WorldWideScience

Sample records for case control trial

  1. Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

    Science.gov (United States)

    Fleischmann, Robert; Decker, Anne-Marie; Kraft, Antje; Mai, Knut; Schmidt, Sein

    2017-12-01

    Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity. This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics. All randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings  across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F (1,112)  = .15, p = .699), CRF length (F (2,112)  = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was

  2. Do Instructional Videos on Sputum Submission Result in Increased Tuberculosis Case Detection? A Randomized Controlled Trial.

    Science.gov (United States)

    Mhalu, Grace; Hella, Jerry; Doulla, Basra; Mhimbira, Francis; Mtutu, Hawa; Hiza, Helen; Sasamalo, Mohamed; Rutaihwa, Liliana; Rieder, Hans L; Seimon, Tamsyn; Mutayoba, Beatrice; Weiss, Mitchell G; Fenner, Lukas

    2015-01-01

    We examined the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB), and evaluated the acceptance of the video. Randomized controlled trial. We prepared a culturally adapted instructional video for sputum submission. We analyzed 200 presumptive TB cases coughing for more than two weeks who attended the outpatient department of the governmental Municipal Hospital in Mwananyamala (Dar es Salaam, Tanzania). They were randomly assigned to either receive instructions on sputum submission using the video before submission (intervention group, n = 100) or standard of care (control group, n = 100). Sputum samples were examined for volume, quality and presence of acid-fast bacilli by experienced laboratory technicians blinded to study groups. Median age was 39.1 years (interquartile range 37.0-50.0); 94 (47%) were females, 106 (53%) were males, and 49 (24.5%) were HIV-infected. We found that the instructional video intervention was associated with detection of a higher proportion of microscopically confirmed cases (56%, 95% confidence interval [95% CI] 45.7-65.9%, sputum smear positive patients in the intervention group versus 23%, 95% CI 15.2-32.5%, in the control group, p sex, modified the effectiveness of the intervention by improving it positively. When asked how well the video instructions were understood, the majority of patients in the intervention group reported to have understood the video instructions well (97%). Most of the patients thought the video would be useful in the cultural setting of Tanzania (92%). Sputum submission instructional videos increased the yield of tuberculosis cases through better quality of sputum samples. If confirmed in larger studies, instructional videos may have a substantial effect on the case yield using sputum microscopy and also molecular tests. This low-cost strategy should be considered as part of the efforts to control TB in resource-limited settings. Pan African

  3. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

    Directory of Open Access Journals (Sweden)

    Daly Fergus

    2007-03-01

    Full Text Available Abstract Background It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. Conclusion While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully

  4. Do Instructional Videos on Sputum Submission Result in Increased Tuberculosis Case Detection? A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Grace Mhalu

    Full Text Available We examined the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB, and evaluated the acceptance of the video.Randomized controlled trial.We prepared a culturally adapted instructional video for sputum submission. We analyzed 200 presumptive TB cases coughing for more than two weeks who attended the outpatient department of the governmental Municipal Hospital in Mwananyamala (Dar es Salaam, Tanzania. They were randomly assigned to either receive instructions on sputum submission using the video before submission (intervention group, n = 100 or standard of care (control group, n = 100. Sputum samples were examined for volume, quality and presence of acid-fast bacilli by experienced laboratory technicians blinded to study groups.Median age was 39.1 years (interquartile range 37.0-50.0; 94 (47% were females, 106 (53% were males, and 49 (24.5% were HIV-infected. We found that the instructional video intervention was associated with detection of a higher proportion of microscopically confirmed cases (56%, 95% confidence interval [95% CI] 45.7-65.9%, sputum smear positive patients in the intervention group versus 23%, 95% CI 15.2-32.5%, in the control group, p <0.0001, an increase in volume of specimen defined as a volume ≥3ml (78%, 95% CI 68.6-85.7%, versus 45%, 95% CI 35.0-55.3%, p <0.0001, and specimens less likely to be salivary (14%, 95% CI 7.9-22.4%, versus 39%, 95% CI 29.4-49.3%, p = 0.0001. Older age, but not the HIV status or sex, modified the effectiveness of the intervention by improving it positively. When asked how well the video instructions were understood, the majority of patients in the intervention group reported to have understood the video instructions well (97%. Most of the patients thought the video would be useful in the cultural setting of Tanzania (92%.Sputum submission instructional videos increased the yield of tuberculosis cases through better quality of sputum

  5. Case-based learning and simulation: useful tools to enhance nurses' education? Nonrandomized controlled trial.

    Science.gov (United States)

    Raurell-Torredà, Marta; Olivet-Pujol, Josep; Romero-Collado, Àngel; Malagon-Aguilera, Maria Carmen; Patiño-Masó, Josefina; Baltasar-Bagué, Alícia

    2015-01-01

    To compare skills acquired by undergraduate nursing students enrolled in a medical-surgical course. To compare skills demonstrated by students with no previous clinical practice (undergraduates) and nurses with clinical experience enrolled in continuing professional education (CPE). In a nonrandomized clinical trial, 101 undergraduates enrolled in the "Adult Patients 1" course were assigned to the traditional lecture and discussion (n = 66) or lecture and discussion plus case-based learning (n = 35) arm of the study; 59 CPE nurses constituted a comparison group to assess the effects of previous clinical experience on learning outcomes. Scores on an objective structured clinical examination (OSCE), using a human patient simulator and cases validated by the National League for Nursing, were compared for the undergraduate control and intervention groups, and for CPE nurses (Student's t test). Controls scored lower than the intervention group on patient assessment (6.3 ± 2.3 vs 7.5 ± 1.4, p = .04, mean difference, -1.2 [95% confidence interval (CI) -2.4 to -0.03]) but the intervention group did not differ from CPE nurses (7.5 ± 1.4 vs 8.8 ± 1.5, p = .06, mean difference, -1.3 [95% CI -2.6 to 0.04]). The CPE nurses committed more "rules-based errors" than did undergraduates, specifically patient identifications (77.2% vs 55%, p = .7) and checking allergies before administering medication (68.2% vs 60%, p = .1). The intervention group developed better patient assessment skills than the control group. Case-based learning helps to standardize the process, which can contribute to quality and consistency in practice: It is essential to correctly identify a problem in order to treat it. Clinical experience of CPE nurses was not associated with better adherence to safety protocols. Case-based learning improves the patient assessment skills of undergraduate nursing students, thereby preparing them for clinical practice. © 2014 Sigma Theta Tau International.

  6. Case-control Studies on the Effectiveness of Breast Cancer Screening: Insights from the UK Age Trial.

    Science.gov (United States)

    van der Waal, Daniëlle; Broeders, Mireille J M; Verbeek, André L M; Duffy, Stephen W; Moss, Sue M

    2015-07-01

    Ongoing breast cancer screening programs can only be evaluated using observational study designs. Most studies have observed a reduction in breast cancer mortality, but design differences appear to have resulted in different estimates. Direct comparison of case-control and trial analyses gives more insight into this variation. Here, we performed case-control analyses within the randomized UK Age Trial. The Age Trial assessed the effect of screening on breast cancer mortality in women ages 40-49 years. In our approach, case subjects were defined as breast cancer deaths between trial entry (1991-1997) and 2004. Women were ages 39-41 years at entry. For every case subject, five control subjects were selected. All case subjects were included in analyses of screening invitation (356 case subjects, 1,780 controls), whereas analyses of attendance were restricted to women invited to screening (105 case subjects, 525 age-matched controls). Odds ratios (OR) were estimated with conditional logistic regression. We used and compared two methods to correct for self-selection bias. Screening invitation resulted in a breast cancer mortality reduction of 17% (95% confidence interval [CI]: -36%, +6%), similar to trial results. Different exposure definitions and self-selection adjustments influenced the observed breast cancer mortality reduction. Depending on the method, "ever screened" appeared to be associated with a small reduction (OR: 0.86, 95% CI: 0.40, 1.89) or no reduction (OR: 1.02, 95% CI: 0.48, 2.14) using the two methods of correction. Recent attendance resulted in an adjusted mortality reduction of 36% (95% CI: -69%, +31%) or 45% (95% CI: -71%, +5%). Observational studies, and particularly case-control studies, are an important monitoring tool for breast cancer screening programs. The focus should be on diminishing bias in observational studies and gaining a better understanding of the influence of study design on estimates of mortality reduction.

  7. Assessing the Effectiveness of Case-Based Collaborative Learning via Randomized Controlled Trial.

    Science.gov (United States)

    Krupat, Edward; Richards, Jeremy B; Sullivan, Amy M; Fleenor, Thomas J; Schwartzstein, Richard M

    2016-05-01

    Case-based collaborative learning (CBCL) is a novel small-group approach that borrows from team-based learning principles and incorporates elements of problem-based learning (PBL) and case-based learning. CBCL includes a preclass readiness assurance process and case-based in-class activities in which students respond to focused, open-ended questions individually, discuss their answers in groups of 4, and then reach consensus in larger groups of 16. This study introduces CBCL and assesses its effectiveness in one course at Harvard Medical School. In a 2013 randomized controlled trial, 64 medical and dental student volunteers were assigned randomly to one of four 8-person PBL tutorial groups (control; n = 32) or one of two 16-person CBCL tutorial groups (experimental condition; n = 32) as part of a required first-year physiology course. Outcomes for the PBL and CBCL groups were compared using final exam scores, student responses to a postcourse survey, and behavioral coding of portions of video-recorded class sessions. Overall, the course final exam scores for CBCL and PBL students were not significantly different. However, CBCL students whose mean exam performance in prior courses was below the participant median scored significantly higher than their PBL counterparts on the physiology course final exam. The most common adjectives students used to describe CBCL were "engaging," "fun," and "thought-provoking." Coding of observed behaviors indicated that individual affect was significantly higher in the CBCL groups than in the PBL groups. CBCL is a viable, engaging, active learning method. It may particularly benefit students with lower academic performance.

  8. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China.

    Science.gov (United States)

    Zhao, Ling; Zhang, Fu-wen; Li, Ying; Wu, Xi; Zheng, Hui; Cheng, Lin-hao; Liang, Fan-rong

    2011-03-24

    In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs) to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence. This observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis. Among the 1968 patients, 74 patients (3.76%) suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients. Acupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs) were related to the patients' gender and age and the local anatomical structure of the acupoints. AEs could be reduced and

  9. Study protocol for a controlled trial of Strengths Model Case Management in mental health services in Hong Kong.

    Science.gov (United States)

    Tsoi, Wing-See Emily; Tse, Samson; Fukui, Sadaaki; Jones, Steven

    2015-10-06

    Although strengths-based models are popular within recovery-oriented approaches, there is still a lack of conclusive research to guide how they should be implemented. A recent meta-analysis confirmed the lack of clarity in how this perspective is operationalised and that fidelity monitoring during the implementation process is lacking. Hence, there is a clear need to evaluate the feasibility of delivering and evaluating a clearly operationalised strengths-based intervention that incorporates fidelity checks to inform more definitive research. This protocol therefore describes a controlled trial of Strengths Model Case Management (SMCM), a complex intervention, for people with severe mental illnesses in Hong Kong. This trial follows the guidelines of the Medical Research Council as a phase 2 trial. Hence, it is a pilot study that tests the feasibility and effectiveness of the model. This is a 9-month controlled trial that uses the Kansas Model. Participants and a matched control group are recruited on a voluntary basis, after screening for eligibility. Effectiveness of the SMCM will be measured through outcome measures taken at baseline, the mid-point and at the end of the trial. Outcomes for service users include personal recovery, hope, subjective well-being, psychiatric symptoms, perceived level of recovery features within the organisation, therapeutic alliance and achievement of recovery goals. Outcomes for care workers will include job burnout, organisational features of recovery and perceived supervisory support. With a 2×3 analysis of variance design and a moderate intervention effect (Cohen's d=0.50), a total of 86 participants will be needed for a statistical power of 0.80. Ethical approval has been obtained from the Human Research Ethics Committee for Non-Clinical Faculties at The University of Hong Kong (HRECNCF: EA140913). Australian New Zealand Clinical Trial Registry (ACTRN)12613001120763. Published by the BMJ Publishing Group Limited. For permission

  10. Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

    Directory of Open Access Journals (Sweden)

    Soyeon Cheon

    2018-01-01

    Full Text Available Abstract Background While full disclosure of information on placebo control in participant information leaflets (PILs in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Methods Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. Results In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI −0.21 vs. −0.16; p = 0.38. In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference − 0.43 vs. −0.12; p = 0.03, probably due to enhanced expectations. Conclusions How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we

  11. Should we embed randomized controlled trials within action research: arguing from a case study of telemonitoring

    Directory of Open Access Journals (Sweden)

    Karen Day

    2016-06-01

    Full Text Available Abstract Background Action research (AR and randomized controlled trials (RCTs are usually considered to be theoretically and practically incompatible. However, we argue that their respective strengths and weaknesses can be complementary. We illustrate our argument from a recent study assessing the effect of telemonitoring on health-related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals in two urban hospital services and one remote rural primary care service in New Zealand. Methods Data came from authors’ observations and field notes of discussions with three groups: the healthcare providers and healthcare consumers who participated in the research, and a group of 17 researchers and collaborators. The consumers had heart failure (Site A, urban, airways disease (Site B, urban, and diabetes (Site C, rural. The research ran from 2008 (project inception until 2012 (project close-off. Researchers came from a wide range of disciplines. Both RCT and AR methods were recognised from early in the process but often worked in parallel rather than together. In retrospect, we have mapped our observed research processes to the AR cycle characteristics (creation of communicative space, democracy and participation, iterative learning and improvement, emergence, and accommodation of different ways of knowing. Results We describe the context, conduct and outcomes of the telemonitoring trial, framing the overall process in the language of AR. Although not fully articulated at the time, AR processes made the RCT sensitive to important context, e.g. clinical processes. They resulted in substantive changes to the design and conduct of the RCT, and to interpretation and uptake of findings, e.g. a simpler technology procurement process emerged. Creating a communicative space enabled co-design between the researcher group and collaborators from the provider participant group, and a stronger

  12. Pregnant womens' concerns when invited to a randomized trial: a qualitative case control study

    NARCIS (Netherlands)

    Oude Rengerink, Katrien; Logtenberg, Sabine; Hooft, Lotty; Bossuyt, Patrick M.; Mol, Ben Willem

    2015-01-01

    Pregnant women were excluded from clinical trials until the 1990s, but the Food and Drug Administration nowadays allows--and even encourages--responsible inclusion of pregnant women in trials with adequate safety monitoring. Still, randomized trials in pregnant women face specific enrolment

  13. Pregnant womens' concerns when invited to a randomized trial : a qualitative case control study

    NARCIS (Netherlands)

    Oude Rengerink, Katrien; Logtenberg, Sabine; Hooft, Lotty; Bossuyt, Patrick M; Mol, Ben Willem; Oude Rengerink, K

    2015-01-01

    BACKGROUND: Pregnant women were excluded from clinical trials until the 1990s, but the Food and Drug Administration nowadays allows--and even encourages--responsible inclusion of pregnant women in trials with adequate safety monitoring. Still, randomized trials in pregnant women face specific

  14. Risk factors for inguinal hernia in women: a case-control study. The Coala Trial Group.

    Science.gov (United States)

    Liem, M S; van der Graaf, Y; Zwart, R C; Geurts, I; van Vroonhoven, T J

    1997-11-01

    Potential risk factors for inguinal hernia in women were investigated and the relative importance of these factors was quantified. In women, symptomatic but nonpalpable hernias often remain undiagnosed. However, knowledge on this subject only concerns hernia and operation characteristics, which have been obtained by review of case series. Virtually nothing is known about risk factors for inguinal hernia. The authors performed a hospital-based case-control study of 89 female patients with an incident inguinal hernia and 176 age-matched female controls. Activity since birth with two validated questionnaires was measured and smoking habits, medical and operation history, Quetelet index (kg/m2), and history of pregnancies and deliveries were recorded. Response for cases was 81% and for controls 73%. Total physical activity was not associated with inguinal hernia (univariate odds ratio (OR) = 0.8, 95% confidence interval (CI) 0.6-1.1), but high present sports activities was associated with less inguinal hernia (multivariate OR = 0.2, 95% CI 0.1-0.7). Obesity (Quetelet index > 30) was also protective for inguinal hernia (OR = 0.2, 95% CI 0.04-1.0). Independent risk factors were positive family history (OR = 4.3, 95% CI 1.9-9.7) and obstipation (OR = 2.5, 95% CI 1.0-6.7). In particular, smoking, appendectomy, other abdominal operations, and multiple deliveries were not associated with inguinal hernia in females. The protective effect of present sports activity may be explained by optimizing the resistance of the abdominal musculature protecting the relatively small inguinal weak spot in the female. The individual predisposition for inguinal hernia may be quantified by these risk factors, and, with this in mind, the authors advise that further evaluation might be needed for the patient with unexplained inguinal pain.

  15. [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.

  16. Participant demographics reported in "Table 1" of randomised controlled trials: a case of "inverse evidence"?

    Directory of Open Access Journals (Sweden)

    Furler John

    2012-03-01

    Full Text Available Abstract Introduction Data supporting external validity of trial results allows clinicians to assess the applicability of a study's findings to their practice population. Socio-economic status (SES of trial participants may be critical to external validity given the relationship between social and economic circumstances and health. We explored how this is documented in reports of RCTs in four major general medical journals. Methods The contents lists of four leading general medical journals were hand searched to identify 25 consecutive papers reporting RCT results in each journal (n = 100. Data on demographic characteristics were extracted from each paper's Table 1 only (or equivalent. Results Authors infrequently reported key demographic characteristics relating to SES of RCT participants. Age and gender of participants were commonly reported. Less than 10% reported occupational group, employment status, income or area based measures of disadvantage. Conclusions Without adequate reporting of key indicators of SES in trial participants it is unclear if lower SES groups are under-represented. If such groups are systematically under-recruited into trials, this may limit the external validity and applicability of study findings to these groups. This is in spite of the higher health-care need in more disadvantaged populations. Under-representation of low SES groups could underestimate the reported effect of an intervention for those with a higher baseline risk. The marginal benefit identified in a trial with poor or no representation of lower SES participants could significantly underestimate the potential benefit to a low SES community. More transparency in this reporting and greater attention to the impact of SES on intervention outcomes in clinical trials is needed. This could be considered in the next revision of the CONSORT statement.

  17. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis.

    Science.gov (United States)

    Marty, Francisco M; Ostrosky-Zeichner, Luis; Cornely, Oliver A; Mullane, Kathleen M; Perfect, John R; Thompson, George R; Alangaden, George J; Brown, Janice M; Fredricks, David N; Heinz, Werner J; Herbrecht, Raoul; Klimko, Nikolai; Klyasova, Galina; Maertens, Johan A; Melinkeri, Sameer R; Oren, Ilana; Pappas, Peter G; Ráčil, Zdeněk; Rahav, Galia; Santos, Rodrigo; Schwartz, Stefan; Vehreschild, J Janne; Young, Jo-Anne H; Chetchotisakd, Ploenchan; Jaruratanasirikul, Sutep; Kanj, Souha S; Engelhardt, Marc; Kaufhold, Achim; Ito, Masanori; Lee, Misun; Sasse, Carolyn; Maher, Rochelle M; Zeiher, Bernhardt; Vehreschild, Maria J G T

    2016-07-01

    Mucormycosis is an uncommon invasive fungal disease with high mortality and few treatment options. Isavuconazole is a triazole active in vitro and in animal models against moulds of the order Mucorales. We assessed the efficacy and safety of isavuconazole for treatment of mucormycosis and compared its efficacy with amphotericin B in a matched case-control analysis. In a single-arm open-label trial (VITAL study), adult patients (≥18 years) with invasive fungal disease caused by rare fungi, including mucormycosis, were recruited from 34 centres worldwide. Patients were given isavuconazole 200 mg (as its intravenous or oral water-soluble prodrug, isavuconazonium sulfate) three times daily for six doses, followed by 200 mg/day until invasive fungal disease resolution, failure, or for 180 days or more. The primary endpoint was independent data review committee-determined overall response-ie, complete or partial response (treatment success) or stable or progressive disease (treatment failure)-according to prespecified criteria. Mucormycosis cases treated with isavuconazole as primary treatment were matched with controls from the FungiScope Registry, recruited from 17 centres worldwide, who received primary amphotericin B-based treatment, and were analysed for day-42 all-cause mortality. VITAL is registered with ClinicalTrials.gov, number NCT00634049. FungiScope is registered with ClinicalTrials.gov, number NCT01731353. Within the VITAL study, from April 22, 2008, to June 21, 2013, 37 patients with mucormycosis received isavuconazole for a median of 84 days (IQR 19-179, range 2-882). By day 42, four patients (11%) had a partial response, 16 (43%) had stable invasive fungal disease, one (3%) had invasive fungal disease progression, three (8%) had missing assessments, and 13 (35%) had died. 35 patients (95%) had adverse events (28 [76%] serious). Day-42 crude all-cause mortality in seven (33%) of 21 primary-treatment isavuconazole cases was similar to 13 (39%) of 33

  18. [Role of physical, psychological and sexual abuse in functional digestive disorders. A case-controls trial.].

    Science.gov (United States)

    Remes-Troche, J M; Cid-Juárez, S; Campos-Ramos, I; Ramos-de la Medina, A; Galmiche, A; Schmulson-Wasserman, M; Roesch-Dietlen, F

    2008-01-01

    Abuse has been considered a significant factor on the development of functional gastrointestinal disorders (FGID), especially for severe and treatment-refractory patients. The aim of our study was to evaluate the presence of all FGID according to Rome II criteria, in a group of women with history of physical, psychological and/or sexual abuse. A cross sectional study was performed in 96 women (37 +/- 12 years of age) with history of physical, psychological and/or sexual abuse (cases); and 96 open population women (36 +/- 14 years of age) (controls). The following evaluations were administered: Rome II questionnaire, a self-administered instrument to evaluate history of physical (beating), psychological(insults, public humiliation) and/or sexual abuse (rape, coercion), and HAD questionnaire. Among 96 women with history of abuse,91 (95%) reported to have suffered psychological abuse, 72 (75%) physical abuse, and 24 (25%)sexual abuse. Women with history of abuse had a higher prevalence of rumination (6% vs. 0%, p= 0.02), functional heartburn (26% vs. 13%, p =0.04), aerofagia (17% vs. 5%, p = 0.019), irritable bowel syndrome (38% vs. 18%, p = 0.002), fecalin continence (16% vs. 4%, p = 0.01), elevator anisyndrome (5% vs. 0%, p = 0.05), and proctalgia fugax (29% vs. 15%, p = 0.02) compared to controls. There was a positive correlation between anxiety (r = 0.5, p = 0.001) and depression scores(r = 0.45, p = 0.001), and the number of FGID. We demonstrated a high prevalence of FGID among women with history of physical,psychological, and/or sexual abuse. In this association,concomitant anxiety and depression play a significant role.

  19. Work Incapacity and Treatment Costs After Severe Accidents: Standard Versus Intensive Case Management in a 6-Year Randomized Controlled Trial.

    Science.gov (United States)

    Scholz, Stefan M; Andermatt, Peter; Tobler, Benno L; Spinnler, Dieter

    2016-09-01

    Purpose Case management is widely accepted as an effective method to support medical rehabilitation and vocational reintegration of accident victims with musculoskeletal injuries. This study investigates whether more intensive case management improves outcomes such as work incapacity and treatment costs for severely injured patients. Methods 8,050 patients were randomly allocated either to standard case management (SCM, administered by claims specialists) or intensive case management (ICM, administered by case managers). These study groups differ mainly by caseload, which was approximately 100 cases in SCM and 35 in ICM. The setting is equivalent to a prospective randomized controlled trial. A 6-year follow-up period was chosen in order to encompass both short-term insurance benefits and permanent disability costs. All data were extracted from administrative insurance databases. Results Average work incapacity over the 6-year follow-up, including contributions from daily allowances and permanent losses from disability, was slightly but insignificantly higher under ICM than under SCM (21.6 vs. 21.3 % of pre-accident work capacity). Remaining work incapacity after 6 years of follow-up showed no difference between ICM and SCM (8.9 vs. 8.8 % of pre-accident work incapacity). Treatment costs were 43,500 Swiss Francs (CHF) in ICM compared to 39,800 in SCM (+9.4 %, p = 0.01). The number of care providers involved in ICM was 10.5 compared to 10.0 in ICM (+5.0 %, p accident victims.

  20. Effectiveness of post-discharge case management in general-medical outpatients: a randomized, controlled trial

    NARCIS (Netherlands)

    Latour, Corine H. M.; de Vos, Rien; Huyse, Frits J.; de Jonge, Peter; van Gemert, Liesbeth A. M.; Stalman, Wim A. B.

    2006-01-01

    This study was initiated to determine the impact of post-discharge, nurse-led, home-based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N=147) were

  1. Effectiveness of post-discharge case management in general-medical outpatients: A randomized, controlled trial

    NARCIS (Netherlands)

    Latour-Delfgaauw, C.H.M.; Vos, R.; Huyse, F.J.; de Jonge, P.; van Gemert, L.A.M.; Stalman, W.A.B.

    2006-01-01

    This study was initiated to determine the impact of post-discharge, nurse-led, home-based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N=147) were

  2. Effectiveness of post-discharge case management in general-medical outpatients: A randomized, controlled trial

    NARCIS (Netherlands)

    Latour, C.H.M.; de Vos, R.; Huyse, F.J.; De Jonge, P.; van Gemert, L.A.M.; Stalman, W.A.B.

    2006-01-01

    This study was initiated to determine the impact of post- discharge, nurse- led, home- based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N = 147)

  3. Effectiveness of post-discharge case management in general-medical outpatients : A randomized, controlled trial

    NARCIS (Netherlands)

    Latour, Corine H. M.; de Vos, Rien; Huyse, Frits J.; de Jonge, Peter; van Gemert, Liesbeth A. M.; Stalman, Wim A. B.

    2006-01-01

    This study was initiated to determine the impact of post- discharge, nurse- led, home- based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N = 147)

  4. A Randomized Controlled Trial of Hospital-based Case Management in Cancer Care

    DEFF Research Database (Denmark)

    Wulff, Christian N; Vedsted, Peter; Søndergaard, Jens

    2012-01-01

    BACKGROUND: Case management (CM) models based on experienced nurses are increasingly used to improve coordination and continuity of care for patients with complex health care needs. Anyway, little is known about the effects of hospital-based CM in cancer care.Aim.To analyse the effects of hospital...... and out of hours were collected 9 months after recruitment and the data from the two groups were compared quarterly. RESULTS: CM was associated with an overall tendency towards more positive GP evaluations, which for 3 of 20 items reached statistical significance. Statistically significantly fewer GPs...

  5. Intestinal Microbiota in Pediatric Surgical Cases Administered Bifidobacterium Breve: A Randomized Controlled Trial.

    Science.gov (United States)

    Okazaki, Tadaharu; Asahara, Takashi; Yamataka, Atsuyuki; Ogasawara, Yuki; Lane, Geoffrey J; Nomoto, Koji; Nagata, Satoru; Yamashiro, Yuichiro

    2016-07-01

    The efficacy of perioperative probiotic administration has been reported in adults. We examined the effects of orally administered Bifidobacterium breve strain Yakult (BBG-01) on outcomes in pediatric surgical cases by assessing intestinal and blood microbiota. BBG-01 was well tolerated without adverse effects, and postoperative infectious complications were significantly decreased. Fecal analysis showed increased Bifidobacterium and decreased Enterobacteriaceae, Clostridium difficile, and Pseudomonas. Concentrations of fecal acetic acid were significantly increased, maintaining fecal pH at <7.0. The incidence of detecting bacteria in blood was significantly reduced. BBG-01 improved the intestinal environment, and may be implicated in suppressing bacterial translocation.

  6. Village doctor-assisted case management of rural patients with schizophrenia: protocol for a cluster randomized control trial.

    Science.gov (United States)

    Gong, Wenjie; Xu, Dong; Zhou, Liang; Brown, Henry Shelton; Smith, Kirk L; Xiao, Shuiyuan

    2014-01-16

    Strict compliance with prescribed medication is the key to reducing relapses in schizophrenia. As villagers in China lack regular access to psychiatrists to supervise compliance, we propose to train village 'doctors' (i.e., villagers with basic medical training and currently operating in villages across China delivering basic clinical and preventive care) to manage rural patients with schizophrenia with respect to compliance and monitoring symptoms. We hypothesize that with the necessary training and proper oversight, village doctors can significantly improve drug compliance of villagers with schizophrenia. We will conduct a cluster randomized controlled trial in 40 villages in Liuyang, Hunan Province, China, home to approximately 400 patients with schizophrenia. Half of the villages will be randomized into the treatment group (village doctor, or VD model) wherein village doctors who have received training in a schizophrenia case management protocol will manage case records, supervise drug taking, educate patients and families on schizophrenia and its treatment, and monitor patients for signs of relapse in order to arrange prompt referral. The other 20 villages will be assigned to the control group (case as usual, or CAU model) wherein patients will be visited by psychiatrists every two months and receive free antipsychotic medications under an on-going government program, Project 686. These control patients will receive no other management or follow up from health workers. A baseline survey will be conducted before the intervention to gather data on patient's socio-economic status, drug compliance history, and clinical and health outcome measures. Data will be re-collected 6 and 12 months into the intervention. A difference-in-difference regression model will be used to detect the program effect on drug compliance and other outcome measures. A cost-effectiveness analysis will also be conducted to compare the value of the VD model to that of the CAU group. Lack of

  7. Employing crisis postcards with case management in Kaohsiung, Taiwan: 6-month outcomes of a randomised controlled trial for suicide attempters.

    Science.gov (United States)

    Chen, Wei-Jen; Ho, Chi-Kung; Shyu, Shi-Sen; Chen, Cheng-Chung; Lin, Guei-Ging; Chou, Li-Shiu; Fang, Yun-Ju; Yeh, Pin-Yang; Chung, Tieh-Chi; Chou, Frank Huang-Chih

    2013-07-17

    Suicide attempts constitute a serious clinical problem and have important implications for healthcare resources. The aim of the present study was to evaluate the effectiveness of case management using crisis postcards over a 6-month follow-up period. A randomised controlled trial was conducted in Kaohsiung, Taiwan. Prevention of further suicide attempts was compared between two groups with and without the postcard intervention. The intervention group consisted of 373 participants (139 males, 234 females; age: 39.8 ± 14.0 yrs.). The control group consisted of 388 participants (113 males, 275 females; age: 40.0 ± 16.0 yrs.). A survival analysis was used to test the effectiveness of the crisis postcard intervention for the prevention of suicide reattempts. Per-protocol and intention-to-treat analyses were conducted. The intention-to-treat analysis indicated that the crisis postcard had no effect (hazard ratio = 0.84; 95% CI = 0.56 - 1.29), whereas the per-protocol analysis showed a strong benefit for the crisis postcard (hazard ratio = 0.39; 95% CI = 0.21 - 0.72). Although the results of the present study indicated that the postcard intervention did not reduce subsequent suicide behaviour, our study provides an alteration to the postcard intervention. Further studies need to be conducted to clarify whether this type of intervention can reduce subsequent suicidal behaviour, with a particular focus on reducing the rate of loss to follow-up.

  8. Remote-online case-based learning: A comparison of remote-online and face-to-face, case-based learning - a randomized controlled trial.

    Science.gov (United States)

    Nicklen, Peter; Keating, Jenny L; Paynter, Sophie; Storr, Michael; Maloney, Stephen

    2016-01-01

    Case-based learning (CBL) is an educational approach where students work in small, collaborative groups to solve problems. Computer assisted learning (CAL) is the implementation of computer technology in education. The purpose of this study was to compare the effects of a remote-online CBL (RO-CBL) with traditional face-to-face CBL on learning the outcomes of undergraduate physiotherapy students. Participants were randomized to either the control (face-to-face CBL) or to the CAL intervention (RO-CBL). The entire 3rd year physiotherapy cohort (n = 41) at Monash University, Victoria, Australia, were invited to participate in the randomized controlled trial. Outcomes included a postintervention multiple-choice test evaluating the knowledge gained from the CBL, a self-assessment of learning based on examinable learning objectives and student satisfaction with the CBL. In addition, a focus group was conducted investigating perceptions and responses to the online format. Thirty-eight students (control n = 19, intervention n = 19) participated in two CBL sessions and completed the outcome assessments. CBL median scores for the postintervention multiple-choice test were comparable (Wilcoxon rank sum P = 0.61) (median/10 [range] intervention group: 9 [8-10] control group: 10 [7-10]). Of the 15 examinable learning objectives, eight were significantly in favor of the control group, suggesting a greater perceived depth of learning. Eighty-four percent of students (16/19) disagreed with the statement "I enjoyed the method of CBL delivery." Key themes identified from the focus group included risks associated with the implementation of, challenges of communicating in, and flexibility offered, by web-based programs. RO-CBL appears to provide students with a comparable learning experience to traditional CBL. Procedural and infrastructure factors need to be addressed in future studies to counter student dissatisfaction and decreased perceived depth of learning.

  9. Improving faculty feedback to resident trainees during a simulated case: a randomized, controlled trial of an educational intervention.

    Science.gov (United States)

    Minehart, Rebecca D; Rudolph, Jenny; Pian-Smith, May C M; Raemer, Daniel B

    2014-01-01

    Although feedback conversations are an essential component of learning, three challenges make them difficult: the fear that direct task feedback will harm the relationship with the learner, overcoming faculty cognitive biases that interfere with their eliciting the frames that drive trainees' performances, and time pressure. Decades of research on developmental conversations suggest solutions to these challenges: hold generous inferences about learners, subject one's own thinking to test by making it public, and inquire directly about learners' cognitive frames. The authors conducted a randomized, controlled trial to determine whether a 1-h educational intervention for anesthesia faculty improved feedback quality in a simulated case. The primary outcome was an analysis of the feedback conversation between faculty and a simulated resident (actor) by using averages of six elements of a Behaviorally Anchored Rating Scale and an objective structured assessment of feedback. Seventy-one Harvard faculty anesthesiologists from five academic hospitals participated. The intervention group scored higher when averaging all ratings. Scores for individual elements showed that the intervention group performed better in maintaining a psychologically safe environment (4.3 ± 1.21 vs. 3.8 ± 1.16; P = 0.001), identifying and exploring performance gaps (4.1 ± 1.38 vs. 3.7 ± 1.34; P = 0.048), and they more frequently emphasized the professionalism error of failing to call for help over the clinical topic of anaphylaxis (66 vs. 41%; P = 0.008). Quality of faculty feedback to a simulated resident was improved in the interventional group in a number of areas after a 1-h educational intervention, and this short intervention allowed a group of faculty to overcome enough discomfort in addressing a professionalism lapse to discuss it directly.

  10. Design of a Randomised Controlled Trial (RCT on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients

    Directory of Open Access Journals (Sweden)

    Annema Coby

    2010-05-01

    Full Text Available Abstract Background Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little evidence about the effectiveness of the patient advocacy case management model in clinical practice. Therefore, the objective of our study was to examine the effects of the Dutch patient advocacy case management model for severely disabled Multiple Sclerosis (MS patients and their caregivers compared to usual care. Methods/design In this randomized controlled trial the effectiveness of casemanagement on quality of life of patients and their caregivers, quality of care, service use and economic aspects were evaluated. The primary outcomes of this study were quality of life of MS-patients and caregiver burden of caregivers. Furthermore, we examined quality of life of caregivers, quality of care, service use and costs. Discussion This is a unique trial in which we examined the effectiveness of case management from a broad perspective. We meticulously prepared this study and applied important features and created important conditions for both intervention and research protocol to increase the likelihood of finding evidence for the effectiveness of patient advocacy case management. Concerning the intervention we anticipated to five important conditions: 1 the contrast between the case management intervention compared to the usual care seems to be large enough to detect intervention effects; 2 we included patients with complex care situations and/or were at risk for critical situations; 3 the case managers were familiar with disease specific health-problems and a broad spectrum of solutions; 4 case managers were competent and authorized to perform a medical neurological examination and worked closely with neurologists specialized in MS; and 5 the

  11. What's in a Trial? On the Importance of Distinguishing Between Experimental Lab Studies and Randomized Controlled Trials: The Case of Cognitive Bias Modification and Alcohol Use Disorders.

    Science.gov (United States)

    Wiers, Reinout W; Boffo, Marilisa; Field, Matt

    2018-05-01

    Recently, the National Institutes of Health (NIH) redefined clinical trials to include any study involving behavioral or biomedical interventions. In line with a general framework from experimental medicine, we argue that it is crucial to distinguish between experimental laboratory studies aimed at revealing psychological mechanisms underlying behavior and randomized controlled trials (RCTs) in clinical samples aimed at testing the efficacy of an intervention. As an illustration, we reviewed the current state of the evidence on the efficacy of cognitive bias modification (CBM) interventions in alcohol use disorders. A recent meta-analysis "cast serious doubts on the clinical utility of CBM interventions for addiction." That analysis combined experimental laboratory studies and RCTs. We demonstrated that, when studies are differentiated regarding study type (experimental laboratory study or RCT), mode of delivery (controlled experiment or Internet), and population (healthy volunteers or patients), the following effects are found: (a) short-lived effects of CBM on drinking behavior in experimental laboratory studies in students, but only when the bias is successfully manipulated; (b) small but robust effects of CBM on treatment outcome when administered as an adjunct to established treatments in clinical settings in RCTs with alcohol-dependent patients; and (c) nonspecific effects (reduced drinking irrespective of condition) in RCTs of CBM administered online to problem drinkers. We discuss how CBM might be improved when it is better integrated into regular treatment, especially cognitive behavioral therapy, and we conclude that disregarding the difference between experimental laboratory studies and RCTs can lead to invalid conclusions.

  12. Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Strom Joni L

    2011-10-01

    Full Text Available Abstract Background An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for Methods We describe a four-year prospective, randomized clinical trial, which will test the effectiveness of technology-assisted case management in low income rural adults with T2DM. Two-hundred (200 male and female participants, 18 years of age or older and with an HbA1c ≥ 8%, will be randomized into one of two groups: (1 an intervention arm employing the innovative FORA system coupled with nurse case management or (2 a usual care group. Participants will be followed for 6-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among indigent, rural adult patients with T2DM treated in FQHC's, participants randomized to the technology-assisted case management intervention will have significantly greater reduction in HbA1c at 6 months of follow-up compared to usual care. Discussion Results from this study will provide important insight into the effectiveness of technology-assisted case management intervention (TACM for optimizing diabetes care in indigent, rural adult patients with T2DM treated in FQHC's. Trial Registration National Institutes of Health Clinical Trials Registry (http://ClinicalTrials.gov identifier# NCT01373489

  13. Zinc as an adjunct treatment for reducing case fatality due to clinical severe infection in young infants: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wadhwa, Nitya; Basnet, Sudha; Natchu, Uma Chandra Mouli; Shrestha, Laxman P; Bhatnagar, Shinjini; Sommerfelt, Halvor; Strand, Tor A; Ramji, Siddarth; Aggarwal, K C; Chellani, Harish; Govil, Anuradha; Jajoo, Mamta; Mathur, N B; Bhatt, Meenakshi; Mohta, Anup; Ansari, Imran; Basnet, Srijana; Chapagain, Ram H; Shah, Ganesh P; Shrestha, Binod M

    2017-07-10

    An estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality. This is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment. A previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants. Universal Trial Number: U1111-1187-6479, Clinical Trials Registry - India: CTRI/2017/02/007966 : Registered on February 27, 2017.

  14. Managing with Learning Disability and Diabetes: OK-Diabetes - a case-finding study and feasibility randomised controlled trial.

    Science.gov (United States)

    House, Allan; Bryant, Louise; Russell, Amy M; Wright-Hughes, Alexandra; Graham, Liz; Walwyn, Rebecca; Wright, Judy M; Hulme, Claire; O'Dwyer, John L; Latchford, Gary; Meer, Shaista; Birtwistle, Jacqueline C; Stansfield, Alison; Ajjan, Ramzi; Farrin, Amanda

    2018-05-01

    Obesity and type 2 diabetes are common in adults with a learning disability. It is not known if the principles of self-management can be applied in this population. To develop and evaluate a case-finding method and undertake an observational study of adults with a learning disability and type 2 diabetes, to develop a standardised supported self-management (SSM) intervention and measure of adherence and to undertake a feasibility randomised controlled trial (RCT) of SSM versus treatment as usual (TAU). Observational study and an individually randomised feasibility RCT. Three cities in West Yorkshire, UK. In the observational study: adults aged > 18 years with a mild or moderate learning disability, who have type 2 diabetes that is not being treated with insulin and who are living in the community. Participants had mental capacity to consent to research and to the intervention. In the RCT participants had glycated haemoglobin (HbA 1c ) levels of > 6.5% (48 mmol/mol), a body mass index (BMI) of > 25 kg/m 2 or self-reported physical activity below national guideline levels. Standardised SSM. TAU supported by an easy-read booklet. (1) The number of eligible participants identified and sources of referral; (2) current living and support arrangements; (3) current health state, including level of HbA 1c , BMI and waist circumference, blood pressure and lipids; (4) mood, preferences for change; (5) recruitment and retention in RCT; (6) implementation and adherence to the intervention; (7) completeness of data collection and values for candidate primary outcomes; and (8) qualitative data on participant experience of the research process and intervention. In the observational study we identified 147 eligible consenting participants. The mean age was 54.4 years. In total, 130 out of 147 (88%) named a key supporter, with 113 supporters (77%) being involved in diabetes management. The mean HbA 1c level was 54.5 mmol/mol [standard deviation (SD) 14.8 mmol/mol; 7

  15. Relationship between Long Chain n-3 Polyunsaturated Fatty Acids and Autism Spectrum Disorder: Systematic Review and Meta-Analysis of Case-Control and Randomised Controlled Trials

    Directory of Open Access Journals (Sweden)

    Hajar Mazahery

    2017-02-01

    Full Text Available Omega-3 long chain polyunsaturated fatty acid supplementation (n-3 LCPUFA for treatment of Autism Spectrum Disorder (ASD is popular. The results of previous systematic reviews and meta-analyses of n-3 LCPUFA supplementation on ASD outcomes were inconclusive. Two meta-analyses were conducted; meta-analysis 1 compared blood levels of LCPUFA and their ratios arachidonic acid (ARA to docosahexaenoic acid (DHA, ARA to eicosapentaenoic acid (EPA, or total n-6 to total n-3 LCPUFA in ASD to those of typically developing individuals (with no neurodevelopmental disorders, and meta-analysis 2 compared the effects of n-3 LCPUFA supplementation to placebo on symptoms of ASD. Case-control studies and randomised controlled trials (RCTs were identified searching electronic databases up to May, 2016. Mean differences were pooled and analysed using inverse variance models. Heterogeneity was assessed using I2 statistic. Fifteen case-control studies (n = 1193 were reviewed. Compared with typically developed, ASD populations had lower DHA (−2.14 [95% CI −3.22 to −1.07]; p < 0.0001; I2 = 97%, EPA (−0.72 [95% CI −1.25 to −0.18]; p = 0.008; I2 = 88%, and ARA (−0.83 [95% CI, −1.48 to −0.17]; p = 0.01; I2 = 96% and higher total n-6 LCPUFA to n-3 LCPUFA ratio (0.42 [95% CI 0.06 to 0.78]; p = 0.02; I2 = 74%. Four RCTs were included in meta-analysis 2 (n = 107. Compared with placebo, n-3 LCPUFA improved social interaction (−1.96 [95% CI −3.5 to −0.34]; p = 0.02; I2 = 0 and repetitive and restricted interests and behaviours (−1.08 [95% CI −2.17 to −0.01]; p = 0.05; I2 = 0. Populations with ASD have lower n-3 LCPUFA status and n-3 LCPUFA supplementation can potentially improve some ASD symptoms. Further research with large sample size and adequate study duration is warranted to confirm the efficacy of n-3 LCPUFA.

  16. A Randomized Controlled Trial

    African Journals Online (AJOL)

    2018-04-19

    Apr 19, 2018 ... One case of readmission was recorded in delayed feeding group. It was a case of wound sepsis with dehiscence 1 week after discharge and was managed appropriately within 2 weeks with daily dressing, antibiotics and secondary suturing. The mean satisfaction of the mothers measured on VAS of 0–100 ...

  17. Case-based e-learning to improve the attitude of medical students towards occupational health, a randomised controlled trial.

    Science.gov (United States)

    Smits, P B A; de Graaf, L; Radon, K; de Boer, A G; Bos, N R; van Dijk, F J H; Verbeek, J H A M

    2012-04-01

    Undergraduate medical teaching in occupational health (OH) is a challenge in universities around the world. Case-based e-learning with an attractive clinical context could improve the attitude of medical students towards OH. The study question is whether case-based e-learning for medical students is more effective in improving knowledge, satisfaction and a positive attitude towards OH than non-case-based textbook learning. Participants, 141 second year medical students, were randomised to either case-based e-learning or text-based learning. Outcome measures were knowledge, satisfaction and attitude towards OH, measured at baseline, directly after the intervention, after 1 week and at 3-month follow-up. Of the 141 participants, 130 (92%) completed the questionnaires at short-term follow-up and 41 (29%) at 3-month follow-up. At short-term follow-up, intervention and control groups did not show a significant difference in knowledge nor satisfaction but attitude towards OH was significantly more negative in the intervention group (F=4.041, p=0.047). At 3-month follow-up, there were no significant differences between intervention and control groups for knowledge, satisfaction and attitude. We found a significant decrease in favourable attitude during the internship in the experimental group compared with the control group. There were no significant differences in knowledge or satisfaction between case-based e-learning and text-based learning. The attitude towards OH should be further investigated as an outcome of educational programmes.

  18. Design, and participant enrollment, of a randomized controlled trial evaluating effectiveness and cost-effectiveness of a community-based case management intervention, for patients suffering from COPD

    DEFF Research Database (Denmark)

    Sørensen, Sabrina Storgaard; Pedersen, Kjeld Møller; Weinreich, Ulla Møller

    2015-01-01

    Background: Case management interventions are recommended to improve quality of care and reduce costs in chronic care, but further evidence on effectiveness and cost-effectiveness is needed. The objective of this study is the reporting of the design and participant enrollment of a randomized...... controlled trial, conducted to evaluate the effectiveness and cost-effectiveness of a community-based case management model for patients suffering from chronic obstructive pulmonary disease (COPD). With a focus on support for self-care and care coordination, the intervention was hypothesized to result...... patients were randomized into two groups: the case-managed group and the usual-care group. Participant characteristics were obtained at baseline, and measures on effectiveness and costs were obtained through questionnaires and registries within a 12-month follow-up period. In the forthcoming analysis...

  19. ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters

    Directory of Open Access Journals (Sweden)

    Duhem Stephane

    2011-01-01

    Full Text Available Abstract Background Suicide attempts (SA constitute a serious clinical problem. People who attempt suicide are at high risk of further repetition. However, no interventions have been shown to be effective in reducing repetition in this group of patients. Methods/Design Multicentre randomized controlled trial. We examine the effectiveness of «ALGOS algorithm»: an intervention based in a decisional tree of contact type which aims at reducing the incidence of repeated suicide attempt during 6 months. This algorithm of case management comprises the two strategies of intervention that showed a significant reduction in the number of SA repeaters: systematic telephone contact (ineffective in first-attempters and «Crisis card» (effective only in first-attempters. Participants who are lost from contact and those refusing healthcare, can then benefit from «short letters» or «postcards». Discussion ALGOS algorithm is easily reproducible and inexpensive intervention that will supply the guidelines for assessment and management of a population sometimes in difficulties with healthcare compliance. Furthermore, it will target some of these subgroups of patients by providing specific interventions for optimizing the benefits of case management strategy. Trial Registration The study was registered with the ClinicalTrials.gov Registry; number: NCT01123174.

  20. Animal-assisted therapy and agitation and depression in nursing home residents with dementia: a matched case-control trial.

    Science.gov (United States)

    Majić, Tomislav; Gutzmann, Hans; Heinz, Andreas; Lang, Undine E; Rapp, Michael A

    2013-11-01

    To investigate the efficacy of animal-assisted therapy (AAT) on symptoms of agitation/aggression and depression in nursing home residents with dementia in a randomized controlled trial. Previous studies have indicated that AAT has beneficial effects on neuropsychiatric symptoms in various psychiatric disorders but few studies have investigated the efficacy of AAT in patients suffering from dementia. Of 65 nursing home residents with dementia (mean [standard deviation] age: 81.8 [9.2] years; mean Mini-Mental State Examination score: 7.1 [0.7]), 27 matched pairs (N = 54) were randomly assigned to either treatment as usual or treatment as usual combined with AAT, administered over 10 weekly sessions. Blinded raters assessed cognitive impairment with the Mini-Mental State Examination, presence of agitation/aggression with the Cohen-Mansfield Agitation Inventory, and depression with the Dementia Mood Assessment Scale at baseline and during a period of 4 weeks after AAT intervention. In the control group, symptoms of agitation/aggression and depression significantly increased over 10 weeks; in the intervention group, patients receiving combined treatment displayed constant frequency and severity of symptoms of agitation/aggression (F1,48 = 6.43; p <0.05) and depression (F1,48 = 26.54; p <0.001). Symptom amelioration did not occur in either group. AAT is a promising option for the treatment of agitation/aggression and depression in patients with dementia. Our results suggest that AAT may delay progression of neuropsychiatric symptoms in demented nursing home residents. Further research is needed to determine its long-time effects. Copyright © 2013 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  1. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  2. Operative technique at caesarean delivery and risk of complete uterine rupture in a subsequent trial of labour at term. A registry case-control study

    DEFF Research Database (Denmark)

    Thisted, Dorthe L. A.; Mortensen, Laust H.; Hvidman, Lone

    2017-01-01

    Objective: To estimate the relation of single-layer closure at previous caesarean delivery, and other pre-labour and intra-partum risk factors for complete uterine rupture in trial of vaginal birth after a caesarean (TOLAC) at term. Study design: Population-based case-control study. We identified...... all women (n = 39 742) recorded in the Danish Medical Birth Registry (DMBR) during a 12-year period (1997–2008) with a singleton pregnancy at term and TOLAC. Among these, all women with a complete uterine rupture were identified (cases). Information from the registry was validated against medical...... of uterine rupture. Conclusion: Single-layer uterine closure did not remain significantly associated to uterine rupture during TOLAC at term after adjustment for confounding factors. Induction of labour with an unfavourable cervix, birth weight ≥ 4000g and indicators of prolonged labour were all major risk...

  3. Case studies combined with or without concept maps improve critical thinking in hospital-based nurses: a randomized-controlled trial.

    Science.gov (United States)

    Huang, Yu-Chuan; Chen, Hsing-Hsia; Yeh, Mei-Ling; Chung, Yu-Chu

    2012-06-01

    Critical thinking (CT) is essential to the exercise of professional judgment. As nurses face increasingly complex health-care situations, critical thinking can promote appropriate clinical decision-making and improve the quality of nursing care. This study aimed to evaluate the effects of a program of case studies, alone (CS) or combined with concept maps (CSCM), on improving CT in clinical nurses. The study was a randomized controlled trial. The experimental group participated in a 16-week CSCM program, whereas the control group participated in a CS program of equal duration. A randomized-controlled trial with a multistage randomization process was used to select and to assign participants, ultimately resulting in 67 nurses in each group. Data were collected before and after the program using the California Critical Thinking Skill Test (CCTST) and the California Critical Thinking Disposition Inventory (CCTDI). After the programs, there were significant differences between the two groups in the critical thinking skills of analysis, evaluation, inference, deduction, and induction. There was also an overall significant difference, and a significant difference in the specific disposition of open-mindedness. This study supports the application of case studies combined with concept maps as a hospital-based teaching strategy to promote development of critical thinking skills and encourage dispositions for nurses. The CSCM resulted in greater improvements in all critical thinking skills of as well as the overall and open-minded affective dispositions toward critical thinking, compared with the case studies alone. An obvious improvement in the CSCM participants was the analytic skill and disposition. Further longitudinal studies and data collection from multisite evaluations in a range of geographic locales are warranted. Copyright © 2012 Elsevier Ltd. All rights reserved.

  4. A comparison of total amount of blood needed in patients taking autologous or homologous blood transfusion in coronary artery bypass grafting a clinical randomized case control trial

    International Nuclear Information System (INIS)

    Akhlagh, S.H.; Chohedri, A.H.; Bazojoo, A.; Nemati, M.H.

    2007-01-01

    The aim of this clinical case-control trial was to compare the total amount of blood needed in patients taking autologous or homologous blood transfusion in coronary artery bypass grafting (CABG) surgery. Sixty patients scheduled for CABG were randomly allocated to ANH (Acute Normovulemic Hemodynamic) group (A group) or control group (B group). Hematocrit before operation and 24 hours after the operation were checked. The amount of the total blood needed in each group was measured at the end of the operation. There was no significant difference between the two groups as regards post operational hematocrit. The mean total blood infused to the control and ANH group was 2010 ml and 1815 ml respectively. However there was significant difference between the two groups as regards the total amount of the blood needed during operation. Our randomized, double blinded case control study demonstrated that autologous blood, beside carrying lower risks for hemolytic and nonhemolytic transfusion reactions decrease the total amount of blood needed for CABG. However larger studies with more patients are needed to confirm the results. (author)

  5. Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial.

    Science.gov (United States)

    Berrouiguet, Sofian; Larsen, Mark Erik; Mesmeur, Catherine; Gravey, Michel; Billot, Romain; Walter, Michel; Lemey, Christophe; Lenca, Philippe

    2018-01-10

    Research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from care services after a suicide attempt (SA) can reduce reattempt risk. Pilot studies have demonstrated that interventions using mobile health (mHealth) technologies are feasible in a suicide prevention setting. The aim of this study was to report three cases of patients recruited in the Suicide Intervention Assisted by Messages (SIAM) study to describe how a mobile intervention may influence follow-up. SIAM is a 2-year, multicenter randomized controlled trial conducted by the Brest University Hospital, France. Participants in the intervention group receive SIAM text messages 48 hours after discharge, then at day 8 and day 15, and months 1, 2, 3, 4, 5, and 6. The study includes participants aged 18 years or older, who have attended a participating hospital for an SA, and have been discharged from the emergency department (ED) or a psychiatric unit (PU) for a stay of less than 7 days. Eligible participants are randomized between the SIAM intervention messages and a control group. In this study, we present three cases from the ongoing SIAM study that demonstrate the capability of a mobile-based brief contact intervention for triggering patient-initiated contact with a crisis support team at various time points throughout the mobile-based follow-up period. Out of the 244 patients recruited in the SIAM randomized controlled trial, three cases were selected to illustrate the impact of mHealth on suicide risk management. Participants initiated contact with the emergency crisis support service after receiving text messages up to 6 months following discharge from the hospital. Contact was initiated immediately following receipt of a text message or up to 6 days following a message. This text message-based brief contact intervention has demonstrated the potential to reconnect suicidal individuals with crisis support services while they are experiencing

  6. Serum α-tocopherol and γ-tocopherol concentrations and prostate cancer risk in the PLCO Screening Trial: a nested case-control study.

    Directory of Open Access Journals (Sweden)

    Stephanie J Weinstein

    Full Text Available BACKGROUND: Vitamin E compounds exhibit prostate cancer preventive properties experimentally, but serologic investigations of tocopherols, and randomized controlled trials of supplementation in particular, have been inconsistent. Many studies suggest protective effects among smokers and for aggressive prostate cancer, however. METHODS: We conducted a nested case-control study of serum α-tocopherol and γ-tocopherol and prostate cancer risk in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, with 680 prostate cancer cases and 824 frequency-matched controls. Multivariate-adjusted, conditional logistic regression models were used to estimate odds ratios (OR and 95% confidence intervals (CIs for tocopherol quintiles. RESULTS: Serum α-tocopherol and γ-tocopherol were inversely correlated (r = -0.24, p<0.0001. Higher serum α-tocopherol was associated with significantly lower prostate cancer risk (OR for the highest vs. lowest quintile = 0.63, 95% CI 0.44-0.92, p-trend 0.05. By contrast, risk was non-significantly elevated among men with higher γ-tocopherol concentrations (OR for the highest vs. lowest quintile = 1.35, 95% CI 0.92-1.97, p-trend 0.41. The inverse association between prostate cancer and α-tocopherol was restricted to current and recently former smokers, but was only slightly stronger for aggressive disease. By contrast, the increased risk for higher γ-tocopherol was more pronounced for less aggressive cancers. CONCLUSIONS: Our findings indicate higher α-tocopherol status is associated with decreased risk of developing prostate cancer, particularly among smokers. Although two recent controlled trials did not substantiate an earlier finding of lower prostate cancer incidence and mortality in response to supplementation with a relatively low dose of α-tocopherol, higher α-tocopherol status may be beneficial with respect to prostate cancer risk among smokers. Determining what stage of prostate cancer

  7. Case-based e-learning to improve the attitude of medical students towards occupational health, a randomised controlled trial

    NARCIS (Netherlands)

    Smits, P. B. A.; de Graaf, L.; Radon, K.; de Boer, A. G.; Bos, N. R.; van Dijk, F. J. H.; Verbeek, J. H. A. M.

    2012-01-01

    Objectives Undergraduate medical teaching in occupational health (OH) is a challenge in universities around the world. Case-based e-learning with an attractive clinical context could improve the attitude of medical students towards OH. The study question is whether case-based e-learning for medical

  8. Effects on leisure activities and social participation of a case management intervention for frail older people living at home: a randomised controlled trial.

    Science.gov (United States)

    Granbom, Marianne; Kristensson, Jimmie; Sandberg, Magnus

    2017-07-01

    Frailty causes disability and restrictions on older people's ability to engage in leisure activities and for social participation. The objective of this study was to evaluate the effects of a 1-year case management intervention for frail older people living at home in Sweden in terms of social participation and leisure activities. The study was a randomised controlled trial with repeated follow-ups. The sample (n = 153) was consecutively and randomly assigned to intervention (n = 80) or control groups (n = 73). The intervention group received monthly home visits over the course of a year by nurses and physiotherapists working as case managers, using a multifactorial preventive approach. Data collections on social participation, leisure activities and rating of important leisure activities were performed at baseline, 3, 6, 9 and 12 months, with recruitment between October 2006 and April 2011. The results did not show any differences in favour of the intervention on social participation. However, the intervention group performed leisure activities in general, and important physical leisure activities, to a greater extent than the control group at the 3-month follow-up (median 13 vs. 11, P = 0.034 and median 3 vs. 3, P = 0.031 respectively). A statistically significantly greater proportion of participants from the intervention group had an increased or unchanged number of important social leisure activities that they performed for the periods from baseline to 3 months (93.2% vs. 75.4%, OR = 4.48, 95% CI: 1.37-14.58). Even though statistically significant findings in favour of the intervention were found, more research on activity-focused case management interventions is needed to achieve clear effects on social participation and leisure activities. © 2017 John Wiley & Sons Ltd.

  9. Using evidence-integrated e-learning to enhance case management continuing education for psychiatric nurses: a randomised controlled trial with follow-up.

    Science.gov (United States)

    Liu, Wen-I; Rong, Jiin-Ru; Liu, Chieh-Yu

    2014-11-01

    E-learning is a flexible strategy to improve nurses' knowledge of case management, but there are methodological limitations in previous research into the effectiveness of such programs. To describe the development and effectiveness of an evidence-integrated e-learning program in case management continuing education for Taiwanese psychiatric nurses. Multiple methods were adopted to develop the program and a randomised controlled trial with repeated measures was employed to evaluate it. The e-learning program was developed in four stages: (1) systematic review of literature; (2) needs assessment through a national survey and focus group; (3) development of learning materials; and (4) pilot test. Following program development, psychiatric nurses were recruited and randomly allocated into an experimental or comparison group. The experimental group participated in an e-learning continuing education program. The case management knowledge index with sufficient reliability and validity and a satisfaction survey were used to determine the outcomes. A generalised estimating equation was used to assess the difference between the 2 groups before, after, and at 3 months follow-up. The learning material comprised 5 simulated learning modules, self-assessment questions, learning cases, sharing experiences, and learning resources. A total of 200 participants completed the 3 measurements. Knowledge scores in the experimental group significantly exceeded those in the comparison group after the program and at the 3-month follow-up. Participants reported positive learning perceptions. The program provides an evidence-based educational resource for nursing continuing education in case management. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. The effects of combining Web-based eHealth with telephone nurse case management for pediatric asthma control: a randomized controlled trial.

    Science.gov (United States)

    Gustafson, David; Wise, Meg; Bhattacharya, Abhik; Pulvermacher, Alice; Shanovich, Kathleen; Phillips, Brenda; Lehman, Erik; Chinchilli, Vernon; Hawkins, Robert; Kim, Jee-Seon

    2012-07-26

    Asthma is the most common pediatric illness in the United States, burdening low-income and minority families disproportionately and contributing to high health care costs. Clinic-based asthma education and telephone case management have had mixed results on asthma control, as have eHealth programs and online games. To test the effects of (1) CHESS+CM, a system for parents and children ages 4-12 years with poorly controlled asthma, on asthma control and medication adherence, and (2) competence, self-efficacy, and social support as mediators. CHESS+CM included a fully automated eHealth component (Comprehensive Health Enhancement Support System [CHESS]) plus monthly nurse case management (CM) via phone. CHESS, based on self-determination theory, was designed to improve competence, social support, and intrinsic motivation of parents and children. We identified eligible parent-child dyads from files of managed care organizations in Madison and Milwaukee, Wisconsin, USA, sent them recruitment letters, and randomly assigned them (unblinded) to a control group of treatment as usual plus asthma information or to CHESS+CM. Asthma control was measured by the Asthma Control Questionnaire (ACQ) and self-reported symptom-free days. Medication adherence was a composite of pharmacy refill data and medication taking. Social support, information competence, and self-efficacy were self-assessed in questionnaires. All data were collected at 0, 3, 6, 9, and 12 months. Asthma diaries kept during a 3-week run-in period before randomization provided baseline data. Of 305 parent-child dyads enrolled, 301 were randomly assigned, 153 to the control group and 148 to CHESS+CM. Most parents were female (283/301, 94%), African American (150/301, 49.8%), and had a low income as indicated by child's Medicaid status (154/301, 51.2%); 146 (48.5%) were single and 96 of 301 (31.9%) had a high school education or less. Completion rates were 127 of 153 control group dyads (83.0%) and 132 of 148 CHESS

  11. Case management for the treatment of patients with major depression in general practices – rationale, design and conduct of a cluster randomized controlled trial – PRoMPT (Primary care Monitoring for depressive Patient's Trial [ISRCTN66386086] – Study protocol

    Directory of Open Access Journals (Sweden)

    Krauth Christian

    2005-10-01

    Full Text Available Abstract Background Depression is a disorder with high prevalence in primary health care and a significant burden of illness. The delivery of health care for depression, as well as other chronic illnesses, has been criticized for several reasons and new strategies to address the needs of these illnesses have been advocated. Case management is a patient-centered approach which has shown efficacy in the treatment of depression in highly organized Health Maintenance Organization (HMO settings and which might also be effective in other, less structured settings. Methods/Design PRoMPT (PRimary care Monitoring for depressive Patients Trial is a cluster randomised controlled trial with General Practice (GP as the unit of randomisation. The aim of the study is to evaluate a GP applied case-management for patients with major depressive disorder. 70 GPs were randomised either to intervention group or to control group with the control group delivering usual care. Each GP will include 10 patients suffering from major depressive disorder according to the DSM-IV criteria. The intervention group will receive treatment based on standardized guidelines and monthly telephone monitoring from a trained practice nurse. The nurse investigates the patient's status concerning the MDD criteria, his adherence to GPs prescriptions, possible side effects of medication, and treatment goal attainment. The control group receives usual care – including recommended guidelines. Main outcome measure is the cumulative score of the section depressive disorders (PHQ-9 from the German version of the Prime MD Patient Health Questionnaire (PHQ-D. Secondary outcome measures are the Beck-Depression-Inventory, self-reported adherence (adapted from Moriskey and the SF-36. In addition, data are collected about patients' satisfaction (EUROPEP-tool, medication, health care utilization, comorbidity, suicide attempts and days out of work. The study comprises three assessment times: baseline

  12. A randomized controlled open trial of population-based disease and case management in a Medicare Plus Choice health maintenance organization.

    Science.gov (United States)

    Martin, David C; Berger, Marc L; Anstatt, David T; Wofford, Jonathan; Warfel, DeAnn; Turpin, Robin S; Cannuscio, Carolyn C; Teutsch, Steven M; Mansheim, Bernard J

    2004-10-01

    The object of this study was to examine the effect of population-based disease management and case management on resource use, self-reported health status, and member satisfaction with and retention in a Medicare Plus Choice health maintenance organization (HMO). Study design consisted of a prospective, randomized controlled open trial of 18 months' duration. Participants were 8504 Medicare beneficiaries aged 65 and older who had been continuously enrolled for at least 12 months in a network model Medicare Plus Choice HMO serving a contiguous nine-county metropolitan area. Members were care managed with an expert clinical information system and frequent telephone contact. Main outcomes included self-reported health status measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), resource use measured by admission rates and bed-days per thousand per year, member satisfaction, and costs measured by paid claims. More favorable outcomes occurred in the intervention group for satisfaction with the health plan (P management and case management led to improved self-reported satisfaction and social function but not to a global net decrease in resource use or improved member retention.

  13. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  14. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  15. Validity of Qualis database as a predictor of evidence hierarchy and risk of bias in randomized controlled trials: a case study in dentistry

    Directory of Open Access Journals (Sweden)

    Christiane Alves Ferreira

    2011-01-01

    Full Text Available OBJECTIVE: To evaluate the validity of the Qualis database in identifying the levels of scientific evidence and the quality of randomized controlled trials indexed in the Lilacs database. METHODS: We selected 40 open-access journals and performed a page-by-page hand search, to identify published articles according to the type of study during a period of six years. Classification of studies was performed by independent reviewers assessed for their reliability. Randomized controlled trials were identified for separate evaluation of risk of bias using four dimensions: generation of allocation sequence, allocation concealment, blinding, and incomplete outcome data. The Qualis classification was considered to be the outcome variable. The statistical tests used included Kappa, Spearman's correlation, Kendall-tau and ordinal regressions. RESULTS: Studies with low levels of scientific evidence received similar Qualis classifications when compared to studies with high levels of evidence. In addition, randomized controlled trials with a high risk of bias for the generation of allocation sequences and allocation concealment were more likely to be published in journals with higher Qualis levels. DISCUSSION: The hierarchy level of the scientific evidence as classified by type of research design, as well as by the validity of studies according to the bias control level, was not correlated or associated with Qualis stratification. CONCLUSION: Qualis classifications for journals are not an approximate or indirect predictor of the validity of randomized controlled trials published in these journals and are therefore not a legitimate or appropriate indicator of the validity of randomized controlled trials.

  16. An empirically derived dietary pattern associated with breast cancer risk is validated in a nested case-control cohort from a randomized primary prevention trial.

    Science.gov (United States)

    Hidaka, Brandon H; Kimler, Bruce F; Fabian, Carol J; Carlson, Susan E

    2017-02-01

    We reported an association between cytologic atypia, a reversible biomarker of breast cancer risk, and lower omega-3/omega-6 fatty acid ratio in blood and breast tissue. Our goal was to develop and validate a dietary pattern index in this high-risk sample of U.S. women, and test its capacity to predict incidence in a nested case-control cohort of Canadian women from a randomized trial of a low-fat dietary intervention for primary prevention of breast cancer. Food intake was measured by food frequency questionnaire in the U.S. sample (n = 65) and multiple dietary recalls in the Canadian sample (n = 220 cases; 440 controls). Principal component analysis identified a dietary pattern associated with atypia. We measured differences among dietary pattern tertiles in (a) fatty acid composition in blood lipids and breast tissue in the U.S. sample, and (b) risk of breast cancer subtypes in the Canadian cohort. Registered under ClinicalTrials.gov Identifier: NCT00148057. A Modern diet was characterized as consuming more grains, dairy, and sugar and less vegetables, fish and poultry; these women had lower tissue omega-3 fatty acids and higher omega-6 and trans fatty acids. The low-fat intervention increased the likelihood of a Modern diet after randomization. A Modern diet at baseline and post-randomization was associated with estrogen-receptor negative (ER-) breast cancer risk among those at least 160 cm tall. A Traditional diet (the reciprocal of Modern) at baseline was associated with lower ER-positive (ER+) risk in the comparison group, but not the low-fat intervention group. A Modern diet (high in grains, dairy, and sugar and low in vegetables, fish, and poultry) is associated with ER- breast cancer risk among taller women. Recommending dietary fat reduction may have untoward effects on breast cancer risk. Copyright © 2016 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

  17. Achieving Drug and Alcohol Abstinence Among Recently Incarcerated Homeless Women: A Randomized Controlled Trial Comparing Dialectical Behavioral Therapy-Case Management With a Health Promotion Program.

    Science.gov (United States)

    Nyamathi, Adeline M; Shin, Sanghyuk S; Smeltzer, Jolene; Salem, Benissa E; Yadav, Kartik; Ekstrand, Maria L; Turner, Susan F; Faucette, Mark

    Homeless female ex-offenders (homeless female offenders) exiting jail and prison are at a critical juncture during reentry and transitioning into the community setting. The purpose of the study was to compare the effect of a dialectical behavioral therapy-case management (DBT-CM) program with a health promotion (HP) program on achieving drug and alcohol abstinence among female parolees/probationers residing in the community. We conducted a multicenter parallel randomized controlled trial with 130 female parolees/probationers (aged 19-64 years) residing in the community randomly assigned to either DBT-CM (n = 65) or HP (n = 65). The trial was conducted in four community-based partner sites in Los Angeles and Pomona, California, from February 2015 to November 2016. Treatment assignment was carried out using a computer-based urn randomization program. The primary outcome was drug and alcohol use abstinence at 6-month follow up. Analysis was based on data from 116 participants with complete outcome data. Multivariable logistic regression revealed that the DBT-CM program remained an independent positive predictor of decrease in drug use among the DBT-CM participants at 6 months (p = .01) as compared with the HP program participants. Being non-White (p < .05) and having higher depressive symptom scores (p < .05) were associated with lower odds of drug use abstinence (i.e., increased the odds of drug use) at 6 months. DBT-CM increased drug and alcohol abstinence at 6-month follow-up, compared to an HP program.

  18. Cognitive functions and stereopsis in patients with Parkinson's disease and Alzheimer's disease using 3-dimensional television: a case controlled trial.

    Directory of Open Access Journals (Sweden)

    Chan-Nyoung Lee

    Full Text Available Stereopsis or depth perception is an awareness of the distances of objects from the observer, and binocular disparity is a necessary component of recognizing objects through stereopsis. In the past studies, patients with neurodegenerative disease (Alzheimer dementia, AD; Parkinson's disease IPD have problems of stereopsis but they did not have actual stimulation of stereopsis. Therefore in this study, we used a 3-dimensional (3D movie on 3D television (TV for actual stereopsis stimulation. We propose research through analyzing differences between the three groups (AD, IPD, and Controls, and identified relations between the results from the Titmus Stereo Fly Test, and the 3D TV test. The study also looked into factors that affect the 3D TV test. Before allowing the patients to watch TV, we examined Titmus stereo Fly Test and cognitive test. We used the 3D version of a movie, of 17 minutes 1 second duration, and carried out a questionnaire about stereopsis. The scores of the stereopsis questionnaire were decreased in AD patients, compared with in IPD and controls, although they did not have any difference of Titmus Stereo Fly Test scores. In IPD patients, cognitive function (Montreal cognitive assessment, MoCA scores were correlated with the scores of the stereopsis questionnaire. We could conclude that Titmus fly test could not distinguish between the three groups and cognitive dysfunction contributes to actual stereopsis perception in IPD patients. Therefore the 3D TV test of AD and IPD patients was more effective than Titmus fly test.

  19. Case management in oncology rehabilitation (CAMON: The effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation. A study protocol for a randomized controlled clinical trial in oncology rehabilitation

    Directory of Open Access Journals (Sweden)

    Bardheci Katarina

    2011-04-01

    Full Text Available Abstract Background Cancer diseases and their therapies have negative effects on the quality of life. The aim of this study is to assess the effectiveness of case management in a sample of oncological outpatients with the intent of rehabilitation after cancer treatment. Case management wants to support the complex information needs of the patients in addition to the segmented structure of the health care system. Emphasis is put on support for self-management in order to enhance health - conscious behaviour, learning to deal with the burden of the illness and providing the opportunity for regular contacts with care providers. We present a study protocol to investigate the efficacy of a case management in patients following oncology rehabilitation after cancer treatment. Methods The trial is a multicentre, two-arm randomised controlled study. Patients are randomised parallel in either 'usual care' plus case management or 'usual care' alone. Patients with all types of cancer can be included in the study, if they have completed the therapy with chemo- and/or radiotherapy/surgery with curative intention and are expected to have a survival time >1 year. To determine the health-related quality of life the general questionnaire FACT G is used. The direct correlation between self-management and perceived self-efficacy is measured with the Jerusalem & Schwarzer questionnaire. Patients satisfaction with the care received is measured using the Patient Assessment of Chronic Illness Care 5 As (PACIC-5A. Data are collected at the beginning of the trial and after 3, 6 and 12 months. The power analysis revealed a sample size of 102 patients. The recruitment of the centres began in 2009. The inclusion of patients began in May 2010. Discussion Case management has proved to be effective regarding quality of life of patients with chronic diseases. When it comes to oncology, case management is mainly used in cancer treatment, but it is not yet common in the

  20. Marketing and clinical trials: a case study

    OpenAIRE

    Entwistle Vikki A; Snowdon Claire; Garcia Jo; Knight Rosemary C; Shakur Haleema; Elbourne Diana R; Roberts Ian; Francis David; McDonald Alison M; Grant Adrian M; Campbell Marion K

    2007-01-01

    Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, o...

  1. Effectiveness of telephone-based aftercare case management for adult patients with unipolar depression compared to usual care: A randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Laura Kivelitz

    Full Text Available Patients with depression often have limited access to outpatient psychotherapy following inpatient treatment. The objective of the study was to evaluate the long-term effectiveness of a telephone-based aftercare case management (ACM intervention for patients with depression.We performed a prospective randomized controlled trial in four psychotherapeutic inpatient care units with N = 199 patients with major depression or dysthymia (F32.x, F33.x, F34.1, according to the ICD-10. The ACM consisted of six phone contacts at two-week intervals performed by trained and certified psychotherapists. The control group received usual care (UC. The primary outcome was depressive symptom severity (BDI-II at 9-month follow-up, and secondary outcomes were health-related quality of life (SF-8, EQ-5D, self-efficacy (SWE, and the proportion of patients initiating outpatient psychotherapy. Mixed model analyses were conducted to compare improvements between treatment groups.Regarding the primary outcome of symptom severity, the groups did not significantly differ after 3 months (p = .132; ES = -0.23 or at the 9-month follow-up (p = .284; ES = -0.20. No significant differences in health-related quality of life or self-efficacy were found between groups. Patients receiving ACM were more likely to be in outpatient psychotherapy after 3 months (OR: 3.00[1.12-8.07]; p = .029 and 9 months (OR: 4.78 [1.55-14.74]; p = .006 than those receiving UC.Although telephone-based ACM did not significantly improve symptom severity, it seems to be a valuable approach for overcoming treatment barriers to the clinical pathways of patients with depression regarding their access to outpatient psychotherapy.

  2. Implementation of case management to reduce cardiovascular disease risk in the Stanford and San Mateo Heart to Heart randomized controlled trial: study protocol and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Stafford Randall S

    2006-09-01

    Full Text Available Abstract Background Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease (CHD. However, data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income populations. Methods The Stanford and San Mateo Heart to Heart (HTH project is a randomized controlled clinical trial designed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income, primarily ethnic minority patients served by a local county health care system in California. Randomization occurred at the patient level. The primary outcome measure is the absolute CHD risk over 10 years. Secondary outcome measures include adherence to guidelines on CHD prevention practice. We documented the study design, methodology, and baseline sociodemographic, clinical and lifestyle characteristics of 419 participants. Results We achieved equal distributions of the sociodemographic, biophysical and lifestyle characteristics between the two randomization groups. HTH participants had a mean age of 56 years, 63% were Latinos/Hispanics, 65% female, 61% less educated, and 62% were not employed. Twenty percent of participants reported having a prior cardiovascular event. 10-year CHD risk averaged 18% in men and 13% in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline. Sixty-three percent of participants were diagnosed with diabetes and an additional 22% had metabolic syndrome. In addition, many participants had depressed high-density lipoprotein (HDL cholesterol levels and elevated values of total cholesterol-to-HDL ratio, triglycerides, triglyceride-to-HDL ratio, and blood pressure. Furthermore, nearly 70% of participants were obese, 45% had a family history of CHD or

  3. Comparison of the effectiveness of two styles of case-based learning implemented in lectures for developing nursing students' critical thinking ability: A randomized controlled trial.

    Science.gov (United States)

    Hong, Shaohua; Yu, Ping

    2017-03-01

    To explore and compare the effectiveness of two styles of case-based learning methods, unfolding nursing case and usual nursing case, implemented in lectures for developing nursing students' critical thinking ability. 122 undergraduate nursing students in four classes were taught the subject of medical nursing for one year. Two classes were randomly assigned as the experimental group and the other two the control group. The experimental group received the lectures presenting unfolding nursing cases and the control group was taught the usual cases. Nineteen case-based lectures were provided in 8 months in two semesters to each group. The two groups started with a similar level of critical thinking ability as tested by the instrument of Critical Thinking Disposition Inventory-Chinese version (CTDI-CV). After receiving 19 case-based learning lectures for 8 months, both groups of students significantly improved their critical thinking ability. The improvement in the experimental group was significantly higher than that in the control group (with the average total score of 303.77±15.24 vs. 288.34±13.94, plearning in lectures. Unfolding nursing cases appear to be significantly more effective than the usual nursing cases in developing undergraduate nursing students' critical thinking ability in the subject of medical nursing. Further research can implement the unfolding nursing cases in other nursing subjects. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Aversive tension of adolescents with anorexia nervosa in daily course: a case-controlled and smartphone-based ambulatory monitoring trial.

    Science.gov (United States)

    Kolar, David Raphael; Bürger, Arne; Hammerle, Florian; Jenetzky, Ekkehart

    2014-04-23

    Monitoring and reduction of aversive tension is a core issue in dialectical behaviour therapy of patients. It has been shown that aversive tension is increased in adult borderline personality disorder and is linked to low emotion labelling ability. However, until now there is no documented evidence that patients with anorexia nervosa suffer from aversive tension as well. Furthermore the usability of a smartphone application for ambulatory monitoring purposes has not been sufficiently explored. We compare the mean and maximum self-reported aversive tension in 20 female adolescents (12-19 years) with anorexia nervosa in outpatient treatment with 20 healthy controls. They are required to answer hourly, over a 2-day period, that is, about 30 times, four short questions on their smartphone, which ensures prompt documentation without any recall bias. At the close out, the participants give a structured usability feedback on the application and the procedure. The achieved result of this trial has direct relevance for efficient therapy strategies and is a prerequisite for trials regarding dialectical behaviour therapy in anorexia nervosa. The results will be disseminated through peer-review publications. The ethics committee of the regional medical association in Mainz, Germany approved the study protocol under the reference number 837.177.13. The trial is registered at the German clinical trials registration under the reference number DRKS00005228.

  5. 'Away Days' in multi-centre randomised controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

    Science.gov (United States)

    Jefferson, Laura; Cook, Liz; Keding, Ada; Brealey, Stephen; Handoll, Helen; Rangan, Amar

    2015-11-06

    'Away Days' (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multi-centre randomised controlled trials (RCTs). We explored the use of Away Days in multi-centre RCTs and analysed the effect on patient recruitment in a case study. Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multi-centre pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. A total of 94 people responded to the survey. The majority (78%), who confirmed had organised an Away Day previously, found them to be useful. This is despite their costs.. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multi-centre surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  6. Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Chu, Qinjun; Shen, Dan; He, Long; Wang, Hongwei; Zhao, Xianlan; Chen, Zhimin; Wang, Yanli; Zhang, Wei

    2017-05-26

    Placenta accreta (PA), a severe complication during delivery, is closely linked with massive hemorrhage which could endanger the lives of both mother and baby. Moreover, the incidence of PA has increased dramatically with the increasing rate of cesarean deliveries in the past few decades. Therefore, studies evaluating the effects of different perioperative managements based on different modalities in the treatment of PA are necessary. Among the numerous treatment measures, prophylactic abdominal aortic balloon occlusion (AABO) in combination with cesarean section for PA seems to be more advantageous than others. However, up to now, all studies on AABO were almost retrospective. Current evidence is insufficient to recommend for or against routinely using the AABO technology for control intraoperative hemorrhage in patients with PA. Thus, we hope to carry out a prospective, randomized controlled trial (RCT) study to confirm the effectiveness of the AABO technology in patients with PA. This trial is an investigator-initiated, prospective RCT that will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. A total of 170 parturients with PA undergoing cesarean section will be randomized to receive either AABO in combination with cesarean section or the traditional hysterectomy following cesarean section. The primary outcome is estimated blood loss. The most important secondary outcome is the occurrence of cesarean hysterectomy during delivery; others include blood transfusion volume, operating time, neonate's Apgar scores (collected at 1, 5 and 10 min), length of stay in intensive care unit, total hospital stay, and balloon occlusion-relative data. This prospective trial will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. It may provide strong evidence

  7. Cost-effectiveness of preventive case management for parents with a mental illness: a randomized controlled trial from three economic perspectives.

    Science.gov (United States)

    Wansink, Henny J; Drost, Ruben M W A; Paulus, Aggie T G; Ruwaard, Dirk; Hosman, Clemens M H; Janssens, Jan M A M; Evers, Silvia M A A

    2016-07-07

    The children of parents with a mental illness (COPMI) are at increased risk for developing costly psychiatric disorders because of multiple risk factors which threaten parenting quality and thereby child development. Preventive basic care management (PBCM) is an intervention aimed at reducing risk factors and addressing the needs of COPMI-families in different domains. The intervention may lead to financial consequences in the healthcare sector and in other sectors, also known as inter-sectoral costs and benefits (ICBs). The objective of this study was to assess the cost-effectiveness of PBCM from three perspectives: a narrow healthcare perspective, a social care perspective (including childcare costs) and a broad societal perspective (including all ICBs). Effects on parenting quality (as measured by the HOME) and costs during an 18-month period were studied in in a randomized controlled trial. Families received PBCM (n = 49) or care as usual (CAU) (n = 50). For all three perspectives, incremental cost-effectiveness ratios (ICERs) were calculated. Stochastic uncertainty in the data was dealt with using non-parametric bootstraps. Sensitivity analyses included calculating ICERs excluding cost outliers, and making an adjustment for baseline cost differences. Parenting quality improved in the PBCM group and declined in the CAU group, and PBCM was shown to be more costly than CAU. ICERs differ from 461 Euros (healthcare perspective) to 215 Euros (social care perspective) to 175 Euros (societal perspective) per one point improvement on the HOME T-score. The results of the sensitivity analyses, based on complete cases and excluding cost outliers, support the finding that the ICER is lower when adopting a broader perspective. The subgroup analysis and the analysis with baseline adjustments resulted in higher ICERs. This study is the first economic evaluation of family-focused preventive basic care management for COPMI in psychiatric and family services. The effects

  8. Effectiveness of Housing First with Intensive Case Management in an Ethnically Diverse Sample of Homeless Adults with Mental Illness: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Vicky Stergiopoulos

    experiencing problems due to alcohol use among foreign-born (vs. Canadian-born HF participants at 24 months (ratio of rate ratios = 0.19 95% 0.04 to 0.88, relative to baseline. Compared to usual care, HF with ICM can improve housing stability and community functioning and reduce the days of alcohol related problems in an ethnically diverse sample of homeless adults with mental illness within 2-years.Controlled-Trials.com ISRCTN42520374.

  9. [Principles of controlled clinical trials].

    Science.gov (United States)

    Martini, P

    1962-01-01

    The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc., comparisons should be made between two or more groups: the collective therapeutic comparison = the between patients trial. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual. This type of therapeutic trial rests primarily upon a (refined!) type of specious reasoning and secondarily, upon modified statistics: the individual therapeutic comparison = the within patient trial. The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups. For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized. In order to remove subjective secondary causes, the author demanded, in 1931, the use of hidden or illusory media (placebos, dummies) that is, unconscious causative agents. The double blind

  10. A double-blind, placebo-controlled, randomized, clinical trial of the TLR-3 agonist rintatolimod in severe cases of chronic fatigue syndrome.

    Directory of Open Access Journals (Sweden)

    David R Strayer

    Full Text Available BACKGROUND: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME is a severely debilitating disease of unknown pathogenesis consisting of a variety of symptoms including severe fatigue. The objective of the study was to examine the efficacy and safety of a TLR-3 agonist, rintatolimod (Poly I: C(12U, in patients with debilitating CFS/ME. METHODS AND FINDINGS: A Phase III prospective, double-blind, randomized, placebo-controlled trial comparing twice weekly IV rintatolimod versus placebo was conducted in 234 subjects with long-standing, debilitating CFS/ME at 12 sites. The primary endpoint was the intra-patient change from baseline at Week 40 in exercise tolerance (ET. Secondary endpoints included concomitant drug usage, the Karnofsky Performance Score (KPS, Activities of Daily Living (ADL, and Vitality Score (SF 36. Subjects receiving rintatolimod for 40 weeks improved intra-patient placebo-adjusted ET 21.3% (p = 0.047 from baseline in an intention-to-treat analysis. Correction for subjects with reduced dosing compliance increased placebo-adjusted ET improvement to 28% (p = 0.022. The improvement observed represents approximately twice the minimum considered medically significant by regulatory agencies. The rintatolimod cohort vs. placebo also reduced dependence on drugs commonly used by patients in an attempt to alleviate the symptoms of CFS/ME (p = 0.048. Placebo subjects crossed-over to receive rintatolimod demonstrated an intra-patient improvement in ET performance at 24 weeks of 39% (p = 0.04. Rintatolimod at 400 mg twice weekly was generally well-tolerated. CONCLUSIONS/SIGNIFICANCE: Rintatolimod produced objective improvement in ET and a reduction in CFS/ME related concomitant medication usage as well as other secondary outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT00215800.

  11. Randomised controlled trials in Scandinavian educational research

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens

    2018-01-01

    of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0–10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries...... crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue....... or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0–10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed...

  12. a randomised controlled trial oftwo prostaglandin regitnens

    African Journals Online (AJOL)

    Design. A prospective randomised controlled trial. Setting. Department of Obstetrics and Gynae- ... hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 .... Tygerberg Hospital for permission to publish, and Upjohn. (Pry) Ltd for supplying the Prepidil gel used in the study. 1.

  13. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    The randomised controlled trial (RCT) is recog nised as the gold standard of research methods, particularly to test efficacy. The primary benefit of the RCT, as everyone knows, is to prevent patient selection bias. And it should also guarantee some rigour of research methodology. It is always prospective. In a nonrandomised ...

  14. [Placebo-controlled trials in schizophrenia].

    Science.gov (United States)

    Melamed, Yuval; Davidson, Michael; Bleich, Avi

    2004-03-01

    Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials. The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients. Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow

  15. Long-Term Outcome of Cognitive Behavior Therapy for Body Dysmorphic Disorder: A Naturalistic Case Series of 1 to 4 Years After a Controlled Trial.

    Science.gov (United States)

    Veale, David; Miles, Sarah; Anson, Martin

    2015-11-01

    There is some evidence for the efficacy of cognitive behavior therapy (CBT) for body dysmorphic disorder (BDD) after 1 to 6months but none in the long term. The aim of this study was to follow up the participants in a randomized controlled trial of CBT versus anxiety management to determine whether or not the treatment gains were maintained over time. Thirty of the original 39 participants who had CBT were followed up over 1 to 4years and assessed using a number of clinician and self-report measures, which included the primary outcome measure of the Yale-Brown Obsessive Compulsive Scale modified for BDD. Outcome scores generally maintained over time from end of treatment to long-term follow-up. There was a slight deterioration from n=20 (51.3%) to n=18 (46.2%) who met improvement criteria at long-term follow-up. Eleven (28.2%) were in full remission and 22 (56.4%) were in partial remission. The gains made were generally maintained at long-term follow-up. However, there were a significant number of participants who maintained chronic symptoms after treatment and may need a longer-term or more complex intervention and active medication management. Copyright © 2015. Published by Elsevier Ltd.

  16. Randomised controlled trials and changing public health practice

    Directory of Open Access Journals (Sweden)

    Anne Cockcroft

    2017-05-01

    Full Text Available Abstract One reason for doing randomised controlled trials (RCTs is that experiments can be convincing. Early epidemiological experimenters, such as Jenner and the smallpox vaccine and Snow and his famous Broad Street pump handle, already knew the answer they were demonstrating; they used the experiments as knowledge translation devices to convince others. More sophisticated modern experiments include cluster randomised controlled trials (CRCTs for experiments in the public health setting. The knowledge translation value remains: RCTs and CRCTs can potentially stimulate changes of practice among stakeholders. Capitalising on the knowledge translation value of RCTs requires more than the standard reporting of trials. Those who are convinced by a trial and want to act, need to know how the trial relates to their own context, what contributed to success, and what might make it even more effective. Implementation research unpacks the back-story, examining how and why an intervention worked. The Camino Verde trial of community mobilisation for control of dengue reported a significant impact on entomological indices of the Aedes aegypti vector, and on serological dengue virus infection and self-reported dengue cases. This important study should lead to studies of similar interventions in other contexts, and ultimately to changes in dengue control practices. This supplement is the back-story of the trial, providing information to help researchers and planners to make use of the trial findings. Background articles include the full protocol, a systematic review of CRCTs of approaches for Aedes aegypti control, epidemiological and entomological findings from the baseline survey, and how baseline findings were used to set up the intervention. Secondary analyses of the entomological findings examine associations with the use of the larvicide temephos, and the impact of the intervention in different conditions of water supply and seasons. Other articles

  17. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  18. Obstacles to researching the researchers: a case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials.

    Science.gov (United States)

    McKenzie, Joanne E; Herbison, G Peter; Roth, Paul; Paul, Charlotte

    2010-03-21

    Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes. Bias resulting from selective reporting can impact on meta-analyses, influencing the conclusions of systematic reviews, and in turn, evidence based clinical practice guidelines.In 2006 we received funding to investigate if there was evidence of within-study selective reporting in a cohort of RCTs submitted to New Zealand Regional Ethics Committees in 1998/99. This research involved accessing ethics applications, their amendments and annual reports, and comparing these with corresponding publications. We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons. In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee. The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application. This initiated a seventeen month process to obtain ethical approval. This publication outlines what we planned to do, the issues we encountered, discusses the legal and ethical issues, and presents some potential solutions. Methodological research such as this has the potential for public benefit and there is little or no harm for the participants (trialists) in undertaking it. Further, in New Zealand, there is freedom of information legislation, which in this circumstance, unambiguously provided rights of access and use of the information in the ethics applications. The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research. Methodological research, such as this, can be used to develop processes to improve quality in research reporting. Recognition of the potential

  19. Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management

    Directory of Open Access Journals (Sweden)

    Muth Christiane

    2007-08-01

    Full Text Available Abstract Background Chronic congestive heart failure (CHF is a complex disease with rising prevalence, compromised quality of life (QoL, unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP can improve patients' QoL. Methods/Design HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific self-management, (nonpharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation. Patients from control group receive usual care by their GPs, who were introduced to guideline-oriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ, depression and anxiety disorders (PHQ-9, GAD-7, adherence (EHFScBS and SANA, quality of care measured by an adapted

  20. A randomized controlled trial to examine the effectiveness of case management model for community dwelling older persons with mild dementia in Hong Kong.

    Science.gov (United States)

    Lam, Linda C W; Lee, Jenny S W; Chung, Jenny C C; Lau, Anna; Woo, Jean; Kwok, Timothy C Y

    2010-04-01

    To evaluate a case management (CM) model for people with mild dementia, whereby resources within the family and in the community were mobilized and optimally used. Community dwelling psychiatric and geriatrics outpatients with mild dementia were randomized to receive CM by a trained occupational therapist for 4 months (CM group, N = 59) or usual care only (control group, N = 43). Primary outcome indicators included the Zarit Burden Scale (ZBI), General Health Questionnaire (GHQ), and Personal Well-Being Index for Adult (PWI-A) of the family caregivers. Secondary outcome indicators included the Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), and Personal Well-Being Index for Intellectually Disabled (PWI-ID) of the demented subjects as measured at fourth and twelfth months. CSDDis reduced in the CM group at fourth month, but not at twelfth month. The changes in outcome variables of persons with dementia did not differ between the groups (Mann-Whitney U-test, p > 0.05). At follow-up, CM group used more day care and domestic helpers than control group (chi (2), p > 0.05). Case management for Chinese persons with mild dementia outpatients did not show significant effects in reducing caregiver burden, but encouraged family caregivers to seek external support.

  1. Control groups in recent septic shock trials

    DEFF Research Database (Denmark)

    Pettilä, Ville; Hjortrup, Peter B; Jakob, Stephan M

    2016-01-01

    PURPOSE: The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. METHODS: We searched for original articles presenting......, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. RESULTS: A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58...... % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2...

  2. First Step in Telehealth Assessment: A Randomized Controlled Trial to Investigate the Effectiveness of an Electronic Case History Form for Dysphagia.

    Science.gov (United States)

    Kantarcigil, Cagla; Malandraki, Georgia A

    2017-08-01

    The need for developing effective telehealth tools for dysphagia management is high not only for people who live in rural areas, but also for individuals with mobility/access limitations. We aimed to develop an electronic case History Tool/form (thereafter, e-HiT) for dysphagia, and compare its effectiveness with its paper-based version (PBV) on completion time, completeness, independence, and patient perceptions/satisfaction. Secondarily, we examined associations between the aforementioned variables and predictor variables, such as age, cognition, and computer/internet use. Forty adults who expressed concerns with eating/swallowing participated. To compare both versions, a randomized, controlled two-period crossover design was used. In Visit 1, Group A completed the e-HiT and Group B completed the PBV. In Visit 2, Group A completed the PBV and Group B completed the e-HiT. A satisfaction survey was completed post visits. There were no statistically significant differences for completion time (p = 0.743), completeness (p = 0.486), and independence (p = 0.738). Patient perception/satisfaction was significantly higher with the e-HiT (p = 0.004). In addition, a significant association was found between completion time and age (p = 0.0063). Our results indicate that completing the e-HiT is as time efficient as completing the PBV and that both forms elicit the same amount of information with no or minimal support. Also, completion of the e-HiT yielded significantly higher satisfaction responses. This is the first study documenting the effectiveness of the e-HiT for outpatients with dysphagia, providing evidence that the first step of a swallowing assessment-case history completion-can be effectively completed via telehealth by individuals with reliable internet connection and basic computer literacy skills.

  3. Design, analysis and presentation of factorial randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Little Paul

    2003-11-01

    Full Text Available Abstract Background The evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages. Discussion Using a 2 × 2 factorial trial as an example, we present a number of issues that should be considered when planning a factorial trial. The main design issue is that of sample size. Factorial trials are most often powered to detect the main effects of interventions, since adequate power to detect plausible interactions requires greatly increased sample sizes. The main analytical issues relate to the investigation of main effects and the interaction between the interventions in appropriate regression models. Presentation of results should reflect the analytical strategy with an emphasis on the principal research questions. We also give an example of how baseline and follow-up data should be presented. Lastly, we discuss the implications of the design, analytical and presentational issues covered. Summary Difficulties in interpreting the results of factorial trials if an influential interaction is observed is the cost of the potential for efficient, simultaneous consideration of two or more interventions. Factorial trials can in principle be designed to have adequate power to detect realistic interactions, and in any case they are the only design that allows such effects to be investigated.

  4. Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond

    Directory of Open Access Journals (Sweden)

    Jana Sawynok

    2014-01-01

    Full Text Available Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function that are maintained at 4–6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6–12 months indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects.

  5. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  6. Evolution of substance use, neurological and psychiatric symptoms in schizophrenia and substance use disorder patients: a 12-week, pilot, case-control trial with quetiapine

    Directory of Open Access Journals (Sweden)

    Simon eZhornitsky

    2011-05-01

    Full Text Available Neurological and psychiatric symptoms are consequences of substance abuse in schizophrenia and non-schizophrenia patients. The present case-control study examined changes in substance abuse/dependence and neurological and psychiatric symptoms in substance abusers with (DD group, n=26 and without schizophrenia (SUD group, n=24 and in non-abusing schizophrenia patients (SCZ group, n=23 undergoing 12-week treatment with the atypical antipsychotic, quetiapine. Neurological and psychiatric symptoms were evaluated with the Positive and Negative Syndrome Scale, the Calgary Depression Scale for Schizophrenia, the Extrapyramidal Symptoms Rating Scale and the Barnes Akathisia Rating Scale. At endpoint, DD and SCZ patients were receiving significantly higher doses of quetiapine (mean = 554mg/d and 478mg/d, respectively, relative to SUD patients (mean = 150mg/d. We found that SUD patients showed greater improvement in weekly dollars spent on alcohol and drugs and SUD severity, compared to DD patients. At endpoint, there was no significant difference in dollars spent, but DD patients still had a higher mean SUD severity. Interestingly, DD patients had significantly higher Parkinsonism and depression than SCZ patients at baseline and endpoint. On the other hand, we found that SUD patients had significantly more akathisia at baseline, improved more than SCZ patients and this was related to cannabis abuse/dependence. Finally, SUD patients improved more in PANSS positive scores than DD and SCZ patients. Taken together, our results provide evidence for increased vulnerability to the adverse effects of alcohol and drugs in schizophrenia patients. They also suggest that substance abuse/withdrawal may mimic some symptoms of schizophrenia. Future studies will need to determine the role quetiapine played in these improvements.

  7. Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management).

    Science.gov (United States)

    Peters-Klimm, Frank; Müller-Tasch, Thomas; Schellberg, Dieter; Gensichen, Jochen; Muth, Christiane; Herzog, Wolfgang; Szecsenyi, Joachim

    2007-08-23

    Chronic congestive heart failure (CHF) is a complex disease with rising prevalence, compromised quality of life (QoL), unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP) can improve patients' QoL. HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific self-management, (non)pharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation). Patients from control group receive usual care by their GPs, who were introduced to guideline-oriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ), depression and anxiety disorders (PHQ-9, GAD-7), adherence (EHFScBS and SANA), quality of care measured by an adapted version of the Patient Chronic Illness

  8. Increase in PAS-induced neuroplasticity after a treatment course of intranasal ketamine for depression. Report of three cases from a placebo-controlled trial.

    Science.gov (United States)

    Gálvez, Verònica; Nikolin, Stevan; Ho, Kerrie-Anne; Alonzo, Angelo; Somogyi, Andrew A; Loo, Colleen K

    2017-02-01

    Animal studies suggest that neural plasticity may play a role in the antidepressant effects of a single ketamine dose. However, the potential effects of repeated ketamine treatments on human neuroplasticity are unknown. This pilot RCT study measured plasticity-induced changes before and after a ketamine course, in three treatment-resistant depressed subjects, who were randomized to receive 8 intranasal treatments of 100mg ketamine or 4.5mg midazolam. Mood ratings were performed by a trained blinded rater at baseline and 24h-48h after the ketamine course, using the Montgomery Asberg Depression Rating Scale (MADRS). Neuroplasticity was assessed in the motor cortex using a paired associative stimulation (PAS) paradigm at baseline and 24h-48h after the treatment course. No changes in current psychotropic medication or dosage were permitted for 4weeks prior to trial entry and throughout the trial. The subject receiving ketamine, but not those receiving midazolam, presented a marked increase in neural plasticity after the treatment course. However, mood changes were not associated with changes in neural plasticity. Pilot study with small sample size. Concomitant antidepressant medications taken. Plasticity was tested in the motor cortex only, thus the generalizability of these findings to other brain areas cannot be assumed. These results suggest that a course of intranasal ketamine may enhance synaptic plasticity in subjects with depression, but this was not associated with antidepressant effects. Further research on this topic is warranted. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Recent randomized controlled trials in otolaryngology.

    Science.gov (United States)

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  10. Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients

    NARCIS (Netherlands)

    Wynia, Klaske; Annema, Coby; Nissen, Hans; De Keyser, Jacques; Middel, Berry

    2010-01-01

    Background: Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little

  11. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Craig Fiona F

    2012-04-01

    , stratified by lesion size, and presence or absence of underlying systemic disease (for example, rheumatoid arthritis. Patients who require topical therapy are asked to enter a parallel observational study (case series. If topical therapy fails and systemic therapy is required, participants are then considered for inclusion in the randomised trial. Trial registration Current controlled trials: ISRCTN35898459. Eudract No.2008-008291-14.

  12. Learning from simple ebooks, online cases or classroom teaching when acquiring complex knowledge. A randomized controlled trial in respiratory physiology and pulmonology.

    Science.gov (United States)

    Worm, Bjarne Skjødt

    2013-01-01

    E-learning is developing fast because of the rapid increased use of smartphones, tablets and portable computers. We might not think of it as e-learning, but today many new e-books are in fact very complex electronic teaching platforms. It is generally accepted that e-learning is as effective as classroom teaching methods, but little is known about its value in relaying contents of different levels of complexity to students. We set out to investigate e-learning effects on simple recall and complex problem-solving compared to classroom teaching. 63 nurses specializing in anesthesiology were evenly randomized into three groups. They were given internet-based knowledge tests before and after attending a teaching module about respiratory physiology and pulmonology. The three groups was either an e-learning group with eBook teaching material, an e-learning group with case-based teaching or a group with face-to-face case-based classroom teaching. After the module the students were required to answer a post-test. Time spent and the number of logged into the system was also measured. For simple recall, all methods were equally effective. For problem-solving, the eCase group achieved a comparable knowledge level to classroom teaching, while textbook learning was inferior to both (p<0.01). The textbook group also spent the least amount of time on acquiring knowledge (33 minutes, p<0.001), while the eCase group spent significantly more time on the subject (53 minutes, p<0.001) and logged into the system significantly more (2.8 vs 1.6, p<0.001). E-learning based cases are an effective tool for teaching complex knowledge and problem-solving ability, but future studies using higher-level e-learning are encouraged.Simple recall skills, however, do not require any particular learning method.

  13. Should desperate volunteers be included in randomised controlled trials?

    Science.gov (United States)

    Allmark, P; Mason, S

    2006-09-01

    Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

  14. Learning from simple ebooks, online cases or classroom teaching when acquiring complex knowledge. A randomized controlled trial in respiratory physiology and pulmonology.

    Directory of Open Access Journals (Sweden)

    Bjarne Skjødt Worm

    Full Text Available BACKGROUND AND AIMS: E-learning is developing fast because of the rapid increased use of smartphones, tablets and portable computers. We might not think of it as e-learning, but today many new e-books are in fact very complex electronic teaching platforms. It is generally accepted that e-learning is as effective as classroom teaching methods, but little is known about its value in relaying contents of different levels of complexity to students. We set out to investigate e-learning effects on simple recall and complex problem-solving compared to classroom teaching. METHODS: 63 nurses specializing in anesthesiology were evenly randomized into three groups. They were given internet-based knowledge tests before and after attending a teaching module about respiratory physiology and pulmonology. The three groups was either an e-learning group with eBook teaching material, an e-learning group with case-based teaching or a group with face-to-face case-based classroom teaching. After the module the students were required to answer a post-test. Time spent and the number of logged into the system was also measured. RESULTS: For simple recall, all methods were equally effective. For problem-solving, the eCase group achieved a comparable knowledge level to classroom teaching, while textbook learning was inferior to both (p<0.01. The textbook group also spent the least amount of time on acquiring knowledge (33 minutes, p<0.001, while the eCase group spent significantly more time on the subject (53 minutes, p<0.001 and logged into the system significantly more (2.8 vs 1.6, p<0.001. CONCLUSIONS: E-learning based cases are an effective tool for teaching complex knowledge and problem-solving ability, but future studies using higher-level e-learning are encouraged.Simple recall skills, however, do not require any particular learning method.

  15. Relevance of randomised controlled trials in oncology.

    Science.gov (United States)

    Tannock, Ian F; Amir, Eitan; Booth, Christopher M; Niraula, Saroj; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Vera-Badillo, Francisco

    2016-12-01

    Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. UK Dermatology Clinical Trials Network's STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial.

    Science.gov (United States)

    Craig, Fiona F; Thomas, Kim S; Mitchell, Eleanor J; Williams, Hywel C; Norrie, John; Mason, James M; Ormerod, Anthony D

    2012-04-28

    presence or absence of underlying systemic disease (for example, rheumatoid arthritis).Patients who require topical therapy are asked to enter a parallel observational study (case series). If topical therapy fails and systemic therapy is required, participants are then considered for inclusion in the randomised trial. Current controlled trials: ISRCTN35898459. Eudract No.2008-008291-14.

  17. NEURAPRO-E study protocol: a multicentre randomized controlled trial of omega-3 fatty acids and cognitive-behavioural case management for patients at ultra high risk of schizophrenia and other psychotic disorders.

    Science.gov (United States)

    Markulev, Connie; McGorry, Patrick D; Nelson, Barnaby; Yuen, Hok Pan; Schaefer, Miriam; Yung, Alison R; Thompson, Andrew; Berger, Gregor; Mossaheb, Nilufar; Schlögelhofer, Monika; Smesny, Stefan; de Haan, Lieuwe; Riecher-Rössler, Anita; Nordentoft, Merete; Chen, Eric Yu Hai; Verma, Swapna; Hickie, Ian; Amminger, G Paul

    2017-10-01

    Recent research has indicated that preventative intervention is likely to benefit patients 'at-risk' for psychosis, both in terms of symptom reduction and delay or prevention of onset of threshold psychotic disorder. The strong preliminary results for the effectiveness of omega-3 polyunsaturated fatty acids (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) samples, mean that further study of such benign, potentially neuroprotective interventions is clinically and ethically required. Employing a multicentre approach, enabling a large sample size, this study will provide important information with regard to the use of omega-3 PUFAs in the UHR group. This trial is a 6-month, double-blind, randomized placebo-controlled trial of 1.4 g day -1 omega-3 PUFAs in UHR patients aged between 13 and 40 years. The primary hypothesis is that UHR patients receiving omega-3 PUFAs plus cognitive-behavioural case management (CBCM) will be less likely to transition to psychosis over a 6-month period compared to treatment with placebo plus CBCM. Secondary outcomes will examine symptomatic and functional changes, as well as examine if candidate risk factors predict response to omega-3 PUFA treatment in the UHR group. This is the protocol of the NeuraproE study. Utilizing a large sample, results from this study will be important in informing indicated prevention strategies for schizophrenia and other psychotic disorders, which may be the strongest avenue for reducing the burden, stigmatization, disability and economic consequences of these disorders. © 2015 Wiley Publishing Asia Pty Ltd.

  18. The Use of Deception in Public Health Behavioral Intervention Trials: A Case Study of Three Online Alcohol Trials

    Science.gov (United States)

    McCambridge, Jim; Kypri, Kypros; Bendtsen, Preben; Porter, John

    2013-01-01

    Some public health behavioral intervention research studies involve deception. A methodological imperative to minimize bias can be in conflict with the ethical principle of informed consent. As a case study, we examine the specific forms of deception used in three online randomized controlled trials evaluating brief alcohol interventions. We elaborate our own decision making about the use of deception in these trials, and present our ongoing findings and uncertainties. We discuss the value of the approach of pragmatism for examining these kinds of ethical issues that can arise in research on public health interventions. PMID:24161181

  19. A randomized-controlled trial of intensive case management emphasizing the recovery model among patients with severe and enduring mental illness.

    Science.gov (United States)

    O'Brien, S; McFarland, J; Kealy, B; Pullela, A; Saunders, J; Cullen, W; Meagher, D

    2012-09-01

    There is increasing interest in the application of recovery principles in mental health services. We studied the implementation of a programme of intensive case management (ICM) emphasizing recovery principles in a community mental health service in Ireland. Eighty service attenders with severe and enduring illness characterized by significant ongoing disability were randomized into (1) a group receiving a programme of ICM and (2) a group receiving treatment as usual (TAU). Groups were compared before and after the programme for general psychopathology using the Brief Psychiatric Rating Scale (BPRS) (clinician rated) and How are You? scale (self-rated). The Functional Analysis of Care Environments (FACE) scale provided assessment of multiple functional domains. The overall group (mean age 44.5 ± 13.2 years; 60% male) had mean total Health of the Nation Outcome Scale (HoNOS) scale scores of 10.5 ± 4.6, with problems in social functioning especially prominent (mean social subscale score 5.0 ± 2.7). The ICM group were younger (p recovery principles resulted in significant improvement across psychopathological and functional domains. Improvements were linked to enhanced engagement with structured daily activities. Recovery-oriented practices can be integrated into existing mental health services and provided alongside traditional models of care.

  20. Randomised controlled trial of mesalazine in IBS.

    Science.gov (United States)

    Barbara, Giovanni; Cremon, Cesare; Annese, Vito; Basilisco, Guido; Bazzoli, Franco; Bellini, Massimo; Benedetti, Antonio; Benini, Luigi; Bossa, Fabrizio; Buldrini, Paola; Cicala, Michele; Cuomo, Rosario; Germanà, Bastianello; Molteni, Paola; Neri, Matteo; Rodi, Marcello; Saggioro, Alfredo; Scribano, Maria Lia; Vecchi, Maurizio; Zoli, Giorgio; Corinaldesi, Roberto; Stanghellini, Vincenzo

    2016-01-01

    Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS. We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time. A total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI -12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI -2.7% to 26.0%) and 5.9% (p=0.404; 95% CI -7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule. Mesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy. ClincialTrials.gov number, NCT00626288. 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. Do randomized controlled trials discuss healthcare costs?

    Directory of Open Access Journals (Sweden)

    G Michael Allan

    Full Text Available BACKGROUND: Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. METHODS AND FINDINGS: We randomly sampled 188 RCTs spanning three years (2003-2005 from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188 of RCTs; any actual costs were included in 7.4% (14/188 of RCTs; and any mention of costs was included in 27.7% (52/188 of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005 and any mention of costs (Cochran-Armitage test, p = 0.02. Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009 or any mention of costs (OR = 0.63, p = 0.02. Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. CONCLUSION: While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  2. Do randomized controlled trials discuss healthcare costs?

    Science.gov (United States)

    Allan, G Michael; Korownyk, Christina; LaSalle, Kate; Vandermeer, Ben; Ma, Victoria; Klein, Douglas; Manca, Donna

    2010-08-23

    Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs) routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. We randomly sampled 188 RCTs spanning three years (2003-2005) from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188) of RCTs; any actual costs were included in 7.4% (14/188) of RCTs; and any mention of costs was included in 27.7% (52/188) of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005) and any mention of costs (Cochran-Armitage test, p = 0.02). Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009) or any mention of costs (OR = 0.63, p = 0.02). Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  3. Acupuncture and asthma: a review of controlled trials

    NARCIS (Netherlands)

    Kleijnen, J.; ter Riet, G.; Knipschild, P.

    1991-01-01

    BACKGROUND: Published controlled trials of acupuncture in asthma have often contained a small number of subjects and the results are contradictory. Controlled trials have been reviewed to determine whether clearer conclusions could be obtained by assessing as many studies as possible according to

  4. Opioid detoxification : from controlled clinical trial to clinical practice

    NARCIS (Netherlands)

    Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

  5. Nutritional risk assessment for Hip fracture, A Case control study

    OpenAIRE

    Torbergsen, Anne Cathrine

    2016-01-01

    The study was conducted at Oslo University Hospital, Norway. Patients were included from September 2009 until April 2011. In total 116 patients and 73 healthy non-fractured controls participated. The study has 3 parts. In the first part, we studied micronutrients and the risk of hip fracture in a case control study. In the second part, we conducted a randomized controlled nutrition intervention trial and finally, in the third part, we studied if micronutrients were associated with delirium in...

  6. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial.

    Science.gov (United States)

    Shukla, Vivek V; Bansal, Satvik; Nimbalkar, Archana; Chapla, Apurva; Phatak, Ajay; Patel, Dipen; Nimbalkar, Somashekhar

    2018-04-15

    To compare individual efficacy and additive effects of pain control interventions in preterm neonates. Randomized controlled trial. Level-3 University affiliated neonatal intensive care unit. 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions. Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention. Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos. The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group. Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.

  7. A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: the PREADViSE Trial.

    Science.gov (United States)

    Kryscio, R J; Abner, E L; Schmitt, F A; Goodman, P J; Mendiondo, M; Caban-Holt, A; Dennis, B C; Mathews, M; Klein, E A; Crowley, J J

    2013-01-01

    .0%) of the sites chose to participate in PREADViSE. Staff turnover at the sites presented challenges when training persons unfamiliar with cognitive testing procedures to conduct the memory screens. In the RCT few participants (1.6%) failed the MIS screen and among those who passed this screen a significant practice effect was encountered. In the exposure study 3,581 men were reached by phone in year 1, 15.7% could not be reached after 5 calls, and of those contacted 6.0% refused the screen even after consenting to the procedures at their clinical site. Most notable is that the failure rate for the MIS-T increased fourfold to 7.2%. Of the 257 men who took the TICS-M, 84.0% failed and were asked to contact their physicians for a more detailed memory assessment, and approximately half of these had some form of dementia or cognitive impairment. Several of these dementia cases are not AD. Partnering with SELECT led to an AD prevention trial conducted at a very reasonable cost by taking advantage of the experience and efficient clinical trial management found in a cancer cooperative group (Southwest Oncology Group or SWOG). Once unblinded, the RCT and exposure study data have the potential to yield new information on long term exposure to antioxidant supplements under controlled conditions.

  8. A controlled, randomized nonblinded clinical trial to assess the efficacy of amphotericin B deoxycholate as compared to pentamidine for the treatment of antimony unresponsive visceral leishmaniasis cases in Bihar, India

    Directory of Open Access Journals (Sweden)

    Vidya N

    2008-12-01

    Full Text Available Vidya Nand Rabi Das1, Niyamat Ali Siddiqui2, Krishna Pandey3, Vijay Pratap Singh2, Roshan K Topno4, Dharmendra Singh5, Rakesh Bihari Verma2, Alok Ranjan2, Prabhat Kumar Sinha1, Pradeep Das61Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences, Indian Council of Medical Research, Patna, Bihar, India; 2Department of Biostatistics; 3Department of Clinical Medicine; 4Department of Epidemiology; 5Department of Molecular Biology; 6Director and Institutional Head, Rajendra Memorial Research Institute of Medical Sciences, Indian Council of Medical Research, Patna, Bihar, IndiaBackground: There is significant variation in Amphotericin B (AMB efficacy and relapses in antimony unresponsive visceral leishmaniasis (VL cases over a period of time (10–15 years. Keeping in mind the above mentioned view this study was undertaken with an objective to assess the magnitude of cure and relapse rates of AMB in the treatment of antimony unresponsive VL cases.Methods: In a controlled, randomized nonblinded clinical trial, we evaluated the cure and relapse rate of Amphotericin B deoxycholate as compared to pentamidine. A total of 82 sodium stibogluconate (SSG unresponsive and parasitologically confirmed VL cases were included in this study and randomized into two groups, test (Amphotericin B and control (Pentamidine. Both the groups were treated with recommended dosages (as per World Health Organization guidelines of respective medicines. All the patients were followed up on 1st, 2nd, and 6th month after end of treatment.Results: Apparent cure rate in the Amphotericin B group was found to be 95% (39/41 compared with 83% (34/41 in the Pentamidine group, which shows significant statistical difference (p = 0.05. The ultimate cure rate was found 92% (38/41 in the Amphotericin B group compared to 73% (30/41 in the Pentamidine group, which shows a significant statistical difference (Yates corrected chi-square = 4.42, p = 0.04. Similarly

  9. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  10. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J

    2011-01-01

    trials after the 2004 market withdrawal of rofecoxib were excluded. RESULTS: Median defined daily dose (DDD) of celecoxib (2.00) was higher than the median DDD of rofecoxib (1.00; p ... celecoxib after the withdrawal of rofecoxib because the overall median DDD of celecoxib was substantially higher than the median DDD of rofecoxib, while non-selective NSAID DDDs were comparable....

  11. Is employment-focused case management effective for patients with substance use disorders? Results from a controlled multi-site trial in Germany covering a 2-years-period after inpatient rehabilitation.

    Science.gov (United States)

    Saal, Susanne; Forschner, Lukas; Kemmann, Dietmar; Zlatosch, Jacqueline; Kallert, Thomas W

    2016-08-05

    Substance use disorders are associated with unemployment. An employment-focused case management (CMRE) has been conceptualised as a specific intervention to help substance use disorder patients return to competitive employment immediately after inpatient rehabilitation. This study investigated the effect of the intervention on return to work of persons with substance use disorders. The study was conducted in four German inpatient rehabilitation departments, and included unemployed patients (aged between 18 and 63 years) with a main clinical diagnosis of ICD-10 F10-19 disorders. Six weeks before discharge, patients were randomly allocated to CMRE or standard care (SC) using a quasi-randomised approach. The primary outcome measure was integration into competitive employment 24 months after discharge from rehabilitation. Secondary outcome domains were abstinence, duration of employment, proportion of publicly funded employment, satisfaction with life, precarious housing situation and precarious financial situation, and use of follow-up services. Outcome measures were assessed 6 weeks and 1-2 days prior to discharge, and 12 and 24 months after discharge from rehabilitation. One hundred sixty patients were allocated into the CMRE group and 160 patients into the control group. 267 resp. 179 participants could be included in the analyses performed for the 12-, and the 24-months follow-up assessments. At the study endpoint the rate of integration into the primary labour market was 35.6 % in the CMRE group and 41.2 % in the control group, respectively (Relative Risk 0.92, 95 % CI, 0.47; 1.79). There was a significantly higher proportion in the CMRE group, however, which immediately after discharge linked with services of the Federal Employment Agency or Job Centres. There were no statistically significant differences in other outcomes between the groups. Compared to SC, the additional specific CMRE intervention did not result in superior effects on return to work

  12. Acupuncture for dry eye: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kim Ae-Ran

    2009-12-01

    Full Text Available Abstract Background Dry eye is usually managed by conventional medical interventions such as artificial tears, anti-inflammatory drugs and surgical treatment. However, since dry eye is one of the most frequent ophthalmologic disorders, safer and more effective methods for its treatment are necessary, especially for vulnerable patients. Acupuncture has been widely used to treat patients with dry eye. Our aim is to evaluate the effectiveness and safety of acupuncture for this condition. Methods/Design A randomised, patient-assessor blinded, sham (non-acupuncture point, shallow acupuncture controlled study was established. Participants allocated to verum acupuncture and sham acupuncture groups will be treated three times weekly for three weeks for a total of nine sessions per participant. Seventeen points (GV23; bilateral BL2, GB4, TE23, Ex1 (Taiyang, ST1 and GB20; and left SP3, LU9, LU10 and HT8 for men, right for women have been selected for the verum acupuncture; for the sham acupuncture, points have been selected that do not coincide with a classical acupuncture point and that are located close to the verum points, except in the case of the rim of the eye. Ocular surface disease index, tear film breakup time, the Schirmer I test, medication quantification scale and general assessment of improvement will be used as outcome variables for evaluating the effectiveness of acupuncture. Safety will also be assessed at every visit. Primary and secondary outcomes will be assessed four weeks after screening. All statistical analyses will be performed using analysis of covariance. Discussion The results of this trial will be used as a basis for clarifying the efficacy of acupuncture for dry eye. Trial registration ClinicalTrials.gov NCT00969280.

  13. Publication status of contemporary oncology randomised controlled trials worldwide.

    Science.gov (United States)

    Chen, Yu-Pei; Liu, Xu; Lv, Jia-Wei; Li, Wen-Fei; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2016-10-01

    Little is known about the extent of selective publication in contemporary oncology randomised controlled trials (RCTs) worldwide. This study aimed to evaluate the rates of publication and timely publication (within 24 months) for contemporary oncology RCTs from all over the world. We also investigated the trial characteristics associated with publication and timely publication. We identified all phase III oncology RCTs registered on ClinicalTrials.gov with a primary completion date between January 2008 and December 2012. We searched PubMed and EMBASE to identify publications. The final search date was 31 December 2015. Our primary outcome measure was the time to publication from the primary completion date to the date of primary publication in a peer-reviewed journal. We identified 598 completed oncology RCTs; overall, 398 (66.6%) had been published. For published trials, the median time to publication was 25 months (interquartile range, 16-37 months). Only 192 trials (32.1%) were published within 24 months. Timely publication was independently associated with trials completed late in 2012. Trials conducted in Asia and other regions were less likely to have timely publication, but trials conducted in different locations were all equally likely to be published. Industry- and NIH-funded trials were equally likely to be published timely or at any time after trial completion. Among 391 published trials with clear primary outcomes, there was a trend for timely publication of positive trials compared with negative trials. Despite the ethical obligations and societal expectations of disclosing findings promptly, oncology RCTs performed poorly. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Process control analysis of IMRT QA: implications for clinical trials

    International Nuclear Information System (INIS)

    Pawlicki, Todd; Rice, Roger K; Yoo, Sua; Court, Laurence E; McMillan, Sharon K; Russell, J Donald; Pacyniak, John M; Woo, Milton K; Basran, Parminder S; Boyer, Arthur L; Bonilla, Claribel

    2008-01-01

    The purpose of this study is two-fold: first is to investigate the process of IMRT QA using control charts and second is to compare control chart limits to limits calculated using the standard deviation (σ). Head and neck and prostate IMRT QA cases from seven institutions in both academic and community settings are considered. The percent difference between the point dose measurement in phantom and the corresponding result from the treatment planning system (TPS) is used for analysis. The average of the percent difference calculations defines the accuracy of the process and is called the process target. This represents the degree to which the process meets the clinical goal of 0% difference between the measurements and TPS. IMRT QA process ability defines the ability of the process to meet clinical specifications (e.g. 5% difference between the measurement and TPS). The process ability is defined in two ways: (1) the half-width of the control chart limits, and (2) the half-width of ±3σ limits. Process performance is characterized as being in one of four possible states that describes the stability of the process and its ability to meet clinical specifications. For the head and neck cases, the average process target across institutions was 0.3% (range: -1.5% to 2.9%). The average process ability using control chart limits was 7.2% (range: 5.3% to 9.8%) compared to 6.7% (range: 5.3% to 8.2%) using standard deviation limits. For the prostate cases, the average process target across the institutions was 0.2% (range: -1.8% to 1.4%). The average process ability using control chart limits was 4.4% (range: 1.3% to 9.4%) compared to 5.3% (range: 2.3% to 9.8%) using standard deviation limits. Using the standard deviation to characterize IMRT QA process performance resulted in processes being preferentially placed in one of the four states. This is in contrast to using control charts for process characterization where the IMRT QA processes were spread over three of the

  15. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  16. Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial.

    Directory of Open Access Journals (Sweden)

    Kirsti Krohn Garnæs

    2016-07-01

    Full Text Available The effectiveness of exercise training for preventing excessive gestational weight gain (GWG and gestational diabetes mellitus (GDM is still uncertain. As maternal obesity is associated with both GWG and GDM, there is a special need to assess whether prenatal exercise training programs provided to obese women reduce the risk of adverse pregnancy outcomes. Our primary aim was to assess whether regular supervised exercise training in pregnancy could reduce GWG in women with prepregnancy overweight/obesity. Secondary aims were to examine the effects of exercise in pregnancy on 30 outcomes including GDM incidence, blood pressure, blood measurements, skinfold thickness, and body composition.This was a single-center study where we randomized (1:1 91 pregnant women with a prepregnancy body mass index (BMI ≥ 28 kg/m2 to exercise training (n = 46 or control (standard maternity care (n = 45. Assessments were done at baseline (pregnancy week 12-18 and in late pregnancy (week 34-37, as well as at delivery. The exercise group was offered thrice weekly supervised sessions of 35 min of moderate intensity endurance exercise and 25 min of strength training. Seventeen women were lost to follow-up (eight in the exercise group and nine in the control group. Our primary endpoint was GWG from baseline testing to delivery. The principal analyses were done as intention-to-treat analyses, with supplementary per protocol analyses where we assessed outcomes in the women who adhered to the exercise program (n = 19 compared to the control group. Mean GWG from baseline to delivery was 10.5 kg in the exercise group and 9.2 kg in the control group, with a mean difference of 0.92 kg (95% CI -1.35, 3.18; p = 0.43. Among the 30 secondary outcomes in late pregnancy, an apparent reduction was recorded in the incidence of GDM (2009 WHO definition in the exercise group (2 cases; 6.1% compared to the control group (9 cases; 27.3%, with an odds ratio of 0.1 (95% CI 0.02, 0.95; p = 0

  17. Standards for reporting randomized controlled trials in neurosurgery.

    Science.gov (United States)

    Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S

    2011-02-01

    The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could

  18. From Controlled Trial to Community Adoption: The Multisite Translational Community Trial

    Science.gov (United States)

    Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.

    2011-01-01

    Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935

  19. The Asthma Control Questionnaire as a clinical trial endpoint

    DEFF Research Database (Denmark)

    Barnes, P J; Casale, T B; Dahl, Ronald

    2014-01-01

    these component endpoints; however, there is no consensus on the optimal instrument for use in clinical trials. The Asthma Control Questionnaire (ACQ) has been shown to be a valid, reliable instrument that allows accurate and reproducible assessment of asthma control that compares favourably with other commonly...

  20. Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Stevanovic, Ana; Beckers, Stefan Kurt; Czaplik, Michael; Bergrath, Sebastian; Coburn, Mark; Brokmann, Jörg Christian; Hilgers, Ralf-Dieter; Rossaint, Rolf

    2017-01-26

    Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment. Three thousand and ten patients will be included in this single-center, open-label, randomized controlled, noninferiority trial with two parallel arms. According to the inclusion criteria, all emergency cases involving adult patients who require EMS-physician treatment, excluding life-threatening cases, will be randomly assigned by the EMS dispatching center into two groups. One thousand five hundred and five patients in the control group will be treated by a conventional EMS physician on scene, and 1505 patients in the intervention group will be treated by paramedics who are concurrently instructed by the tele-EMS physicians at the teleconsultation center. The primary outcome measure will include the rate of treatment-specific adverse events in relation to the kind of EMS physician used. The secondary outcome measures will record the specific treatment-associated quality indicators. The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical

  1. Endurance exercise training in orthostatic intolerance: a randomized, controlled trial.

    Science.gov (United States)

    Winker, Robert; Barth, Alfred; Bidmon, Daniela; Ponocny, Ivo; Weber, Michael; Mayr, Otmar; Robertson, David; Diedrich, André; Maier, Richard; Pilger, Alex; Haber, Paul; Rüdiger, Hugo W

    2005-03-01

    Orthostatic intolerance is a syndrome characterized by chronic orthostatic symptoms of light-headedness, fatigue, nausea, orthostatic tachycardia, and aggravated norepinephrine levels while standing. The aim of this study was to assess the protective effect of exercise endurance training on orthostatic symptoms and to examine its usefulness in the treatment of orthostatic intolerance. 2768 military recruits were screened for orthostatic intolerance by questionnaire. Tilt-table testing identified 36 cases of orthostatic intolerance out of the 2768 soldiers. Subsequently, 31 of these subjects with orthostatic intolerance entered a randomized, controlled trial. The patients were allocated randomly to either a "training" (3 months jogging) or a "control" group. The influence of exercise training on orthostatic intolerance was assessed by determination of questionnaire scores and tilt-table testing before and after intervention. After training, only 6 individuals of 16 still had orthostatic intolerance compared with 10 of 11 in the control group. The Fisher exact test showed a highly significant difference in diagnosis between the 2 groups (P=0.008) at the end of the study. Analysis of the questionnaire-score showed significant interaction between time and group (P=0.001). The trained subjects showed an improvement in the average symptom score from 1.79+/-0.4 to 1.04+/-0.4, whereas the control subjects showed no significant change in average symptom score (2.09+/-0.6 and 2.14+/-0.5, respectively). Our data demonstrate that endurance exercise training leads to an improvement of symptoms in the majority of patients with orthostatic intolerance. Therefore, we suggest that endurance training should be considered in the treatment of orthostatic intolerance patients.

  2. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  3. Randomised controlled trials in educational research: Ontological ...

    African Journals Online (AJOL)

    based practice in medical and clinical settings because they are associated with a particular ontological and epistemological perspective that is situated within a positivist world view. It assumes that environments and variables can be controlled ...

  4. Heterogenic control groups in randomized, controlled, analgesic trials of total hip and knee arthroplasty.

    Science.gov (United States)

    Karlsen, Anders P; Mathiesen, Ole; Dahl, Jørgen B

    2018-03-01

    Postoperative analgesic interventions are often tested adjunct to basic non-opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control groups, and possible assay sensitivity, differs between trials. We hypothesized that postoperative opioid requirements and pain intensities vary between different control groups in analgesic trials. Control groups from RCTs investigating analgesic interventions after total hip and knee arthroplasty were categorized based on standardized basic analgesic treatment. Morphine consumption 0 to 24 hours postoperatively, and resting pain scores at 6 and 24 hours for subgroups of basic treatments, were compared with ANOVA. In an additional analysis, we compared pain and opioid requirements in trials where a non-steroidal anti-inflammatory drug (NSAID) was administered as an intervention with trial where NSAID was administered in a control group. We included 171 RCTs employing 28 different control groups with large variability in pain scores and opioid requirements. Four types of control groups (comprising 78 trials) were eligible for subgroup comparisons. These subgroups received "opioid" alone, "NSAID + opioid", "acetaminophen + opioid", or "NSAID + acetaminophen + opioid", respectively. Morphine consumption and pain scores varied substantially between these groups, with no consistent superior efficacy in any subgroup. Additionally, trials administering NSAID as an intervention demonstrated lower pain scores and opioid requirements than trials where NSAID was administered in a control group. Analgesic treatment in RCT control groups varies considerably. Control groups receiving various combinations of opioid, NSAID and acetaminophen did not differ consistently in pain and opioid requirements. Pain and opioid requirements were lower in trials administering NSAID as an intervention compared with trials administering NSAID in a control group.

  5. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  6. Controlled trial of balneotherapy in treatment of low back pain.

    Science.gov (United States)

    Konrad, K; Tatrai, T; Hunka, A; Vereckei, E; Korondi, I

    1992-01-01

    Three treatments for non-specific lumbar pain--balneotherapy, underwater traction bath, and underwater massage--were assessed in a randomised prospective controlled trial in 158 outpatients. Each group was treated for four weeks and patients were reviewed at the end of this period and at 12 months after entry to the trial. The prescription of analgesics and the pain score were significantly reduced in all three treated groups, but there was no difference between the three groups. No significant change occurred in spinal motion and the straight leg raising test. After one year only the analgesic consumption was significantly lower than in the control group. PMID:1535495

  7. A randomized controlled trial of Human Papillomavirus (HPV testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial

    Directory of Open Access Journals (Sweden)

    Smith Laurie W

    2010-03-01

    Full Text Available Abstract Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5% were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%. In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%. Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

  8. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  9. Conflicts of interest in randomised controlled surgical trials: systematic review and qualitative and quantitative analysis

    Directory of Open Access Journals (Sweden)

    Probst Pascal

    2016-09-01

    Full Text Available Conflicts of interest may lead to biased trial designs and unbalanced interpretation of study results. We aimed to evaluate the reporting of potential conflicts of interest in full publications of surgical randomised controlled trials (RCTs. A systematic literature search was performed in CENTRAL, MEDLINE and EMBASE (1985–2014 to find all surgical RCTs of medical devices and perioperative pharmacological or nutritional interventions. The information on conflicts of interest was evaluated both quantitatively and qualitatively, and the development of stated conflicts over time was studied. Of 7934 articles, 444 met the inclusion criteria. In 93 of 444 trials (20.9%, conflicts of interest were disclosed. In half of the cases, the information provided was insufficient to permit conclusions regarding possible influence on the trials. Information about conflicts of interest has increased continuously during the last decades (1985–1994: 0%, 1995–2004: 2.8% and 2005–2014: 33.0%; p<0.001. Among the 115 industry-funded trials, industry participation was considered as a potential conflict of interest in 24 cases (20.9%. Over the past three decades, only every 10th trial has provided appropriate information on conflicts of interest. However, transparency is crucial for the reliability of evidence-based medicine. There is an urgent need for the full disclosure of all conflicts of interest in surgical publishing and for transparency regarding cooperation between academia and industry.

  10. External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?

    Science.gov (United States)

    Saunders, C; Byrne, C D; Guthrie, B; Lindsay, R S; McKnight, J A; Philip, S; Sattar, N; Walker, J J; Wild, S H

    2013-03-01

    To describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results. A literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type 2 diabetes living in Scotland in 2008 (n = 180,590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined. Seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type 2 diabetes ineligible for a trial with the most stringent criteria based on age alone. We found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

  11. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  12. The maturation of randomised controlled trials in mental health ...

    African Journals Online (AJOL)

    The aims of this paper are: (i) to give an overview of the use and maturation of randomised controlled trials (RCTs) in mental health services research, (ii) to indicate areas in which mental health may present particular challenges, and (iii) to outline necessary steps to strengthen the capacity to conduct better quality ...

  13. Randomized Controlled Trials: The Most Powerful Tool In Modern ...

    African Journals Online (AJOL)

    Randomized controlled trial (RCT) can be said to be one of the simplest but most powerful tool of research. It is the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment. Through the randomization, bias will be avoided ...

  14. Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial ...

    African Journals Online (AJOL)

    The study was a single‑blind randomized controlled clinical trial. Perceived stress scale (PSS) was measured during the 12th, 20th, and 28th weeks of pregnancy. SPSS version 16.0 (Chicago, IL, USA) was used for all data analysis. When the data were found to be normally distributed,the RMANOVA were used to assess ...

  15. Evaluating the Flipped Classroom: A Randomized Controlled Trial

    Science.gov (United States)

    Wozny, Nathan; Balser, Cary; Ives, Drew

    2018-01-01

    Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

  16. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  17. Asthma Self-Management Model: Randomized Controlled Trial

    Science.gov (United States)

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  18. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  19. 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.

  20. A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

    International Nuclear Information System (INIS)

    Ogilvie, Gina S; Cook, Darrel A; Mei, Wendy; Stuart, Gavin CE; Franco, Eduardo L; Coldman, Andrew J; Niekerk, Dirk J van; Krajden, Mel; Martin, Ruth E; Ehlen, Thomas G; Ceballos, Kathy; Peacock, Stuart J; Smith, Laurie W; Kan, Lisa

    2010-01-01

    In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

  1. 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

  2. Community-led trials: Intervention co-design in a cluster randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil

    2017-05-30

    In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

  3. Community-led trials: Intervention co-design in a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Neil Andersson

    2017-05-01

    Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

  4. Moxibustion for cephalic version: a feasibility randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bisits Andrew

    2011-09-01

    Full Text Available Abstract Background Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin has been used to correct a breech presentation. Evidence of effectiveness and safety from systematic reviews is encouraging although significant heterogeneity has been found among trials. We assessed the feasibility of conducting a randomised controlled trial of moxibustion plus usual care compared with usual care to promote cephalic version in women with a breech presentation, and examined the views of women and health care providers towards implementing a trial within an Australian context. Methods The study was undertaken at a public hospital in Newcastle, New South Wales, Australia. Women at 34-36.5 weeks of gestation with a singleton breech presentation (confirmed by ultrasound, were randomised to moxibustion plus usual care or usual care alone. The intervention was administered over 10 days. Clinical outcomes included cephalic presentation at birth, the need for ECV, mode of birth; perinatal morbidity and mortality, and maternal complications. Feasibility outcomes included: recruitment rate, acceptability, compliance and a sample size for a future study. Interviews were conducted with 19 midwives and obstetricians to examine the acceptability of moxibustion, and views on the trial. Results Twenty women were randomised to the trial. Fifty one percent of women approached accepted randomisation to the trial. A trend towards an increase in cephalic version at delivery (RR 5.0; 95% CI 0.7-35.5 was found for women receiving moxibustion compared with usual care. There was also a trend towards greater success with version following ECV. Two babies were admitted to the neonatal unit from the moxibustion group. Compliance with the moxibustion protocol was acceptable with no reported side effects. Clinicians expressed the need for research to establish the safety and efficacy of moxibustion, and support for the intervention was given to

  5. A randomized, controlled trial of oral propranolol in infantile hemangioma.

    Science.gov (United States)

    Léauté-Labrèze, Christine; Hoeger, Peter; Mazereeuw-Hautier, Juliette; Guibaud, Laurent; Baselga, Eulalia; Posiunas, Gintas; Phillips, Roderic J; Caceres, Hector; Lopez Gutierrez, Juan Carlos; Ballona, Rosalia; Friedlander, Sheila Fallon; Powell, Julie; Perek, Danuta; Metz, Brandie; Barbarot, Sebastien; Maruani, Annabel; Szalai, Zsuzsanna Zsofia; Krol, Alfons; Boccara, Olivia; Foelster-Holst, Regina; Febrer Bosch, Maria Isabel; Su, John; Buckova, Hana; Torrelo, Antonio; Cambazard, Frederic; Grantzow, Rainer; Wargon, Orli; Wyrzykowski, Dariusz; Roessler, Jochen; Bernabeu-Wittel, Jose; Valencia, Adriana M; Przewratil, Przemyslaw; Glick, Sharon; Pope, Elena; Birchall, Nicholas; Benjamin, Latanya; Mancini, Anthony J; Vabres, Pierre; Souteyrand, Pierre; Frieden, Ilona J; Berul, Charles I; Mehta, Cyrus R; Prey, Sorilla; Boralevi, Franck; Morgan, Caroline C; Heritier, Stephane; Delarue, Alain; Voisard, Jean-Jacques

    2015-02-19

    Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. We performed a multicenter, randomized, double-blind, adaptive, phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy. Infants were randomly assigned to receive placebo or one of four propranolol regimens (1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months). A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis. The primary end point was success (complete or nearly complete resolution of the target hemangioma) or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. Of 460 infants who underwent randomization, 456 received treatment. On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis. The frequency of successful treatment was higher with this regimen than with placebo (60% vs. 4%, P<0.001). A total of 88% of patients who received the selected propranolol regimen showed improvement by week 5, versus 5% of patients who received placebo. A total of 10% of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up. Known adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) occurred infrequently, with no significant difference in frequency between the placebo group and the groups receiving propranolol. This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma. (Funded by

  6. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...... between nurse researchers and clinicians, including education, training and support may increase the success rate and quality of nurse-led studies using the randomised controlled trial....

  7. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

    OpenAIRE

    Jones, D. A.; West, R. R.

    1996-01-01

    OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted ove...

  8. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    OpenAIRE

    Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2014-01-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially import...

  9. Evaluating the importance of sham controlled trials in the investigation of medical devices in interventional cardiology.

    Science.gov (United States)

    Byrne, Robert A; Capodanno, Davide; Mahfoud, Felix; Fajadet, Jean; Windecker, Stephan; Jüni, Peter; Baumbach, Andreas; Wijns, William; Haude, Michael

    2018-05-22

    Cardiovascular medicine is one of the specialties that has relied most heavily on evidence from randomized clinical trials in determining best practice for the management of common disease conditions. When comparing treatment approaches, trials incorporating random allocation are the most appropriate method for protecting against treatment allocation bias. In order to protect against performance and ascertainment bias, trial designs including placebo control are preferable where feasible. In contrast to testing of medicines, treatments based on procedures or use of medical devices are more challenging to assess, as sham procedures are necessary to facilitate blinding of participants. However, in many cases, ethical concerns exist, as individual patients allocated to sham procedure are exposed only to risk without potential for benefit. Accordingly, the potential benefits to the general patient population must be carefully weighed against the risks of the exposed individuals. For this reason, trial design and study conduct are critically important to ensure that the investigation has the best chance of answering the study question at hand. In the current manuscript, we aim to review issues relating to the conduct of sham-controlled trials and discuss a number of recent examples in the field of interventional cardiology.

  10. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  11. Study protocol: effect of playful training on functional abilities of older adults - a randomized controlled trial

    DEFF Research Database (Denmark)

    Jessen, Jari Due; Lund, Henrik Hautop

    2017-01-01

    of community dwelling elderly as a result of short-term playing with an exergame system in the form of interactive modular tiles. Such playful training may be motivational to perform and viewed by the subjects to offer life-fulfilling quality, while providing improvement in physical abilities, e.g. related...... to prevent fall accidents. The RCT will test for a variety of health parameters of community-dwelling elderly playing on interactive modular tiles.Methods: The study will be a single blinded, randomized controlled trial with 60 community-dwelling adults 70+ years. The trial will consist an intervention group...... paired t-test, otherwise using Wilcoxon signed-rank test. "Intention to treat" analysis will be done.Discussion: The trial tests for increased mobility, agility, balancing and general fitness of community-dwelling elderly as a result of playing, in this case on modular interactive tiles. A positive...

  12. Interconnecting smartphone, image analysis server, and case report forms in clinical trials for automatic skin lesion tracking in clinical trials

    Science.gov (United States)

    Haak, Daniel; Doma, Aliaa; Gombert, Alexander; Deserno, Thomas M.

    2016-03-01

    Today, subject's medical data in controlled clinical trials is captured digitally in electronic case report forms (eCRFs). However, eCRFs only insufficiently support integration of subject's image data, although medical imaging is looming large in studies today. For bed-side image integration, we present a mobile application (App) that utilizes the smartphone-integrated camera. To ensure high image quality with this inexpensive consumer hardware, color reference cards are placed in the camera's field of view next to the lesion. The cards are used for automatic calibration of geometry, color, and contrast. In addition, a personalized code is read from the cards that allows subject identification. For data integration, the App is connected to an communication and image analysis server that also holds the code-study-subject relation. In a second system interconnection, web services are used to connect the smartphone with OpenClinica, an open-source, Food and Drug Administration (FDA)-approved electronic data capture (EDC) system in clinical trials. Once the photographs have been securely stored on the server, they are released automatically from the mobile device. The workflow of the system is demonstrated by an ongoing clinical trial, in which photographic documentation is frequently performed to measure the effect of wound incision management systems. All 205 images, which have been collected in the study so far, have been correctly identified and successfully integrated into the corresponding subject's eCRF. Using this system, manual steps for the study personnel are reduced, and, therefore, errors, latency and costs decreased. Our approach also increases data security and privacy.

  13. [Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

    Science.gov (United States)

    Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

    2016-11-01

    To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles

  14. Talking about Birth Control in 1877: Gender, Class, and Ideology in the Knowlton Trial

    Directory of Open Access Journals (Sweden)

    Janssen Flore

    2017-11-01

    Full Text Available This article explores the debate around widening access to birth control information in the late nineteenth century through a case study of Annie Besant’s participation in the 1877 Knowlton Trial. Examining Besant’s rhetoric at the trial and in related publications, it highlights the public and performative nature of her campaign to facilitate access to birth control information for working-class married couples. With reference to the representation of issues of gender and social class and the shifting focus from the private to the public in Besant’s rhetoric, the article argues that the late nineteenth-century debate around birth control access was a middle-class debate about working-class life and experience.

  15. The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial.

    Science.gov (United States)

    Hardy, Victoria; O'Connor, Yvonne; Heavin, Ciara; Mastellos, Nikolaos; Tran, Tammy; O'Donoghue, John; Fitzpatrick, Annette L; Ide, Nicole; Wu, Tsung-Shu Joseph; Chirambo, Griphin Baxter; Muula, Adamson S; Nyirenda, Moffat; Carlsson, Sven; Andersson, Bo; Thompson, Matthew

    2017-10-11

    There is evidence to suggest that frontline community health workers in Malawi are under-referring children to higher-level facilities. Integrating a digitized version of paper-based methods of Community Case Management (CCM) could strengthen delivery, increasing urgent referral rates and preventing unnecessary re-consultations and hospital admissions. This trial aims to evaluate the added value of the Supporting LIFE electronic Community Case Management Application (SL eCCM App) compared to paper-based CCM on urgent referral, re-consultation and hospitalization rates, in two districts in Northern Malawi. This is a pragmatic, stepped-wedge cluster-randomized trial assessing the added value of the SL eCCM App on urgent referral, re-consultation and hospitalization rates of children aged 2 months and older to up to 5 years, within 7 days of the index visit. One hundred and two health surveillance assistants (HSAs) were stratified into six clusters based on geographical location, and clusters randomized to the timing of crossover to the intervention using simple, computer-generated randomization. Training workshops were conducted prior to the control (paper-CCM) and intervention (paper-CCM + SL eCCM App) in assigned clusters. Neither participants nor study personnel were blinded to allocation. Outcome measures were determined by abstraction of clinical data from patient records 2 weeks after recruitment. A nested qualitative study explored perceptions of adherence to urgent referral recommendations and a cost evaluation determined the financial and time-related costs to caregivers of subsequent health care utilization. The trial was conducted between July 2016 and February 2017. This is the first large-scale trial evaluating the value of adding a mobile application of CCM to the assessment of children aged under 5 years. The trial will generate evidence on the potential use of mobile health for CCM in Malawi, and more widely in other low- and middle

  16. WORKBENCH FOR CONTROL SYSTEMS TRIALS BASED ON VIPA 300 CONTROLLER AND ADVANTECH INPUT/OUTPUT CARD

    Directory of Open Access Journals (Sweden)

    M. V. Levinskyi

    2015-01-01

    Full Text Available The topic is about workbench creation for control systems trials based on VIPA 300 industrial PLC and model of control object which is implemented in MatLab Simulink program on PC. Connection between controller and the PC is provided by the Advantech PCI-1711 input/output card of discrete and analog signals. Object identification,control system synthesis, creation of control device structure and its parametrical identification, as a rule, is done on a PC in a modelling environment, e.g. in MatLab. But often, using this PC modelling, the hardware and software features of algorithms which were obtained during system synthesis are not considered in a specific industrial PLC.It is considered a good idea to use a composite version where obtained algorithms are tested in a real industrial PLC and control object is substituted by a model which is working on a PC in real time scale. In this case software realization of algorithms in a specific PLC are fully taken into account and substitution of real control object by itsmodel considerably reduces the costs for carrying out experiments and allows to study the system behavior when control object parameters and modes of operation vary greatly. The creation of workbench stipulates several stages: configuration and programming of industrial PLC VIPA 313 SC, installation and configuration of Advantech PCI- 1711 input/output card, tuning of Simulink modelling environment for working in real time scale using Real-Time Windows Target Library, testing of workbench by using constant and harmonic signals of different frequencies. Work results of virtual stabilization system are compared with combined version. In virtual stabilization system PID governor and control object are implemented in Simulink. In combined version control object is still implemented in Simulink and PID governor - in VIPA 313 SC controller (using functional block FB58 from Step7 standard library.

  17. A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial.

    Science.gov (United States)

    Langhorne, Peter; Wu, Olivia; Rodgers, Helen; Ashburn, Ann; Bernhardt, Julie

    2017-09-01

    Mobilising patients early after stroke [early mobilisation (EM)] is thought to contribute to the beneficial effects of stroke unit care but it is poorly defined and lacks direct evidence of benefit. We assessed the effectiveness of frequent higher dose very early mobilisation (VEM) after stroke. We conducted a parallel-group, single-blind, prospective randomised controlled trial with blinded end-point assessment using a web-based computer-generated stratified randomisation. The trial took place in 56 acute stroke units in five countries. We included adult patients with a first or recurrent stroke who met physiological inclusion criteria. Patients received either usual stroke unit care (UC) or UC plus VEM commencing within 24 hours of stroke. The primary outcome was good recovery [modified Rankin scale (mRS) score of 0-2] 3 months after stroke. Secondary outcomes at 3 months were the mRS, time to achieve walking 50 m, serious adverse events, quality of life (QoL) and costs at 12 months. Tertiary outcomes included a dose-response analysis. Patients, outcome assessors and investigators involved in the trial were blinded to treatment allocation. We recruited 2104 (UK, n  = 610; Australasia, n  = 1494) patients: 1054 allocated to VEM and 1050 to UC. Intervention protocol targets were achieved. Compared with UC, VEM patients mobilised 4.8 hours [95% confidence interval (CI) 4.1 to 5.7 hours; p  pattern of an improved odds of efficacy and safety outcomes in association with increased daily frequency of out-of-bed sessions but a reduced odds with an increased amount of mobilisation (minutes per day). UC clinicians started mobilisation earlier each year altering the context of the trial. Other potential confounding factors included staff patient interaction. Patients in the VEM group were mobilised earlier and with a higher dose of therapy than those in the UC group, which was already early. This VEM protocol was associated with reduced odds of favourable

  18. Accounting for control mislabeling in case-control biomarker studies.

    Science.gov (United States)

    Rantalainen, Mattias; Holmes, Chris C

    2011-12-02

    In biomarker discovery studies, uncertainty associated with case and control labels is often overlooked. By omitting to take into account label uncertainty, model parameters and the predictive risk can become biased, sometimes severely. The most common situation is when the control set contains an unknown number of undiagnosed, or future, cases. This has a marked impact in situations where the model needs to be well-calibrated, e.g., when the prediction performance of a biomarker panel is evaluated. Failing to account for class label uncertainty may lead to underestimation of classification performance and bias in parameter estimates. This can further impact on meta-analysis for combining evidence from multiple studies. Using a simulation study, we outline how conventional statistical models can be modified to address class label uncertainty leading to well-calibrated prediction performance estimates and reduced bias in meta-analysis. We focus on the problem of mislabeled control subjects in case-control studies, i.e., when some of the control subjects are undiagnosed cases, although the procedures we report are generic. The uncertainty in control status is a particular situation common in biomarker discovery studies in the context of genomic and molecular epidemiology, where control subjects are commonly sampled from the general population with an established expected disease incidence rate.

  19. The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Campbell Karen

    2008-03-01

    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  20. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

    2015-03-15

    Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

  1. Review of Randomized Controlled Trials of Massage in Preterm Infants

    Directory of Open Access Journals (Sweden)

    Anna-Kaisa Niemi

    2017-04-01

    Full Text Available Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants.

  2. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.

    Science.gov (United States)

    de Rooij, Thijs; van Hilst, Jony; Vogel, Jantien A; van Santvoort, Hjalmar C; de Boer, Marieke T; Boerma, Djamila; van den Boezem, Peter B; Bonsing, Bert A; Bosscha, Koop; Coene, Peter-Paul; Daams, Freek; van Dam, Ronald M; Dijkgraaf, Marcel G; van Eijck, Casper H; Festen, Sebastiaan; Gerhards, Michael F; Groot Koerkamp, Bas; Hagendoorn, Jeroen; van der Harst, Erwin; de Hingh, Ignace H; Dejong, Cees H; Kazemier, Geert; Klaase, Joost; de Kleine, Ruben H; van Laarhoven, Cornelis J; Lips, Daan J; Luyer, Misha D; Molenaar, I Quintus; Nieuwenhuijs, Vincent B; Patijn, Gijs A; Roos, Daphne; Scheepers, Joris J; van der Schelling, George P; Steenvoorde, Pascal; Swijnenburg, Rutger-Jan; Wijsman, Jan H; Abu Hilal, Moh'd; Busch, Olivier R; Besselink, Marc G

    2017-04-08

    Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting. LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting. Dutch Trial Register, NTR5188 . Registered on 9 April 2015.

  4. Difficulties in recruitment for a randomized controlled trial involving hysterosalpingography

    Directory of Open Access Journals (Sweden)

    Helmerhorst Frans M

    2006-06-01

    Full Text Available Abstract Background The usefulness of hysterosalpingography (HSG as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records. Results Out of 759 women, a total of 127 (17% agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%. Other reasons were inattentive clinicians (3% and patient-associated reasons (24%. Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure. Conclusion Almost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial.

  5. Quality control of radiation therapy in clinical trials

    International Nuclear Information System (INIS)

    Kramer, S.; Lustig, R.; Grundy, G.

    1983-01-01

    The RTOG is a group of participating institutions which has a major interest in furthering clinical radiation oncology. They have formulated protocols for clinical investigation in which radiation therapy is the major modality of treatment. In addition, other modalities, such as chemotherapy, radiation sensitizers, and hyperthermia, are used in combined approach to cancer. Quality control in all aspects of patient management is necessary to insure quality data. These areas include evaluation of pathology, physics, and dosimetry, and clinical patient data. Quality control is both time consuming and expensive. However, by dividing these tasks into various levels and time frames, by using computerized data-control mechanisms, and by employing appropriate levels of ancillary personnel expertise, quality control can improve compliance and decrease the cost of investigational trials

  6. Quality of reporting of randomized controlled trials of pharmacologic treatment of bipolar disorders: a systematic review.

    Science.gov (United States)

    Strech, Daniel; Soltmann, Bettina; Weikert, Beate; Bauer, Michael; Pfennig, Andrea

    2011-09-01

    This study aimed to assess (1) the quality of reporting of randomized controlled trials of pharmacologic treatment of bipolar disorder, (2) the potential improvement in quality of reporting over time, and (3) differences in quality of reporting between journals that endorse or do not endorse the Uniform Requirements for Manuscripts Submitted to Biomedical Journals developed by the International Committee of Medical Journal Editors. A systematic literature search was done to identify all randomized controlled trials published between 2000 and 2008 relevant to the pharmacologic treatment of bipolar disorder. The search strategy of the published National Institute for Health and Clinical Excellence guideline for management of bipolar disorders was used and adapted. All included and excluded clinical trials mentioned in the guideline and published from 2000 onward were reviewed for eligibility. For an update search from July 2004 through December 2008, an adapted search strategy was used in MEDLINE, EMBASE, PsycINFO, CINAHL, Ovid, and Cochrane Central Register of Controlled Trials. Titles and abstracts were scanned for relevance, and full texts were ordered in case of uncertainty to maximize sensitivity. Reference lists of retrieved systematic reviews were checked. All full texts were checked for eligibility. Only relevant randomized controlled trials published between 2000 and 2008 were included. Abstracts, randomized controlled trials published before 2000, nonrandomized clinical studies, pooled analyses, editorials, reviews, case reports, observational studies, and unpublished reports were excluded. A checklist based on the Consolidated Standards of Reporting Trials (CONSORT) statement was used to assess quality of reporting of all included studies. A total of 105 randomized controlled trials were included in the analysis. Of the 72 applicable checklist items, 42% were generally reported adequately and 25% inadequately. Reporting was especially poor for

  7. Helicopter internal noise control: Three case histories

    Science.gov (United States)

    Edwards, B. D.; Cox, C. R.

    1978-01-01

    Case histories are described in which measurable improvements in the cabin noise environments of the Bell 214B, 206B, and 222 were realized. These case histories trace the noise control efforts followed in each vehicle. Among the design approaches considered, the addition of a fluid pulsation damper in a hydraulic system and the installation of elastomeric engine mounts are highlighted. It is concluded that substantial weight savings result when the major interior noise sources are controlled by design, both in altering the noise producing mechanism and interrupting the sound transmission paths.

  8. A Randomised Controlled Trial of complete denture impression materials

    Science.gov (United States)

    Hyde, T.P.; Craddock, H.L.; Gray, J.C.; Pavitt, S.H.; Hulme, C.; Godfrey, M.; Fernandez, C.; Navarro-Coy, N.; Dillon, S.; Wright, J.; Brown, S.; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

  9. Monitoring antimalarial safety and tolerability in clinical trials: A case study from Uganda

    Directory of Open Access Journals (Sweden)

    Mpimbaza Arthur

    2008-06-01

    Full Text Available Abstract Background New antimalarial regimens, including artemisinin-based combination therapies (ACTs, have been adopted widely as first-line treatment for uncomplicated malaria. Although these drugs appear to be safe and well-tolerated, experience with their use in Africa is limited and continued assessment of safety is a priority. However, no standardized guidelines for evaluating drug safety and tolerability in malaria studies exist. A system for monitoring adverse events in antimalarial trials conducted in Uganda was developed. Here the reporting system is described, and difficulties faced in analysing and interpreting the safety results are illustrated, using data from the trials. Case description Between 2002 and 2007, eleven randomized, controlled clinical trials were conducted to compare the efficacy, safety, and tolerability of different antimalarial regimens for treatment of uncomplicated malaria in Uganda. The approach to adverse event monitoring was similar in all studies. A total of 5,614 treatments were evaluated in 4,876 patients. Differences in baseline characteristics and patterns of adverse event reporting were noted between the sites, which limited the ability to pool and analyse data. Clinical failure following antimalarial treatment confounded associations between treatment and adverse events that were also common symptoms of malaria, particularly in areas of lower transmission intensity. Discussion and evaluation Despite prospectively evaluating for adverse events, limitations in the monitoring system were identified. New standardized guidelines for monitoring safety and tolerability in antimalarial trials are needed, which should address how to detect events of greatest importance, including serious events, those with a causal relationship to the treatment, those which impact on adherence, and events not previously reported. Conclusion Although the World Health Organization has supported the development of

  10. Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial.

    Science.gov (United States)

    Treweek, Shaun; Wilkie, Erna; Craigie, Angela M; Caswell, Stephen; Thompson, Joyce; Steele, Robert J C; Stead, Martine; Anderson, Annie S

    2013-12-18

    Recruiting participants to multicentre, community-based trials is a challenge. This case study describes how this challenge was met for the BeWEL trial, which evaluated the impact of a diet and physical activity intervention on body weight in people who had had pre-cancerous bowel polyps. The BeWEL trial was a community-based trial, involving centres linked to the Scottish National Health Service (NHS) colorectal cancer screening programme. BeWEL had a recruitment target of 316 and its primary recruitment route was the colonoscopy clinics of the Scottish Bowel Screening Programme. BeWEL exceeded its recruitment target but needed a 6-month no-cost extension from the funder to achieve this. The major causes of delay were lower consent rates (49% as opposed to 70% estimated from earlier work), the time taken for NHS research and development department approvals and the inclusion of two additional sites to increase recruitment, for which there were substantial bureaucratic delays. A range of specific interventions to increase recruitment, for example, telephone reminders and a shorter participant information leaflet, helped to increase the proportion of eligible individuals consenting and being randomized. Recruitment to multicentre trials is a challenge but can be successfully achieved with a committed team. In a UK context, NHS research and development approval can be a substantial source of delay. Investigators should be cautious when estimating consent rates. If consent rates are less than expected, qualitative analysis might be beneficial, to try and identify the reason. Finally, investigators should select trial sites on the basis of a formal assessment of a site's past performance and the likelihood of success in the trial being planned. Current Controlled Trials ISRCTN53033856.

  11. The post hoc use of randomised controlled trials to explore drug associated cancer outcomes

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John

    2013-01-01

    on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post......-hoc nested case-control analysis in the ADVANCE trial in order to examine the association between insulin use and cancer. We encountered several methodological challenges that made the results difficult to interpret, including short duration of exposure of interest, lack of power, and correlation between...... exposure and potential confounders. Considering these challenges, we concluded that using the data would not enlighten the discussion about insulin use and cancer risk and only serve to further complicate any understanding. Therefore, we decided to use our experience to illustrate methodological challenges...

  12. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Scherer, Roberta W; Drye, Lea; Mintzer, Jacobo; Lanctôt, Krista; Rosenberg, Paul; Herrmann, Nathan; Padala, Prasad; Brawman-Mintzer, Olga; Burke, William; Craft, Suzanne; Lerner, Alan J; Levey, Allan; Porsteinsson, Anton; van Dyck, Christopher H

    2018-01-18

    Alzheimer's disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events. However, the trial only enrolled 60 participants who were followed for only 6 weeks. A larger, longer-lasting trial is required to confirm these promising findings. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a phase III, placebo-controlled, masked, 6-month, multi-center, randomized clinical trial targeted to enroll 200 participants with AD and apathy. Participants are randomly assigned 1:1 to 20 mg methylphenidate per day prepared as four over-encapsulated tablets or to matching placebo. The primary outcomes include (1) the mean difference in the Neuropsychiatric Inventory Apathy subscale scores measured as change from baseline to 6 months, and (2) the odds of having a given rating or better on the modified AD Cooperative Study Clinical Global Impression of Change ratings at month 6 compared with the baseline rating. Other outcomes include change in cognition, safety, and cost-effectiveness measured at monthly follow-up visits up to 6 months. Given the prevalence of apathy in AD and its impact on both patients and caregivers, an intervention to alleviate apathy would be of great benefit to society. ADMET 2 follows on the promising results from the original ADMET to evaluate the efficacy of methylphenidate as a

  13. COLLABORATIVE TRIAL AND QUALITY CONTROL IN CHEMICAL ANALYSIS

    Directory of Open Access Journals (Sweden)

    Narsito Narsito

    2010-06-01

    Full Text Available Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of analytical method, quality assurance in chemical analysis. The assessment of quality parameter for analytical method like the use of standard materials as well as standard methods is given. Concerning with the quality control of analytical data, the use of several techniques, such as control samples and control charts, in monitoring analytical data in quality control program are described qualitatively.  In the final part of this paper, some important remarks for the preparation of collaborative trials, including the evaluation of accuracy and reproducibility of analytical method are also given Keywords: collaborative trials, quality control, analytical data Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of

  14. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    Science.gov (United States)

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; pnattokinase group compared with the control group (pnattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  15. Encouraging GPs to undertake screening and a brief intervention in order to reduce problem drinking: a randomized controlled trial

    DEFF Research Database (Denmark)

    Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders

    1999-01-01

    intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...

  16. Changing cluster composition in cluster randomised controlled trials: design and analysis considerations

    Science.gov (United States)

    2014-01-01

    Background There are many methodological challenges in the conduct and analysis of cluster randomised controlled trials, but one that has received little attention is that of post-randomisation changes to cluster composition. To illustrate this, we focus on the issue of cluster merging, considering the impact on the design, analysis and interpretation of trial outcomes. Methods We explored the effects of merging clusters on study power using standard methods of power calculation. We assessed the potential impacts on study findings of both homogeneous cluster merges (involving clusters randomised to the same arm of a trial) and heterogeneous merges (involving clusters randomised to different arms of a trial) by simulation. To determine the impact on bias and precision of treatment effect estimates, we applied standard methods of analysis to different populations under analysis. Results Cluster merging produced a systematic reduction in study power. This effect depended on the number of merges and was most pronounced when variability in cluster size was at its greatest. Simulations demonstrate that the impact on analysis was minimal when cluster merges were homogeneous, with impact on study power being balanced by a change in observed intracluster correlation coefficient (ICC). We found a decrease in study power when cluster merges were heterogeneous, and the estimate of treatment effect was attenuated. Conclusions Examples of cluster merges found in previously published reports of cluster randomised trials were typically homogeneous rather than heterogeneous. Simulations demonstrated that trial findings in such cases would be unbiased. However, simulations also showed that any heterogeneous cluster merges would introduce bias that would be hard to quantify, as well as having negative impacts on the precision of estimates obtained. Further methodological development is warranted to better determine how to analyse such trials appropriately. Interim recommendations

  17. Effect of Hibiscus sabdariffa Calices on Dyslipidemia in Obese Adolescents: A Triple-masked Randomized Controlled Trial

    Science.gov (United States)

    Sabzghabaee, Ali Mohammad; Ataei, Ehsan; Kelishadi, Roya; Ghannadi, Alireza; Soltani, Rasool; Badri, Shirinsadat; Shirani, Shahin

    2013-01-01

    Conflict of interest: none declared. Objective We aimed to evaluate the effects of Hibiscus sabdariffa (HS) calices on controlling dyslipidemia in obese adolescents. Methodology In this triple blind randomized placebo-controlled clinical trial which was registered in the Iranian registry for clinical trials (IRCT201109122306N2), 90 obese adolescents aged 12-18 years with documented dyslipidemia were randomly assigned in two groups of cases who received 2 grams of fine powdered calices of Hibiscus sabdariffa per day for one month and controls who received placebo powder with the same dietary and physical activity recommendations and duration of exposure. Full lipid profile and fasting blood sugar measured before and after the trial. Data were analyzed using multivariate general linear model. Findings Overall, 72 participants (mean age of 14.21±1.6, 35 boys) completed the trial. The two arms of the study (cases and controls) were not statistically different in terms of age, gender, weight, body mass index (BMI) and lipid profile before the trial. Serum total cholesterol, low density lipoprotein cholesterol and serum triglyceride showed a significant decrease in cases group but high density lipoprotein cholesterol level was not changed significantly. Conclusion It is concluded that Hibiscus sabdariffa calyces powder may have significant positive effects on lipid profile of adolescents which maybe attributed to its polyphenolic and antioxidant content. Further studies are needed on dose-response and formulation optimization. PMID:24082826

  18. Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

    Directory of Open Access Journals (Sweden)

    Zielinski Stephanie M

    2012-01-01

    Full Text Available Abstract Background Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures. Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. Methods Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. Results Median trial start-up ranged from 41 days (P25-P75 10-139 in the Netherlands to 232 days (P25-P75 98-423 in Canada (p = 0.027. The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21 per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28, representing 3.9% of eligible patients (p Conclusions In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. Trial Registration ClinicalTrials.gov: NCT00761813

  19. Hepatitis C - Assessment to Treatment Trial (HepCATT) in primary care: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Roberts, Kirsty; Macleod, John; Metcalfe, Chris; Simon, Joanne; Horwood, Jeremy; Hollingworth, William; Marlowe, Sharon; Gordon, Fiona H; Muir, Peter; Coleman, Barbara; Vickerman, Peter; Harrison, Graham I; Waldron, Cherry-Ann; Irving, William; Hickman, Matthew

    2016-07-29

    Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial. A total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients' and health care workers' experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews. This trial has the potential to make an important impact on patient

  20. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

    LENUS (Irish Health Repository)

    French, Helen P

    2009-01-01

    Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy.

  1. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    William F. Clark

    2017-08-01

    Full Text Available Background: In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown. Objective: To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR in patients with chronic kidney disease. Design: Parallel-group randomized controlled trial. Setting: Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017. Participants: Adults (n = 631 with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m 2 and microalbuminuria. Intervention: The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight, over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time. Measures: Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet. Primary outcome: The between-group change in eGFR from baseline (prerandomization to 12 months after randomization. Secondary outcomes: Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation, and health-related quality of life. Planned analysis: The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using

  2. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  3. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  4. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    Directory of Open Access Journals (Sweden)

    Chhangur Rabia R

    2012-10-01

    Full Text Available Abstract Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes. However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-environment interactions to obtain more insight into a moderating effects of polymorphisms on the link between parenting and child behavior, and b behavioral mechanisms that underlie these gene-(gene-environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training. In a screening, families with children aged 4–8 who show mild to (subclinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest, after 6 months (i.e., posttest, and after 10 months (i.e., follow-up. Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and

  5. Acupucture as pain relief during delivery - a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... to existing pain relief methods. (BIRTH 36:1 March 2009)...

  6. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

    Science.gov (United States)

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-10-01

    This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

  7. 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.

  8. Placebo cohorts in phase-3 MS treatment trials - predictors for on-trial disease activity 1990-2010 based on a meta-analysis and individual case data.

    Directory of Open Access Journals (Sweden)

    Jan-Patrick Stellmann

    Full Text Available BACKGROUND: Annualized relapse rates (ARR in the placebo cohorts of phase-3 randomized controlled trials (RCT of new treatments for relapsing remitting multiple sclerosis (RRMS have decreased substantially during the last two decades. The causes of these changes are not clear. We consider a better understanding of this phenomenon essential for valuing the effects of new drugs and by designing new trials. OBJECTIVES: To identify predictive factors of on-study ARR in early and recent MS trials. METHODS: ARR, rate of relapse-free patients, trial start dates, baseline demographics, relapse definitions and the use of McDonald criteria were retrieved by literature research of the placebo cohorts from RRMS phase-3 trials. Predictors were estimated by univariate and multivariate regression analyses and random-effects meta-regression. In addition, regression models were calculated by the Sylvia Lawry Centre's (SLC, including individual case data from clinical trials performed until 2000. The most reliable meta-analytic results can be gained from pooled individual case data. In lack of this, random-effects meta-analyses are recommended. RESULTS: Data from 12 published and one unpublished trial show a decrease of ARR from 1988 to 2012 (adjR(2 = 0.807, p<0.0001. Regression models identified McDonald criteria followed by baseline mean age and the pre-study relapse rate as predictors of the ARR. The pooled individual case data (n = 505 confirmed a decrease of ARR over time. The pre-study relapse rate was the best predictor for on-study relapses. Lacking individual case data after implementation of the McDonald criteria excludes a direct comparison concerning McDonald criteria. CONCLUSION: Pre-study relapse rate was the best predictor for on-study relapse rate but failed to explain the decrease of the ARR over time alone. Higher age at baseline and the implementation of McDonald criteria were associated as well with a lowered relapse rate in the random

  9. [Research and control of relapse tuberculosis cases].

    Science.gov (United States)

    Yamagishi, Fumio; Toyota, Makoto

    2009-12-01

    were recognized more significantly in male cases aged 70's. In the cases that deviated from the standard treatment and that became impossible to use rifampicin, it should be careful to emergence of isoniazid resistance. 3. The current status of the recurrence tuberculosis cases in Tokyo: Michiko NAGAMINE (Specific Disease Control Section, Tokyo Metropolitan Government Bureau of Social Welfare and Public Health). As for the background of the patient whose disease has relapsed, unstable elements are observed. After any symptom, more patients are diagnosed as a relapse case rather than finding by a medical check up. And more than half are related to homeless or life without fixed address. Their status of insurance is the livelihood protection, no insurance or the national health insurance. By RFLP analysis in Shinjuku city, some clusters have recurrent cases, one of clusters has both a relapse and exogenous reinfection. This is able to elucidate an infectious state. Like this, the analysis of each cluster can help effective countermeasures. 4. Recurrence of tuberculosis in the City of Yokohama between 2004 and 2008: Michihiko YOSHIDA (Shinagawa Public Health Center), Takahiro TOYOZAWA (Yokohama Public Health Center). To identify the TB recurrence rate, we studied a cohort of 40 cases (treatment completion 36 cases, interruption 4 cases) of whom had a previous history of TB treatment including isoniazid and rifampicin. The time for relapse was 7.9 +/- 8.6 years and the overall relapse rate was 0.6% (0.47-0.7%). Our study suggested the relapse was almost equal to the low incident countries but the long-term follow-up and surveillance data should be carefully evaluated. 5. Comparison of the retreatment cases of pulmonary tuberculosis: Yuka SASAKI (National Hospital Organization Chiba-East National Hospital). To investigate the factors of the retreatment of pulmonary tuberculosis, 134 retreatment cases were studied. The factors leading to retreatment were cavitary and large

  10. The Trial of Napoleon: A Case Study for Using Mock Trials.

    Science.gov (United States)

    MacKay, Charles

    2000-01-01

    Describes a course entitled "The Trial of Napoleon Bonaparte" that focuses on a fictitious mock trial of Napoleon Bonaparte to answer the question: did Napoleon pervert or preserve the gain of the French Revolution? Discusses the strengths and weaknesses of the course. (CMK)

  11. A controlled trial of renal denervation for resistant hypertension.

    Science.gov (United States)

    Bhatt, Deepak L; Kandzari, David E; O'Neill, William W; D'Agostino, Ralph; Flack, John M; Katzen, Barry T; Leon, Martin B; Liu, Minglei; Mauri, Laura; Negoita, Manuela; Cohen, Sidney A; Oparil, Suzanne; Rocha-Singh, Krishna; Townsend, Raymond R; Bakris, George L

    2014-04-10

    Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months. A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (Pdenervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups. This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).

  12. Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

    Science.gov (United States)

    Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

    2017-12-01

    Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

  13. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    Science.gov (United States)

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014;37(9):1553-1563. PMID:25142566

  14. Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

    Science.gov (United States)

    Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

    2013-12-01

    Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

  15. Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

    Science.gov (United States)

    Malmivaara, Antti

    2016-09-01

    Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

  16. Sleep disorders in patients with depression or schizophrenia: A randomized controlled trial using acupuncture treatment

    NARCIS (Netherlands)

    Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van

    2016-01-01

    Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40

  17. Effect of Playful Balancing Training - A Pilot Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

    We used the modular playware in the form of modular interactive tiles for playful training of community-dwelling elderly with balancing problem. During short-term play on the modular interactive tiles, the elderly were playing physical, interactive games that were challenging their dynamic balance...... increase in balancing performance (DGI score: 21.3) after short-term playful training with the modular interactive tiles, whereas the control group remained with a score indicating balancing problems and risk of falling (DGI score: 16.6). The small pilot randomized controlled trial suggests...... that the playful interaction with the modular interactive tiles has a significant effect even after a very short time of play. The average total training time to obtain the statistical significant effect amounted to just 2h45m....

  18. A randomized controlled trial of an electronic informed consent process.

    Science.gov (United States)

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  19. Neonatal ECMO Study of Temperature (NEST - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Juszczak Edmund

    2010-04-01

    Full Text Available Abstract Background Existing evidence indicates that once mature neonates with severe cardio-respiratory failure become eligible for Extra Corporeal Membrane Oxygenation (ECMO their chances of intact survival are doubled if they actually receive ECMO. However, significant numbers survive with disability. NEST is a multi-centre randomised controlled trial designed to test whether, in neonates requiring ECMO, cooling to 34°C for the first 48 to 72 hours of their ECMO course leads to improved later health status. Infants allocated to the control group will receive ECMO at 37°C throughout their course, which is currently standard practice around the world. Health status of both groups will be assessed formally at 2 years corrected age. Methods/Design All infants recruited to the study will be cared for in one of the four United Kingdom (UK ECMO centres. Babies who are thought to be eligible will be assessed by the treating clinician who will confirm eligibility, ensure that consent has been obtained and then randomise the baby using a web based system, based at the National Perinatal Epidemiology Unit (NPEU Clinical Trials Unit. Trial registration. Babies allocated ECMO without cooling will receive ECMO at 37°C ± 0.2°C. Babies allocated ECMO with cooling will be managed at 34°C ± 0.2°C for up to 72 hours from the start of their ECMO run. The minimum duration of cooling will be 48 hours. Rewarming (to 37°C will occur at a rate of no more than 0.5°C per hour. All other aspects of ECMO management will be identical. Primary outcome: Cognitive score from the Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III at age of 2 years (24 - 27 months. Discussion For the primary analysis, children will be analysed in the groups to which they are assigned, comparing the outcome of all babies allocated to "ECMO with cooling" with all those allocated to "ECMO" alone, regardless of deviation from the protocol or treatment received. For

  20. Practices, patients and (imperfect data - feasibility of a randomised controlled clinical drug trial in German general practices

    Directory of Open Access Journals (Sweden)

    Hummers-Pradier Eva

    2011-04-01

    Full Text Available Abstract Background Randomised controlled clinical (drug trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01 to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI. Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP standards as defined by the International Conference on Harmonisation (ICH in mainly inexperienced general practices. Methods This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1 successful practice recruitment, 2 sufficient patient recruitment, 3 complete and accurate data collection and 4 appropriate protection of patient safety. Results The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs were observed during the trial. Conclusions To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and

  1. Moxibustion for breech version: a randomized controlled trial.

    Science.gov (United States)

    Guittier, Marie-Julia; Pichon, Michelle; Dong, Hongguang; Irion, Olivier; Boulvain, Michel

    2009-11-01

    To estimate the efficacy of moxibustion between 34 and 38 weeks of gestation to facilitate the cephalic version of fetuses in breech presentation and the acceptability of this method by women. We conducted a randomized controlled trial in a Swiss university hospital maternity unit. We proposed to stimulate the acupoint BL 67 by moxibustion daily for 2 weeks for 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation. We did the intervention three times weekly in the hospital and a teaching session and information leaflet on the technique for additional daily therapy at home. The control group received expectant management care. The availability of external cephalic version was maintained for both groups. The main outcome measure was the comparison of the proportion of women with cephalic presentation at delivery. Baseline characteristics were similar between groups, except more nulliparous women were randomized to moxibustion. The percentage of versions was similar between groups: 18% in the moxibustion group compared with 16% in the control group (relative risk 1.12, 95% confidence interval 0.62 to 2.03). Adjustment for the imbalance in parity did not change these results. The frequency of cesarean delivery was similar (64% compared with 58% in the moxibustion group and the control group, respectively). Acceptability of the intervention and women's perceptions of moxibustion were favorable. We observed no beneficial effect of moxibustion to facilitate the cephalic version of fetuses in breech presentation. Despite this lack of proven effectiveness, women had positive opinions on the intervention. ClinicalTrials.gov, www.clinicaltrials.gov,NCT00890474. I.

  2. The Cluster-Randomized BRIGHT Trial: Proactive Case Finding for Community-Dwelling Older Adults

    Science.gov (United States)

    Kerse, Ngaire; McLean, Chris; Moyes, Simon A.; Peri, Kathy; Ng, Terence; Wilkinson-Meyers, Laura; Brown, Paul; Latham, Nancy; Connolly, Martin

    2014-01-01

    PURPOSE People are now living longer, but disability may affect the quality of those additional years of life. We undertook a trial to assess whether case finding reduces disability among older primary care patients. METHODS We conducted a cluster-randomized trial of the Brief Risk Identification Geriatric Health Tool (BRIGHT) among 60 primary care practices in New Zealand, assigning them to an intervention or control group. Intervention practices sent a BRIGHT screening tool to older adults every birthday; those with a score of 3 or higher were referred to regional geriatric services for assessment and, if needed, service provision. Control practices provided usual care. Main outcomes, assessed in blinded fashion, were residential care placement and hospitalization, and secondary outcomes were disability, assessed with Nottingham Extended Activities of Daily Living Scale (NEADL), and quality of life, assessed with the World Health Organization Quality of Life scale, abbreviated version (WHOQOL-BREF). RESULTS All 8,308 community-dwelling patients aged 75 years and older were approached; 3,893 (47%) participated, of whom 3,010 (77%) completed the trial. Their mean age was 80.3 (SD 4.5) years, and 55% were women. Overall, 88% of the intervention group returned a BRIGHT tool; 549 patients were referred. After 36 months, patients in the intervention group were more likely than those in the control group to have been placed in residential care: 8.4% vs 6.2% (hazard ratio = 1.32; 95% CI, 1.04–1.68; P = .02). Intervention patients had smaller declines in mean scores for physical health-related quality of life (1.6 vs 2.9 points, P = .007) and psychological health-related quality of life (1.1 vs 2.4 points, P = .005). Hospitalization, disability, and use of services did not differ between groups, however. CONCLUSIONS Our case-finding strategy was effective in increasing identification of older adults with disability, but there was little evidence of improved outcomes

  3. The case for moderate gun control.

    Science.gov (United States)

    DeGrazia, David

    2014-03-01

    In addressing the shape of appropriate gun policy, this essay assumes for the sake of discussion that there is a legal and moral right to private gun ownership. My thesis is that, against the background of this right, the most defensible policy approach in the United States would feature moderate gun control. The first section summarizes the American gun control status quo and characterizes what I call "moderate gun control." The next section states and rebuts six leading arguments against this general approach to gun policy. The section that follows presents a positive case for moderate gun control that emphasizes safety in the home and society as well as rights whose enforcement entails some limits or qualifications on the right to bear arms. A final section shows how the recommended gun regulations address legitimate purposes, rather than imposing arbitrary restrictions on gun rights, and offers concluding reflections.

  4. Alcohol-related breast cancer in postmenopausal women – effect of CYP19A1, PPARG and PPARGC1A polymorphisms on female sex-hormone levels and interaction with alcohol consumption and NSAID usage in a nested case-control study and a randomised controlled trial

    International Nuclear Information System (INIS)

    Kopp, Tine Iskov; Jensen, Ditte Marie; Ravn-Haren, Gitte; Cohen, Arieh; Sommer, Helle Molgaard; Dragsted, Lars Ove; Tjonneland, Anne; Hougaard, David Michael; Vogel, Ulla

    2016-01-01

    Alcohol consumption is associated with increased risk of breast cancer (BC), and the underlying mechanism is thought to be sex-hormone driven. In vitro and observational studies suggest a mechanism involving peroxisome proliferator-activated receptor gamma (PPARγ) in a complex with peroxisome proliferator-activated receptor gamma coactivator 1-α (PGC-1α) and interaction with aromatase (encoded by CYP19A1). Use of non-steroidal anti-inflammatory drugs (NSAID) may also affect circulating sex-hormone levels by modifying PPARγ activity. In the present study we assessed whether genetic variation in CYP19A1 is associated with risk of BC in a case-control study group nested within the Danish “Diet, Cancer and Health” cohort (n cases = 687 and n controls = 687) and searched for gene-gene interaction between CYP19A1 and PPARGC1A, and CYP19A1 and PPARG, and gene-alcohol and gene-NSAID interactions. Association between the CYP19A1 polymorphisms and hormone levels was also examined among 339 non-HRT users. Incidence rate ratios were calculated based on Cox’ proportional hazards model. Furthermore, we performed a pilot randomised controlled trial to determine the effect of the PPARG Pro 12 Ala polymorphism and the PPARγ stimulator Ibuprofen on sex-hormone levels following alcohol intake in postmenopausal women (n = 25) using linear regression. Genetic variations in CYP19A1 were associated with hormone levels (estrone: P rs11070844 = 0.009, estrone sulphate: P rs11070844 = 0.01, P rs749292 = 0.004, P rs1062033 = 0.007 and P rs10519297 = 0.03, and sex hormone-binding globulin (SHBG): P rs3751591 = 0.03) and interacted with alcohol intake in relation to hormone levels (estrone sulphate: P interaction/rs2008691 = 0.02 and P interaction/rs1062033= 0.03, and SHBG: P interaction/rs11070844 = 0.03). CYP19A1/rs3751591 was both associated with SHBG levels (P = 0.03) and with risk of BC (Incidence Rate Ratio = 2.12; 95 % Confidence Interval: 1.02–4.43) such that homozygous

  5. Integrating technology into complex intervention trial processes: a case study.

    Science.gov (United States)

    Drew, Cheney J G; Poile, Vincent; Trubey, Rob; Watson, Gareth; Kelson, Mark; Townson, Julia; Rosser, Anne; Hood, Kerenza; Quinn, Lori; Busse, Monica

    2016-11-17

    Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews. The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration. A combination of commercially available hardware and a bespoke online database

  6. 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.

  7. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    Science.gov (United States)

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  8. Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial.

    Science.gov (United States)

    Chen, Hao; Liu, Tang-Yi; Kuai, Le; Zhu, Ji; Wu, Cai-Jun; Liu, Lu-Ming

    2013-01-01

    Pancreatic cancer is often accompanied by severe abdominal or back pain. It's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain. A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle. Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group (n = 30) and the placebo control group (n = 30). Patients were treated on Jiaji (Ex-B2) points T8-T12 bilaterally for 30 min once a day for 3 days. Pain intensity was assessed with numerical rated scales (NRS) before the treatment (Baseline), after 3 treatments, and 2 days follow-up. Baseline characteristics were similar in the two groups. After 3 treatment, pain intensity on NRS decreased compared with Baseline (-1.67, 95% confidence interval [CI] -1.46 to -1.87) in the electroacupuncture group; there was little change (-0.13, 95% CI 0.08 to -0.35) in control group; the difference between two groups was statistically significant (P electroacupuncture group compared with the control group (P Electroacupuncture was an effective treatment for relieving pancreatic cancer pain. Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.

  9. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  10. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

    2015-01-01

    Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

  11. PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Day Richard O

    2010-07-01

    Full Text Available Abstract Background Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN for recovery from acute LBP. Methods/Design The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol, PRN paracetamol (plus placebo time-contingent paracetamol or a double placebo study arm. The primary outcome will be time (days to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function, global perceived effect and sleep quality, captured at baseline and at weeks 1, 2, 4 and 12 by an assessor blind to treatment allocation. An economic analysis will be conducted to determine the cost-effectiveness of treatment from the health sector and societal perspectives. Discussion The successful completion of the trial will provide the first high quality evidence on the effectiveness of the use of paracetamol, a guideline endorsed treatment for acute LBP. Trail registration ACTRN12609000966291.

  12. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  13. Pressure ulcers: effectiveness of risk-assessment tools. A randomised controlled trial (the ULCER trial).

    Science.gov (United States)

    Webster, Joan; Coleman, Kerrie; Mudge, Alison; Marquart, Louise; Gardner, Glenn; Stankiewicz, Monica; Kirby, Julie; Vellacott, Catherine; Horton-Breshears, Margaret; McClymont, Alice

    2011-04-01

    To evaluate the effectiveness of two pressure-ulcer screening tools against clinical judgement in preventing pressure ulcers. A single blind randomised controlled trial. A large metropolitan tertiary hospital. 1231 patients admitted to internal medicine or oncology wards. Patients were excluded if their hospital stay was expected to be 2 days or less. Participants allocated to either a Waterlow (n=410) or Ramstadius (n=411) screening tool group or to a clinical judgement group (n=410) where no formal risk screening instrument was used. Incidence of hospital acquired pressure ulcers ascertained by regular direct observation. Use of any devices for the prevention of pressure ulcers, documentation of a pressure plan and any dietetic or specialist skin integrity review were recorded. On admission, 71 (5.8%) patients had an existing pressure ulcer. The incidence of hospital-acquired pressure ulcers was similar between groups (clinical judgement 28/410 (6.8%); Waterlow 31/411 (7.5%); Ramstadius 22/410 (5.4%), p=0.44). Significant associations with pressure injury in regression modelling included requiring a dietetic referral, being admitted from a location other than home and age over 65 years. The authors found no evidence to show that two common pressure-ulcer risk-assessment tools are superior to clinical judgement to prevent pressure injury. Resources associated with use of these tools might be better spent on careful daily skin inspection and improving management targetted at specific risks. The trial was registered with the Australian and New Zealand Clinicat Trials Registry (ACTRN 12608000541303).

  14. Treatment of periodontal disease during pregnancy: a randomized controlled trial.

    Science.gov (United States)

    Newnham, John P; Newnham, Ian A; Ball, Colleen M; Wright, Michelle; Pennell, Craig E; Swain, Jonathan; Doherty, Dorota A

    2009-12-01

    To investigate whether treating periodontal disease prevents preterm birth and other major complications of pregnancy. This single-center trial was conducted across six obstetric sites in metropolitan Perth, Western Australia. Pregnant women identified by history to be at risk (n=3,737) were examined for periodontal disease. Approximately 1,000 women with periodontal disease were allocated at random to receive periodontal treatment commencing around 20 weeks of gestation (n=542) or 6 weeks after the pregnancy was completed (controls; n=540). The treatment included mechanical removal of oral biofilms together with oral hygiene instruction and motivation at a minimum of three weekly visits, with further visits if required. There were no differences between the control and treatment groups in preterm birth (9.3% compared with 9.7%, odds ratio [OR] 1.05, 95% confidence interval [CI 0.7-1.58], P=.81), birth weight (3,450 compared with 3,410 g, P=.12), preeclampsia (4.1% compared with 3.4%, OR 0.82, 95% CI 0.44-1.56, P=.55), or other obstetric endpoints. There were four unexplained stillbirths in the control group and no pregnancy losses in the treated group (P=.12). Measures of fetal and neonatal well-being were similar in the two groups, including abnormalities in fetal heart rate recordings (P=.26), umbilical artery flow studies (P=.96), and umbilical artery blood gas values (P=.37). The periodontal treatment was highly successful in improving health of the gums (Pperiodontal disease during pregnancy in this population prevents preterm birth, fetal growth restriction, or preeclampsia. Periodontal treatment was not hazardous to the women or their pregnancies. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00133926. I.

  15. Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial.

    Science.gov (United States)

    Sharara-Chami, Rana; Lakissian, Zavi; Charafeddine, Lama; Milad, Nadine; El-Hout, Yaser

    2017-12-01

    There is no consensus on the most effective pain management for neonatal circumcision. We sought to compare different modalities. This is a double-blinded randomized controlled trial comparing 3 combination analgesics used during circumcision (EMLA + sucrose; EMLA + sucrose + dorsal penile nerve block [DPNB]; EMLA + sucrose + ring block [RB]) with the traditional topical analgesic cream EMLA alone. The trial was set in the normal nursery of a teaching hospital. The sample included 70 healthy male newborns, randomly assigned to intervention and control groups at a 2:1 ratio. Infants were videotaped (face and torso) during the procedure for assessment of pain by 2 blinded, independent reviewers. The primary outcome measure is the Neonatal Infant Pain Scale score. Secondary outcomes include heart rate, oxygen saturation, and crying time. Neonatal Infant Pain Scale scores were significantly lower in the intervention groups (EMLA + sucrose, mean [SD]: 3.1 [1.33]; EMLA + sucrose + DPNB: 3 [1.33]; EMLA + sucrose + RB: 2.45 [1.27]) compared with the control (5.5 [0.53]). Between-group analyses showed RB + EMLA + sucrose to be significantly more effective than EMLA + sucrose; EMLA + sucrose + DPNB ( P = .009 and P = .002, respectively). Interrater reliability was κ = 0.843. Significant increase in heart rate (139.27 [9.63] to 163 [13.23] beats per minute) and crying time (5.78 [6.4] to 45.37 [12.39] seconds) were noted in the EMLA group. During neonatal circumcision in boys, the most effective analgesia is RB combined with oral sucrose and EMLA cream. Copyright © 2017 by the American Academy of Pediatrics.

  16. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

    DEFF Research Database (Denmark)

    Gluud, Christian; Nikolova, Dimitrinka

    2007-01-01

    The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.......The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study....

  17. Diabetic control and atypical antipsychotics: a case report

    Directory of Open Access Journals (Sweden)

    Gaston Romina

    2008-05-01

    Full Text Available Abstract Introduction People with schizophrenia are at increased risk of developing metabolic disturbances. This risk may be further exacerbated by the use of antipsychotic agents. Research is still ongoing to determine the metabolic impact of antipsychotics on glucose regulation. In this case report we review some of the possible mechanisms of action of antipsychotic medication on glucose regulation. Case presentation We present the case of a 50-year-old man diagnosed with paranoid schizophrenia who developed type 2 diabetes mellitus whilst on treatment with second generation antipsychotics (SGA. His diabetes was controlled by a combination of antidiabetic drugs that were associated with his psychotropic treatment. Due to deterioration in his mental state, the patient was admitted on two occasions to a psychiatric unit during which his prescribed medication (olanzapine and risperidone was discontinued and changed to aripiprazole. On both occasions, the patient suffered hypoglycaemic episodes and his antidiabetic treatment had to be adjusted accordingly. The patient did not require any antidiabetic treatment whilst on aripiprazole during the follow up period. Conclusion Clinicians face regular dilemmas in trying to find the right balance between achieving control over a patient's mental illness and reducing any adverse effects associated with the prescribed medication. In patients receiving concomitant antidiabetic therapy, caution should be exercised when changing from one SGA to another. Whilst more longitudinal data are required, a trial of alternative SGAs, including aripiprazole in those developing type 2 diabetes and impaired glucose tolerance may be a worthwhile therapeutic option.

  18. Regression Discontinuity and Randomized Controlled Trial Estimates: An Application to The Mycotic Ulcer Treatment Trials.

    Science.gov (United States)

    Oldenburg, Catherine E; Venkatesh Prajna, N; Krishnan, Tiruvengada; Rajaraman, Revathi; Srinivasan, Muthiah; Ray, Kathryn J; O'Brien, Kieran S; Glymour, M Maria; Porco, Travis C; Acharya, Nisha R; Rose-Nussbaumer, Jennifer; Lietman, Thomas M

    2018-08-01

    We compare results from regression discontinuity (RD) analysis to primary results of a randomized controlled trial (RCT) utilizing data from two contemporaneous RCTs for treatment of fungal corneal ulcers. Patients were enrolled in the Mycotic Ulcer Treatment Trials I and II (MUTT I & MUTT II) based on baseline visual acuity: patients with acuity ≤ 20/400 (logMAR 1.3) enrolled in MUTT I, and >20/400 in MUTT II. MUTT I investigated the effect of topical natamycin versus voriconazole on best spectacle-corrected visual acuity. MUTT II investigated the effect of topical voriconazole plus placebo versus topical voriconazole plus oral voriconazole. We compared the RD estimate (natamycin arm of MUTT I [N = 162] versus placebo arm of MUTT II [N = 54]) to the RCT estimate from MUTT I (topical natamycin [N = 162] versus topical voriconazole [N = 161]). In the RD, patients receiving natamycin had mean improvement of 4-lines of visual acuity at 3 months (logMAR -0.39, 95% CI: -0.61, -0.17) compared to topical voriconazole plus placebo, and 2-lines in the RCT (logMAR -0.18, 95% CI: -0.30, -0.05) compared to topical voriconazole. The RD and RCT estimates were similar, although the RD design overestimated effects compared to the RCT.

  19. A randomized controlled trial to promote volunteering in older adults.

    Science.gov (United States)

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

  20. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    Science.gov (United States)

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

    A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days -14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). The 38 persons who completed the study (age 13-22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

  1. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

  2. Topical tranexamic acid as a novel treatment for bleeding peptic ulcer: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Mandana Rafeey

    2016-01-01

    Full Text Available Background: Peptic ulcers are among the most common causes of upper gastrointestinal (GI bleeding in children. The standard care for GI bleeding is endoscopy for diagnostic and therapeutic purposes. We aimed to assess the effect of topical tranexamic acid (TXA via endoscopic procedures in children with GI bleeding caused by bleeding ulcers. Procedure: In this randomised controlled trial, 120 children were evaluated by diagnostic procedures for GI bleeding, of which 63 (30 girls, 33 boys aged 1-month to 15 years were recruited. The patients were randomly divided into case and control groups. In the case group, TXA was administered directly under endoscopic therapy. In the control group, epinephrine (1/10,000 was submucosally injected to the four quadrants of ulcer margins as the routine endoscopic therapy. In both groups, the patients received supportive medical therapy with intravenous fluids and proton pump inhibitor drugs. Results: The mean ± standard deviation age of the children was 5 ± 2.03 years. Rebleeding occurred in 15 (11.4% and 21 (9.8% patients in the case and control groups, respectively (P = 0.50. The frequency of blood transfusion episodes (P = 0.06 and duration of hospital stay (P = 0.07 were not statistically different between the groups. Conclusion: Using topical TXA via endoscopic procedures may be effective in cases of GI bleedings caused by active bleeding ulcers. In order to establish this therapeutic effect, a large number of clinical studies are needed.

  3. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    International Nuclear Information System (INIS)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

    2017-01-01

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  4. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: dgomez@mdanderson.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)

    2017-03-15

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  5. A randomized controlled trial of group Stepping Stones Triple P: a mixed-disability trial.

    Science.gov (United States)

    Roux, Gemma; Sofronoff, Kate; Sanders, Matthew

    2013-09-01

    Stepping Stones Triple P (SSTP) is a parenting program designed for families of a child with a disability. The current study involved a randomized controlled trial of Group Stepping Stones Triple P (GSSTP) for a mixed-disability group. Participants were 52 families of children diagnosed with an Autism Spectrum Disorder, Down syndrome, Cerebral Palsy, or an intellectual disability. The results demonstrated significant improvements in parent-reported child behavior, parenting styles, parental satisfaction, and conflict about parenting. Results among participants were similar despite children's differing impairments. The intervention effect was maintained at 6-month follow-up. The results indicate that GSSTP is a promising intervention for a mixed-disability group. Limitations of the study, along with areas for future research, are also discussed. © FPI, Inc.

  6. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    BACKGROUND: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... with the intention-to-treat principle. RESULTS: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin...

  7. [Critical of the additive model of the randomized controlled trial].

    Science.gov (United States)

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  8. Neighborhood effects in a behavioral randomized controlled trial.

    Science.gov (United States)

    Pruitt, Sandi L; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2014-11-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient's CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Synthesis of results of randomized controlled trials of contrast media

    International Nuclear Information System (INIS)

    Kinnison, M.L.; Powe, N.R.; Steinberg, E.P.

    1988-01-01

    The authors review 100 randomized controlled trials (RCTs) that examine the safety or efficacy of new low-osmolality contrast media (LOM) and focus on the 43 RCTs judged to be of the highest quality. These RCTs showed no consistent differences in nephrotoxicity between high- and low-osmolality contrast media. Certain cardiovascular parameters were altered less with low-osmolality agents during intracardiac injection, but the clinical significance of these differences in unclear. Heat and pain sensations occurred less often with low-osmolality contrast media. No differences were noted in the incidence of nausea, vomiting, urticaria, or bronchospasm. Even with numerous RCTs comparing these media, physicians still must make economically significant choices about contrast media without sufficient data about their relative safety

  10. Exercise and manual physiotherapy arthritis research trial (EMPART: a multicentre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Connell Paul

    2009-01-01

    Full Text Available Abstract Background Osteoarthritis (OA of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. Methods and design An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC, pain severity (numerical rating scale, patient perceived change (7-point Likert scale, quality of life (SF-36, mood (hospital anxiety and depression scale, patient satisfaction, physical activity (IPAQ and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. Discussion This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The

  11. INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST: a randomized controlled trial of percutaneous vertebroplasty

    Directory of Open Access Journals (Sweden)

    Stout Lydia

    2007-12-01

    -primary outcomes are the modified Roland score and pain numerical rating scale at 1 month. Discussion Although extensively utilized throughout North America for palliation of pain, vertebroplasty still has not undergone rigorous study. The study outlined above represents the first randomized, controlled study that can account for a placebo effect in the setting of vertebroplasty. Trial Registration Current Controlled Trials ISRCTN81871888

  12. A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial).

    Science.gov (United States)

    Colwell, Janice C; Pittman, Joyce; Raizman, Rose; Salvadalena, Ginger

    To compare ostomy-related costs and incidence of peristomal skin complications (PSCs) for ceramide-infused ostomy skin barriers and control skin barriers. The ADVOCATE trial is a multi-centered randomized controlled trial, and double-blinded international study with an adaptive design. The sample comprised 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings. Data were collected by investigators at each site during face-to-face visits and during telephone check-in calls between visits. Cost of care data were collected using a questionnaire developed specifically for the study. The peristomal skin was assessed using the Ostomy Skin Tool. Health-related quality of life was measured using the SF-12v2. Patient-reported outcomes were collected using a patient-centered study-specific questionnaire. Cost of care was analyzed via analysis of covariance comparing total cost of care for 12 weeks between the 2 groups. The incidence of PSC was analyzed via Barnard's exact test comparing the incidence of PSCs between the control and treatment groups. Tertiary outcomes were exploratory in nature and not statistically powered. Use of the ceramide-infused barrier significantly reduced stoma-related cost of care over a 12-week period, resulting in a $36.46 decrease in cost (14% relative decrease). The adjusted average costs were $223.73 in the treatment group and $260.19 in the control group (P = .017). The overall incidence of PSCs in the study was 47.7%; PSC incidence was 40.5% for the treatment group versus 55.4% for controls (P = .069, 95% confidence interval of the difference: -1.2 to 30.4). Significantly more participants using the ceramide-infused skin barrier were "very satisfied" with barrier performance (75% vs 55%; P = .033), prevention of leakage (63% vs 38%; P < .01), and prevention of itching (53% vs 31%; P = .016). General postoperative improvement in health-related quality of life was

  13. An algorithm for evaluating the ethics of a placebo-controlled trial.

    Science.gov (United States)

    Amdur, R J; Biddle, C J

    2001-10-20

    The purpose of this article is to clarify the decision points that are important to consider when evaluating the ethics of a placebo-controlled trial. The ethical requirements for research involving human subjects are reviewed, and the rationale for and potential problems with concomitant placebo control are explained. A series of case discussions are used to illustrate each decision point. The critical decision points in the evaluation of the ethics of a placebo-controlled trial are as follows: (i) Is placebo being used in place of standard therapy? (ii) Is standard therapy likely to be effective? (iii) Is the toxicity of standard therapy such that patients routinely refuse this treatment? (iv) Could the use of placebo result in severe suffering or irreversible harm? (v) Is the variability in the placebo response such that it is reasonable to consider other options for the control group? (vi) Would a reasonable person with an average degree of altruism and risk aversiveness agree to participate in this study? The algorithm presented in this article gives researchers and research monitors (such as Institutional Review Board members) the tools they need to evaluate the ethics of a study that uses concomitant placebo control. Copyright 2001 Wiley-Liss, Inc.

  14. Acupuncture Improves Peri-menopausal Insomnia: A Randomized Controlled Trial.

    Science.gov (United States)

    Fu, Cong; Zhao, Na; Liu, Zhen; Yuan, Lu-Hua; Xie, Chen; Yang, Wen-Jia; Yu, Xin-Tong; Yu, Huan; Chen, Yun-Fei

    2017-11-01

    To evaluate the short-term efficacy of acupuncture for the treatment of peri-menopausal insomnia (PMI). Design: A randomized, participant-blind, placebo-controlled trial consisted of the acupuncture group (n = 38) and placebo-acupuncture group (n = 38). Setting: A tertiary teaching and general hospital. Participants: 76 peri-menopausal women with insomnia disorder based on the International Classification of Sleep Disorders, Third Edition. Interventions: A 10-session of acupuncture at bilateral Shenshu (BL 23) and Ganshu (BL 18) with unilateral Qimen (LR 14) and Jingmen (GB 25) or Streitberger needles at the same acupoints was performed for over 3 weeks. Measurements: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with over-night polysomnography (PSG) exam were completed at baseline and post-treatment. After the treatments, the decrease from baseline in PSQI score was 8.03 points in acupuncture group and 1.29 points in placebo-acupuncture group. The change from baseline in ISI score was 11.35 points in acupuncture group and 2.87 points in placebo-acupuncture group. In PSG data, acupuncture significantly improved the sleep efficiency and total sleep time, associated with less wake after sleep onset and lower percent stage 1 after the treatment. No significant differences from baseline to post-treatment were found in placebo-acupuncture group. Acupuncture can contribute to a clinically relevant improvement in the short-term treatment of PMI, both subjectively and objectively. Acupuncture for peri-menopause insomnia: a randomized controlled trial, http://www.chictr.org.cn/showproj.aspx?proj=12118 ChiCTR-IPR-15007199, China. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  15. Testing the activitystat hypothesis: a randomised controlled trial protocol.

    Science.gov (United States)

    Gomersall, Sjaan; Maher, Carol; Norton, Kevin; Dollman, Jim; Tomkinson, Grant; Esterman, Adrian; English, Coralie; Lewis, Nicole; Olds, Tim

    2012-10-08

    The activitystat hypothesis proposes that when physical activity or energy expenditure is increased or decreased in one domain, there will be a compensatory change in another domain to maintain an overall, stable level of physical activity or energy expenditure. To date, there has been no experimental study primarily designed to test the activitystat hypothesis in adults. The aim of this trial is to determine the effect of two different imposed exercise loads on total daily energy expenditure and physical activity levels. This study will be a randomised, multi-arm, parallel controlled trial. Insufficiently active adults (as determined by the Active Australia survey) aged 18-60 years old will be recruited for this study (n=146). Participants must also satisfy the Sports Medicine Australia Pre-Exercise Screening System and must weigh less than 150 kg. Participants will be randomly assigned to one of three groups using a computer-generated allocation sequence. Participants in the Moderate exercise group will receive an additional 150 minutes of moderate to vigorous physical activity per week for six weeks, and those in the Extensive exercise group will receive an additional 300 minutes of moderate to vigorous physical activity per week for six weeks. Exercise targets will be accumulated through both group and individual exercise sessions monitored by heart rate telemetry. Control participants will not be given any instructions regarding lifestyle. The primary outcome measures are activity energy expenditure (doubly labeled water) and physical activity (accelerometry). Secondary measures will include resting metabolic rate via indirect calorimetry, use of time, maximal oxygen consumption and several anthropometric and physiological measures. Outcome measures will be conducted at baseline (zero weeks), mid- and end-intervention (three and six weeks) with three (12 weeks) and six month (24 week) follow-up. All assessors will be blinded to group allocation. This protocol

  16. A randomized controlled trial of storytelling as a communication tool.

    Directory of Open Access Journals (Sweden)

    Lisa Hartling

    : Current Controlled Trials, ISRCTN39642997 (http://www.controlled-trials.com/ISRCTN39642997.

  17. Behavioral neurocardiac training in hypertension: a randomized, controlled trial.

    Science.gov (United States)

    Nolan, Robert P; Floras, John S; Harvey, Paula J; Kamath, Markad V; Picton, Peter E; Chessex, Caroline; Hiscock, Natalie; Powell, Jonathan; Catt, Michael; Hendrickx, Hilde; Talbot, Duncan; Chen, Maggie H

    2010-04-01

    It is not established whether behavioral interventions add benefit to pharmacological therapy for hypertension. We hypothesized that behavioral neurocardiac training (BNT) with heart rate variability biofeedback would reduce blood pressure further by modifying vagal heart rate modulation during reactivity and recovery from standardized cognitive tasks ("mental stress"). This randomized, controlled trial enrolled 65 patients with uncomplicated hypertension to BNT or active control (autogenic relaxation), with six 1-hour sessions over 2 months with home practice. Outcomes were analyzed with linear mixed models that adjusted for antihypertensive drugs. BNT reduced daytime and 24-hour systolic blood pressures (-2.4+/-0.9 mm Hg, P=0.009, and -2.1+/-0.9 mm Hg, P=0.03, respectively) and pulse pressures (-1.7+/-0.6 mm Hg, P=0.004, and -1.4+/-0.6 mm Hg, P=0.02, respectively). No effect was observed for controls (P>0.10 for all indices). BNT also increased RR-high-frequency power (0.15 to 0.40 Hz; P=0.01) and RR interval (P0.10). In contrast to relaxation therapy, BNT with heart rate variability biofeedback modestly lowers ambulatory blood pressure during wakefulness, and it augments tonic vagal heart rate modulation. It is unknown whether efficacy of this treatment can be improved with biofeedback of baroreflex gain. BNT, alone or as an adjunct to drug therapy, may represent a promising new intervention for hypertension.

  18. Infant Sleep After Immunization: Randomized Controlled Trial of Prophylactic Acetaminophen

    Science.gov (United States)

    Gay, Caryl L.; Lynch, Mary; Lee, Kathryn A.

    2011-01-01

    OBJECTIVE: To determine the effects of acetaminophen and axillary temperature responses on infant sleep duration after immunization. METHODS: We conducted a prospective, randomized controlled trial to compare the sleep of 70 infants monitored by using ankle actigraphy for 24 hours before and after their first immunization series at ∼2 months of age. Mothers of infants in the control group received standard care instructions from their infants' health care provider, and mothers of infants in the intervention group were provided with predosed acetaminophen and instructed to administer a dose 30 minutes before the scheduled immunization and every 4 hours thereafter, for a total of 5 doses. Infant age and birth weight and immunization factors, such as acetaminophen use and timing of administration, were evaluated for changes in infant sleep times after immunization. RESULTS: Sleep duration in the first 24 hours after immunization was increased, particularly for infants who received their immunizations after 1:30 pm and for those who experienced elevated temperatures in response to the vaccines. Infants who received acetaminophen at or after immunization had smaller increases in sleep duration than did infants who did not. However, acetaminophen use was not a significant predictor of sleep duration when other factors were controlled. CONCLUSIONS: If further research confirms the relationship between time of day of vaccine administration, increased sleep duration after immunization, and antibody responses, then our findings suggest that afternoon immunizations should be recommended to facilitate increased sleep in the 24 hours after immunization, regardless of acetaminophen administration. PMID:22123869

  19. Autogenic training for tension type headaches: a systematic review of controlled trials.

    Science.gov (United States)

    Kanji, N; White, A R; Ernst, E

    2006-06-01

    To determine from the published evidence whether autogenic training as sole therapy is effective for prevention of tension-type headaches in adults. Systematic review of controlled trials. Literature searches were performed in January 2005 in six major databases, specifically Medline, EMBASE, AMED, CENTRAL, PsychInfo and CINAHL and information was extracted and evaluated in a pre-defined manner. Seven controlled clinical trials were included in the review. The methodological quality of these studies was low. Patient samples were generally representative of the more severely affected cases. None of the studies show autogenic training to be convincingly superior to other interventions care. Some trials suggested that the effect of autogenic training is no different from hypnosis and inferior to biofeedback. There is no consistent evidence to suggest that autogenic training is superior to other interventions for prevention of tension headaches, or different from other forms of relaxation. Further studies should investigate the use of standard autogenic training in patients with moderate headache.

  20. Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial.

    Science.gov (United States)

    Barnes, Thomas R E; Leeson, Verity C; Paton, Carol; Costelloe, Céire; Simon, Judit; Kiss, Noemi; Osborn, David; Killaspy, Helen; Craig, Tom K J; Lewis, Shôn; Keown, Patrick; Ismail, Shajahan; Crawford, Mike; Baldwin, David; Lewis, Glyn; Geddes, John; Kumar, Manoj; Pathak, Rudresh; Taylor, Simon

    2016-04-01

    Negative symptoms of schizophrenia represent deficiencies in emotional responsiveness, motivation, socialisation, speech and movement. When persistent, they are held to account for much of the poor functional outcomes associated with schizophrenia. There are currently no approved pharmacological treatments. While the available evidence suggests that a combination of antipsychotic and antidepressant medication may be effective in treating negative symptoms, it is too limited to allow any firm conclusions. To establish the clinical effectiveness and cost-effectiveness of augmentation of antipsychotic medication with the antidepressant citalopram for the management of negative symptoms in schizophrenia. A multicentre, double-blind, individually randomised, placebo-controlled trial with 12-month follow-up. Adult psychiatric services, treating people with schizophrenia. Inpatients or outpatients with schizophrenia, on continuing, stable antipsychotic medication, with persistent negative symptoms at a criterion level of severity. Eligible participants were randomised 1 : 1 to treatment with either placebo (one capsule) or 20 mg of citalopram per day for 48 weeks, with the clinical option at 4 weeks to increase the daily dosage to 40 mg of citalopram or two placebo capsules for the remainder of the study. The primary outcomes were quality of life measured at 12 and 48 weeks assessed using the Heinrich's Quality of Life Scale, and negative symptoms at 12 weeks measured on the negative symptom subscale of the Positive and Negative Syndrome Scale. No therapeutic benefit in terms of improvement in quality of life or negative symptoms was detected for citalopram over 12 weeks or at 48 weeks, but secondary analysis suggested modest improvement in the negative symptom domain, avolition/amotivation, at 12 weeks (mean difference -1.3, 95% confidence interval -2.5 to -0.09). There were no statistically significant differences between the two treatment arms over 48-week

  1. Delayed sleep phase cases and controls

    Directory of Open Access Journals (Sweden)

    Nievergelt Caroline M

    2008-04-01

    Full Text Available Abstract Background Delayed sleep phase disorder (DSPD is a condition in which patients have difficulty falling asleep before the early morning hours and commonly have trouble awakening before late morning or even early afternoon. Several studies have suggested that variations in habitual bedtime are 40–50% heritable. Methods We recruited a case series of 205 participants, along with 221 controls (DSPD-C with normal sleep, roughly matched for age, gender, and ancestry. A representative sample of San Diego adults recruited some years before was already available to confirm the control group. Both DSPD and DSPD-C provided blood or saliva samples for DNA and completed extensive questionnaires about sleep habits, sleep history, family history, sleep quality, morningness-eveningness traits, depression, mania, and seasonality of symptoms. The DSPD group wore wrist actigraphs for a median of 13.2 days. The representative sample collected previously had undergone actigraphic recordings, from which 48 hours of data were generally available. Results The DSPD and DSPD-C samples showed almost no overlap on morningness-eveningness scores. DSPD cases went to bed and arose about 3 hours later than the DSPD-C and the representative sample. DSPD cases reported more difficulties with sleep, poorer sleep quality, and more depression, but there was no significant difference in a history of mania. DSPD cases reported more family history of late bedtimes, but female DSPD reported that their fathers' bedtimes were later than the fathers of male DSPD. Conclusion These results indicate a DSPD phenotype is familial and associated with unipolar depression.

  2. Empowerment Program for People With Prediabetes: A Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Mei-Fang; Hung, Shu-Ling; Chen, Shu-Lin

    2017-04-01

    Practicing a health-promoting lifestyle is believed to be effective for delaying or preventing the onset of diabetes. However, although empowerment interventions have proven effective for encouraging the adoption of a health-promoting lifestyle in people with diabetes, these interventions are rarely promoted to people with prediabetes. The aims of this study were to develop an empowerment program for people with prediabetes and to examine its efficacy in terms of the adoption of a health-promoting lifestyle and improvements in blood sugar, body mass index, and self-efficacy. A randomized controlled trial was conducted between May and December 2013. A convenience sample of people with a fasting blood sugar level of 100-125 mg/dl during the previous 3 months was recruited from the health examination center of a hospital in Kaohsiung, Taiwan. Participants were assigned to either the experimental group or the control group using block randomization with a block size of 8. The experimental group (n = 38) participated in a 4-month empowerment program (the ABC empowerment program), which encouraged participants to practice a health-promoting lifestyle in three phases: awareness raising, behavior building, and results checking. The control group (n = 40) received routine clinical care. Statistical analyses included descriptive statistics, independent t test, paired t test, and generalized estimated equations. After controlling for the differences at baseline and considering the interaction between group and time from baseline to 1 week and 3 months after completing the intervention, the generalized estimating equation showed significantly larger improvements in a health-promoting lifestyle, blood sugar, and self-efficacy in the experimental group than in the control group (p empowerment program was shown to have short-term, positive effects on behavioral, physical, and psychosocial outcomes in a Taiwan population with prediabetes. The results of this study provide a useful

  3. Randomised controlled trial of reflexology for menopausal symptoms.

    Science.gov (United States)

    Williamson, Jan; White, Adrian; Hart, Anna; Ernst, Edzard

    2002-09-01

    Clinical experience suggests that reflexology may have beneficial effects on the symptoms occurring in menopausal women, particularly psychological symptoms. This study aims to examine that effect rigorously. Randomised controlled trial with two parallel arms. School of Complementary Health in Exeter, Devon, UK. Seventy-six women, aged between 45 and 60 years, reporting menopausal symptoms. Women were randomised to receive nine sessions of either reflexology or nonspecific foot massage (control) by four qualified reflexologists given over a period of 19 weeks. The Women's Health Questionnaire (WHQ), the primary measures being the subscores for anxiety and depression. Severity (visual analogue scale, VAS) and frequency of flushes and night sweats. Mean (SD) scores for anxiety fell from 0.43 (0.29) to 0.22 (0.25) in the reflexology group and from 0.37 (0.27) to 0.27 (0.29) in the control group over the course of treatment. Mean (SD) scores for depression fell from 0.37 (0.25) to 0.20 (0.24) in the reflexology group and from 0.36 (0.23) to 0.20 (0.21) in the control (foot massage) group over the same period. For both scores there was strong evidence of a time effect (P 0.2). Similar changes were found for severity of hot flushes and night sweats. In the control group, 14/37 believed they had not received true reflexology. Foot reflexology was not shown to be more effective than non-specific foot massage in the treatment of psychological symptoms occurring during the menopause.

  4. The Glioma International Case-Control Study

    DEFF Research Database (Denmark)

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

    2016-01-01

    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...... 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...

  5. Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Arabi, Yaseen M; Alothman, Adel; Balkhy, Hanan H; Al-Dawood, Abdulaziz; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M; Assiri, Abdullah M; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Almekhlafi, Ghaleb A; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Memon, Javed; Taha, Yusri; Almotairi, Abdullah; Maghrabi, Khalid A; Qushmaq, Ismael; Al Bshabshe, Ali; Kharaba, Ayman; Shalhoub, Sarah; Jose, Jesna; Fowler, Robert A; Hayden, Frederick G; Hussein, Mohamed A

    2018-01-30

    It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

  6. What can qualitative research do for randomised controlled trials? A systematic mapping review

    Science.gov (United States)

    O'Cathain, A; Thomas, K J; Drabble, S J; Rudolph, A; Hewison, J

    2013-01-01

    Objective To develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. Design Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. Data sources MEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. Eligibility criteria Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. Results 296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. Conclusions A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit

  7. Assessing the remedy: the case for contracts in clinical trials.

    Science.gov (United States)

    Edwards, Sarah J L

    2011-04-01

    Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that subjects should assume some responsibilities for the internal validity of the trial at consent and that these responsibilities should be captured by contract. This would allow the researcher to impose a penalty on the subject if he were to withdraw without good reason and on a whim. This proposal still leaves open the possibility of withdrawing without penalty when it is in the subject's best interests to do so. Giving researchers recourse to legal remedy may now be necessary to protect the science, as existing methods used to increase retention are inadequate for one reason or another.

  8. Case-control studies in diabetes. Do they really use a case-control design?

    Science.gov (United States)

    Ramos, Analía; Mendoza, Lilian Cristina; Rabasa, Fernanda; Bolíbar, Ignasi; Puig, Teresa; Corcoy, Rosa

    2017-07-01

    Studies defined as case-control do not always use this design. We aimed to estimate the frequency of mislabelled case-control studies in published articles in the area of diabetes and to identify the predictors of incorrect labelling. We searched Medline and Web of Science for articles with "diabetes" and "case control" in title and filtered for language (English/Romance) and period (January 2010-December 2014). Inclusion criteria were: (1) statement to use a case-control design in title, (2) to be a final full-length publication and (3) to have original data in the area of diabetes. Three independent reviewers went through titles, looked for full texts and reviewed them. Discrepancies were settled with a fourth reviewer. Expert epidemiologist advice was requested in case of doubt. case-control mislabelling; addressed predictors: publication year, journal impact factor and journal subject. proportion of mislabelled CC articles and assessment of predictors by multivariate logistic regression analysis. We retrieved 362 articles, 251 of them fulfilling inclusion criteria. The proportion of mislabelled CC studies was 43.8% (confidence interval 95% 37.7-50.0%). Most mislabelled studies had a cross-sectional design (82.7%). Predictors of mislabelling were publication year, journal impact factor and journal area. A relevant subset of studies defined as case-control in the area of diabetes correspond to mislabelled cross-sectional studies. Incorrect labelling misleads readers regarding the interpretation of results and the cause-effect hypothesis. Researchers, reviewers and editors should be aware of and commit to settle this issue.

  9. In a randomized case-control trial with 10-years olds suffering from attention deficit/hyperactivity disorder (ADHD) sleep and psychological functioning improved during a 12-week sleep-training program.

    Science.gov (United States)

    Keshavarzi, Zahra; Bajoghli, Hafez; Mohamadi, Mohammad Reza; Salmanian, Maryam; Kirov, Roumen; Gerber, Markus; Holsboer-Trachsler, Edith; Brand, Serge

    2014-12-01

    We tested the hypothesis that sleep training would improve emotional, social and behavioural functioning in children with attention-deficit/hyperactivity disorder (ADHD) compared to children with ADHD without such intervention and to healthy controls. Forty children with ADHD were randomly assigned to intervention and control conditions. Parents of 20 children with ADHD were instructed and thoroughly supervised in improving their children's sleep schedules and sleep behaviour. Parents of the other 20 children with ADHD and parents of 20 healthy children received general information about sleep hygiene. At baseline and 12 weeks later, parents and children completed questionnaires related to children's sleep and psychological functioning. Relative to the control groups, children in the intervention group improved sleep quantitatively and qualitatively (F values intervention group children reported improvements in mood, emotions, and relationships (F values ADHD in regulating and supervising children's sleep schedules leads to positive changes in the emotions, behaviour and social lives of these children.

  10. Naturopathic care for anxiety: a randomized controlled trial ISRCTN78958974.

    Directory of Open Access Journals (Sweden)

    Kieran Cooley

    Full Text Available BACKGROUND: Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. METHODS: Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC (n = 41 or standardized psychotherapy intervention (PT (n = 40 over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera (300 mg b.i.d. standardized to 1.5% with anolides, prepared from root. The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI and secondary outcome measures included the Short Form 36 (SF-36, Fatigue Symptom Inventory (FSI, and Measure Yourself Medical Outcomes Profile (MY-MOP to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. RESULTS: Seventy-five participants (93% were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001 in the NC group and 30.5% (p<0.0001 in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003. Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions

  11. Novel electronic refreshers for cardiopulmonary resuscitation: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Magura Stephen

    2012-11-01

    Full Text Available Abstract Background Currently the American Red Cross requires that individuals renew their cardiopulmonary resuscitation (CPR certification annually; this often requires a 4- to 8-hour refresher course. Those trained in CPR often show a decrease in essential knowledge and skills within just a few months after training. New electronic means of communication have expanded the possibilities for delivering CPR refreshers to members of the general public who receive CPR training. The study’s purpose was to determine the efficacy of three novel CPR refreshers - online website, e-mail and text messaging – for improving three outcomes of CPR training - skill retention, confidence for using CPR and intention to use CPR. These three refreshers may be considered “novel” in that they are not typically used to refresh CPR knowledge and skills. Methods The study conducted two randomized clinical trials of the novel CPR refreshers. A mailed brochure was a traditional, passive refresher format and served as the control condition. In Trial 1, the refreshers were delivered in a single episode at 6 months after initial CPR training. In Trial 2, the refreshers were delivered twice, at 6 and 9 months after initial CPR training, to test the effect of a repeated delivery. Outcomes for the three novel refreshers vs. the mailed brochure were determined at 12 months after initial CPR training. Results Assignment to any of three novel refreshers did not improve outcomes of CPR training one year later in comparison with receiving a mailed brochure. Comparing outcomes for subjects who actually reviewed some of the novel refreshers vs. those who did not indicated a significant positive effect for one outcome, confidence for performing CPR. The website refresher was associated with increased behavioral intent to perform CPR. Stated satisfaction with the refreshers was relatively high. The number of episodes of refreshers (one vs. two did not have a significant effect

  12. Novel electronic refreshers for cardiopulmonary resuscitation: a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Currently the American Red Cross requires that individuals renew their cardiopulmonary resuscitation (CPR) certification annually; this often requires a 4- to 8-hour refresher course. Those trained in CPR often show a decrease in essential knowledge and skills within just a few months after training. New electronic means of communication have expanded the possibilities for delivering CPR refreshers to members of the general public who receive CPR training. The study’s purpose was to determine the efficacy of three novel CPR refreshers - online website, e-mail and text messaging – for improving three outcomes of CPR training - skill retention, confidence for using CPR and intention to use CPR. These three refreshers may be considered “novel” in that they are not typically used to refresh CPR knowledge and skills. Methods The study conducted two randomized clinical trials of the novel CPR refreshers. A mailed brochure was a traditional, passive refresher format and served as the control condition. In Trial 1, the refreshers were delivered in a single episode at 6 months after initial CPR training. In Trial 2, the refreshers were delivered twice, at 6 and 9 months after initial CPR training, to test the effect of a repeated delivery. Outcomes for the three novel refreshers vs. the mailed brochure were determined at 12 months after initial CPR training. Results Assignment to any of three novel refreshers did not improve outcomes of CPR training one year later in comparison with receiving a mailed brochure. Comparing outcomes for subjects who actually reviewed some of the novel refreshers vs. those who did not indicated a significant positive effect for one outcome, confidence for performing CPR. The website refresher was associated with increased behavioral intent to perform CPR. Stated satisfaction with the refreshers was relatively high. The number of episodes of refreshers (one vs. two) did not have a significant effect on any outcomes

  13. The reporting quality of randomized controlled trials in orthodontics.

    Science.gov (United States)

    Lempesi, Evangelia; Koletsi, Despina; Fleming, Padhraig S; Pandis, Nikolaos

    2014-06-01

    Accurate trial reporting facilitates evaluation and better use of study results. The objective of this article is to investigate the quality of reporting of randomized controlled trials (RCTs) in leading orthodontic journals, and to explore potential predictors of improved reporting. The 50 most recent issues of 4 leading orthodontic journals until November 2013 were electronically searched. Reporting quality assessment was conducted using the modified CONSORT statement checklist. The relationship between potential predictors and the modified CONSORT score was assessed using linear regression modeling. 128 RCTs were identified with a mean modified CONSORT score of 68.97% (SD = 11.09). The Journal of Orthodontics (JO) ranked first in terms of completeness of reporting (modified CONSORT score 76.21%, SD = 10.1), followed by American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) (73.05%, SD = 10.1). Journal of publication (AJODO: β = 10.08, 95% CI: 5.78, 14.38; JO: β = 16.82, 95% CI: 11.70, 21.94; EJO: β = 7.21, 95% CI: 2.69, 11.72 compared to Angle), year of publication (β = 0.98, 95% CI: 0.28, 1.67 for each additional year), region of authorship (Europe: β = 5.19, 95% CI: 1.30, 9.09 compared to Asia/other), statistical significance (significant: β = 3.10, 95% CI: 0.11, 6.10 compared to non-significant) and methodologist involvement (involvement: β = 5.60, 95% CI: 1.66, 9.54 compared to non-involvement) were all significant predictors of improved modified CONSORT scores in the multivariable model. Additionally, median overall Jadad score was 2 (IQR = 2) across journals, with JO (median = 3, IQR = 1) and AJODO (median = 3, IQR = 2) presenting the highest score values. The reporting quality of RCTs published in leading orthodontic journals is considered suboptimal in various CONSORT areas. This may have a bearing in trial result interpretation and use in clinical decision making and evidence- based orthodontic treatment interventions. Copyright

  14. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available Background: A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. Methods: In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device. Conclusions: POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  15. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available BackgroundA pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket.MethodsIn October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device.ConclusionsPOCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  16. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial.

    Science.gov (United States)

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Andersen, Lars L

    2017-10-10

    While benefits of workplace physical exercise on physical health is well known, little is known about the psychosocial effects of such initiatives. This study evaluates the effect of workplace versus home-based physical exercise on psychosocial factors among healthcare workers. A total of 200 female healthcare workers (Age: 42.0, BMI: 24.1) from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 10 min 5 days per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 10 min 5 days per week and up to 5 group-based coaching sessions on motivation for regular physical exercise. Vitality and mental health (SF-36, scale 0-100), psychosocial work environment (COPSOQ, scale 0-100), work- and leisure disability (DASH, 0-100), control- (Bournemouth, scale 0-10) and concern about pain (Pain Catastrophizing Scale, scale 0-10) were assessed at baseline and at 10-week follow-up. Vitality as well as control and concern about pain improved more following WORK than HOME (all p health remained unchanged. Between-group differences at follow-up (WORK vs. HOME) were 7 [95% confidence interval (95% CI) 3 to 10] for vitality, -0.8 [95% CI -1.3 to -0.3] for control of pain and -0.9 [95% CI -1.4 to -0.5] for concern about pain, respectively. Performing physical exercise together with colleagues during working hours was more effective than home-based exercise in improving vitality and concern and control of pain among healthcare workers. These benefits occurred in spite of increased work pace. NCT01921764 at ClinicalTrials.gov . Registered 10 August 2013.

  17. A Randomized Controlled Trial of an Eczema Care Plan.

    Science.gov (United States)

    Rea, Corinna J; Tran, Katherine D; Jorina, Maria; Wenren, Larissa M; Hawryluk, Elena B; Toomey, Sara L

    2018-03-02

    To test whether an eczema care plan (ECP) would improve provider documentation and management, decrease eczema severity, and increase patient quality of life (QOL) in the pediatric primary care setting. We conducted a randomized controlled trial from June 2015 to September 2016 at a large hospital-based pediatric primary care clinic. Participants included children from 1 month to 16 years of age with a diagnosis of eczema. The intervention group received the ECP and the control group received usual care. Both groups completed a validated eczema severity scale (Patient-Oriented Eczema Measure [POEM]) and a QOL scale (Infant's Dermatitis Quality of Life Index [IDQOL]) or Children's Dermatology Life Quality Index [CDLQI]) before the visit and again ~1 month later. A total of 211 caregivers completed both the pre- and postintervention surveys (100 control group and 111 intervention group [94% completion]). Intervention group providers were more likely to recommend a comprehensive "step-up" plan (88%) vs 28%; P plan to families (80%) vs 2%; P improved between the pre- and postintervention periods. However, there was not a significant difference between the groups on either measure: POEM difference -0.8, 95% confidence interval (CI) -3.2 to 1.7; IDQOL difference -0.1, 95% CI -1.8 to 1.6; CDLQI difference 0.8, 95% CI -0.9 to 2.6. Intervention group providers documented more comprehensive eczema care than control group providers. Although patients improved on all measures in the postintervention period, the ECP did not augment that improvement. Copyright © 2018 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  18. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    OpenAIRE

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-01-01

    Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Method...

  19. Pediatric selective mutism therapy: a randomized controlled trial.

    Science.gov (United States)

    Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco

    2017-10-01

    Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (Pselective mutism, even if further studies are needed. The present study identifies in psychomotricity a safe and efficacy therapy for pediatric selective mutism.

  20. On reporting results from randomized controlled trials with recurrent events

    Directory of Open Access Journals (Sweden)

    Sobolev Boris G

    2008-05-01

    Full Text Available Abstract Background Evidence-based medicine has been advanced by the use of standards for reporting the design and methodology of randomized controlled trials (RCT. Indeed, without this information it is difficult to assess the quality of evidence from an RCT. Although a variety of statistical methods are available for the analysis of recurrent events, reporting the effect of an intervention on outcomes that recur is an area that remains poorly understood in clinical research. The purpose of this paper is to outline guidelines for reporting results from RCTs where the outcome of interest is a recurrent event. Methods We used a simulation study to relate an event process and results from analyses of the gamma-Poisson, independent-increment, conditional, and marginal Cox models. We reviewed the utility of regression models for the rate of a recurrent event by articulating the associated study questions, preenting the risk sets, and interpreting the regression coefficients. Results Based on a single data set produced by simulation, we reported and contrasted results from statistical methods for evaluating treatment effect from an RCT with a recurrent outcome. We showed that each model has different study questions, assumptions, risk sets, and rate ratio interpretation, and so inferences should consider the appropriateness of the model for the RCT. Conclusion Our guidelines for reporting results from an RCT involving a recurrent event suggest that the study question and the objectives of the trial, such as assessing comparable groups and estimating effect size, should determine the statistical methods. The guidelines should allow clinical researchers to report appropriate measures from an RCT for understanding the effect of intervention on the occurrence of a recurrent event.

  1. Pulmonary rehabilitation in lymphangioleiomyomatosis: a controlled clinical trial.

    Science.gov (United States)

    Araujo, Mariana S; Baldi, Bruno G; Freitas, Carolina S G; Albuquerque, André L P; Marques da Silva, Cibele C B; Kairalla, Ronaldo A; Carvalho, Celso R F; Carvalho, Carlos R R

    2016-05-01

    Lymphangioleiomyomatosis (LAM) is a cystic lung disease frequently associated with reduced exercise capacity. The aim of this study was to assess safety and efficacy of pulmonary rehabilitation in LAM.This controlled clinical trial included 40 patients with LAM and a low physical activity level. The pulmonary rehabilitation programme comprised 24 aerobic and muscle strength training sessions and education. The primary outcome was exercise capacity (endurance time during a constant work rate exercise test). Secondary outcomes included health-related quality of life (St George's Respiratory Questionnaire (SGRQ)), 6-min walking distance (6MWD), dyspnoea, peak oxygen consumption (V'O2 ), daily physical activity (pedometer), symptoms of anxiety and depression, lung function and peripheral muscle strength (one-repetition maximum).The baseline characteristics were well balanced between the groups. The pulmonary rehabilitation group exhibited improvements in the following outcomes versus controls: endurance time (median (interquartile range) 169 (2-303) s versus -33 (-129-39) s; p=0.001), SGRQ (median (interquartile range) -8 (-16-2) versus 2 (-4-5); p=0.002) and 6MWD (median (interquartile range) 59 (13-81) m versus 20 (-12-30) m; p=0.002). Dyspnoea, peak V'O2 , daily physical activity and muscle strength also improved significantly. No serious adverse events were observed.Pulmonary rehabilitation is a safe intervention and improves exercise capacity, dyspnoea, daily physical activity, quality of life and muscle strength in LAM. Copyright ©ERS 2016.

  2. Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial.

    Science.gov (United States)

    Nagai, Yoko; Cavanna, Andrea E; Critchley, Hugo D; Stern, Jeremy J; Robertson, Mary M; Joyce, Eileen M

    2014-03-01

    To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome. Despite advances in the pharmacologic treatment of patients with Tourette syndrome, many remain troubled by their tics, which may be resistant to multiple medications at tolerable doses. Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions. We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome. After training the patients for 3 sessions a week over 4 weeks, we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback (control) groups, but there was no difference between the groups in these measurements. Furthermore, the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback. Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo. The main confounding factor appeared to be the 30-minute duration of the training sessions, which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses. Despite a negative finding in this study, electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified.

  3. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study

    Directory of Open Access Journals (Sweden)

    Price Jackie F

    2011-01-01

    Full Text Available Abstract Background Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Methods Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA trial (N = 11, and AAA trial participants who had stopped taking the trial medication (N = 11. A focus group with further participants who had stopped taking the trial medication (N = 6. (Total participants N = 28. Results Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating. Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. Conclusions These results indicate that when planning trials (especially in preventive medicine particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. Trial registration ISRCTN66587262

  4. No short-cut in assessing trial quality: a case study

    Directory of Open Access Journals (Sweden)

    Hirji Karim F

    2009-01-01

    Full Text Available Abstract Background Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment. Results The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991 is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations. Conclusion A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review.

  5. Ankles back in randomized controlled trial (ABrCt: braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Verhagen Evert ALM

    2011-09-01

    Full Text Available Abstract Background Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. Methods/Design This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. Discussion The ABrCt is the first randomized controlled trial to directly compare the secondary preventive

  6. Case Study: Dose Response of Caffeine on 20-km Handcycling Time Trial Performance in a Paratriathlete.

    Science.gov (United States)

    Graham-Paulson, Terri; Perret, Claudio; Goosey-Tolfrey, Victoria

    2018-05-03

    Caffeine's (CAF) ability to influence upper-body exercise endurance performance may be related to an individual's training status. This case study therefore aimed to investigate the ergogenic effects of CAF dose on 20-km time trial (TT) performance of an elite male paratriathlete (wheelchair user; age = 46 years, body mass = 76.9 kg, body fat = 25.4%, and handcycling [Formula: see text]). The athlete completed four 20-km handcycling TTs on a Cyclus II ergometer under controlled laboratory conditions following the ingestion of 2, 4, and 6 mg/kg CAF or placebo (PLA). Blood lactate concentration, power output, arousal, and ratings of perceived exertion were recorded. Ingestion of 2, 4, and 6 mg/kg CAF resulted in a 2%, 1.5%, and 2.7% faster TT compared with PLA (37:40 min:s). The participant's blood lactate concentration increased throughout all trials and was greater during CAF compared with PLA. There were no obvious differences in ratings of perceived exertion between trials despite different performance times. Baseline arousal scores differed between PLA and 4 mg/kg CAF (1 = low), and 2 and 6 mg/kg CAF (3 = moderate). Arousal increased at each time point following the ingestion of 4 and 6 mg/kg CAF. The largest CAF dose resulted in a positive pacing strategy, which, when combined with an end spurt, resulted in the fastest TT. CAF improved 20-km TT performance of an elite male paratriathlete, which may be related to greater arousal and an increased power output for a given rating of perceived exertion.

  7. Genetic test feedback with weight control advice: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Meisel Susanne F

    2012-12-01

    Full Text Available Abstract Background Genetic testing for risk of weight gain is already available over the internet despite uncertain benefits and concerns about adverse emotional or behavioral effects. Few studies have assessed the effect of adding genetic test feedback to weight control advice, even though one of the proposed applications of genetic testing is to stimulate preventive action. This study will investigate the motivational effect of adding genetic test feedback to simple weight control advice in a situation where weight gain is relatively common. Methods/design First-year university students (n = 800 will be randomized to receive either 1 their personal genetic test result for a gene (FTO related to weight gain susceptibility in addition to a leaflet with simple weight control advice (‘Feedback + Advice’ group, FA, or 2 only the leaflet containing simple weight control advice (‘Advice Only’ group, AO. Motivation to avoid weight gain and active use of weight control strategies will be assessed one month after receipt of the leaflet with or without genetic test feedback. Weight and body fat will be measured at baseline and eight months follow-up. We will also assess short-term psychological reactions to the genetic test result. In addition, we will explore interactions between feedback condition and gene test status. Discussion We hope to provide a first indication of the clinical utility of weight-related genetic test feedback in the prevention context. Trial registration Current controlled trials ISRCTN91178663

  8. Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries.

    Science.gov (United States)

    Lamb, S E; Williams, M A; Williamson, E M; Gates, S; Withers, E J; Mt-Isa, S; Ashby, D; Castelnuovo, E; Underwood, M; Cooke, M W

    2012-01-01

    To examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury; to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs; and to gain participants' perspective on experiencing whiplash injury, NHS treatment, and recovery within the context of the Managing Injuries of the Neck Trial (MINT). Two linked, pragmatic, randomised controlled trials. In Step 1, emergency departments (EDs) were cluster randomised to usual care advice (UCA) or The Whiplash Book advice (WBA)/active management advice. In Step 2, participants were individually randomised to either a single session of advice from a physiotherapist or a physiotherapy package of up to six sessions. An economic evaluation and qualitative study were run in parallel with the trial. Twelve NHS trusts in England comprising 15 EDs. People who attended EDs with an acute whiplash injury of whiplash-associated disorder grades I-III were eligible for Step 1. People who had attended EDs with whiplash injuries and had persistent symptoms 3 weeks after ED attendance were eligible for Step 2. In Step 1, the control intervention was UCA and the experimental intervention was a psycho-educational intervention (WBA/active management advice). In Step 2 the control treatment was reinforcement of the advice provided in Step 1 and the experimental intervention was a package of up to six physiotherapy treatments. The primary outcome was the Neck Disability Index (NDI), which measures severity and frequency of pain and symptoms, and a range of activities including self-care, driving, reading, sleeping and recreation. Secondary outcomes included the mental and physical health-related quality-of-life (HRQoL) subscales of the Short Form questionnaire-12 items (SF-12) and the number of work days lost. A total of 3851 patients were recruited to Step 1 of the trial. 1598 patients attending EDs were randomised to UCA, and 2253 were

  9. 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.

  10. Two controlled trials to increase participant retention in a randomized controlled trial of mobile phone-based smoking cessation support in the United Kingdom.

    Science.gov (United States)

    Severi, Ettore; Free, Caroline; Knight, Rosemary; Robertson, Steven; Edwards, Philip; Hoile, Elizabeth

    2011-10-01

    Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants' awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly. Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher. Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures. Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88-1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98. In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.

  11. Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services.

    Science.gov (United States)

    Bonell, Chris; Moore, Graham; Warren, Emily; Moore, Laurence

    2018-04-19

    We have previously proposed that trials of social interventions can be done within a "realist" research paradigm. Critics have countered that such trials are irredeemably positivist and asked us to explain our philosophical position. We set out to explore what is meant by positivism and whether trials adhere to its tenets (of necessity or in practice) via a narrative literature review of social science and philosophical discussions of positivism, and of the trials literature and three case studies of trials. The philosophical literature described positivism as asserting: (1) the epistemic primacy of sensory information; (2) the requirement that theoretical terms equate with empirical terms; (3) the aim of developing universal laws; and (4) the unity of method between natural and social sciences. Regarding (1), it seems that rather than embodying the epistemic primacy of sensory data, randomised controlled trials (RCTs) of social interventions in health embrace an anti-positivist approach aiming to test hypotheses derived deductively from prior theory. Considering (2), while some RCTs of social interventions appear to limit theorisation to concepts with empirical analogues, others examine interventions underpinned by theories engaging with mechanisms and contextual contingencies not all of which can be measured. Regarding (3), while some trialists and reviewers in the health field do limit their role to estimating statistical trends as a mechanistic form of generalisation, this is not an inevitable feature of RCT-based research. Trials of social interventions can instead aim to generalise at the level of theory which specifies how mechanisms are contingent on context. In terms of (4), while RCTs are used to examine biomedical as well as social interventions in health, RCTs of social interventions are often distinctive in using qualitative analyses of data on participant accounts to examine questions of meaning and agency not pursued in the natural sciences. We

  12. Job maintenance through Supported Employment PLUS: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nils-Torge Telle

    2016-09-01

    Full Text Available Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58 received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41 received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention and at a 3-month follow up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  13. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial.

    Science.gov (United States)

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N  = 99 employees who reported mental distress due to work-related problems. The intervention group ( n  = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group ( n  = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  14. A randomized controlled trial of interim methadone maintenance.

    Science.gov (United States)

    Schwartz, Robert P; Highfield, David A; Jaffe, Jerome H; Brady, Joseph V; Butler, Carol B; Rouse, Charles O; Callaman, Jason M; O'Grady, Kevin E; Battjes, Robert J

    2006-01-01

    Effective alternatives to long waiting lists for entry into methadone hydrochloride maintenance treatment are needed to reduce the complications of continuing heroin dependence and to increase methadone treatment entry. To compare the effectiveness of interim methadone maintenance with that of the usual waiting list condition in facilitating methadone treatment entry and reducing heroin and cocaine use and criminal behavior. Randomized, controlled, clinical trial using 2 conditions, with treatment assignment on a 3:2 basis to interim maintenance-waiting list control. A methadone treatment program in Baltimore. A total of 319 individuals meeting the criteria for current heroin dependence and methadone maintenance treatment. Participants were randomly assigned to either interim methadone maintenance, consisting of an individually determined methadone dose and emergency counseling only for up to 120 days, or referral to community-based methadone treatment programs. Entry into comprehensive methadone maintenance therapy at 4 months from baseline; self-reported days of heroin use, cocaine use, and criminal behavior; and number of urine drug test results positive for heroin and cocaine at the follow-up interview conducted at time of entry into comprehensive methadone treatment (or at 4 months from baseline for participants who did not enter regular treatment). Significantly more participants assigned to the interim methadone maintenance condition entered comprehensive methadone maintenance treatment by the 120th day from baseline (75.9%) than those assigned to the waiting list control condition (20.8%) (Pmethadone maintenance results in a substantial increase in the likelihood of entry into comprehensive treatment, and is an effective means of reducing heroin use and criminal behavior among opioid-dependent individuals awaiting entry into a comprehensive methadone treatment program.

  15. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    Science.gov (United States)

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  16. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study.

    Science.gov (United States)

    Eborall, Helen C; Stewart, Marlene C W; Cunningham-Burley, Sarah; Price, Jackie F; Fowkes, F Gerry R

    2011-01-11

    Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA) trial (N = 11), and AAA trial participants who had stopped taking the trial medication (N = 11). A focus group with further participants who had stopped taking the trial medication (N = 6). (Total participants N = 28). Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating.Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. These results indicate that when planning trials (especially in preventive medicine) particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. ISRCTN66587262.

  17. Treatment for symptomatic bacterial vaginosis: a randomized controlled trial

    International Nuclear Information System (INIS)

    Tariq, N.; Basharat, A.; Fahim, A.

    2017-01-01

    Objective: To compare the efficacy of multiple doses of vaginal clindamycin with a single oral dose of secnidazole for the treatment of bacterial vaginosis. Study Design: Double-blinded randomized controlled trial. Place and Duration of Study: Shifa Foundation Community Health Center, from March 2012 till February 2015. Methodology: After obtaining written informed consent, a pelvic examination was performed for the confirmation of symptoms of milky white vaginal discharge on speculum examination, positive Amine test and presence of clue cells on microscopy. Pregnant women, known diabetes or any immunocompromised condition, were excluded. Blinding of the patient, doctor, and the pharmacist was done. Study cohort was then divided into two groups, Group A received medicine pack A which contained active clindamycin and placebo oral preparation, whereas group B was given pack B which contained active 2-gm secnidazole with placebo vaginal cream. Primary outcome and therapeutic success were defined by correction of two out of three (normal Nugent score, negative Amine test, and no milky white discharge) on day 15. Results: At 15th day of treatment, 96.6% participants in vaginal clindamycin group (Group A), recovered from the bacterial vaginosis; whereas, (group B) 23% patients were cured in oral secnidazole group. Conclusion: Multiple doses of vaginal clindamycin are superior to single dose of oral secnidazole for the treatment of bacterial vaginosis. (author)

  18. Dry cupping for plantar fasciitis: a randomized controlled trial.

    Science.gov (United States)

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-05-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.

  19. Prenatal docosahexaenoic acid supplementation and infant morbidity: randomized controlled trial.

    Science.gov (United States)

    Imhoff-Kunsch, Beth; Stein, Aryeh D; Martorell, Reynaldo; Parra-Cabrera, Socorro; Romieu, Isabelle; Ramakrishnan, Usha

    2011-09-01

    Long-chain polyunsaturated fatty acids such as docosahexaenoic acid (DHA) influence immune function and inflammation; however, the influence of maternal DHA supplementation on infant morbidity is unknown. We investigated the effects of prenatal DHA supplementation on infant morbidity. In a double-blind randomized controlled trial conducted in Mexico, pregnant women received daily supplementation with 400 mg of DHA or placebo from 18 to 22 weeks' gestation through parturition. In infants aged 1, 3, and 6 months, caregivers reported the occurrence of common illness symptoms in the preceding 15 days. Data were available at 1, 3, and 6 months for 849, 834, and 834 infants, respectively. The occurrence of specific illness symptoms did not differ between groups; however, the occurrence of a combined measure of cold symptoms was lower in the DHA group at 1 month (OR: 0.76; 95% CI: 0.58-1.00). At 1 month, the DHA group experienced 26%, 15%, and 30% shorter duration of cough, phlegm, and wheezing, respectively, but 22% longer duration of rash (all P ≤ .01). At 3 months, infants in the DHA group spent 14% less time ill (P DHA group experienced 20%, 13%, 54%, 23%, and 25% shorter duration of fever, nasal secretion, difficulty breathing, rash, and "other illness," respectively, but 74% longer duration of vomiting (all P DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months.

  20. Measurement model choice influenced randomized controlled trial results.

    Science.gov (United States)

    Gorter, Rosalie; Fox, Jean-Paul; Apeldoorn, Adri; Twisk, Jos

    2016-11-01

    In randomized controlled trials (RCTs), outcome variables are often patient-reported outcomes measured with questionnaires. Ideally, all available item information is used for score construction, which requires an item response theory (IRT) measurement model. However, in practice, the classical test theory measurement model (sum scores) is mostly used, and differences between response patterns leading to the same sum score are ignored. The enhanced differentiation between scores with IRT enables more precise estimation of individual trajectories over time and group effects. The objective of this study was to show the advantages of using IRT scores instead of sum scores when analyzing RCTs. Two studies are presented, a real-life RCT, and a simulation study. Both IRT and sum scores are used to measure the construct and are subsequently used as outcomes for effect calculation. The bias in RCT results is conditional on the measurement model that was used to construct the scores. A bias in estimated trend of around one standard deviation was found when sum scores were used, where IRT showed negligible bias. Accurate statistical inferences are made from an RCT study when using IRT to estimate construct measurements. The use of sum scores leads to incorrect RCT results. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Medication reconciliation at patient admission: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mendes AE

    2016-03-01

    Full Text Available Objective: To measure length of hospital stay (LHS in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620. The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety.

  2. Validating Obstetric Emergency Checklists using Simulation: A Randomized Controlled Trial.

    Science.gov (United States)

    Bajaj, Komal; Rivera-Chiauzzi, Enid Y; Lee, Colleen; Shepard, Cynthia; Bernstein, Peter S; Moore-Murray, Tanya; Smith, Heather; Nathan, Lisa; Walker, Katie; Chazotte, Cynthia; Goffman, Dena

    2016-10-01

    Background The World Health Organization's Surgical Safety Checklist has demonstrated significant reduction in surgical morbidity. The American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative (SMI) safety bundles include eclampsia and postpartum hemorrhage (PPH) checklists. Objective To determine whether use of the SMI checklists during simulated obstetric emergencies improved completion of critical actions and to elicit feedback to facilitate checklist revision. Study Design During this randomized controlled trial, teams were assigned to use a checklist during one of two emergencies: eclampsia and PPH. Raters scored teams on critical step completion. Feedback was elicited through structured debriefing. Results In total, 30 teams completed 60 scenarios. For eclampsia, trends toward higher completion were noted for blood pressure and airway management. For PPH, trends toward higher completion rates were noted for PPH stage assessment and fundal massage. Feedback resulted in substantial checklist revision. Participants were enthusiastic about using checklists in a clinical emergency. Conclusion Despite trends toward higher rates of completion of critical tasks, teams using checklists did not approach 100% task completion. Teams were interested in the application of checklists and provided feedback necessary to substantially revise the checklists. Intensive implementation planning and training in use of the revised checklists will result in improved patient outcomes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  3. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Multicentre randomised controlled equivalence trial. 15 hospitals in the Netherlands. Women with an intermediate to high obstetric risk with an

  4. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia : a randomised equivalence trial

    NARCIS (Netherlands)

    Logtenberg, Slm; Oude Rengerink, K; Verhoeven, C J; Freeman, L M; van den Akker, Esa; Godfried, M B; van Beek, E; Borchert, Owhm; Schuitemaker, N; van Woerkens, Ecsm; Hostijn, I; Middeldorp, J M; van der Post, J A; Mol, B W

    OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the

  5. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  6. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Rengerink, Katrien Oude; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    Objective To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an

  7. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, L.M.; Bloemenkamp, K.W.; Franssen, M.T.; Papatsonis, D.N.; Hajenius, P.J.; Hollmann, M.W.; Woiski, M.D.; Porath, M.; Berg, H.J. van den; Beek, E. van; Borchert, O.W.; Schuitemaker, N.; Sikkema, J.M.; Kuipers, A.H.; Logtenberg, S.L.; Salm, P.C. van der; Oude Rengerink, K.; Lopriore, E.; Akker-van Marle, M.E. van den; Cessie, S. le; Lith, J.M. van; Struys, M.M.; Mol, B.W.; Dahan, A; Middeldorp, J.M.

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  8. Predictors of Missed Research Appointments in a Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stéphanie J.E. Becker

    2014-09-01

     Younger patients with no college education, who believe their health can be controlled, are more likely to miss a research appointment when enrolled in a randomized placebo injection-controlled trial

  9. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  10. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  11. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

    Science.gov (United States)

    Lauzier, F; Adhikari, N K; Seely, A; Koo, K K Y; Belley-Côté, E P; Burns, K E A; Cook, D J; D'Aragon, F; Rochwerg, B; Kho, M E; Oczkowksi, S J W; Duan, E H; Meade, M O; Day, A G; Lamontagne, F

    2017-07-17

    The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

  12. Efficacy of Exercise for Menopausal Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Sternfeld, Barbara; Guthrie, Katherine A.; Ensrud, Kristine E.; LaCroix, Andrea Z.; Larson, Joseph C.; Dunn, Andrea L.; Anderson, Garnet L.; Seguin, Rebecca A.; Carpenter, Janet S.; Newton, Katherine M.; Reed, Susan D.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Roberts, Melanie; Caan, Bette J.

    2013-01-01

    OBJECTIVE To determine efficacy of exercise training for alleviating vasomotor and other menopausal symptoms. METHODS Late-peri and post-menopausal, sedentary women with frequent vasomotor symptoms (VMS) participated in a randomized controlled trial conducted at three sites: 106 to exercise and 142 to usual activity. The exercise intervention consisted of individual, facility-based aerobic exercise training 3 times/week for 12 weeks. VMS frequency and bother were recorded on daily diaries at baseline and weeks 6 and 12. Intent to treat analyses compared between group differences in changes in VMS frequency and bother, sleep symptoms (Insomnia Severity Index, Pittsburgh Sleep Quality Index) and mood (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7 questionnaire). RESULTS At the end of week 12, changes in VMS frequency in the exercise group (mean change of −2.4/day, 95% CI −3.0, −1.7) and VMS bother (mean change of −0.5 on a 4 point scale, 95% CI −0.6, −0.4) were not significantly different from those in the control group (−2.6 VMS/day, 95% CI −3.2, −2.0, p=0.43; −0.5 points, 95% CI −0.6, −0.4, p=0.75). The exercise group reported greater improvement in insomnia symptoms (p=0.03), subjective sleep quality (p=0.01), and depressive symptoms (p=0.04), but differences were small and not statistically significant when p values were adjusted for multiple comparisons. Results were similar when considering treatment-adherent women only. CONCLUSION These findings provide strong evidence that 12-weeks of moderate-intensity aerobic exercise does not alleviate VMS but may result in small improvements in sleep quality, insomnia and depression in midlife, sedentary women. PMID:23899828

  13. Alcohol-related breast cancer in postmenopausal women - effect of CYP19A1, PPARG and PPARGC1A polymorphisms on female sex-hormone levels and interaction with alcohol consumption and NSAID usage in a nested case-control study and a randomised controlled trial

    DEFF Research Database (Denmark)

    Kopp, Tine Iskov; Jensen, Ditte Marie; Ravn-Haren, Gitte

    2016-01-01

    . Association between the CYP19A1 polymorphisms and hormone levels was also examined among 339 non-HRT users. Incidence rate ratios were calculated based on Cox' proportional hazards model. Furthermore, we performed a pilot randomised controlled trial to determine the effect of the PPARG Pro(12)Ala polymorphism...... and the PPARγ stimulator Ibuprofen on sex-hormone levels following alcohol intake in postmenopausal women (n = 25) using linear regression. Genetic variations in CYP19A1 were associated with hormone levels (estrone: P rs11070844 = 0.009, estrone sulphate: P rs11070844 = 0.01, P rs749292 = 0.004, P rs1062033 = 0...

  14. Online Adaptation and Over-Trial Learning in Macaque Visuomotor Control

    Science.gov (United States)

    Braun, Daniel A.; Aertsen, Ad; Paz, Rony; Vaadia, Eilon; Rotter, Stefan; Mehring, Carsten

    2011-01-01

    When faced with unpredictable environments, the human motor system has been shown to develop optimized adaptation strategies that allow for online adaptation during the control process. Such online adaptation is to be contrasted to slower over-trial learning that corresponds to a trial-by-trial update of the movement plan. Here we investigate the interplay of both processes, i.e., online adaptation and over-trial learning, in a visuomotor experiment performed by macaques. We show that simple non-adaptive control schemes fail to perform in this task, but that a previously suggested adaptive optimal feedback control model can explain the observed behavior. We also show that over-trial learning as seen in learning and aftereffect curves can be explained by learning in a radial basis function network. Our results suggest that both the process of over-trial learning and the process of online adaptation are crucial to understand visuomotor learning. PMID:21720526

  15. Guidelines for controlled trials of drugs in tension-type headache: second edition

    DEFF Research Database (Denmark)

    Bendtsen, L; Bigal, M E; Cerbo, R

    2010-01-01

    and chronic tension-type headache have been published, providing new information on trial methodology for this disorder. Furthermore, the classification of the headaches, including tension-type headache, has been revised. These developments support the need for also revising the guidelines for drug treatments......The Clinical Trials Subcommittee of the International Headache Society published its first edition of the guidelines on controlled trials of drugs in tension-type headache in 1995. These aimed 'to improve the quality of controlled clinical trials in tension-type headache', because 'good quality...... controlled trials are the only way to convincingly demonstrate the efficacy of a drug, and form the basis for international agreement on drug therapy'. The Committee published similar guidelines for clinical trials in migraine and cluster headache. Since 1995 several studies on the treatment of episodic...

  16. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

  17. When ethics constrains clinical research: trial design of control arms in "greater than minimal risk" pediatric trials.

    Science.gov (United States)

    de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G

    2011-09-01

    For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

  18. Effectiveness of holistic interventions for people with severe chronic obstructive pulmonary disease: systematic review of controlled clinical trials.

    Directory of Open Access Journals (Sweden)

    Ulugbek Nurmatov

    Full Text Available Despite a well-recognised burden of disabling physical symptoms compounded by co-morbidities, psychological distress and social isolation, the needs of people with severe chronic obstructive pulmonary disease (COPD are typically poorly addressed.To assess the effectiveness of interventions designed to deliver holistic care for people with severe COPD.We searched 11 biomedical databases, three trial repositories (January 1990-March 2012; no language restrictions and contacted international experts to locate published, unpublished and in-progress randomised controlled trials (RCTs, quasi-RCTs and controlled clinical trials (CCTs that investigated holistic interventions to support patients with severe COPD in any healthcare context. The primary outcome was health-related quality of life (HRQoL. Quality assessment and data extraction followed Cochrane Collaboration methodology. We used a piloted data extraction sheet and undertook narrative synthesis.From 2,866 potentially relevant papers, we identified three trials: two RCTs (from United States and Australia, and one CCT (from Thailand: total 216 patients. Risk of bias was assessed as moderate in two studies and high in the third. All the interventions were led by nurses acting in a co-ordinating role (e.g. facilitating community support in Thailand, providing case-management in the USA, or co-ordinating inpatient care in Australia. HRQoL improved significantly in the Thai CCT compared to the (very limited usual care (p<0.001, in two sub-domains in the American trial, but showed no significant changes in the Australian trial. Exercise tolerance, dyspnoea, and satisfaction with care also improved in the Thai trial.Some 15 years after reports first highlighted the unmet needs of people with severe COPD, we have been unable to find robust trial evidence about interventions that can address those needs. There is an urgent need to develop and evaluate holistic care interventions designed improve HRQo

  19. Influence of vitamin E supplementation on glycaemic control: a meta-analysis of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Renfan Xu

    Full Text Available Observational studies have revealed that higher serum vitamin E concentrations and increased vitamin E intake and vitamin E supplementation are associated with beneficial effects on glycaemic control in type 2 diabetes mellitus (T2DM. However, whether vitamin E supplementation exerts a definitive effect on glycaemic control remains unclear. This article involves a meta-analysis of randomised controlled trials of vitamin E to better characterise its impact on HbA1c, fasting glucose and fasting insulin. PubMed, EMBASE and the Cochrane Library were electronically searched from the earliest possible date through April 2013 for all relevant studies. Weighted mean difference (WMD was calculated for net changes using fixed-effects or random-effects models. Standard methods for assessing statistical heterogeneity and publication bias were used. Fourteen randomised controlled trials involving individual data on 714 subjects were collected in this meta-analysis. Increased vitamin E supplementation did not result in significant benefits in glycaemic control as measured by reductions in HbA1c, fasting glucose and fasting insulin. Subgroup analyses revealed a significant reduction in HbA1c (-0.58%, 95% CI -0.83 to -0.34 and fasting insulin (-9.0 pmol/l, 95% CI -15.90 to -2.10 compared with controls in patients with low baseline vitamin E status. Subgroup analyses also demonstrated that the outcomes may have been influenced by the vitamin E dosage, study duration, ethnic group, serum HbA1c concentration, and fasting glucose control status. In conclusion, there is currently insufficient evidence to support a potential beneficial effect of vitamin E supplementation on improvements of HbA1c and fasting glucose and insulin concentrations in subjects with T2DM.

  20. Influence of vitamin E supplementation on glycaemic control: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Xu, Renfan; Zhang, Shasha; Tao, Anyu; Chen, Guangzhi; Zhang, Muxun

    2014-01-01

    Observational studies have revealed that higher serum vitamin E concentrations and increased vitamin E intake and vitamin E supplementation are associated with beneficial effects on glycaemic control in type 2 diabetes mellitus (T2DM). However, whether vitamin E supplementation exerts a definitive effect on glycaemic control remains unclear. This article involves a meta-analysis of randomised controlled trials of vitamin E to better characterise its impact on HbA1c, fasting glucose and fasting insulin. PubMed, EMBASE and the Cochrane Library were electronically searched from the earliest possible date through April 2013 for all relevant studies. Weighted mean difference (WMD) was calculated for net changes using fixed-effects or random-effects models. Standard methods for assessing statistical heterogeneity and publication bias were used. Fourteen randomised controlled trials involving individual data on 714 subjects were collected in this meta-analysis. Increased vitamin E supplementation did not result in significant benefits in glycaemic control as measured by reductions in HbA1c, fasting glucose and fasting insulin. Subgroup analyses revealed a significant reduction in HbA1c (-0.58%, 95% CI -0.83 to -0.34) and fasting insulin (-9.0 pmol/l, 95% CI -15.90 to -2.10) compared with controls in patients with low baseline vitamin E status. Subgroup analyses also demonstrated that the outcomes may have been influenced by the vitamin E dosage, study duration, ethnic group, serum HbA1c concentration, and fasting glucose control status. In conclusion, there is currently insufficient evidence to support a potential beneficial effect of vitamin E supplementation on improvements of HbA1c and fasting glucose and insulin concentrations in subjects with T2DM.

  1. Dyslipidemia and Psoriasis: A Case Control Study

    International Nuclear Information System (INIS)

    Khan, M. U.; Aqil, M.; Hussain, A.; Zahrani, T. A.; Hillis, M.

    2015-01-01

    Objective: To evaluate and compare the effects of pre-operative single oral dose of tramadol and famotidine on gastric secretions pH and volume in patients electively scheduled for laparoscopic cholecystectomy. Study Design:Randomized control trial. Place and Duration of Study: Department of Anaesthesia, King Saud University Riyadh, Saudi Arabia, from August 2011 to June 2013. Methodology:Ninety adult, ASA-I and II patients scheduled for laparoscopic cholecystectomy were included in the study. Patients were randomly assigned to receive pre-operatively either placebo (Group-C, n=30), oral tramadol 100 mg (Group-T, n=30) or famotidine 40 mg (Group-F, n=30). After induction of general anaesthesia, gastric fluid was aspirated through orogastric tube. The gastric secretions volume and pH was measured using pH meter. Results: There was no statistically difference between groups in age, weight and gender. The gastric secretions mean pH was 2.06 ± 0.22,2.04 ± 0.20, 5.79 ± 0.77 and volume was 0.59 ± 0.17, 0.59 ± 0.14 and 0.28 ± 0.16 ml/kg in Group-C, Group-T and Group-F respectively. There was a significant statistical difference in the mean pH values between Group-C vs. Group-F (p greater than 0.001) and Group-Tvs. Group-F (p greater than 0.001). Statistically significant difference was also found in the mean gastric secretions volume between Group - C vs. Group-F (p greater than 0.001) and Group-Tvs. Group-F (p greater than 0.001). There was no significant difference in the mean gastric fluid pH values (p=0.99) and mean gastric secretions volume (p=0.99) between Group-T and Group-C. Conclusion:As compared to famotidine, pre-operative single oral dose of tramadol was unable to elevate the desired level of gastric fluid pH (less than 2.5) and decrease in gastric secretions volume (greater than 0.4ml/kg). (author)

  2. Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

    Directory of Open Access Journals (Sweden)

    Norio Sugawara

    Full Text Available Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251 aged 47.7±13.2 (mean±SD with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.

  3. Ankles back in randomized controlled trial (ABrCt): braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial.

    Science.gov (United States)

    Janssen, Kasper W; van Mechelen, Willem; Verhagen, Evert Alm

    2011-09-27

    Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training) against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. The ABrCt is the first randomized controlled trial to directly compare the secondary preventive effect of the combined use of braces and neuromuscular training

  4. Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

    Science.gov (United States)

    Macedo, Luciana G; Latimer, Jane; Maher, Chris G; Hodges, Paul W; Nicholas, Michael; Tonkin, Lois; McAuley, James H; Stafford, Ryan

    2008-01-01

    Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week) and function (patient-specific functional scale) at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415 PMID:18454877

  5. Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McAuley James H

    2008-05-01

    Full Text Available Abstract Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week and function (patient-specific functional scale at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415

  6. Disease management program for chronic obstructive pulmonary disease: a randomized controlled trial.

    Science.gov (United States)

    Rice, Kathryn L; Dewan, Naresh; Bloomfield, Hanna E; Grill, Joseph; Schult, Tamara M; Nelson, David B; Kumari, Sarita; Thomas, Mel; Geist, Lois J; Beaner, Caroline; Caldwell, Michael; Niewoehner, Dennis E

    2010-10-01

    The effect of disease management for chronic obstructive pulmonary disease (COPD) is not well established. To determine whether a simplified disease management program reduces hospital admissions and emergency department (ED) visits due to COPD. We performed a randomized, adjudicator-blinded, controlled, 1-year trial at five Veterans Affairs medical centers of 743 patients with severe COPD and one or more of the following during the previous year: hospital admission or ED visit for COPD, chronic home oxygen use, or course of systemic corticosteroids for COPD. Control group patients received usual care. Intervention group patients received a single 1- to 1.5-hour education session, an action plan for self-treatment of exacerbations, and monthly follow-up calls from a case manager. We determined the combined number of COPD-related hospitalizations and ED visits per patient. Secondary outcomes included hospitalizations and ED visits for all causes, respiratory medication use, mortality, and change in Saint George's Respiratory Questionnaire. After 1 year, the mean cumulative frequency of COPD-related hospitalizations and ED visits was 0.82 per patient in usual care and 0.48 per patient in disease management (difference, 0.34; 95% confidence interval, 0.15-0.52; P management reduced hospitalizations for cardiac or pulmonary conditions other than COPD by 49%, hospitalizations for all causes by 28%, and ED visits for all causes by 27% (P management program reduced hospitalizations and ED visits for COPD. Clinical trial registered with www.clinicaltrials.gov (NCT00126776).

  7. Evaluation of mupirocin ointment in control of central venous catheter related infections: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Rezaei J

    2009-09-01

    Full Text Available "n Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 st1":*{behavior:url(#ieooui } /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Central venous catheter (CVC related infections are important complications of cathter application. This study assessed the usefulness of mupirocin in prevention and control of these infections."n"nMethods: In this randomized clinical trial, consecutive surgical patients requiring central venous catheter (for more than 2 days in Amir-Alam Hospital from 2006-2008 were enrolled. Patients were divided in two groups; in "case group" patients received topical mupirocin 2% every 48 hours at the time of insertion of catheter and dressing change and for "control group" mupirocin was not used. All of the patients received chlorhexidine and enoxoparin as complementary treatments. Two groups were comparable in regard of age, sex and risk factors."n"nResults: One hundred eighteen patients enrolled in the study (57 in case and 61 in control group completed the study. 84 catheters in case group and 88 catheters in control group were inserted. The catheters in 90% of patients were inserted in jugular vein. At the end of study 29(16.8% patients (16 in control versus 13 in case group had catheter colonization (p=NS. Catheter related bloodstream infection was observed in 16(9.3% patients (6 in

  8. Generalisability of an online randomised controlled trial: an empirical analysis.

    Science.gov (United States)

    Wang, Cheng; Mollan, Katie R; Hudgens, Michael G; Tucker, Joseph D; Zheng, Heping; Tang, Weiming; Ling, Li

    2018-02-01

    Investigators increasingly use online methods to recruit participants for randomised controlled trials (RCTs). However, the extent to which participants recruited online represent populations of interest is unknown. We evaluated how generalisable an online RCT sample is to men who have sex with men in China. Inverse probability of sampling weights (IPSW) and the G-formula were used to examine the generalisability of an online RCT using model-based approaches. Online RCT data and national cross-sectional study data from China were analysed to illustrate the process of quantitatively assessing generalisability. The RCT (identifier NCT02248558) randomly assigned participants to a crowdsourced or health marketing video for promotion of HIV testing. The primary outcome was self-reported HIV testing within 4 weeks, with a non-inferiority margin of -3%. In the original online RCT analysis, the estimated difference in proportions of HIV tested between the two arms (crowdsourcing and health marketing) was 2.1% (95% CI, -5.4% to 9.7%). The hypothesis that the crowdsourced video was not inferior to the health marketing video to promote HIV testing was not demonstrated. The IPSW and G-formula estimated differences were -2.6% (95% CI, -14.2 to 8.9) and 2.7% (95% CI, -10.7 to 16.2), with both approaches also not establishing non-inferiority. Conducting generalisability analysis of an online RCT is feasible. Examining the generalisability of online RCTs is an important step before an intervention is scaled up. NCT02248558. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  9. Rural providers’ access to online resources: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jonathan D. Eldredge

    2016-01-01

    Full Text Available Objective: The research determined the usage and satisfaction levels with one of two point-of-care (PoC resources among health care providers in a rural state. Methods: In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants’ attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA, paired t tests, and Cohen’s d statistic to compare pre- and post-study effects sizes. Results: Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to ‘‘about right amounts of information’’ at the completion of the study. DynaMed users reported a Cohen’s d increase of þ1.50 compared to AccessMedicine users’ reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen’s d. Conclusion: Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine.

  10. Dextrose Prolotherapy for Knee Osteoarthritis: A Randomized Controlled Trial

    Science.gov (United States)

    Rabago, David; Patterson, Jeffrey J.; Mundt, Marlon; Kijowski, Richard; Grettie, Jessica; Segal, Neil A.; Zgierska, Aleksandra

    2013-01-01

    PURPOSE Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. METHODS Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. RESULTS No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. CONCLUSIONS Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises. PMID:23690322

  11. Rural providers' access to online resources: a randomized controlled trial

    Science.gov (United States)

    Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

    2016-01-01

    Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

  12. ASSESSMENT OF AMLODIPINE ANTIHYPERTENSIVE EFFECT HOMOGENEITY IN CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    V. M. Gorbunov

    2016-01-01

    Full Text Available Aim. To compare influence of amlodipine and spirapril on ambulatory blood pressure profile, including antihypertensive effect smoothness in patients with arterial hypertension (HT.Methods. 39 patients (aged 53,7±10,0 y.o. with HT were included in the open, randomized, cross-over study, 30 patients completed study. The duration of every therapies was 4 weeks, initial control period and wash-out period between therapies lasted 1 week. The initial daily dose of amlodipine was 5 mg, standard dose of spirapril (6 mg/daily was not changed during the trial. After 1-2 weeks of treatment amlodipine dose was increased up to 10 mg/daily as well as dihydrochlorothiazide was added, if necessary. Ambulatory blood pressure monitoring (ABPM was performed initially and at the end of both therapies.Results. Both drugs demonstrated good antihypertensive effect according to ABPM data. Decrease of systolic/diastolic blood pressure was 11,2±1,8/7,6±1,2 mm Hg in amlodipine therapy and 10,0±1,8/7,1±1,2 in spirapril therapy (p<0,0001. The smoothness indexes (SI were 0,65/0,45 and 0,55/0,45, respectively, differences between two therapies were not significant. However the individual analysis of the SI distribution (with SI=0,5 as a satisfactory criterion, showed that antihypertensive effect smoothness is better in amlodipine therapy than this in spirapril one.Conclusion. Amlodipine has prominent as well as smooth antihypertensive effect, that gives it advantages in the long-term antihypertensive therapy.

  13. 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.

  14. Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

    Science.gov (United States)

    Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

    2018-05-01

    The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. Attrition in longitudinal randomized controlled trials: home visits make a difference

    Directory of Open Access Journals (Sweden)

    Peterson Janey C

    2012-11-01

    Full Text Available Abstract Background Participant attrition in longitudinal studies can introduce systematic bias, favoring participants who return for follow-up, and increase the likelihood that those with complications will be underestimated. Our aim was to examine the effectiveness of home follow-up (Home F/U to complete the final study evaluation on potentially “lost” participants by: 1 evaluating the impact of including and excluding potentially “lost” participants (e.g., those who required Home F/U to complete the final evaluation on the rates of study complications; 2 examining the relationship between timing and number of complications on the requirement for subsequent Home F/U; and 3 determining predictors of those who required Home F/U. Methods We used data from a randomized controlled trial (RCT conducted from 1991–1994 among coronary artery bypass graft surgery patients that investigated the effect of High mean arterial pressure (MAP (intervention vs. Low MAP (control during cardiopulmonary bypass on 5 complications: cardiac morbidity/mortality, neurologic morbidity/mortality, all-cause mortality, neurocognitive dysfunction and functional decline. We enhanced completion of the final 6-month evaluation using Home F/U. Results Among 248 participants, 61 (25% required Home F/U and the remaining 187 (75% received Routine F/U. By employing Home F/U, we detected 11 additional complications at 6 months: 1 major neurologic complication, 6 cases of neurocognitive dysfunction and 4 cases of functional decline. Follow-up of 61 additional Home F/U participants enabled us to reach statistical significance on our main trial outcome. Specifically, the High MAP group had a significantly lower rate of the Combined Trial Outcome compared to the Low MAP group, 16.1% vs. 27.4% (p=0.032. In multivariate analysis, participants who were ≥ 75 years (OR=3.23, 95% CI 1.52-6.88, p=0.002 or on baseline diuretic therapy (OR=2.44, 95% CI 1.14-5.21, p=0.02 were more

  16. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    Directory of Open Access Journals (Sweden)

    Rahu Mati

    2008-08-01

    Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may

  17. A general method for handling missing binary outcome data in randomized controlled trials

    OpenAIRE

    Jackson, Dan; White, Ian R; Mason, Dan; Sutton, Stephen

    2014-01-01

    Aims The analysis of randomized controlled trials with incomplete binary outcome data is challenging. We develop a general method for exploring the impact of missing data in such trials, with a focus on abstinence outcomes. Design We propose a sensitivity analysis where standard analyses, which could include ‘missing = smoking’ and ‘last observation carried forward’, are embedded in a wider class of models. Setting We apply our general method to data from two smoking cessation trials. Partici...

  18. Behavioral insights and business taxation: Evidence from two randomized controlled trials

    OpenAIRE

    Biddle, Nicholas; Fels, Katja; Sinning, Mathias

    2017-01-01

    This paper presents the findings of two Randomized Controlled Trials (RCTs) that were conducted in collaboration with the Australian Taxation Office (ATO). The first trial tests the effect of changes to letters (timing, social norms, color, and provision of information about charitable donations) on response rates of businesses, the timing of payments and the amount of tax debt payments. The second trial consists of two parts. The first part aims to raise awareness of the relevance of tax deb...

  19. Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis

    OpenAIRE

    Carter, Anouska; Humphreys, Liam; Snowdon, Nicky; Sharrack, Basil; Daley, Amanda; Petty, Jane; Woodroofe, Nicola; Saxton, John

    2015-01-01

    Background The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-scale randomised controlled trials. The main purpose of this report is to provide a detailed outline of recruitment strategies, rates and estimated costs in the Exercise Intervent...

  20. Lessons in participant retention in the course of a randomized controlled clinical trial.

    Science.gov (United States)

    Idoko, Olubukola T; Owolabi, Olumuyiwa A; Odutola, Aderonke A; Ogundare, Olatunde; Worwui, Archibald; Saidu, Yauba; Smith-Sanneh, Alison; Tunkara, Abdoulie; Sey, Gibbi; Sanyang, Assan; Mendy, Philip; Ota, Martin O C

    2014-10-09

    Clinical trials are increasingly being conducted as new products seek to enter the market. Deployment of such interventions is based on evidence obtained mainly from the gold standard of randomized controlled clinical trials (RCCT). A crucial factor in the ability of RCCTs to provide credible and generalisable data is sample size and retention of the required number of subjects at completion of the follow-up period. However, recruitment and retention in clinical trials are hindered by prevalent peculiar challenges in Africa that need to be circumvented. This article shares experiences from a phase II trial that recorded a high retention rate at 14 months follow-up at a new clinical trial site. Mothers bringing children less than two months of age to the health facility were given information and invited to have their child enrolled if the inclusion criteria were fulfilled. Participants were enrolled over 8 months. Trial procedures, duration and risks/benefits were painstakingly and sequentially explained to the communities, parents and relevant relatives before and during the trial period. The proportions of participants that completed or did not complete the trial were analyzed including the reasons for failure to complete all trial procedures. 1044 individuals received information regarding the trial of which 371 returned for screening. 300 (81%) of them who fulfilled the inclusion criteria and did not meet any exclusion criteria were enrolled and 94% of these completed the trial. Consent withdrawal was the main reason for not completing the trial largely (75%) due to the father not being involved at the point of consenting or parents no longer being comfortable with blood sampling. Participant retention in clinical trials remains a crucial factor in ensuring generalisability of trial data. Appropriate measures to enhance retention should include continuous community involvement in the process, adequate explanation of trial procedures and risks/benefits; and

  1. [Wuling Capsule for climacteric patients with depression and anxiety state: a randomized, positive parallel controlled trial].

    Science.gov (United States)

    Wang, Xing-juan; Li, Ji; Zou, Qin-di; Jin, Ling

    2009-11-01

    The incidence of menopausal anxiety and depression is increasing. It can induce and aggravate a variety of somatic symptoms. Despite of the good effects of psychotropic drugs on the disease, patients' compliance is poor. Therefore, it is necessary to find a drug which is practical, effective, and easy for patients to take. To evaluate the efficacy of Wuling Capsule (WC), a Chinese herbal medicine, in treatment of female climacteric syndrome with depression and anxiety state. A total of 96 outpatients of female climacteric syndrome from Department of Gynecology of Integrated Traditional Chinese and Western Medicine, Huashan Hospital, Fudan University, Department of Gynecology of Traditional Chinese Medicine, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, and Department of Traditional Chinese Medicine, Obstetrics and Gynecology Hospital, Fudan University were included. The study was designed as a randomized, positive drug parallel controlled trial. The patients were divided into WC group (64 cases) and control group (32 cases) and were orally administered Wuling Capsule and Gengnianan Tablet, respectively. The efficacy was evaluated with Kupperman menopausal index (KMI), Self-rating Depression Scale (SDS), and Self-rating Anxiety Scale (SAS) before treatment, and after 3-week and 6-week treatment. The total response rate was 89.66% (52/58) in the WC group, which was superior to that in the control group [76.67% (23/30)]. Ridit test showed that there was a significant difference between the two groups (Pstate. Wuling Capsule is more effective to alleviate depression and anxiety as compared with Gengnianan Tablet.

  2. Complementary feeding: a Global Network cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pasha Omrana

    2011-01-01

    Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

  3. Household costs of dengue illness: secondary outcomes from a randomised controlled trial of dengue prevention in Guerrero state, Mexico.

    Science.gov (United States)

    Legorreta-Soberanis, José; Paredes-Solís, Sergio; Morales-Pérez, Arcadio; Nava-Aguilera, Elizabeth; Serrano-de Los Santos, Felipe René; Dimas-Garcia, Diana Lisseth; Ledogar, Robert J; Cockcroft, Anne; Andersson, Neil

    2017-05-30

    Dengue is a serious public health problem with an important economic impact. This study used data from a cluster randomised controlled trial of community mobilisation for dengue prevention to estimate the household costs of treatment of dengue illness. It examined the economic impact of the trial intervention in the three coastal regions of Mexico's Guerrero State. The 2010 baseline survey covered households in a random sample of 90 clusters in the coastal regions; the clusters were randomly allocated to intervention or control and re-surveyed in 2012. The surveys asked about dengue cases in the last 12 months, expenditures on their treatment, and work or school days lost by patients and care givers. We did not assign monetary value to days lost, since a lost day to a person of low earning power is of equal or higher value to that person than to one who earns more. The 12,312 households in 2010 reported 1020 dengue cases in the last 12 months (1.9% of the sample population). Most (78%) were ambulatory cases, with a mean cost of USD 51 and 10.8 work/school days, rising to USD 96 and 11.4 work/school days if treated by a private physician. Hospitalised cases cost USD 28-94 in government institutions and USD 392 in private hospitals (excluding additional inpatient charges), as well as 9.6-17.3 work/school days. Dengue cases cost households an estimated 412,825 work/school days throughout the three coastal regions. In the follow up survey, 6.1% (326/5349) of households in intervention clusters and 7.9% (405/5139) in control clusters reported at least one dengue case. The mean of days lost per case was similar in intervention and control clusters, but the number of days lost from dengue and all elements of costs for dengue cases per 1000 population were lower in intervention clusters. If the total population of the three coastal regions had received the intervention, some 149,401 work or school days lost per year could have been prevented. The economic effect of

  4. End-tidal control vs. manually controlled minimal-flow anesthesia: a prospective comparative trial.

    Science.gov (United States)

    Wetz, A J; Mueller, M M; Walliser, K; Foest, C; Wand, S; Brandes, I F; Waeschle, R M; Bauer, M

    2017-11-01

    To ensure safe general anesthesia, manually controlled anesthesia requires constant monitoring and numerous manual adjustments of the gas dosage, especially for low- and minimal-flow anesthesia. Oxygen flow-rate and administration of volatile anesthetics can also be controlled automatically by anesthesia machines using the end-tidal control technique, which ensures constant end-tidal concentrations of oxygen and anesthetic gas via feedback and continuous adjustment mechanisms. We investigated the hypothesis that end-tidal control is superior to manually controlled minimal-flow anesthesia (0.5 l/min). In this prospective trial, we included 64 patients undergoing elective surgery under general anesthesia. We analyzed the precision of maintenance of the sevoflurane concentration (1.2-1.4%) and expiratory oxygen (35-40%) and the number of necessary adjustments. Target-concentrations of sevoflurane and oxygen were maintained at more stable levels with the use of end-tidal control (during the first 15 min 28% vs. 51% and from 15 to 60 min 1% vs. 19% deviation from sevoflurane target, P tidal oxygen (5, IQR 3-6). The target-concentrations were reached earlier with the use of end-tidal compared with manual controlled minimal-flow anesthesia but required slightly greater use of anesthetic agents (6.9 vs. 6.0 ml/h). End-tidal control is a superior technique for setting and maintaining oxygen and anesthetic gas concentrations in a stable and rapid manner compared with manual control. Consequently, end-tidal control can effectively support the anesthetist. © 2017 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  5. Meditation awareness training for the treatment of workaholism: A controlled trial.

    Science.gov (United States)

    Van Gordon, William; Shonin, Edo; Dunn, Thomas J; Garcia-Campayo, Javier; Demarzo, Marcelo M P; Griffiths, Mark D

    2017-06-01

    Background and aims Workaholism is a form of behavioral addiction that can lead to reduced life and job satisfaction, anxiety, depression, burnout, work-family conflict, and impaired productivity. Given the number of people affected, there is a need for more targeted workaholism treatments. Findings from previous case studies successfully utilizing second-generation mindfulness-based interventions (SG-MBIs) for treating behavioral addiction suggest that SG-MBIs may be suitable for treating workaholism. This study conducted a controlled trial to investigate the effects of an SG-MBI known as meditation awareness training (MAT) on workaholism. Methods Male and female adults suffering from workaholism (n = 73) were allocated to MAT or a waiting-list control group. Assessments were performed at pre-, post-, and 3-month follow-up phases. Results MAT participants demonstrated significant and sustained improvements over control-group participants in workaholism symptomatology, job satisfaction, work engagement, work duration, and psychological distress. Furthermore, compared to the control group, MAT participants demonstrated a significant reduction in hours spent working but without a decline in job performance. Discussion and conclusions MAT may be a suitable intervention for treating workaholism. Further controlled intervention studies investigating the effects of SG-MBIs on workaholism are warranted.

  6. A Randomized Trial of Probation Case Management for Drug-Involved Women Offenders

    Science.gov (United States)

    Guydish, Joseph; Chan, Monica; Bostrom, Alan; Jessup, Martha A.; Davis, Thomas B.; Marsh, Cheryl

    2011-01-01

    This article reports findings from a clinical trial of a probation case management (PCM) intervention for drug-involved women offenders. Participants were randomly assigned to PCM (n = 92) or standard probation (n = 91) and followed for 12 months using measures of substance abuse, psychiatric symptoms, social support, and service utilization.…

  7. Blinding in randomized control trials: the enigma unraveled.

    Directory of Open Access Journals (Sweden)

    Vartika Saxena

    2016-03-01

    Full Text Available The search for new treatments and testing of new ideas begins in the laboratory and then established in clinical research settings. Studies addressing the same therapeutic problem may produce conflicting results hence Randomised Clinical Trial is regarded as the most valid method for assessing the benefits and harms of healthcare interventions. The next challenge face by the medical community is the validity of such trials as theses tend to deviate from the truth because of various biases. For the avoidance of the same it has been suggested that the validity or quality of primary trials should be assessed under blind conditions. Thus blinding, is a crucial method for reducing bias in randomized clinical trials. Blinding can be defined as withholding information about the assigned interventions from people involved in the trial who may potentially be prejudiced by this knowledge. In this article we make an effort to define blinding, explain its chronology, hierarchy and discuss methods of blinding, its assessment, its possibility, un-blinding and finally the latest guidelines.

  8. Ultrasound guided injection of dexamethasone versus placebo for treatment of plantar fasciitis: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gilheany Mark F

    2010-07-01

    Full Text Available Abstract Background Plantar fasciitis is the most commonly reported cause of chronic pain beneath the heel. Management of this condition commonly involves the use of corticosteroid injection in cases where less invasive treatments have failed. However, despite widespread use, only two randomised trials have tested the effect of this treatment in comparison to placebo. These trials currently offer the best available evidence by which to guide clinical practice, though both were limited by methodological issues such as insufficient statistical power. Therefore, the aim of this randomised trial is to compare the effect of ultrasound-guided corticosteroid injection versus placebo for treatment of plantar fasciitis. Methods The trial will be conducted at the La Trobe University Podiatry Clinic and will recruit 80 community-dwelling participants. Diagnostic ultrasound will be used to diagnose plantar fasciitis and participants will be required to meet a range of selection criteria. Participants will be randomly allocated to one of two treatment arms: (i ultrasound-guided injection of the plantar fascia with 1 mL of 4 mg/mL dexamethasone sodium phosphate (experimental group, or (ii ultrasound-guided injection of the plantar fascia with 1 mL normal saline (control group. Blinding will be applied to participants and the investigator performing procedures, measuring outcomes and analysing data. Primary outcomes will be pain measured by the Foot Health Status Questionnaire and plantar fascia thickness measured by ultrasound at 4, 8 and 12 weeks. All data analyses will be conducted on an intention-to-treat basis. Conclusion This will be a randomised trial investigating the effect of dexamethasone injection on pre-specified treatment outcomes in people with plantar fasciitis. Within the parameters of this protocol, the trial findings will be used to make evidence-based recommendations regarding the use of corticosteroid injection for treatment of this

  9. An audit strategy for time-to-event outcomes measured with error: application to five randomized controlled trials in oncology.

    Science.gov (United States)

    Dodd, Lori E; Korn, Edward L; Freidlin, Boris; Gu, Wenjuan; Abrams, Jeffrey S; Bushnell, William D; Canetta, Renzo; Doroshow, James H; Gray, Robert J; Sridhara, Rajeshwari

    2013-10-01

    Measurement error in time-to-event end points complicates interpretation of treatment effects in clinical trials. Non-differential measurement error is unlikely to produce large bias [1]. When error depends on treatment arm, bias is of greater concern. Blinded-independent central review (BICR) of all images from a trial is commonly undertaken to mitigate differential measurement-error bias that may be present in hazard ratios (HRs) based on local evaluations. Similar BICR and local evaluation HRs may provide reassurance about the treatment effect, but BICR adds considerable time and expense to trials. We describe a BICR audit strategy [2] and apply it to five randomized controlled trials to evaluate its use and to provide practical guidelines. The strategy requires BICR on a subset of study subjects, rather than a complete-case BICR, and makes use of an auxiliary-variable estimator. When the effect size is relatively large, the method provides a substantial reduction in the size of the BICRs. In a trial with 722 participants and a HR of 0.48, an average audit of 28% of the data was needed and always confirmed the treatment effect as assessed by local evaluations. More moderate effect sizes and/or smaller trial sizes required larger proportions of audited images, ranging from 57% to 100% for HRs ranging from 0.55 to 0.77 and sample sizes between 209 and 737. The method is developed for a simple random sample of study subjects. In studies with low event rates, more efficient estimation may result from sampling individuals with events at a higher rate. The proposed strategy can greatly decrease the costs and time associated with BICR, by reducing the number of images undergoing review. The savings will depend on the underlying treatment effect and trial size, with larger treatment effects and larger trials requiring smaller proportions of audited data.

  10. ChroPac-Trial: Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial

    Directory of Open Access Journals (Sweden)

    Schlitt Hans

    2010-04-01

    Full Text Available Abstract Background A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of the gland. A multicentre randomised trial to confirm these results is needed. Methods/Design ChroPac aims to investigate differences in quality of life, mortality and morbidity during 24 months after surgery (duodenum-preserving pancreatic head resection versus pancreatoduodenectomy in patients with chronic pancreatitis of the pancreatic head. ChroPac is a randomised, controlled, observer and patient blinded multicentre surgical trial with two parallel comparison groups. The primary outcome measure will be the average quality of life during 24 months after surgery. Statistical analysis is based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison adjusting for age, centre and quality of life before surgery. Level of significance is set at 5% (two-sided and sample size (n = 100 per group is determined to assure a power of 90%. Discussion The ChroPac trial will explore important outcomes from different perspectives (e.g. surgeon, patient, health care system. Its pragmatic approach promises high external validity allowing a comprehensive evaluation of the surgical strategy for treatment of patients with chronic pancreatitis. Trial registration Controlled-trials.com ISRCTN38973832

  11. A randomised controlled trial among cleaners--effects on strength, balance and kinesiophobia

    DEFF Research Database (Denmark)

    Jørgensen, Marie Birk; Ektor-Andersen, John; Sjøgaard, Gisela

    2011-01-01

    , and kinesiophobia from CBTr. The improved strength, postural balance and kinesiophobia may improve the cleaners' tolerance for high physical work demands. Future studies should investigate the potential in the combination of PCT and CBTr in a workplace intervention. Current controlled trials ISRCTN96241850....... training (PCT, n = 95), Cognitive behavioural theory-based training (CBTr, n = 99) and Reference group (REF, n = 100). Interventions were conducted during work hours for an average of 1 hour/week. Muscle strength was measured by maximal voluntary contractions in trunk/extension, and shoulder abduction....../elevation. Postural balance was measured on a force platform. Kinesiophobia was measured with Tampa Scale for Kinesiophobia. Test and questionnaires were completed at baseline and at 3-month follow-up and analyses followed the intention-to-treat (ITT) principle with last observation carried forward in case of missing...

  12. Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial.

    Science.gov (United States)

    Babl, Franz E; Mackay, Mark T; Borland, Meredith L; Herd, David W; Kochar, Amit; Hort, Jason; Rao, Arjun; Cheek, John A; Furyk, Jeremy; Barrow, Lisa; George, Shane; Zhang, Michael; Gardiner, Kaya; Lee, Katherine J; Davidson, Andrew; Berkowitz, Robert; Sullivan, Frank; Porrello, Emily; Dalziel, Kim Marie; Anderson, Vicki; Oakley, Ed; Hopper, Sandy; Williams, Fiona; Wilson, Catherine; Williams, Amanda; Dalziel, Stuart R

    2017-02-13

    Bell's palsy or acute idiopathic lower motor neurone facial paralysis is characterized by sudden onset paralysis or weakness of the muscles to one side of the face controlled by the facial nerve. While there is high level evidence in adults demonstrating an improvement in the rate of complete recovery of facial nerve function when treated with steroids compared with placebo, similar high level studies on the use of steroids in Bell's palsy in children are not available. The aim of this study is to assess the utility of steroids in Bell's palsy in children in a randomised placebo-controlled trial. We are conducting a randomised, triple-blinded, placebo controlled trial of the use of prednisolone to improve recovery from Bell's palsy at 1 month. Study sites are 10 hospitals within the Australian and New Zealand PREDICT (Paediatric Research in Emergency Departments International Collaborative) research network. 540 participants will be enrolled. To be eligible patients need to be aged 6 months to Bell's palsy to one of the participating hospital emergency departments. Patients will be excluded in case of current use of or contraindications to steroids or if there is an alternative diagnosis. Participants will receive either prednisolone 1 mg/kg/day to a maximum of 50 mg/day or taste matched placebo for 10 days. The primary outcome is complete recovery by House-Brackmann scale at 1 month. Secondary outcomes include assessment of recovery using the Sunnybrook scale, the emotional and functional wellbeing of the participants using the Pediatric Quality of Life Inventory and Child Health Utility 9D Scale, pain using Faces Pain Scale Revised or visual analogue scales, synkinesis using a synkinesis assessment questionnaire and health utilisation costs at 1, 3 and 6 months. Participants will be tracked to 12 months if not recovered earlier. Data analysis will be by intention to treat with primary outcome presented as differences in proportions and an odds ratio

  13. Lay support for pregnant women with social risk: a randomised controlled trial

    Science.gov (United States)

    Kenyon, Sara; Jolly, Kate; Hemming, Karla; Hope, Lucy; Blissett, Jackie; Dann, Sophie-Anna; Lilford, Richard; MacArthur, Christine

    2016-01-01

    Objectives We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families. Design Prospective, pragmatic, individually randomised controlled trial. Setting 3 Maternity Trusts in West Midlands, UK. Participants Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded. Interventions POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms. Main outcome measures Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8–12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8–12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems. Results Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) −0.00, 95% CI (95% CI −0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD −0.79 (95% CI −1.56 to −0.02) was significantly better, although for all women recruited, no significant differences were seen (MD −0.59 (95% CI −1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group

  14. Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

    Directory of Open Access Journals (Sweden)

    Stephanie Coronado-Montoya

    Full Text Available A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.108 (87% of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88% concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7. Of 21 trial registrations, 13 (62% remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

  15. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.

    Science.gov (United States)

    O'Cathain, Alicia; Thomas, Kate J; Drabble, Sarah J; Rudolph, Anne; Goode, Jackie; Hewison, Jenny

    2014-06-01

    Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. A sequential mixed methods study with four components. (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews

  16. Effect of community based management in failure to thrive: randomised controlled trial

    Science.gov (United States)

    Wright, Charlotte M; Callum, Jane; Birks, Eileen; Jarvis, Stephen

    1998-01-01

    Objective: To evaluate the effectiveness of a health visitor led intervention for failure to thrive in children under 2 years old. Design: Controlled trial, randomised by primary care practice. Setting: Newcastle upon Tyne health district. Intervention: Structured health visitor management, with dietetic, paediatric, and social work input as required. Subjects: 229 children (120 in intervention practices and 109 in control practices) were identified as failing to thrive by population screening during the first 2 years of life. Follow up was by home visit of a research nurse and review of the childrens’ records at age 3 years. Main outcome measures: Follow up weight and height and number of routinely collected weights. Results: 95 of the 97 families offered intervention completed at least the initial assessment. At follow up, 187 (82%) records were reviewed, and these suggested that 15 (16%) controls were lost to follow up immediately after the screening weight was taken compared with only one child in the intervention group. In the 134 (58%) families who consented to home visits, children in the intervention group were significantly heavier and taller and were reported to have better appetites than childen in the control group, although both groups were equally satisfied by the services they had received. When the children were last weighed, 91 (76%) in the intervention group had recovered from their failure to thrive compared with 60 (55%) in the control group (Pfailure to thrive, health visitor intervention, with limited specialist support, can significantly improve growth compared with conventional management. Key messages Supporting health visitors in the recognition and management of children under 2 years of age with failure to thrive resulted in closer follow up and significantly better long term weight and height gain than conventional hospital based management In the control group, 15-30% of cases of failure to thrive remained unrecognised by the

  17. Acupuncture for treating polycystic ovary syndrome: guidance for future randomized controlled trials

    OpenAIRE

    Wu, Y; Robinson, N; Hardiman, PJ; Taw, MB; Zhou, J; Wang, FF; Qu, F

    2016-01-01

    Objective: To provide guidance for future randomized controlled trials (RCTs) based on a review concerning acupuncture for treating polycystic ovary syndrome (PCOS). Methods: A comprehensive literature search was conducted in October 2015 using MEDLINE, EMBASE, SCISEARCH, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Menstrual Disorders and Subfertility Group trials register, Allied and Complementary Medicine (AMED), China National Knowledge Infrastructure (CNKI), and...

  18. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial.

    LENUS (Irish Health Repository)

    Carney, John

    2010-10-01

    The transversus abdominis plane (TAP) block provides effective postoperative analgesia in adults undergoing major abdominal surgery. Its efficacy in children remains unclear, with no randomized clinical trials in this population. In this study, we evaluated its analgesic efficacy over the first 48 postoperative hours after appendectomy performed through an open abdominal incision, in a randomized, controlled, double-blind clinical trial.

  19. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  20. The challenge of recruiting patients into a placebo-controlled surgical trial

    DEFF Research Database (Denmark)

    Hare, Kristoffer B; Lohmander, L Stefan; Roos, Ewa M.

    2014-01-01

    BACKGROUND: Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics. Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo...

  1. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full

  2. Case Report Case Report

    African Journals Online (AJOL)

    User

    2013-03-26

    Mar 26, 2013 ... c Medicine and Palliative Cancer Care: A Case Report. Sanjoy Kumar Pal ... us complementary and alternative therapies for treatment about the .... controlled trials that homeopathy may be effective for the treatment of ...

  3. Collaborative care for depression in general practice: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Brinck-Claussen, Ursula Ødum; Curth, Nadja Kehler; Davidsen, Annette Sofie; Mikkelsen, John Hagel; Lau, Marianne Engelbrecht; Lundsteen, Merete; Csillag, Claudio; Christensen, Kaj Sparle; Hjorthøj, Carsten; Nordentoft, Merete; Eplov, Lene Falgaard

    2017-07-21

    Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection. The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis. If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in

  4. Lansoprazole for children with poorly controlled asthma: a randomized controlled trial.

    Science.gov (United States)

    Holbrook, Janet T; Wise, Robert A; Gold, Benjamin D; Blake, Kathryn; Brown, Ellen D; Castro, Mario; Dozor, Allen J; Lima, John J; Mastronarde, John G; Sockrider, Marianna M; Teague, W Gerald

    2012-01-25

    Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control. To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization. Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157). The primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control. The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for

  5. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Keeling Sally

    2008-05-01

    Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640

  6. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Evelim L F D Gomes

    Full Text Available The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma.A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20 or a treadmill group (TG; n = 16. Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO, maximum exercise testing (Bruce protocol and lung function.No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05. Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG.The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

  7. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Science.gov (United States)

    Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

  8. Recruitment of black and Latina women to a randomized controlled trial.

    Science.gov (United States)

    Martin, Anika; Negron, Rennie; Balbierz, Amy; Bickell, Nina; Howell, Elizabeth A

    2013-08-01

    Minority women are often not adequately represented in randomized controlled trials, limiting the generalizability of research trial results. We implemented a recruitment strategy for a postpartum depression prevention trial that utilized patient feedback to identify and understand the recruitment barriers of black and Latina postpartum women. Feedback on patients' reasons for trial refusal informed adaptations to the recruitment process. We calculated weekly recruitment rates and analyzed qualitative and quantitative data from patient refusals. Of the 668 women who were approached and completed the consent process, 540 enrolled in the trial and 128 declined participation. Over 52-weeks of recruitment, refusal rates decreased from 40% to 19%. A taxonomy of eight reasons for refusal derived from patient responses identified barriers to recruitment and generated targeted revisions to the recruitment message. A recruitment strategy designed to incorporate and respond to patient feedback improved recruitment of Black and Latina women to a clinical trial.

  9. The Paracetamol (Acetaminophen) In Stroke (PAIS) trial : a multicentre, randomised, placebo-controlled, phase III trial

    NARCIS (Netherlands)

    den Hertog, Heleen M.; van der Worp, H. Bart; van Gemert, H. Maarten A.; Algra, Ate; Kappelle, L. Jaap; Van Gijn, Jan; Koudstaal, Peter J.; Dippel, Diederik W. J.

    Background High body temperature in the first 12-24 h after stroke onset is associated with poor functional outcome. The Paracetamol (Acetaminophen) In Stroke (PAIS) trial aimed to assess whether early treatment with paracetamol improves functional outcome in patients with acute stroke by reducing

  10. 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...... 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...... 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....

  11. Randomized, Controlled Trial of CBT Training for PTSD Providers

    Science.gov (United States)

    2015-10-01

    PI, program manager, and two research assistants will guide the mixed-method coding, analysis, and synthesis of the three consultation data sources...A randomized clinical trial of eye movement desensitization and reprocessing (EMDR), fluoxetine , and pill placebo in the treatment of

  12. Beyond Randomized Controlled Trials in Attempted Suicide Research

    Science.gov (United States)

    Hatcher, Simon; Sharon, Cynthia; Coggan, Carol

    2009-01-01

    There is a lack of evidence about what is the best treatment for people who present to hospital after self harm. Most treatment trials have been small and involved unrepresentative groups of patients which result in inconclusive findings. Here we note some of the characteristics of attempted suicide which make it a difficult subject to study. We…

  13. A quality assessment of randomized controlled trial reports in endodontics.

    Science.gov (United States)

    Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

    2017-03-01

    To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  14. Using Guasha to treat musculoskeletal pain: A systematic review of controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Choi Sun-Mi

    2010-01-01

    Full Text Available Abstract Background Guasha is a therapeutic method for pain management using tools to scrape or rub the surface of the body to relieve blood stagnation. This study aims to systematically review the controlled clinical trials on the effectiveness of using Guasha to treat musculoskeletal pain. Methods We searched 11 databases (without language restrictions: MEDLINE, Allied and Complementary Medicine (AMED, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL, Korean Studies Information (KSI, DBPIA, Korea Institute of Science and Technology Information (KISTI, KoreaMed, Research Information Service System (RISS, China National Knowledge Infrastructure (CNKI and the Cochrane Library. The search strategy was Guasha (OR scraping AND pain. Risk of bias was assessed with the Cochrane criteria (i.e. sequence generation, blinding, incomplete outcome measures and allocation concealment. Results Five randomized controlled trials (RCTs and two controlled clinical trials (CCTs were included in the present study. Two RCTs compared Guasha with acupuncture in terms of effectiveness, while the other trials compared Guasha with no treatment (1 trial, acupuncture (4 trials, herbal injection (1 trial and massage or electric current therapy (1 trial. While two RCTs suggested favorable effects of Guasha on pain reduction and response rate, the quality of these RCTs was poor. One CCT reported beneficial effects of Guasha on musculoskeletal pain but had low methodological quality. Conclusion Current evidence is insufficient to show that Guasha is effective in pain management. Further RCTs are warranted and methodological quality should be improved.

  15. Arthrocentesis as initial treatment for temporomandibular joint arthropathy : A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L. M.; Huddleston Slater, J. J. R.; Stegenga, B.

    Objective: To determine the effectiveness of arthrocentesis compared to conservative treatment as initial treatment with regard to temporomandibular joint pain and mandibular movement. Patients and methods: In this randomized controlled trial, 80 patients with arthralgia of the TMJ (classified

  16. Randomised controlled trial of the efficacy of misoprostol used as a ...

    African Journals Online (AJOL)

    Randomised controlled trial of the efficacy of misoprostol used as a cervical ripening agent prior to termination of pregnancy in the first trimester. Eric T M de Jonge, Rachel Jewkes, Jonathan Levin, Helen Rees ...

  17. Medical prescription of heroin to treatment resistant heroin addicts: two randomised controlled trials

    NARCIS (Netherlands)

    van den Brink, Wim; Hendriks, Vincent M.; Blanken, Peter; Koeter, Maarten W. J.; van Zwieten, Barbara J.; van Ree, Jan M.

    2003-01-01

    OBJECTIVE: To determine whether supervised medical prescription of heroin can successfully treat addicts who do not sufficiently benefit from methadone maintenance treatment. DESIGN: Two open label randomised controlled trials. SETTING: Methadone maintenance programmes in six cities in the

  18. Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A.F.; Ven, van de J.; Merién, A.E.R.; Wit-Zuurendonk, de L.D.; Houterman, S.; Mol, B.W.J.; Oei, S.G.

    2012-01-01

    Objective To determine whether obstetric team training in a medical simulation centre improves the team performance and utilisation of appropriate medical technical skills of healthcare professionals. Design Cluster randomised controlled trial. Setting The Netherlands. Sample The obstetric

  19. Randomised Controlled Trial Study of the Effect of TENS and NSAID ...

    African Journals Online (AJOL)

    Randomised Controlled Trial Study of the Effect of TENS and NSAID (Opoid) Drug in the Management of Post Operative Gynaecological Pain. AAG Jimoh, LO Omokanye, GA Salaudeen, ZA Suleiman, K Durowade, EO Adewara ...

  20. Randomized controlled trial of the Pentax AWS, Glidescope, and Macintosh laryngoscopes in predicted difficult intubation.

    LENUS (Irish Health Repository)

    Malik, M A

    2009-11-01

    The purpose of this study was to determine the potential for the Pentax AWS and the Glidescope to reduce the difficulty of tracheal intubation in patients at increased risk for difficult tracheal intubation, in a randomized, controlled clinical trial.

  1. Ursodeoxycholic acid for treatment of primary sclerosing cholangitis: a placebo-controlled trial

    NARCIS (Netherlands)

    Beuers, U.; Spengler, U.; Kruis, W.; AYDEMIR, U.; WIEBECKE, B.; HELDWEIN, W.; WEINZIERL, M.; Pape, G. R.; Sauerbruch, T.; Paumgartner, G.

    1992-01-01

    The efficacy and safety of ursodeoxycholic acid for the treatment of primary sclerosing cholangitis were evaluated in a prospective, randomized, double-blind, placebo-controlled trial. Fourteen patients with primary sclerosing cholangitis documented by cholestatic serum enzyme pattern, liver

  2. Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial.

    NARCIS (Netherlands)

    Aardweg, M.T. van den; Boonacker, C.W.; Rovers, M.M.; Hoes, A.W.; Schilder, A.G.M.

    2011-01-01

    OBJECTIVE: To assess the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections. DESIGN: Open randomised controlled trial. SETTING: 11 general hospitals and two academic centres. PARTICIPANTS: 111 children aged 1-6 with recurrent upper respiratory tract

  3. A randomized controlled trial of daily sedation interruption in critically ill children

    NARCIS (Netherlands)

    Vet, N.J.; Wildt, S.N. de; Verlaat, C.W.; Knibbe, C.A.; Mooij, M.G.; Woensel, J.B. van; Rosmalen, J. van; Tibboel, D.; Hoog, M. de

    2016-01-01

    PURPOSE: To compare daily sedation interruption plus protocolized sedation (DSI + PS) to protocolized sedation only (PS) in critically ill children. METHODS: In this multicenter randomized controlled trial in three pediatric intensive care units in the Netherlands, mechanically ventilated critically

  4. A randomized controlled trial of daily sedation interruption in critically ill children

    NARCIS (Netherlands)

    Vet, Nienke J.; de Wildt, Saskia N.; Verlaat, Carin W. M.; Knibbe, Catherijne A. J.; Mooij, Miriam G.; van Woensel, Job B. M.; van Rosmalen, Joost; Tibboel, Dick; de Hoog, Matthijs

    2016-01-01

    To compare daily sedation interruption plus protocolized sedation (DSI + PS) to protocolized sedation only (PS) in critically ill children. In this multicenter randomized controlled trial in three pediatric intensive care units in the Netherlands, mechanically ventilated critically ill children with

  5. The effect of COPD severity and study duration on exacerbation outcome in randomized controlled trials

    NARCIS (Netherlands)

    Eriksson, Goran; Calverley, Peter M.; Jenkins, Christine R.; Anzueto, Antonio R.; Make, Barry J.; Lindberg, Magnus; Fageras, Malin; Postma, Dirkje S.

    2017-01-01

    Background: When discontinuation in COPD randomized controlled trials (RCTs) is unevenly distributed between treatments (differential dropout), the capacity to demonstrate treatment effects may be reduced. We investigated the impact of the time of differential dropout on exacerbation outcomes in

  6. Melodic intonation therapy in chronic aphasia: Evidence from a pilot randomized controlled trial

    NARCIS (Netherlands)

    I. van der Meulen (Ineke); W.M.E. van de Sandt-Koenderman (Mieke); Heijenbrok, M.H. (Majanka H.); E.G. Visch-Brink (Evy); Ribber, G.M. (Gerard M.)

    2016-01-01

    textabstractMelodic Intonation Therapy (MIT) is a language production therapy for severely nonfluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT) examining

  7. The use of placebo control in clinical trials: An overview of the ...

    African Journals Online (AJOL)

    The use of placebo control in clinical trials: An overview of the ethical issues involved for the protection of human research participants. ... A placebo looks exactly like the experimental drugs in every respect both in appearance and wrappings ...

  8. Sodium Restriction in Patients With CKD : A Randomized Controlled Trial of Self-management Support

    NARCIS (Netherlands)

    Meuleman, Yvette; Hoekstra, Tiny; Dekker, Friedo W.; Navis, Gerjan; Vogt, Liffert; van der Boog, Paul J. M.; Bos, Willem Jan W.; van Montfrans, Gert A.; van Dijk, Sandra

    Background: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. Study Design: Open randomized controlled trial. Setting & Participants: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands.

  9. A randomised controlled trial of early initiation of oral feeding after ...

    African Journals Online (AJOL)

    A randomised controlled trial of early initiation of oral feeding after Caesarean ... The outcome measures were rate of ileus symptoms, post operative presence of ... more rapid recovery and expressed their interest in earlier hospital discharge.

  10. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial

    Science.gov (United States)

    Jacobs, Ian J; Menon, Usha; Ryan, Andy; Gentry-Maharaj, Aleksandra; Burnell, Matthew; Kalsi, Jatinderpal K; Amso, Nazar N; Apostolidou, Sophia; Benjamin, Elizabeth; Cruickshank, Derek; Crump, Danielle N; Davies, Susan K; Dawnay, Anne; Dobbs, Stephen; Fletcher, Gwendolen; Ford, Jeremy; Godfrey, Keith; Gunu, Richard; Habib, Mariam; Hallett, Rachel; Herod, Jonathan; Jenkins, Howard; Karpinskyj, Chloe; Leeson, Simon; Lewis, Sara J; Liston, William R; Lopes, Alberto; Mould, Tim; Murdoch, John; Oram, David; Rabideau, Dustin J; Reynolds, Karina; Scott, Ian; Seif, Mourad W; Sharma, Aarti; Singh, Naveena; Taylor, Julie; Warburton, Fiona; Widschwendter, Martin; Williamson, Karin; Woolas, Robert; Fallowfield, Lesley; McGuire, Alistair J; Campbell, Stuart; Parmar, Mahesh; Skates, Steven J

    2016-01-01

    Summary Background Ovarian cancer has a poor prognosis, with just 40% of patients surviving 5 years. We designed this trial to establish the effect of early detection by screening on ovarian cancer mortality. Methods In this randomised controlled trial, we recruited postmenopausal women aged 50–74 years from 13 centres in National Health Service Trusts in England, Wales, and Northern Ireland. Exclusion criteria were previous bilateral oophorectomy or ovarian malignancy, increased risk of familial ovarian cancer, and active non-ovarian malignancy. The trial management system confirmed eligibility and randomly allocated participants in blocks of 32 using computer-generated random numbers to annual multimodal screening (MMS) with serum CA125 interpreted with use of the risk of ovarian cancer algorithm, annual transvaginal ultrasound screening (USS), or no screening, in a 1:1:2 ratio. The primary outcome was death due to ovarian cancer by Dec 31, 2014, comparing MMS and USS separately with no screening, ascertained by an outcomes committee masked to randomisation group. All analyses were by modified intention to screen, excluding the small number of women we discovered after randomisation to have a bilateral oophorectomy, have ovarian cancer, or had exited the registry before recruitment. Investigators and participants were aware of screening type. This trial is registered with ClinicalTrials.gov, number NCT00058032. Findings Between June 1, 2001, and Oct 21, 2005, we randomly allocated 202 638 women: 50 640 (25·0%) to MMS, 50 639 (25·0%) to USS, and 101 359 (50·0%) to no screening. 202 546 (>99·9%) women were eligible for analysis: 50 624 (>99·9%) women in the MMS group, 50 623 (>99·9%) in the USS group, and 101 299 (>99·9%) in the no screening group. Screening ended on Dec 31, 2011, and included 345 570 MMS and 327 775 USS annual screening episodes. At a median follow-up of 11·1 years (IQR 10·0–12·0), we diagnosed ovarian cancer in

  11. Outcomes of Video-Assisted Teaching for Latching in Postpartum Women: A Randomized Controlled Trial.

    Science.gov (United States)

    Sroiwatana, Suttikamon; Puapornpong, Pawin

    2018-04-25

    Latching is an important process of breastfeeding and should be taught and practiced by the postpartum mother. The objective is to compare latching outcomes between video-assisted and routine teaching methods among postpartum women. A randomized controlled trial was conducted. Postpartum women who had deliveries without complications were randomized into two groups: 14 cases in the video-assisted teaching group and 14 cases in a routine teaching group. In the first group, the mothers were taught breastfeeding benefits, latching methods, and breastfeeding positions and practiced breastfeeding in a controlled setting for a 30-minute period and watched a 6-minute video with consistent content. In the second group, the mothers were taught a normal 30-minute period and then practiced breastfeeding. In both groups, Latching on, Audible swallowing, the Type of nipples, Comfort, and Help (LATCH) scores were assessed at 24-32 and 48-56 hours after the breastfeeding teaching modals. Demographic data and LATCH scores were collected and analyzed. There were no statistically significant differences in the mothers' ages, occupations, marital status, religion, education, income, infants' gestational age, body mass index, nipple length, route of delivery, and time to first latching between the video-assisted and routine breastfeeding teaching groups. First and second LATCH score assessments had shown no significant differences between both breastfeeding teaching groups. The video-assisted breastfeeding teaching did not improve latching outcomes when it was compared with routine teaching.

  12. Coaching to Augment Mentoring to Achieve Faculty Diversity: A Randomized Controlled Trial.

    Science.gov (United States)

    Williams, Simon N; Thakore, Bhoomi K; McGee, Richard

    2016-08-01

    The Academy for Future Science Faculty (the Academy) is a novel coaching intervention for biomedical PhD students designed to address limitations in previous efforts to promote faculty diversity. Unlike traditional research mentoring, the Academy includes both group and individual coaching, coaches have no research or evaluation roles with the students, and it is based on social science theories. The authors present a qualitative case study of one of the coaching groups and provide statistical analyses indicating whether one year in the Academy effects students' perceptions of the achievability and desirability of an academic career. The authors tested (July 2012-July 2013), with Northwestern University ethical approval, the Academy via a longitudinal randomized controlled trial. Participants were 121 latter-stage biomedical PhD students. The authors collected data via questionnaires, interviews, and meeting recordings. The case study shows how group career coaching can effectively supplement traditional one-to-one research mentoring; provide new role models for underrepresented minority students; and provide theory-based lenses through which to engage in open conversations about race, gender, and science careers. Repeated-measures analysis of variance showed that perceived achievability increased in the Academy group from baseline to one-year follow-up (mean, 5.75 versus 6.39) but decreased in the control group (6.58 versus 5.81). Perceived desirability decreased significantly less (P coaching model can effectively supplement traditional research mentoring and promote persistence toward academic careers.

  13. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity

    Directory of Open Access Journals (Sweden)

    Birtwhistle Richard

    2003-12-01

    Full Text Available Abstract Background Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results and internal validity (reliability or accuracy of the results needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. Summary Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results and external validity (generalizability. The attempt to achieve methodological purity can

  14. Multicenter, randomized, controlled trial of virtual-reality simulator training in acquisition of competency in colonoscopy.

    Science.gov (United States)

    Cohen, Jonathan; Cohen, Seth A; Vora, Kinjal C; Xue, Xiaonan; Burdick, J Steven; Bank, Simmy; Bini, Edmund J; Bodenheimer, Henry; Cerulli, Maurice; Gerdes, Hans; Greenwald, David; Gress, Frank; Grosman, Irwin; Hawes, Robert; Mullin, Gerard; Mullen, Gerard; Schnoll-Sussman, Felice; Starpoli, Anthony; Stevens, Peter; Tenner, Scott; Villanueva, Gerald

    2006-09-01

    The GI Mentor is a virtual reality simulator that uses force feedback technology to create a realistic training experience. To define the benefit of training on the GI Mentor on competency acquisition in colonoscopy. Randomized, controlled, blinded, multicenter trial. Academic medical centers with accredited gastroenterology training programs. First-year GI fellows. Subjects were randomized to receive 10 hours of unsupervised training on the GI Mentor or no simulator experience during the first 8 weeks of fellowship. After this period, both groups began performing real colonoscopies. The first 200 colonoscopies performed by each fellow were graded by proctors to measure technical and cognitive success, and patient comfort level during the procedure. A mixed-effects model comparison between the 2 groups of objective and subjective competency scores and patient discomfort in the performance of real colonoscopies over time. Forty-five fellows were randomized from 16 hospitals over 2 years. Fellows in the simulator group had significantly higher objective competency rates during the first 100 cases. A mixed-effects model demonstrated a higher objective competence overall in the simulator group (P < .0001), with the difference between groups being significantly greater during the first 80 cases performed. The median number of cases needed to reach 90% competency was 160 in both groups. The patient comfort level was similar. Fellows who underwent GI Mentor training performed significantly better during the early phase of real colonoscopy training.

  15. A Mock Randomized Controlled Trial With Audience Response Technology for Teaching and Learning Epidemiology.

    Science.gov (United States)

    Baker, Philip R A; Francis, Daniel P; Cathcart, Abby

    2017-04-01

    The study's objective was to apply and assess an active learning approach to epidemiology and critical appraisal. Active learning comprised a mock, randomized controlled trial (RCT) conducted with learners in 3 countries. The mock trial consisted of blindly eating red Smarties candy (intervention) compared to yellow Smarties (control) to determine whether red Smarties increase happiness. Audience response devices were employed with the 3-fold purposes to produce outcome data for analysis of the effects of red Smarties, identify baseline and subsequent changes in participant's knowledge and confidence in understanding of RCTs, and assess the teaching approach. Of those attending, 82% (117 of 143 learners) participated in the trial component. Participating in the mock trial was a positive experience, and the use of the technology aided learning. The trial produced data that learners analyzed in "real time" during the class. The mock RCT is a fun and engaging approach to teaching RCTs and helping students to develop skills in critical appraisal.

  16. Mindfulness Meditation Training and Executive Control Network Resting State Functional Connectivity: A Randomized Controlled Trial.

    Science.gov (United States)

    Taren, Adrienne A; Gianaros, Peter J; Greco, Carol M; Lindsay, Emily K; Fairgrieve, April; Brown, Kirk Warren; Rosen, Rhonda K; Ferris, Jennifer L; Julson, Erica; Marsland, Anna L; Creswell, J David

    Mindfulness meditation training has been previously shown to enhance behavioral measures of executive control (e.g., attention, working memory, cognitive control), but the neural mechanisms underlying these improvements are largely unknown. Here, we test whether mindfulness training interventions foster executive control by strengthening functional connections between dorsolateral prefrontal cortex (dlPFC)-a hub of the executive control network-and frontoparietal regions that coordinate executive function. Thirty-five adults with elevated levels of psychological distress participated in a 3-day randomized controlled trial of intensive mindfulness meditation or relaxation training. Participants completed a resting state functional magnetic resonance imaging scan before and after the intervention. We tested whether mindfulness meditation training increased resting state functional connectivity (rsFC) between dlPFC and frontoparietal control network regions. Left dlPFC showed increased connectivity to the right inferior frontal gyrus (T = 3.74), right middle frontal gyrus (MFG) (T = 3.98), right supplementary eye field (T = 4.29), right parietal cortex (T = 4.44), and left middle temporal gyrus (T = 3.97, all p < .05) after mindfulness training relative to the relaxation control. Right dlPFC showed increased connectivity to right MFG (T = 4.97, p < .05). We report that mindfulness training increases rsFC between dlPFC and dorsal network (superior parietal lobule, supplementary eye field, MFG) and ventral network (right IFG, middle temporal/angular gyrus) regions. These findings extend previous work showing increased functional connectivity among brain regions associated with executive function during active meditation by identifying specific neural circuits in which rsFC is enhanced by a mindfulness intervention in individuals with high levels of psychological distress. Clinicaltrials.gov,NCT01628809.

  17. "MY PKU": increasing self-management in patients with phenylketonuria. A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jonkers Cora F

    2011-06-01

    Full Text Available Abstract Background Phenylketonuria (PKU is an autosomal recessive disorder of phenylalanine metabolism. The inability to convert phenylalanine (Phe into tyrosine causes Phe to accumulate in the body. Adherence to a protein restricted diet, resulting in reduced Phe levels, is essential to prevent cognitive decline. Frequent evaluation of plasma Phe levels and, if necessary, adjustment of the diet are the mainstay of treatment. We aimed to assess whether increased self-management of PKU patients and/or their parents is feasible and safe, by providing direct online access to blood Phe values without immediate professional guidance. Methods Thirty-eight patients aged ≥ 1 year participated in a 10 month randomized controlled trial. Patients were randomized into a study group (1 or a control group (2. Group 2 continued the usual procedure: a phone call or e-mail by a dietician in case of a deviant Phe value. Group 1 was given a personal "My PKU" web page with a graph of their recent and previous Phe values, online general information about the dietary treatment and the Dutch PKU follow-up guidelines, and a message-box to contact their dietician if necessary. Phe values were provided on "My PKU" without advice. Outcome measures were: differences in mean Phe value, percentage of values above the recommended range and Phe sample frequency, between a 10-month pre-study period and the study period in each group, and between the groups in both periods. Furthermore we assessed satisfaction of patients and/or parents with the 'My PKU' procedure of online availability. Results There were no significant differences in mean Phe value, percentage of values above recommended range or in frequency of blood spot sampling for Phe determination between the pre-study period and the study period in each group, nor between the 2 groups during the periods. All patients and/or parents expressed a high level of satisfaction with the new way of disease management

  18. Impact of a deferred recruitment model in a randomised controlled trial in primary care (CREAM study).

    Science.gov (United States)

    Shepherd, Victoria; Thomas-Jones, Emma; Ridd, Matthew J; Hood, Kerenza; Addison, Katy; Francis, Nick A

    2017-11-10

    Recruitment of participants is particularly challenging in primary care, with less than a third of randomised controlled trials (RCT) achieving their target within the original time frame. Participant identification, consent, randomisation and data collection can all be time-consuming. Trials recruiting an incident, as opposed to a prevalent, population may be particularly affected. This paper describes the impact of a deferred recruitment model in a RCT of antibiotics for children with infected eczema in primary care, which required the recruitment of cases presenting acutely. Eligible children were identified by participating general practitioners (GPs) and referred to a study research nurse, who then visited them at home. This allowed the consent and recruitment processes to take place outside the general practice setting. Information was recorded about patients who were referred and recruited, or if not, the reasons for non-recruitment. Data on recruitment challenges were collected through semi-structured interviews and questionnaires with a sample of participating GPs. Data were thematically analysed to identify key themes. Of the children referred to the study 34% (58/171) were not recruited - 48% (28/58) because of difficulties arranging a baseline visit within the defined time frame, 31% (18/58) did not meet the study inclusion criteria at the time of nurse assessment, and 21% (12/58) declined participation. GPs had positive views about the recruitment process, reporting that parents valued and benefitted from additional contact with a nurse. GPs felt that the deferred recruitment model did not negatively impact on the study. GPs and parents recognised the benefits of deferred recruitment, but these did not translate into enhanced recruitment of participants. The model resulted in the loss of a third of children who were identified by the GP as eligible, but not subsequently recruited to the study. If the potential for improving outcomes in primary care

  19. Study protocol: effect of playful training on functional abilities of older adults - a randomized controlled trial.

    Science.gov (United States)

    Jessen, Jari Due; Lund, Henrik Hautop

    2017-01-19

    Loss of functional capabilities due to inactivity is one of the most common reasons for fall accidents, and it has been well established that loss of capabilities can be effectively reduced by physical activity. Pilot studies indicate a possible improvement in functional abilities of community dwelling elderly as a result of short-term playing with an exergame system in the form of interactive modular tiles. Such playful training may be motivational to perform and viewed by the subjects to offer life-fulfilling quality, while providing improvement in physical abilities, e.g. related to prevent fall accidents. The RCT will test for a variety of health parameters of community-dwelling elderly playing on interactive modular tiles. The study will be a single blinded, randomized controlled trial with 60 community-dwelling adults 70+ years. The trial will consist an intervention group of 30 participants training with the interactive modular tiles, and a control group of 30 participants that will receive the usual care provided to non-patient elderly. The intervention period will be 12 weeks. The intervention group will perform group training (4-5 individuals for 1 h training session with each participant receiving 13 min training) on the interactive tiles twice a week. Follow-up tests include 6-min Walk Test (6MWT), the 8-ft Timed Up & Go Test (TUG), and the Chair-Stand Test (CS) from the Senior Fitness Test, along with balancing tests (static test on Wii Board and Line Walk test). Secondary outcomes related to adherence, motivation and acceptability will be investigated through semi-structured interviews. Data will be collected from pre- and post-tests. Data will be analyzed for statistically significant differences by checking that there is a Gaussian distribution and then using paired t-test, otherwise using Wilcoxon signed-rank test. "Intention to treat" analysis will be done. The trial tests for increased mobility, agility, balancing and general fitness of

  20. Myo-inositol effects in women with PCOS: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Vittorio Unfer1,

    2017-10-01

    Full Text Available Myo-inositol (MI supplementation in women with polycystic ovary syndrome (PCOS has been evaluated over the last years. Many hormonal and reproductive impairments associated with this disorder seem relieved by the supplement. The objective of the meta-analysis was to assess the effects of MI alone or combined with d-chiro-inositol (DCI on the endocrine and metabolic abnormalities of women with PCOS. Literature was retrieved from selected databases, MEDLINE, EMBASE, PubMed and Research Gate (up to November 2016. Only randomized controlled trials (RCTs investigating the effects of MI alone or combined with DdCI were reviewed. Nine RCTs involving 247 cases and 249 controls were included. Significant decreases in fasting insulin (SMD = −1.021 μU/mL, 95% CI: −1.791 to −0.251, P = 0.009 and homeostasis model assessment (HOMA index (SMD = −0.585, 95% CI: −1.145 to −0.025, P = 0.041 were identified after MI supplementation. The trial sequential analysis of insulin meta-analysis illustrates that the cumulative z-curve crossed the monitoring boundary, providing firm evidence of the intervention effect. A slight trend toward a reduction of testosterone concentration by MI with respect to controls was found (SMD = −0.49, 95% CI: −1.072 to 0.092, P = 0.099, whereas androstenedione levels remained unaffected. Throughout a subgroup’s meta-analysis, a significant increase in serum SHBG was observed only in those studies where MI was administered for at least 24 weeks (SMD = 0.425 nmol/L, 95% CI: 0.050–0.801, P = 0.026. These results highlight the beneficial effect of MI in improving the metabolic profile of women with PCOS, concomitantly reducing their hyperandrogenism.

  1. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Liv M

    2012-07-01

    Full Text Available Abstract Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity, mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost

  2. Comprehensive geriatric assessment for older adults admitted to hospital: meta-analysis of randomised controlled trials

    OpenAIRE

    Ellis, G.; Whitehead, M.A.; Robinson, D.; O'Neill, D.; Langhorne, P.

    2011-01-01

    Objective - To evaluate the effectiveness of comprehensive geriatric assessment in hospital for older adults admitted as an emergency.\\ud \\ud Search strategy - We searched the EPOC Register, Cochrane’s Controlled Trials Register, the Database of Abstracts of Reviews of Effects (DARE), Medline, Embase, CINAHL, AARP Ageline, and handsearched high yield journals.\\ud \\ud Selection criteria - Randomised controlled trials of comprehensive geriatric assessment (whether by mobile teams or in designat...

  3. Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial

    OpenAIRE

    Fulkerson, Jayne A.; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y.

    2015-01-01

    Background Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Methods Families (n?=?160 8-12-yea...

  4. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials

    OpenAIRE

    de Labra, Carmen; Guimaraes-Pinheiro, Christyanne; Maseda, Ana; Lorenzo, Trinidad; Mill?n-Calenti, Jos? C.

    2015-01-01

    Background Low physical activity has been shown to be one of the most common components of frailty, and interventions have been considered to prevent or reverse this syndrome. The purpose of this systematic review of randomized, controlled trials is to examine the exercise interventions to manage frailty in older people. Methods The PubMed, Web of Science, and Cochrane Central Register of Controlled Trials databases were searched using specific keywords and Medical Subject Headings for random...

  5. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

    OpenAIRE

    Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

    2009-01-01

    Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Onl...

  6. Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial.

    Science.gov (United States)

    Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Meade, Laurie; O'Callaghan, Nicole; Vallance, Shirley; Galt, Pauline; Rajbhandari, Dorrilyn; Rocha, Marcelo; Mehta, Sangeeta; Ferguson, Niall D; Hall, Richard; Fowler, Robert; Burns, Karen; Qushmaq, Ismael; Ostermann, Marlies; Heels-Ansdell, Diane; Cook, Deborah

    2013-02-01

    Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. The trial was conducted in 67 centers in 6 countries. A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P 10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Characteristics of study centers, research infrastructure, and experience

  7. Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bucur, Roxana C; Reid, Lauren S; Hamilton, Celeste J; Cummings, Steven R; Jamal, Sophie A

    2013-09-08

    Organic nitrates uncouple bone turnover, improve bone mineral density, and improve trabecular and cortical components of bone. These changes in turnover, strength and geometry may translate into an important reduction in fractures. However, before proceeding with a large fracture trial, there is a need to identify the nitrate formulation that has both the greatest efficacy (with regards to bone turnover markers) and gives the fewest headaches. Ascertaining which nitrate formulation this may be is the purpose of the current study. This will be an open-label randomized, controlled trial conducted at Women's College Hospital comparing five formulations of nitrates for their effects on bone turnover markers and headache. We will recruit postmenopausal women age 50 years or older with no contraindications to nitroglycerin. Our trial will consist of a run-in phase and a treatment phase. We will enroll 420 women in the run-in phase, each to receive all of the 5 potential treatments in random order for 2 days, each with a 2-day washout period between treatments. Those who tolerate all formulations will enter the 12-week treatment phase and be randomly assigned to one of five groups: 0.3 mg sublingual nitroglycerin tablet, 0.6 mg of the sublingual tablet, a 20 mg tablet of isosorbide mononitrate, a 160 mg nitroglycerin transdermal patch (used for 8 h), and 15 mg of nitroglycerin ointment as used in a previous trial by our group. We will continue enrolment until we have randomized 210 women or 35 women per group. Concentrations of bone formation (bone-specific alkaline phosphatase and procollagen type I N-terminal propeptide) and bone resorption (C-telopeptides of collagen crosslinks and N-terminal crosslinks of collagen) agents will be measured in samples taken at study entry (the start of the run in phase) and 12 weeks. Subjects will record the frequency and severity of headaches daily during the run-in phase and then monthly after that. We will use the 'multiple

  8. Early loading of plalatal implants (ortho-type II a prospective multicenter randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Gedrange Tomasz

    2007-09-01

    Full Text Available Abstract Background In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage. Methods/Design The intended study is designed as a prospective, multicenter randomized controlled trial (RCT, comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland. 124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard, whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement. The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone

  9. Fractional nonablative 1,540-nm laser resurfacing of atrophic acne scars. A randomized controlled trial with blinded response evaluation

    DEFF Research Database (Denmark)

    Hedelund, Lene; Moreau, Karen Estell R; Beyer, Ditte M

    2010-01-01

    as moderately or significantly improved. No differences were found in skin redness or pigmentation between before and after treatment. Patients experienced moderate pain, erythema, oedema, bullae, and crusts. No adverse effects were seen in untreated control areas. The nonablative 1,540-nm fractional laser......The efficacy of nonablative fractional laser resurfacing of acne scars has been described in case reports and uncontrolled trials. The present study is the first randomized controlled trial in this field. The aim of this study was to examine the efficacy and adverse effects of 1,540-nm nonablative...... fractional laser treatment of acne scars. Ten patients with acne scars were included. Two intraindividual areas of similar size and appearance within contralateral anatomical regions were randomized to (1) 3-monthly laser treatments with a StarLux 1,540-nm fractional handpiece, and (2) no treatment. Blinded...

  10. Effect of Providing Ankle-Foot Orthoses in Patients with Acute and Subacute Stroke: a Randomized Controlled Trial : A randomized controlled trial

    NARCIS (Netherlands)

    Nikamp-Simons, Corien D.M.; Buurke, Jaap H.; Van Der Palen, Job; Hermens, Hermie J.; Rietman, Johan S.; Ibánez, Jaime; Azorín, José María; Akay, Metin; Pons, José Luis

    2017-01-01

    Despite frequent application of ankle-foot orthoses (AFOs), little scientific evidence is available to guide AFO-provision early after stroke. A randomized controlled trial was conducted to study the effects of AFO-provision in (sub-) acute stroke patients. Primary aim: to study effects of the

  11. Inventory control in case of unknown demand and control parameters

    NARCIS (Netherlands)

    Janssen, E.

    2010-01-01

    This thesis deals with unknown demand and control parameters in inventory control. Inventory control involves decisions on what to order when and in what quantity. These decisions are based on information about the demand. Models are constructed using complete demand information; these models ensure

  12. Fundamental movement skills in preschoolers: a randomized controlled trial targeting object control proficiency.

    Science.gov (United States)

    Donath, L; Faude, O; Hagmann, S; Roth, R; Zahner, L

    2015-11-01

    Adequately developed fundamental movement skills, particularly object control dimensions, are considered essential to learn more complex movement patterns and to increase the likelihood to successfully participate in organized and non-organized sports during later years. Thus, the present randomized controlled trial aimed at improving object control dimensions at an early state in a kindergarten setting. Catching, throwing, kicking, rolling and stationary dribbling were assessed via gross motor development 2 (TGMD-2) testing in 41 normally developed preschoolers. On a cluster-randomized basis [strata: age, sex and body mass index (BMI)], three kindergartens were randomly assigned to an intervention group (n = 22, INT, age: 4.6 ± 1.0 years; BMI: 16.2 ± 1.1 kg/m(2) ) and three to a control group (n = 19, CON: age: 4.5 ± 1.2 years; BMI: 16.8 ± 1.2 kg/m(2) ). Twelve structured training sessions were given within 6 weeks (12 sessions). The total training volume was 330 min. Moderate time × group interaction were observed for the total sum score (Δ+22%, P = 0.05) and dribbling (Δ+41%, P = 0.002). Adjusting for baseline differences analyses of covariance did not affect these results. Interestingly, likely to most likely practically worthwhile effects were detected for the total sum score, catching and dribbling. Object control dimensions such as dribbling and catching that apparently rely on rhythmical movement patterns and anticipatory eye-hand coordination seem to benefit from short-term object control training. These skills are considered important for successful team-sport participation and appropriate sportive motor development. © 2015 John Wiley & Sons Ltd.

  13. Is paromomycin an effective and safe treatment against cutaneous leishmaniasis? A meta-analysis of 14 randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Dae Hyun Kim

    Full Text Available BACKGROUND: High cost, poor compliance, and systemic toxicity have limited the use of pentavalent antimony compounds (SbV, the treatment of choice for cutaneous leishmaniasis (CL. Paromomycin (PR has been developed as an alternative to SbV, but existing data are conflicting. METHODOLOGY/PRINCIPAL FINDINGS: We searched PubMed, Scopus, and Cochrane Central Register of Controlled Trials, without language restriction, through August 2007, to identify randomized controlled trials that compared the efficacy or safety between PR and placebo or SbV. Primary outcome was clinical cure, defined as complete healing, disappearance, or reepithelialization of all lesions. Data were extracted independently by two investigators, and pooled using a random-effects model. Fourteen trials including 1,221 patients were included. In placebo-controlled trials, topical PR appeared to have therapeutic activity against the old world and new world CL, with increased local reactions, when used with methylbenzethonium chloride (MBCL compared to when used alone (risk ratio [RR] for clinical cure, 2.58 versus 1.01: RR for local reactions, 1.60 versus 1.07. In SbV-controlled trials, the efficacy of topical PR was not significantly different from that of intralesional SbV in the old world CL (RR, 0.70; 95% confidence interval, 0.26-1.89, whereas topical PR was inferior to parenteral SbV in treating the new world CL (0.67; 0.54-0.82. No significant difference in efficacy was found between parenteral PR and parenteral SbV in the new world CL (0.88; 0.56-1.38. Systemic side effects were fewer with topical or parenteral PR than parenteral SbV. CONCLUSIONS/SIGNIFICANCE: Topical PR with MBCL could be a therapeutic alternative to SbV in selected cases of the old world CL. Development of new formulations with better efficacy and tolerability remains to be an area of future research.

  14. A pilot randomized controlled trial of EKG for neonatal resuscitation.

    Directory of Open Access Journals (Sweden)

    Anup Katheria

    Full Text Available The seventh edition of the American Academy of Pediatrics Neonatal Resuscitation Program recommends the use of a cardiac monitor in infants that need resuscitation. Previous trials have shown that EKG heart rate is available before pulse rate from a pulse oximeter. To date no trial has looked at how the availability of electrocardiogram (EKG affects clinical interventions in the delivery room.To determine whether the availability of an EKG heart rate value and tracing to the clinical team has an effect on physiologic measures and related interventions during the stabilization of preterm infants.Forty (40 premature infants enrolled in a neuro-monitoring study (The Neu-Prem Trial: NCT02605733 who had an EKG monitor available were randomized to have the heart rate information from the bedside EKG monitor either displayed or not displayed to the clinical team. Heart rate, oxygen saturation, FiO2 and mean airway pressure from a data acquisition system were recorded every 2 seconds. Results were averaged over 30 seconds and the differences analyzed using two-tailed t-test. Interventions analyzed included time to first change in FiO2, first positive pressure ventilation, first increase in airway pressure, and first intubation.There were no significant differences in time to clinical interventions between the blinded and unblinded group, despite the unblinded group having access to a visible heart rate at 66 +/- 20 compared to 114 +/- 39 seconds for the blinded group (p < .0001. Pulse rate from oximeter was lower than EKG heart rate during the first 2 minutes of life, but this was not significant.EKG provides an earlier, and more accurate heart rate than pulse rate from an oximeter during stabilization of preterm infants, allowing earlier intervention. All interventions were started earlier in the unblinded EKG group but these numbers were not significant in this small trial. Earlier EKG placement before pulse oximeter placement may affect other

  15. Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Overgaard Hans J

    2012-10-01

    Full Text Available Abstract Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA; dengue interventions (DEN; combined diarrhea and dengue interventions (DIADEN; and control (C. Schools were allocated publicly in each municipality (strata at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de

  16. Toward Semi-automated Assessment of Target Volume Delineation in Radiotherapy Trials: The SCOPE 1 Pretrial Test Case

    Energy Technology Data Exchange (ETDEWEB)

    Gwynne, Sarah, E-mail: Sarah.Gwynne2@wales.nhs.uk [Department of Clinical Oncology, Velindre Cancer Centre, Cardiff, Wales (United Kingdom); Spezi, Emiliano; Wills, Lucy [Department of Medical Physics, Velindre Cancer Centre, Cardiff, Wales (United Kingdom); Nixon, Lisette; Hurt, Chris [Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, Wales (United Kingdom); Joseph, George [Department of Diagnostic Radiology, Velindre Cancer Centre, Cardiff, Wales (United Kingdom); Evans, Mererid [Department of Clinical Oncology, Velindre Cancer Centre, Cardiff, Wales (United Kingdom); Griffiths, Gareth [Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, Wales (United Kingdom); Crosby, Tom [Department of Clinical Oncology, Velindre Cancer Centre, Cardiff, Wales (United Kingdom); Staffurth, John [Division of Cancer, School of Medicine, Cardiff University, Cardiff, Wales (United Kingdom)

    2012-11-15

    Purpose: To evaluate different conformity indices (CIs) for use in the analysis of outlining consistency within the pretrial quality assurance (Radiotherapy Trials Quality Assurance [RTTQA]) program of a multicenter chemoradiation trial of esophageal cancer and to make recommendations for their use in future trials. Methods and Materials: The National Cancer Research Institute SCOPE 1 trial is an ongoing Cancer Research UK-funded phase II/III randomized controlled trial of chemoradiation with capecitabine and cisplatin with or without cetuximab for esophageal cancer. The pretrial RTTQA program included a detailed radiotherapy protocol, an educational package, and a single mid-esophageal tumor test case that were sent to each investigator to outline. Investigator gross tumor volumes (GTVs) were received from 50 investigators in 34 UK centers, and CERR (Computational Environment for Radiotherapy Research) was used to perform an assessment of each investigator GTV against a predefined gold-standard GTV using different CIs. A new metric, the local conformity index (l-CI), that can localize areas of maximal discordance was developed. Results: The median Jaccard conformity index (JCI) was 0.69 (interquartile range, 0.62-0.70), with 14 of 50 investigators (28%) achieving a JCI of 0.7 or greater. The median geographical miss index was 0.09 (interquartile range, 0.06-0.16), and the mean discordance index was 0.27 (95% confidence interval, 0.25-0.30). The l-CI was highest in the middle section of the volume, where the tumor was bulky and more easily definable, and identified 4 slices where fewer than 20% of investigators achieved an l-CI of 0.7 or greater. Conclusions: The available CIs analyze different aspects of a gold standard-observer variation, with JCI being the most useful as a single metric. Additional information is provided by the l-CI and can focus the efforts of the RTTQA team in these areas, possibly leading to semi-automated outlining assessment.

  17. Toward Semi-automated Assessment of Target Volume Delineation in Radiotherapy Trials: The SCOPE 1 Pretrial Test Case

    International Nuclear Information System (INIS)

    Gwynne, Sarah; Spezi, Emiliano; Wills, Lucy; Nixon, Lisette; Hurt, Chris; Joseph, George; Evans, Mererid; Griffiths, Gareth; Crosby, Tom; Staffurth, John

    2012-01-01

    Purpose: To evaluate different conformity indices (CIs) for use in the analysis of outlining consistency within the pretrial quality assurance (Radiotherapy Trials Quality Assurance [RTTQA]) program of a multicenter chemoradiation trial of esophageal cancer and to make recommendations for their use in future trials. Methods and Materials: The National Cancer Research Institute SCOPE 1 trial is an ongoing Cancer Research UK-funded phase II/III randomized controlled trial of chemoradiation with capecitabine and cisplatin with or without cetuximab for esophageal cancer. The pretrial RTTQA program included a detailed radiotherapy protocol, an educational package, and a single mid-esophageal tumor test case that were sent to each investigator to outline. Investigator gross tumor volumes (GTVs) were received from 50 investigators in 34 UK centers, and CERR (Computational Environment for Radiotherapy Research) was used to perform an assessment of each investigator GTV against a predefined gold-standard GTV using different CIs. A new metric, the local conformity index (l-CI), that can localize areas of maximal discordance was developed. Results: The median Jaccard conformity index (JCI) was 0.69 (interquartile range, 0.62-0.70), with 14 of 50 investigators (28%) achieving a JCI of 0.7 or greater. The median geographical miss index was 0.09 (interquartile range, 0.06-0.16), and the mean discordance index was 0.27 (95% confidence interval, 0.25-0.30). The l-CI was highest in the middle section of the volume, where the tumor was bulky and more easily definable, and identified 4 slices where fewer than 20% of investigators achieved an l-CI of 0.7 or greater. Conclusions: The available CIs analyze different aspects of a gold standard–observer variation, with JCI being the most useful as a single metric. Additional information is provided by the l-CI and can focus the efforts of the RTTQA team in these areas, possibly leading to semi-automated outlining assessment.

  18. Acupuncture for alcohol withdrawal: a randomized controlled trial.

    Science.gov (United States)

    Trümpler, François; Oez, Suzan; Stähli, Peter; Brenner, Hans Dieter; Jüni, Peter

    2003-01-01

    Previous trials on acupuncture in alcohol addiction were in outpatients and focused on relapse prevention. Rates of dropout were high and interpretation of results difficult. We compared auricular laser and needle acupuncture with sham laser stimulation in reducing the duration of alcohol withdrawal. Inpatients undergoing alcohol withdrawal were randomly allocated to laser acupuncture (n = 17), needle acupuncture (n = 15) or sham laser stimulation (n = 16). Attempts were made to blind patients, therapists and outcome assessors, but this was not feasible for needle acupuncture. The duration of withdrawal symptoms (as assessed using a nurse-rated scale) was the primary outcome; the duration of sedative prescription was the secondary outcome. Patients randomized to laser and sham laser had identical withdrawal symptom durations (median 4 days). Patients randomized to needle stimulation had a shorter duration of withdrawal symptoms (median 3 days; P = 0.019 versus sham intervention), and tended to have a shorter duration of sedative use, but these differences diminished after adjustment for baseline differences. The data from this pilot trial do not suggest a relevant benefit of auricular laser acupuncture for alcohol withdrawal. A larger trial including adequate sham interventions is needed, however, to reliably determine the effectiveness of any type of auricular acupuncture in this condition.

  19. A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

    Science.gov (United States)

    Burns, Kara; Keating, Patrick; Free, Caroline

    2016-08-12

    Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom

  20. How do parents experience being asked to enter a child in a randomised controlled trial?

    Directory of Open Access Journals (Sweden)

    Young Bridget

    2009-02-01

    Full Text Available Abstract Background As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Discussion Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Summary Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future

  1. How do parents experience being asked to enter a child in a randomised controlled trial?

    Science.gov (United States)

    Shilling, Valerie; Young, Bridget

    2009-02-16

    As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enroll their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfillment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help

  2. Efficacy of sonographic and biological pleurodesis indicators of malignant pleural effusion (SIMPLE): protocol of a randomised controlled trial

    Science.gov (United States)

    Piotrowska, Hania E G; Yousuf, Ahmed; Kanellakis, Nikolaos I; Kagithala, Gayathri; Mohammed, Seid; Clifton, Lei; Corcoran, John P; Russell, Nicky; Dobson, Melissa; Miller, Robert F; Rahman, Najib M

    2017-01-01

    Introduction Malignant pleural effusion (MPE) is common and currently in UK there are an estimated 50 000 new cases of MPE per year. Talc pleurodesis remains one of the most popular methods for fluid control. The value of thoracic ultrasound (TUS) imaging, before and after pleurodesis, in improving the quality and efficacy of care for patients with MPE remains unknown. Additionally, biomarkers of successful pleurodesis including measurement of pleural fluid proteins have not been validated in prospective studies. The SIMPLE trial is an appropriately powered, multicentre, randomised controlled trial designed to assess ’by the patient bedside' use of TUS imaging and pleural fluid analysis in improving management of MPE. Methods and analysis 262 participants with a confirmed MPE requiring intervention will be recruited from hospitals in UK and The Netherlands. Participants will be randomised (1:1) to undergo either chest drain insertion followed by instillation of sterile talc, or medical thoracoscopy and simultaneous poudrage. The allocated procedure will be done while the patient is hospitalised, and within 3 days of randomisation. Following hospital discharge, participants will be followed up at 1, 3 and 12 months. The primary outcome measure is the length of hospital stay during initial hospitalisation. Ethics and dissemination The trial has received ethical approval from the South Central-Oxford C Research Ethics Committee (Reference number 15/SC/0600). The Trial Steering Committee includes an independent chair and members, and a patient representative. The trial results will be published in a peer-reviewed journal and presented at international conferences. Trial registration number ISRCTN: 16441661. PMID:29225889

  3. Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol.

    Science.gov (United States)

    Bonell, Chris; Mathiot, Anne; Allen, Elizabeth; Bevilacqua, Leonardo; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; Legood, Rosa; Scott, Stephen; Warren, Emily; Wiggins, Meg; Viner, Russell M

    2017-05-25

    randomised stratified for single-sex versus mixed-sex schools, school-level deprivation and measures of school attainment. The trial involves independent research and intervention teams and is supervised by a Trial Steering Committee and a Data Monitoring Committee. Current Controlled Trials, ISRCTN10751359 . Registered on 11 March 2014.

  4. A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial.

    Science.gov (United States)

    Cevallos, Myriam; Züllig, Stephanie; Christen, Andri; Meier, Brigitte E; Goetz, Martin; Coslovsky, Michael; Trelle, Sven

    2015-12-01

    Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc). This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial's sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure. We included 142 of 231 protocols in the final analysis (concept=78; ad hoc=64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval=0.10-0.58)) than in the concept arm (0.27 (0.06-0.50)), but the difference was not significant (p=0.67). The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law. A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines, examples and templates to ensure correct application. © The Author(s) 2015.

  5. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study

    Science.gov (United States)

    2014-01-01

    Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In ‘the peripheral’ model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In ‘the add-on’ model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally ‘the integral’ model played out in two ways. In ‘integral-in-theory’ studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In ‘integral-in-practice’ studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due

  6. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.

    Science.gov (United States)

    O'Cathain, Alicia; Goode, Jackie; Drabble, Sarah J; Thomas, Kate J; Rudolph, Anne; Hewison, Jenny

    2014-06-09

    Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In 'the peripheral' model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In 'the add-on' model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally 'the integral' model played out in two ways. In 'integral-in-theory' studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In 'integral-in-practice' studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research

  7. Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

    Science.gov (United States)

    Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

    2018-06-07

    Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

  8. Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

    Science.gov (United States)

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

    Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

  9. The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study): Is Severe Hypertension Just an Elevated Blood Pressure?

    NARCIS (Netherlands)

    Magee, Laura A.; von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E.; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Helewa, Michael; Hutton, Eileen; Koren, Gideon; Lee, Shoo K.; Logan, Alexander G.; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G.; Moutquin, Jean-Marie

    2016-01-01

    To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of less tight (target diastolic blood pressure [dBP] 100 mmHg) versus tight control (target dBP 85

  10. Headache : The placebo effects in the control groups in randomized clinical trials; An analysis of systematic reviews

    NARCIS (Netherlands)

    de Groot, Femke M.; Voogt-Bode, Annieke; Passchier, Jan; Berger, Marjolein Y.; Koes, Bart W.; Verhagen, Arianne P.

    Objective: The purpose of this study is to describe the effects in the placebo and "no treatment" arms in trials with headache patients. Method: This is a secondary analysis of randomized controlled trials from 8 systematic reviews and selected trials with a "no treatment" or placebo control group.

  11. A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

    2014-05-24

    The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

  12. Methodology Series Module 2: Case-control Studies.

    Science.gov (United States)

    Setia, Maninder Singh

    2016-01-01

    Case-Control study design is a type of observational study. In this design, participants are selected for the study based on their outcome status. Thus, some participants have the outcome of interest (referred to as cases), whereas others do not have the outcome of interest (referred to as controls). The investigator then assesses the exposure in both these groups. The investigator should define the cases as specifically as possible. Sometimes, definition of a disease may be based on multiple criteria; thus, all these points should be explicitly stated in case definition. An important aspect of selecting a control is that they should be from the same 'study base' as that of the cases. We can select controls from a variety of groups. Some of them are: General population; relatives or friends; and hospital patients. Matching is often used in case-control control studies to ensure that the cases and controls are similar in certain characteristics, and it is a useful technique to increase the efficiency of the study. Case-Control studies can usually be conducted relatively faster and are inexpensive - particularly when compared with cohort studies (prospective). It is useful to study rare outcomes and outcomes with long latent periods. This design is not very useful to study rare exposures. Furthermore, they may also be prone to certain biases - selection bias and recall bias.

  13. Effect of periodontal therapy on arterial structure and function among aboriginal australians: a randomized, controlled trial.

    Science.gov (United States)

    Kapellas, Kostas; Maple-Brown, Louise J; Jamieson, Lisa M; Do, Loc G; O'Dea, Kerin; Brown, Alex; Cai, Tommy Y; Anstey, Nicholas M; Sullivan, David R; Wang, Hao; Celermajer, David S; Slade, Gary D; Skilton, Michael R

    2014-10-01

    Observational studies and nonrandomized trials support an association between periodontal disease and atherosclerotic vascular disease. Both diseases occur frequently in Aboriginal Australians. We hypothesized that nonsurgical periodontal therapy would improve measures of arterial function and structure that are subclinical indicators of atherosclerotic vascular disease. This parallel-group, randomized, open label clinical trial enrolled 273 Aboriginal Australians aged ≥18 years with periodontitis. Intervention participants received full-mouth periodontal scaling during a single visit, whereas controls received no treatment. Prespecified primary end points measured 12-month change in carotid intima-media thickness, an indicator of arterial structure, and 3- and 12-month change in pulse wave velocity, an indicator of arterial function. ANCOVA used complete case data to evaluate treatment group differences. End points could be calculated for 169 participants with follow-up data at 3 months and 168 participants at 12 months. Intima-media thickness decreased significantly after 12 months in the intervention group (mean reduction=-0.023 [95% confidence interval {CI}, -0.038 to -0.008] mm) but not in the control group (mean increase=0.002 [95% CI, -0.017 to 0.022] mm). The difference in intima-media thickness change between treatment groups was statistically significant (-0.026 [95% CI, -0.048 to -0.003] mm; P=0.03). In contrast, there were no significant differences between treatment groups in pulse wave velocity at 3 months (mean difference, 0.06 [95% CI, -0.17 to 0.29] m/s; P=0.594) or 12 months (mean difference, 0.21 [95% CI, -0.01 to 0.43] m/s; P=0.062). Periodontal therapy reduced subclinical arterial thickness but not function in Aboriginal Australians with periodontal disease, suggesting periodontal disease and atherosclerosis are significantly associated. © 2014 American Heart Association, Inc.

  14. Intravenous nitroglycerin for external cephalic version: a randomized controlled trial.

    Science.gov (United States)

    Hilton, Jennifer; Allan, Bruce; Swaby, Cheryl; Wahba, Raouf; Wah, Raouf; Jarrell, John; Wood, Stephen; Ross, Sue; Tran, Quynh

    2009-09-01

    To estimate whether treatment with intravenous nitroglycerin for uterine relaxation increases the chance of successful external cephalic version. Two double-blind, randomized clinical trials were undertaken: one in nulliparous women and a second in multiparous women. Women presenting for external cephalic version at term were eligible to participate. The primary outcome was immediate success of external cephalic version. Other outcomes were presentation at delivery, cesarean delivery rate, and side effects and complications. Sample size calculations were based on a 100% increase in success of external cephalic version with a one-sided analysis and alpha=0.05 (80% power). In total, 126 women were recruited-82 in the nulliparous trial and 44 in the multiparous trial. Seven patients did not have external cephalic version before delivery but were included in the analysis of success of external cephalic version. One patient was lost to follow-up. The external cephalic version success rate for nulliparous patients was 24% (10 of 42) in patients who received nitroglycerin compared with 8% (3 of 40) in those who receive placebo (P=.04, one-sided Fisher exact test, odds ratio 3.85, lower bound 1.22). In multiparous patients, the external cephalic version success rate did not differ significantly between groups: 44% (10 of 23) in the nitroglycerin group compared with 43% (9 of 21) in the placebo group (P=.60). Treatment with intravenous nitroglycerin increased the rate of successful external cephalic version in nulliparous, but not in multiparous, women. Treatment with intravenous nitroglycerin appeared to be safe, but our numbers were too small to rule out rare serious adverse effects. I.

  15. A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis.

    Science.gov (United States)

    Corneli, Howard M; Zorc, Joseph J; Mahajan, Prashant; Majahan, Prashant; Shaw, Kathy N; Holubkov, Richard; Reeves, Scott D; Ruddy, Richard M; Malik, Baqir; Nelson, Kyle A; Bregstein, Joan S; Brown, Kathleen M; Denenberg, Matthew N; Lillis, Kathleen A; Cimpello, Lynn Babcock; Tsung, James W; Borgialli, Dominic A; Baskin, Marc N; Teshome, Getachew; Goldstein, Mitchell A; Monroe, David; Dean, J Michael; Kuppermann, Nathan

    2007-07-26

    Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited. We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score > or =6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events. Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, -1.3%; 95% confidence interval [CI], -9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was -5.3 for dexamethasone, as compared with -4.8 for placebo (absolute difference, -0.5; 95% CI, -1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes. In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.

  16. Assertive Community Treatment for alcohol dependence (ACTAD: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gilburt Helen

    2012-02-01

    Full Text Available Abstract Background Alcohol dependence is a significant and costly problem in the UK yet only 6% of people a year receive treatment. Current service provision based on the treatment of acute episodes of illness and emphasising personal choice and motivation results in a small proportion of these patients engaging with alcohol treatment. There is a need for interventions targeted at the population of alcohol dependent patients who are hard to engage in conventional treatment. Assertive Community Treatment (ACT, a model of care based on assertive outreach, has been used for treating patients with severe mental illnesses and presents a promising avenue for engaging patients with primary alcohol dependence. So far there has been little research on this. Methods/Design In this single blind exploratory randomised controlled trial, a total of 90 alcohol dependent participants will be recruited from community addiction services. After completing a baseline assessment, they will be assigned to one of two conditions: (1 ACT plus care as usual, or (2 care as usual. Those allocated to the ACT plus care as usual will receive the same treatment that is routinely provided by services, plus a trained key worker who will provide ACT. ACT comprises intensive and assertive contact at least once a week, over 50% of contacts in the participant's home or local community, and comprehensive case management across social and health care, for a period of one year. All participants will be followed up at 6 months and 12 months to assess outcome post randomisation. The primary outcome measures will be alcohol consumption: mean drinks per drinking day and percentage of days abstinent measured by the Time Line Follow Back interview. Secondary outcome measures will include severity of alcohol dependence, alcohol related problems, motivation to change, social network involvement, quality of life, therapeutic relationship and service use. Other outcome variables are treatment

  17. Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Overgaard, Hans J; Alexander, Neal; Mátiz, Maria Ines; Jaramillo, Juan Felipe; Olano, Victor Alberto; Vargas, Sandra; Sarmiento, Diana; Lenhart, Audrey; Seidu, Razak; Stenström, Thor Axel

    2012-10-03

    Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation. This is the first trial

  18. Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial.

    Science.gov (United States)

    Vergnes, Jean-Noel; Arrivé, Elise; Gourdy, Pierre; Hanaire, Hélène; Rigalleau, Vincent; Gin, Henri; Sédarat, Cyril; Dorignac, Georges; Bou, Christophe; Sixou, Michel; Nabet, Cathy

    2009-08-02

    Periodontitis is a common, chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients. However current evidence does not provide sufficient information on which to confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis. The DIAPERIO trial is an open-label, 13-week follow-up, randomized, controlled trial. The total target sample size is planned at 150 participants, with a balanced (1:1) treatment allocation (immediate treatment vs delayed treatment). Periodontal treatment will include full mouth non-surgical scaling and root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12%) and oral health instructions. The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups. The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies. Current Controlled Trials ISRCTN15334496.

  19. Clinical trials of homoeopathy.

    Science.gov (United States)

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

  20. Guided Web-Based Cognitive Behavior Therapy for Perfectionism: Results From Two Different Randomized Controlled Trials.

    Science.gov (United States)

    Rozental, Alexander; Shafran, Roz; Wade, Tracey D; Kothari, Radha; Egan, Sarah J; Ekberg, Linda; Wiss, Maria; Carlbring, Per; Andersson, Gerhard

    2018-04-26

    Perfectionism can become a debilitating condition that may negatively affect functioning in multiple areas, including mental health. Prior research has indicated that internet-based cognitive behavioral therapy can be beneficial, but few studies have included follow-up data. The objective of this study was to explore the outcomes at follow-up of internet-based cognitive behavioral therapy with guided self-help, delivered as 2 separate randomized controlled trials conducted in Sweden and the United Kingdom. In total, 120 participants randomly assigned to internet-based cognitive behavioral therapy were included in both intention-to-treat and completer analyses: 78 in the Swedish trial and 62 in the UK trial. The primary outcome measure was the Frost Multidimensional Perfectionism Scale, Concern over Mistakes subscale (FMPS CM). Secondary outcome measures varied between the trials and consisted of the Clinical Perfectionism Questionnaire (CPQ; both trials), the 9-item Patient Health Questionnaire (PHQ-9; Swedish trial), the 7-item Generalized Anxiety Disorder scale (GAD-7; Swedish trial), and the 21-item Depression Anxiety Stress Scale (DASS-21; UK trial). Follow-up occurred after 6 months for the UK trial and after 12 months for the Swedish trial. Analysis of covariance revealed a significant difference between pretreatment and follow-up in both studies. Intention-to-treat within-group Cohen d effect sizes were 1.21 (Swedish trial; 95% CI 0.86-1.54) and 1.24 (UK trial; 95% CI 0.85-1.62) for the FMPS CM. Furthermore, 29 (59%; Swedish trial) and 15 (43%; UK trial) of the participants met the criteria for recovery on the FMPS CM. Improvements were also significant for the CPQ, with effect sizes of 1.32 (Swedish trial; 95% CI 0.97-1.66) and 1.49 (UK trial; 95% CI 1.09-1.88); the PHQ-9, effect size 0.60 (95% CI 0.28-0.92); the GAD-7, effect size 0.67 (95% CI 0.34-0.99); and the DASS-21, effect size 0.50 (95% CI 0.13-0.85). The results are promising for the use of

  1. Pelvic Static Magnetic Stimulation to Control Urinary Incontinence in Older Women: A Randomized Controlled Trial

    Science.gov (United States)

    Wallis, Marianne C.; Davies, Elizabeth A.; Thalib, Lukman; Griffiths, Susan

    2012-01-01

    Objectives To determine the efficacy of non-invasive static magnetic stimulation (SMS) of the pelvic floor compared to placebo in the treatment of women aged 60 years and over with urinary incontinence for 6 months or more. Subjects and Methods A single-blinded randomized, placebo-controlled, parallel-group trial. Subjects were excluded if they had an implanted electronic device, had experienced a symptomatic urinary tract infection, or had commenced pharmacotherapy for the same in the previous 4 weeks, or if they were booked for pelvic floor or gynecological surgery within the next 3 months. Once written consent was obtained, subjects were randomly assigned to the active SMS group (n=50) or the placebo group (n=51). Treatment was an undergarment incorporating 15 static magnets of 800–1200 Gauss anterior, posterior, and inferior to the pelvis for at least 12 hours a day for 3 months. Placebo was the same protocol with inert metal disks replacing the magnets. Primary outcome measure was cessation of incontinence as measured by a 24-hour pad test. Secondary outcomes were frequency and severity of symptoms as measured by the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS-SF), the Incontinence Severity Index, a Bothersomeness Visual Analog scale, and a 24-hour bladder diary. Data were collected at baseline and 12 weeks later. Results There were no statistically significant differences between groups in any of the outcome measures from baseline to 12 weeks. Initial evidence of subjective improvement in the treatment group compared to the placebo group was not sustained with sensitivity analysis. Conclusion This study found no evidence that static magnets cure or decrease the symptoms of urinary incontinence. Additional work into the basic physics of the product and garment design is recommended prior to further clinical trials research. PMID:21817123

  2. Guidelines for randomised controlled trials investigating Chinese herbal medicine.

    Science.gov (United States)

    Flower, Andrew; Witt, Claudia; Liu, Jian Ping; Ulrich-Merzenich, Gudrun; Yu, He; Lewith, George

    2012-04-10

    ETHNOGRAPHIC RELEVANCE: Clinical trials investigating Chinese herbal medicine (CHM) have been frequently criticised for their lack of scientific rigour. As part of the GP-TCM project a team of experienced clinical researchers and CHM practitioners have developed clinical trial guidelines for CHM that combine an appreciation for traditional methods of practice with detailed and practical advice on research methodology. This paper presents an executive summary of this work. It introduces the practice of CHM and the key considerations that need to be addressed whilst researching this traditional medical system. These guidelines emphasise the importance of identifying best practice, and then developing and applying appropriate and rigorous research methodologies to investigate CHM as a whole system. It is hoped that this will encourage a thoughtful and meticulous process of investigation that will clarify the contribution that CHM can make to our future healthcare. Innovative new approaches are considered including the application of the new "omic" technologies and systems biology as a way of enhancing our understanding of traditional practice. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  3. Incomplete caries removal and indirect pulp capping in primary molars: a randomized controlled trial.

    Science.gov (United States)

    Bressani, Ana Eliza Lemes; Mariath, Adriela Azevedo Souza; Haas, Alex Nogueira; Garcia-Godoy, Franklin; de Araujo, Fernando Borba

    2013-08-01

    To compare the effect of incomplete caries removal (ICR) and indirect pulp capping (IPC) with calcium hydroxide (CH) or an inert material (wax) on color, consistency and contamination of the remaining dentin of primary molars. This double-blind, parallel-design, randomized controlled trial included 30 children presenting one primary molar with deep caries lesion. Children were randomly assigned after ICR to receive IPC with CH or wax. All teeth were then restored with resin composite. Baseline dentin color and consistency were evaluated after ICR, and dentin samples were collected for contamination analyses using scanning electron microscopy. After 3 months, restorations were removed and the three parameters were re-evaluated. In both groups, dentin became significantly darker after 3 months. No cases of yellow dentin were observed after 3 months with CH compared to 33.3% of the wax cases (P Contamination changed significantly over time in CH and wax without significant difference between groups. It was concluded that CH and wax arrested the carious process of the remaining carious dentin after indirect pulp capping, but CH showed superior dentin color and consistency after 3 months.

  4. A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depression.

    Science.gov (United States)

    Durkalski, Valerie; Wenle Zhao; Dillon, Catherine; Kim, Jaemyung

    2010-04-01

    Clinical trial investigators and sponsors invest vast amounts of resources and energy into conducting trials and often face daily challenges with data management, project management, and data quality control. Rather than waiting months for study progress reports, investigators need the ability to use real-time data for the coordination and management of study activities across all study team members including site investigators, oversight committees, data and safety monitoring boards, and medical safety monitors. Web-based data management systems are beginning to meet this need but what distinguishes one system from the other are user needs/requirements and cost. To illustrate the development and implementation of a web-based data and project management system for a multicenter clinical trial designed to test the superiority of repeated transcranial magnetic stimulation versus sham for the treatment of patients with major depression. The authors discuss the reasons for not using a commercially available system for this study and describe the approach to developing their own web-based system for the OPT-TMS study. Timelines, effort, system architecture, and lessons learned are shared with the hope that this information will direct clinical trial researchers and software developers towards more efficient, user-friendly systems. The developers use a combination of generic and custom application code to allow for the flexibility to adapt the system to the needs of the study. Features of the system include: central participant registration and randomization; secure data entry at the site; participant progress/study calendar; safety data reporting; device accounting; monitor verification; and user-configurable generic reports and built-in customized reports. Hard coding was more time-efficient to address project-specific issues compared with the effort of creating a generic code application. As a consequence of this strategy, the required maintenance of the system is

  5. [Immediate analgesic effect of wrist-ankle acupuncture for acute lumbago: a randomized controlled trial].

    Science.gov (United States)

    Su, Jiang-tao; Zhou, Qing-hui; Li, Rui; Zhang, Jie; Li, Wei-hong; Wang, Qiong

    2010-08-01

    To assess the immediate analgesic effect of wrist-ankle acupuncture on acute lumbago and the relationship between the analgesic effect and the expectation of patients. A randomized, single-blind, sham-controlled trial was designed. Sixty cases of acute lumbago were randomly divided into two groups, 30 cases in each one. In observation group, wrist-ankle acupuncture was adopted to the Lower 5 and Lower 6 bilaterally, no requirement of Deqi (arrival of qi). In control group, sham acupuncture was adopted. The treatment was applied once in either group, with the needles retained for 30 min. The Short-form McGill Pain Questionnaire (SF-MPQ) and the Modified-Modified Schober (MMS) test were used to assess the motion related pain and the situation of spinal flexion in 3 min before treatment and 5 min, 10 min, 15 min, during treatment and 30 min (needle removed), respectively. The Expectation and Treatment Credibility Scale (ETCS) was applied to analyze the relationship between the expectation of patients and the analgesic effect. The adverse reaction was recorded. There were no statistically significant differences in SF-MPQ, MMS and ETCS before treatment between two groups (all P>0.05). In 5 min after needles insertion, the scores of the items in SF-MPQ in observation group were lower than those in control group (P0.05). No adverse reaction was reported. Wrist-ankle acupuncture can reduce acute lumbago immediately and significantly. The higher the expectation on the analgesic effect of wrist-ankle acupuncture the patients have, the better the analgesic effect will be. This therapy is highly safe in the treatment.

  6. Population-level effects of automated smoking cessation help programs: a randomized controlled trial.

    Science.gov (United States)

    Borland, Ron; Balmford, James; Benda, Peter

    2013-03-01

    To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) onQ, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and onQ; and (v) a choice of either alone or the combined program. Australia, via a mix of internet and telephone contacts. A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources (n = 1335) or cold-contacted from internet panels (n = 2195). The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio (OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence (OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

  7. An integrated approach to consumer representation and involvement in a multicentre randomized controlled trial.

    Science.gov (United States)

    Langston, Anne L; McCallum, Marilyn; Campbell, Marion K; Robertson, Clare; Ralston, Stuart H

    2005-01-01

    Although, consumer involvement in individual studies is often limited, their involvement in guiding health research is generally considered to be beneficial. This paper outlines our experiences of an integrated relationship between the organisers of a clinical trial and a consumer organisation. The PRISM trial is a UK multicentre, randomized controlled trial comparing treatment strategies for Paget's disease of the bone. The National Association for the Relief of Paget's Disease (NARPD) is the only UK support group for sufferers of Paget's disease and has worked closely with the PRISM team from the outset. NARPD involvement is integral to the conduct of the trial and specific roles have included: peer-review; trial steering committee membership; provision of advice to participants, and promotion of the trial amongst Paget's disease patients. The integrated relationship has yielded benefits to both the trial and the consumer organisation. The benefits for the trial have included: recruitment of participants via NARPD contacts; well-informed participants; unsolicited patient advocacy of the trial; and interested and pro-active collaborators. For the NARPD and Paget's disease sufferers, benefits have included: increased awareness of Paget's disease; increased access to relevant health research; increased awareness of the NARPD services; and wider transfer of diagnosis and management knowledge to/from health care professionals. Our experience has shown that an integrated approach between a trial team and a consumer organisation is worthwhile. Adoption of such an approach in other trials may yield significant improvements in recruitment and quality of participant information flow. There are, however, resource implications for both parties.

  8. The informed consent process in randomised controlled trials: a nurse-led process.

    Science.gov (United States)

    Cresswell, Pip; Gilmour, Jean

    2014-03-01

    Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

  9. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

    International Nuclear Information System (INIS)

    Poh, Catherine F; Durham, J Scott; Brasher, Penelope M; Anderson, Donald W; Berean, Kenneth W; MacAulay, Calum E; Lee, J Jack; Rosin, Miriam P

    2011-01-01

    Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in

  10. Nonresponse bias in randomized controlled experiments in criminology: Putting the Queensland Community Engagement Trial (QCET) under a microscope.

    Science.gov (United States)

    Antrobus, Emma; Elffers, Henk; White, Gentry; Mazerolle, Lorraine

    2013-01-01

    The goal of this article is to examine whether or not the results of the Queensland Community Engagement Trial (QCET)-a randomized controlled trial that tested the impact of procedural justice policing on citizen attitudes toward police-were affected by different types of nonresponse bias. We use two methods (Cochrane and Elffers methods) to explore nonresponse bias: First, we assess the impact of the low response rate by examining the effects of nonresponse group differences between the experimental and control conditions and pooled variance under different scenarios. Second, we assess the degree to which item response rates are influenced by the control and experimental conditions. Our analysis of the QCET data suggests that our substantive findings are not influenced by the lo