Sapienza University of Rome, Italy; 2Department of Public Health and Infectious Diseases, Faculty of Pharmacy and Medicine, Sapienza University of Rome, ItalyBackground: Acanthamoeba keratitis (AK is ever more frequently reported in industrialized countries. The loss of the corneal surface integrity consequent to secondary microtrauma produced by the use of contact lens (CL favors the penetration of the parasite into the corneal tissue.Objectives: A scientific review was performed to investigate the association of CL wear as an Acanthamoeba keratitis (AK risk factor.Methods: A computerized screening of 7834 Medline articles (4623 from PubMed; 3211 from Scopus used a strict selection criteria of case-control studies involving CL wear and/or trauma.Results: The search yielded five case-control studies published from 1995 to 2012. All studies included showed a statistically significant positive association between AK and CL use, with a combined odds ratio (OR of 10.21 (95%, confidence intervals [CI]; 3.57–27.64.Statistical analysis: All studies included showed a statistically significant positive association between AK and CL use, though with differing OR values.Conclusion: Though rare, AK should be held in higher consideration when ophthalmologists are faced with CL users exhibiting simplex-like lesions associated with circular stromal infiltrates and disproportionate ocular pain in respect to the objective clinical picture.Keywords: keratitis, contact lens, Acanthamoeba

  2. Identifying risk factors for blindness from primary open-angle glaucoma by race: a case-control study.

    Science.gov (United States)

    Williams, Andrew M; Huang, Wei; Muir, Kelly W; Stinnett, Sandra S; Stone, Jordan S; Rosdahl, Jullia A

    2018-01-01

    To examine the factors associated with blindness from primary open-angle glaucoma (POAG) among black and white patients at our institution. For this retrospective, case-control study, patients legally blind from POAG ("cases") were matched on age, race, and gender with non-blind POAG patients ("controls"). Thirty-seven black case-control pairs and 19 white case-control pairs were included in this study. Clinical variables were compared at initial presentation and over the course of follow-up. Black case-control pairs and white case-control pairs had similar characteristics at presentation, including cup-to-disc ratio and number of glaucoma medications. However, over the course of follow-up, black cases underwent significantly more glaucoma surgeries than matched controls (2.4 versus 1.2, p =0.001), whereas white cases and controls had no significant difference in glaucoma operations (0.9 versus 0.6, p =0.139). Our analysis found that glaucoma surgery is associated with blindness in black patients (odds ratio [OR] 1.6, 95% CI 1.1-2.2) but not in white patients (OR 1.5, 95% CI 0.7-3.2). Black and white case-control pairs with POAG shared similar risk factors for blindness at presentation. However, over the follow-up period, black cases required significantly more glaucoma surgeries compared to black controls, whereas there was no significant difference in surgery between white cases and controls. There was no difference in medication changes in either case-control set.

  3. Evaluating psychiatric case-control studies using the STROBE (STrengthening the Reporting of OBservational Studies in Epidemiology statement

    Directory of Open Access Journals (Sweden)

    Pedro Domingues Goi

    Full Text Available CONTEXT AND OBJECTIVE:Case-control studies are important in developing clinical and public health knowledge. The STROBE statement (STrengthening the Reporting of OBservational Studies in Epidemiology was developed to establish a checklist of items that should be included in articles reporting observational studies. Our aim was to analyze whether the psychiatric case-control articles published in Brazilian journals with CAPES Qualis rating B1/B2 in 2009 conformed with the STROBE statement.DESIGN AND SETTING:Descriptive study on psychiatric papers published in Brazilian journals, within the Postgraduate Medical Program on Psychiatry, at Universidade Federal do Rio Grande do Sul.METHODS:All psychiatric case-control studies from Brazilian Qualis B1/B2 journals of psychiatry, neurology and public health in 2009 were analyzed. The four most specific items of the STROBE statement were used to evaluate whether these studies fitted within the case-control parameters: 1 selection of cases and controls; 2 controlling for bias; 3 statistical analysis; and 4 presentation of results.RESULTS:Sixteen case-control studies were identified, of which eleven (68.75% were in psychiatry-focused journals. From analysis using the STROBE statement, all of the articles conformed with item 1; two (12.5% completely conformed with item 2; none completely conformed with item 3; and only three (18.8% conformed with item 4.CONCLUSION:The case-control studies analyzed here did not completely conform with the four STROBE statement items for case-control design. In view of the inadequate methodology of the published studies, these findings justify focusing on research and methodology and expanding the investigations on adherence of studies to their designs.

  4. Evaluating psychiatric case-control studies using the STROBE (STrengthening the Reporting of OBservational Studies in Epidemiology) statement.

    Science.gov (United States)

    Goi, Pedro Domingues; Goi, Julia Domingues; Cordini, Kariny Larissa; Ceresér, Keila Mendes; Rocha, Neusa Sica da

    2014-01-01

    Case-control studies are important in developing clinical and public health knowledge. The STROBE statement (STrengthening the Reporting of OBservational Studies in Epidemiology) was developed to establish a checklist of items that should be included in articles reporting observational studies. Our aim was to analyze whether the psychiatric case-control articles published in Brazilian journals with CAPES Qualis rating B1/B2 in 2009 conformed with the STROBE statement. Descriptive study on psychiatric papers published in Brazilian journals, within the Postgraduate Medical Program on Psychiatry, at Universidade Federal do Rio Grande do Sul. All psychiatric case-control studies from Brazilian Qualis B1/B2 journals of psychiatry, neurology and public health in 2009 were analyzed. The four most specific items of the STROBE statement were used to evaluate whether these studies fitted within the case-control parameters: 1) selection of cases and controls; 2) controlling for bias; 3) statistical analysis; and 4) presentation of results. Sixteen case-control studies were identified, of which eleven (68.75%) were in psychiatry-focused journals. From analysis using the STROBE statement, all of the articles conformed with item 1; two (12.5%) completely conformed with item 2; none completely conformed with item 3; and only three (18.8%) conformed with item 4. The case-control studies analyzed here did not completely conform with the four STROBE statement items for case-control design. In view of the inadequate methodology of the published studies, these findings justify focusing on research and methodology and expanding the investigations on adherence of studies to their designs.

  5. Comparison of nested case-control and survival analysis methodologies for analysis of time-dependent exposure

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    Platt Robert W

    2005-01-01

    Full Text Available Abstract Background Epidemiological studies of exposures that vary with time require an additional level of methodological complexity to account for the time-dependence of exposure. This study compares a nested case-control approach for the study of time-dependent exposure with cohort analysis using Cox regression including time-dependent covariates. Methods A cohort of 1340 subjects with four fixed and seven time-dependent covariates was used for this study. Nested case-control analyses were repeated 100 times for each of 4, 8, 16, 32, and 64 controls per case, and point estimates were compared to those obtained using Cox regression on the full cohort. Computational efficiencies were evaluated by comparing central processing unit times required for analysis of the cohort at sizes 1, 2, 4, 8, 16, and 32 times its initial size. Results Nested case-control analyses yielded results that were similar to results of Cox regression on the full cohort. Cox regression was found to be 125 times slower than the nested case-control approach (using four controls per case. Conclusions The nested case-control approach is a useful alternative for cohort analysis when studying time-dependent exposures. Its superior computational efficiency may be particularly useful when studying rare outcomes in databases, where the ability to analyze larger sample sizes can improve the power of the study.

  6. The quality of reporting of cohort, case-control studies in the korean journal of family medicine.

    Science.gov (United States)

    Kim, Mi Ra; Kim, Min Young; Kim, Soo Young; Hwang, In Hong; Yoon, Yeo Jung

    2012-03-01

    The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement was developed to improve the reporting of observational studies. We aimed to evaluate the quality of reporting in cohort studies and case-control studies among observational studies published in the Korean Journal of Family Medicine. We searched for cohort studies and case-control studies published as original articles in the Journal of the Korean Academy of Family Medicine during the period January 1992 through December 2009. The main outcome measures were the number and proportion of cohort studies and case-control studies that reported each of 22 checklist items of STROBE. We identified a total of 84 articles, of which 46 articles were cohort studies and 38 were case-control studies. Concerning methods, study designs (10%), bias (13%), study size (0%), statistical methods (12-c and 12-e items, 0%; 12-d item, cohort study, 6%) have been poorly reported. Of results, participants (5-6%), descriptive data (14-b item, 5%), and funding (1%) among other information have been poorly reported. The degree of adherence the STROBE recommendations was relatively low in cohort studies and case-control studies published in the Korean Journal of Family Medicine. An effort to improve the reporting of observational studies by application and recommendation of the STROBE statement is required.

  7. The prediction of discharge from in-patient psychiatric rehabilitation: a case-control study

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    Mountain Debbie A

    2011-09-01

    Full Text Available Abstract Background At any time, about 1% of people with severe and enduring mental illness such as schizophrenia require in-patient psychiatric rehabilitation. In-patient rehabilitation enables individuals with the most challenging difficulties to be discharged to successful and stable community living. However, the length of rehabilitation admission that is required is highly variable and the reasons for this are poorly understood. There are very few case-control studies of predictors of outcome following hospitalisation. None have been carried out for in-patient rehabilitation. We aimed to identify the factors that are associated with achieving discharge from in-patient rehabilitation by carrying out a case-control study. Methods We compared two groups: 34 people who were admitted to the Rehabilitation Service at the Royal Edinburgh Hospital and discharged within a six year study period, and 31 people who were admitted in the same period, but not discharged. We compared the groups on demographic, illness, treatment and risk variables that were present at the point of their admission to rehabilitation. We used independent t tests and Pearson Chi-Square tests to compare the two groups. Results We found that serious self harm and suicide attempts, treatment with high dose antipsychotics, antipsychotic polypharmacy and previous care in forensic psychiatric services were all significantly associated with non-discharge. The non-discharged group were admitted significantly later in the six year study period and had already spent significantly longer in hospital. People who were admitted to rehabilitation within the first ten years of developing psychosis were more likely to have achieved discharge. Conclusions People admitted later in the study period required longer rehabilitation admissions and had higher rates of serious self harm and treatment resistant illness. They were also more likely to have had previous contact with forensic services. This

  8. Delirium markers in older fallers: a case-control study

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    Doherty K

    2014-11-01

    Full Text Available Kelly Doherty,1 Elizabeth Archambault,1 Brittany Kelly,1,2 James L Rudolph1,3,4 1Geriatric Research, Education, and Clinical Center, VA Boston Healthcare System, Boston, MA, USA; 2School of Nursing, Science & Health Professions, Regis College, Boston, MA, USA; 3Division of Aging, Brigham and Women’s Hospital, Boston, MA, USA; 4Harvard Medical School, Boston, MA, USA Background: When a hospitalized older patient falls or develops delirium, there are significant consequences for the patient and the health care system. Assessments of inattention and altered consciousness, markers for delirium, were analyzed to determine if they were also associated with falls. Methods: This retrospective case-control study from a regional tertiary Veterans Affairs referral center identified falls and delirium risk factors from quality databases from 2010 to 2012. Older fallers with complete delirium risk assessments prior to falling were identified. As a control, non-fallers were matched at a 3:1 ratio. Admission risk factors that were compared in fallers and non-fallers included altered consciousness, cognitive performance, attention, sensory deficits, and dehydration. Odds ratio (OR was reported (95% confidence interval [CI]. Results: After identifying 67 fallers, the control population (n=201 was matched on age (74.4±9.8 years and ward (83.6% medical; 16.4% intensive care unit. Inattention as assessed by the Months of the Year Backward test was more common in fallers (67.2% versus 50.8%, OR=2.0; 95% CI: 1.1–3.7. Fallers tended to have altered consciousness prior to falling (28.4% versus 12.4%, OR=2.8; 95% CI: 1.3–5.8. Conclusion: In this case-control study, alterations in consciousness and inattention, assessed prior to falling, were more common in patients who fell. Brief assessments of consciousness and attention should be considered for inclusion in fall prediction. Keywords: geriatrics, patient centered outcomes research, patient safety

  9. [Risk factors for contact lens-related microbial keratitis: A multicenter case-control study].

    Science.gov (United States)

    Becmeur, P H; Abry, F; Bourcier, T; Meyer, N; Sauer, A

    2017-03-01

    Currently, the most feared complication by ophthalmologists of contact lens (CL) wear is microbial keratitis (MK), even though its incidence remains low. It is also a significant financial burden for society. This study aimed to identify the risk factors for CL-related MK especially with regard to hygiene and pattern of use, in a large, prospective, multicenter, case-control study. A multicenter retrospective case-control study was designed. The CL-related MK subpopulation (case) was compared with healthy CL wearers (control) using a 52-item anonymous questionnaire designed to determine subject demographics, lens wear history, lens type and disinfection solution, fitting, patient education, hygiene and maintenance of contact lenses, and patient history. Univariate logistic regression analysis was performed to compare both groups. The study included 497 cases and 364 controls. The risk factors associated with the greatest increased odds of CL-related MK were as follows: extended wear (OR=2.96 [1.65-5.33], P<0.001), occasional overnight lens use (OR=6.37 [4,55-8.90], P<0.001), fitting by an optician (OR=1.97 [1.38-2.83], P<0.001), absence of ophthalmologic exam (OR=6.56 [2-22], P<0.01) or no training in handling the contact lens (OR=4.47 [2.27-8.77], P<0.01), use of optician's disinfection solution (OR=5.55 [3.12-9.85], P<0.001), mixing solutions ("topping off") (OR=4.68 [2.73-8.04], P<0.001), no case replacement (OR=3.95 [2.28-6.82] P<0.01), no compliance with hygiene rules and smoking (OR=2.29 [1.67-3.14], P<0.01). The protective factors associated with the greatest reduction in OR were female gender (OR=0.49 [0.36-0.66], P<0.01), hypermetropia (OR=0.28 [0.16-0.48], P=0.01), rigid contact lens wear, fitting by an ophthalmologist, written and verbal instruction, and daily case maintenance. The knowledge of these risks factors incentivizes action at all levels to reduce the incidence of MK, from the prescriber to the patient, including the type of CL, case and

  10. Sleep disturbances in fibromyalgia: A meta-analysis of case-control studies.

    Science.gov (United States)

    Wu, Yu-Lin; Chang, Ling-Yin; Lee, Hsin-Chien; Fang, Su-Chen; Tsai, Pei-Shan

    2017-05-01

    Sleep disturbances are common in fibromyalgia, but the features of sleep disturbances are not well understood. We performed a systematic review and meta-analysis of case-control studies to compare the sleep outcomes of individuals with fibromyalgia and healthy controls. We systematically searched eight databases (PubMed, Ovid MEDLINE, Embase, CINAHL, PsycINFO, Web of Science, Airiti Library and Wanfang Data) for articles published before April 2016. Twenty-five case-controlled studies and a total of 2086 participants were included in the meta-analysis. Sleep was assessed using polysomnography and the Pittsburgh Sleep Quality Index. When sleep was assessed using polysomnography (19 studies), significant differences were observed in wake time after sleep onset (g=0.81, 95% confidence interval [CI] 0.21-1.41), total sleep time (g=-0.78, 95% CI=-1.34 to -0.15), sleep efficiency (g=-0.78, 95% CI=-1.23 to -0.32), percentage of stage 1 sleep (g=0.55, 95% CI=0.15-0.95), and percentage of slow-wave sleep (g=-0.66, 95% CI=-1.21 to -0.12) between participants with fibromyalgia and healthy controls. When sleep was assessed using the Pittsburgh Sleep Quality Index (7 studies), significant differences were observed in global scores (g=2.19, 95% CI 1.58-2.79), sleep onset latency (g=1.75, 95% CI 0.80-2.70), and sleep efficiency (g=-1.08, 95% CI -1.65 to -0.51) between participants with fibromyalgia and healthy controls. Individuals with fibromyalgia experience lower sleep quality and sleep efficiency; longer wake time after sleep onset, short sleep duration, and light sleep when objectively assessed and more difficulty in initiating sleep when subjectively assessed. Sleep difficulties in fibromyalgia appear to be more when reported subjectively than when assessed objectively. This study received no funding from any source. All authors declare that they have no conflict of interest. This article does not contain any studies with human participants performed by any of the authors

  11. Opium consumption and risk of bladder cancer: A case-control analysis.

    Science.gov (United States)

    Hosseini, Seyyed Yousof; Safarinejad, Mohammad Reza; Amini, Erfan; Hooshyar, Hassan

    2010-01-01

    We evaluated the relationship between opium consumption and bladder cancer (BC) in a case-control study of an Iranian population. In a hospital-based case-control study of 179 patients with BC and 179 cancer-free controls frequency-matched by age, sex, and smoking status, we investigated the relationship between opium consumption and BC. A comprehensive epidemiologic interview was conducted on all participants to collect personal information, such as demographics and smoking status. Overall, we found significant age, sex, cigarette smoking adjusted association between BC risk and opium consumption, [odds ratio (OR) = 4.60; 95% confidence interval (CI) = 3.53-6.28]. The elevated risk was more evident in older individuals (OR = 5.42; 95% CI, 4.12-7.28) than younger individuals (OR = 3.65; 95% CI, 2.76-4.76) (P = 0.01). Heavy smokers with the opium consumption exhibited a 6-fold elevated risk for BC (OR = 6.16; 95% CI, 3.34-8.32) (P = 0.0001). When stratified according to different grades of BC, a 3.4-fold increased risk was associated with the opium consumption in grade III with an OR of 3.44 (95% CI, 2.82-8.28) (P = 0.001). A similar but slightly higher risk was also seen in case of grade IV tumors (OR = 3.86; 95% CI, 2.14-10.16) (P = 0.001). Invasive bladder tumors were more common among the opiates users (OR = 2.6; 95% CI, 1.44-5.42) (P = 0.01). Cumulative risk of BC in women with opium consumption (OR = 4.10 95% CI, 3.54-5.88) (P = 0.001) was slightly less than in men (OR = 5.10 95% CI, 3.54-5.88) (P = 0.0001). Based on Pearson correlations, the risk of BC significantly correlated with opium dependence duration (r = 0.74, P = 0.001), type of opiate used (r = 0.65, P = 0.001), and simultaneous cigarette smoking (r = 0.74, P = 0.0001). The results indicated that there is about 5-fold increase in risk of developing this cancer in the presence of opium consumption. Further research is needed to investigate the functional implications of the opium consumption in BC

  12. Acetylcholinesterase inhibitors and the risk of osteoporotic fractures: nested case-control study.

    Science.gov (United States)

    Tamimi, I; Nicolau, B; Eimar, H; Arekunnath Madathil, S; Kezouh, A; Karp, I; Tamimi, F

    2018-04-01

    The objective of this study was to analyze the effect of acetylcholinesterase inhibitors (AChEIs) on the risk of osteoporotic fractures in Alzheimer patients. A nested case-control study was conducted on 1190 cases and 4760 controls. The use of AChEIs was found to decrease the risk of osteoporotic fractures in these patients. The objective of this study is to estimate the extent to which the use of AChEIs is associated with a reduction in the risk of osteoporotic fractures. A nested case-control study was conducted using data from the UK Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) database (1998-2013). The study cohort consisted of Alzheimer's Disease (AD) patients aged ≥ 65 years with no previous history of osteoporotic fractures at cohort baseline. Cases were individuals who suffered an osteoporotic fracture during the study period, whereas controls were subject who did not experience any osteoporotic fractures during the same period. Controls were drawn from the population time at risk while being matched to the cases in respect to age, sex, up-to-standard follow-up in the CPRD, calendar time, and duration of AD (control-to-case ratio: 4-to-1). Information on the use of AChEIs and the relevant potential confounders was ascertained from the CPRD database for all the cases and controls. We identified 1190 cases and 4760 controls. Compared to non-users, any use of AChEIs prior to the fracture was associated with a reduction in the fracture risk [adjusted odds ratio (OR) 0.80 (confidence interval (CI) 95%, 0.70-0.91)]. The use of AChEIs corresponding to a proportion of days covered of 0.8-1.0 was associated with a lower osteoporotic fracture risk compared to non-use [adjusted OR 0.76 (CI 95%, 0.66-0.87)]. In this study using large primary care databases, the use and treatment adherence to AChEIs were associated with a decreased risk of osteoporotic fractures in elderly AD patients.

  13. Artificial sweeteners and cancer risk in a network of case-control studies.

    Science.gov (United States)

    Gallus, S; Scotti, L; Negri, E; Talamini, R; Franceschi, S; Montella, M; Giacosa, A; Dal Maso, L; La Vecchia, C

    2007-01-01

    The role of sweeteners on cancer risk has been widely debated over the last few decades. To provide additional information on saccharin and other sweeteners (mainly aspartame), we considered data from a large network of case-control studies. An integrated network of case-control studies has been conducted between 1991 and 2004 in Italy. Cases were 598 patients with incident, histologically confirmed cancers of the oral cavity and pharynx, 304 of the oesophagus, 1225 of the colon, 728 of the rectum, 460 of the larynx, 2569 of the breast, 1031 of the ovary, 1294 of the prostate and 767 of the kidney (renal cell carcinoma). Controls were 7028 patients (3301 men and 3727 women) admitted to the same hospitals as cases for acute, non-neoplastic disorders. Odds ratios (ORs), and the corresponding 95% confidence intervals (CIs), were derived by unconditional logistic regression models. The ORs for consumption of saccharin were 0.83 (95% CI 0.30-2.29) for cancers of the oral cavity and pharynx, 1.58 (95% CI 0.59-4.25) for oesophageal, 0.95 (95% CI 0.67-1.35) for colon, 0.93 (95% CI 0.60-1.45) for rectal, 1.55 (95% CI 0.76-3.16) for laryngeal, 1.01 (95% CI 0.77-1.33) for breast, 0.46 (95% CI 0.29-0.74) for ovarian, 0.91 (95% CI 0.59-1.40) for prostate and 0.79 (95% CI 0.49-1.28) for kidney cancer. The ORs for consumption of other sweeteners, mainly aspartame, were 0.77 (95% CI 0.39-1.53) for cancers of the oral cavity and pharynx, 0.77 (95% CI 0.34-1.75) for oesophageal, 0.90 (95% CI 0.70-1.16) for colon, 0.71 (95% CI 0.50-1.02) for rectal, 1.62 (95% CI 0.84-3.14) for laryngeal, 0.80 (95% CI 0.65-0.97) for breast, 0.75 (95% CI 0.56-1.00) for ovarian, 1.23 (95% CI 0.86-1.76) for prostate and 1.03 (95% CI 0.73-1.46) for kidney cancer. A significant inverse trend in risk for increasing categories of total sweeteners was found for breast and ovarian cancer, and a direct one for laryngeal cancer. The present work indicates a lack of association between saccharin, aspartame and

  14. Symptoms and sources of Yersinia enterocolitica-infection: a case-control study

    Directory of Open Access Journals (Sweden)

    Siitonen Anja

    2010-05-01

    Full Text Available Abstract Background Yersinia enterocolitica (YE is the causative agent of yersiniosis. YE encompass strains of diverse pathogenicity: YE biotypes 1B and 2-5 are considered pathogenic, whereas biotype 1A is in general considered nonvirulent. Also YE-like species, which can sometimes be misidentified as YE, are considered nonvirulent. Methods In order to study differences in clinical picture caused by different YE types and their possible sources a case-control study was conducted in 2006. In this case-control study, 295 case-patients with YE or YE-like finding and their 758 controls responded to the questionnaire about symptoms and possible sources of infection. Results Strains of pathogenic YE bio/serotypes 3-4/O:3 or 2/O:9 were found in 18%, YE biotype 1A in 65% and YE -like strains of 17% of the patients. Patients infected with the strains of pathogenic YE bio/serotypes were younger and had fever more often than those with BT 1A who suffered more from vomiting. Symptoms of reactive arthritis were reported by 10% of pathogenic YE infections, 3% of YE BT 1A, and 0.3% of the controls. Eating or tasting raw or medium done pork was a significant risk factor for pathogenic YE bio/serotype infection (OR 6.6; 95% CI 1.7-24.9 as well as eating in a canteen (OR 3.5; 95% CI 1.6-7.9. Imported fruits and berries were associated with increased risk of YE BT 1A finding. Conclusions The symptoms of the patients with YE BT 1A differed from yersiniosis caused by the classic pathogenic YE bio/serotypes. In addition, the patients with YE BT 1A had more protracted gastrointestinal disorders and unspecific complaints. Small children were overrepresented in classic pathogenic bio/serotypes while in BT 1A or YE-like species were not found among children younger than two years. This suggests the lacking virulence of the BT 1A strains. We can not, however, rule out the possibility that some strains of genetically heterogeneous group of BT 1A may cause an illness.

  15. High failure rate of anterior cruciate ligament reconstruction with bimeniscal repair: A case-control study.

    Science.gov (United States)

    Gonçalves, H; Steltzlen, C; Boisrenoult, P; Beaufils, P; Pujol, N

    2017-10-01

    Bimeniscal lesions are common in patients with anterior cruciate ligament (ACL) tears. However, bimeniscal repair is rarely performed during ACL reconstruction. To assess outcomes after ACL reconstruction with bimeniscal repair. Bimeniscal lesions, even when repaired, are associated with poorer outcomes of ACL reconstruction. A retrospective case-control design was used. The cases were 15 patients who underwent ACL reconstruction, without procedures on any other ligaments, combined with bimeniscal repair, between May 2009 and May 2013 (3.2% of all ACL reconstructions during the study period). This group (2-Mc group) was matched on age, gender, body mass index, and time to surgery to 30 patients who underwent ACL reconstruction and had no meniscal lesions (0-Mc group) and to 30 patients who underwent ACL reconstruction and repair of the medial meniscus (1-Mc group). After a mean follow-up of 3.6 years, clinical outcomes were assessed based on the KOOS, Lysholm, and IKDC scores and knee laxity based on TELOS and GNRB measurements. The primary outcome measure was the rate of ACL re-rupture. Secondary outcome measures were functional outcomes and rate of delayed meniscectomy. The ACL re-rupture rate was significantly higher in the 2-Mc group than in the 0-Mc and 1-Mc groups pooled (20%, vs. 1.7%; P=0.02). The functional scores showed no significant differences across groups. Post-operative differential laxity was significantly greater in the 2-Mc group (3.3mm by TELOS, P=0.02; and 2.5mm by GNRB, P=0.03) than in the 0-Mc and 1-Mc groups pooled. Delayed meniscectomy was performed in none of the 2-Mc group patients and in 2 of the 1-Mc group patients. ACL reconstruction combined with