Cohort profile: Pacific Islands Families (PIF) growth study, Auckland, New Zealand

OpenAIRE

Rush, E; Oliver, M; Plank, L D; Taylor, S; Iusitini, L; Jalili-Moghaddam, S; Savila, F; Paterson, J; Tautolo, E

2016-01-01

Purpose This article profiles a birth cohort of Pacific children participating in an observational prospective study and describes the study protocol used at ages 14?15?years to investigate how food and activity patterns, metabolic risk and family and built environment are related to rates of physical growth of Pacific children. Participants From 2000 to 2015, the Pacific Islands Families Study has followed, from birth, the growth and development of over 1000 Pacific children born in Auckland...

Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study.

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Kalmet, Pishtiwan H S; Meys, Guido; V Horn, Yvette Y; Evers, Silvia M A A; Seelen, Henk A M; Hustinx, Paul; Janzing, Heinrich; Vd Veen, Alexander; Jaspars, Coen; Sintenie, Jan Bernard; Blokhuis, Taco J; Poeze, Martijn; Brink, Peter R G

2018-02-02

The standard aftercare treatment in surgically treated trauma patients with fractures around or in a joint, known as (peri)- or intra-articular fractures of the lower extremities, is either non-weight bearing or partial weight bearing. We have developed an early permissive weight bearing post-surgery rehabilitation protocol in surgically treated patients with fractures of the lower extremities. In this proposal we want to compare our early permissive weight bearing protocol to the existing current non-weight bearing guidelines in a prospective comparative cohort study. The study is a prospective multicenter comparative cohort study in which two rehabilitation aftercare treatments will be contrasted, i.e. permissive weight bearing and non-weight bearing according to the AO-guideline. The study population consists of patients with a surgically treated fracture of the pelvis/acetabulum or a surgically treated (peri)- or intra-articular fracture of the lower extremities. The inclusion period is 12 months. The duration of follow up is 6 months, with measurements taken at baseline, 2,6,12 and 26 weeks post-surgery. ADL with Lower Extremity Functional Scale. Outcome variables for compliance, as measured with an insole pressure measurement system, encompass peak load and step duration. This study will investigate the (cost-) effectiveness of a permissive weight bearing aftercare protocol. The results will provide evidence whether a permissive weight bearing protocol is more effective than the current non-weight bearing protocol. The study is registered in the Dutch Trial Register ( NTR6077 ). Date of registration: 01-09-2016.

Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol

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van der Vlugt Maureen J

2011-02-01

Full Text Available Abstract Background Cerebral small vessel disease (SVD is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects with SVD become demented or get parkinsonism. This might be explained by the diversity of underlying pathology of both white matter lesions (WML and the normal appearing white matter (NAWM. Both cannot be properly appreciated with conventional MRI. Diffusion tensor imaging (DTI provides alternative information on microstructural white matter integrity. The association between SVD, its microstructural integrity, and incident dementia and parkinsonism has never been investigated. Methods/Design The RUN DMC study is a prospective cohort study on the risk factors and cognitive and motor consequences of brain changes among 503 non-demented elderly, aged between 50-85 years, with cerebral SVD. First follow up is being prepared for July 2011. Participants alive will be included and invited to the research centre to undergo a structured questionnaire on demographics and vascular risk factors, and a cognitive, and motor, assessment, followed by a MRI protocol including conventional MRI, DTI and resting state fMRI. Discussion The follow up of the RUN DMC study has the potential to further unravel the causes and possibly better predict the consequences of changes in white matter integrity in elderly with SVD by using relatively new imaging techniques. When proven, these changes might function as a surrogate endpoint for cognitive and motor function in future therapeutic trials. Our data could furthermore provide a better understanding of the pathophysiology of cognitive and motor disturbances in elderly with SVD. The execution and completion of the follow up of our study might ultimately unravel the role of SVD on the microstructural integrity of the white

Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol.

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van Norden, Anouk Gw; de Laat, Karlijn F; Gons, Rob Ar; van Uden, Inge Wm; van Dijk, Ewoud J; van Oudheusden, Lucas Jb; Esselink, Rianne Aj; Bloem, Bastiaan R; van Engelen, Baziel Gm; Zwarts, Machiel J; Tendolkar, Indira; Olde-Rikkert, Marcel G; van der Vlugt, Maureen J; Zwiers, Marcel P; Norris, David G; de Leeuw, Frank-Erik

2011-02-28

Cerebral small vessel disease (SVD) is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects with SVD become demented or get parkinsonism. This might be explained by the diversity of underlying pathology of both white matter lesions (WML) and the normal appearing white matter (NAWM). Both cannot be properly appreciated with conventional MRI. Diffusion tensor imaging (DTI) provides alternative information on microstructural white matter integrity. The association between SVD, its microstructural integrity, and incident dementia and parkinsonism has never been investigated. The RUN DMC study is a prospective cohort study on the risk factors and cognitive and motor consequences of brain changes among 503 non-demented elderly, aged between 50-85 years, with cerebral SVD. First follow up is being prepared for July 2011. Participants alive will be included and invited to the research centre to undergo a structured questionnaire on demographics and vascular risk factors, and a cognitive, and motor, assessment, followed by a MRI protocol including conventional MRI, DTI and resting state fMRI. The follow up of the RUN DMC study has the potential to further unravel the causes and possibly better predict the consequences of changes in white matter integrity in elderly with SVD by using relatively new imaging techniques. When proven, these changes might function as a surrogate endpoint for cognitive and motor function in future therapeutic trials. Our data could furthermore provide a better understanding of the pathophysiology of cognitive and motor disturbances in elderly with SVD. The execution and completion of the follow up of our study might ultimately unravel the role of SVD on the microstructural integrity of the white matter in the transition from "normal" aging to cognitive and

Protocol for a cohort study of adolescent mental health service users with a nested cluster randomised controlled trial to assess the clinical and cost-effectiveness of managed transition in improving transitions from child to adult mental health services (the MILESTONE study)

DEFF Research Database (Denmark)

Singh, Swaran P.; Tuomainen, Helena; Girolamo, Giovanni De

2017-01-01

of 840 participants randomised in a 1:2 intervention to control are required, providing 89% power to detect a difference in HoNOSCA score of 0.30 SD. The addition of 210 recruits for the cohort study ensures sufficient power for studying predictors, resulting in 1050 participants and an approximate 1...... Healthcare) study evaluates the longitudinal course and outcomes of adolescents approaching the transition boundary (TB) of their CAMHS and determines the effectiveness of the model of managed transition in improving outcomes, compared with usual care. Methods and analysis This is a cohort study......:3 randomisation. Ethics and dissemination The study protocol was approved by the UK National Research Ethics Service (15/WM/0052) and equivalent ethics boards in participating countries. Results will be reported at conferences, in peer-reviewed publications and to all relevant stakeholder groups. Trial...

Study design of DIACORE (DIAbetes COhoRtE – a cohort study of patients with diabetes mellitus type 2

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Dörhöfer Lena

2013-02-01

Full Text Available Abstract Background Diabetes mellitus type 2 (DM2 is highly associated with increased risk for chronic kidney disease (CKD, end stage renal disease (ESRD and cardiovascular morbidity. Epidemiological and genetic studies generate hypotheses for innovative strategies in DM2 management by unravelling novel mechanisms of diabetes complications, which is essential for future intervention trials. We have thus initiated the DIAbetes COhoRtE study (DIACORE. Methods DIACORE is a prospective cohort study aiming to recruit 6000 patients of self-reported Caucasian ethnicity with prevalent DM2 for at least 10 years of follow-up. Study visits are performed in University-based recruiting clinics in Germany using standard operating procedures. All prevalent DM2 patients in outpatient clinics surrounding the recruiting centers are invited to participate. At baseline and at each 2-year follow-up examination, patients are subjected to a core phenotyping protocol. This includes a standardized online questionnaire and physical examination to determine incident micro- and macrovascular DM2 complications, malignancy and hospitalization, with a primary focus on renal events. Confirmatory outcome information is requested from patient records. Blood samples are obtained for a centrally analyzed standard laboratory panel and for biobanking of aliquots of serum, plasma, urine, mRNA and DNA for future scientific use. A subset of the cohort is subjected to extended phenotyping, e.g. sleep apnea screening, skin autofluorescence measurement, non-mydriatic retinal photography and non-invasive determination of arterial stiffness. Discussion DIACORE will enable the prospective evaluation of factors involved in DM2 complication pathogenesis using high-throughput technologies in biosamples and genetic epidemiological studies.

Factors and motivations associated with use of e-cigarette among primary care patients in a prospective cohort study: e-TAC study protocol.

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Kinouani, Shérazade; Castéra, Philippe; Laporte, Catherine; Pétrègne, François; Gay, Bernard

2016-06-15

While the relationship between electronic cigarette use and smoking has often been studied, the association between electronic cigarette use and socioeconomic factors has received less attention. This is a study protocol aiming to describe the relationship between the consumption of psychoactive products (in particular: smoking) or some socioeconomic factors and the evolution of the use of electronic cigarette in primary healthcare over 1 year. Electronic cigarette, Tobacco, Alcohol and Cannabis (e-TAC) is a prospective multisite cohort study, including 473 patients at baseline and carrying out in general practices in the Aquitaine area (France). The volunteer patients participated in the study regardless of their initial reason for consultation. They filled out a self-administered questionnaire at baseline and will also do so after 12 months by phone, email or letter. The study will focus on the factors that explain the experimentation with or the current use of the electronic cigarette, as well as factors associated with their evolutions over time using multivariate logistic regression modelling or Cox regression modelling. This study received ethical approval from the University of Bordeaux Committee for the protection of persons. It was also approved by the National Commission for Data Processing and Freedoms. Findings will be submitted for publication in peer-reviewed journals and we will disseminate them by presentations at national or international conferences. RCB: 2015-A00778-41; Pre-results. 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/

Cancer in ANCA-Associated Glomerulonephritis: A Registry-Based Cohort Study

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Sanjeevan Sriskandarajah

2017-01-01

Full Text Available Background. Immunosuppressive therapy for antineutrophil cytoplasmic antibody-associated vasculitis has been associated with increased malignancy risk. Objectives. To quantify the cancer risk associated with contemporary cyclophosphamide-sparing protocols. Methods. Patients from the Norwegian Kidney Biopsy Registry between 1988 and 2012 who had biopsy-verified pauci-immune glomerulonephritis and positive antineutrophil cytoplasmic antibody (ANCA serology were included. Standardised incidence ratios (SIRs were calculated to compare the study cohort with the general population. Results. The study cohort included 419 patients. During 3010 person-years, cancer developed in 41 patients (9.79%; the expected number of cancer cases was 37.5 (8.95%. The cohort had SIRs as follows: 1.09, all cancer types (95% CI, 0.81 to 1.49; 0.96, all types except nonmelanoma skin cancer (95% CI, 0.69 to 1.34; 3.40, nonmelanoma skin cancer (95% CI, 1.62 to 7.14; 3.52, hematologic cancer (95% CI, 1.32 to 9.37; 2.12, posttransplant cancer (95% CI, 1.01 to 4.44; and 1.53, during the 1–5-year follow-up after diagnosis (95% CI, 1.01 to 2.32. Conclusions. Cancer risk did not increase significantly in this cohort with ANCA-associated glomerulonephritis. However, increased risk of nonmelanoma skin cancer, posttransplant cancer, and hematologic cancer indicates an association between immunosuppression and malignancy.

Influence of a multidisciplinary protocol on nutritional status at diagnosis in amyotrophic lateral sclerosis.

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López-Gómez, Juan José; Torres-Torres, Beatriz; Gómez-Hoyos, Emilia; Fernández-Buey, Nieves; Ortolá-Buigues, Ana; Castro-Lozano, Ángeles; Arenillas-Lara, Juan F; De Luis-Román, Daniel A

2018-04-01

The aim of this study were to understand the influence of a multidisciplinary care protocol in amyotrophic lateral sclerosis (ALS) on the change in the delay of remission to the nutrition specialist and the initial nutritional status. A cohort study was performed in 43 patients with ALS who were referred to the Nutrition Unit between April 2015 and April 2017. Anthropometric parameters and diagnostic times were collected, and the nutritional status was studied through subjective global assessment (SGA). Patients who were included before (control cohort [NoP]) and after (protocol cohort [P]) a multidisciplinary protocol were compared. The mean age of the participants was 66.79 y (10.86 y). Of the patients, 62.8% belonged to the protocol cohort. Patients who started the protocol had a lower delay in initial assessment by a nutrition specialist (P:2 [1-6] mo/NoP:12 [10-29] mo; P = 0.03). When the nutritional status was analyzed according to the SGA, more patients who did not initiate protocol were in the state of severe malnutrition (C) (P 22.2% versus NoP 60%; P = 0.01). Entry into the protocol was an independent protective factor of the presence of severe malnutrition at the beginning of the nutritional follow-up (odds ratio, 0.20; 95% confidence interval, 0.03-0.73; P = 0.02). The implementation of a multidisciplinary protocol in ALS allowed patients to present a lower percentage of severe malnutrition in an initial assessment by the nutrition specialist. This protocol is a protective factor for the presence of malnutrition at the beginning of support. Copyright © 2017 Elsevier Inc. All rights reserved.

Effectiveness of an early mobilization protocol in a trauma and burns intensive care unit: a retrospective cohort study.

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Clark, Diane E; Lowman, John D; Griffin, Russell L; Matthews, Helen M; Reiff, Donald A

2013-02-01

Bed rest and immobility in patients on mechanical ventilation or in an intensive care unit (ICU) have detrimental effects. Studies in medical ICUs show that early mobilization is safe, does not increase costs, and can be associated with decreased ICU and hospital lengths of stay (LOS). The purpose of this study was to assess the effects of an early mobilization protocol on complication rates, ventilator days, and ICU and hospital LOS for patients admitted to a trauma and burn ICU (TBICU). This was a retrospective cohort study of an interdisciplinary quality-improvement program. Pre- and post-early mobility program patient data from the trauma registry for 2,176 patients admitted to the TBICU between May 2008 and April 2010 were compared. No adverse events were reported related to the early mobility program. After adjusting for age and injury severity, there was a decrease in airway, pulmonary, and vascular complications (including pneumonia and deep vein thrombosis) post-early mobility program. Ventilator days and TBICU and hospital lengths of stay were not significantly decreased. Using a historical control group, there was no way to account for other changes in patient care that may have occurred between the 2 periods that could have affected patient outcomes. The dose of physical activity both before and after the early mobility program were not specifically assessed. Early mobilization of patients in a TBICU was safe and effective. Medical, nursing, and physical therapy staff, as well as hospital administrators, have embraced the new culture of early mobilization in the ICU.

A patient cohort on long-term sequelae of sepsis survivors: study protocol of the Mid-German Sepsis Cohort.

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Scherag, André; Hartog, Christiane S; Fleischmann, Carolin; Ouart, Dominique; Hoffmann, Franziska; König, Christian; Kesselmeier, Miriam; Fiedler, Sandra; Philipp, Monique; Braune, Anke; Eichhorn, Cornelia; Gampe, Christin; Romeike, Heike; Reinhart, Konrad

2017-08-23

An increasing number of patients survive sepsis; however, we lack valid data on the long-term impact on morbidity from prospective observational studies. Therefore, we designed an observational cohort to quantify mid-term and long-term functional disabilities after intensive care unit (ICU)-treated sepsis. Ultimately, findings for the Mid-German Sepsis Cohort (MSC) will serve as basis for the implementation of follow-up structures for patients with sepsis and help to increase quality of care for sepsis survivors. All patients surviving ICU-treated sepsis are eligible and are recruited from five study centres in Germany (acute care hospital setting in Jena, Halle/Saale, Leipzig, Bad Berka, Erfurt; large long-term acute care hospital and rehabilitation setting in Klinik Bavaria Kreischa). Screening is performed by trained study nurses. Data are collected on ICU management of sepsis. On written informed consent provided by patients or proxies, follow-up is carried out by trained research staff at 3, 6 and 12 months and yearly thereafter. The primary outcome is functional disability as assessed by (instrumental) activities of daily living. Other outcomes cover domains like mortality, cognitive, emotional and physical impairment, and resource use. The estimated sample size of 3000 ICU survivors is calculated to allow detection of relevant changes in the primary outcome in sepsis survivors longitudinally. The study is conducted according to the current version of the Declaration of Helsinki and has been approved by four local/federal responsible institutional ethics committees and by the respective federal data protection commissioners. Results of MSC will be fed back to the patients and published in peer-reviewed journals. German Clinical Trials Registry DRKS00010050. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A Student Teamwork Induction Protocol

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Kamau, Caroline; Spong, Abigail

2015-01-01

Faulty group processes have harmful effects on performance but there is little research about intervention protocols to pre-empt them in higher education. This naturalistic experiment compared a control cohort with an inducted cohort. The inducted cohort attended a workshop, consultations, elected a leader and used tools (a group log and group…

Development of a systematic observation protocol of physical exposure of the back: a preliminary study.

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Tousignant, M; Tougas, G; Rossignol, M; Goulet, L

2002-04-01

At present there is no systematic observation protocol for the assessment of the multi-factorial aspects of physical exposure related to the back used within the constraints of occupational epidemiological research. In this context, a new preliminary systematic observation protocol is proposed to assess exposure to physical loading of the back using nine categories of physical risk factors: the SOPE back protocol. The objective of this study was to investigate whether the new protocol can correctly identify the level of exposure related to measured physical loading of the back. The subjects of this closed cohort study were 451 manual workers at a natural gas distribution company. The assessment of exposure was made with the protocol using groups with different job titles. The workers were followed for a 2 yr period to establish the risk of a new occurrence of complete disability related to the back (NOCD back injury) in each job grouping. Based on the median of the total scores derived from the protocol, two levels of exposure were identified (high and low). Taking into account the limitations of this study, the protocol in development may be a good tool to establish two levels of exposure to physical loading of the back in large epidemiological studies of occupational low back pain. Further research is needed to replicate these results with larger samples and to test the reliability and predictive validity of the protocol.

Optimizing life success through residential immersive life skills programs for youth with disabilities: study protocol of a mixed-methods, prospective, comparative cohort study.

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McPherson, Amy C; King, Gillian; Rudzik, Alanna; Kingsnorth, Shauna; Gorter, Jan Willem

2016-09-06

Young people with disabilities often lag behind their typically developing peers in the achievement of adult roles, which has been attributed to a lack of opportunities to develop critical life skills. Residential Immersive Life Skills (RILS) programs provide situated learning opportunities to develop life skills alongside peers and away from home in real-world settings. Retrospective research suggests that attending RILS programs is a transformative experience that empowers youth, provides parental hope, and increases service provider expertise. However, prospective, comparative research is needed to determine longer term benefits of these programs on youth life trajectories, in addition to exploring the program features and participant experiences that optimize program success. This protocol describes a 5-year, multi-site prospective study examining the effects of RILS programs for youth with disabilities. The study involves RILS programs at three sites in Ontario, Canada. Cohorts of treatment and control groups will receive the study protocol over 3 successive years. Thirty English-speaking participants aged 14-21 years with a child-onset disability and the cognitive capacity to engage in goal setting will be recruited every year for 3 years in the following groups: youth attending a RILS program (Group A); a deferred RILS control group of youth (Group B); a control group of youth attending a non-residential life skills program (Group C); and a control group matched on age, diagnoses, and cognitive capacity not receiving any life skills intervention (Group D). All participants will complete measures of self-determination and self-efficacy at four time points. Program opportunities and experiences will also be assessed in-the-moment at the RILS programs. Qualitative interviews pre-program and at 3- and 12-months post-program will be undertaken with a sub-sample of youth and parents to explore their expectations and experiences. This study will address key gaps

Age and gender leucocytes variances and references values generated using the standardized ONE-Study protocol

DEFF Research Database (Denmark)

Kverneland, Anders H.; Streitz, Mathias; Geissler, Edward

2016-01-01

blood flow cytometry. The performance of our protocols was challenged here by profiling samples from healthy volunteers to reveal age- and gender-dependent differences and to establish a standardized reference cohort for use in clinical trials. Whole blood samples from two different cohorts were...... analyzed (first cohort: n = 52, second cohort: n = 46, both 20–84 years with equal gender distribution). The second cohort was run as a validation cohort by a different operator. The “ONE Study” panels were applied to analyze expression of >30 different surface markers to enumerate proportional...... cohort. Thus, we have proven the utility of our strategy and generated reproducible reference ranges accounting for age- and gender-dependent differences, which are crucial for a better patient monitoring and individualized therapy....

Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

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Reveiz, Ludovic; Haby, Michelle M; Martínez-Vega, Ruth; Pinzón-Flores, Carlos E; Elias, Vanessa; Smith, Emma; Pinart, Mariona; Broutet, Nathalie; Becerra-Posada, Francisco; Aldighieri, Sylvain; Van Kerkhove, Maria D

2017-01-01

Given the severity and impact of the current Zika virus (ZIKV) outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV. We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols. Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome). Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design. Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to minimize bias at

Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

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Ludovic Reveiz

Full Text Available Given the severity and impact of the current Zika virus (ZIKV outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV.We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols.Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome. Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design.Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to

Methodology Series Module 1: Cohort Studies.

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Setia, Maninder Singh

2016-01-01

Cohort design is a type of nonexperimental or observational study design. In a cohort study, the participants do not have the outcome of interest to begin with. They are selected based on the exposure status of the individual. They are then followed over time to evaluate for the occurrence of the outcome of interest. Some examples of cohort studies are (1) Framingham Cohort study, (2) Swiss HIV Cohort study, and (3) The Danish Cohort study of psoriasis and depression. These studies may be prospective, retrospective, or a combination of both of these types. Since at the time of entry into the cohort study, the individuals do not have outcome, the temporality between exposure and outcome is well defined in a cohort design. If the exposure is rare, then a cohort design is an efficient method to study the relation between exposure and outcomes. A retrospective cohort study can be completed fast and is relatively inexpensive compared with a prospective cohort study. Follow-up of the study participants is very important in a cohort study, and losses are an important source of bias in these types of studies. These studies are used to estimate the cumulative incidence and incidence rate. One of the main strengths of a cohort study is the longitudinal nature of the data. Some of the variables in the data will be time-varying and some may be time independent. Thus, advanced modeling techniques (such as fixed and random effects models) are useful in analysis of these studies.

Methodology series module 1: Cohort studies

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Maninder Singh Setia

2016-01-01

Full Text Available Cohort design is a type of nonexperimental or observational study design. In a cohort study, the participants do not have the outcome of interest to begin with. They are selected based on the exposure status of the individual. They are then followed over time to evaluate for the occurrence of the outcome of interest. Some examples of cohort studies are (1 Framingham Cohort study, (2 Swiss HIV Cohort study, and (3 The Danish Cohort study of psoriasis and depression. These studies may be prospective, retrospective, or a combination of both of these types. Since at the time of entry into the cohort study, the individuals do not have outcome, the temporality between exposure and outcome is well defined in a cohort design. If the exposure is rare, then a cohort design is an efficient method to study the relation between exposure and outcomes. A retrospective cohort study can be completed fast and is relatively inexpensive compared with a prospective cohort study. Follow-up of the study participants is very important in a cohort study, and losses are an important source of bias in these types of studies. These studies are used to estimate the cumulative incidence and incidence rate. One of the main strengths of a cohort study is the longitudinal nature of the data. Some of the variables in the data will be time-varying and some may be time independent. Thus, advanced modeling techniques (such as fixed and random effects models are useful in analysis of these studies.

Survival effect of first- and second-line treatments for patients with primary glioblastoma: a cohort study from a prospective registry, 1997-2010.

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Nava, Francesca; Tramacere, Irene; Fittipaldo, Andrea; Bruzzone, Maria Grazia; Dimeco, Francesco; Fariselli, Laura; Finocchiaro, Gaetano; Pollo, Bianca; Salmaggi, Andrea; Silvani, Antonio; Farinotti, Mariangela; Filippini, Graziella

2014-05-01

Prospective follow-up studies of large cohorts of patients with glioblastoma (GBM) are needed to assess the effectiveness of conventional treatments in clinical practice. We report GBM survival data from the Brain Cancer Register of the Fondazione Istituto Neurologico Carlo Besta (INCB) in Milan, Italy, which collected longitudinal data for all consecutive patients with GBM from 1997 to 2010. Survival data were obtained from 764 patients (aged>16 years) with histologically confirmed primary GBM who were diagnosed and treated over a 7-year period (2004-2010) with follow-up to April 2012 (cohort II). Equivalent data from 490 GBM patients diagnosed and treated over the preceding 7 years (1997-2003) with follow-up to April 2005 (cohort I) were available for comparison. Progression-free survival (PFS) was available from 361 and 219 patients actively followed up at INCB in cohorts II and I, respectively. Survival probabilities were 54% at 1 year, 21% at 2 years, and 11% at 3 years, respectively, in cohort II compared with 47%, 11%, and 5%, respectively, in cohort I. PFS was 22% and 12% at 1 year in cohorts II and I. Better survival and PFS in cohort II was significantly associated with introduction of the Stupp protocol into clinical practice, with adjusted hazard ratios (HRs) of 0.78 for survival and 0.73 for PFS, or a 22% relative decrease in the risk of death and a 27% relative decrease in the risk of recurrence. After recurrence, reoperation was performed in one-fifth of cohort I and in one-third of cohort II but was not effective (HR, 1.05 in cohort I and 1.02 in cohort II). Second-line chemotherapy, mainly consisting of nitrosourea-based chemotherapy, temozolomide, mitoxantrone, fotemustine, and bevacizumab, improved survival in both cohorts (HR, 0.57 in cohort I and 0.74 in cohort II). Radiosurgery was also effective (HR, 0.52 in cohort II). We found a significant increase in overall survival, PFS, and survival after recurrence after 2004, likely due to

The "Medicine in Australia: Balancing Employment and Life (MABEL" longitudinal survey - Protocol and baseline data for a prospective cohort study of Australian doctors' workforce participation

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Witt Julia

2010-02-01

Full Text Available Abstract Background While there is considerable research on medical workforce supply trends, there is little research examining the determinants of labour supply decisions for the medical workforce. The "Medicine in Australia: Balancing Employment and Life (MABEL" study investigates workforce participation patterns and their determinants using a longitudinal survey of Australian doctors. It aims to generate evidence to support developing effective policy responses to workforce issues such as shortages and maldistribution. This paper describes the study protocol and baseline cohort, including an analysis of response rates and response bias. Methods/Design MABEL is a prospective cohort study. All Australian doctors undertaking clinical work in 2008 (n = 54,750 were invited to participate, and annual waves of data collections will be undertaken until at least 2011. Data are collected by paper or optional online version of a questionnaire, with content tailored to four sub-groups of clinicians: general practitioners, specialists, specialists in training, and hospital non-specialists. In the baseline wave, data were collected on: job satisfaction, attitudes to work and intentions to quit or change hours worked; a discrete choice experiment examining preferences and trade-offs for different types of jobs; work setting; workload; finances; geographic location; demographics; and family circumstances. Discussion The baseline cohort includes 10,498 Australian doctors, representing an overall response rate of 19.36%. This includes 3,906 general practitioners, 4,596 specialists, 1,072 specialists in training, and 924 hospital non-specialists. Respondents were more likely to be younger, female, and to come from non-metropolitan areas, the latter partly reflecting the effect of a financial incentive on response for doctors in remote and rural areas. Specialists and specialists in training were more likely to respond, whilst hospital non-specialists were less

Clinicopathologic characteristics, laboratory parameters, treatment protocols, and outcomes of pancreatic cancer: a retrospective cohort study of 1433 patients in China

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Shuisheng Zhang

2018-05-01

Full Text Available Objectives The prognosis of people with pancreatic cancer is extremely unfavorable. However, the prognostic factors remain largely undefined. We aimed to perform comprehensive analyses of clinicopathologic characteristics, laboratory parameters, and treatment protocols for exploring their role as prognostic factors of pancreatic cancer. Methods Patients diagnosed with pancreatic cancer and hospitalized at the China National Cancer Center between April 2006 and May 2016 were enrolled in this retrospective cohort study. Clinicopathologic characteristics, laboratory parameters, and treatment protocols were compared among patients at different stages of the disease. The association between these factors and overall survival (OS was analyzed using the Kaplan–Meier method and Cox proportional hazards model. Results The present study included 1,433 consecutive patients with pancreatic cancer. Median OS was 10.6 months (95% confidence interval [CI] 9.8–11.3 months, with 1-, 3-, and 5-year survival rates of 43.7%, 14.8%, and 8.8%, respectively. Cox multivariate analysis findings identified the following factors as independent predictors of OS: gender (female vs male, hazard ratio 0.72, 95% CI [0.54–0.95]; elevated total bilirubin (TBil; 1.82, 1.34–2.47; elevated carbohydrate antigen 19-9 (CA19-9; 1.72, 1.17–2.54; tumor being located in pancreatic body and tail (1.52, 1.10–2.10; advanced T stage (T3-4 vs T1-2, 1.62, 1.15–2.27; lymph node metastasis (1.57, 1.20–2.07; distant metastasis (1.59, 1.12–2.27; the presence of surgical resection (0.53, 0.34–0.81; and the presence of systemic chemotherapy (0.62, 0.45–0.82. Conclusions Being male, elevated TBil and carcinoembryonic antigen, tumor being located in pancreatic body and tail, advanced T stage, lymph node and distant metastasis, the absence of surgical resection, and the absence of systematic chemotherapy were associated with worse OS in patients with pancreatic cancer.

A cohort study protocol to analyze the predisposing factors to common chronic non-communicable diseases in rural areas: Fasa Cohort Study

Directory of Open Access Journals (Sweden)

Mojtaba Farjam

2016-10-01

Full Text Available Abstract Background Non-communicable diseases (NCDs have become the main causes of morbidity and mortality even in rural areas of many developing countries, including Iran. In view of this increased risk, Fasa Cohort Study (FACS has been established to assess the risk factors for NCDs with the ultimate goal of providing optimal risk calculators for Iranian population and finding grounds for interventions at the population level. Methods In a population-based cohort, at least 10,000 people within the age range of 35 to 70 years old from Sheshdeh, the suburb of Fasa city and its 24 satellite villages are being recruited. A detailed demographic, socioeconomic, anthropometric, nutrition, and medical history is obtained for each individual besides limited physical examinations and determination of physical activity and sleep patterns supplemented by body composition and electrocardiographic records. Routine laboratory assessments are done and a comprehensive biobank is compiled for future biological investigations. All data are stored online using a dedicated software. Discussion FACS enrolls the individuals from rural and little township areas to evaluate the health conditions and analyze the risk factors pertinent to major NCDs. This study will provide an evidence-based background for further national and international policies in preventive medicine. Yearly follow ups are designed to assess the health events in the participating population. It is believed that the results would construct a contemporary knowledge of Iranian high risk health characteristics and behaviors as well as the platform for further interventions of risk reduction in a typical Iranian population. Constantly probing for future advances in NCDs prevention and management, the accumulated database and biobank serves as a potential for state of the art research and international collaborations.

The Korea Nurses' Health Study: A Prospective Cohort Study.

Science.gov (United States)

Kim, Oksoo; Ahn, Younjhin; Lee, Hea-Young; Jang, Hee Jung; Kim, Sue; Lee, Jung Eun; Jung, Heeja; Cho, Eunyoung; Lim, Joong-Yeon; Kim, Min-Ju; Willett, Walter C; Chavarro, Jorge E; Park, Hyun-Young

2017-08-01

The Korea Nurses' Health Study (KNHS) is a prospective cohort study of female nurses, focusing on the effects of occupational, environmental, and lifestyle risk factors on the health of Korean women. Female registered nurses aged 20-45 years and living in the Republic of Korea were invited to join the study, which began in July 2013. They were asked to complete a web-based baseline survey. The study protocols and questionnaires related to the KNHS are based on the Nurses' Health Study 3 (NHS3) in the United States, although they were modified to reflect the Korean lifestyle. Participants were asked about demographic, lifestyle factors, disease history, occupational exposure, reproductive factors, and dietary habits during their adolescence: Follow-up questionnaires were/will be completed at 6-8 month intervals after the baseline survey. If a participant became pregnant, she answered additional questionnaires containing pregnancy-related information. Among 157,569 eligible female nurses, 20,613 (13.1%) completed the web-based baseline questionnaire. The mean age of the participants was 29.4 ± 5.9 years, and more than half of them were in their 20s. Eighty-eight percent of the participants had worked night shifts as a nurse (mean, 5.3 ± 4.3 nights per month). Approximately 80% of the participants had a body mass index below 23 kg/m 2 . Gastrointestinal diseases were the most prevalent health issues (25.9%). The findings from this prospective cohort study will help to identify the effects of lifestyle-related and occupational factors on reproductive health and development of chronic diseases in Korean women.

Study protocol: quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 2, UK Prospective Cohort Study

Science.gov (United States)

Wotherspoon, Lisa M; Boyd, Kathleen Anne; Morris, Rachel K; Jackson, Lesley; Chandiramani, Manju; David, Anna L; Khalil, Asma; Shennan, Andrew; Hodgetts Morton, Victoria; Lavender, Tina; Khan, Khalid; Harper-Clarke, Susan; Mol, Ben; Riley, Richard D; Norrie, John; Norman, Jane

2018-01-01

Introduction The aim of the QUIDS study is to develop a decision support tool for the management of women with symptoms and signs of preterm labour, based on a validated prognostic model using quantitative fetal fibronectin (fFN) concentration, in combination with clinical risk factors. Methods and analysis The study will evaluate the Rapid fFN 10Q System (Hologic, Marlborough, Massachusetts, USA) which quantifies fFN in a vaginal swab. In QUIDS part 2, we will perform a prospective cohort study in at least eight UK consultant-led maternity units, in women with symptoms of preterm labour at 22+0 to 34+6 weeks gestation to externally validate a prognostic model developed in QUIDS part 1. The effects of quantitative fFN on anxiety will be assessed, and acceptability of the test and prognostic model will be evaluated in a subgroup of women and clinicians (n=30). The sample size is 1600 women (with estimated 96–192 events of preterm delivery within 7 days of testing). Clinicians will be informed of the qualitative fFN result (positive/negative) but be blinded to quantitative fFN result. Research midwives will collect outcome data from the maternal and neonatal clinical records. The final validated prognostic model will be presented as a mobile or web-based application. Ethics and dissemination The study is funded by the National Institute of Healthcare Research Health Technology Assessment (HTA 14/32/01). It has been approved by the West of Scotland Research Ethics Committee (16/WS/0068). Version Protocol V.2, Date 1 November 2016. Trial registration number ISRCTN41598423 and CPMS: 31277. PMID:29674373

A longitudinal cohort study of HIV 'treatment as prevention' in gay, bisexual and other men who have sex with men: the Treatment with Antiretrovirals and their Impact on Positive And Negative men (TAIPAN) study protocol.

Science.gov (United States)

Callander, D; Stoové, M; Carr, A; Hoy, J F; Petoumenos, K; Hellard, M; Elliot, J; Templeton, D J; Liaw, S; Wilson, D P; Grulich, A; Cooper, D A; Pedrana, A; Donovan, B; McMahon, J; Prestage, G; Holt, M; Fairley, C K; McKellar-Stewart, N; Ruth, S; Asselin, J; Keen, P; Cooper, C; Allan, B; Kaldor, J M; Guy, R

2016-12-12

Australia has increased coverage of antiretroviral treatment (ART) over the past decade, reaching 73% uptake in 2014. While ART reduces AIDS-related deaths, accumulating evidence suggests that it could also bolster prevention efforts by reducing the risk of HIV transmission ('treatment as prevention'). While promising, evidence of community-level impact of treatment as prevention on reducing HIV incidence among gay and bisexual men is limited. We describe a study protocol that aims to determine if scale up of testing and treatment for HIV leads to a reduction in community viraemia and, in turn, if this reduction is temporally associated with a reduction in HIV incidence among gay and bisexual men in Australia's two most populous states. Over the period 2009 to 2017, we will establish two cohorts making use of clinical and laboratory data electronically extracted retrospectively and prospectively from 73 health services and laboratories in the states of New South Wales and Victoria. The 'positive cohort' will consist of approximately 13,000 gay and bisexual men (>90% of all people living with HIV). The 'negative cohort' will consist of at least 40,000 HIV-negative gay and bisexual men (approximately half of the total population). Within the negative cohort we will use standard repeat-testing methods to calculate annual HIV incidence. Community prevalence of viraemia will be defined as the proportion of men with a viral load ≥200RNA copies/mm 3 , which will combine viral load data from the positive cohort and viraemia estimates among those with an undiagnosed HIV infection. Using regression analyses and adjusting for behavioural and demographic factors associated with infection, we will assess the temporal association between the community prevalence of viraemia and the incidence of HIV infection. Further analyses will make use of these cohorts to assess incidence and predictors of treatment initiation, repeat HIV testing, and viral suppression. This study will

The UAE healthy future study: a pilot for a prospective cohort study of 20,000 United Arab Emirates nationals.

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Abdulle, Abdishakur; Alnaeemi, Abdullah; Aljunaibi, Abdullah; Al Ali, Abdulrahman; Al Saedi, Khaled; Al Zaabi, Eiman; Oumeziane, Naima; Al Bastaki, Marina; Al-Houqani, Mohammed; Al Maskari, Fatma; Al Dhaheri, Ayesha; Shah, Syed M; Loney, Tom; El-Sadig, Mohamed; Oulhaj, Abderrahim; Wareth, Leila Abdel; Al Mahmeed, Wael; Alsafar, Habiba; Hirsch, Benjamin; Al Anouti, Fatme; Yaaqoub, Jamila; Inman, Claire K; Al Hamiz, Aisha; Al Hosani, Ayesha; Haji, Muna; Alsharid, Teeb; Al Zaabi, Thekra; Al Maisary, Fatima; Galani, Divya; Sprosen, Tim; El Shahawy, Omar; Ahn, Jiyoung; Kirchhoff, Tomas; Ramasamy, Ravichandran; Schmidt, Ann Marie; Hayes, Richard; Sherman, Scott; Ali, Raghib

2018-01-05

The United Arab Emirates (UAE) is faced with a rapidly increasing burden of non-communicable diseases including obesity, diabetes, and cardiovascular disease. The UAE Healthy Future study is a prospective cohort designed to identify associations between risk factors and these diseases amongst Emiratis. The study will enroll 20,000 UAE nationals aged ≥18 years. Environmental and genetic risk factors will be characterized and participants will be followed for future disease events. As this was the first time a prospective cohort study was being planned in the UAE, a pilot study was conducted in 2015 with the primary aim of establishing the feasibility of conducting the study. Other objectives were to evaluate the implementation of the main study protocols, and to build adequate capacity to conduct advanced clinical laboratory analyses. Seven hundred sixty nine UAE nationals aged ≥18 years were invited to participate voluntarily in the pilot study. Participants signed an informed consent, completed a detailed questionnaire, provided random blood, urine, and mouthwash samples and were assessed for a series of clinical measures. All specimens were transported to the New York University Abu Dhabi laboratories where samples were processed and analyzed for routine chemistry and hematology. Plasma, serum, and a small whole blood sample for DNA extraction were aliquoted and stored at -80 °C for future analyses. Overall, 517 Emirati men and women agreed to participate (68% response rate). Of the total participants, 495 (95.0%), 430 (82.2%), and 492 (94.4%), completed the questionnaire, physical measurements, and provided biological samples, respectively. The pilot study demonstrated the feasibility of recruitment and completion of the study protocols for the first large-scale cohort study designed to identify emerging risk factors for the major non-communicable diseases in the region.

Characterisation of exposure to non-ionising electromagnetic fields in the Spanish INMA birth cohort: Study protocol

NARCIS (Netherlands)

M. Gallastegi (Mara); M. Guxens Junyent (Mònica); A. Jiménez-Zabala (Ana); I. Calvente (Irene); M. Fernández (Marta); L. Birks (Laura); B. Struchen (Benjamin); M. Vrijheid (Martine); M. Estarlich (Marisa); M.F. Fernandez (Mariana); M. Torrent (Maties); F. Ballester (Ferran); J.J. Aurrekoetxea (Juan José); J. Ibarluzea (Jesús); D. Guerra (David); J. González (Julián); M. Röösli (Martin); L. Santa-Marina (Loreto)

2016-01-01

textabstractBackground: Analysis of the association between exposure to electromagnetic fields of non-ionising radiation (EMF-NIR) and health in children and adolescents is hindered by the limited availability of data, mainly due to the difficulties on the exposure assessment. This study protocol

Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design

International Nuclear Information System (INIS)

Velden, Joanne M. van der; Verkooijen, Helena M.; Seravalli, Enrica; Hes, Jochem; Gerlich, A. Sophie; Kasperts, Nicolien; Eppinga, Wietse S. C.; Verlaan, Jorrit-Jan; Vulpen, Marco van

2016-01-01

Standard radiotherapy is the treatment of first choice in patients with symptomatic spinal metastases, but is only moderately effective. Stereotactic body radiation therapy is increasingly used to treat spinal metastases, without randomized evidence of superiority over standard radiotherapy. The VERTICAL study aims to quantify the effect of stereotactic radiation therapy in patients with metastatic spinal disease. This study follows the ‘cohort multiple Randomized Controlled Trial’ design. The VERTICAL study is conducted within the PRESENT cohort. In PRESENT, all patients with bone metastases referred for radiation therapy are enrolled. For each patient, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. In addition, patients give informed consent to be offered experimental interventions. Within PRESENT, 110 patients are identified as a sub cohort of eligible patients (i.e. patients with unirradiated painful, mechanically stable spinal metastases who are able to undergo stereotactic radiation therapy). After a protocol amendment, also patients with non-spinal bony metastases are eligible. From the sub cohort, a random selection of patients is offered stereotactic radiation therapy (n = 55), which patients may accept or refuse. Only patients accepting stereotactic radiation therapy sign informed consent for the VERTICAL trial. Non-selected patients (n = 55) receive standard radiotherapy, and are not aware of them serving as controls. Primary endpoint is pain response after three months. Data will be analyzed by intention to treat, complemented by instrumental variable analysis in case of substantial refusal of the stereotactic radiation therapy in the intervention arm. This study is designed to quantify the treatment response after (stereotactic) radiation therapy in patients with symptomatic spinal metastases. This is the first randomized study in palliative care following the cohort multiple Randomized

1970 British Cohort Study

Directory of Open Access Journals (Sweden)

Matt Brown

2014-10-01

Full Text Available The 1970 British Cohort Study (BCS70 is one of Britain’s world famous national longitudinal birth cohort studies, three of which are run by the Centre for Longitudinal Studies at the Institute of Education, University of London.  BCS70 follows the lives of more than 17,000 people born in England, Scotland and Wales in a single week of 1970. Over the course of cohort members lives, the BCS70 has collected information on health, physical, educational and social development, and economic circumstances among other factors. Since the birth survey in 1970, there have been nine ‘sweeps’ of all cohort members at ages 5, 10, 16, 26, 30, 34, 38 and most recently at 42. Data has been collected from a number of different sources (the midwife present at birth, parents of the cohort members, head and class teachers, school health service personnel and the cohort members themselves. The data has been collected in a variety of ways including via paper and electronic questionnaires, clinical records, medical examinations, physical measurements, tests of ability, educational assessments and diaries. The majority of BCS70 survey data can be accessed by bona fide researchers through the UK Data Service at the University of Essex.

Protocol to assess the impact of tobacco-induced volatile organic compounds on cardiovascular risk in a cross- sectional cohort: Cardiovascular Injury due to Tobacco Use study.

Science.gov (United States)

Keith, Rachel J; Fetterman, Jessica L; Riggs, Daniel W; O'Toole, Timothy; Nystoriak, Jessica L; Holbrook, Monika; Lorkiewicz, Pawel; Bhatnagar, Aruni; DeFilippis, Andrew P; Hamburg, Naomi M

2018-03-30

Tobacco use leads to increased mortality, the majority of which is attributed to cardiovascular disease. Despite this knowledge, the early cardiovascular impact of tobacco product use is not well understood. Tobacco use increases exposure to harmful and potentially harmful constituents including volatile organic compounds (VOCs) such as acrolein and crotonaldehyde, which may contribute to cardiovascular risk. The link between exposure patterns, risk profiles and demographic distribution of tobacco product users, particularly users of new and emerging products, are not well known. Therefore, we designed the Cardiovascular Injury due to Tobacco Use (CITU) study to assess population characteristics, demographic features, exposure patterns and cardiovascular risk in relation to tobacco. We present the design and methodology of the CITU study, a cross-sectional observational tobacco study conducted in Boston, Massachusetts and Louisville, Kentucky starting in 2014. Healthy participants 21-45 years of age who use tobacco products, including electronic nicotine devices, or who never used tobacco are being recruited. The study aims to recruit an evenly split cohort of African-Americans and Caucasians, that is, sex balanced for evaluation of self-reported tobacco exposure, VOC exposure and tobacco-induced injury profiling. Detailed information about participant's demographics, health status and lifestyle is also collected. The study protocol was approved institutional review boards at both participating universities. All study protocols will protect participant confidentiality. Results from the study will be disseminated via peer-reviewed journals and presented at scientific conferences. © 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.

A prospective cohort study to evaluate peridomestic infection as a determinant of dengue transmission: Protocol

Directory of Open Access Journals (Sweden)

Martínez-Vega Ruth

2012-04-01

Full Text Available Abstract Background Vector control programs, which have focused mainly on the patient house and peridomestic areas around dengue cases, have not produced the expected impact on transmission. This project will evaluate the assumption that the endemic/epidemic transmission of dengue begins around peridomestic vicinities of the primary cases. Its objective is to assess the relationship between symptomatic dengue case exposure and peridomestic infection incidence. Methods/Design A prospective cohort study will be conducted (in Tepalcingo and Axochiapan, in the state of Morelos, Mexico, using the state surveillance system for the detection of incident cases. Paired blood specimens will be collected from both the individuals who live with the incident cases and a sample of subjects residing within a 25-meter radius of such cases (exposed cohort, in order to measure dengue-specific antibodies. Other subjects will be selected from areas which have not presented any incident cases within 200 meters, during the two months preceding the sampling (non-exposed cohort. Symptomatic/asymptomatic incident infection will be considered as the dependent variable, exposure to confirmed dengue cases, as the principal variable, and the socio-demographic, environmental and socio-cultural conditions of the subjects, as additional explanatory variables. Discussion Results indicating a high infection rate among the exposed subjects would justify the application of peridomestic control measures and call for an evaluation of alternate causes for insufficient program impact. On the other hand, a low incidence of peridomestic-infected subjects would support the hypothesis that infection occurs outside the domicile, and would thus explain why the vector control measures applied in the past have exerted such a limited impact on cases incidence rates. The results of the present study may therefore serve to reassess site selection for interventions of this type.

Ovarian response to 150 µg corifollitropin alfa in a GnRH-antagonist multiple-dose protocol: a prospective cohort study.

Science.gov (United States)

Lerman, Tamara; Depenbusch, Marion; Schultze-Mosgau, Askan; von Otte, Soeren; Scheinhardt, Markus; Koenig, Inke; Kamischke, Axel; Macek, Milan; Schwennicke, Arne; Segerer, Sabine; Griesinger, Georg

2017-05-01

The incidence of low (18 oocytes) ovarian response to 150 µg corifollitropin alfa in relation to anti-Müllerian hormone (AMH) and other biomarkers was studied in a multi-centre (n = 5), multi-national, prospective, investigator-initiated, observational cohort study. Infertile women (n = 212), body weight >60 kg, underwent controlled ovarian stimulation in a gonadotrophin-releasing hormone-antagonist multiple-dose protocol. Demographic, sonographic and endocrine parameters were prospectively assessed on cycle day 2 or 3 of a spontaneous menstruation before the administration of 150 µg corifollitropin alfa. Serum AMH showed the best correlation with the number of oocytes obtained among all predictor variables. In receiver-operating characteristic analysis, AMH at a threshold of 0.91 ng/ml showed a sensitivity of 82.4%, specificity of 82.4%, positive predictive value 52.9%and negative predictive value 95.1% for predicting low response (area under the curve [AUC], 95% CI; P-value: 0.853, 0.769-0.936; <0.0001). For predicting high response, the optimal threshold for AMH was 2.58 ng/ml, relating to a sensitivity of 80.0%, specificity 82.1%, positive predictive value 42.5% and negative predictive value 96.1% (AUC, 95% CI; P-value: 0.871, 0.787-0.955; <0.0001). In conclusion, patients with serum AMH concentrations between approximately 0.9 and 2.6 ng/ml were unlikely to show extremes of response. Copyright © 2017. Published by Elsevier Ltd.

Active aging - resilience and external support as modifiers of the disablement outcome: AGNES cohort study protocol.

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Rantanen, Taina; Saajanaho, Milla; Karavirta, Laura; Siltanen, Sini; Rantakokko, Merja; Viljanen, Anne; Rantalainen, Timo; Pynnönen, Katja; Karvonen, Anu; Lisko, Inna; Palmberg, Lotta; Eronen, Johanna; Palonen, Eeva-Maija; Hinrichs, Timo; Kauppinen, Markku; Kokko, Katja; Portegijs, Erja

2018-05-02

Population aging increases the need for knowledge on positive aspects of aging, and contributions of older people to their own wellbeing and that of others. We defined active aging as an individual's striving for elements of wellbeing with activities as per their goals, abilities and opportunities. This study examines associations of health, health behaviors, health literacy and functional abilities, environmental and social support with active aging and wellbeing. We will develop and validate assessment methods for physical activity and physical resilience suitable for research on older people, and examine their associations with active aging and wellbeing. We will examine cohort effects on functional phenotypes underlying active aging and disability. For this population-based study, we plan to recruit 1000 participants aged 75, 80 or 85 years living in central Finland, by drawing personal details from the population register. Participants are interviewed on active aging, wellbeing, disability, environmental and social support, mobility, health behavior and health literacy. Physical activity and heart rate are monitored for 7 days with wearable sensors. Functional tests include hearing, vision, muscle strength, reaction time, exercise tolerance, mobility, and cognitive performance. Clinical examination by a nurse and physician includes an electrocardiogram, tests of blood pressure, orthostatic regulation, arterial stiffness, and lung function, as well as a review of chronic and acute conditions and prescribed medications. C-reactive protein, small blood count, cholesterol and vitamin D are analyzed from blood samples. Associations of factors potentially underlying active aging and wellbeing will be studied using multivariate methods. Cohort effects will be studied by comparing test results of physical and cognitive functioning with results of a cohort examined in 1989-90. The current study will renew research on positive gerontology through the novel approach to

Comparison of Outcomes before and after Ohio's Law Mandating Use of the FDA-Approved Protocol for Medication Abortion: A Retrospective Cohort Study.

Directory of Open Access Journals (Sweden)

Ushma D Upadhyay

2016-08-01

Full Text Available In February 2011, an Ohio law took effect mandating use of the United States Food and Drug Administration (FDA-approved protocol for mifepristone, which is used with misoprostol for medication abortion. Other state legislatures have passed or enacted similar laws requiring use of the FDA-approved protocol for medication abortion. The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization.We used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law's implementation (January 2010-January 2011 to 3 y post implementation (February 2011-October 2014 at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoing abortion at ≤49 d gestation during the study period. The main outcomes were as follows: need for additional intervention following medication abortion (such as aspiration, repeat misoprostol, and blood transfusion, frequency of continuing pregnancy, reports of side effects, and the proportion of abortions that were medication abortions (versus other abortion procedures. Among the 2,783 medication abortions ≤49 d gestation, 4.9% (95% CI: 3.7%-6.2% in the prelaw and 14.3% (95% CI: 12.6%-16.0% in the postlaw period required one or more additional interventions. Women obtaining a medication abortion in the postlaw period had three times the odds of requiring an additional intervention as women in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI: 2.27-4.27. In a mixed effects multivariable model that uses facility-months as the unit of analysis to account for lack of independence by site, we found that the law change was associated with a 9.4% (95% CI: 4.0%-18.4% absolute increase in the rate of requiring an additional

Survival effect of first- and second-line treatments for patients with primary glioblastoma: a cohort study from a prospective registry, 1997–2010

Science.gov (United States)

Nava, Francesca; Tramacere, Irene; Fittipaldo, Andrea; Bruzzone, Maria Grazia; DiMeco, Francesco; Fariselli, Laura; Finocchiaro, Gaetano; Pollo, Bianca; Salmaggi, Andrea; Silvani, Antonio; Farinotti, Mariangela; Filippini, Graziella

2014-01-01

Background Prospective follow-up studies of large cohorts of patients with glioblastoma (GBM) are needed to assess the effectiveness of conventional treatments in clinical practice. We report GBM survival data from the Brain Cancer Register of the Fondazione Istituto Neurologico Carlo Besta (INCB) in Milan, Italy, which collected longitudinal data for all consecutive patients with GBM from 1997 to 2010. Methods Survival data were obtained from 764 patients (aged>16 years) with histologically confirmed primary GBM who were diagnosed and treated over a 7-year period (2004–2010) with follow-up to April 2012 (cohort II). Equivalent data from 490 GBM patients diagnosed and treated over the preceding 7 years (1997–2003) with follow-up to April 2005 (cohort I) were available for comparison. Progression-free survival (PFS) was available from 361 and 219 patients actively followed up at INCB in cohorts II and I, respectively. Results Survival probabilities were 54% at 1 year, 21% at 2 years, and 11% at 3 years, respectively, in cohort II compared with 47%, 11%, and 5%, respectively, in cohort I. PFS was 22% and 12% at 1 year in cohorts II and I. Better survival and PFS in cohort II was significantly associated with introduction of the Stupp protocol into clinical practice, with adjusted hazard ratios (HRs) of 0.78 for survival and 0.73 for PFS, or a 22% relative decrease in the risk of death and a 27% relative decrease in the risk of recurrence. After recurrence, reoperation was performed in one-fifth of cohort I and in one-third of cohort II but was not effective (HR, 1.05 in cohort I and 1.02 in cohort II). Second-line chemotherapy, mainly consisting of nitrosourea-based chemotherapy, temozolomide, mitoxantrone, fotemustine, and bevacizumab, improved survival in both cohorts (HR, 0.57 in cohort I and 0.74 in cohort II). Radiosurgery was also effective (HR, 0.52 in cohort II). Conclusions We found a significant increase in overall survival, PFS, and survival after

Publication trends of study protocols in rehabilitation.

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Jesus, Tiago S; Colquhoun, Heather L

2017-09-04

Growing evidence points for the need to publish study protocols in the health field. To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. Observational study using publication data and its indexation in PubMed. Not applicable. Not applicable. PubMed was searched with appropriate combinations of Medical Subject Headings up to December 2014. The effective presence of study protocols was manually screened. Regression models analyzed the yearly growth of publications. Two-sample Z-tests analyzed whether the proportion of Systematic Reviews (SRs) and Randomized Controlled Trials (RCTs) among study protocols differed from that of the same designs for the broader rehabilitation research. Up to December 2014, 746 publications of rehabilitation study protocols were identified, with an exponential growth since 2005 (r2=0.981; p<0.001). RCT protocols were the most common among rehabilitation study protocols (83%), while RCTs were significantly more prevalent among study protocols than among the broader rehabilitation research (83% vs. 35.8%; p<0.001). For SRs, the picture was reversed: significantly less common among study protocols (2.8% vs. 9.3%; p<0.001). Funding was more often reported by rehabilitation study protocols than the broader rehabilitation research (90% vs. 53.1%; p<0.001). Rehabilitation journals published a significantly lower share of rehabilitation study protocols than they did for the broader rehabilitation research (1.8% vs.16.7%; p<0.001). Identifying the reasons for these discrepancies and reverting unwarranted disparities (e.g. low rate of publication for rehabilitation SR protocols) are likely new avenues for rehabilitation research and its publication. SRs, particularly those aggregating RCT results, are considered the best standard of evidence to guide rehabilitation clinical practice; however, that standard can be improved

Protocol for a multicentre, prospective, population-based cohort study of variation in practice of cholecystectomy and surgical outcomes (The CholeS study).

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Vohra, Ravinder S; Spreadborough, Philip; Johnstone, Marianne; Marriott, Paul; Bhangu, Aneel; Alderson, Derek; Morton, Dion G; Griffiths, Ewen A

2015-01-12

Cholecystectomy is one of the most common general surgical operations performed. Despite level one evidence supporting the role of cholecystectomy in the management of specific gallbladder diseases, practice varies between surgeons and hospitals. It is unknown whether these variations account for the differences in surgical outcomes seen in population-level retrospective data sets. This study aims to investigate surgical outcomes following acute, elective and delayed cholecystectomies in a multicentre, contemporary, prospective, population-based cohort. UK and Irish hospitals performing cholecystectomies will be recruited utilising trainee-led research collaboratives. Two months of consecutive, adult patient data will be included. The primary outcome measure of all-cause 30-day readmission rate will be used in this study. Thirty-day complication rates, bile leak rate, common bile duct injury, conversion to open surgery, duration of surgery and length of stay will be measured as secondary outcomes. Prospective data on over 8000 procedures is anticipated. Individual hospitals will be surveyed to determine local policies and service provision. Variations in outcomes will be investigated using regression modelling to adjust for confounders. Research ethics approval is not required for this study and has been confirmed by the online National Research Ethics Service (NRES) decision tool. This novel study will investigate how hospital-level surgical provision can affect patient outcomes, using a cross-sectional methodology. The results are essential to inform commissioning groups and implement changes within the National Health Service (NHS). Dissemination of the study protocol is primarily through the trainee-led research collaboratives and the Association of Upper Gastrointestinal Surgeons (AUGIS). Individual centres will have access to their own results and the collective results of the study will be published in peer-reviewed journals and presented at relevant

The Bipolar Illness Onset study: research protocol for the BIO cohort study.

Science.gov (United States)

Kessing, Lars Vedel; Munkholm, Klaus; Faurholt-Jepsen, Maria; Miskowiak, Kamilla Woznica; Nielsen, Lars Bo; Frikke-Schmidt, Ruth; Ekstrøm, Claus; Winther, Ole; Pedersen, Bente Klarlund; Poulsen, Henrik Enghusen; McIntyre, Roger S; Kapczinski, Flavio; Gattaz, Wagner F; Bardram, Jakob; Frost, Mads; Mayora, Oscar; Knudsen, Gitte Moos; Phillips, Mary; Vinberg, Maj

2017-06-23

Bipolar disorder is an often disabling mental illness with a lifetime prevalence of 1%-2%, a high risk of recurrence of manic and depressive episodes, a lifelong elevated risk of suicide and a substantial heritability. The course of illness is frequently characterised by progressive shortening of interepisode intervals with each recurrence and increasing cognitive dysfunction in a subset of individuals with this condition. Clinically, diagnostic boundaries between bipolar disorder and other psychiatric disorders such as unipolar depression are unclear although pharmacological and psychological treatment strategies differ substantially. Patients with bipolar disorder are often misdiagnosed and the mean delay between onset and diagnosis is 5-10 years. Although the risk of relapse of depression and mania is high it is for most patients impossible to predict and consequently prevent upcoming episodes in an individual tailored way. The identification of objective biomarkers can both inform bipolar disorder diagnosis and provide biological targets for the development of new and personalised treatments. Accurate diagnosis of bipolar disorder in its early stages could help prevent the long-term detrimental effects of the illness.The present Bipolar Illness Onset study aims to identify (1) a composite blood-based biomarker, (2) a composite electronic smartphone-based biomarker and (3) a neurocognitive and neuroimaging-based signature for bipolar disorder. The study will include 300 patients with newly diagnosed/first-episode bipolar disorder, 200 of their healthy siblings or offspring and 100 healthy individuals without a family history of affective disorder. All participants will be followed longitudinally with repeated blood samples and other biological tissues, self-monitored and automatically generated smartphone data, neuropsychological tests and a subset of the cohort with neuroimaging during a 5 to 10-year study period. The study has been approved by the Local

The Bipolar Illness Onset study: research protocol for the BIO cohort study

Science.gov (United States)

Munkholm, Klaus; Faurholt-Jepsen, Maria; Miskowiak, Kamilla Woznica; Nielsen, Lars Bo; Frikke-Schmidt, Ruth; Ekstrøm, Claus; Winther, Ole; Pedersen, Bente Klarlund; Poulsen, Henrik Enghusen; McIntyre, Roger S; Kapczinski, Flavio; Gattaz, Wagner F; Bardram, Jakob; Frost, Mads; Mayora, Oscar; Knudsen, Gitte Moos; Phillips, Mary; Vinberg, Maj

2017-01-01

Introduction Bipolar disorder is an often disabling mental illness with a lifetime prevalence of 1%–2%, a high risk of recurrence of manic and depressive episodes, a lifelong elevated risk of suicide and a substantial heritability. The course of illness is frequently characterised by progressive shortening of interepisode intervals with each recurrence and increasing cognitive dysfunction in a subset of individuals with this condition. Clinically, diagnostic boundaries between bipolar disorder and other psychiatric disorders such as unipolar depression are unclear although pharmacological and psychological treatment strategies differ substantially. Patients with bipolar disorder are often misdiagnosed and the mean delay between onset and diagnosis is 5–10 years. Although the risk of relapse of depression and mania is high it is for most patients impossible to predict and consequently prevent upcoming episodes in an individual tailored way. The identification of objective biomarkers can both inform bipolar disorder diagnosis and provide biological targets for the development of new and personalised treatments. Accurate diagnosis of bipolar disorder in its early stages could help prevent the long-term detrimental effects of the illness. The present Bipolar Illness Onset study aims to identify (1) a composite blood-based biomarker, (2) a composite electronic smartphone-based biomarker and (3) a neurocognitive and neuroimaging-based signature for bipolar disorder. Methods and analysis The study will include 300 patients with newly diagnosed/first-episode bipolar disorder, 200 of their healthy siblings or offspring and 100 healthy individuals without a family history of affective disorder. All participants will be followed longitudinally with repeated blood samples and other biological tissues, self-monitored and automatically generated smartphone data, neuropsychological tests and a subset of the cohort with neuroimaging during a 5 to 10-year study period. Ethics

Study protocol for the Maule Cohort (MAUCO) of chronic diseases, Chile 2014-2024.

Science.gov (United States)

Ferreccio, Catterina; Roa, Juan Carlos; Bambs, Claudia; Vives, Alejandra; Corvalán, Alejandro H; Cortés, Sandra; Foerster, Claudia; Acevedo, Johanna; Huidobro, Andrea; Passi, Alvaro; Toro, Pablo; Covacevich, Yerko; de la Cruz, Rolando; Koshiol, Jill; Olivares, Mauricio; Miquel, Juan Francisco; Cruz, Francisco; Silva, Raúl; Quest, Andrew F; Kogan, Marcelo J; Castro, Pablo F; Lavandero, Sergio

2016-02-04

Maule Cohort (MAUCO), a Chilean cohort study, seeks to analyze the natural history of chronic diseases in the agricultural county of Molina (40,000 inhabitants) in the Maule Region, Chile. Molina´s population is of particular interest because in the last few decades it changed from being undernourished to suffering excess caloric intake, and it currently has the highest national rates of cardiovascular diseases, stomach cancer and gallbladder cancer. Between 2009 and 2011 Molina´s poverty rate dropped from 24.1 % to 13.5 % (national average 20.4 %); in this period the county went from insufficient to almost complete basic sanitation. Despite these advances, chemical pollutants in the food and air are increasing. Thus, in Molina risk factors typical of both under-developed and developed countries coexist, generating a unique profile associated with inflammation, oxidative stress and chronic diseases. MAUCO is the core project of the recently established Advanced Center for Chronic Diseases (ACCDiS), Universidad de Chile & Pontificia Universidad Católica de Chile. In this study, we are enrolling and following 10,000 adults aged 38 to 74 years over 10 years. All eligible Molina residents will be enrolled. Participants were identified through a household census. Consenting individuals answer an epidemiological survey exploring risk factors (psycho-social, pesticides, diet, alcohol, and physical activity), medical history and physical and cognitive conditions; provide fasting blood, urine, and saliva samples; receive an electrocardiogram, abdominal ultrasound and bio-impedance test; and take a hand-grip strength test. These subjects will be re-interviewed after 2, 5 and 7 years. Active surveillance of health events is in place throughout the regional healthcare system. The MAUCO Bio-Bank will store 30 to 50 aliquots per subject using an NIH/NCI biorepository system for secure and anonymous linkage of samples with data. MAUCO´s results will help design public health

Impact of CAre-related Regret Upon Sleep (ICARUS) cohort study: protocol of a 3-year multicentre, international, prospective cohort study of novice healthcare professionals.

Science.gov (United States)

Cheval, Boris; Cullati, Stéphane; Pihl-Thingvad, Jesper; Mongin, Denis; Von Arx, Martina; Chopard, Pierre; Courvoisier, Delphine S

2018-03-27

Healthcare professionals are particularly at risk of developing numerous physical and psychological health problems. The experiences of emotional burden associated with providing healthcare, notably care-related regret, have been associated with these health problems, but only using cross-sectional data so far. Evidence of a causal impact of regret has not been assessed. The Impact of CAre-related Regret Upon Sleep (ICARUS) study is the first prospective and international cohort study established to examine how newly practising healthcare professionals adapt to their challenging job by assessing the impact of care-related regret on sleep and job quitting. The ICARUS cohort study will include newly practising healthcare professionals working in acute care hospitals and clinics recruited between May 2017 and November 2019. Data collection, which will begin as soon as the participant starts working with patients, will consist of a 1-year weekly assessment using a secure web survey. Follow-up data will be collected at 6, 12, 18 and 24 months after the end of the first year. We will collect detailed information on the experience of care-related regret (ie, highest regret intensity, accumulation of regrets and coping strategies related to regrets), sleep problems and job quitting. Moreover, quality of life, health status and burnout will be assessed during the follow-up. Several confounders factors, including sociodemographic characteristics, personality, night shifts and work environment characteristics, will be assessed. The study was approved by the Ethics Committee of Geneva Canton, Switzerland (CCER2016-02041), the Ethics Committee of London South Bank University (HSCSEP/17/06) and the University Research Ethics Committee of Bedfordshire (UREC106). Other study centres deemed local ethical approval unnecessary since the main ethics committee (Geneva) had already accepted the project. Results will be published in relevant scientific journals and be disseminated in

HIV cohort collaborations: proposal for harmonization of data exchange

DEFF Research Database (Denmark)

Kjær, Jesper; Ledergerber, Bruno

2004-01-01

than can be achieved with the individual studies. This requires each cohort to map data into a standard format before merging. Until recently, this standard format has differed for each such collaborative analysis. We have therefore developed the HIV Cohort Data Exchange Protocol (HICDEP), which...... is freely available at http://www.cphiv.dk/HICDEP.pdf. Once individual cohorts have set up a means of transfering data into this format, as and when required, this should greatly facilitate data merging for future joint analyses. The HICDEP incorporates data from HIV drug resistance tests, which have been...

Cohort profile: the Spanish WORKing life Social Security (WORKss) cohort study.

Science.gov (United States)

López Gómez, María Andrée; Durán, Xavier; Zaballa, Elena; Sanchez-Niubo, Albert; Delclos, George L; Benavides, Fernando G

2016-03-07

The global economy is changing the labour market and social protection systems in Europe. The effect of both changes on health needs to be monitored in view of an ageing population and the resulting increase in prevalence of chronic health conditions. The Spanish WORKing life Social Security (WORKss) cohort study provides unique longitudinal data to study the impact of labour trajectories and employment conditions on health, in terms of sickness absence, permanent disability and death. The WORKss cohort originated from the Continuous Working Life Sample (CWLS) generated by the General Directorate for the Organization of the Social Security in Spain. The CWLS contains a 4% representative sample of all individuals in contact with the Social Security system. The WORKss cohort exclusively includes individuals with a labour trajectory from 1981 or later. In 2004, the cohort was initiated with 1,022 ,79 Social Security members: 840,770 (82.2%) contributors and 182,009 (17.8%) beneficiaries aged 16 and older. The WORKss cohort includes demographic characteristics, chronological data about employment history, retirement, permanent disability and death. These data make possible the measurement of incidence of permanent disability, the number of potential years of working life lost, and the number of contracts and inactive periods with the Social Security system. The WORKss cohort was linked to temporary sickness absence registries to study medical diagnoses that lead to permanent disability and consequently to an earlier exit from the labour market in unhealthy conditions. Thanks to its administrative source, the WORKss cohort study will continue follow-up in the coming years, keeping the representativeness of the Spanish population affiliated to the Social Security system. The linkage between the WORKss cohort and temporary sickness absence registries is envisioned to continue. Future plans include the linkage of the cohort with mortality registries. Published by the BMJ

Fast diffusion tensor magnetic resonance imaging of the mouse brain at ultrahigh-field: aiming at cohort studies.

Directory of Open Access Journals (Sweden)

Hans-Peter Müller

Full Text Available INTRODUCTION: In-vivo high resolution diffusion tensor imaging (DTI of the mouse brain is often limited by the low signal to noise ratio (SNR resulting from the required small voxel sizes. Recently, cryogenically cooled resonators (CCR have demonstrated significant increase of the effective SNR. It is the objective of this study to enable fast DTI of the mouse brain. In this context, CCRs appear attractive for SNR improvement. METHODS: Three mice underwent a DTI examination at 156²×250 µm³ spatial resolution with a CCR at ultrahigh field (11.7T. Diffusion images were acquired along 30 gradient directions plus 5 references without diffusion encoding, resulting in a total acquisition time of 35 minutes. For comparison, mice additionally underwent a standardized 110 minutes acquisition protocol published earlier. Fractional anisotropy (FA and fiber tracking (FT results including quantitative tractwise fractional anisotropy statistics (TFAS were qualitatively and quantitatively compared. RESULTS: Qualitative and quantitative assessment of the calculated fractional anisotropy maps and fibre tracking results showed coinciding outcome comparing 35 minute scans to the standardized 110 minute scan. Coefficients of variation for ROI-based FA-comparison as well as for TFAS revealed comparable results for the different scanning protocols. CONCLUSION: Mouse DTI at 11.7 T was performed with an acquisition time of approximately 30 minutes, which is considered feasible for cohort studies. The rapid acquisition protocol reveals reliable and reproducible FA-values and FT reconstructions, thus allowing an experimental setup for in-vivo large scale whole brain murine DTI cohort studies.

Cohort Profile : LifeLines, a three-generation cohort study and biobank

NARCIS (Netherlands)

Scholtens, Salome; Smidt, Nynke; Swertz, Morris A.; Bakker, Stephan J. L.; Dotinga, Aafje; Vonk, Judith M.; van Dijk, Freerk; van Zon, Sander K. R.; Wijmenga, Cisca; Wolffenbuttel, Bruce H. R.; Stolk, Ronald P.

The LifeLines Cohort Study is a large population-based cohort study and biobank that was established as a resource for research on complex interactions between environmental, phenotypic and genomic factors in the development of chronic diseases and healthy ageing. Between 2006 and 2013, inhabitants

A protocol for resuscitation of severe burn patients guided by transpulmonary thermodilution and lactate levels: a 3-year prospective cohort study.

Science.gov (United States)

Sánchez, Manuel; García-de-Lorenzo, Abelardo; Herrero, Eva; Lopez, Teresa; Galvan, Beatriz; Asensio, María; Cachafeiro, Lucia; Casado, Cesar

2013-08-15

The use of urinary output and vital signs to guide initial burn resuscitation may lead to suboptimal resuscitation. Invasive hemodynamic monitoring may result in over-resuscitation. This study aimed to evaluate the results of a goal-directed burn resuscitation protocol that used standard measures of mean arterial pressure (MAP) and urine output, plus transpulmonary thermodilution (TPTD) and lactate levels to adjust fluid therapy to achieve a minimum level of preload to allow for sufficient vital organ perfusion. We conducted a three-year prospective cohort study of 132 consecutive critically burned patients. These patients underwent resuscitation guided by MAP (>65 mmHg), urinary output (0.5 to 1 ml/kg), TPTD and lactate levels. Fluid therapy was adjusted to achieve a cardiac index (CI) >2.5 L/minute/m² and an intrathoracic blood volume index (ITBVI) >600 ml/m2, and to optimize lactate levels. Statistical analysis was performed using mixed models. We also used Pearson or Spearman methods and the Mann-Whitney U-test. A total of 98 men and 34 women (mean age, 48 ± 18 years) was studied. The mean total body surface area (TBSA) burned was 35% ± 22%. During the early resuscitation phase, lactate levels were elevated (2.58 ± 2.05 mmol/L) and TPTD showed initial hypovolemia by the CI (2.68 ± 1.06 L/minute/m²) and the ITBVI (709 ± 254 mL/m²). At 24 to 32 hours, the CI and lactic levels were normalized, although the ITBVI remained below the normal range (744 ± 276 ml/m²). The mean fluid rate required to achieve protocol targets in the first 8 hours was 4.05 ml/kg/TBSA burned, which slightly increased in the next 16 hours. Patients with a urine output greater than or less than 0.5 ml/kg/hour did not show differences in heart rate, mean arterial pressure, CI, ITBVI or lactate levels. Initial hypovolemia may be detected by TPTD monitoring during the early resuscitation phase. This hypovolemia might not be reflected by blood pressure and hourly urine output. An

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol.

Science.gov (United States)

Buttolph, Jasmine; Inwani, Irene; Agot, Kawango; Cleland, Charles M; Cherutich, Peter; Kiarie, James N; Osoti, Alfred; Celum, Connie L; Baeten, Jared M; Nduati, Ruth; Kinuthia, John; Hallett, Timothy B; Alsallaq, Ramzi; Kurth, Ann E

2017-03-08

Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (Pr

MR imaging of the brain in large cohort studies: feasibility report of the population- and patient-based BiDirect study

International Nuclear Information System (INIS)

Teuber, Anja; Berger, Klaus; Wersching, Heike; Sundermann, Benedikt; Kugel, Harald; Schwindt, Wolfram; Heindel, Walter; Minnerup, Jens; Dannlowski, Udo

2017-01-01

To describe the implementation and protocol of cerebral magnetic resonance imaging (MRI) in the longitudinal BiDirect study and to report rates of study participation as well as management of incidental findings. Data came from the BiDirect study that investigates the relationship between depression and arteriosclerosis and comprises 2258 participants in three cohorts: 999 patients with depression, 347 patients with manifest cardiovascular disease (CVD) and 912 population-based controls. The study program includes MRI of the brain. Reasons for non-participation were systematically collected. Incidental findings were categorized and disclosed according to clinical relevance. At baseline 2176 participants were offered MRI, of whom 1453 (67 %) completed it. Reasons for non-participation differed according to cohort, age and gender with controls showing the highest participation rate of 79 %. Patient cohorts had higher refusal rates and CVD patients a high prevalence of contraindications. In the first follow-up examination 69 % of participating subjects completed MRI. Incidental findings were disclosed to 246 participants (17 %). The majority of incidental findings were extensive white matter hyperintensities requiring further diagnostic work-up. Knowledge about subjects and sensible definition of incidental findings are crucial for large-scale imaging projects. Our data offer practical and concrete information for the design of future studies. (orig.)

MR imaging of the brain in large cohort studies: feasibility report of the population- and patient-based BiDirect study

Energy Technology Data Exchange (ETDEWEB)

Teuber, Anja; Berger, Klaus; Wersching, Heike [University of Muenster, Institute of Epidemiology and Social Medicine, Muenster (Germany); Sundermann, Benedikt; Kugel, Harald; Schwindt, Wolfram; Heindel, Walter [University Hospital Muenster, Department of Clinical Radiology, Muenster (Germany); Minnerup, Jens [University Hospital Muenster, Department of Neurology, Muenster (Germany); Dannlowski, Udo [University of Muenster, Department of Psychiatry, Muenster (Germany); University of Marburg, Department of Psychiatry, Marburg (Germany)

2017-01-15

To describe the implementation and protocol of cerebral magnetic resonance imaging (MRI) in the longitudinal BiDirect study and to report rates of study participation as well as management of incidental findings. Data came from the BiDirect study that investigates the relationship between depression and arteriosclerosis and comprises 2258 participants in three cohorts: 999 patients with depression, 347 patients with manifest cardiovascular disease (CVD) and 912 population-based controls. The study program includes MRI of the brain. Reasons for non-participation were systematically collected. Incidental findings were categorized and disclosed according to clinical relevance. At baseline 2176 participants were offered MRI, of whom 1453 (67 %) completed it. Reasons for non-participation differed according to cohort, age and gender with controls showing the highest participation rate of 79 %. Patient cohorts had higher refusal rates and CVD patients a high prevalence of contraindications. In the first follow-up examination 69 % of participating subjects completed MRI. Incidental findings were disclosed to 246 participants (17 %). The majority of incidental findings were extensive white matter hyperintensities requiring further diagnostic work-up. Knowledge about subjects and sensible definition of incidental findings are crucial for large-scale imaging projects. Our data offer practical and concrete information for the design of future studies. (orig.)

The Horsens-Aarhus Femoro Acetabular Impingement (HAFAI) cohort: outcome of arthroscopic treatment for femoroacetabular impingement. Protocol for a prospective cohort study.

Science.gov (United States)

Kierkegaard, Signe; Lund, Bent; Dalgas, Ulrik; Sørensen, Henrik; Søballe, Kjeld; Mechlenburg, Inger

2015-09-07

During the past decade, it has become increasingly more common to offer hip arthroscopic surgery when treating people with femoroacetabular impingement (FAI). Nevertheless, the latest reviews conclude that it still remains to be properly investigated how surgery affects the patients. Specifically, detailed information on the functional, muscular and mechanical impact of surgery in larger groups is lacking. Furthermore, the long-term outcome of the surgery is still to be investigated. In this prospective cohort study, a total of 60 patients with FAI scheduled for arthroscopic surgery will be followed and tested preoperatively, and again after 3, 6, 9 and 12 months. Assessment includes isokinetic dynamometry evaluating hip flexion and extension; evaluation of functional capacity in a three-dimensional motion laboratory; pain assessment; self-reported function, quality of life, expectation and satisfaction with the surgery; recording of previous and present sporting activities and accelerometry. In addition, data on surgical procedure, rehabilitation progress, adverse events and failure will be recorded. Patients will be compared with an age-matched and gender-matched reference group of 30 persons with no hip, knee, ankle or back problems. Long-term follow-up of this cohort may evaluate possible reoperations and development of hip osteoarthritis. Furthermore, analysis on how subgroups respond to the treatment could be performed together with identification of possible "non-responders". The study is approved by the Central Denmark Region Committee on Biomedical Research Ethics (Journal No 1-10-72-239-14). The results from this study will be presented at national and international congresses and published in peer-reviewed journals. NCT02306525. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The costs and cost-effectiveness of an integrated sepsis treatment protocol.

Science.gov (United States)

Talmor, Daniel; Greenberg, Dan; Howell, Michael D; Lisbon, Alan; Novack, Victor; Shapiro, Nathan

2008-04-01

Sepsis is associated with high mortality and treatment costs. International guidelines recommend the implementation of integrated sepsis protocols; however, the true cost and cost-effectiveness of these are unknown. To assess the cost-effectiveness of an integrated sepsis protocol, as compared with conventional care. Prospective cohort study of consecutive patients presenting with septic shock and enrolled in the institution's integrated sepsis protocol. Clinical and economic outcomes were compared with a historical control cohort. Beth Israel Deaconess Medical Center. Overall, 79 patients presenting to the emergency department with septic shock in the treatment cohort and 51 patients in the control group. An integrated sepsis treatment protocol incorporating empirical antibiotics, early goal-directed therapy, intensive insulin therapy, lung-protective ventilation, and consideration for drotrecogin alfa and steroid therapy. In-hospital treatment costs were collected using the hospital's detailed accounting system. The cost-effectiveness analysis was performed from the perspective of the healthcare system using a lifetime horizon. The primary end point for the cost-effectiveness analysis was the incremental cost per quality-adjusted life year gained. Mortality in the treatment group was 20.3% vs. 29.4% in the control group (p = .23). Implementing an integrated sepsis protocol resulted in a mean increase in cost of approximately $8,800 per patient, largely driven by increased intensive care unit length of stay. Life expectancy and quality-adjusted life years were higher in the treatment group; 0.78 and 0.54, respectively. The protocol was associated with an incremental cost of $11,274 per life-year saved and a cost of $16,309 per quality-adjusted life year gained. In patients with septic shock, an integrated sepsis protocol, although not cost-saving, appears to be cost-effective and compares very favorably to other commonly delivered acute care interventions.

Danish method study on cervical screening in women offered HPV vaccination as girls (Trial23): a study protocol.

Science.gov (United States)

Thamsborg, Lise Holst; Andersen, Berit; Larsen, Lise Grupe; Christensen, Jette; Johansen, Tonje; Hariri, Jalil; Christiansen, Sanne; Rygaard, Carsten; Lynge, Elsebeth

2018-05-26

The first birth cohorts of women offered human papillomavirus (HPV) vaccination as girls are now entering cervical screening. However, there is no international consensus on how to screen HPV vaccinated women. These women are better protected against cervical cancer and could therefore be offered less intensive screening. Primary HPV testing is more sensitive than cytology, allowing for a longer screening interval. The aim of Trial23 is to investigate if primary HPV testing with cytology triage of HPV positive samples is a reasonable screening scheme for women offered HPV vaccination as girls. Trial23 is a method study embedded in the existing cervical screening programme in four out of five Danish regions. Without affecting the screening programme, women born in 1994 are randomised to present screening with liquid-based cytology every third year (present programme arm) or present screening plus an HPV test (HPV arm). The study started 1 February 2017 and will run over three screening rounds corresponding to 7-8 years. The primary endpoint is cervical intraepithelial neoplasia grade 3 or above. The trial is undertaken as a non-inferiority study including intention-to-treat and per-protocol analyses. The potential effect of primary HPV screening with a 6-year interval will be calculated from the observed data. The study protocol has been submitted to the ethical committee and deemed a method study. All women are screened according to routine guidelines. The study will contribute new evidence on the future screening of HPV vaccinated birth cohorts of women. All results will be published in open-access journal. NCT03049553; 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.

Standardized Duplex Ultrasound-Based Protocol for Early Diagnosis of Transplant Renal Artery Stenosis: Results of a Single-Institution Retrospective Cohort Study

Directory of Open Access Journals (Sweden)

Vincenzo Li Marzi

2018-01-01

Full Text Available Transplant renal artery stenosis (TRAS is the most frequent vascular complication after kidney transplantation (KT and has been associated with potentially reversible refractory hypertension, graft dysfunction, and reduced patient survival. The aim of the study is to describe the outcomes of a standardized Duplex Ultrasound- (DU- based screening protocol for early diagnosis of TRAS and for selection of patients potentially requiring endovascular intervention. We retrospectively reviewed our prospectively collected database of KT from January 1998 to select patients diagnosed with TRAS. The follow-up protocol was based on a risk-adapted, dynamic subdivision of eligible KT patients in different risk categories (RC with different protocol strategies (PS. Of 598 patients included in the study, 52 (9% patients had hemodynamically significant TRAS and underwent percutaneous angioplasty (PTA and stent placement. Technical and clinical success rates were 97% and 90%, respectively. 7 cases of restenosis were recorded at follow-up and treated with re-PTA plus stenting. Both DU imaging and clinical parameters improved after stent placement. Prospective high-quality studies are needed to test the efficacy and safety of our protocol in larger series. Accurate trial design and standardized reporting of patient outcomes will be key to address the current clinical needs.

Peripheral ARtery Atherosclerotic DIsease and SlEep disordered breathing (PARADISE) trial - protocol for an observational cohort study.

Science.gov (United States)

Szymański, Filip M; Gałązka, Zbigniew; Płatek, Anna E; Górko, Dariusz; Ostrowski, Tomasz; Adamkiewicz, Karolina; Łęgosz, Paweł; Ryś, Anna; Semczuk-Kaczmarek, Karolina; Celejewski, Krzysztof; Filipiak, Krzysztof J

2017-01-01

Peripheral arterial disease (PAD) is in fact a group of disease entities with different symptoms and course but a common underlying cause, i.e. atherosclerosis. Atherosclerosis is known to be aggravated by several cardiovascular risk factors, including obstructive sleep apnoea (OSA). Following paper is a protocol for the Peripheral ARtery Atherosclerotic DIsease and SlEep disordered breathing (PARADISE) trial, which aims to describe the prevalence of OSA in PAD patients scheduled for revascularisation, and to determine the effect of OSA on the procedure outcomes. The PARADISE study is an observational cohort trial. It plans to include 200 consecutive patients hospitalised for revascularisation due to PAD. In every patient an overnight sleep study will be performed to diagnose sleep disorders. Accord¬ing to the results of the test, patients will be divided into two groups: group A - patients with OSA, and group B - patients without OSA (control group). All patients will also be screened for classical and non-classical cardiovascular risk factors. In some of the patients, during surgery, a fragment of atherosclerotic plaque will be collected for further testing. Patients will be followed for one year for adverse events and end-points. Primary end-point of the study will be the failure of revascularisa¬tion defined as recurrence or new onset of the symptoms of ischaemia from the treated region, a need for re-operation or procedure revision, or recurrence of ischaemia signs on the imaging tests. The data obtained will help determine the incidence of OSA in the population of patients with PAD. The au¬thors expect to show that, as with other cardiovascular diseases associated with atherosclerosis, also in patients with PAD the incidence of undiagnosed OSA is high and its presence is associated with elevated cholesterol, inflammatory markers, and higher prevalence of arterial hypertension and poor control of other cardiovascular risk factors. In addition, due to

Cohort profile: the lidA Cohort Study-a German Cohort Study on Work, Age, Health and Work Participation.

Science.gov (United States)

Hasselhorn, Hans Martin; Peter, Richard; Rauch, Angela; Schröder, Helmut; Swart, Enno; Bender, Stefan; du Prel, Jean-Baptist; Ebener, Melanie; March, Stefanie; Trappmann, Mark; Steinwede, Jacob; Müller, Bernd Hans

2014-12-01

The lidA Cohort Study (German Cohort Study on Work, Age, Health and Work Participation) was set up to investigate and follow the effects of work and work context on the physical and psychological health of the ageing workforce in Germany and subsequently on work participation. Cohort participants are initially employed people subject to social security contributions and born in either 1959 (n = 2909) or 1965 (n = 3676). They were personally interviewed in their homes in 2011 and will be visited every 3 years. Data collection comprises socio-demographic data, work and private exposures, work ability, work and work participation attitudes, health, health-related behaviour, personality and attitudinal indicators. Employment biographies are assessed using register data. Subjective health reports and physical strength measures are complemented by health insurance claims data, where permission was given. A conceptual framework has been developed for the lidA Cohort Study within which three confirmatory sub-models assess the interdependencies of work and health considering age, gender and socioeconomic status. The first set of the data will be available to the scientific community by 2015. Access will be given by the Research Data Centre of the German Federal Employment Agency at the Institute for Employment Research (http://fdz.iab.de/en.aspx). © The Author 2014. Published by Oxford University Press on behalf of the International Epidemiological Association.

Validating prediction scales of type 2 diabetes mellitus in Spain: the SPREDIA-2 population-based prospective cohort study protocol

Science.gov (United States)

Salinero-Fort, Miguel Ángel; de Burgos-Lunar, Carmen; Mostaza Prieto, José; Lahoz Rallo, Carlos; Abánades-Herranz, Juan Carlos; Gómez-Campelo, Paloma; Laguna Cuesta, Fernando; Estirado De Cabo, Eva; García Iglesias, Francisca; González Alegre, Teresa; Fernández Puntero, Belén; Montesano Sánchez, Luis; Vicent López, David; Cornejo Del Río, Víctor; Fernández García, Pedro J; Sabín Rodríguez, Concesa; López López, Silvia; Patrón Barandío, Pedro

2015-01-01

Introduction The incidence of type 2 diabetes mellitus (T2DM) is increasing worldwide. When diagnosed, many patients already have organ damage or advance subclinical atherosclerosis. An early diagnosis could allow the implementation of lifestyle changes and treatment options aimed at delaying the progression of the disease and to avoid cardiovascular complications. Different scores for identifying undiagnosed diabetes have been reported, however, their performance in populations of southern Europe has not been sufficiently evaluated. The main objectives of our study are: to evaluate the screening performance and cut-off points of the main scores that identify the risk of undiagnosed T2DM and prediabetes in a Spanish population, and to develop and validate our own predictive models of undiagnosed T2DM (screening model), and future T2DM (prediction risk model) after 5-year follow-up. As a secondary objective, we will evaluate the atherosclerotic burden of the population with undiagnosed T2DM. Methods and analysis Population-based prospective cohort study with baseline screening, to evaluate the performance of the FINDRISC, DANISH, DESIR, ARIC and QDScore, against the gold standard tests: Fasting plasma glucose, oral glucose tolerance and/or HbA1c. The sample size will include 1352 participants between the ages of 45 and 74 years. Analysis: sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio positive, likelihood ratio negative and receiver operating characteristic curves and area under curve. Binary logistic regression for the first 700 individuals (derivation) and last 652 (validation) will be performed. All analyses will be calculated with their 95% CI; statistical significance will be p<0.05. Ethics and dissemination The study protocol has been approved by the Research Ethics Committee of the Carlos III Hospital (Madrid). The score performance and predictive model will be presented in medical conferences, workshops

Optimizing the high-resolution manometry (HRM) study protocol.

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Patel, A; Ding, A; Mirza, F; Gyawali, C P

2015-02-01

Intolerance of the esophageal manometry catheter may prolong high-resolution manometry (HRM) studies and increase patient distress. We assessed the impact of obtaining the landmark phase at the end of the study when the patient has acclimatized to the HRM catheter. 366 patients (mean age 55.4 ± 0.8 years, 62.0% female) undergoing esophageal HRM over a 1-year period were studied. The standard protocol consisted of the landmark phase, 10 5 mL water swallows 20-30 s apart, and multiple rapid swallows where 4-6 2 mL swallows were administered in rapid succession. The modified protocol consisted of the landmark phase at the end of the study after test swallows. Study duration, technical characteristics, indications, and motor findings were compared between standard and modified protocols. Of the 366 patients, 89.6% underwent the standard protocol (study duration 12.9 ± 0.3 min). In 10.4% with poor catheter tolerance undergoing the modified protocol, study duration was significantly longer (15.6 ± 1.0 min, p = 0.004) despite similar duration of study maneuvers. Only elevated upper esophageal sphincter basal pressures at the beginning of the study segregated modified protocol patients. The 95th percentile time to landmark phase in the standard protocol patients was 6.1 min; as many as 31.4% of modified protocol patients could not obtain their first study maneuver within this period (p = 0.0003). Interpretation was not impacted by shifting the landmark phase to the end of the study. Modification of the HRM study protocol with the landmark phase obtained at the end of the study optimizes study duration without compromising quality. © 2014 John Wiley & Sons Ltd.

Effects of a screening and treatment protocol with haloperidol on post-cardiotomy delirium: a prospective cohort study†

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Schrøder Pedersen, Sofie; Kirkegaard, Thomas; Balslev Jørgensen, Martin; Lind Jørgensen, Vibeke

2014-01-01

OBJECTIVES Post-cardiotomy delirium is common and associated with increased morbidity and mortality. No gold standard exists for detecting delirium, and evidence to support the choice of treatment is needed. Haloperidol is widely used for treating delirium, but indication, doses and therapeutic targets vary. Moreover, doubt has been raised regarding overall efficacy. The purpose of this study was to assess the effect of a combination of early detection and standardized treatment with haloperidol on post-cardiotomy delirium, with the hypothesis that the proportion of delirium- and coma-free days could be increased. Length of stay (LOS), complications and 180-day mortality are reported. METHODS Prospective interventional cohort study. One hundred and seventeen adult patients undergoing cardiac surgery were included before introduction of a screening and treatment protocol with haloperidol for delirium, and 123 patients were included after. Nurses screened patients using validated tools (the Delirium Observation Screening (DOS) scale and confusion assessment method for the intensive care unit (CAM-ICU)). In case of delirium, a checklist to eliminate precipitating/ inducing factors and a protocol for standardized dosing with haloperidol was applied. Group comparison was done using non-parametric tests and analysis of fractions, and associations between delirium and predefined covariates were analysed with logistic regression. RESULTS Incidence of delirium after cardiac surgery was 21 (14–29) and 22 (15–30) %, onset was on postoperative day 1 (1–4) and 1 (1–3), duration was 1 (1–4) day and 3 (1–5) days, respectively, with no significant difference (Period 1 vs 2, all values are given as the median and 95% confidence interval). The proportion of delirium- and coma-free days was 67 (61–73) and 65 (60–70) %, respectively (ns). There was no difference in LOS or complication rate. Delirium was associated to increasing age, increased length of stay and

Tranexamic acid use in severely injured civilian patients and the effects on outcomes: a prospective cohort study.

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Cole, Elaine; Davenport, Ross; Willett, Keith; Brohi, Karim

2015-02-01

To characterize the relationship between tranexamic acid (TXA) use and patient outcomes in a severely injured civilian cohort, and to determine any differential effect between patients who presented with and without shock. TXA has demonstrated survival benefits in trauma patients in an international randomized control trial and the military setting. The uptake of TXA into civilian major hemorrhage protocols (MHPs) has been variable. The evidence gap in mature civilian trauma systems is limiting the widespread use of TXA and its potential benefits on survival. Prospective cohort study of severely injured adult patients (Injury severity score > 15) admitted to a civilian trauma system during the adoption phase of TXA into the hospital's MHP. Outcomes measured were mortality, multiple organ failure (MOF), venous thromboembolism, infection, stroke, ventilator-free days (VFD), and length of stay. Patients receiving TXA (n = 160, 42%) were more severely injured, shocked, and coagulopathic on arrival. TXA was not independently associated with any change in outcome for either the overall or nonshocked cohorts. In multivariate analysis, TXA was independently associated with a reduction in MOF [odds ratio (OR) = 0.27, confidence interval (CI): 0.10-0.73, P = 0.01] and was protective for adjusted all-cause mortality (OR = 0.16 CI: 0.03-0.86, P = 0.03) in shocked patients. TXA as part of a major hemorrhage protocol within a mature civilian trauma system provides outcome benefits specifically for severely injured shocked patients.

The Canadian HIV and aging cohort study - determinants of increased risk of cardio-vascular diseases in HIV-infected individuals: rationale and study protocol.

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Durand, Madeleine; Chartrand-Lefebvre, Carl; Baril, Jean-Guy; Trottier, Sylvie; Trottier, Benoit; Harris, Marianne; Walmsley, Sharon; Conway, Brian; Wong, Alexander; Routy, Jean-Pierre; Kovacs, Colin; MacPherson, Paul A; Monteith, Kenneth Marc; Mansour, Samer; Thanassoulis, George; Abrahamowicz, Michal; Zhu, Zhitong; Tsoukas, Christos; Ancuta, Petronela; Bernard, Nicole; Tremblay, Cécile L

2017-09-11

With potent antiretroviral drugs, HIV infection is becoming a chronic disease. Emergence of comorbidities, particularly cardiovascular disease (CVD) has become a leading concern for patients living with the infection. We hypothesized that the chronic and persistent inflammation and immune activation associated with HIV disease leads to accelerated aging, characterized by CVD. This will translate into higher incidence rates of CVD in HIV infected participants, when compared to HIV negative participants, after adjustment for traditional CVD risk factors. When characterized further using cardiovascular imaging, biomarkers, immunological and genetic profiles, CVD associated with HIV will show different characteristics compared to CVD in HIV-negative individuals. The Canadian HIV and Aging cohort is a prospective, controlled cohort study funded by the Canadian Institutes of Health Research. It will recruit patients living with HIV who are aged 40 years or older or have lived with HIV for 15 years or more. A control population, frequency matched for age, sex, and smoking status, will be recruited from the general population. Patients will attend study visits at baseline, year 1, 2, 5 and 8. At each study visit, data on complete medical and pharmaceutical history will be captured, along with anthropometric measures, a complete physical examination, routine blood tests and electrocardiogram. Consenting participants will also contribute blood samples to a research biobank. The primary outcome is incidence of a composite of: myocardial infarction, coronary revascularization, stroke, hospitalization for angina or congestive heart failure, revascularization or amputation for peripheral artery disease, or cardiovascular death. Preplanned secondary outcomes are all-cause mortality, incidence of the metabolic syndrome, incidence of type 2 diabetes, incidence of renal failure, incidence of abnormal bone mineral density and body fat distribution. Patients participating to the

Canadian Alliance for Healthy Hearts and Minds: First Nations Cohort Study Rationale and Design.

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Anand, Sonia S; Abonyi, Sylvia; Arbour, Laura; Brook, Jeff; Bruce, Sharon; Castleden, Heather; Desai, Dipika; de Souza, Russell J; Harris, Stewart; Irvine, James; Lai, Christopher; Lewis, Diana; Oster, Richard T; Poirier, Paul; Toth, Ellen L; Bannon, Karen; Chrisjohn, Vicky; Davis, Albertha D; L'Hommecourt, Jean; Littlechild, Randy; McMullin, Kathleen; McIntosh, Sarah; Morrison, Julie; Picard, Manon; Landing First Nation, Pictou; M Thomas, Melissa; Tusevljak, Natasa; Friedrich, Matthias G; Tu, Jack V

2018-01-01

This is the first national indigenous cohort study in which a common, in-depth protocol with a common set of objectives has been adopted by several indigenous communities across Canada. The overarching objective of the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort is to investigate how the community-level environment is associated with individual health behaviors and the presence and progression of chronic disease risk factors and chronic diseases such as cardiovascular disease (CVD) and cancer. CAHHM aims to recruit approximately 2,000 First Nations indigenous individuals from up to nine communities across Canada and have participants complete questionnaires, blood collection, physical measurements, cognitive assessments, and magnetic resonance imaging (MRI). Through individual- and community-level data collection, we will develop an understanding of the specific role of the socioenvironmental, biological, and contextual factors have on the development of chronic disease risk factors and chronic diseases. Information collected in the indigenous cohort will be used to assist communities to develop local management strategies for chronic disease, and can be used collectively to understand the contextual, environmental, socioeconomic, and biological determinants of differences in health status in harmony with First Nations beliefs and reality.

Cohort profile: Pacific Islands Families (PIF) growth study, Auckland, New Zealand.

Science.gov (United States)

Rush, E; Oliver, M; Plank, L D; Taylor, S; Iusitini, L; Jalili-Moghaddam, S; Savila, F; Paterson, J; Tautolo, E

2016-11-02

This article profiles a birth cohort of Pacific children participating in an observational prospective study and describes the study protocol used at ages 14-15 years to investigate how food and activity patterns, metabolic risk and family and built environment are related to rates of physical growth of Pacific children. From 2000 to 2015, the Pacific Islands Families Study has followed, from birth, the growth and development of over 1000 Pacific children born in Auckland, New Zealand. In 2014, 931 (66%) of the original cohort had field measures of body composition, blood pressure and glycated haemoglobin. A nested subsample (n=204) was drawn by randomly selecting 10 males and 10 females from each decile of body weight. These participants had measurement of body composition by dual-energy X-ray absorptiometry, food frequency, 6 min walk test and accelerometer-determined physical activity and sedentary behaviours, and blood biomarkers for metabolic disease such as diabetes. Built environment variables were generated from individual addresses. Compared to the Centres for Disease Control and Prevention (CDC) reference population with mean SD scores (SDS) of 0, this cohort of 931 14-year-olds was taller, weighed more and had a higher body mass index (BMI) (mean SDS height >0.6, weight >1.6 and BMI >1.4). 7 of 10 youth were overweight or obese. The nested-sampling frame achieved an even distribution by body weight. Cross-sectional relationships between body size, fatness and growth rate, food patterns, activity patterns, pubertal development, risks for diabetes and hypertension and the family and wider environment will be examined. In addition, analyses will investigate relationships with data collected earlier in the life course and measures of the cohort in the future. Understanding past and present influences on child growth and health will inform timely interventions to optimise future health and reduce inequalities for Pacific people. Published by the BMJ

Cohort profile: Pacific Islands Families (PIF) growth study, Auckland, New Zealand

Science.gov (United States)

Rush, E; Oliver, M; Plank, L D; Taylor, S; Iusitini, L; Jalili-Moghaddam, S; Savila, F; Paterson, J; Tautolo, E

2016-01-01

Purpose This article profiles a birth cohort of Pacific children participating in an observational prospective study and describes the study protocol used at ages 14–15 years to investigate how food and activity patterns, metabolic risk and family and built environment are related to rates of physical growth of Pacific children. Participants From 2000 to 2015, the Pacific Islands Families Study has followed, from birth, the growth and development of over 1000 Pacific children born in Auckland, New Zealand. In 2014, 931 (66%) of the original cohort had field measures of body composition, blood pressure and glycated haemoglobin. A nested subsample (n=204) was drawn by randomly selecting 10 males and 10 females from each decile of body weight. These participants had measurement of body composition by dual-energy X-ray absorptiometry, food frequency, 6 min walk test and accelerometer-determined physical activity and sedentary behaviours, and blood biomarkers for metabolic disease such as diabetes. Built environment variables were generated from individual addresses. Findings to date Compared to the Centres for Disease Control and Prevention (CDC) reference population with mean SD scores (SDS) of 0, this cohort of 931 14-year-olds was taller, weighed more and had a higher body mass index (BMI) (mean SDS height >0.6, weight >1.6 and BMI >1.4). 7 of 10 youth were overweight or obese. The nested-sampling frame achieved an even distribution by body weight. Future plans Cross-sectional relationships between body size, fatness and growth rate, food patterns, activity patterns, pubertal development, risks for diabetes and hypertension and the family and wider environment will be examined. In addition, analyses will investigate relationships with data collected earlier in the life course and measures of the cohort in the future. Understanding past and present influences on child growth and health will inform timely interventions to optimise future health and reduce

The population-based Occupational and Environmental Health Prospective Cohort Study (AMIGO) in The Netherlands.

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Slottje, Pauline; Yzermans, C Joris; Korevaar, Joke C; Hooiveld, Mariëtte; Vermeulen, Roel C H

2014-11-26

Occupational and environmental exposures remain important modifiable risk factors of public health. Existing cohort studies are often limited by the level of detail of data collected on these factors and health. It is also often assumed that the more healthy group is over-represented in cohort studies, which is of concern for their external validity. In this cohort profile, we describe how we set up the population-based Occupational and Environmental Health Cohort Study (AMIGO) to longitudinally study occupational and environmental determinants of diseases and well-being from a multidisciplinary and life course point of view. Reviewed by the Medical Ethics Research Committee of the University Medical Center Utrecht (protocol 10-268/C). All cohort members participate voluntarily and gave informed consent prior to their inclusion. 14,829 adult cohort members (16% of those invited) consented and filled in the online baseline questionnaire. Determinants include chemical, biological, physical (eg, electromagnetic fields), and psychosocial factors. Priority health outcomes include cancer, neurological, cardiovascular and respiratory diseases and non-specific symptoms. Owing to the recruitment strategy via general practitioners of an established network, we also collect longitudinal data registered in their electronic medical records including symptoms, diagnosis and treatments. Besides the advantage of health outcomes that cannot be easily captured longitudinally by other means, this created a unique opportunity to assess health-related participation bias by comparing general practitioner-registered prevalence rates in the cohort and its source population. We found no indications of such a systematic bias. The major assets of the AMIGO approach are its detailed occupational and environmental determinants in combination with the longitudinal health data registered in general practice besides linkage to cancer and mortality registries and self-reported health. We are now

[Application of cohort study in cancer prevention and control].

Science.gov (United States)

Dai, Min; Bai, Yana; Pu, Hongquan; Cheng, Ning; Li, Haiyan; He, Jie

2016-03-01

Cancer control is a long-term work. Cancer research and intervention really need the support of cohort study. In the recent years, more and more cohort studies on cancer control were conducted in China along with the increased ability of scientific research in China. Since 2010, Cancer Hospital, Chinese Academy of Medical Sciences, collaborated with Lanzhou University and the Worker' s Hospital of Jinchuan Group Company Limited, have carried out a large-scale cohort study on cancer, which covered a population of more than 50 000 called " Jinchang cohort". Since 2012, a National Key Public Health Project, "cancer screening in urban China" , has been conducted in Jinchang, which strengthened the Jinchang cohort study. Based on the Jinchang cohort study, historical cohort study, cross-sectional study and prospective cohort study have been conducted, which would provide a lot of evidence for the cancer control in China.

Elder mistreatment in a community dwelling population: the Malaysian Elder Mistreatment Project (MAESTRO) cohort study protocol.

Science.gov (United States)

Choo, Wan Yuen; Hairi, Noran Naqiah; Sooryanarayana, Rajini; Yunus, Raudah Mohd; Hairi, Farizah Mohd; Ismail, Norliana; Kandiben, Shathanapriya; Mohd Ali, Zainudin; Ahmad, Sharifah Nor; Abdul Razak, Inayah; Othman, Sajaratulnisah; Tan, Maw Pin; Mydin, Fadzilah Hanum Mohd; Peramalah, Devi; Brownell, Patricia; Bulgiba, Awang

2016-05-25

Despite being now recognised as a global health concern, there is still an inadequate amount of research into elder mistreatment, especially in low and middle-income regions. The purpose of this paper is to report on the design and methodology of a population-based cohort study on elder mistreatment among the older Malaysian population. The study aims at gathering data and evidence to estimate the prevalence and incidence of elder mistreatment, identify its individual, familial and social determinants, and quantify its health consequences. This is a community-based prospective cohort study using randomly selected households from the national census. A multistage sampling method was employed to obtain a total of 2496 older adults living in the rural Kuala Pilah district. The study is divided into two phases: cross-sectional study (baseline), and a longitudinal follow-up study at the third and fifth years. Elder mistreatment was measured using instrument derived from the previous literature and modified Conflict Tactic Scales. Outcomes of elder mistreatment include mortality, physical function, mental health, quality of life and health utilisation. Logistic regression models are used to examine the relationship between risk factors and abuse estimates. Cox proportional hazard regression will be used to estimate risk of mortality associated with abuse. Associated annual rate of hospitalisation and health visit frequency, and reporting of abuse, will be estimated using Poisson regression. The study has been approved by the Medical Ethics Committee of the University of Malaya Medical Center (MEC Ref 902.2) and the Malaysian National Medical Research Register (NMRR-12-1444-11726). Written consent was obtained from all respondents prior to baseline assessment and subsequent follow-up. Findings will be disseminated to local stakeholders via forums with community leaders, and health and social welfare departments, and published in appropriate scientific journals and

[Ethical considerations in genomic cohort study].

Science.gov (United States)

Choi, Eun Kyung; Kim, Ock-Joo

2007-03-01

During the last decade, genomic cohort study has been developed in many countries by linking health data and genetic data in stored samples. Genomic cohort study is expected to find key genetic components that contribute to common diseases, thereby promising great advance in genome medicine. While many countries endeavor to build biobank systems, biobank-based genome research has raised important ethical concerns including genetic privacy, confidentiality, discrimination, and informed consent. Informed consent for biobank poses an important question: whether true informed consent is possible in population-based genomic cohort research where the nature of future studies is unforeseeable when consent is obtained. Due to the sensitive character of genetic information, protecting privacy and keeping confidentiality become important topics. To minimize ethical problems and achieve scientific goals to its maximum degree, each country strives to build population-based genomic cohort research project, by organizing public consultation, trying public and expert consensus in research, and providing safeguards to protect privacy and confidentiality.

Study protocol

DEFF Research Database (Denmark)

Smith, Benjamin E; Hendrick, Paul; Bateman, Marcus

2017-01-01

avoidance behaviours, catastrophising, self-efficacy, sport and leisure activity participation, and general quality of life. Follow-up will be 3 and 6 months. The analysis will focus on descriptive statistics and confidence intervals. The qualitative components will follow a thematic analysis approach....... DISCUSSION: This study will evaluate the feasibility of running a definitive large-scale trial on patients with patellofemoral pain, within the NHS in the UK. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from...... this study will inform the design of a multicentre trial. TRIAL REGISTRATION: ISRCTN35272486....

Factors and motivations associated with use of e-cigarette among primary care patients in a prospective cohort study: e-TAC study protocol

OpenAIRE

Kinouani, Sh?razade; Cast?ra, Philippe; Laporte, Catherine; P?tr?gne, Fran?ois; Gay, Bernard

2016-01-01

Introduction While the relationship between electronic cigarette use and smoking has often been studied, the association between electronic cigarette use and socioeconomic factors has received less attention. This is a study protocol aiming to describe the relationship between the consumption of psychoactive products (in particular: smoking) or some socioeconomic factors and the evolution of the use of electronic cigarette in primary healthcare over 1?year. Methods and analysis Electronic cig...

The Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals (RBANS-H) before and after Cochlear Implantation: A Protocol for a Prospective, Longitudinal Cohort Study.

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Claes, Annes J; Mertens, Griet; Gilles, Annick; Hofkens-Van den Brandt, Anouk; Fransen, Erik; Van Rompaey, Vincent; Van de Heyning, Paul

2016-01-01

Background: Currently, an independent relationship between hearing loss and cognitive decline in older adults is suggested by large prospective studies. In general, cochlear implants improve hearing and the quality of life in severely to profoundly hearing impaired older persons. However, little is known about the effects of cochlear implantation on the cognitive evolution in this population. Aim of the study: The primary goal of this prospective, longitudinal cohort study is to explore the cognitive profile of severely to profoundly postlingually hearing impaired subjects before and after cochlear implantation. In addition, the current study aims to investigate the relationship between the cognitive function, audiometric performances, quality of life, and self-reliance in these patients. Methods: Twenty-five patients aged 55 or older, scheduled for cochlear implantation, will be enrolled in the study. They will be examined prior to implantation, at 6 and 12 months after implantation and annually thereafter. The test battery consists of (1) a cognitive examination, using the Repeatable Battery for the Assessment of Neuropsychological Status adapted for Hearing impaired persons (RBANS-H), (2) an audiological examination, including unaided and aided pure tone audiometry, speech audiometry in quiet and speech audiometry in noise, (3) the administration of four questionnaires evaluating quality of life and subjective hearing benefit and (4) a semi-structured interview about the self-reliance of the participant. Discussion: Up until now only one study has been conducted on this topic, focusing on the short-term effects of cochlear implantation on cognition in older adults. The present study is the first study to apply a comprehensive neuropsychological assessment adapted for severely to profoundly hearing impaired subjects in order to investigate the cognitive capabilities before and after cochlear implantation. Trial registration: The present protocol is

Real-world effects of medications for chronic obstructive pulmonary disease: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results.

Science.gov (United States)

Wing, Kevin; Williamson, Elizabeth; Carpenter, James R; Wise, Lesley; Schneeweiss, Sebastian; Smeeth, Liam; Quint, Jennifer K; Douglas, Ian

2018-03-25

Chronic obstructive pulmonary disease (COPD) is a progressive disease affecting 3 million people in the UK, in which patients exhibit airflow obstruction that is not fully reversible. COPD treatment guidelines are largely informed by randomised controlled trial results, but it is unclear if these findings apply to large patient populations not studied in trials. Non-interventional studies could be used to study patient groups excluded from trials, but the use of these studies to estimate treatment effectiveness is in its infancy. In this study, we will use individual trial data to validate non-interventional methods for assessing COPD treatment effectiveness, before applying these methods to the analysis of treatment effectiveness within people excluded from, or under-represented in COPD trials. Using individual patient data from the landmark COPD Towards a Revolution in COPD Health (TORCH) trial and validated methods for detecting COPD and exacerbations in routinely collected primary care data, we will assemble a cohort in the UK Clinical Practice Research Datalink (selecting people between 1 January 2004 and 1 January 2017) with similar characteristics to TORCH participants and test whether non-interventional data can generate comparable results to trials, using cohort methodology with propensity score techniques to adjust for potential confounding. We will then use the methodological template we have developed to determine risks and benefits of COPD treatments in people excluded from TORCH. Outcomes are pneumonia, COPD exacerbation, mortality and time to treatment change. Groups to be studied include the elderly (>80 years), people with substantial comorbidity, people with and without underlying cardiovascular disease and people with mild COPD. Ethical approval has been granted by the London School of Hygiene & Tropical Medicine Ethics Committee (Ref: 11997). The study has been approved by the Independent Scientific Advisory Committee of the UK Medicines and

Estimated risk of radiation-induced cancer from paediatric chest CT: two-year cohort study

Energy Technology Data Exchange (ETDEWEB)

Niemann, Tilo [Cantonal Hospital Baden, Department of Radiology, Baden (Switzerland); University Lille Nord de France, Department of Thoracic Imaging, Hospital Calmette, Lille (France); Colas, Lucie; Santangelo, Teresa; Faivre, Jean Baptiste; Remy, Jacques; Remy-Jardin, Martine [University Lille Nord de France, Department of Thoracic Imaging, Hospital Calmette, Lille (France); Roser, Hans W.; Bremerich, Jens [University of Basel Hospital, Clinic of Radiology and Nuclear Medicine, Medical Physics, Basel (Switzerland)

2015-03-01

The increasing absolute number of paediatric CT scans raises concern about the safety and efficacy and the effects of consecutive diagnostic ionising radiation. To demonstrate a method to evaluate the lifetime attributable risk of cancer incidence/mortality due to a single low-dose helical chest CT in a two-year patient cohort. A two-year cohort of 522 paediatric helical chest CT scans acquired using a dedicated low-dose protocol were analysed retrospectively. Patient-specific estimations of radiation doses were modelled using three different mathematical phantoms. Per-organ attributable cancer risk was then estimated using epidemiological models. Additional comparison was provided for naturally occurring risks. Total lifetime attributable risk of cancer incidence remains low for all age and sex categories, being highest in female neonates (0.34%). Summation of all cancer sites analysed raised the relative lifetime attributable risk of organ cancer incidence up to 3.6% in female neonates and 2.1% in male neonates. Using dedicated scan protocols, total lifetime attributable risk of cancer incidence and mortality for chest CT is estimated low for paediatric chest CT, being highest for female neonates. (orig.)

A Systematic Evaluation of Blood Serum and Plasma Pre-Analytics for Metabolomics Cohort Studies

Directory of Open Access Journals (Sweden)

Elodie Jobard

2016-12-01

Full Text Available The recent thriving development of biobanks and associated high-throughput phenotyping studies requires the elaboration of large-scale approaches for monitoring biological sample quality and compliance with standard protocols. We present a metabolomic investigation of human blood samples that delineates pitfalls and guidelines for the collection, storage and handling procedures for serum and plasma. A series of eight pre-processing technical parameters is systematically investigated along variable ranges commonly encountered across clinical studies. While metabolic fingerprints, as assessed by nuclear magnetic resonance, are not significantly affected by altered centrifugation parameters or delays between sample pre-processing (blood centrifugation and storage, our metabolomic investigation highlights that both the delay and storage temperature between blood draw and centrifugation are the primary parameters impacting serum and plasma metabolic profiles. Storing the blood drawn at 4 °C is shown to be a reliable routine to confine variability associated with idle time prior to sample pre-processing. Based on their fine sensitivity to pre-analytical parameters and protocol variations, metabolic fingerprints could be exploited as valuable ways to determine compliance with standard procedures and quality assessment of blood samples within large multi-omic clinical and translational cohort studies.

Born in Bradford, a cohort study of babies born in Bradford, and their parents: Protocol for the recruitment phase

Directory of Open Access Journals (Sweden)

Raynor Pauline

2008-09-01

Full Text Available Abstract Background Bradford, one of the most deprived cities in the United Kingdom, has a wide range of public health problems associated with socioeconomic deprivation, including an infant mortality rate almost double that for England and Wales. Infant mortality is highest for babies of Pakistani origin, who comprise almost half the babies born in Bradford. The Born in Bradford cohort study aims to examine environmental, psychological and genetic factors that impact on health and development perinatally, during childhood and subsequent adult life, and those that influence their parents' health and wellbeing. This protocol outlines methods for the recruitment phase of the study. Methods Most Bradford women attend for antenatal care and give birth at the Bradford Royal Infirmary, which has approximately 5,800 births per year. Women are eligible for recruitment if they plan to give birth here. Babies born from March 2007 are eligible to participate, recruitment is planned to continue until 2010. Fathers of babies recruited are invited to participate. Women are usually recruited when they attend for a routine oral glucose tolerance test at 26–28 weeks gestation. Recruitment of babies is at birth. Fathers are recruited whenever possible during the antenatal period, or soon after the birth. The aim is to recruit 10,000 women, their babies, and the babies' fathers. At recruitment women have blood samples taken, are interviewed to complete a semi-structured questionnaire, weighed, and have height, arm circumference and triceps skinfold measured. Umbilical cord blood is collected at birth. Within two weeks of birth babies have their head, arm and abdominal circumference measured, along with subscapular and triceps skinfold thickness. Fathers self-complete a questionnaire at recruitment, have height and weight measured, and provide a saliva sample. Participants are allocated a unique study number. NHS numbers will be used to facilitate record linkage

Extraction protocols for orthodontic treatment: A retrospective study

Directory of Open Access Journals (Sweden)

Vaishnevi N Thirunavukkarasu

2016-01-01

Full Text Available Background and Objectives: Various extraction protocols have been followed for successful orthodontic treatment. The purpose of this study was to evaluate the extraction protocols in patients who had previously undergone orthodontic treatment and also who had reported for continuing orthodontic treatment from other clinics. Materials and Methods: One hundred thirty eight patients who registered for orthodontic treatment at the Faculty of Dentistry were divided into 10 extraction protocols based on the Orthodontic treatment protocol given by Janson et al. and were evaluated for statistical significance. Results: The descriptive statistics of the study revealed a total of 40 (29% patients in protocol 1, 43 (31.2% in protocol 2, 18 (13% in protocol 3, 16 (11.6% in protocol 5, and 12 (8.7% in Type 3 category of protocol 9. The Type 3 category in protocol 9 was statistically significant compared to other studies. Midline shift and collapse of the arch form were noticed in these individuals. Conclusion: Extraction of permanent teeth such as canine and lateral incisors without rational reasons could have devastating consequences on the entire occlusion. The percentage of cases wherein extraction of permanent teeth in the crowded region was adopted as a treatment option instead of orthodontic treatment is still prevalent in dental practice. The shortage of orthodontists in Malaysia, the long waiting period, and lack of subjective need for orthodontic treatment at an earlier age group were the reasons for the patient's to choose extraction of the mal-aligned teeth such as the maxillary canine or maxillary lateral incisors.

The German MultiCare-study: Patterns of multimorbidity in primary health care – protocol of a prospective cohort study

Directory of Open Access Journals (Sweden)

Schäfer Ingmar

2009-08-01

Full Text Available Abstract Background Multimorbidity is a highly frequent condition in older people, but well designed longitudinal studies on the impact of multimorbidity on patients and the health care system have been remarkably scarce in numbers until today. Little is known about the long term impact of multimorbidity on the patients' life expectancy, functional status and quality of life as well as health care utilization over time. As a consequence, there is little help for GPs in adjusting care for these patients, even though studies suggest that adhering to present clinical practice guidelines in the care of patients with multimorbidity may have adverse effects. Methods/Design The study is designed as a multicentre prospective, observational cohort study of 3.050 patients aged 65 to 85 at baseline with at least three different diagnoses out of a list of 29 illnesses and syndromes. The patients will be recruited in approx. 120 to 150 GP surgeries in 8 study centres distributed across Germany. Information about the patients' morbidity will be collected mainly in GP interviews and from chart reviews. Functional status, resources/risk factors, health care utilization and additional morbidity data will be assessed in patient interviews, in which a multitude of well established standardized questionnaires and tests will be performed. Discussion The main aim of the cohort study is to monitor the course of the illness process and to analyse for which reasons medical conditions are stable, deteriorating or only temporarily present. First, clusters of combinations of diseases/disorders (multimorbidity patterns with a comparable impact (e.g. on quality of life and/or functional status will be identified. Then the development of these clusters over time will be analysed, especially with regard to prognostic variables and the somatic, psychological and social consequences as well as the utilization of health care resources. The results will allow the development of an

An Outcomes Study on the Effects of the Singapore General Hospital Burns Protocol.

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Liang, Weihao; Kok, Yee Onn; Tan, Bien Keem; Chong, Si Jack

2018-01-01

The Singapore General Hospital Burns Protocol was implemented in May 2014 to standardize treatment for all burns patients, incorporate new techniques and materials, and streamline the processes and workflow of burns management. This study aims to analyze the effects of the Burns Protocol 2 years after its implementation. Using a REDCap electronic database, all burns patients admitted from May 2013 to April 2016 were included in the study. The historical preimplementation control group composed of patients admitted from May 2013 to April 2014 (n = 96). The postimplementation prospective study cohort consisted of patients admitted from May 2014 to April 2016 (n = 243). Details of the patients collected included age, sex, comorbidities, total body surface area (TBSA) burns, time until surgery, number of surgeries, number of positive tissue and blood cultures, and length of hospital stay. There was no statistically significant difference in the demographics of both groups. The study group had a statistically significant shorter time to surgery compared with the control group (20.8 vs 38.1, P burns, was statistically significant (number of surgeries/TBSA, 0.324 vs 0.506; P = 0.0499). The study group also had significantly shorter length of stay (12.5 vs 16.8, P = 0.0273), a shorter length of stay/TBSA burns (0.874 vs 1.342, P = 0.0101), and fewer positive tissue cultures (0.6 vs 1.3, P = 0.0003). The study group also trended toward fewer positive blood culture results (0.09 vs 0.35, P = 0.0593), although the difference was just shy of statistical significance. The new Singapore General Hospital Burns Protocol had revolutionized Singapore burns care by introducing a streamlined, multidisciplinary burns management, resulting in improved patient outcomes, lowered health care costs, and improved system resource use.

Efficacy of a high-observation protocol in major head and neck cancer surgery: A prospective study.

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Barber, Brittany; Harris, Jeffrey; Shillington, Cameron; Rychlik, Shannon; Dort, Joseph; Meier, Michael; Estey, Angela; Elwi, Adam; Wickson, Patty; Buss, Michael; Zygun, David; Ansari, Kal; Biron, Vincent; O'Connell, Daniel; Seikaly, Hadi

2017-08-01

The purpose of this study was to optimize an existing clinical care pathway (CCP) for head and neck cancer with a high-observation protocol (HOP) and to determine the effect on length of intensive care unit (ICU) admission and length of stay in hospital (LOS). The HOP mandated initiation of spontaneous breathing trials before the conclusion of the surgery, weaning of sedation, and limiting mechanical ventilation. All patients with head and neck cancer undergoing primary surgery on the HOP were compared to a historical cohort regarding length of ICU admission, ICU readmissions, and LOS. Ninety-six and 52 patients were observed in "historical" and "HOP" cohorts. The length of ICU admission (1.9 vs 1.2 days; p = .021), LOS (20.3 vs 14.1 days; p = .020), and ICU readmissions (10.4% vs 1.9%; p = .013) were significantly decreased in the "HOP" cohort. Rapid weaning of sedation and limiting mechanical ventilation may contribute to a shorter length of ICU admission and LOS, as well as decreased ICU readmissions. © 2017 Wiley Periodicals, Inc. Head Neck 39: 1689-1695, 2016. © 2017 Wiley Periodicals, Inc.

Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears: Study Protocol for a Randomized Controlled Trial (HIPARTI) and a Prospective Cohort Study (HARP).

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Risberg, May Arna; Ageberg, Eva; Nilstad, Agnethe; Lund, Bent; Nordsletten, Lars; Løken, Sverre; Ludvigsen, Tom; Kierkegaard, Signe; Carsen, Sasha; Kostogiannis, Ioannis; Crossley, Kay M; Glyn-Jones, Sion; Kemp, Joanne L

2018-04-01

Study Design Study protocol for a randomized controlled trial and a prospective cohort. Background The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. Objectives The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patient-reported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). Methods The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. Conclusion To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenerative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined. J Orthop Sports Phys Ther 2018;48(4):325-335. doi:10.2519/jospt.2018.7931.

Minimizing variance in Care of Pediatric Blunt Solid Organ Injury through Utilization of a hemodynamic-driven protocol: a multi-institution study.

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Cunningham, Aaron J; Lofberg, Katrine M; Krishnaswami, Sanjay; Butler, Marilyn W; Azarow, Kenneth S; Hamilton, Nicholas A; Fialkowski, Elizabeth A; Bilyeu, Pamela; Ohm, Erika; Burns, Erin C; Hendrickson, Margo; Krishnan, Preetha; Gingalewski, Cynthia; Jafri, Mubeen A

2017-12-01

An expedited recovery protocol for management of pediatric blunt solid organ injury (spleen, liver, and kidney) was instituted across two Level 1 Trauma Centers, managed by nine pediatric surgeons within three hospital systems. Data were collected for 18months on consecutive patients after protocol implementation. Patient demographics (including grade of injury), surgeon compliance, National Surgical Quality Improvement Program (NSQIP) complications, direct hospital cost, length of stay, time in the ICU, phlebotomy, and re-admission were compared to an 18-month control period immediately preceding study initiation. A total of 106 patients were treated (control=55, protocol=51). Demographics were similar among groups, and compliance was 78%. Hospital stay (4.6 vs. 3.5days, p=0.04), ICU stay (1.9 vs. 1.0days, p=0.02), and total phlebotomy (7.7 vs. 5.3 draws, p=0.007) were significantly less in the protocol group. A decrease in direct hospital costs was also observed ($11,965 vs. $8795, p=0.09). Complication rates (1.8% vs. 3.9%, p=0.86, no deaths) were similar. An expedited, hemodynamic-driven, pediatric solid organ injury protocol is achievable across hospital systems and surgeons. Through implementation we maintained quality while impacting length of stay, ICU utilization, phlebotomy, and cost. Future protocols should work to further limit resource utilization. Retrospective cohort study. Level II. Copyright © 2017 Elsevier Inc. All rights reserved.

Switching From Age-Based Stimulus Dosing to Dose Titration Protocols in Electroconvulsive Therapy: Empirical Evidence for Better Patient Outcomes With Lower Peak and Cumulative Energy Doses.

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O'Neill-Kerr, Alex; Yassin, Anhar; Rogers, Stephen; Cornish, Janie

2017-09-01

The aim of this study was to test the proposition that adoption of a dose titration protocol may be associated with better patient outcomes, at lower treatment dose, and with comparable cumulative dose to that in patients treated using an age-based stimulus dosing protocol. This was an analysis of data assembled from archived records and based on cohorts of patients treated respectively on an age-based stimulus dosing protocol and on a dose titration protocol in the National Health Service in England. We demonstrated a significantly better response in the patient cohort treated with dose titration than with age-based stimulus dosing. Peak doses were less and the total cumulative dose was less in the dose titration group than in the age-based stimulus dosing group. Our findings are consistent with superior outcomes in patients treated using a dose titration protocol when compared with age-based stimulus dosing in a similar cohort of patients.

Implementation and Effects of Risk-Dependent Obstetric Care in the Netherlands (Expect Study II): Protocol for an Impact Study.

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van Montfort, Pim; Willemse, Jessica Ppm; Dirksen, Carmen D; van Dooren, Ivo Ma; Meertens, Linda Je; Spaanderman, Marc Ea; Zelis, Maartje; Zwaan, Iris M; Scheepers, Hubertina Cj; Smits, Luc Jm

2018-05-04

Recently, validated risk models predicting adverse obstetric outcomes combined with risk-dependent care paths have been made available for early antenatal care in the southeastern part of the Netherlands. This study will evaluate implementation progress and impact of the new approach in obstetric care. The objective of this paper is to describe the design of a study evaluating the impact of implementing risk-dependent care. Validated first-trimester prediction models are embedded in daily clinical practice and combined with risk-dependent obstetric care paths. A multicenter prospective cohort study consisting of women who receive risk-dependent care is being performed from April 2017 to April 2018 (Expect Study II). Obstetric risk profiles will be calculated using a Web-based tool, the Expect prediction tool. The primary outcomes are the adherence of health care professionals and compliance of women. Secondary outcomes are patient satisfaction and cost-effectiveness. Outcome measures will be established using Web-based questionnaires. The secondary outcomes of the risk-dependent care cohort (Expect II) will be compared with the outcomes of a similar prospective cohort (Expect I). Women of this similar cohort received former care-as-usual and were prospectively included between July 1, 2013 and December 31, 2015 (Expect I). Currently, women are being recruited for the Expect Study II, and a total of 300 women are enrolled. This study will provide information about the implementation and impact of a new approach in obstetric care using prediction models and risk-dependent obstetric care paths. Netherlands Trial Register NTR4143; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4143 (Archived by WebCite at http://www.webcitation.org/6t8ijtpd9). ©Pim van Montfort, Jessica PPM Willemse, Carmen D Dirksen, Ivo MA van Dooren, Linda JE Meertens, Marc EA Spaanderman, Maartje Zelis, Iris M Zwaan, Hubertina CJ Scheepers, Luc JM Smits. Originally published in JMIR

The impact of an ED-only full-capacity protocol.

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Watase, Taketo; Fu, Rongwei; Foster, Denise; Langley, Denise; Handel, Daniel A

2012-10-01

The objective of this study was to assess the impact of an emergency department (ED)-only full-capacity protocol and diversion, controlling for patient volumes and other potential confounding factors. This was a preintervention and postintervention cohort study using data 12 months before and 12 months after the implementation of the protocol. During the implementation period, attending physicians and charge nurses were educated with clear and simple figures on the criteria for the initiation of the new protocol. A multiple logistic regression model was used to compare ambulance diversion between the 2 periods. The proportion of days when the ED went on diversion at least once during a 24-hour period was 60.4% during the preimplementation period and 20% in the postimplementation periods (P model, the use of the new protocol was significantly associated with decreased odds of diversion rate in the postimplementation period (odds ratio, 0.32; 95% confidence interval, 0.21-0.48). Our predivert/full-capacity protocol is a simple and generalizable strategy that can be implemented within the boundaries of the ED and is significantly associated with a decreased diversion rate. Copyright © 2012 Elsevier Inc. All rights reserved.

Global teaching and training initiatives for emerging cohort studies

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Jessica K. Paulus

2012-09-01

Full Text Available A striking disparity exists across the globe, with essentially no large-scale longitudinal studies ongoing in regions that will be significantly affected by the oncoming non-communicable disease epidemic. The successful implementation of cohort studies in most low-resource research environments presents unique challenges that may be aided by coordinated training programs. Leaders of emerging cohort studies attending the First World Cohort Integration Workshop were surveyed about training priorities, unmet needs and potential cross-cohort solutions to these barriers through an electronic pre-workshop questionnaire and focus groups. Cohort studies representing India, Mexico, Nigeria, South Africa, Sweden, Tanzania and Uganda described similar training needs, including on-the-job training, data analysis software instruction, and database and bio-bank management. A lack of funding and protected time for training activities were commonly identified constraints. Proposed solutions include a collaborative cross-cohort teaching platform with web-based content and interactive teaching methods for a range of research personnel. An international network for research mentorship and idea exchange, and modifying the graduate thesis structure were also identified as key initiatives. Cross-cohort integrated educational initiatives will efficiently meet shared needs, catalyze the development of emerging cohorts, speed closure of the global disparity in cohort research, and may fortify scientific capacity development in low-resource settings.

Assessing the consequences of gestational diabetes mellitus on offspring's cardiovascular health: MySweetHeart Cohort study protocol, Switzerland.

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Di Bernardo, Stefano; Mivelaz, Yvan; Epure, Adina Mihaela; Vial, Yvan; Simeoni, Umberto; Bovet, Pascal; Estoppey Younes, Sandrine; Chiolero, Arnaud; Sekarski, Nicole

2017-11-14

Gestational diabetes mellitus (GDM) is a state of glucose intolerance with onset during pregnancy. GDM carries prenatal and perinatal risks as well as long-term risks for the mother and her child. GDM may be involved in the foetal programming of long-term cardiovascular health. However, evidence is sparse and the effect of GDM on cardiovascular health is unknown. To address these issues, we will conduct MySweetHeart Cohort study. The objectives are to assess the effect of GDM on offspring's cardiovascular health early in life by using surrogate markers of cardiovascular disease and atherosclerosis. This is a cohort study of 100 offspring of women with GDM and 100 offspring of women without GDM. At inclusion, a baseline assessment of the mothers will be conducted through means of self-report questionnaires, a researcher-administrated interview, blood pressure and anthropometric measurements, and a maternal blood sampling. Between the 30th and 34th weeks of gestation, a foetal echography will be performed to assess the foetal cardiac structure and function, the fetomaternal circulation and the hepatic volume. At birth, maternal and neonatal characteristics will be assessed. An echocardiography will be performed to assess cardiac structure and function 2-7 days after birth; carotid intima-media thickness will be also measured to assess vascular structure. MySweetHeart Cohort is linked to MySweetHeart Trial (clinicaltrials.gov/ct2/show/NCT02890693), a randomised controlled trial assessing the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardiometabolic and mental health of women with GDM and their offspring. A long-term follow-up of children is planned. Ethical approval has been obtained through the state Human Research Ethics Committee of the Canton de Vaud (study number 2016-00745). We aim to disseminate the findings through regional, national and international conferences and through peer-reviewed journals

RADAR study: protocol for an observational cohort study to identify early warning signals on the pathways to alcohol use disorder.

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Slade, Tim; Swift, Wendy; Mewton, Louise; Kypri, Kypros; Lynskey, Michael T; Butterworth, Peter; Tibbetts, Joel; McCraw, Stacey; Upton, Emily

2017-08-21

Harmful alcohol consumption, particularly alcohol use disorder (AUD), is a worldwide health priority, contributing substantially to global morbidity and mortality. The peak age of onset of AUD is 18-24, thus a deeper understanding of the young adult experience is vital if we are to identify modifiable risk factors and intervene early in the developmental course of this disabling disorder. Critical unanswered questions include: How soon after drinking initiation do AUD symptoms begin to emerge? Which symptoms come first? Do the symptoms unfold in a predictable pattern? In what ways do the emerging symptoms interact with individual, peer, family and environmental risk factors to impact on the transition to disorder? The proposed RADAR study will examine the prospective development of AUD symptoms over the young adulthood (18-24) years. We will capitalise on an existing cohort of 1911 community-based adolescents who were recruited at age 13 and have completed a baseline and five annual follow-up assessments as part of an observational cohort study. We will interview these adolescents every 6 months between the ages of 19 and 23 to derive monthly histories of both alcohol use and AUD symptomatology, along with a comprehensive battery of risk and protective factor scales hypothesised to predict the emergence and course of AUD. The results of this study will inform the natural history of AUD and will be used to identify specific targets for prevention and early intervention of AUD. Ethical approval has already been granted for the study (UNSW HREC 10144). We will disseminate the results of the study through published manuscripts, conferences and seminar presentations. Data used in published manuscripts will be made available through a suitable online repository (eg, Dryad-datadryad.org). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly

Complications of Peripherally Inserted Central Venous Catheters: A Retrospective Cohort Study.

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Paula Parás-Bravo

Full Text Available The use of venous catheters is a widespread practice, especially in oncological and oncohematological units. The objective of this study was to evaluate the complications associated with peripherally inserted central catheters (PICCs in a cohort of patients.In this retrospective cohort study, we included all patient carrying PICCs (n = 603 inserted at our institute between October 2010 and December 2013. The main variables collected were medical diagnosis, catheter care, location, duration of catheterization, reasons for catheter removal, complications, and nursing care. Complications were classified as infection, thrombosis, phlebitis, migration, edema, and/or ecchymosis.All patients were treated according to the same "nursing care" protocol. The incidence rate of complications was two cases per 1000 days of catheter duration. The most relevant complications were infection and thrombosis, both with an incidence of 0.17 cases per 1000 days of the total catheterization period. The total average duration of catheterization was 170 days [SD 6.06]. Additionally to "end of treatment" (48.42% and "exitus", (22.53% the most frequent cause of removal was migration (displacement towards the exterior of the catheter (5.80%.PICCs are safe devices that allow the administration of long-term treatment and preserve the integrity of the venous system of the patient. Proper care of the catheter is very important to improve the quality life of patients with oncologic and hematologic conditions. Therefore, correct training of professionals and patients as well as following the latest scientific recommendations are particularly relevant.

The Dresden Burnout Study: Protocol of a prospective cohort study for the bio-psychological investigation of burnout.

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Penz, Marlene; Wekenborg, Magdalena K; Pieper, Lars; Beesdo-Baum, Katja; Walther, Andreas; Miller, Robert; Stalder, Tobias; Kirschbaum, Clemens

2018-06-01

The Dresden Burnout Study (DBS) is a 12-year longitudinal cohort study that aims to provide a description of the burnout syndrome on the basis of time and symptom criteria with a special focus on the search for biomarkers. Biological and psychosocial approaches are applied to examine the long-term course and consequences of burnout within a population-based German-speaking sample aged 18 to 68 years. Demographics and psychosocial data are generated by online assessments, including demographics and questionnaires on burnout, burnout-related constructs, work-environment, and health-related factors. The lab-based biomarker assessment includes endocrine, physiological, immunological, and epigenetic markers obtained from blood and hair samples. In addition, heart rate variability is also measured repeatedly. Within the first 2 years, the DBS collected psychosocial data from over 7,600 participants with biological data obtained from more than 800 individuals. During the following 10 years, detailed assessments of biomarkers and psychosocial factors will be collected in annual study waves. Results will be generated during the following decade. The findings of the DBS are expected to pave the road for an in-depth biopsychosocial characterization of burnout and to give insight into the long-term course and potential mental and physical health consequences of the burnout syndrome. Copyright © 2018 John Wiley & Sons, Ltd.

A police education programme to integrate occupational safety and HIV prevention: protocol for a modified stepped-wedge study design with parallel prospective cohorts to assess behavioural outcomes

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Strathdee, Steffanie A; Arredondo, Jaime; Rocha, Teresita; Abramovitz, Daniela; Rolon, Maria Luisa; Patiño Mandujano, Efrain; Rangel, Maria Gudelia; Olivarria, Horcasitas Omar; Gaines, Tommi; Patterson, Thomas L; Beletsky, Leo

2015-01-01

Introduction Policing practices are key drivers of HIV among people who inject drugs (PWID). This paper describes the protocol for the first study to prospectively examine the impact of a police education programme (PEP) to align law enforcement and HIV prevention. PEPs incorporating HIV prevention (including harm reduction programmes like syringe exchange) have been successfully piloted in several countries but were limited to brief pre–post assessments; the impact of PEPs on policing behaviours and occupational safety is unknown. Objectives Proyecto ESCUDO (SHIELD) aims to evaluate the efficacy of the PEP on uptake of occupational safety procedures, as assessed through the incidence of needle stick injuries (NSIs) (primary outcome) and changes in knowledge of transmission, prevention and treatment of HIV and viral hepatitis; attitudes towards PWID, adverse behaviours that interfere with HIV prevention and protective behaviours (secondary outcomes). Methods/analysis ESCUDO is a hybrid type I design that simultaneously tests an intervention and an implementation strategy. Using a modified stepped-wedge design involving all active duty street-level police officers in Tijuana (N=∼1200), we will administer one 3 h PEP course to groups of 20–50 officers until the entire force is trained. NSI incidence and geocoded arrest data will be assessed from department-wide de-identified data. Of the consenting police officers, a subcohort (N=500) will be randomly sampled from each class to undergo pre-PEP and post-PEP surveys with a semiannual follow-up for 2 years to assess self-reported NSIs, attitudes and behaviour changes. The impact on PWIDs will be externally validated through a parallel cohort of Tijuana PWIDs. Ethics/dissemination Research ethics approval was obtained from the USA and Mexico. Findings will be disseminated through open access to protocol materials through the Law Enforcement and HIV Network. Trial registration number NCT02444403. PMID:26260350

A community-based prospective cohort study of dengue viral infection in Malaysia: the study protocol.

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Jahan, Nowrozy Kamar; Ahmad, Mohtar Pungut; Dhanoa, Amreeta; Meng, Cheong Yuet; Ming, Lau Wee; Reidpath, Daniel D; Allotey, Pascale; Zaini, Anuar; Phipps, Maude Elvira; Fatt, Quek Kia; Rabu, Aman Bin; Sirajudeen, Rowther; Fatan, Ahmad AbdulBasitz Ahmad; Ghafar, Faidzal Adlee; Ahmad, Hamdan Bin; Othman, Iekhsan; SyedHassan, Sharifah

2016-08-11

Globally, dengue infections constitute a significant public health burden. In recent decades, Malaysia has become a dengue hyper-endemic country with the co-circulation of the four dengue virus serotypes. The cyclical dominance of sub-types contributes to a pattern of major outbreaks. The consequences can be observed in the rising incidence of reported dengue cases and dengue related deaths. Understanding the complex interaction of the dengue virus, its human hosts and the mosquito vectors at the community level may help develop strategies for addressing the problem. A prospective cohort study will be conducted in Segamat district of Johor State in Peninsular Malaysia. Researchers received approval from the Malaysian Medical Research Ethics Committee and Monash University Human Research Ethics Committee. The study will be conducted at a Malaysian based health and demographic surveillance site over a 1 year period in three different settings (urban, semi-urban and rural). The study will recruit healthy adults (male and female) aged 18 years and over, from three ethnic groups (Malay, Chinese and Indian). The sample size calculated using the Fleiss method with continuity correction is 333. Sero-surveillance of participants will be undertaken to identify asymptomatic, otherwise healthy cases; cases with dengue fever who are managed as out-patients; and cases with dengue fever admitted to a hospital. A genetic analysis of the participants will be undertaken to determine whether there is a relationship between genetic predisposition and disease severity. A detailed medical history, past history of dengue infection, vaccination history against other flaviviruses such as Japanese encephalitis and Yellow fever, and the family history of dengue infection will also be collected. In addition, a mosquito surveillance will be carried out simultaneously in recruitment areas to determine the molecular taxonomy of circulating vectors. The research findings will estimate the burden

Mac protocols for wireless sensor network (wsn): a comparative study

International Nuclear Information System (INIS)

Arshad, J.; Akram, Q.; Saleem, Y.

2014-01-01

Data communication between nodes is carried out under Medium Access Control (MAC) protocol which is defined at data link layer. The MAC protocols are responsible to communicate and coordinate between nodes according to the defined standards in WSN (Wireless Sensor Networks). The design of a MAC protocol should also address the issues of energy efficiency and transmission efficiency. There are number of MAC protocols that exist in the literature proposed for WSN. In this paper, nine MAC protocols which includes S-MAC, T-MAC, Wise-MAC, Mu-MAC, Z-MAC, A-MAC, D-MAC, B-MAC and B-MAC+ for WSN have been explored, studied and analyzed. These nine protocols are classified in contention based and hybrid (combination of contention and schedule based) MAC protocols. The goal of this comparative study is to provide a basis for MAC protocols and to highlight different mechanisms used with respect to parameters for the evaluation of energy and transmission efficiency in WSN. This study also aims to give reader a better understanding of the concepts, processes and flow of information used in these MAC protocols for WSN. A comparison with respect to energy reservation scheme, idle listening avoidance, latency, fairness, data synchronization, and throughput maximization has been presented. It was analyzed that contention based MAC protocols are less energy efficient as compared to hybrid MAC protocols. From the analysis of contention based MAC protocols in term of energy consumption, it was being observed that protocols based on preamble sampling consume lesser energy than protocols based on static or dynamic sleep schedule. (author)

Outcomes of Zika virus infection during pregnancy: contributions to the debate on the efficiency of cohort studies.

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Duarte, Elisabeth Carmen; Garcia, Leila Posenato; de Araújo, Wildo Navegantes; Velez, Maria P

2017-12-02

Zika infection during pregnancy (ZIKVP) is known to be associated with adverse outcomes. Studies on this matter involve both rare outcomes and rare exposures and methodological choices are not straightforward. Cohort studies will surely offer more robust evidences, but their efficiency must be enhanced. We aim to contribute to the debate on sample selection strategies in cohort studies to assess outcomes associated with ZKVP. A study can be statistically more efficient than another if its estimates are more accurate (precise and valid), even if the studies involve the same number of subjects. Sample size and specific design strategies can enhance or impair the statistical efficiency of a study, depending on how the subjects are distributed in subgroups pertinent to the analysis. In most ZIKVP cohort studies to date there is an a priori identification of the source population (pregnant women, regardless of their exposure status) which is then sampled or included in its entirety (census). Subsequently, the group of pregnant women is classified according to exposure (presence or absence of ZIKVP), respecting the exposed:unexposed ratio in the source population. We propose that the sample selection be done from the a priori identification of groups of pregnant women exposed and unexposed to ZIKVP. This method will allow for an oversampling (even 100%) of the pregnant women with ZKVP and a optimized sampling from the general population of pregnant women unexposed to ZIKVP, saving resources in the unexposed group and improving the expected number of incident cases (outcomes) overall. We hope that this proposal will broaden the methodological debate on the improvement of statistical power and protocol harmonization of cohort studies that aim to evaluate the association between Zika infection during pregnancy and outcomes for the offspring, as well as those with similar objectives.

The Northern Norway mother-and-child contaminant cohort study: implementation, population characteristics and summary of dietary findings

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Anna Sofía Veyhe

2012-05-01

Full Text Available Objectives. To describe the essential features of a new Northern Norway mother-and-child contaminant cohort study called MISA, including its rationale, content, implementation and selected findings (mostly dietary. Study design. Cross-sectional with longitudinal aspects. Methods. Five hundred and fifteen eligible women were enrolled in early pregnancy, with 391 completing the study protocol that included a self-administrated food frequency questionnaire (FFQ and donation of biological samples for contaminant analysis in the 2nd trimester, just after delivery, and 6 weeks postpartum. Macronutrient consumption was converted to energy intake, and the amounts of both macro- and micronutrients ingested were estimated. Some of the MISA findings were compared to data available in the Medical Birth Registry of Norway (MBRN. Results. Compared to all 2004–2006 mothers in Northern Norway, the study cohort women were about 2 years older and smoked less; on average, they had close to 16 years of education. Parity, gestational age and birth weight of the newborn were comparable as well. The estimated average dietary intake of 8.1 MJ per day was less than that recommended by the Nordic Nutritional Recommendations (NNR, but the intake of micronutrients per MJ complied. Conclusions. Although the final cohort sample size was less than targeted, the generally good comparisons observed between MBRN-registered information for the study cohort and dropouts suggest that this occurrence introduced minimal bias. The agreement of the observed demographic and clinical characteristics of the cohort women and newborns with all births in Northern Norway implied acceptable external validity. Also, the dietary findings aligned well with Norwegian national data and guidelines and other studies, as did the high prevalence of breastfeeding. The MISA database is considered suitable for exploring associations between contaminant exposure and diet, enhancing our knowledge of the

The Perinatal Adverse events and Special Trends in Cognitive Trajectory (PLASTICITY - pre-protocol for a prospective longitudinal follow-up cohort study [v1; ref status: indexed, http://f1000r.es/qe

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Laura Hokkanen

2013-02-01

Full Text Available Prospective follow-up studies on long term effects of pre- and perinatal adverse conditions in adulthood are rare. We will continue to follow the prospective cohort of initially 1196 subjects with predefined at-delivery risk factors out of 22,359 consecutive deliveries during 1971-74 at a single maternity hospital. The risk cohort and 93 controls have been followed up with a comprehensive clinical program at 5, 9, and 16 years of age and by questionnaire at the age of 30 years. Major medical events known to affect the development and growth of the brain, or cognitive functions and personality have been documented. Here we present a pre-protocol for the project, which we will call PLASTICITY, whose aim is to follow consenting subjects and controls into mid-adulthood and beyond, and to explore how the neonatal risk factors modulate neurodevelopmental and neurodegenerative processes such as learning disabilities, ADHD, aging, early onset mild cognitive impairment and even dementia. Our first focus is on the neurological and cognitive outcomes at age 40 years, using detailed neurological, neuropsychological, neuroimaging, genetic, blood chemistry and registry based methods. Results will be expected to offer information on the risk of neurological, psychiatric, metabolic and other medical consequences as well as the need for health and social services at the brink of middle age, when new degenerative phenomena are known to emerge. The evaluation at age 40 years will serve as a baseline for later aging studies. We welcome all comments and suggestions, which we will apply in finalizing details and inviting collaboration.

The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS): a study protocol for a prospective longitudinal study.

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Fagher, Kristina; Jacobsson, Jenny; Timpka, Toomas; Dahlström, Örjan; Lexell, Jan

2016-01-01

Paralympic sport provides sporting opportunities for athletes with a disability, with the Paralympic Games as the main event. Participation in sport is, however, associated with a significant risk for sustaining injuries and illnesses. Our knowledge of sports-related injuries and illnesses in Paralympic sport is very limited and there are no large-scale epidemiological cohort studies. The purpose here is to present a protocol for a prospective longitudinal study: The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS). An argument-based method for investigation of design problems was used to structure the study protocol. The primary requirement of the protocol is to allow prospective studies over time and include exposure to both training and competition. To reflect the complexity of Paralympic sport with athletes' pre-existing impairments, use of assistive equipment, pain and other and medical issues, it is required that the data collection system is specifically adapted to Paralympic sport. To allow the collection of data, at the same time as there is limited access to coaches and medical personnel, it is advantageous that data can be collected online directly from the athletes. Based on this a self-report athlete monitoring system will be developed, where the athletes can enter data weekly via their mobile phones or lap-tops. Data will be collected from around 100 Swedish Paralympic athletes for approximately 1 year, which will allow us to i) prospectively estimate the annual incidence of sports-related injuries and illnesses and ii) explore risk factors and mechanisms for sustaining sports-related injuries and illnesses based on athlete exposure and training loads. For effective implementation of injury and illness prevention measures, comprehensive epidemiological knowledge is required. This study will be the first prospective longitudinal self-report study of sports-related injuries and illnesses in Paralympic sport over a longer period

PREDICT-CP: study protocol of implementation of comprehensive surveillance to predict outcomes for school-aged children with cerebral palsy.

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Boyd, Roslyn N; Davies, Peter Sw; Ziviani, Jenny; Trost, Stewart; Barber, Lee; Ware, Robert; Rose, Stephen; Whittingham, Koa; Sakzewski, Leanne; Bell, Kristie; Carty, Christopher; Obst, Steven; Benfer, Katherine; Reedman, Sarah; Edwards, Priya; Kentish, Megan; Copeland, Lisa; Weir, Kelly; Davenport, Camilla; Brooks, Denise; Coulthard, Alan; Pelekanos, Rebecca; Guzzetta, Andrea; Fiori, Simona; Wynter, Meredith; Finn, Christine; Burgess, Andrea; Morris, Kym; Walsh, John; Lloyd, Owen; Whitty, Jennifer A; Scuffham, Paul A

2017-07-12

Cerebral palsy (CP) remains the world's most common childhood physical disability with total annual costs of care and lost well-being of $A3.87b. The PREDICT-CP (NHMRC 1077257 Partnership Project: Comprehensive surveillance to PREDICT outcomes for school age children with CP) study will investigate the influence of brain structure, body composition, dietary intake, oropharyngeal function, habitual physical activity, musculoskeletal development (hip status, bone health) and muscle performance on motor attainment, cognition, executive function, communication, participation, quality of life and related health resource use costs. The PREDICT-CP cohort provides further follow-up at 8-12 years of two overlapping preschool-age cohorts examined from 1.5 to 5 years (NHMRC 465128 motor and brain development; NHMRC 569605 growth, nutrition and physical activity). This population-based cohort study undertakes state-wide surveillance of 245 children with CP born in Queensland (birth years 2006-2009). Children will be classified for Gross Motor Function Classification System; Manual Ability Classification System, Communication Function Classification System and Eating and Drinking Ability Classification System. Outcomes include gross motor function, musculoskeletal development (hip displacement, spasticity, muscle contracture), upper limb function, communication difficulties, oropharyngeal dysphagia, dietary intake and body composition, participation, parent-reported and child-reported quality of life and medical and allied health resource use. These detailed phenotypical data will be compared with brain macrostructure and microstructure using 3 Tesla MRI (3T MRI). Relationships between brain lesion severity and outcomes will be analysed using multilevel mixed-effects models. The PREDICT-CP protocol is a prospectively registered and ethically accepted study protocol. The study combines data at 1.5-5 then 8-12 years of direct clinical assessment to enable prediction of outcomes

The BioFIND study: Characteristics of a clinically typical Parkinson's disease biomarker cohort

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Goldman, Jennifer G.; Alcalay, Roy N.; Xie, Tao; Tuite, Paul; Henchcliffe, Claire; Hogarth, Penelope; Amara, Amy W.; Frank, Samuel; Rudolph, Alice; Casaceli, Cynthia; Andrews, Howard; Gwinn, Katrina; Sutherland, Margaret; Kopil, Catherine; Vincent, Lona; Frasier, Mark

2016-01-01

ABSTRACT Background Identifying PD‐specific biomarkers in biofluids will greatly aid in diagnosis, monitoring progression, and therapeutic interventions. PD biomarkers have been limited by poor discriminatory power, partly driven by heterogeneity of the disease, variability of collection protocols, and focus on de novo, unmedicated patients. Thus, a platform for biomarker discovery and validation in well‐characterized, clinically typical, moderate to advanced PD cohorts is critically needed. Methods BioFIND (Fox Investigation for New Discovery of Biomarkers in Parkinson's Disease) is a cross‐sectional, multicenter biomarker study that established a repository of clinical data, blood, DNA, RNA, CSF, saliva, and urine samples from 118 moderate to advanced PD and 88 healthy control subjects. Inclusion criteria were designed to maximize diagnostic specificity by selecting participants with clinically typical PD symptoms, and clinical data and biospecimen collection utilized standardized procedures to minimize variability across sites. Results We present the study methodology and data on the cohort's clinical characteristics. Motor scores and biospecimen samples including plasma are available for practically defined off and on states and thus enable testing the effects of PD medications on biomarkers. Other biospecimens are available from off state PD assessments and from controls. Conclusion Our cohort provides a valuable resource for biomarker discovery and validation in PD. Clinical data and biospecimens, available through The Michael J. Fox Foundation for Parkinson's Research and the National Institute of Neurological Disorders and Stroke, can serve as a platform for discovering biomarkers in clinically typical PD and comparisons across PD's broad and heterogeneous spectrum. © 2016 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society PMID:27113479

The Northern Norway mother-and-child contaminant cohort study: implementation, population characteristics and summary of dietary findings.

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Veyhe, Anna Sofía; Hansen, Solrunn; Sandanger, Torkjel M; Nieboer, Evert; Odland, Jon Øyvind

2012-01-01

To describe the essential features of a new Northern Norway mother-and-child contaminant cohort study called MISA, including its rationale, content, implementation and selected findings (mostly dietary). Cross-sectional with longitudinal aspects. Five hundred and fifteen eligible women were enrolled in early pregnancy, with 391 completing the study protocol that included a self-administrated food frequency questionnaire (FFQ) and donation of biological samples for contaminant analysis in the 2nd trimester, just after delivery, and 6 weeks postpartum. Macronutrient consumption was converted to energy intake, and the amounts of both macro- and micronutrients ingested were estimated. Some of the MISA findings were compared to data available in the Medical Birth Registry of Norway (MBRN). Compared to all 2004-2006 mothers in Northern Norway, the study cohort women were about 2 years older and smoked less; on average, they had close to 16 years of education. Parity, gestational age and birth weight of the newborn were comparable as well. The estimated average dietary intake of 8.1 MJ per day was less than that recommended by the Nordic Nutritional Recommendations (NNR), but the intake of micronutrients per MJ complied. Although the final cohort sample size was less than targeted, the generally good comparisons observed between MBRN-registered information for the study cohort and dropouts suggest that this occurrence introduced minimal bias. The agreement of the observed demographic and clinical characteristics of the cohort women and newborns with all births in Northern Norway implied acceptable external validity. Also, the dietary findings aligned well with Norwegian national data and guidelines and other studies, as did the high prevalence of breastfeeding. The MISA database is considered suitable for exploring associations between contaminant exposure and diet, enhancing our knowledge of the interplay of the physiological changes that occur in mothers with

Redactions in protocols for drug trials: what industry sponsors concealed.

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Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C

2018-04-01

Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.

A comparison of Cox and logistic regression for use in genome-wide association studies of cohort and case-cohort design.

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Staley, James R; Jones, Edmund; Kaptoge, Stephen; Butterworth, Adam S; Sweeting, Michael J; Wood, Angela M; Howson, Joanna M M

2017-06-01

Logistic regression is often used instead of Cox regression to analyse genome-wide association studies (GWAS) of single-nucleotide polymorphisms (SNPs) and disease outcomes with cohort and case-cohort designs, as it is less computationally expensive. Although Cox and logistic regression models have been compared previously in cohort studies, this work does not completely cover the GWAS setting nor extend to the case-cohort study design. Here, we evaluated Cox and logistic regression applied to cohort and case-cohort genetic association studies using simulated data and genetic data from the EPIC-CVD study. In the cohort setting, there was a modest improvement in power to detect SNP-disease associations using Cox regression compared with logistic regression, which increased as the disease incidence increased. In contrast, logistic regression had more power than (Prentice weighted) Cox regression in the case-cohort setting. Logistic regression yielded inflated effect estimates (assuming the hazard ratio is the underlying measure of association) for both study designs, especially for SNPs with greater effect on disease. Given logistic regression is substantially more computationally efficient than Cox regression in both settings, we propose a two-step approach to GWAS in cohort and case-cohort studies. First to analyse all SNPs with logistic regression to identify associated variants below a pre-defined P-value threshold, and second to fit Cox regression (appropriately weighted in case-cohort studies) to those identified SNPs to ensure accurate estimation of association with disease.

Cohort profile: The Limache, Chile, birth cohort study.

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Amigo, Hugo; Bustos, Patricia; Zumelzú, Elinor; Rona, Roberto J

2014-08-01

The Limache cohort was set up to assess the programming and life course events hypotheses in relation to cardiovascular risk factors and chronic respiratory conditions, especially asthma, in the context of an unprecedented economic growth in Chile. The cohort was a representative sample of 1232 participants born between 1974 and 1978 in the hospital of Limache. The study includes data collected at birth, during the 1st year of life, at 22 to 28 years (collected between 2000 and 2002) and at 32 to 38 years (collected between 2010 and 2012). The data collected include anthropometric measurements at birth, 1st year of life and in adulthood, socio-economic and demographic data, lifestyle information including smoking, alcohol consumption and food intake, respiratory symptoms, lung function, broncho-reactivity to methacholine and skin prick reaction to eight allergens, measurement of cardiovascular risk factors and information on common mental health, mainly in the most recent study. The principal researchers welcome collaborative projects, especially those that will compare similar data sets in other settings. Published by Oxford University Press on behalf of the International Epidemiological Association © The Author 2013; all rights reserved.

Dementia and Traffic Accidents: A Danish Register-Based Cohort Study.

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Petersen, Jindong Ding; Siersma, Volkert; Nielsen, Connie Thurøe; Vass, Mikkel; Waldorff, Frans Boch

2016-09-27

As a consequence of a rapid growth of an ageing population, more people with dementia are expected on the roads. Little is known about whether these people are at increased risk of road traffic-related accidents. Our study aims to investigate the risk of road traffic-related accidents for people aged 65 years or older with a diagnosis of dementia in Denmark. We will conduct a nationwide population-based cohort study consisting of Danish people aged 65 or older living in Denmark as of January 1, 2008. The cohort is followed for 7 years (2008-2014). Individual's personal data are available in Danish registers and can be linked using a unique personal identification number. A person is identified with dementia if the person meets at least one of the following criteria: (1) a diagnosis of the disease in the Danish National Patient Register or in the Danish Psychiatric Central Research Register, and/or (2) at least one dementia diagnosis-related drug prescription registration in the Danish National Prescription Registry. Police-, hospital-, and emergency room-reported road traffic-related accidents occurred within the study follow-up are defined as the study outcome. Cox proportional hazard regression models are used for the main analysis. Our study protocol has 3 phases including data collection, data analysis, and reporting. The first phase of register-based data collection of 853,228 individual's personal information was completed in August, 2016. The next phase is data analysis, which is expected to be finished before December 2016, and thereafter writing publications based on the findings. The study started in January 2016 and will end in December 2018. This study covers the entire elderly population of Denmark, and thereby will avoid selection bias due to nonparticipation and loss to follow-up. Furthermore, this ensures that the study results are reliable and generalizable. However, underreporting of traffic-related accidents may occur, which will limit estimation

Age, time period, and birth cohort differences in self-esteem: Reexamining a cohort-sequential longitudinal study.

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Twenge, Jean M; Carter, Nathan T; Campbell, W Keith

2017-05-01

Orth, Trzesniewski, and Robins (2010) concluded that the nationally representative Americans' Changing Lives (ACL) cohort-sequential study demonstrated moderate to large age differences in self-esteem, and no birth cohort (generational) differences in the age trajectory. In a reanalysis of these data using 2 different statistical techniques, we find significant increases in self-esteem that could be attributed to birth cohort or time period. First, hierarchical linear modeling analyses with birth cohort as a continuous variable (vs. the multiple group formulation used by Orth et al.) find that birth cohort has a measurable influence on self-esteem through its interaction with age. Participants born in later years (e.g., 1960) were higher in self-esteem and were more likely to increase in self-esteem as they aged than participants born in earlier years (e.g., 1920). However, the estimated age trajectory up to age 60 is similar in Orth et al.'s results and in the results from our analyses including cohort. Second, comparing ACL respondents of the same age in 1986 versus 2002 (a time-lag design) yields significant birth cohort differences in self-esteem, with 2002 participants of the same age higher in self-esteem than those in 1986. Combined with some previous studies finding significant increases in self-esteem and positive self-views over time, these results suggest that cultural change in the form of cohort and time period cannot be ignored as influences in cross-sectional and longitudinal studies. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

The Netherlands Chlamydia cohort study (NECCST) protocol to assess the risk of late complications following Chlamydia trachomatis infection in women.

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Hoenderboom, B M; van Oeffelen, A A M; van Benthem, B H B; van Bergen, J E A M; Dukers-Muijrers, N H T M; Götz, H M; Hoebe, C J P A; Hogewoning, A A; van der Klis, F R M; van Baarle, D; Land, J A; van der Sande, M A B; van Veen, M G; de Vries, F; Morré, S A; van den Broek, I V F

2017-04-11

Chlamydia trachomatis (CT), the most common bacterial sexually transmitted infection (STI) among young women, can result in serious sequelae. Although the course of infection is often asymptomatic, CT may cause pelvic inflammatory disease (PID), leading to severe complications, such as prolonged time to pregnancy, ectopic pregnancy, and tubal factor subfertility. The risk of and risk factors for complications following CT-infection have not been assessed in a long-term prospective cohort study, the preferred design to define infections and complications adequately. In the Netherlands Chlamydia Cohort Study (NECCST), a cohort of women of reproductive age with and without a history of CT-infection is followed over a minimum of ten years to investigate (CT-related) reproductive tract complications. This study is a follow-up of the Chlamydia Screening Implementation (CSI) study, executed between 2008 and 2011 in the Netherlands. For NECCST, female CSI participants who consented to be approached for follow-up studies (n = 14,685) are invited, and prospectively followed until 2022. Four data collection moments are foreseen every two consecutive years. Questionnaire data and blood samples for CT-Immunoglobulin G (IgG) measurement are obtained as well as host DNA to determine specific genetic biomarkers related to susceptibility and severity of infection. CT-history will be based on CSI test outcomes, self-reported infections and CT-IgG presence. Information on (time to) pregnancies and the potential long-term complications (i.e. PID, ectopic pregnancy and (tubal factor) subfertility), will be acquired by questionnaires. Reported subfertility will be verified in medical registers. Occurrence of these late complications and prolonged time to pregnancy, as a proxy for reduced fertility due to a previous CT-infection, or other risk factors, will be investigated using longitudinal statistical procedures. In the proposed study, the occurrence of late complications following

Compliance With Protocols for Prevention of Neonatal Group B Streptococcal Sepsis: Practicalities and Limitations

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Gwendolyn L. Gilbert

2003-01-01

Full Text Available Objective: To compare two protocols for intrapartum antibiotic prophylaxis (IAP against neonatal group B streptococcal (GBS sepsis, with respect to staff compliance, in a prospective cohort study in the obstetric units of a community hospital (A and a university teaching hospital (B.

Protocol adherence and the ability to achieve target haemoglobin levels in haemodialysis patients.

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Chan, Kevin; Moran, John; Hlatky, Mark; Lafayette, Richard

2009-06-01

Anemia management remains complicated in patients with endstage renal disease on hemodialysis. We wished to evaluate the effect of protocol adherence to EPO and intravenous iron dosing on achieving the desired range of hemoglobin levels. A cohort of hemodialysis patients was studied to evaluate the rate of adherence to EPO and iron dosing protocols over a 5 month period. A database was completed to evaluate all known comorbidities, demographic factors, and facility issues that might affect hemoglobin levels. A logistic regression model was employed to evaluate the effect of adherence to the anemia protocols on the probability of achieving a hemoglobin level below, within or above the targeted range of 11-12.5 g/dl. Among 2114 patients, we found that adherence to both the EPO and iron dosing protocol resulted in the greatest probability of achieving the target hemoglobin range (56 +/- 5% in anemia protocol adherent patients versus 42 +/- 7% in non adherent patients). This was predominantly due to a lowered risk of having above target hemoglobin levels rather than below. The use of the anemia protocols was associated with lower rates of hospitalization (9 +/- 0.7 visits/100 months in adherent group vs 15 +/- 2 in non adherent group) and lower utilization of both EPO and intravenous iron. Furthermore, patients in the adherent groups had less variability of their hemoglobin levels month by month, at least as judged by standard deviation. Adherence to anemia protocols, as practiced in the dialysis units included in this cohort, may improve hemodialysis patients' ability to achieve target hemoglobin levels, and by avoiding above target hemoglobin values, lower drug utilization and reduce variability of hemoglobin levels.

Interactive verification of Markov chains: Two distributed protocol case studies

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Johannes Hölzl

2012-12-01

Full Text Available Probabilistic model checkers like PRISM only check probabilistic systems of a fixed size. To guarantee the desired properties for an arbitrary size, mathematical analysis is necessary. We show for two case studies how this can be done in the interactive proof assistant Isabelle/HOL. The first case study is a detailed description of how we verified properties of the ZeroConf protocol, a decentral address allocation protocol. The second case study shows the more involved verification of anonymity properties of the Crowds protocol, an anonymizing protocol.

Protocol for the Delirium and Cognitive Impact in Dementia (DECIDE) study: A nested prospective longitudinal cohort study.

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Richardson, Sarah J; Davis, Daniel H J; Stephan, Blossom; Robinson, Louise; Brayne, Carol; Barnes, Linda; Parker, Stuart; Allan, Louise M

2017-04-28

Delirium is common, affecting at least 20% of older hospital inpatients. It is widely accepted that delirium is associated with dementia but the degree of causation within this relationship is unclear. Previous studies have been limited by incomplete ascertainment of baseline cognition or a lack of prospective delirium assessments. There is an urgent need for an improved understanding of the relationship between delirium and dementia given that delirium prevention may plausibly impact upon dementia prevention. A well-designed, observational study could also answer fundamental questions of major importance to patients and their families regarding outcomes after delirium. The Delirium and Cognitive Impact in Dementia (DECIDE) study aims to explore the association between delirium and cognitive function over time in older participants. In an existing population based cohort aged 65 years and older, the effect on cognition of an episode of delirium will be measured, independent of baseline cognition and illness severity. The predictive value of clinical parameters including delirium severity, baseline cognition and delirium subtype on cognitive outcomes following an episode of delirium will also be explored. Over a 12 month period, surviving participants from the Cognitive Function and Ageing Study II-Newcastle will be screened for delirium on admission to hospital. At the point of presentation, baseline characteristics along with a number of disease relevant clinical parameters will be recorded. The progression/resolution of delirium will be monitored. In those with and without delirium, cognitive decline and dementia will be assessed at one year follow-up. We will evaluate the effect of delirium on cognitive function over time along with the predictive value of clinical parameters. This study will be the first to prospectively elucidate the size of the effect of delirium upon cognitive decline and incident dementia. The results will be used to inform future

Treatment of triple-negative breast cancer with Chinese herbal medicine: A prospective cohort study protocol.

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Meng, Hui; Peng, Nan; Yu, Mingwei; Sun, Xu; Ma, Yunfei; Yang, Guowang; Wang, Xiaomin

2017-11-01

Triple-negative breast cancer (TNBC) is featured with the biological properties of strong aggressive behaviors, rapid disease progression, high risk of recurrence and metastasis, and low disease free survival. Patients with this tumor are insensitive to the endocrine therapy and target treatment for HER-2; therefore, chemotherapy is often used as routine treatment in clinical. Because of the fact that a considerable number of patients seek for Chinese herbal medicine (CHM) treatment after operation and chemotherapy and (or) radiotherapy, it is thus need to evaluate the correlation between Chinese herbal medicine treatment and prognosis. This is a multicenter, prospective cohort study started in March 2016 in Beijing. A simple of 220 participants diagnosed with TNBC were recruited from nine hospitals and are followed up every 3 to 6 months till March 2020. Detailed information of participants includes personal information, history of cancer, quality of life, symptoms of traditional Chinese medicine and fatigue status is taken face-to-face at baseline. The study has received ethical approval from the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (No.2016BL-014-01). Articles summarizing the primary results and ancillary analyses will be published in peer-reviewed journals. Chinese Clinical Trial Registry: ChiCTR-OOC-16008246.

Public perceptions of cohort studies and biobanks in Germany.

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Starkbaum, Johannes; Gottweis, Herbert; Gottweis, Ursula; Kleiser, Christina; Linseisen, Jakob; Meisinger, Christa; Kamtsiuris, Panagiotis; Moebus, Susanne; Jöckel, Karl-Heinz; Börm, Sonja; Wichmann, H-Erich

2014-04-01

Cohort studies and biobank projects have led to public discussions in several European countries in the past. In Germany, many medium-sized studies are currently running successfully in terms of respondent rates. However, EU-wide research on general public perceptions of biobanks and cohort studies have shown that Germany is among those countries where people express the highest reluctance for providing body material and other data for research purposes. Because of early efforts of the just-initiated German National Cohort Study, we are able to begin to investigate in greater detail how various groups of people across Germany reflect and discuss the ongoing implementation of cohort studies and biobanking in Germany. Our research is based on 15 focus group discussions in four German regions, as well as on Eurobarometer poll data on biobanking.

Implant loading protocols for edentulous patients with fixed prostheses: a systematic review and meta-analysis.

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Papaspyridakos, Panos; Chen, Chun-Jung; Chuang, Sung-Kiang; Weber, Hans-Peter

2014-01-01

To report on the effect of immediate implant loading with fixed prostheses compared to early and conventional loading on implant and prosthesis survival, failure, and complications. An electronic and manual search was conducted to identify randomized controlled clinical trials (RCTs) as well as prospective and retrospective studies involving rough surface implants and implant fixed complete dental prostheses for edentulous patients. The 62 studies that fulfilled the inclusion criteria featured 4 RCTs, 2 prospective case-control studies, 34 prospective cohort studies, and 22 retrospective cohort studies. These studies yielded data from 2,695 patients (2,757 edentulous arches) with 13,653 implants. Studies were grouped according to the loading protocol applied; 45 studies reported on immediate loading, 8 on early loading, and 11 on conventional loading. For the immediate loading protocol with flap surgery, the implant and prosthesis survival rates ranged from 90.1% to 100% and 93.75% to 100%, respectively (range of follow-up, 1 to 10 years). When immediate loading was combined with guided flapless implant placement, the implant survival rates ranged from 90% to 99.4%. For the early loading protocol, the implant and prosthesis survival rates ranged from 94.74% to 100% and 93.75% to 100%, respectively (range of follow-up, 1 to 10 years). For the conventional loading protocol, the implant and prosthesis survival rates ranged from 94.95% to 100% and 87.5% to 100%, respectively (range of follow-up, 2 to 15 years). No difference was identified between maxilla and mandible. When selecting cases carefully and using dental implants with a rough surface, immediate loading with fixed prostheses in edentulous patients results in similar implant and prosthesis survival and failure rates as early and conventional loading. For immediate loading, most of the studies recommended a minimal insertion torque of 30 Ncm. The estimated 1-year implant survival was above 99% with all three

Comparative study of 2 oral care protocols in intensive care units.

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Ory, Jérôme; Raybaud, Evelyne; Chabanne, Russell; Cosserant, Bernard; Faure, Jean Sébastien; Guérin, Renaud; Calvet, Laure; Pereira, Bruno; Mourgues, Charline; Guelon, Dominique; Traore, Ousmane

2017-03-01

The quality of oral care is important in limiting the emergence of ventilator-associated pneumonia (VAP) in intubated patients. Our main objective was to measure the quality improvement in oral care following the implementation of a new oral care protocol. We also monitored VAP rates. This was a cohort study of patients in 5 adult ICUs covering different specialties. During period 1, caregivers used a foam stick for oral care and during period 2 a stick and tooth brushing with aspiration. Oral chlorhexidine was used during both periods. The caregivers rated improvement in oral health on the basis of 4 criteria (tongue, mucous membranes, gingivae, and teeth). Caregiver satisfaction was also assessed. The incidence of VAP was monitored. A total of 2,030 intubated patients admitted to intensive care units benefited from oral care. The patient populations during the 2 periods were similar with regard to demographic data and VAP potential risk factors. Oral health was significantly better from the third day of oral care in period 2 onward (period 1, 6.4 ± 2.1; period 2, 5.6 ± 1.8; P = .043). Caregivers found the period 2 protocol easier to implement and more effective. VAP rates decreased significantly between the 2 periods (period 1, 12.8%; period 2, 8.5%; P = .002). Our study showed that the implementation of a simple strategy improved the quality of oral care of patients in intensive care units, and decreased VAP rates. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Cohort studies in health sciences librarianship.

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Eldredge, Jonathan

2002-10-01

What are the key characteristics of the cohort study design and its varied applications, and how can this research design be utilized in health sciences librarianship? The health, social, behavioral, biological, library, earth, and management sciences literatures were used as sources. All fields except for health sciences librarianship were scanned topically for either well-known or diverse applications of the cohort design. The health sciences library literature available to the author principally for the years 1990 to 2000, supplemented by papers or posters presented at annual meetings of the Medical Library Association. A narrative review for the health, social, behavioral, biological, earth, and management sciences literatures and a systematic review for health sciences librarianship literature for the years 1990 to 2000, with three exceptions, were conducted. The author conducted principally a manual search of the health sciences librarianship literature for the years 1990 to 2000 as part of this systematic review. The cohort design has been applied to answer a wide array of theoretical or practical research questions in the health, social, behavioral, biological, and management sciences. Health sciences librarianship also offers several major applications of the cohort design. The cohort design has great potential for answering research questions in the field of health sciences librarianship, particularly evidence-based librarianship (EBL), although that potential has not been fully explored.

Mortality in Transition: Study Protocol of the PrivMort Project, a multilevel convenience cohort study.

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Irdam, Darja; King, Lawrence; Gugushvili, Alexi; Azarova, Aytalina; Fazekas, Mihaly; Scheiring, Gabor; Stefler, Denes; Doniec, Katarzyna; Horvat, Pia; Kolesnikova, Irina; Popov, Vladimir; Szelenyi, Ivan; Marmot, Michael; Murphy, Michael; McKee, Martin; Bobak, Martin

2016-07-30

Previous research using routine data identified rapid mass privatisation as an important driver of mortality crisis following the collapse of Communism in Central and Eastern Europe. However, existing studies on the mortality crisis relying on individual level or routine data cannot assess both distal (societal) and proximal (individual) causes of mortality simultaneously. The aim of the PrivMort Project is to overcome these limitations and to investigate the role of societal factors (particularly rapid mass privatisation) and individual-level factors (e.g. alcohol consumption) in the mortality changes in post-communist countries. The PrivMort conducts large-sample surveys in Russia, Belarus and Hungary. The approach is unique in comparing towns that have undergone rapid privatisation of their key industrial enterprises with those that experienced more gradual forms of privatisation, employing a multi-level retrospective cohort design that combines data on the industrial characteristics of the towns, socio-economic descriptions of the communities, settlement-level data, individual socio-economic characteristics, and individuals' health behaviour. It then incorporates data on mortality of different types of relatives of survey respondents, employing a retrospective demographic approach, which enables linkage of historical patterns of mortality to exposures, based on experiences of family members. By May 2016, 63,073 respondents provided information on themselves and 205,607 relatives, of whom 102,971 had died. The settlement-level dataset contains information on 539 settlements and 12,082 enterprises in these settlements in Russia, 96 settlements and 271 enterprises in Belarus, and 52 settlement and 148 enterprises in Hungary. In addition to reinforcing existing evidence linking smoking, hazardous drinking and unemployment to mortality, the PrivMort dataset will investigate the variation in transition experiences for individual respondents and their families across

Japanese Legacy Cohorts: The Life Span Study Atomic Bomb Survivor Cohort and Survivors’ Offspring

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Kotaro Ozasa

2018-04-01

Full Text Available Cohorts of atomic bomb survivors—including those exposed in utero—and children conceived after parental exposure were established to investigate late health effects of atomic bomb radiation and its transgenerational effects by the Atomic Bomb Casualty Commission (ABCC in the 1950s. ABCC was reorganized to the Radiation Effects Research Foundation (RERF in 1975, and all work has been continued at RERF. The Life Span Study, the cohort of survivors, consists of about 120,000 subjects and has been followed since 1950. Cohorts of in utero survivors and the survivors’ children include about 3,600 and 77,000 subjects, respectively, and have been followed since 1945. Atomic bomb radiation dose was estimated for each subject based on location at the time of the bombing and shielding conditions from exposure, which were obtained through enormous efforts of investigators and cooperation of subjects. Outcomes include vital status, cause of death, and cancer incidence. In addition, sub-cohorts of these three cohorts were constructed to examine clinical features of late health effects, and the subjects have been invited to periodic health examinations at clinics of ABCC and RERF. They were also asked to donate biosamples for biomedical investigations. Epidemiological studies have observed increased radiation risks for malignant diseases among survivors, including those exposed in utero, and possible risks for some non-cancer diseases. In children of survivors, no increased risks due to parental exposure to radiation have been observed for malignancies or other diseases, but investigations are continuing, as these cohorts are still relatively young.

Japanese Legacy Cohorts: The Life Span Study Atomic Bomb Survivor Cohort and Survivors' Offspring.

Science.gov (United States)

Ozasa, Kotaro; Grant, Eric J; Kodama, Kazunori

2018-04-05

Cohorts of atomic bomb survivors-including those exposed in utero-and children conceived after parental exposure were established to investigate late health effects of atomic bomb radiation and its transgenerational effects by the Atomic Bomb Casualty Commission (ABCC) in the 1950s. ABCC was reorganized to the Radiation Effects Research Foundation (RERF) in 1975, and all work has been continued at RERF. The Life Span Study, the cohort of survivors, consists of about 120,000 subjects and has been followed since 1950. Cohorts of in utero survivors and the survivors' children include about 3,600 and 77,000 subjects, respectively, and have been followed since 1945. Atomic bomb radiation dose was estimated for each subject based on location at the time of the bombing and shielding conditions from exposure, which were obtained through enormous efforts of investigators and cooperation of subjects. Outcomes include vital status, cause of death, and cancer incidence. In addition, sub-cohorts of these three cohorts were constructed to examine clinical features of late health effects, and the subjects have been invited to periodic health examinations at clinics of ABCC and RERF. They were also asked to donate biosamples for biomedical investigations. Epidemiological studies have observed increased radiation risks for malignant diseases among survivors, including those exposed in utero, and possible risks for some non-cancer diseases. In children of survivors, no increased risks due to parental exposure to radiation have been observed for malignancies or other diseases, but investigations are continuing, as these cohorts are still relatively young.

Japanese Legacy Cohorts: The Life Span Study Atomic Bomb Survivor Cohort and Survivors’ Offspring

Science.gov (United States)

Grant, Eric J; Kodama, Kazunori

2018-01-01

Cohorts of atomic bomb survivors—including those exposed in utero—and children conceived after parental exposure were established to investigate late health effects of atomic bomb radiation and its transgenerational effects by the Atomic Bomb Casualty Commission (ABCC) in the 1950s. ABCC was reorganized to the Radiation Effects Research Foundation (RERF) in 1975, and all work has been continued at RERF. The Life Span Study, the cohort of survivors, consists of about 120,000 subjects and has been followed since 1950. Cohorts of in utero survivors and the survivors’ children include about 3,600 and 77,000 subjects, respectively, and have been followed since 1945. Atomic bomb radiation dose was estimated for each subject based on location at the time of the bombing and shielding conditions from exposure, which were obtained through enormous efforts of investigators and cooperation of subjects. Outcomes include vital status, cause of death, and cancer incidence. In addition, sub-cohorts of these three cohorts were constructed to examine clinical features of late health effects, and the subjects have been invited to periodic health examinations at clinics of ABCC and RERF. They were also asked to donate biosamples for biomedical investigations. Epidemiological studies have observed increased radiation risks for malignant diseases among survivors, including those exposed in utero, and possible risks for some non-cancer diseases. In children of survivors, no increased risks due to parental exposure to radiation have been observed for malignancies or other diseases, but investigations are continuing, as these cohorts are still relatively young. PMID:29553058

Follow-up methods for retrospective cohort studies in New Zealand.

Science.gov (United States)

Fawcett, Jackie; Garrett, Nick; Bates, Michael N

2002-01-01

To define a general methodology for maximising the success of follow-up processes for retrospective cohort studies in New Zealand, and to illustrate an approach to developing country-specific follow-up methodologies. We recently conducted a cohort study of mortality and cancer incidence in New Zealand professional fire fighters. A number of methods were used to trace vital status, including matching with records of the New Zealand Health Information Service (NZHIS), pension records of Work and Income New Zealand (WINZ), and electronic electoral rolls. Non-electronic methods included use of paper electoral rolls and the records of the Registrar of Births Deaths and Marriages. 95% of the theoretical person-years of follow-up of the cohort were traced using these methods. In terms of numbers of cohort members traced to end of follow-up, the most useful tracing methods were fire fighter employment records, the NZHIS, WINZ, and the electronic electoral rolls. The follow-up process used for the cohort study was highly successful. On the basis of this experience, we propose a generic, but flexible, model for follow-up of retrospective cohort studies in New Zealand. Similar models could be constructed for other countries. Successful follow-up of cohort studies is possible in New Zealand using established methods. This should encourage the use of cohort studies for the investigation of epidemiological issues. Similar models for follow-up processes could be constructed for other countries.

Study protocol for examining job strain as a risk factor for severe unipolar depression in an individual participant meta-analysis of 14 European cohorts

DEFF Research Database (Denmark)

Madsen, Ida E H; Hannerz, Harald; Nyberg, Solja T

2013-01-01

scales that do not necessarily correspond to clinically diagnosed depression. In addition, a meta-analysis from 2008 indicated publication bias in the field. METHODS: This study protocol describes the planned design and analyses of an individual participant data meta-analysis, to examine whether job...... using random effects meta-analysis. DISCUSSION: The planned analyses will help clarify whether job strain is associated with an increased risk of clinically diagnosed unipolar depression. As the analysis is based on pre-planned study protocols and an individual participant data meta-analysis, the pooled......BACKGROUND: Previous studies have shown that gainfully employed individuals with high work demands and low control at work (denoted "job strain") are at increased risk of common mental disorders, including depression. Most existing studies have, however, measured depression using self-rated symptom...

Does Extended Preoperative Rehabilitation Influence Outcomes 2 Years After ACL Reconstruction? A Comparative Effectiveness Study Between the MOON and Delaware-Oslo ACL Cohorts.

Science.gov (United States)

Failla, Mathew J; Logerstedt, David S; Grindem, Hege; Axe, Michael J; Risberg, May Arna; Engebretsen, Lars; Huston, Laura J; Spindler, Kurt P; Snyder-Mackler, Lynn

2016-10-01

Rehabilitation before anterior cruciate ligament (ACL) reconstruction (ACLR) is effective at improving postoperative outcomes at least in the short term. Less is known about the effects of preoperative rehabilitation on functional outcomes and return-to-sport (RTS) rates 2 years after reconstruction. The purpose of this study was to compare functional outcomes 2 years after ACLR in a cohort that underwent additional preoperative rehabilitation, including progressive strengthening and neuromuscular training after impairments were resolved, compared with a nonexperimental cohort. We hypothesized that the cohort treated with extended preoperative rehabilitation would have superior functional outcomes 2 years after ACLR. Cohort study; Level of evidence, 3. This study compared outcomes after an ACL rupture in an international cohort (Delaware-Oslo ACL Cohort [DOC]) treated with extended preoperative rehabilitation, including neuromuscular training, to data from the Multicenter Orthopaedic Outcomes Network (MOON) cohort, which did not undergo extended preoperative rehabilitation. Inclusion and exclusion criteria from the DOC were applied to the MOON database to extract a homogeneous sample for comparison. Patients achieved knee impairment resolution before ACLR, and postoperative rehabilitation followed each cohort's respective criterion-based protocol. Patients completed the International Knee Documentation Committee (IKDC) subjective knee form and Knee injury and Osteoarthritis Outcome Score (KOOS) at enrollment and again 2 years after ACLR. RTS rates were calculated for each cohort at 2 years. After adjusting for baseline IKDC and KOOS scores, the DOC patients showed significant and clinically meaningful differences in IKDC and KOOS scores 2 years after ACLR. There was a significantly higher (P < .001) percentage of DOC patients returning to preinjury sports (72%) compared with those in the MOON cohort (63%). The cohort treated with additional preoperative

Case-Cohort Studies: Design and Applicability to Hand Surgery.

Science.gov (United States)

Vojvodic, Miliana; Shafarenko, Mark; McCabe, Steven J

2018-04-24

Observational studies are common research strategies in hand surgery. The case-cohort design offers an efficient and resource-friendly method for risk assessment and outcomes analysis. Case-cohorts remain underrepresented in upper extremity research despite several practical and economic advantages over case-control studies. This report outlines the purpose, utility, and structure of the case-cohort design and offers a sample research question to demonstrate its value to risk estimation for adverse surgical outcomes. The application of well-designed case-cohort studies is advocated in an effort to improve the quality and quantity of observational research evidence in hand and upper extremity surgery. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

CoReumaPt Protocol: the Portuguese Cohort of Rheumatic Diseases

NARCIS (Netherlands)

Laires, Pedro A.; Canhão, Helena; Araújo, Domingos; Fonseca, João Eurico; Machado, Pedro; Mourão, Ana Filipa; Ramiro, Sofia; Romeu, José Carlos; Santos, Maria José; Silva, Inês; Silva, José A.; Sousa, Elsa; Tavares, Viviana; Gouveia, Nélia; Branco, Jaime C.

2012-01-01

Introduction: Rheumatic diseases (RD) are conditions with a variety of clinical manifestations and prognosis influenced by several factors. Cohorts and registries have been already established in some countries and have contributed to important knowledge about the disease course and the long-term

Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols

DEFF Research Database (Denmark)

Chan, A.W.; Hrobjartsson, A.; Jorgensen, K.J.

2008-01-01

OBJECTIVE: To evaluate how often sample size calculations and methods of statistical analysis are pre-specified or changed in randomised trials. DESIGN: Retrospective cohort study. Data source Protocols and journal publications of published randomised parallel group trials initially approved...... in 1994-5 by the scientific-ethics committees for Copenhagen and Frederiksberg, Denmark (n=70). MAIN OUTCOME MEASURE: Proportion of protocols and publications that did not provide key information about sample size calculations and statistical methods; proportion of trials with discrepancies between...... of handling missing data was described in 16 protocols and 49 publications. 39/49 protocols and 42/43 publications reported the statistical test used to analyse primary outcome measures. Unacknowledged discrepancies between protocols and publications were found for sample size calculations (18/34 trials...

Riyadh Mother and Baby Multicenter Cohort Study: The Cohort Profile.

Directory of Open Access Journals (Sweden)

Hayfaa Wahabi

Full Text Available To assess the effects of non-communicable diseases, such as diabetes, hypertension and obesity, on the mother and the infant.A multicentre cohort study was conducted in three hospitals in the city of Riyadh in Saudi Arabia. All Saudi women and their babies who delivered in participating hospitals were eligible for recruitment. Data on socio-demographic characteristics in addition to the maternal and neonatal outcomes of pregnancy were collected. The cohort demographic profile was recorded and the prevalence of maternal conditions including gestational diabetes, pre-gestational diabetes, hypertensive disorders in pregnancy and obesity were estimated.The total number of women who delivered in participating hospitals during the study period was 16,012 of which 14,568 women participated in the study. The mean age of the participants was 29 ± 5.9 years and over 40% were university graduates. Most of the participants were housewives, 70% were high or middle income and 22% were exposed to secondhand smoke. Of the total cohort, 24% were married to a first cousin. More than 68% of the participants were either overweight or obese. The preterm delivery rate was 9%, while 1.5% of the deliveries were postdate. The stillbirth rate was 13/1000 live birth. The prevalence of gestational diabetes was 24% and that of pre-gestational diabetes was 4.3%. The preeclampsia prevalence was 1.1%. The labour induction rate was 15.5% and the cesarean section rate was 25%.Pregnant women in Saudi Arabia have a unique demographic profile. The prevalence of obesity and diabetes in pregnancy are among the highest in the world.

Cohort profile: LIFEWORK, a prospective cohort study on occupational and environmental risk factors and health in the Netherlands.

NARCIS (Netherlands)

Reedijk, M.; Lenters, V.; Slottje, P.; Pijpe, A.; Peeters, P.H.; Korevaar, J.C.; Bueno-de-Mesquita, B.; Verschuren, W.M.M.; Verheij, R.A.; Pieterson, I.; Leeuwen, F.E. van; Rookus, M.A.; Kromhout, H.; Vermeulen, R.C.H.

2017-01-01

Purpose LIFEWORK is a large federated prospective cohort established in the Netherlands to quantify the health effects of occupational and environmental exposures. This cohort is also the Dutch contribution to the international Cohort Study of Mobile Phone Use and Health (COSMOS). In this paper, we

The Fangshan/Family-based Ischemic Stroke Study In China (FISSIC protocol

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Chen Dafang

2007-09-01

Full Text Available Abstract Background The exact etiology of ischemic stroke remains unclear, because multiple genetic predispositions and environmental risk factors may be involved, and their interactions dictate the complexity. Family-based studies provide unique features in design, while they are currently underrepresented for studies of ischemic stroke in developing countries. The Fangshan/Family-based Ischemic Stroke Study In China (FISSIC program aims to conduct a genetic pedigree study of ischemic stroke in rural communities of China. Methods/Design The pedigrees of ischemic stroke with clear documentation are recruited by using the proband-initiated contact method, based on the stroke registry in hospital and communities. Blood samples and detailed information of pedigrees are collected through the health care network in the rural area, and prospective follow-up of the pedigrees cohort is scheduled. Complementary strategies of both family-based design and matched case-spousal control design are used, and comprehensive statistical methods will be implemented to ascertain potential complex genetic and environmental factors and their interactions as well. Discussion This study is complementary to other genetic pedigree studies of ischemic stroke, such as the Siblings With Ischemic Stroke Study (SWISS, which are established in developed countries. We describe the protocol of this family-based genetic epidemiological study that may be used as a new practical guideline and research paradigm in developing countries and facilitate initiatives of stroke study for international collaborations.

Impact of targeted scanning protocols on perinatal outcomes in pregnancies at risk of placenta accreta spectrum or vasa previa.

Science.gov (United States)

Melcer, Yaakov; Jauniaux, Eric; Maymon, Shlomit; Tsviban, Anna; Pekar-Zlotin, Marina; Betser, Moshe; Maymon, Ron

2018-04-01

Placenta accreta spectrum and vasa previa (VP) are congenital disorders of placentation associated with high morbidity and mortality for both mothers and newborns when undiagnosed before delivery. Prenatal diagnosis of these conditions is essential to allow multidisciplinary management and thus improve perinatal outcomes. The objective of the study was to compare perinatal outcome in women with placenta accreta spectrum or vasa previa before and after implementation of targeted scanning protocols. This retrospective study included 2 nonconcurrent cohorts for each condition before and after implementation of the corresponding protocols (2004-1012 vs 2013-2016 for placenta accreta spectrum and 1988-2007 vs 2008-2016 for vasa previa). Clinical reports of women diagnosed with placenta accreta spectrum and vasa previa during the study periods were reviewed and outcomes were compared. In total, there were 97 cases of placenta accreta spectrum and 51 cases with vasa previa, all confirmed at delivery. In both cohorts, the prenatal detection rate increased after implementation of the scanning protocols (28 of 65 cases [43.1%] vs 31 of 32 cases [96.9%], P accreta spectrum and 9 of 18 cases [50%] vs 29 of 33 cases [87.9%], 87.9%, P accreta spectrum cohort, the estimated blood loss and the postoperative hospitalization stay decreased between periods (1520 ± 845 vs 1168 ± 707 mL, P accreta spectrum and vasa previa was associated with improved maternal and neonatal outcomes. The continuous increases in the rates of caesarean deliveries and use of assisted reproductive technology highlights the need to develop training programs and introduce targeted scanning protocols at the national and international levels. Copyright © 2018 Elsevier Inc. All rights reserved.

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

Directory of Open Access Journals (Sweden)

Benjamin Kasenda

2016-06-01

Full Text Available Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i the existence and types of publication agreements in trial protocols, (ii the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii the frequency of co-authorship by industry employees.We used a retrospective cohort of randomized clinical trials (RCTs based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5% mentioned an agreement regarding publication of results. Of these 456, 393 (86.2% documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6% agreements were without constraints of publication. The remaining 24 (5.3% protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0% trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]. Of 71 agreements reported in publications, 52 (73.2% were concordant with those documented in the protocol. In 14 of 37 (37.8% publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements.Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

Science.gov (United States)

Kasenda, Benjamin; von Elm, Erik; You, John J.; 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.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

2016-01-01

Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on

Mortality in Transition: Study Protocol of the PrivMort Project, a multilevel convenience cohort study

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Darja Irdam

2016-07-01

Full Text Available Abstract Background Previous research using routine data identified rapid mass privatisation as an important driver of mortality crisis following the collapse of Communism in Central and Eastern Europe. However, existing studies on the mortality crisis relying on individual level or routine data cannot assess both distal (societal and proximal (individual causes of mortality simultaneously. The aim of the PrivMort Project is to overcome these limitations and to investigate the role of societal factors (particularly rapid mass privatisation and individual-level factors (e.g. alcohol consumption in the mortality changes in post-communist countries. Methods The PrivMort conducts large-sample surveys in Russia, Belarus and Hungary. The approach is unique in comparing towns that have undergone rapid privatisation of their key industrial enterprises with those that experienced more gradual forms of privatisation, employing a multi-level retrospective cohort design that combines data on the industrial characteristics of the towns, socio-economic descriptions of the communities, settlement-level data, individual socio-economic characteristics, and individuals’ health behaviour. It then incorporates data on mortality of different types of relatives of survey respondents, employing a retrospective demographic approach, which enables linkage of historical patterns of mortality to exposures, based on experiences of family members. By May 2016, 63,073 respondents provided information on themselves and 205,607 relatives, of whom 102,971 had died. The settlement-level dataset contains information on 539 settlements and 12,082 enterprises in these settlements in Russia, 96 settlements and 271 enterprises in Belarus, and 52 settlement and 148 enterprises in Hungary. Discussion In addition to reinforcing existing evidence linking smoking, hazardous drinking and unemployment to mortality, the PrivMort dataset will investigate the variation in transition

Study protocol for the Cities Changing Diabetes programme

DEFF Research Database (Denmark)

Napier, A David; Nolan, John J; Bagger, Malene

2017-01-01

and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through...... the Cities Changing Diabetes (CCD) partnership programme. METHODS AND ANALYSIS: A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan...... Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. ETHICS AND DISSEMINATION: The protocol steers the collection of primary and secondary data across the study sites. Research ethics...

Occupational radiation exposure and its health effects on interventional medical workers: study protocol for a prospective cohort study.

Science.gov (United States)

Ko, Seulki; Chung, Hwan Hoon; Cho, Sung Bum; Jin, Young Woo; Kim, Kwang Pyo; Ha, Mina; Bang, Ye Jin; Ha, Yae Won; Lee, Won Jin

2017-12-15

Although fluoroscopically guided procedures involve a considerably high dose of radiation, few studies have investigated the effects of radiation on medical workers involved in interventional fluoroscopy procedures. Previous research remains in the early stages and has not reached a level comparable with other occupational studies thus far. Furthermore, the study of radiation workers provides an opportunity to estimate health risks at low doses and dose rates of ionising radiation. Therefore, the objectives of this study are (1) to initiate a prospective cohort study by conducting a baseline survey among medical radiation workers who involve interventional fluoroscopy procedures and (2) to assess the effect of occupational radiation exposure and on the overall health status through an in-depth cross-sectional study. Intervention medical workers in Korea will be enrolled by using a self-administered questionnaire survey, and the survey data will be linked with radiation dosimetry data, National Health Insurance claims data, cancer registry and mortality data. After merging these data, the radiation organ dose, lifetime attributable risk due to cancer and the risk per unit dose will be estimated. For the cross-sectional study, approximately 100 intervention radiology department workers will be investigated for blood tests, clinical examinations such as ultrasonography (thyroid and carotid artery scan) and lens opacity, the validation of badge dose and biodosimetry. This study was reviewed and approved by the institutional review board of Korea University (KU-IRB-12-12-A-1). All participants will provide written informed consent prior to enrolment. The findings of the study will be disseminated through peer-reviewed scientific journals, conference presentations, and a report will be submitted to the relevant public health authorities in the Korea Centers for Disease Control and Prevention to help with the development of appropriate research and management policies. �

Regression analysis for secondary response variable in a case-cohort study.

Science.gov (United States)

Pan, Yinghao; Cai, Jianwen; Kim, Sangmi; Zhou, Haibo

2017-12-29

Case-cohort study design has been widely used for its cost-effectiveness. In any real study, there are always other important outcomes of interest beside the failure time that the original case-cohort study is based on. How to utilize the available case-cohort data to study the relationship of a secondary outcome with the primary exposure obtained through the case-cohort study is not well studied. In this article, we propose a non-parametric estimated likelihood approach for analyzing a secondary outcome in a case-cohort study. The estimation is based on maximizing a semiparametric likelihood function that is built jointly on both time-to-failure outcome and the secondary outcome. The proposed estimator is shown to be consistent, efficient, and asymptotically normal. Finite sample performance is evaluated via simulation studies. Data from the Sister Study is analyzed to illustrate our method. © 2017, The International Biometric Society.

A longitudinal study of risk and protective factors associated with successful transition to secondary school in youth with ADHD: prospective cohort study protocol.

Science.gov (United States)

Zendarski, Nardia; Sciberras, Emma; Mensah, Fiona; Hiscock, Harriet

2016-01-28

Attention-Deficit/Hyperactivity Disorder (ADHD) has a significant impact on child and adolescent development, especially in relation to school functioning and academic outcomes. Despite the transition to high school being a potentially critical period for children with ADHD, most research in this period has focused on academic outcomes. This study aims to extend previous research by describing academic, school engagement, behaviour and social-emotional outcomes for young people with ADHD in the first and third years of high school and to identify risk and protective factors predictive of differing outcomes across these four domains. The Moving Up study is a longitudinal, prospective cohort study of children with ADHD as they transition and adjust to high school (age 12-15 years). Data are collected through direct assessment and child, parent and teacher surveys. The primary outcome is academic achievement, obtained by linking to standardised test results. Secondary outcomes include measures of behaviour, ADHD symptoms, school engagement (attitudes and attendance), and social and emotional functioning, including depressive symptoms. The mean performance of the study cohort on each outcome measure will be compared to the population mean for same aged children, using t-tests. Risk and protective factors to be examined using multiple regression include a child, family and school factors know to impact academic and school functioning. The Moving up study is the first Australian study prospectively designed to measure a broad range of student outcomes for children with ADHD during the high school transition period. Examining both current (cross sectional) and earlier childhood (longitudinal) factors gives us the potential to learn more about risk and protective factors associated with school functioning in young people with ADHD. The richness and depth of this information could lead to more targeted and effective interventions that may alter academic and wellbeing

How safe are our paediatric emergency departments? Protocol for a national prospective cohort study.

Science.gov (United States)

Plint, Amy C; Newton, Amanda; Stang, Antonia; Bhatt, Maala; Barrowman, Nick; Calder, Lisa

2014-12-04

Adverse events (AEs), defined as unintended patient harm related to healthcare provided rather than an underlying medical condition, represent a significant threat to patient safety and public health. The emergency department (ED) is a high-risk patient safety setting for many reasons including presentation 'outside of regular hours', high patient volumes, and a chaotic work environment. Children have also been identified as particularly vulnerable to AEs. Despite the identification of the ED as a high-risk setting and the vulnerability of the paediatric population, little research has been conducted regarding paediatric patient safety in the ED. The study objective is to generate an estimate of the risk and type of AEs, as well as their preventability and severity, for children seen in Canadian paediatric EDs. This multicentre, prospective cohort study will enrol patients under 18 years of age from nine paediatric EDs across Canada. A stratified cluster random sampling scheme will be used to ensure patients recruited are representative of the overall ED population. A rigorous, standardised two-stage process will be used for AE identification. The primary outcome will be the proportion of children with AEs associated with ED care in the 3 weeks following the ED visit. Secondary outcomes will include the proportion of children with preventable AEs and the types and severity of AEs. We will aim to recruit 5632 patients over 1 year and this will allow us to detect a proportion of patients with an AE of 5% (to within an absolute margin of error of 0.6%). Ethics approval has been obtained from participating sites. Results will be disseminated through presentations, peer review publications, linkages with emergency research network and a webinars for key knowledge user groups. This study is registered at Clinicaltrials.gov (NCT02162147; https://clinicaltrials.gov/ct2/show/NCT02162147). Published by the BMJ Publishing Group Limited. For permission to use (where not

Swiss national community survey on functioning after spinal cord injury : Protocol, characteristics of participants and determinants of non-response

NARCIS (Netherlands)

Brinkhof, Martin W G; Fekete, Christine; Chamberlain, Jonviea D; Post, Marcel W M; Gemperli, Armin

2016-01-01

OBJECTIVE: To detail the protocol, recruitment, study population, response, and data quality of the first population-based community survey of the Swiss Spinal Cord Injury (SwiSCI) Cohort Study. DESIGN: The survey consisted of 3 successive modules administered between September 2011 and March 2013.

Swiss national community survey on functioning after spinal cord injury : Protocol, characteristics of participants and determinants of non-response

NARCIS (Netherlands)

Brinkhof, Martin W. G.; Fekete, Christine; Chamberlain, Jonviea D.; Post, Marcel W. M.; Gemperli, Armin

Objective: To detail the protocol, recruitment, study population, response, and data quality of the first population-based community survey of the Swiss Spinal Cord Injury (SwiSCI) Cohort Study. Design: The survey consisted of 3 successive modules administered between September 2011 and March 2013.

A Study of Shared-Memory Mutual Exclusion Protocols Using CADP

Science.gov (United States)

Mateescu, Radu; Serwe, Wendelin

Mutual exclusion protocols are an essential building block of concurrent systems: indeed, such a protocol is required whenever a shared resource has to be protected against concurrent non-atomic accesses. Hence, many variants of mutual exclusion protocols exist in the shared-memory setting, such as Peterson's or Dekker's well-known protocols. Although the functional correctness of these protocols has been studied extensively, relatively little attention has been paid to their non-functional aspects, such as their performance in the long run. In this paper, we report on experiments with the performance evaluation of mutual exclusion protocols using Interactive Markov Chains. Steady-state analysis provides an additional criterion for comparing protocols, which complements the verification of their functional properties. We also carefully re-examined the functional properties, whose accurate formulation as temporal logic formulas in the action-based setting turns out to be quite involved.

A protocol for resuscitation of severe burn patients guided by transpulmonary thermodilution and lactate levels: a 3-year prospective cohort study

OpenAIRE

Sánchez, Manuel; García-de-Lorenzo, Abelardo; Herrero, Eva; Lopez, Teresa; Galvan, Beatriz; Asensio, María José; Cachafeiro, Lucia; Casado, Cesar

2013-01-01

Introduction: The use of urinary output and vital signs to guide initial burn resuscitation may lead to suboptimal resuscitation. Invasive hemodynamic monitoring may result in over-resuscitation. This study aimed to evaluate the results of a goal-directed burn resuscitation protocol that used standard measures of mean arterial pressure (MAP) and urine output, plus transpulmonary thermodilution (TPTD) and lactate levels to adjust fluid therapy to achieve a minimum level of preload ...

Assessing the health effects associated with occupational radiation exposure in Korean radiation workers: protocol for a prospective cohort study.

Science.gov (United States)

Seo, Songwon; Lim, Wan Young; Lee, Dal Nim; Kim, Jung Un; Cha, Eun Shil; Bang, Ye Jin; Lee, Won Jin; Park, Sunhoo; Jin, Young Woo

2018-03-30

The cancer risk of radiation exposure in the moderate-to-high dose range has been well established. However, the risk remains unclear at low-dose ranges with protracted low-dose rate exposure, which is typical of occupational exposure. Several epidemiological studies of Korean radiation workers have been conducted, but the data were analysed retrospectively in most cases. Moreover, groups with relatively high exposure, such as industrial radiographers, have been neglected. Therefore, we have launched a prospective cohort study of all Korean radiation workers to assess the health effects associated with occupational radiation exposure. Approximately 42 000 Korean radiation workers registered with the Nuclear Safety and Security Commission from 2016 to 2017 are the initial target population of this study. Cohort participants are to be enrolled through a nationwide self-administered questionnaire survey between 24 May 2016 and 30 June 2017. As of 31 March 2017, 22 982 workers are enrolled in the study corresponding to a response rate of 75%. This enrolment will be continued at 5-year intervals to update information on existing study participants and recruit newly hired workers. Survey data will be linked with the national dose registry, the national cancer registry, the national vital statistics registry and national health insurance data via personal identification numbers. Age-specific and sex-specific standardised incidence and mortality ratios will be calculated for overall comparisons of cancer risk. For dose-response assessment, excess relative risk (per Gy) and excess absolute risk (per Gy) will be estimated with adjustments for birth year and potential confounders, such as lifestyle factors and socioeconomic status. This study has received ethical approval from the institutional review board of the Korea Institute of Radiological and Medical Sciences (IRB No. K-1603-002-034). All participants provided written informed consent prior to enrolment. The findings

The UNC/UMN Baby Connectome Project (BCP): An overview of the study design and protocol development.

Science.gov (United States)

Howell, Brittany R; Styner, Martin A; Gao, Wei; Yap, Pew-Thian; Wang, Li; Baluyot, Kristine; Yacoub, Essa; Chen, Geng; Potts, Taylor; Salzwedel, Andrew; Li, Gang; Gilmore, John H; Piven, Joseph; Smith, J Keith; Shen, Dinggang; Ugurbil, Kamil; Zhu, Hongtu; Lin, Weili; Elison, Jed T

2018-03-22

The human brain undergoes extensive and dynamic growth during the first years of life. The UNC/UMN Baby Connectome Project (BCP), one of the Lifespan Connectome Projects funded by NIH, is an ongoing study jointly conducted by investigators at the University of North Carolina at Chapel Hill and the University of Minnesota. The primary objective of the BCP is to characterize brain and behavioral development in typically developing infants across the first 5 years of life. The ultimate goals are to chart emerging patterns of structural and functional connectivity during this period, map brain-behavior associations, and establish a foundation from which to further explore trajectories of health and disease. To accomplish these goals, we are combining state of the art MRI acquisition and analysis techniques, including high-resolution structural MRI (T1-and T2-weighted images), diffusion imaging (dMRI), and resting state functional connectivity MRI (rfMRI). While the overall design of the BCP largely is built on the protocol developed by the Lifespan Human Connectome Project (HCP), given the unique age range of the BCP cohort, additional optimization of imaging parameters and consideration of an age appropriate battery of behavioral assessments were needed. Here we provide the overall study protocol, including approaches for subject recruitment, strategies for imaging typically developing children 0-5 years of age without sedation, imaging protocol and optimization, a description of the battery of behavioral assessments, and QA/QC procedures. Combining HCP inspired neuroimaging data with well-established behavioral assessments during this time period will yield an invaluable resource for the scientific community. Copyright © 2018 Elsevier Inc. All rights reserved.

A prospective cohort study on ambient air pollution and respiratory morbidities including childhood asthma in adolescents from the western Cape Province: study protocol.

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Olaniyan, Toyib; Jeebhay, Mohamed; Röösli, Martin; Naidoo, Rajen; Baatjies, Roslynn; Künzil, Nino; Tsai, Ming; Davey, Mark; de Hoogh, Kees; Berman, Dilys; Parker, Bhawoodien; Leaner, Joy; Dalvie, Mohamed Aqiel

2017-09-16

There is evidence from existing literature that ambient air pollutant exposure in early childhood likely plays an important role in asthma exacerbation and other respiratory symptoms, with greater effect among asthmatic children. However, there is inconclusive evidence on the role of ambient air pollutant exposures in relation to increasing asthma prevalence as well as asthma induction in children. At the population level, little is known about the potential synergistic effects between pollen allergens and air pollutants since this type of association poses challenges in uncontrolled real life settings. In particular, data from sub-Sahara Africa is scarce and virtually absent among populations residing in informal residential settlements. A prospective cohort study of 600 school children residing in four informal settlement areas with varying potential ambient air pollutant exposure levels in the Western Cape in South Africa is carried-out. The study has two follow-up periods of at least six-months apart including an embedded panel study in summer and winter. The exposure assessment component models temporal and spatial variability of air quality in the four study areas over the study duration using land-use regression modelling (LUR). Additionally, daily pollen levels (mould spores, tree, grass and weed pollen) in the study areas are recorded. In the panel study asthma symptoms and serial peak flow measurements is recorded three times daily to determine short-term serial airway changes in relation to varying ambient air quality and pollen over 10-days during winter and summer. The health outcome component of the cohort study include; the presence of asthma using a standardised ISAAC questionnaire, spirometry, fractional exhaled nitric-oxide (FeNO) and the presence of atopy (Phadiatop). This research applies state of the art exposure assessment approaches to characterize the effects of ambient air pollutants on childhood respiratory health, with a specific focus on

A prospective cohort study on ambient air pollution and respiratory morbidities including childhood asthma in adolescents from the western Cape Province: study protocol

Directory of Open Access Journals (Sweden)

Toyib Olaniyan

2017-09-01

Full Text Available Abstract Background There is evidence from existing literature that ambient air pollutant exposure in early childhood likely plays an important role in asthma exacerbation and other respiratory symptoms, with greater effect among asthmatic children. However, there is inconclusive evidence on the role of ambient air pollutant exposures in relation to increasing asthma prevalence as well as asthma induction in children. At the population level, little is known about the potential synergistic effects between pollen allergens and air pollutants since this type of association poses challenges in uncontrolled real life settings. In particular, data from sub-Sahara Africa is scarce and virtually absent among populations residing in informal residential settlements. Methods/design A prospective cohort study of 600 school children residing in four informal settlement areas with varying potential ambient air pollutant exposure levels in the Western Cape in South Africa is carried-out. The study has two follow-up periods of at least six-months apart including an embedded panel study in summer and winter. The exposure assessment component models temporal and spatial variability of air quality in the four study areas over the study duration using land-use regression modelling (LUR. Additionally, daily pollen levels (mould spores, tree, grass and weed pollen in the study areas are recorded. In the panel study asthma symptoms and serial peak flow measurements is recorded three times daily to determine short-term serial airway changes in relation to varying ambient air quality and pollen over 10-days during winter and summer. The health outcome component of the cohort study include; the presence of asthma using a standardised ISAAC questionnaire, spirometry, fractional exhaled nitric-oxide (FeNO and the presence of atopy (Phadiatop. Discussion This research applies state of the art exposure assessment approaches to characterize the effects of ambient air

Implementation of a Rapid, Protocol-based TIA Management Pathway.

Science.gov (United States)

Jarhult, Susann J; Howell, Melissa L; Barnaure-Nachbar, Isabelle; Chang, Yuchiao; White, Benjamin A; Amatangelo, Mary; Brown, David F; Singhal, Aneesh B; Schwamm, Lee H; Silverman, Scott B; Goldstein, Joshua N

2018-03-01

Our goal was to assess whether use of a standardized clinical protocol improves efficiency for patients who present to the emergency department (ED) with symptoms of transient ischemic attack (TIA). We performed a structured, retrospective, cohort study at a large, urban, tertiary care academic center. In July 2012 this hospital implemented a standardized protocol for patients with suspected TIA. The protocol selected high-risk patients for admission and low/intermediate-risk patients to an ED observation unit for workup. Recommended workup included brain imaging, vascular imaging, cardiac monitoring, and observation. Patients were included if clinical providers determined the need for workup for TIA. We included consecutive patients presenting during a six-month period prior to protocol implementation, and those presenting between 6-12 months after implementation. Outcomes included ED length of stay (LOS), hospital LOS, use of neuroimaging, and 90-day risk of stroke or TIA. From 01/2012 to 06/2012, 130 patients were evaluated for TIA symptoms in the ED, and from 01/2013 to 06/2013, 150 patients. The final diagnosis was TIA or stroke in 45% before vs. 41% after (p=0.18). Following the intervention, the inpatient admission rate decreased from 62% to 24% (pTIA among those with final diagnosis of TIA was 3% for both periods. Implementation of a TIA protocol significantly reduced ED LOS and total hospital LOS.

Automatic radiation dose monitoring for CT of trauma patients with different protocols: feasibility and accuracy

International Nuclear Information System (INIS)

Higashigaito, K.; Becker, A.S.; Sprengel, K.; Simmen, H.-P.; Wanner, G.; Alkadhi, H.

2016-01-01

Aim: To demonstrate the feasibility and accuracy of automatic radiation dose monitoring software for computed tomography (CT) of trauma patients in a clinical setting over time, and to evaluate the potential of radiation dose reduction using iterative reconstruction (IR). Materials and methods: In a time period of 18 months, data from 378 consecutive thoraco-abdominal CT examinations of trauma patients were extracted using automatic radiation dose monitoring software, and patients were split into three cohorts: cohort 1, 64-section CT with filtered back projection, 200 mAs tube current–time product; cohort 2, 128-section CT with IR and identical imaging protocol; cohort 3, 128-section CT with IR, 150 mAs tube current–time product. Radiation dose parameters from the software were compared with the individual patient protocols. Image noise was measured and image quality was semi-quantitatively determined. Results: Automatic extraction of radiation dose metrics was feasible and accurate in all (100%) patients. All CT examinations were of diagnostic quality. There were no differences between cohorts 1 and 2 regarding volume CT dose index (CTDI_v_o_l; p=0.62), dose–length product (DLP), and effective dose (ED, both p=0.95), while noise was significantly lower (chest and abdomen, both −38%, p<0.017). Compared to cohort 1, CTDI_v_o_l, DLP, and ED in cohort 3 were significantly lower (all −25%, p<0.017), similar to the noise in the chest (–32%) and abdomen (–27%, both p<0.017). Compared to cohort 2, CTDI_v_o_l (–28%), DLP, and ED (both –26%) in cohort 3 was significantly lower (all, p<0.017), while noise in the chest (+9%) and abdomen (+18%) was significantly higher (all, p<0.017). Conclusion: Automatic radiation dose monitoring software is feasible and accurate, and can be implemented in a clinical setting for evaluating the effects of lowering radiation doses of CT protocols over time. - Highlights: • Automatic dose monitoring software can be

Identification of a research protocol to study orthodontic tooth movement

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Annalisa Dichicco

2014-06-01

Full Text Available Aim: The orthodontic movement is associated with a process of tissue remodeling together with the release of several chemical mediators in periodontal tissues. Each mediator is a potential marker of tooth movement and expresses biological processes as: tissue inflammation and bone remodeling. Different amounts of every mediator are present in several tissues and fluids of the oral cavity. Therefore, there are different methods that allow sampling with several degrees of invasiveness. Chemical mediators are also substances of different molecular nature, and multiple kind of analysis methods allow detection. The purpose of this study was to draft the best research protocol for an optimal study on orthodontic movement efficiency. Methods: An analysis of the international literature have been made, to identify the gold standard of each aspect of the protocol: type of mediator, source and method of sampling and analysis method. Results: From the analysis of the international literature was created an original research protocol for the study and the assessment of the orthodontic movement, by using the biomarkers of the tooth movement. Conclusions: The protocol created is based on the choice of the gold standard of every aspect already analyzed in the literature and in existing protocols for the monitoring of orthodontic tooth movement through the markers of tooth movement. Clinical trials re required for the evaluation and validation of the protocol created.

Weight at birth and subsequent fecundability: a prospective cohort study

DEFF Research Database (Denmark)

Nielsen, Cathrine Wildenschild; Hammerich Riis, Anders; Ehrenstein, Vera

2014-01-01

OBJECTIVE: To examine the association between a woman's birth weight and her subsequent fecundability. METHOD: In this prospective cohort study, we included 2,773 Danish pregnancy planners enrolled in the internet-based cohort study "Snart-Gravid", conducted during 2007-2012. Participants were 18...

Rationale, design, and methods for Canadian alliance for healthy hearts and minds cohort study (CAHHM) - a Pan Canadian cohort study.

Science.gov (United States)

Anand, Sonia S; Tu, Jack V; Awadalla, Philip; Black, Sandra; Boileau, Catherine; Busseuil, David; Desai, Dipika; Després, Jean-Pierre; de Souza, Russell J; Dummer, Trevor; Jacquemont, Sébastien; Knoppers, Bartha; Larose, Eric; Lear, Scott A; Marcotte, Francois; Moody, Alan R; Parker, Louise; Poirier, Paul; Robson, Paula J; Smith, Eric E; Spinelli, John J; Tardif, Jean-Claude; Teo, Koon K; Tusevljak, Natasa; Friedrich, Matthias G

2016-07-27

The Canadian Alliance for Healthy Hearts and Minds (CAHHM) is a pan-Canadian, prospective, multi-ethnic cohort study being conducted in Canada. The overarching objective of the CAHHM is to understand the association of socio-environmental and contextual factors (such as societal structure, activity, nutrition, social and tobacco environments, and access to health services) with cardiovascular risk factors, subclinical vascular disease, and cardiovascular and other chronic disease outcomes. Participants between 35 and 69 years of age are being recruited from existing cohorts and a new First Nations Cohort to undergo a detailed assessment of health behaviours (including diet and physical activity), cognitive function, assessment of their local home and workplace environments, and their health services access and utilization. Physical measures including weight, height, waist/hip circumference, body fat percentage, and blood pressure are collected. In addition, eligible participants undergo magnetic resonance imaging (MRI) of the brain, heart, carotid artery and abdomen to detect early subclinical vascular disease and ectopic fat deposition. CAHHM is a prospective cohort study designed to investigate the impact of community level factors, individual health behaviours, and access to health services, on cognitive function, subclinical vascular disease, fat distribution, and the development of chronic diseases among adults living in Canada.

Results from a Nationwide Cohort Temporary Utilization Authorization (ATU) Survey of Patients in France Treated with Pheburane® (Sodium Phenylbutyrate) Taste-Masked Granules

OpenAIRE

Kibleur, Yves; Dobbelaere, Dries; Barth, Magalie; Brassier, Anaïs; Guffon, Nathalie

2014-01-01

Objectives The aim of this study was to describe a nationwide system for pre-marketing follow-up (cohort temporary utilization authorization [ATU] protocol; i.e., ‘therapeutic utilization’) of a new taste-masked formulation of sodium phenylbutyrate (NaPB) granules (Pheburane®) in France and to analyze safety and efficacy in this treated cohort of patients with urea cycle disease (UCD). Methods In October 2012, a cohort ATU was established in France to monitor the use of Pheburane® on a named-...

A retrospective cohort study to investigate fatigue, psychological or cognitive impairment after TIA: protocol paper.

Science.gov (United States)

Moran, Grace M; Calvert, Melanie; Feltham, Max G; Ryan, Ronan; Marshall, Tom

2015-05-03

Transient ischaemic attack (TIA) is defined by short-lasting, stroke-like symptoms, and is recognised as a medical emergency. Symptoms are assumed to completely resolve, and treatment is focused on secondary stroke/TIA prevention. However, evidence suggests that patients with TIA may experience ongoing residual impairments, which they do not receive therapy for as standard practice. TIA-induced sequelae could impact on patients' quality of life and ability to return to work or social activities. We aim to investigate whether TIA is associated with subsequent consultation for fatigue, psychological or cognitive impairment in primary care. A retrospective open cohort study of patients with first-ever TIA and matched controls. Relevant data will be extracted from The Health Improvement Network (THIN) database, an anonymised primary care database which includes data for over 12 million patients and covers approximately 6% of the UK population. Outcomes will be the first consultation for fatigue, anxiety, depression, post-traumatic stress disorder or cognitive impairment. Principal analysis will use Kaplan-Meier survivor functions to estimate time to first consultation, with log-rank tests to compare TIA and control patients. Cox proportional hazard models will predict the effect of demographic and patient characteristics on time to first consultation. Approval was granted by a THIN Scientific Review Committee (ref: 14-008). The study's findings will be published in a peer-reviewed journal and disseminated at national and international conferences and through social media. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Successful implementation of a packed red blood cell and fresh frozen plasma transfusion protocol in the surgical intensive care unit.

Directory of Open Access Journals (Sweden)

Benjamin E Szpila

Full Text Available Blood product transfusions are associated with increased morbidity and mortality. The purpose of this study was to determine if implementation of a restrictive protocol for packed red blood cell (PRBC and fresh frozen plasma (FFP transfusion safely reduces blood product utilization and costs in a surgical intensive care unit (SICU.We performed a retrospective, historical control analysis comparing before (PRE and after (POST implementation of a restrictive PRBC/FFP transfusion protocol for SICU patients. Univariate analysis was utilized to compare patient demographics and blood product transfusion totals between the PRE and POST cohorts. Multivariate logistic regression models were developed to determine if implementation of the restrictive transfusion protocol is an independent predictor of adverse outcomes after controlling for age, illness severity, and total blood products received.829 total patients were included in the analysis (PRE, n=372; POST, n=457. Despite higher mean age (56 vs. 52 years, p=0.01 and APACHE II scores (12.5 vs. 11.2, p=0.006, mean units transfused per patient were lower for both packed red blood cells (0.7 vs. 1.2, p=0.03 and fresh frozen plasma (0.3 vs. 1.2, p=0.007 in the POST compared to the PRE cohort, respectively. There was no difference in inpatient mortality between the PRE and POST cohorts (7.5% vs. 9.2%, p=0.39. There was a decreased risk of urinary tract infections (OR 0.47, 95%CI 0.28-0.80 in the POST cohort after controlling for age, illness severity and amount of blood products transfused.Implementation of a restrictive transfusion protocol can effectively reduce blood product utilization in critically ill surgical patients with no increase in morbidity or mortality.

The Netherlands Cohort Study – Meat Investigation Cohort; a population-based cohort over-represented with vegetarians, pescetarians and low meat consumers

Science.gov (United States)

2013-01-01

Background Vegetarian diets have been associated with lower risk of chronic disease, but little is known about the health effects of low meat diets and the reliability of self-reported vegetarian status. We aimed to establish an analytical cohort over-represented with vegetarians, pescetarians and 1 day/week meat consumers, and to describe their lifestyle and dietary characteristics. In addition, we were able to compare self-reported vegetarians with vegetarians whose status has been confirmed by their response on the extensive food frequency questionnaire (FFQ). Study methods Embedded within the Netherlands Cohort Study (n = 120,852; including 1150 self-reported vegetarians), the NLCS-Meat Investigation Cohort (NLCS-MIC) was defined by combining all FFQ-confirmed-vegetarians (n = 702), pescetarians (n = 394), and 1 day/week meat consumers (n = 1,396) from the total cohort with a random sample of 2–5 days/week- and 6–7 days/week meat consumers (n = 2,965 and 5,648, respectively). Results Vegetarians, pescetarians, and 1 day/week meat consumers had more favorable dietary intakes (e.g. higher fiber/vegetables) and lifestyle characteristics (e.g. lower smoking rates) compared to regular meat consumers in both sexes. Vegetarians adhered to their diet longer than pescetarians and 1 day/week meat consumers. 75% of vegetarians with a prevalent cancer at baseline had changed to this diet after diagnosis. 50% of self-reported vegetarians reported meat or fish consumption on the FFQ. Although the misclassification that occurred in terms of diet and lifestyle when merely relying on self-reporting was relatively small, the impact on associations with disease risk remains to be studied. Conclusion We established an analytical cohort over-represented with persons at the lower end of the meat consumption spectrum which should facilitate prospective studies of major cancers and causes of death using ≥20.3 years of follow-up. PMID:24289207

Cohort Profile: The JS High School study (JSHS): a cohort study of Korean adolescents.

Science.gov (United States)

Choi, Dong Phil; Lee, Joo Young; Kim, Hyeon Chang

2017-04-01

Major aetiologies of atherosclerotic cardiovascular diseases begin in childhood and atherosclerotic vascular abnormalities can be observed among children and adolescents. Adolescent cohort studies have important advantages because they can observe earlier changes in vascular structure and function. The purpose of the JS High School study (JSHS) is to identify biomarkers predicting or indicating early structural and functional vascular change in adolescents. The JSHS is a prospective cohort study of a Korean adolescent population. The target population of the JSHS was first-graders (aged 14 to17 years) at a high school of South Korea. Enrolment and baseline examinations were conducted in years 2007, 2010, 2011 and 2012. Among the total eligible population of 1115 students, 1071 (96.1%) participated in the study and completed all baseline examinations. Informed consent forms were obtained from each participant and his/her parent or guardian. Baseline examinations include: questionnaires on demographics, health behaviours, medical history, and depression symptoms; fasting blood analysis; anthropometric measurement; body impedance analysis; blood pressure measurement; radial artery tonometry; bone densitometry; pulmonary function tests; and carotid ultrasonography. Participants enrolled from 2007 through 2012 were re-examined after 30 months of follow-up, and those who enrolled in 2012 were re-examined after 24 months of follow-up. The corresponding author may be contacted for potential collaboration and data access. © The Author 2015; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

Setting up a cohort study in speech and language therapy: lessons from The UK Cleft Collective Speech and Language (CC-SL) study.

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Wren, Yvonne; Humphries, Kerry; Stock, Nicola Marie; Rumsey, Nichola; Lewis, Sarah; Davies, Amy; Bennett, Rhiannon; Sandy, Jonathan

2018-05-01

Efforts to increase the evidence base in speech and language therapy are often limited by methodological factors that have restricted the strength of the evidence to the lower levels of the evidence hierarchy. Where higher graded studies, such as randomized controlled trials, have been carried out, it has sometimes been difficult to obtain sufficient power to detect a potential effect of intervention owing to small sample sizes or heterogeneity in the participants. With certain clinical groups such as cleft lip and palate, systematic reviews of intervention studies have shown that there is no robust evidence to support the efficacy of any one intervention protocol over another. To describe the setting up of an observational clinical cohort study and to present this as an alternative design for answering research questions relating to prevalence, risk factors and outcomes from intervention. The Cleft Collective Speech and Language (CC-SL) study is a national cohort study of children born with cleft palate. Working in partnership with regional clinical cleft centres, a sample size of over 600 children and 600 parents is being recruited and followed up from birth to age 5 years. Variables being collected include demographic, psychological, surgical, hearing, and speech and language data. The process of setting up the study has led to the creation of a unique, large-scale data set which is available for researchers to access now and in future. As well as exploring predictive factors, the data can be used to explore the impact of interventions in relation to individual differences. Findings from these investigations can be used to provide information on sample criteria and definitions of intervention and dosage which can be used in future trials. The observational cohort study is a useful alternative design to explore questions around prevalence, risk factors and intervention for clinical groups where robust research data are not yet available. Findings from such a

Cohort Differences in Cognitive Aging in the Longitudinal Aging Study Amsterdam.

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Brailean, Anamaria; Huisman, Martijn; Prince, Martin; Prina, A Matthew; Deeg, Dorly J H; Comijs, Hannie

2016-09-30

This study aims to examine cohort differences in cognitive performance and rates of change in episodic memory, processing speed, inductive reasoning, and general cognitive performance and to investigate whether these cohort effects may be accounted for by education attainment. The first cohort (N = 705) was born between 1920 and 1930, whereas the second cohort (N = 646) was born between 1931 and 1941. Both birth cohorts were aged 65 to 75 years at baseline and were followed up 3 and 6 years later. Data were analyzed using linear mixed models. The later born cohort had better general cognitive performance, inductive reasoning, and processing speed at baseline, but cohort differences in inductive reasoning and general cognitive performance disappeared after adjusting for education. The later born cohort showed steeper decline in processing speed. Memory decline was steeper in the earlier born cohort but only from Time 1 to Time 3 when the same memory test was administered. Education did not account for cohort differences in cognitive decline. The later born cohort showed better initial performance in certain cognitive abilities, but no better preservation of cognitive abilities overtime compared with the earlier born cohort. These findings carry implications for healthy cognitive aging. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America.

Impact of maternal antibodies and infant gut microbiota on the immunogenicity of rotavirus vaccines in African, Indian and European infants: protocol for a prospective cohort study.

Science.gov (United States)

Sindhu, Kuladaipalayam Natarajan C; Cunliffe, Nigel; Peak, Matthew; Turner, Mark; Darby, Alistair; Grassly, Nicholas; Gordon, Melita; Dube, Queen; Babji, Sudhir; Praharaj, Ira; Verghese, Valsan; Iturriza-Gómara, Miren; Kang, Gagandeep

2017-03-29

Gastroenteritis is the leading cause of morbidity and mortality among young children living in resource-poor settings, majority of which is attributed to rotavirus. Rotavirus vaccination can therefore have a significant impact on infant mortality. However, rotavirus vaccine efficacy in Sub-Saharan Africa and Southeast Asia is significantly lower than in high-income countries. Maternally derived antibodies, infant gut microbiota and concomitant oral polio vaccination have been proposed as potential reasons for poor vaccine performance in low-income settings. The overall aim of this study is to compare the role of maternally derived antibodies and infant gut microbiota in determining immune response to rotavirus vaccine in high-income and low-income settings, using the same vaccine and a similar study protocol. The study is an observational cohort in three countries-Malawi, India and UK. Mothers will be enrolled in third trimester of pregnancy and followed up, along with infants after delivery, until the infant completes two doses of oral rotavirus vaccine (along with routine immunisation). The levels of prevaccination maternally derived rotavirus-specific antibodies (IgG) will be correlated with infant seroconversion and antibody titres, 4 weeks after the second dose of rotavirus vaccine. Both within-country and between-country comparisons of gut microbiome will be carried out between children who seroconvert and those who do not. The impact of oral polio vaccine coadministration on rotavirus vaccine response will be studied in Indian infants. Ethical approvals have been obtained from Integrated Research Application System (IRAS, NHS ethics) in UK, College of Medicine Research and Ethics Committee (COMREC) in Malawi and Institutional Review Board (IRB), Christian Medical College, Vellore in India. Participant recruitment and follow-up is ongoing at all three sites. Analysis of data, followed by publication of the results, is expected in 2018. Published by the BMJ

Rationale, design, and methods for Canadian alliance for healthy hearts and minds cohort study (CAHHM – a Pan Canadian cohort study

Directory of Open Access Journals (Sweden)

Sonia S. Anand

2016-07-01

Full Text Available Abstract Background The Canadian Alliance for Healthy Hearts and Minds (CAHHM is a pan-Canadian, prospective, multi-ethnic cohort study being conducted in Canada. The overarching objective of the CAHHM is to understand the association of socio-environmental and contextual factors (such as societal structure, activity, nutrition, social and tobacco environments, and access to health services with cardiovascular risk factors, subclinical vascular disease, and cardiovascular and other chronic disease outcomes. Methods/Design Participants between 35 and 69 years of age are being recruited from existing cohorts and a new First Nations Cohort to undergo a detailed assessment of health behaviours (including diet and physical activity, cognitive function, assessment of their local home and workplace environments, and their health services access and utilization. Physical measures including weight, height, waist/hip circumference, body fat percentage, and blood pressure are collected. In addition, eligible participants undergo magnetic resonance imaging (MRI of the brain, heart, carotid artery and abdomen to detect early subclinical vascular disease and ectopic fat deposition. Discussion CAHHM is a prospective cohort study designed to investigate the impact of community level factors, individual health behaviours, and access to health services, on cognitive function, subclinical vascular disease, fat distribution, and the development of chronic diseases among adults living in Canada.

Cohort profile: the Spanish WORKing life Social Security (WORKss) cohort study

OpenAIRE

López Gómez, María Andreé, 1985-; Duran Jordà, Xavier, 1974-; Zaballa, Elena; Sánchez Niubò, Albert; Delclòs i Clanchet, Jordi, 1956-; Benavides, Fernando G. (Fernando García)

2016-01-01

PURPOSE: The global economy is changing the labour market and social protection systems in Europe. The effect of both changes on health needs to be monitored in view of an ageing population and the resulting increase in prevalence of chronic health conditions. The Spanish WORKing life Social Security (WORKss) cohort study provides unique longitudinal data to study the impact of labour trajectories and employment conditions on health, in terms of sickness absence, permanent disability and deat...

Study protocol: A Montessori approach to dementia-related, non-residential respite services in Australia.

Science.gov (United States)

Hanna, Andrew; Donnelly, James; Aggar, Christina

2018-03-27

Given the social burden and significant cost of dementia care in Australia, finding evidence-based approaches that improve outcomes, maintain independence, and reduce the impact on patients and families is essential. Finding effective ways to train and assist the healthcare staff who support these individuals is also critical, as they are considered to be at risk of workplace stress, burnout, and other psychological disturbances which negatively affects standards of care. The current paper describes a protocol for evaluating the effects of a Montessori-based approach to dementia care, in non-residential respite centres. An 18 month prospective observational, cohort controlled design is suggested that will compare participants from a community respite service that has undergone a Montessori-based workplace culture change and those from a service that provides a person-centred 'care as usual' approach. To achieve this, the protocol includes the assessment of participants across multiple variables on a monthly basis including the cognitive, behavioural, and emotional functioning of clients with dementia, levels of caregiver burden experienced by informal carers, and burnout, compassion satisfaction and workplace engagement among respite staff. The protocol also employs a qualitative evaluation of program fidelity. This approach will provide further insight into the potential benefits of early intervention with Montessori approaches for persons living with dementia in the community, their caregivers, and the staff and volunteers who assist them. Copyright © 2018 Elsevier B.V. All rights reserved.

Implementing an Oxygen Supplementation and Monitoring Protocol on Inpatient Pediatric Bronchiolitis: An Exercise in Deimplementation

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Brian LeCleir

2017-01-01

Full Text Available Aim. Our goal in this study is to evaluate the effectiveness of our oxygen (O2 protocol to reduce length of stay (LOS for children hospitalized with bronchiolitis. Methods. In this retrospective cohort study, the outcomes of children ≤ 24 months old that were admitted with bronchiolitis and placed on the O2 protocol were compared to historical controls. The primary outcome was hospital length of stay. Secondary outcomes were duration of O2 supplementation, rates of pediatric intensive care unit transfer, and readmission. Results. Groups were not significantly different in age, gender, and rates of respiratory distress score assessment. Significantly more severely ill patients were in the O2 protocol group. There were no significant differences between control and O2 protocol groups with regard to mean LOS, rates of pediatric intensive care unit transfer, or seven-day readmission rates. By multiple regression analysis, the use of the O2 protocol was associated with a nearly 20% significant decrease in the length of hospitalization (p=0.030. Conclusion. Use of O2 supplementation protocol increased LOS in the more ill patients with bronchiolitis but decreased overall LOS by having a profound effect on patients with mild bronchiolitis.

Life and Living in Advanced Age: A Cohort Study in New Zealand -Te Puāwaitanga o Nga Tapuwae Kia Ora Tonu, LiLACS NZ: Study protocol

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Hayman Karen J

2012-06-01

Full Text Available Abstract Background The number of people of advanced age (85 years and older is increasing and health systems may be challenged by increasing health-related needs. Recent overseas evidence suggests relatively high levels of wellbeing in this group, however little is known about people of advanced age, particularly the indigenous Māori, in Aotearoa, New Zealand. This paper outlines the methods of the study Life and Living in Advanced Age: A Cohort Study in New Zealand. The study aimed to establish predictors of successful advanced ageing and understand the relative importance of health, frailty, cultural, social & economic factors to successful ageing for Māori and non-Māori in New Zealand. Methods/design A total population cohort study of those of advanced age. Two cohorts of equal size, Māori aged 80–90 and non-Māori aged 85, oversampling to enable sufficient power, were enrolled. A defined geographic region, living in the Bay of Plenty and Lakes District Health Board areas of New Zealand, defined the sampling frame. Rūnanga (Māori tribal organisations and Primary Health Organisations were subcontracted to recruit on behalf of the University. Measures - a comprehensive interview schedule was piloted and administered by a trained interviewer using standardised techniques. Socio-demographic and personal history included tribal affiliation for Māori and participation in cultural practices; physical and psychological health status used standardised validated research tools; health behaviours included smoking, alcohol use and nutrition risk; and environmental data included local amenities, type of housing and neighbourhood. Social network structures and social support exchanges are recorded. Measures of physical function; gait speed, leg strength and balance, were completed. Everyday interests and activities, views on ageing and financial interests complete the interview. A physical assessment by a trained nurse included

Study and development of a remote biometric authentication protocol

OpenAIRE

Bistarelli, Stefano; Claudio, Viti

2003-01-01

This paper reports the phases of study and implementation of a remote biometric authentication protocol developed during my internship at the I.i.t. of the C.n.r. in Pisa. Starting from the study of authentication history we had a look from the first system used since the 60ies to the latest technology; this helped us understand how we could realize a demonstration working protocol that could achieve a web remote authentication granting good reliability: to do this we choosed to modify the SS...

Alcohol and ovarian cancer risk: Results from the Netherlands Cohort Study

NARCIS (Netherlands)

Schouten, L.J.; Zeegers, M.P.A.; Goldbohm, R.A.; Brandt, P.A. van den

2004-01-01

Objective: To study alcohol consumption in relation to ovarian cancer risk in a prospective cohort study. Methods: The Netherlands Cohort Study on diet and cancer was initiated in 1986. A self-administered questionnaire on dietary habits and other risk factors for cancer was completed by 62,573

Studying protocol-based pain management in the emergency department

Directory of Open Access Journals (Sweden)

Akkamahadevi Patil

2017-01-01

Full Text Available Background: Majority of the patients presenting to emergency department (ED have pain. ED oligoanalgesia remains a challenge. Aims: This study aims to study the effect of implementing a protocol-based pain management in the ED on (1 time to analgesia and (2 adequacy of analgesia obtained. Settings and Design: Cross-sectional study in the ED. Methods: Patients aged 18–65 years of age with pain of numeric rating scale (NRS ≥4 were included. A series of 100 patients presenting before introduction of the protocol-based pain management were grouped “pre-protocol,” and managed as per existing practice. Following this, a protocol for management of all patients presenting to ED with pain was implemented. Another series of 100 were grouped as “post-protocol” and managed as per the new pain management protocol. The data of patients from both the groups were collected and analyzed. Statistical Analysis Used: Descriptive statistical tests such as percentage, mean and standard deviation and inferential statistical tests such as Pearson coefficient, Student's t-test were applied. Differences were interpreted as significant when P < 0.05. Results: Mean time to administer analgesic was significantly lesser in the postprotocol group (preprotocol 20.30 min vs. postprotocol 13.05 min; P < 0.001. There was significant difference in the pain relief achieved (change in NRS between the two groups, with greater pain relief achieved in the postprotocol group (preprotocol group 4.6800 vs. postprotocol group 5.3600; P < 0.001. Patients' rating of pain relief (assessed on E5 scale was significantly higher in the postprotocol group (preprotocol 3.91 vs. postprotocol 4.27; P = 0.001. Patients' satisfaction (North American Spine Society scale with the overall treatment was also compared and found to be significantly higher in postprotocol group (mean: preprotocol 1.59 vs. postprotocol 1.39; P = 0.008. Conclusion: Protocol-based pain management provided timely and

The Lothian Birth Cohort 1936: a study to examine influences on cognitive ageing from age 11 to age 70 and beyond

Directory of Open Access Journals (Sweden)

Whalley Lawrence J

2007-12-01

Full Text Available Abstract Background Cognitive ageing is a major burden for society and a major influence in lowering people's independence and quality of life. It is the most feared aspect of ageing. There are large individual differences in age-related cognitive changes. Seeking the determinants of cognitive ageing is a research priority. A limitation of many studies is the lack of a sufficiently long period between cognitive assessments to examine determinants. Here, the aim is to examine influences on cognitive ageing between childhood and old age. Methods/Design The study is designed as a follow-up cohort study. The participants comprise surviving members of the Scottish Mental Survey of 1947 (SMS1947; N = 70,805 who reside in the Edinburgh area (Lothian of Scotland. The SMS1947 applied a valid test of general intelligence to all children born in 1936 and attending Scottish schools in June 1947. A total of 1091 participants make up the Lothian Birth Cohort 1936. They undertook: a medical interview and examination; physical fitness testing; extensive cognitive testing (reasoning, memory, speed of information processing, and executive function; personality, quality of life and other psycho-social questionnaires; and a food frequency questionnaire. They have taken the same mental ability test (the Moray House Test No. 12 at age 11 and age 70. They provided blood samples for DNA extraction and testing and other biomarker analyses. Here we describe the background and aims of the study, the recruitment procedures and details of numbers tested, and the details of all examinations. Discussion The principal strength of this cohort is the rarely captured phenotype of lifetime cognitive change. There is additional rich information to examine the determinants of individual differences in this lifetime cognitive change. This protocol report is important in alerting other researchers to the data available in the cohort.

Comparison of DNA quantification methodology used in the DNA extraction protocol for the UK Biobank cohort.

Science.gov (United States)

Welsh, Samantha; Peakman, Tim; Sheard, Simon; Almond, Rachael

2017-01-05

UK Biobank is a large prospective cohort study in the UK established by the Medical Research Council (MRC) and the Wellcome Trust to enable approved researchers to investigate the role of genetic factors, environmental exposures and lifestyle in the causes of major diseases of late and middle age. A wide range of phenotypic data has been collected at recruitment and has recently been enhanced by the UK Biobank Genotyping Project. All UK Biobank participants (500,000) have been genotyped on either the UK Biobank Axiom® Array or the Affymetrix UK BiLEVE Axiom® Array and the workflow for preparing samples for genotyping is described. The genetic data is hoped to provide further insight into the genetics of disease. All data, including the genetic data, is available for access to approved researchers. Data for two methods of DNA quantification (ultraviolet-visible spectroscopy [UV/Vis]) measured on the Trinean DropSense™ 96 and PicoGreen®) were compared by two laboratories (UK Biobank and Affymetrix). The sample processing workflow established at UK Biobank, for genotyping on the custom Affymetrix Axiom® array, resulted in high quality DNA (average DNA concentration 38.13 ng/μL, average 260/280 absorbance 1.91). The DNA generated high quality genotype data (average call rate 99.48% and pass rate 99.45%). The DNA concentration measured on the Trinean DropSense™ 96 at UK Biobank correlated well with DNA concentration measured by PicoGreen® at Affymetrix (r = 0.85). The UK Biobank Genotyping Project demonstrated that the high throughput DNA extraction protocol described generates high quality DNA suitable for genotyping on the Affymetrix Axiom array. The correlation between DNA concentration derived from UV/Vis and PicoGreen® quantification methods suggests, in large-scale genetic studies involving two laboratories, it may be possible to remove the DNA quantification step in one laboratory without affecting downstream analyses. This would result in

Twenty Percent of Patients May Remain Colonized With Methicillin-resistant Staphylococcus aureus Despite a Decolonization Protocol in Patients Undergoing Elective Total Joint Arthroplasty.

Science.gov (United States)

Baratz, Michael D; Hallmark, Ruth; Odum, Susan M; Springer, Bryan D

2015-07-01

Staphylococcus aureus is the most commonly isolated organism in periprosthetic joint infection (PJI). Resistant strains such as methicillin-resistant S aureus (MRSA) are on the rise, and many programs have instituted decolonization protocols. There are limited data on the success of S aureus nasal decolonization programs and their impact on PJI. The purposes of this study were to (1) determine the proportion of patients successfully decolonized using a 2-week protocol; (2) compare infection risks between our surveillance and decolonization protocol group against a historical control cohort to evaluate changes in proportions of S aureus infections; and (3) assess infection risk based on carrier type, comparing S aureus carriers with noncarrier controls. We retrospectively evaluated a group of 3434 patients who underwent elective primary and revision hip and knee arthroplasty over a 2-year period; each patient in the treatment group underwent a surveillance protocol, and a therapeutic regimen of mupurocin and chlorhexidine was instituted when colonization criteria were met. A 2009 to 2010 comparative historical cohort was chosen as the control group. We compared risks of infection between our treatment group and the historical control cohort. Furthermore, in patients who developed surgical site infections (SSIs), we compared the proportions of each S aureus type between the two cohorts. Finally, we compared infection rates based on carrier status. Surveillance for infection was carried out by the hospital infection control coordinator using the Centers for Disease Control and Prevention (CDC) criteria. During the time period of this study, the CDC defined hospital-acquired infection related to a surgical procedure as any infection diagnosed within 1 year of the procedure. With the numbers available, we had 41% power to detect a difference of 0.3% in infection rate between the treatment and control groups. To achieve 80% power, a total of 72,033 patients would be

Subclinical Hyperthyroidism-A Cohort Study

International Nuclear Information System (INIS)

Hashim, R.; Anwer, M. S.; Khan, F. A.; Ijaz, A.

2013-01-01

Objective: To compare the development of overt hyperthyroidism in a cohort of patients of subclinical hyperthyroidism (SCR) and in subjects with normal thyroid function tests. Study Design: A cohort study. Place and Duration of study: The study was conducted in the department of Chemical Pathology and Endocrinology, Armed Forces Institute of Pathology, Rawalpindi from Sept 2006 to Sept 2007. Patients and Methods: Fifty patients of SCR and almost equal number of age and sex-matched subjects with normal Thyroid function test (TFT) were included in the study as controls. Subclinical hyperthyroid patients and controls were followed for a period of one year on a six monthly basis. The patients were examined for signs and symptoms of hyperthyroidism and serum TSH, total T3 and free T4 were estimated. The clinical history, physical examination and TFT results were recorded. Five ml of blood was collected for serum thyroid profile in plain tube. Hormonal analysis(TSH, T4 and T3) was done for the patients and the controls enrolled in the study. The TFTs was analyzed using Chemiluminescence Immunoassay technique on Immulite 2000 an automated, random access, immunoassay analyzer. Results: Six (12%) out of 50 cases of the SCR patients and 2 (4%) out of 50 controls developed overt hyperthyroidism. SCR had no significant risk for conversion to overt hyperthyroidism as compared to healthy controls in this study. In addition to initial levels of serum TSH were one of important predictor for conversion of SCR to overt hyperthyroidism. Conclusion: Patients with SCR have no significant risk but showed an increase in frequency of conversion to overt hyperthyroidism (12% in this study) as compared to controls. (author)

Study on Cloud Security Based on Trust Spanning Tree Protocol

Science.gov (United States)

Lai, Yingxu; Liu, Zenghui; Pan, Qiuyue; Liu, Jing

2015-09-01

Attacks executed on Spanning Tree Protocol (STP) expose the weakness of link layer protocols and put the higher layers in jeopardy. Although the problems have been studied for many years and various solutions have been proposed, many security issues remain. To enhance the security and credibility of layer-2 network, we propose a trust-based spanning tree protocol aiming at achieving a higher credibility of LAN switch with a simple and lightweight authentication mechanism. If correctly implemented in each trusted switch, the authentication of trust-based STP can guarantee the credibility of topology information that is announced to other switch in the LAN. To verify the enforcement of the trusted protocol, we present a new trust evaluation method of the STP using a specification-based state model. We implement a prototype of trust-based STP to investigate its practicality. Experiment shows that the trusted protocol can achieve security goals and effectively avoid STP attacks with a lower computation overhead and good convergence performance.

Cohort profile

DEFF Research Database (Denmark)

Tollånes, Mette C; Strandberg-Larsen, Katrine; Forthun, Ingeborg

2016-01-01

PURPOSE: The purpose of MOthers and BAbies in Norway and Denmark cerebral palsy (MOBAND-CP) was to study CP aetiology in a prospective design. PARTICIPANTS: MOBAND-CP is a cohort of more than 210 000 children, created as a collaboration between the world's two largest pregnancy cohorts-the Norweg......PURPOSE: The purpose of MOthers and BAbies in Norway and Denmark cerebral palsy (MOBAND-CP) was to study CP aetiology in a prospective design. PARTICIPANTS: MOBAND-CP is a cohort of more than 210 000 children, created as a collaboration between the world's two largest pregnancy cohorts......-the Norwegian Mother and Child Cohort study (MoBa) and the Danish National Birth Cohort. MOBAND-CP includes maternal interview/questionnaire data collected during pregnancy and follow-up, plus linked information from national health registries. FINDINGS TO DATE: Initial harmonisation of data from the 2 cohorts...... has created 140 variables for children and their mothers. In the MOBAND-CP cohort, 438 children with CP have been identified through record linkage with validated national registries, providing by far the largest such sample with prospectively collected detailed pregnancy data. Several studies...

Distress among young adult cancer survivors: a cohort study.

Science.gov (United States)

Yanez, Betina; Garcia, Sofia F; Victorson, David; Salsman, John M

2013-09-01

Being diagnosed with cancer as a young adult can lead to significant psychological distress and impaired quality of life. Compared to children and older adults diagnosed with cancer, fewer studies have addressed psychological distress among young adult cancer survivors. This study sought to identify the prevalence of, and factors associated with, distress among young adult cancer survivors (ages 18-39). Young adult cancer survivors (N = 335, mean age = 31.8, women = 68.4%) were recruited from an online research panel and stratified by cohort (time postactive treatment: 0-12, 13-24, and 25-60 months). Participants completed measures assessing demographic and clinical characteristics, global impact of cancer, cancer-related education and work interruption, and cancer-specific distress using the impact of event scale (IES). The mean score on the IES (M = 31.0, range = 0-75) was above the cut point of 20, suggesting clinically elevated distress. Analysis of covariance revealed significant main effects for cohort, global impact and cancer-related education/work interruption, and an interaction between cohort and cancer-related education/work interruption on distress. Although there was no significant effect of education/work interruption on distress for those in the 0-12 month cohort (p = .88), survivors in the 13-24 and 25-60 month cohorts reporting education/work interruption were significantly more distressed than those not reporting education/work interruption in the respective cohorts (p cancer survivors face unique challenges. These data underscore the importance of attending to cancer-related distress beyond the completion of treatment and may help inform targeted interventions to prevent or reduce significant distress and related sequelae in this population.

STATUS REPORT, BEGIN TO DEVELOP COMPLETE OPERATIONS MANUALS FOR THE COHORT: PREPARE TO IMPLEMENT A COHORT STUDY OF CHILDREN'S ENVIRONMENTAL HEALTH

Science.gov (United States)

As a precursor to the National Children's Study (NCS), the North Carolina Cohort Study (NC Cohort Study) will provide the opportunity to field test procedures to better inform the implementation of the NCS. In order to test some of the study hypotheses, it will be important to ob...

The NEIL Memory Research Unit: psychosocial, biological, physiological and lifestyle factors associated with healthy ageing: study protocol.

Science.gov (United States)

Hannigan, Caoimhe; Coen, Robert F; Lawlor, Brian A; Robertson, Ian H; Brennan, Sabina

2015-01-01

Population ageing is a global phenomenon that has characterised demographic trends during the 20th and 21st century. The rapid growth in the proportion of older adults in the population, and resultant increase in the incidence of age-related cognitive decline, dementia and Alzheimer's disease, brings significant social, economic and healthcare challenges. Decline in cognitive abilities represents the most profound threat to active and healthy ageing. Current evidence suggests that a significant proportion of cases of age-related cognitive decline and dementia may be preventable through the modification of risk factors including education, depressive symptomology, physical activity, social engagement and participation in cognitively stimulating activities. The NEIL Memory Research Unit cohort study was established to investigate factors related to brain health and the maintenance of cognitive function. A cohort of 1000 normally ageing adults aged 50 years and over are being recruited to participate in comprehensive assessments at baseline, and at follow-up once every 2 years. The assessment protocol comprises a comprehensive neuropsychological battery, some basic physical measures, psychosocial scales, questionnaire measures related to a range of health, lifestyle and behavioural factors, and a measure of resting state activity using electroencephalography (EEG). The NEIL Memory Research Unit cohort study will address key questions about brain health and cognitive ageing in the population aged 50+, with a particular emphasis on the influence of potentially modifiable factors on cognitive outcomes. Analyses will be conducted with a focus on factors involved in the maintenance of cognitive function among older adults, and therefore will have the potential to contribute significant knowledge related to key questions within the field of cognitive ageing, and to inform the development of public health interventions aimed at preventing cognitive decline and promoting

Historic cohort study in Montreal's fur industry.

Science.gov (United States)

Guay, D; Siemiatycki, J

1987-01-01

A historic cohort mortality study was carried out among two groups of male workers in the Montreal fur industry: 263 dressers and dyers and 599 fur garment manufacturers. The first group is exposed to a very wide variety of chemicals used in tanning, cleaning, and dyeing fur, including substances considered to be carcinogenic and/or mutagenic. The second group is exposed to residue from the dressing and dyeing stage and to respirable fur dust. The cohorts consisted of all active members of two unions as of January 1, 1966. The mean age of the workers was 43.2 and the mean number of years since first employment 14.1. The follow-up period was from January 1, 1966, to December 31, 1981; 95% of the workers were successfully traced. Observed deaths were compared with those expected based on mortality rates of the population of metropolitan Montreal. Standardized mortality ratios (SMRs) for the manufacturers were significantly low, probably because of the ethnic composition of the cohort and a healthy worker effect. SMRs for the dressers and dyers were also low, but not as low as for the manufacturers. When attention was restricted to the French Canadians in the cohort, the observed deaths were close to the expected; there was a noteworthy excess of colorectal cancer (four observed, 0.8 expected) for dressers and dyers. Apart from this weak suggestive evidence, the results did not indicate any excess mortality risks in the fur industry. However, because of the relatively small number of expected and observed deaths in the cohort and especially among the heavily exposed dressers and dyers, the confidence intervals around SMR estimates were wide and excess risks cannot be ruled out.

International Network of Chronic Kidney Disease cohort studies (iNET-CKD): a global network of chronic kidney disease cohorts.

Science.gov (United States)

Dienemann, Thomas; Fujii, Naohiko; Orlandi, Paula; Nessel, Lisa; Furth, Susan L; Hoy, Wendy E; Matsuo, Seiichi; Mayer, Gert; Methven, Shona; Schaefer, Franz; Schaeffner, Elke S; Solá, Laura; Stengel, Bénédicte; Wanner, Christoph; Zhang, Luxia; Levin, Adeera; Eckardt, Kai-Uwe; Feldman, Harold I

2016-09-02

Chronic kidney disease (CKD) is a global health burden, yet it is still underrepresented within public health agendas in many countries. Studies focusing on the natural history of CKD are challenging to design and conduct, because of the long time-course of disease progression, a wide variation in etiologies, and a large amount of clinical variability among individuals with CKD. With the difference in health-related behaviors, healthcare delivery, genetics, and environmental exposures, this variability is greater across countries than within one locale and may not be captured effectively in a single study. Studies were invited to join the network. Prerequisites for membership included: 1) observational designs with a priori hypotheses and defined study objectives, patient-level information, prospective data acquisition and collection of bio-samples, all focused on predialysis CKD patients; 2) target sample sizes of 1,000 patients for adult cohorts and 300 for pediatric cohorts; and 3) minimum follow-up of three years. Participating studies were surveyed regarding design, data, and biosample resources. Twelve prospective cohort studies and two registries covering 21 countries were included. Participants age ranges from >2 to >70 years at inclusion, CKD severity ranges from stage 2 to stage 5. Patient data and biosamples (not available in the registry studies) are measured yearly or biennially. Many studies included multiple ethnicities; cohort size ranges from 400 to more than 13,000 participants. Studies' areas of emphasis all include but are not limited to renal outcomes, such as progression to ESRD and death. iNET-CKD (International Network of CKD cohort studies) was established, to promote collaborative research, foster exchange of expertise, and create opportunities for research training. Participating studies have many commonalities that will facilitate comparative research; however, we also observed substantial differences. The diversity we observed across

A multi-stage approach to maximizing geocoding success in a large population-based cohort study through automated and interactive processes

Directory of Open Access Journals (Sweden)

Jennifer S. Sonderman

2012-05-01

Full Text Available To enable spatial analyses within a large, prospective cohort study of nearly 86,000 adults enrolled in a 12-state area in the southeastern United States of America from 2002-2009, a multi-stage geocoding protocol was developed to efficiently maximize the proportion of participants assigned an address level geographic coordinate. Addresses were parsed, cleaned and standardized before applying a combination of automated and interactive geocoding tools. Our full protocol increased the non-Post Office (PO Box match rate from 74.5% to 97.6%. Overall, we geocoded 99.96% of participant addresses, with only 5.2% at the ZIP code centroid level (2.8% PO Box and 2.3% non-PO Box addresses. One key to reducing the need for interactive geocoding was the use of multiple base maps. Still, addresses in areas with population density 920 persons/km2 (odds ratio (OR = 5.24; 95% confidence interval (CI = 4.23, 6.49, as were addresses collected from participants during in-person interviews compared with mailed questionnaires (OR = 1.83; 95% CI = 1.59, 2.11. This study demonstrates that population density and address ascertainment method can influence automated geocoding results and that high success in address level geocoding is achievable for large-scale studies covering wide geographical areas.

Sardasht-Iran cohort study of chemical warfare victims: design and methods.

Science.gov (United States)

Ghazanfari, Tooba; Faghihzadeh, Soghrat; Aragizadeh, Hassan; Soroush, Mohammad-Reza; Yaraee, Roya; Mohammad Hassan, Zuhair; Foroutan, Abbas; Vaez-Mahdavi, Mohammad-Reza; Javadi, Mohammad-Ali; Moaiedmohseni, Sakine; Azizi, Fereidoun; Panahi, Yunes; Mostafaie, Ali; Ghasemi, Hassan; Shams, Jalaleddin; Pourfarzam, Shahryar; Jalali-Nadoushan, Mohammad-Reza; Fallahi, Faramarz; Ebtekar, Massoumeh; Davoudi, Seyyed-Masoud; Ghazanfari, Zeinab; Ardestani, Sussan K; Shariat-Panahi, Shamsa; Moin, Athar; Rezaei, Abbas; Kariminia, Amina; Ajdary, Soheila; Mahmoudi, Mahmoud; Roshan, Rasoul; Ghaderi, Sulayman; Babai, Mahmoud; Naghizadeh, Mohammad-Mehdi; Ghanei, Mohammad-Mostafa

2009-01-01

Insights into long-term clinical consequences of sulfur mustard have emerged from some investigations but less is known about the basic and molecular mechanisms of these complications. Sardasht-Iran Cohort Study is a comprehensive historical cohort study on Sardasht chemical victims' population which was designed to find out the long-term complications of sulfur mustard exposure and the basic mechanisms underlying clinical manifestations. This paper describes the design and methodology of Sardasht-Iran Cohort Study. In Sardasht-Iran Cohort Study, 500 individuals including 372 subjects from Sardasht, as the exposed group, and 128 subjects from Rabat, as the unexposed age-matched control group were evaluated. The exposed group was divided into two groups based on the severity of clinical complications at the time of exposure. Different samples including blood, sputum, saliva, tear, urine, and semen were collected for immunologic, hematologic, biochemical, and other laboratory analysis. Data were gathered from medical records, clinical examinations, laboratory tests, and questionnaires for psychological and lifestyle situations. The important distinctions setting this study apart from the previous ones are discussed. The Sardasht-Iran Cohort Study provides important information on various aspects of long-term consequences of sulfur mustard exposure. This database will provide a better position to suggest guidelines for the diagnosis, treatment, and prevention of delayed complications in the patients exposed to sulfur mustard.

A multi-centre cohort study shows no association between experienced violence and labour dystocia in nulliparous women at term

Science.gov (United States)

2011-01-01

Background Although both labour dystocia and domestic violence during pregnancy are associated with adverse maternal and fetal outcome, evidence in support of a possible association between experiences of domestic violence and labour dystocia is sparse. The aim of this study was to investigate whether self-reported history of violence or experienced violence during pregnancy is associated with increased risk of labour dystocia in nulliparous women at term. Methods A population-based multi-centre cohort study. A self-administrated questionnaire collected at 37 weeks of gestation from nine obstetric departments in Denmark. The total cohort comprised 2652 nulliparous women, among whom 985 (37.1%) met the protocol criteria for dystocia. Results Among the total cohort, 940 (35.4%) women reported experience of violence, and among these, 66 (2.5%) women reported exposure to violence during their first pregnancy. Further, 39.5% (n = 26) of those had never been exposed to violence before. Univariate logistic regression analysis showed no association between history of violence or experienced violence during pregnancy and labour dystocia at term, crude OR 0.91, 95% CI (0.77-1.08), OR 0.90, 95% CI (0.54-1.50), respectively. However, violence exposed women consuming alcoholic beverages during late pregnancy had increased odds of labour dystocia, crude OR 1.45, 95% CI (1.07-1.96). Conclusions Our findings indicate that nulliparous women who have a history of violence or experienced violence during pregnancy do not appear to have a higher risk of labour dystocia at term, according to the definition of labour dystocia in this study. Additional research on this topic would be beneficial, including further evaluation of the criteria for labour dystocia. PMID:21338523

A multi-centre cohort study shows no association between experienced violence and labour dystocia in nulliparous women at term.

Science.gov (United States)

Finnbogadóttir, Hafrún; Dejin-Karlsson, Elisabeth; Dykes, Anna-Karin

2011-02-21

Although both labour dystocia and domestic violence during pregnancy are associated with adverse maternal and fetal outcome, evidence in support of a possible association between experiences of domestic violence and labour dystocia is sparse. The aim of this study was to investigate whether self-reported history of violence or experienced violence during pregnancy is associated with increased risk of labour dystocia in nulliparous women at term. A population-based multi-centre cohort study. A self-administrated questionnaire collected at 37 weeks of gestation from nine obstetric departments in Denmark. The total cohort comprised 2652 nulliparous women, among whom 985 (37.1%) met the protocol criteria for dystocia. Among the total cohort, 940 (35.4%) women reported experience of violence, and among these, 66 (2.5%) women reported exposure to violence during their first pregnancy. Further, 39.5% (n = 26) of those had never been exposed to violence before. Univariate logistic regression analysis showed no association between history of violence or experienced violence during pregnancy and labour dystocia at term, crude OR 0.91, 95% CI (0.77-1.08), OR 0.90, 95% CI (0.54-1.50), respectively. However, violence exposed women consuming alcoholic beverages during late pregnancy had increased odds of labour dystocia, crude OR 1.45, 95% CI (1.07-1.96). Our findings indicate that nulliparous women who have a history of violence or experienced violence during pregnancy do not appear to have a higher risk of labour dystocia at term, according to the definition of labour dystocia in this study. Additional research on this topic would be beneficial, including further evaluation of the criteria for labour dystocia.

Association between vestibulo-ocular reflex suppression, balance, gait, and fall risk in ageing and neurodegenerative disease: protocol of a one-year prospective follow-up study.

Science.gov (United States)

Srulijes, Karin; Mack, David J; Klenk, Jochen; Schwickert, Lars; Ihlen, Espen A F; Schwenk, Michael; Lindemann, Ulrich; Meyer, Miriam; Srijana, K C; Hobert, Markus A; Brockmann, Kathrin; Wurster, Isabel; Pomper, Jörn K; Synofzik, Matthis; Schneider, Erich; Ilg, Uwe; Berg, Daniela; Maetzler, Walter; Becker, Clemens

2015-10-09

monthly telephone interviews. This study protocol describes an experimental setup allowing the analysis of simultaneously assessed eye, head and body movements. Results will improve our understanding of the influence of the interplay between eye, head and body movements on falls in geriatric high-risk cohorts.

Harmonising measures of knee and hip osteoarthritis in population-based cohort studies

DEFF Research Database (Denmark)

Leyland, K M; Gates, L S; Nevitt, M

2018-01-01

OBJECTIVE: Population-based osteoarthritis (OA) cohorts provide vital data on risk factors and outcomes of OA, however the methods to define OA vary between cohorts. We aimed to provide recommendations for combining knee and hip OA data in extant and future population cohort studies, in order to ...

Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification.

Science.gov (United States)

Stephens, John R; Liles, E Allen; Dancel, Ria; Gilchrist, Michael; Kirsch, Jonathan; DeWalt, Darren A

2014-04-01

Clinicians caring for patients seeking alcohol detoxification face many challenges, including lack of evidence-based guidelines for treatment and high recidivism rates. To develop a standardized protocol for determining which alcohol dependent patients seeking detoxification need inpatient versus outpatient treatment, and to study the protocol's implementation. Review of best evidence by ad hoc task force and subsequent creation of standardized protocol. Prospective observational evaluation of initial protocol implementation. Patients presenting for alcohol detoxification. Development and implementation of a protocol for evaluation and treatment of patients requesting alcohol detoxification. Number of admissions per month with primary alcohol related diagnosis (DRG), 30-day readmission rate, and length of stay, all measured before and after protocol implementation. We identified one randomized clinical trial and three cohort studies to inform the choice of inpatient versus outpatient detoxification, along with one prior protocol in this population, and combined that data with clinical experience to create an institutional protocol. After implementation, the average number of alcohol related admissions was 15.9 per month, compared with 18.9 per month before implementation (p = 0.037). There was no difference in readmission rate or length of stay. Creation and utilization of a protocol led to standardization of care for patients requesting detoxification from alcohol. Initial evaluation of protocol implementation showed a decrease in number of admissions.

A comparison of sennosides-based bowel protocols with and without docusate in hospitalized patients with cancer.

Science.gov (United States)

Hawley, Philippa Helen; Byeon, Jai Jun

2008-05-01

Constipation is a common and distressing condition in patients with cancer, especially those taking opioid analgesics. Many institutions prevent and treat constipation with titrated laxatives, which is known as a bowel protocol. An effective and well-tolerated bowel protocol is a very important component of cancer care, and there is little evidence on which to base selection of the most appropriate agents. This study compares a protocol of the stimulant laxative sennosides alone with a protocol of sennosides plus the stool softener docusate, in hospitalized patients at an oncology center. The docusate-containing protocol had an initial docusate-only step for patients not taking opioids, and four to six 100-mg capsules of docusate sodium in addition to the sennosides for the rest of the protocol. Thirty patients received the sennosides-only (S) protocol and 30 the sennosides plus docusate (DS) protocol. The efficacy and adverse effects of the protocols were monitored for 5-12 days. The two protocols were used sequentially, creating two cohorts, one on each protocol. Eighty percent of patients were taking oral opioids and 72% were admitted for symptom control/supportive care. Over a total of 488 days of observation it was found that the S protocol produced more bowel movements than the DS protocol, and in the symptom control/supportive care patients this difference was statistically significant (p sennosides did not reduce bowel cramps, and was less effective in inducing laxation than the sennosides-only protocol. Further research into the appropriate use of docusate and into the details of bowel protocol design are required.

Methodological aspects of the 1993 Pelotas (Brazil) Birth Cohort Study

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Victora, Cesar Gomes; Araújo, Cora Luiza Pavin; Menezes, Ana Maria Batista; Hallal, Pedro Curi; Vieira, Maria de Fátima; Neutzling, Marilda Borges; Gonçalves, Helen; Valle, Neiva Cristina; Lima, Rosangela Costa; Anselmi, Luciana; Behague, Dominique; Gigante, Denise Petrucci; Barros, Fernando Celso

2010-01-01

This paper describes the main methodological aspects of a cohort study, with emphasis on its recent phases, which may be relevant to investigators planning to carry out similar studies. In 1993, a population based study was launched in Pelotas, Southern Brazil. All 5,249 newborns delivered in the city’s hospitals were enrolled, and sub-samples were visited at the ages of one, three and six months and of one and four years. In 2004-5 it was possible to trace 87.5% of the cohort at the age of 10-12 years. Sub-studies are addressing issues related to oral health, psychological development and mental health, body composition, and ethnography. Birth cohort studies are essential for investigating the early determinants of adult disease and nutritional status, yet few such studies are available from low and middle-income countries where these determinants may differ from those documented in more developed settings. PMID:16410981

Predicting response to physiotherapy treatment for musculoskeletal shoulder pain: protocol for a longitudinal cohort study

Science.gov (United States)

2013-01-01

Background Shoulder pain affects all ages, with a lifetime prevalence of one in three. The most effective treatment is not known. Physiotherapy is often recommended as the first choice of treatment. At present, it is not possible to identify, from the initial physiotherapy assessment, which factors predict the outcome of physiotherapy for patients with shoulder pain. The primary objective of this study is to identify which patient characteristics and baseline measures, typically assessed at the first physiotherapy appointment, are related to the functional outcome of shoulder pain 6 weeks and 6 months after starting physiotherapy treatment. Methods/Design Participants with musculoskeletal shoulder pain of any duration will be recruited from participating physiotherapy departments. For this longitudinal cohort study, the participants care pathway, including physiotherapy treatment will be therapist determined. Potential prognostic variables will be collected from participants during their first physiotherapy appointment and will include demographic details, lifestyle, psychosocial factors, shoulder symptoms, general health, clinical examination, activity limitations and participation restrictions. Outcome measures (Shoulder Pain and Disability Index, Quick Disability of the Arm, Shoulder and Hand, and Global Impression of Change) will be collected by postal self-report questionnaires 6 weeks and 6 months after commencing physiotherapy. Details of attendance and treatment will be collected by the treating physiotherapist. Participants will be asked to complete an exercise dairy. An initial exploratory analysis will assess the relationship between potential prognostic factors at baseline and outcome using univariate statistical tests. Those factors significant at the 5% level will be further considered as prognostic factors using a general linear model. It is estimated that 780 subjects will provide more than 90% power to detect an effect size of less than 0

Possibilities and considerations when merging dietary data from the world's two largest pregnancy cohorts: the Danish National Birth Cohort and the Norwegian Mother and Child Cohort Study.

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Olsen, Sjurdur F; Birgisdottir, Bryndis Eva; Halldorsson, Thorhallur I; Brantsaeter, Anne Lise; Haugen, Margaretha; Torjusen, Hanne; Petersen, Sesilje B; Strøm, Marin; Meltzer, Helle Margrete

2014-11-01

To elucidate the research possibilities when merging data on maternal diet from the Danish National Birth Cohort (DNBC) and the Norwegian Mother and Child Cohort Study (MoBa), through comparison of (i) the methodology used for dietary assessment and (ii) the estimated intake of selected food groups in the two cohorts. Qualitative and quantitative comparison of the two dietary databases. Two national prospective pregnancy cohorts. Denmark, Norway. Comparison of food intake using food frequency questionnaires (FFQs). The FFQs had overlapping time windows and a majority of the questions in the two FFQs were comparable. Calculation principles shared similar features, including the software used and use of global questions to calibrate intakes of different food groups. A total of 63 food groups were defined that could be compared across the two cohorts; these were further aggregated down to 31 broader groups. A comparison of food intakes (grams/d) showed 39, 74 and 141% lower daily intakes of fish, potatoes and rice, respectively, in DNBC vs. MoBa and 39, 54 and 65% higher daily intakes of milk, butter and potatoes in DNBC vs. MoBa. For most other food groups, differences in consumption data were below 20%. The two FFQs are to a large extent compatible and substantial differences in dietary habits were observed between the two cohorts. This may strengthen studies using pooled analysis to examine diet-disease relations. This is a conclusion of great importance given the colossal and costly task involved to establish each of these two cohorts. © 2014 Nordic Federation of Societies of Obstetrics and Gynecology.

Representativeness of the LifeLines Cohort Study

NARCIS (Netherlands)

Klijs, B.; Scholtens, S.; Mandemakers, J.J.; Snieder, H.; Stolk, R.P.; Smidt, N.

2015-01-01

Background LifeLines is a large prospective population-based three generation cohort study in the north of the Netherlands. Different recruitment strategies were adopted: recruitment of an index population via general practitioners, subsequent inclusion of their family members, and online

Age-Related Changes of Intraocular Pressure in Elderly People in Southern China: Lingtou Eye Cohort Study.

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Xiaotong Han

Full Text Available To study age-related changes of intraocular pressure (IOP and assess the cohort effect in both cross-sectional and longitudinal settings among elderly Chinese adults.Participants were enrolled from the Lingtou Eye Cohort Study with Chinese government officials aged 40 years and older at baseline and received physical check-up and ocular examinations from 2010 to 2012. IOP was measured using a non-contact tonometer according to standardized protocols, as well as systolic blood pressure (SBP, diastolic blood pressure (DBP and body mass index (BMI. Participants who had attended IOP measurements in both 2010 and 2012 were included in this study. Cross-sectional association of IOP with age was assessed using multivariate liner regression analyses and based on the data of 2010. Longitudinal changes in IOP were assessed by paired t-test.A total of 3372 subjects were enrolled in the current analysis (2010 mean [SD] age, 61.9 [7.1] years; 60.2% men. The mean IOP in 2010 was 15.4 ± 2.3 mmHg for women and 15.2 ± 2.3 mmHg for men with an intersex difference (P = 0.029. Cross-sectional analysis showed that IOP was negatively associated with age (P = 0.003, β = -0.033 for women and P<0.001, β = -0.061 for men adjusted for baseline SBP, DBP and BMI. Paired t-test suggested that IOP was higher in the year 2012 than 2010 in women (P = 0.006 but did not change significantly in men within 2 years (P = 0.345. In addition, the 2-year changes of IOP were not associated with age adjusted for baseline IOP in 2010 (P = 0.249.Cross-sectional data suggests that IOP is lower in people with older age. Longitudinal data does not support such findings and thus the identified decreasing pattern with age in cross-sectional analysis is likely caused by cohort effects.

Consequences of gestational diabetes in an urban hospital in Viet Nam: a prospective cohort study.

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Hirst, Jane E; Tran, Thach S; Do, My An T; Morris, Jonathan M; Jeffery, Heather E

2012-01-01

Gestational diabetes mellitus (GDM) is increasing and is a risk for type 2 diabetes. Evidence supporting screening comes mostly from high-income countries. We aimed to determine prevalence and outcomes in urban Viet Nam. We compared the proposed International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criterion, requiring one positive value on the 75-g glucose tolerance test, to the 2010 American Diabetes Association (ADA) criterion, requiring two positive values. We conducted a prospective cohort study in Ho Chi Minh City, Viet Nam. Study participants were 2,772 women undergoing routine prenatal care who underwent a 75-g glucose tolerance test and interview around 28 (range 24-32) wk. GDM diagnosed by the ADA criterion was treated by local protocol. Women with GDM by the IADPSG criterion but not the ADA criterion were termed "borderline" and received standard care. 2,702 women (97.5% of cohort) were followed until discharge after delivery. GDM was diagnosed in 164 participants (6.1%) by the ADA criterion, 550 (20.3%) by the IADPSG criterion. Mean body mass index was 20.45 kg/m(2) in women with out GDM, 21.10 in women with borderline GDM, and 21.81 in women with GDM, pViet Nam. Women with GDM by the IADPSG criterion were at risk of preterm delivery and neonatal hypoglycaemia, although this criterion resulted in 20% of pregnant women being positive for GDM. The ability to cope with such a large number of cases and prevent associated adverse outcomes needs to be demonstrated before recommending widespread screening. Please see later in the article for the Editors' Summary.

A Comparative Study of Wireless Sensor Networks and Their Routing Protocols

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Subhajit Pal

2010-11-01

Full Text Available Recent developments in the area of micro-sensor devices have accelerated advances in the sensor networks field leading to many new protocols specifically designed for wireless sensor networks (WSNs. Wireless sensor networks with hundreds to thousands of sensor nodes can gather information from an unattended location and transmit the gathered data to a particular user, depending on the application. These sensor nodes have some constraints due to their limited energy, storage capacity and computing power. Data are routed from one node to other using different routing protocols. There are a number of routing protocols for wireless sensor networks. In this review article, we discuss the architecture of wireless sensor networks. Further, we categorize the routing protocols according to some key factors and summarize their mode of operation. Finally, we provide a comparative study on these various protocols.

The Pelotas birth cohort study, Rio Grande do Sul, Brazil, 1982-2001

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Victora Cesar G.

2003-01-01

Full Text Available Given the growing recognition of the importance of the life course approach for the determination of chronic diseases, birth cohort studies are becoming increasingly important. This paper describes the methods used in the 1982 Pelotas (Brazil birth cohort study, one of the largest and longest studies of this type in developing countries. All 5,914 hospital births occurring in Pelotas in 1982 (over 99% of all deliveries were studied prospectively. The main stages of the study took place in 1983, 1984, 1986, 1995, 1997, 2000, and 2001. More than two thousand variables are available for each subject who participated in all stages of the study. Recent phases of the study included the examination of 2,250 males when presenting for the army recruitment exam in 2000, the study of a 27% sample of men and women in 2001 through household visits, and the study of over 400 children born to the cohort women. Follow-up rates in the recent stages of the cohort were 78.9% for the army examination and 69.0% for the household visits. Ethnographic and oral health studies were conducted in sub-samples. Some recent results on blood pressure, adolescent pregnancy, and asthma are presented as examples of utilization of the data. Suggestions on lessons learned for other cohort studies are proposed.

The Pelotas Birth Cohort Study, Rio Grande do Sul, Brazil, 1982-2001

Science.gov (United States)

2010-01-01

Given the growing recognition of the importance of the life course approach for the determination of chronic diseases, birth cohort studies are becoming increasingly important. This paper describes the methods used in the 1982 Pelotas (Brazil) birth cohort study, one of the largest and longest studies of this type in developing countries. All 5,914 hospital births occurring in Pelotas in 1982 (over 99% of all deliveries) were studied prospectively. The main stages of the study took place in 1983, 1984, 1986, 1995, 1997, 2000, and 2001. More than two thousand variables are available for each subject who participated in all stages of the study. Recent phases of the study included the examination of 2,250 males when presenting for the army recruitment exam in 2000, the study of a 27% sample of men and women in 2001 through household visits, and the study of over 400 children born to the cohort women. Follow-up rates in the recent stages of the cohort were 78.9% for the army examination and 69.0% for the household visits. Ethnographic and oral health studies were conducted in sub-samples. Some recent results on blood pressure, adolescent pregnancy, and asthma are presented as examples of utilization of the data. Suggestions on lessons learned for other cohort studies are proposed. PMID:14666206

Cohorts based on decade of death: no evidence for secular trends favoring later cohorts in cognitive aging and terminal decline in the AHEAD study.

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Hülür, Gizem; Infurna, Frank J; Ram, Nilam; Gerstorf, Denis

2013-03-01

Studies of birth-year cohorts examined over the same age range often report secular trends favoring later-born cohorts, who are cognitively fitter and show less steep cognitive declines than earlier-born cohorts. However, there is initial evidence that those advantages of later-born cohorts do not carry into the last years of life, suggesting that pervasive mortality-related processes minimize differences that were apparent earlier in life. Elaborating this work from an alternative perspective on cohort differences, we compared rates of cognitive aging and terminal decline in episodic memory between cohorts based on the year participants had died, earlier (between 1993 and 1999) or later in historical time (between 2000 and 2010). Specifically, we compared trajectories of cognitive decline in 2 death-year cohorts of participants in the Asset and Health Dynamics Among the Oldest Old study that were matched on age at death and education and controlled for a variety of additional covariates. Results revealed little evidence of secular trends favoring later cohorts. To the contrary, the cohort that died in the 2000s showed a less favorable trajectory of age-related memory decline than the cohort that died in the 1990s. In examinations of change in relation to time to death, the cohort dying in the 2000s experienced even steeper terminal declines than the cohort dying in the 1990s. We suggest that secular increases in "manufacturing" survival may exacerbate age- and mortality-related cognitive declines among the oldest old.

Study protocol of the internet user Cohort for Unbiased Recognition of gaming disorder in Early adolescence (iCURE), Korea, 2015-2019.

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Jeong, Hyunsuk; Yim, Hyeon Woo; Jo, Sun-Jin; Lee, Seung-Yup; Kim, Eunjin; Son, Hye Jung; Han, Hyun-Ho; Lee, Hae Kook; Kweon, Yong-Sil; Bhang, Soo-Young; Choi, Jung-Seok; Kim, Bung-Nyun; Gentile, Douglas A; Potenza, Marc N

2017-10-05

In 2013, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) proposed nine internet gaming disorder (IGD) diagnostic criteria as a condition warranting further empirical and clinical research. The aim of this study is to clarify the natural and clinical courses of IGD proposed DSM-5 in adolescents and to evaluate its risk and protective factors. The Internet user Cohort for Unbiased Recognition of gaming disorder in Early Adolescence (iCURE) study is an ongoing multidisciplinary, prospective, longitudinal cohort study conducted in 21 schools in Korea. Participant recruitment commenced in March 2015 with the goal of registering 3000 adolescents. The baseline assessment included surveys on emotional, social and environmental characteristics. A parent or guardian completed questionnaires and a structured psychiatric comorbidity diagnostic interview regarding their children. Adolescents with the Internet Game Use-Elicited Symptom Screen total scores of 6 or higher were asked to participate in the clinical diagnostic interview. Two subcohorts of adolescents were constructed: a representative subcohort and a clinical evaluation subcohort. The representative subcohort comprises a randomly selected 10% of the iCURE to investigate the clinical course of IGD based on clinical diagnosis and to estimate the false negative rate. The clinical evaluation subcohort comprised participants meeting three or more of the nine IGD criteria, determined by clinical diagnostic interview, to show the clinical course of IGD. Follow-up data will be collected annually for the 3 years following the baseline assessments. The primary endpoint is 2-year incidence, remission and recurrence rates of IGD. Cross-sectional and longitudinal associations between exposures and outcomes as well as mediation factors will be evaluated. This study is approved by the Institutional Review Board of the Catholic University of Korea. Results will be published in peer

Birth cohort differences in cardiovascular risk factors in a Brazilian population of older elderly: the Bambuí cohort study of aging (1997 and 2008

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Marco Polo Dias Freitas

2011-01-01

Full Text Available The aim of this study was to investigate whether cohort differences exist in the prevalence of cardiovascular risk factors among older elderly from the Bambuí Cohort Study of Aging. Participants were those aged 71-81 years at two points in time a decade apart: 457 in 1997 (earlier cohort and 553 in 2008 (recent cohort. The prevalence of hypertension (PR = 1.27; 95%CI: 1.19-1.36 and of diabetes mellitus (PR = 1.39; 95%CI: 1.06-1.83 was higher in the recent cohort compared to the earlier one, regardless of sex. The recent cohort had a lower prevalence of smoking (PR = 0.58; 95%CI: 0.42-0.80, and lower total cholesterol/HDL cholesterol ratio level (PR = 0.85; 95%CI: 0.80-0.89. There was a 136% increase in the pharmacologic treatment of diabetes and a 56% increase in pharmacologic management of hypertension in 2008 in comparison with 1997. Overall, the number of cardiovascular risk factors in the recent cohort remained similar to that of the early cohort.

Development of a Health Empowerment Programme to improve the health of working poor families: protocol for a prospective cohort study in Hong Kong

OpenAIRE

Fung, Colman Siu Cheung; Yu, Esther Yee Tak; Guo, Vivian Yawei; Wong, Carlos King Ho; Kung, Kenny; Ho, Sin Yi; Lam, Lai Ying; Ip, Patrick; Fong, Daniel Yee Tak; Lam, David Chi Leung; Wong, William Chi Wai; Tsang, Sandra Kit Man; Tiwari, Agnes Fung Yee; Lam, Cindy Lo Kuen

2016-01-01

Introduction: People from working poor families are at high risk of poor health partly due to limited healthcare access. Health empowerment, a process by which people can gain greater control over the decisions affecting their lives and health through education and motivation, can be an effective way to enhance health, health-related quality of life (HRQOL), health awareness and health-seeking behaviours of these people. A new cohort study will be launched to explore the potential for a Healt...

Study protocol of the internet user Cohort for Unbiased Recognition of gaming disorder in Early adolescence (iCURE), Korea, 2015–2019

Science.gov (United States)

Jeong, Hyunsuk; Jo, Sun-Jin; Lee, Seung-Yup; Kim, Eunjin; Son, Hye Jung; Han, Hyun-ho; Lee, Hae Kook; Kweon, Yong-Sil; Bhang, Soo-young; Choi, Jung-Seok; Kim, Bung-Nyun; Gentile, Douglas A; Potenza, Marc N

2017-01-01

Introduction In 2013, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) proposed nine internet gaming disorder (IGD) diagnostic criteria as a condition warranting further empirical and clinical research. The aim of this study is to clarify the natural and clinical courses of IGD proposed DSM-5 in adolescents and to evaluate its risk and protective factors. Methods and analysis The Internet user Cohort for Unbiased Recognition of gaming disorder in Early Adolescence (iCURE) study is an ongoing multidisciplinary, prospective, longitudinal cohort study conducted in 21 schools in Korea. Participant recruitment commenced in March 2015 with the goal of registering 3000 adolescents. The baseline assessment included surveys on emotional, social and environmental characteristics. A parent or guardian completed questionnaires and a structured psychiatric comorbidity diagnostic interview regarding their children. Adolescents with the Internet Game Use-Elicited Symptom Screen total scores of 6 or higher were asked to participate in the clinical diagnostic interview. Two subcohorts of adolescents were constructed: a representative subcohort and a clinical evaluation subcohort. The representative subcohort comprises a randomly selected 10% of the iCURE to investigate the clinical course of IGD based on clinical diagnosis and to estimate the false negative rate. The clinical evaluation subcohort comprised participants meeting three or more of the nine IGD criteria, determined by clinical diagnostic interview, to show the clinical course of IGD. Follow-up data will be collected annually for the 3 years following the baseline assessments. The primary endpoint is 2-year incidence, remission and recurrence rates of IGD. Cross-sectional and longitudinal associations between exposures and outcomes as well as mediation factors will be evaluated. Ethics and dissemination This study is approved by the Institutional Review Board of the Catholic University

CPM Test-Retest Reliability: "Standard" vs "Single Test-Stimulus" Protocols.

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Granovsky, Yelena; Miller-Barmak, Adi; Goldstein, Oren; Sprecher, Elliot; Yarnitsky, David

2016-03-01

Assessment of pain inhibitory mechanisms using conditioned pain modulation (CPM) is relevant clinically in prediction of pain and analgesic efficacy. Our objective is to provide necessary estimates of intersession CPM reliability, to enable transformation of the CPM paradigm into a clinical tool. Two cohorts of young healthy subjects (N = 65) participated in two dual-session studies. In Study I, a Bath-Thermode CPM protocol was used, with hot water immersion and contact heat as conditioning- and test-stimuli, respectively, in a classical parallel CPM design introducing test-stimulus first, and then the conditioning- and repeated test-stimuli in parallel. Study II consisted of two CPM protocols: 1) Two-Thermodes, one for each of the stimuli, in the same parallel design as above, and 2) single test-stimulus (STS) protocol with a single administration of a contact heat test-stimulus, partially overlapped in time by a remote shorter contact heat as conditioning stimulus. Test-retest reliability was assessed within 3-7 days. The STS-CPM had superior reliability intraclass correlation (ICC 2 ,: 1  = 0.59) over Bath-Thermode (ICC 2 ,: 1  = 0.34) or Two-Thermodes (ICC 2 ,: 1  = 0.21) protocols. The hand immersion conditioning pain had higher reliability than thermode pain (ICC 2 ,: 1  = 0.76 vs ICC 2 ,: 1  = 0.16). Conditioned test-stimulus pain scores were of good (ICC 2 ,: 1  = 0.62) or fair (ICC 2 ,: 1  = 0.43) reliability for the Bath-Thermode and the STS, respectively, but not for the Two-Thermodes protocol (ICC 2 ,: 1  = 0.20). The newly developed STS-CPM paradigm was more reliable than other CPM protocols tested here, and should be further investigated for its clinical relevance. It appears that large contact size of the conditioning-stimulus and use of single rather than dual test-stimulus pain contribute to augmentation of CPM reliability. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e

Nutrition and dietary intake and their association with mortality and hospitalisation in adults with chronic kidney disease treated with haemodialysis: protocol for DIET-HD, a prospective multinational cohort study.

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Palmer, Suetonia C; Ruospo, Marinella; Campbell, Katrina L; Garcia Larsen, Vanessa; Saglimbene, Valeria; Natale, Patrizia; Gargano, Letizia; Craig, Jonathan C; Johnson, David W; Tonelli, Marcello; Knight, John; Bednarek-Skublewska, Anna; Celia, Eduardo; Del Castillo, Domingo; Dulawa, Jan; Ecder, Tevfik; Fabricius, Elisabeth; Frazão, João Miguel; Gelfman, Ruben; Hoischen, Susanne Hildegard; Schön, Staffan; Stroumza, Paul; Timofte, Delia; Török, Marietta; Hegbrant, Jörgen; Wollheim, Charlotta; Frantzen, Luc; Strippoli, G F M

2015-03-20

Adults with end-stage kidney disease (ESKD) treated with haemodialysis experience mortality of between 15% and 20% each year. Effective interventions that improve health outcomes for long-term dialysis patients remain unproven. Novel and testable determinants of health in dialysis are needed. Nutrition and dietary patterns are potential factors influencing health in other health settings that warrant exploration in multinational studies in men and women treated with dialysis. We report the protocol of the "DIETary intake, death and hospitalisation in adults with end-stage kidney disease treated with HaemoDialysis (DIET-HD) study," a multinational prospective cohort study. DIET-HD will describe associations of nutrition and dietary patterns with major health outcomes for adults treated with dialysis in several countries. DIET-HD will recruit approximately 10,000 adults who have ESKD treated by clinics administered by a single dialysis provider in Argentina, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, Sweden and Turkey. Recruitment will take place between March 2014 and June 2015. The study has currently recruited 8000 participants who have completed baseline data. Nutritional intake and dietary patterns will be measured using the Global Allergy and Asthma European Network (GA(2)LEN) food frequency questionnaire. The primary dietary exposures will be n-3 and n-6 polyunsaturated fatty acid consumption. The primary outcome will be cardiovascular mortality and secondary outcomes will be all-cause mortality, infection-related mortality and hospitalisation. The study is approved by the relevant Ethics Committees in participating countries. All participants will provide written informed consent and be free to withdraw their data at any time. The findings of the study will be disseminated through peer-reviewed journals, conference presentations and to participants via regular newsletters. We expect that the DIET-HD study will inform large pragmatic

Clinic-cytologic study of conjunctivochalasis and its relation to thyroid autoimmune diseases: prospective cohort study.

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de Almeida, Sandra Flavia Fiorentini; de Sousa, Luciene B; Vieira, Luis A; Chiamollera, Maria I; Barros, Jeison de N

2006-08-01

To determine the prevalence of conjunctivochalasis in patients with immune thyroid diseases, to determine whether there is any association between the 2 diseases, and to determine cytologic study of conjunctivochalasis through the cytology impression test. A clinical prospective cohort study carried out by the External Diseases Department in the Ophthalmology Sector and the Thyroid Department in the Endocrinology Sector at Federal University of Sao Paulo (UNIFESP). The patients included were divided into 2 groups following these inclusion criteria: a control group of 25 patients without thyroid diseases, confirmed after clinical and laboratory examinations (thyroid hormones), or any other ocular diseases. The study group consisted of 31 patients with thyroid diseases, the diagnosis of which was confirmed by the Endocrinology Sector. The thyroidopathies included were autoimmune diseases but excluded nonautoimmune diseases. A protocol endorsed by the UNIFESP was followed, using clinical and ophthalmological history, biomicroscopy, and impression cytology. Fifty-two percent of patients without thyroid diseases and 88% of patients with thyroid diseases presented with conjunctivochalasis. The risk ratio was 1.705 (Pr > chi(2) = 0.0038), indicating that there is an association between them. For the impression cytology in inferior bulbar conjunctiva, there was an association between the result of the impression cytology and conjunctivochalasis (Pearson chi(2) = 10.1190 Pr = 0.006). The prevalence of conjunctivochalasis in patients with autoimmune thyroid diseases was 88%. Patients with autoimmune thyroidopathy presented higher percentages of conjunctivochalasis than the control group, confirming the association between them. The cytologic study showed the highest prevalence of abnormal surface features in eyes with conjunctivochalasis.

Impact of age on the selection of nuclear cardiology stress protocols: The INCAPS (IAEA nuclear cardiology protocols) study.

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Al-Mallah, Mouaz H; Pascual, Thomas N B; Mercuri, Mathew; Vitola, João V; Karthikeyan, Ganesan; Better, Nathan; Dondi, Maurizio; Paez, Diana; Einstein, Andrew J

2018-05-15

There is growing concern about radiation exposure from nuclear myocardial perfusion imaging (MPI), particularly among younger patients who are more prone to develop untoward effects of ionizing radiation, and hence US and European professional society guidelines recommend age as a consideration in weighing radiation risk from MPI. We aimed to determine how patient radiation doses from MPI vary across age groups in a large contemporary international cohort. Data were collected as part of a global cross-sectional study of centers performing MPI coordinated by the International Atomic Energy Agency (IAEA). Sites provided information on each MPI study completed during a single week in March-April 2013. We compared across age groups laboratory adherence to pre-specified radiation-related best practices, radiation effective dose (ED; a whole-body measure reflecting the amount of radiation to each organ and its relative sensitivity to radiation's deleterious effects), and the proportion of patients with ED ≤ 9 mSv, a target level specified in guidelines. Among 7911 patients undergoing MPI in 308 laboratories in 65 countries, mean ED was 10.0 ± 4.5 mSv with slightly higher exposure among younger age groups (trend p value < 0.001). There was no difference in the proportion of patients with ED ≤ 9 mSv across age groups, or in adherence to best practices based on the median age of patients in a laboratory. In contemporary nuclear cardiology practice, the age of the patient appears not to impact protocol selection and radiation dose, contrary to professional society guidelines. Copyright © 2018. Published by Elsevier B.V.

The role of birth cohorts in studies of adult health: the New York women's birth cohort.

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Terry, Mary Beth; Flom, Julie; Tehranifar, Parisa; Susser, Ezra

2009-09-01

Epidemiological studies investigating associations between early life factors and adult health are often limited to studying exposures that can be reliably recalled in adulthood or obtained from existing medical records. There are few US studies with detailed data on the pre- and postnatal environment whose study populations are now in adulthood; one exception is the Collaborative Perinatal Project (CPP). We contacted former female participants of the New York site of the CPP who were born from 1959 to 1963 and were prospectively followed for 7 years to examine whether the pre- and postnatal environment is associated with adult health in women 40 years after birth. The New York CPP cohort is particularly diverse; at enrolment, the race/ethnicity distribution of mothers was approximately 30% White, 40% Black and 30% Puerto Rican. Of the 841 eligible women, we successfully traced 375 women (45%) and enrolled 262 women (70% of those traced). Baseline data were available for all eligible women, and we compared those who participated with the remaining cohort (n = 579). Higher family socio-economic status at age 7, availability of maternal social security number, and White race/ethnicity were statistically significantly associated with a higher probability of tracing. Of those traced, race/ethnicity was associated with participation, with Blacks and Puerto Ricans less likely to participate than Whites (OR = 0.5, 95% CI 0.3, 0.8, and OR = 0.5, 95% CI 0.3, 1.0, respectively). In addition, higher weight at 7 years was associated with lower participation (OR = 0.95, 95% CI 0.92, 0.99), but this association was observed only among the non-White participants. None of the other maternal characteristics, infant or early childhood growth measures was associated with participation or with tracing, either overall or within each racial/ethnic subgroup. Daughters' recall of early life factors such as pre-eclampsia (sensitivity = 24%) and birthweight were generally poor, with the

The Congenital Heart Disease Genetic Network Study: Cohort description.

Directory of Open Access Journals (Sweden)

Thanh T Hoang

Full Text Available The Pediatric Cardiac Genomics Consortium (PCGC designed the Congenital Heart Disease Genetic Network Study to provide phenotype and genotype data for a large congenital heart defects (CHDs cohort. This article describes the PCGC cohort, overall and by major types of CHDs (e.g., conotruncal defects and subtypes of conotrucal heart defects (e.g., tetralogy of Fallot and left ventricular outflow tract obstructions (e.g., hypoplastic left heart syndrome. Cases with CHDs were recruited through ten sites, 2010-2014. Information on cases (N = 9,727 and their parents was collected through interviews and medical record abstraction. Four case characteristics, eleven parental characteristics, and thirteen parent-reported neurodevelopment outcomes were summarized using counts and frequencies and compared across CHD types and subtypes. Eleven percent of cases had a genetic diagnosis. Among cases without a genetic diagnosis, the majority had conotruncal heart defects (40% or left ventricular outflow tract obstruction (21%. Across CHD types, there were significant differences (p<0.05 in the distribution of all four case characteristics (e.g., sex, four parental characteristics (e.g., maternal pregestational diabetes, and five neurodevelopmental outcomes (e.g., learning disabilities. Several characteristics (e.g., sex were also significantly different across CHD subtypes. The PCGC cohort is one of the largest CHD cohorts available for the study of genetic determinants of risk and outcomes. The majority of cases do not have a genetic diagnosis. This description of the PCGC cohort, including differences across CHD types and subtypes, provides a reference work for investigators who are interested in collaborating with or using publically available resources from the PCGC.

How to investigate and adjust for selection bias in cohort studies

DEFF Research Database (Denmark)

Nohr, Ellen A; Liew, Zeyan

2018-01-01

National Birth Cohort (DNBC) as examples on how to quantify selection bias and also understand the underlying selection mechanisms. Although women who chose to participate in the cohort were typically of higher social status, healthier and with less disease than all those eligible for study, differential...... of the presented methods are applicable even with limited data on non-participants and those lost to follow-up, and can also be applied to other study designs such as case-control studies and surveys. This article is protected by copyright. All rights reserved.......Longitudinal cohort studies can provide important evidence about preventable causes of disease, but the success relies heavily on the commitment of their participants, both at recruitment and during follow-up. Initial participation rates have decreased in recent decades as have willingness...

Protocol for the BRECAR study: a prospective cohort follow-up on the impact of breast reconstruction timing on health-related quality of life in women with breast cancer.

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Herrera de la Muela, Maria; García López, Enrique; Frías Aldeguer, Laura; Gómez-Campelo, Paloma

2017-12-19

The completion of postmastectomy breast reconstruction (BR) in women with breast cancer can last from months to years, and to our knowledge, there is a lack of studies that analyse how the different types and times of reconstruction impact on the patient's quality of life and psychosocial adjustment.The primary aim of the BREast Cancer Reconstruction (BRECAR Study) is twofold. First, to describe health-related quality of life (HRQoL), overall satisfaction with surgery and psychological impact (body image, self-esteem, depression and anxiety) on women who will have undergone a mastectomy with planned BR, considering the varied timing of BR procedures (immediate BR (iBR), delayed BR (dBR) and two-stage BR (2sBR)). To measure the impact on surgical outcomes, we will obtain data prior to and after surgery (6-9 and at 18 months of follow-up). Second, to analyse sociodemographic, clinical and psychosocial factors associated with HRQoL, satisfaction with surgery and psychological impact. A prospective, observational, clinical cohort study of women diagnosed with breast cancer who have an indication for mastectomy treated at La Paz University Hospital (Madrid, Spain).Patients will be classified into one of three groups under conditions of routine clinical practice, based on the type of BR planned: the iBR group, the dBR group and the 2sBR group.Under typical clinical practice conditions, we will perform three visits: baseline visit (presurgery), V1 (6-9 months after diagnosis) and V2 (18 months after diagnosis). A sample size of 210 patients is estimated. The study protocol and informed consent form have been reviewed and approved by the Institutional Review Board of La Paz Hospital (no. PI-2036). Dissemination of results will be via journal articles and conference presentations. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Systematically missing confounders in individual participant data meta-analysis of observational cohort studies

DEFF Research Database (Denmark)

Jackson, D.; White, I.; Kostis, J.B.

2009-01-01

One difficulty in performing meta-analyses of observational cohort studies is that the availability of confounders may vary between cohorts, so that some cohorts provide fully adjusted analyses while others only provide partially adjusted analyses. Commonly, analyses of the association between an...

Systematically missing confounders in individual participant data meta-analysis of observational cohort studies

NARCIS (Netherlands)

Jackson, D.; White, I.; Kostis, J.B.; Wilson, A.C.; Folsom, A.R.; Feskens, E.J.M.

2009-01-01

One difficulty in performing meta-analyses of observational cohort studies is that the availability of confounders may vary between cohorts, so that some cohorts provide fully adjusted analyses while others only provide partially adjusted analyses. Commonly, analyses of the association between an

Study protocol: Transition from localized low back pain to chronic widespread pain in general practice: Identification of risk factors, preventive factors and key elements for treatment – A cohort study

Directory of Open Access Journals (Sweden)

Viniol Annika

2012-05-01

Full Text Available Abstract Background Chronic localized pain syndromes, especially chronic low back pain (CLBP, are common reasons for consultation in general practice. In some cases chronic localized pain syndromes can appear in combination with chronic widespread pain (CWP. Numerous studies have shown a strong association between CWP and several physical and psychological factors. These studies are population-based cross-sectional and do not allow for assessing chronology. There are very few prospective studies that explore the predictors for the onset of CWP, where the main focus is identifying risk factors for the CWP incidence. Until now there have been no studies focusing on preventive factors keeping patients from developing CWP. Our aim is to perform a cross sectional study on the epidemiology of CLBP and CWP in general practice and to look for distinctive features regarding resources like resilience, self-efficacy and coping strategies. A subsequent cohort study is designed to identify the risk and protective factors of pain generalization (development of CWP in primary care for CLBP patients. Methods/Design Fifty-nine general practitioners recruit consecutively, during a 5 month period, all patients who are consulting their family doctor because of chronic low back pain (where the pain is lasted for 3 months. Patients are asked to fill out a questionnaire on pain anamnesis, pain-perception, co-morbidities, therapy course, medication, socio demographic data and psychosomatic symptoms. We assess resilience, coping resources, stress management and self-efficacy as potential protective factors for pain generalization. Furthermore, we raise risk factors for pain generalization like anxiety, depression, trauma and critical life events. During a twelve months follow up period a cohort of CLBP patients without CWP will be screened on a regular basis (3 monthly for pain generalization (outcome: incident CWP. Discussion This cohort study will be the largest

A multi-centre cohort study shows no association between experienced violence and labour dystocia in nulliparous women at term

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Dykes Anna-Karin

2011-02-01

Full Text Available Abstract Background Although both labour dystocia and domestic violence during pregnancy are associated with adverse maternal and fetal outcome, evidence in support of a possible association between experiences of domestic violence and labour dystocia is sparse. The aim of this study was to investigate whether self-reported history of violence or experienced violence during pregnancy is associated with increased risk of labour dystocia in nulliparous women at term. Methods A population-based multi-centre cohort study. A self-administrated questionnaire collected at 37 weeks of gestation from nine obstetric departments in Denmark. The total cohort comprised 2652 nulliparous women, among whom 985 (37.1% met the protocol criteria for dystocia. Results Among the total cohort, 940 (35.4% women reported experience of violence, and among these, 66 (2.5% women reported exposure to violence during their first pregnancy. Further, 39.5% (n = 26 of those had never been exposed to violence before. Univariate logistic regression analysis showed no association between history of violence or experienced violence during pregnancy and labour dystocia at term, crude OR 0.91, 95% CI (0.77-1.08, OR 0.90, 95% CI (0.54-1.50, respectively. However, violence exposed women consuming alcoholic beverages during late pregnancy had increased odds of labour dystocia, crude OR 1.45, 95% CI (1.07-1.96. Conclusions Our findings indicate that nulliparous women who have a history of violence or experienced violence during pregnancy do not appear to have a higher risk of labour dystocia at term, according to the definition of labour dystocia in this study. Additional research on this topic would be beneficial, including further evaluation of the criteria for labour dystocia.

External Validation Study of First Trimester Obstetric Prediction Models (Expect Study I): Research Protocol and Population Characteristics.

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Meertens, Linda Jacqueline Elisabeth; Scheepers, Hubertina Cj; De Vries, Raymond G; Dirksen, Carmen D; Korstjens, Irene; Mulder, Antonius Lm; Nieuwenhuijze, Marianne J; Nijhuis, Jan G; Spaanderman, Marc Ea; Smits, Luc Jm

2017-10-26

A number of first-trimester prediction models addressing important obstetric outcomes have been published. However, most models have not been externally validated. External validation is essential before implementing a prediction model in clinical practice. The objective of this paper is to describe the design of a study to externally validate existing first trimester obstetric prediction models, based upon maternal characteristics and standard measurements (eg, blood pressure), for the risk of pre-eclampsia (PE), gestational diabetes mellitus (GDM), spontaneous preterm birth (PTB), small-for-gestational-age (SGA) infants, and large-for-gestational-age (LGA) infants among Dutch pregnant women (Expect Study I). The results of a pilot study on the feasibility and acceptability of the recruitment process and the comprehensibility of the Pregnancy Questionnaire 1 are also reported. A multicenter prospective cohort study was performed in The Netherlands between July 1, 2013 and December 31, 2015. First trimester obstetric prediction models were systematically selected from the literature. Predictor variables were measured by the Web-based Pregnancy Questionnaire 1 and pregnancy outcomes were established using the Postpartum Questionnaire 1 and medical records. Information about maternal health-related quality of life, costs, and satisfaction with Dutch obstetric care was collected from a subsample of women. A pilot study was carried out before the official start of inclusion. External validity of the models will be evaluated by assessing discrimination and calibration. Based on the pilot study, minor improvements were made to the recruitment process and online Pregnancy Questionnaire 1. The validation cohort consists of 2614 women. Data analysis of the external validation study is in progress. This study will offer insight into the generalizability of existing, non-invasive first trimester prediction models for various obstetric outcomes in a Dutch obstetric population

Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies

Directory of Open Access Journals (Sweden)

Marent Marta

2010-11-01

Full Text Available Abstract Background With an ever-increasing elderly population, orthopaedic surgeons are faced with treating a high number of fragility fractures. Biomechanical tests have demonstrated the potential role of osteoporosis in the increased risk of fracture fixation complications, yet this has not been sufficiently proven in clinical practice. Based on this knowledge, two clinical studies were designed to investigate the influence of local bone quality on the occurrence of complications in elderly patients with distal radius and proximal humerus fractures treated by open reduction and internal fixation. Methods/Design The studies were planned using a prospective multicentre open cohort design and included patients between 50 and 90 years of age. Distal radius and proximal humerus fractures were treated with locking compression 2.4 mm and proximal humerus internal locking plates, respectively. Follow-up examinations were planned for 6 weeks, 3 and 12 months as well as a telephone interview at 6 months. The primary outcome focuses on the occurrence of at least one local bone quality related complication. Local bone quality is determined by measuring bone mineral density and bone mineral content at the contralateral radius. Primary complications are categorised according to predefined factors directly related to the bone/fracture or the implant/surgical technique. Secondary outcomes include the documentation of soft tissue/wound or general/systemic complications, clinical assessment of range of motion, and patient-rated evaluations of upper limb function and quality of life using both objective and subjective measures. Discussion The prospective multicentre open cohort studies will determine the value of local bone quality as measured by bone mineral density and content, and compare the quality of local bone of patients who experience a complication (cases following surgery with that of patients who do not (controls. These measurements are novel and

Cohort profile: the Italian Network of Longitudinal Metropolitan Studies (IN-LiMeS), a multicentre cohort for socioeconomic inequalities in health monitoring.

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Caranci, Nicola; Di Girolamo, Chiara; Giorgi Rossi, Paolo; Spadea, Teresa; Pacelli, Barbara; Broccoli, Serena; Ballotari, Paola; Costa, Giuseppe; Zengarini, Nicolás; Agabiti, Nera; Bargagli, Anna Maria; Cacciani, Laura; Canova, Cristina; Cestari, Laura; Biggeri, Annibale; Grisotto, Laura; Terni, Gianna; Costanzo, Gianfranco; Mirisola, Concetta; Petrelli, Alessio

2018-04-20

The Italian Network of Longitudinal Metropolitan Studies (IN-LiMeS) is a system of integrated data on health outcomes, demographic and socioeconomic information, and represents a powerful tool to study health inequalities. IN-LiMeS is a multicentre and multipurpose pool of metropolitan population cohorts enrolled in nine Italian cities: Turin, Venice, Reggio Emilia, Modena, Bologna, Florence, Leghorn, Prato and Rome. Data come from record linkage of municipal population registries, the 2001 population census, mortality registers and hospital discharge archives. Depending on the source of enrolment, cohorts can be closed or open. The census-based closed cohort design includes subjects resident in any of the nine cities at the 2001 census day; 4 466 655 individuals were enrolled in 2001 in the nine closed cohorts. The open cohort design includes subjects resident in 2001 or subsequently registered by birth or immigration until the latest available follow-up (currently 31 December 2013). The open cohort design is available for Turin, Venice, Reggio Emilia, Modena, Bologna, Prato and Rome. Detailed socioeconomic data are available for subjects enrolled in the census-based cohorts; information on demographic characteristics, education and citizenship is available from population registries. The first IN-LiMeS application was the study of differentials in mortality between immigrants and Italians. Either using a closed cohort design (nine cities) or an open one (Turin and Reggio Emilia), individuals from high migration pressure countries generally showed a lower mortality risk. However, a certain heterogeneity between the nine cities was noted, especially among men, and an excess mortality risk was reported for some macroareas of origin and specific causes of death. We are currently working on the linkage of the 2011 population census data, the expansion of geographical coverage and the implementation of the open design in all the participating cohorts. © Article author

UK-based, multisite, prospective cohort study of small bowel obstruction in acute surgical services: National Audit of Small Bowel Obstruction (NASBO) protocol.

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Lee, Matthew J; Sayers, Adele E; Drake, Thomas M; Hollyman, Marianne; Bradburn, Mike; Hind, Daniel; Wilson, Timothy R; Fearnhead, Nicola S

2017-10-05

Small bowel obstruction (SBO) is a common indication for emergency laparotomy in the UK, which is associated with a 90-day mortality rate of 13%. There are currently no UK clinical guidelines for the management of this condition. The aim of this multicentre prospective cohort study is to describe the burden, variation in management and associated outcomes of SBO in the UK adult population. UK hospitals providing emergency general surgery are eligible to participate. This study has three components: (1) a clinical preference questionnaire to be completed by consultants providing emergency general surgical care to assesses preferences in diagnostics and therapeutic approaches, including laparoscopy and nutritional interventions; (2) site resource profile questionnaire to indicate ease of access to diagnostic services, operating theatres, nutritional support teams and postoperative support including intensive care; (3) prospective cohort study of all cases of SBO admitted during an 8-week period at participating trusts. Data on diagnostics, operative and nutritional interventions, and in-hospital mortality and morbidity will be captured, followed by data validation. This will be conducted as a national audit of practice in conjunction with trainee research collaboratives, with support from patient representatives, surgeons, anaesthetists, gastroenterologists and a clinical trials unit. Site-specific reports will be provided to each participant site as well as an overall report to be disseminated through specialist societies. Results will be published in a formal project report endorsed by stakeholders, and in peer-reviewed scientific reports. Key findings will be debated at a focused national meeting with a view to quality improvement initiatives. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Neurological recovery in obstetric brachial plexus injuries: an historical cohort study

NARCIS (Netherlands)

Hoeksma, Agnes F.; ter Steeg, Anne Marie; Nelissen, Rob G. H. H.; van Ouwerkerk, Willem J. R.; Lankhorst, Gustaaf J.; de Jong, Bareld A.

2004-01-01

An historical cohort study was conducted to investigate the rate and extent of neurological recovery in obstetric brachial plexus injury (OBPI) and to identify possible prognostic factors in a cohort of children with OBPI from birth to 7 years. All children (n=56; 31 females, 25 males) with OBPI

Can commonly prescribed drugs be repurposed for the prevention or treatment of Alzheimer's and other neurodegenerative diseases? Protocol for an observational cohort study in the UK Clinical Practice Research Datalink.

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Walker, Venexia M; Davies, Neil M; Jones, Tim; Kehoe, Patrick G; Martin, Richard M

2016-12-13

Current treatments for Alzheimer's and other neurodegenerative diseases have only limited effectiveness meaning that there is an urgent need for new medications that could influence disease incidence and progression. We will investigate the potential of a selection of commonly prescribed drugs, as a more efficient and cost-effective method of identifying new drugs for the prevention or treatment of Alzheimer's disease, non-Alzheimer's disease dementias, Parkinson's disease and amyotrophic lateral sclerosis. Our research will focus on drugs used for the treatment of hypertension, hypercholesterolaemia and type 2 diabetes, all of which have previously been identified as potentially cerebroprotective and have variable levels of preclinical evidence that suggest they may have beneficial effects for various aspects of dementia pathology. We will conduct a hypothesis testing observational cohort study using data from the Clinical Practice Research Datalink (CPRD). Our analysis will consider four statistical methods, which have different approaches for modelling confounding. These are multivariable adjusted Cox regression; propensity matched regression; instrumental variable analysis and marginal structural models. We will also use an intention-to-treat analysis, whereby we will define all exposures based on the first prescription observed in the database so that the target parameter is comparable to that estimated by a randomised controlled trial. This protocol has been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). We will publish the results of the study as open-access peer-reviewed publications and disseminate findings through national and international conferences as are appropriate. 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/.

Vertical Protocol Composition

DEFF Research Database (Denmark)

Groß, Thomas; Mödersheim, Sebastian Alexander

2011-01-01

The security of key exchange and secure channel protocols, such as TLS, has been studied intensively. However, only few works have considered what happens when the established keys are actually used—to run some protocol securely over the established “channel”. We call this a vertical protocol.......e., that the combination cannot introduce attacks that the individual protocols in isolation do not have. In this work, we prove a composability result in the symbolic model that allows for arbitrary vertical composition (including self-composition). It holds for protocols from any suite of channel and application...

Association of chronic obstructive pulmonary disease and hemorrhoids: A nationwide cohort study.

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Lin, Lih-Hwa; Siu, Justin Ji-Yuen; Liao, Po-Chi; Chiang, Jen-Huai; Chou, Pei-Chi; Chen, Huey-Yi; Ho, Tsung-Jung; Tsai, Ming-Yen; Chen, Yung-Hsiang; Chen, Wen-Chi

2017-03-01

According to traditional Chinese medicine (TCM) theory, a specific physiological and pathological relationship exists between the lungs and the large intestine. The aim of this study is to delineate the association of chronic obstructive pulmonary disease (COPD) and hemorrhoids in order to verify the "interior-exterior" relationship between the lungs and the large intestine. A retrospective cohort study is conceived from the National Health Insurance Research Database, Taiwan. The 2 samples (COPD cohort and non-COPD cohort) were selected from the 2000 to 2003 beneficiaries of the NHI, representing patients age 20 and older in Taiwan, with the follow-up ending on December 31, 2011. The COPD cohort (n = 51,506) includes every patient newly diagnosed as having Chronic Obstructive Pulmonary Disease (COPD, ICD-9-CM: 490-492, 494, 496), who have made at least 2 confirmed visits to the hospital/clinic. The non-COPD cohort (n = 103,012) includes patients without COPD and is selected via a 1:2 (COPD: non-COPD) matching by age group (per 5 years), gender, and index date (diagnosis date of COPD for the COPD cohort). Compared with non-COPD cohorts, patients with COPD have a higher likelihood of having hemorrhoids and the age-, gender- and comorbidies-adjusted hazard ratio (HR) for hemorrhoids is 1.56 (95% confidence intervals [CI]:1.50-1.62). The adjusted HR of hemorrhoids for females is 0.79 (95% CI: 0.77-0.83), which is significantly less than that for males. The elderly groups, 40 to 59 years and aged 60 or above, have higher adjusted HRs than younger age groups (20-39 years), 1.19 (95% CI: 1.14-1.26), and 1.18 (95% CI: 1.12-1.24), respectively. Patients with COPD may have a higher likelihood to have hemorrhoids in this retrospective cohort study. This study verifies the fundamental theorem of TCM that there is a definite pathogenic association between the lungs and large intestine.

Study of Use of Products and Exposure-Related Behaviors (SUPERB: study design, methods, and demographic characteristics of cohorts

Directory of Open Access Journals (Sweden)

Hertz-Picciotto Irva

2010-08-01

Full Text Available Abstract Background Exposure to toxic chemicals in the home is a growing concern. This report presents an overview of the recruitment, methods for data collection, instruments used to collect data, and participant demographics for a study examining behaviors that influence exposure to environmental toxins in the home environment, also known as SUPERB (Study of Use of Products and Exposure Related Behaviors. Methods The methods involved three different platforms: telephone interviews, internet-based surveys, and home-based monitoring. The purposes of SUPERB were: first, to compare data collection platforms with regard to feasibility, acceptability and reliability; and second, to provide longitudinal population-based data characterizing seasonal and long-term changes in exposure-related behaviors including food consumption, temporal-spatial activity, and household product use. Results Two cohorts of households were enrolled: families (one parent and one child from northern California and older individuals (age 55+ from central California. Parents (n = 499 in Northern California families were on average 36 years of age, 47.1% were Latino or nonwhite, and 10.2% took the survey in Spanish. Most of the children enrolled (n = 566 were under 6 years (82.7%. The older adults enrolled (n = 156 were, on average, 66 years of age and 23.7% were Latino or nonwhite, but only 2.6% completed the survey in Spanish. Conclusions We found that oversampling was successful in improving recruitment of under-represented subgroups, such as those with low education, thereby increasing diversity of our study sample. Protocols that minimize participant time, e.g., use of bar scanners and scales rather than questionnaires regarding use of household products, and the implementation of these protocols by staff who built relationships of trust, resulted in high retention over a longitudinal data collection scheme. A relatively small fraction of those who volunteer for

Analyzing the effect of routing protocols on media access control protocols in radio networks

Energy Technology Data Exchange (ETDEWEB)

Barrett, C. L. (Christopher L.); Drozda, M. (Martin); Marathe, A. (Achla); Marathe, M. V. (Madhav V.)

2002-01-01

We study the effect of routing protocols on the performance of media access control (MAC) protocols in wireless radio networks. Three well known MAC protocols: 802.11, CSMA, and MACA are considered. Similarly three recently proposed routing protocols: AODV, DSR and LAR scheme 1 are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of our experiments was to study how the routing protocols affect the performance of the MAC protocols when the underlying network and traffic parameters are varied. The performance of the protocols was measured w.r.t. five important parameters: (i) number of received packets, (ii) average latency of each packet, (iii) throughput (iv) long term fairness and (v) number of control packets at the MAC layer level. Our results show that combinations of routing and MAC protocols yield varying performance under varying network topology and traffic situations. The result has an important implication; no combination of routing protocol and MAC protocol is the best over all situations. Also, the performance analysis of protocols at a given level in the protocol stack needs to be studied not locally in isolation but as a part of the complete protocol stack. A novel aspect of our work is the use of statistical technique, ANOVA (Analysis of Variance) to characterize the effect of routing protocols on MAC protocols. This technique is of independent interest and can be utilized in several other simulation and empirical studies.

Medical students' communication skills in clinical education: Results from a cohort study.

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Bachmann, Cadja; Roschlaub, Silke; Harendza, Sigrid; Keim, Rebecca; Scherer, Martin

2017-10-01

To assess students' communication skills during clinical medical education and at graduation. We conducted an observational cohort study from 2007 to 2011 with 26 voluntary undergraduate medical students at Hamburg University based on video-taped consultations in year four and at graduation. 176 consultations were analyzed quantitatively with validated and non-validated context-independent communication observation instruments (interrater reliability ≥0.8). Based on observational protocols each consultation was also documented in free-text comments, salient topics were extracted afterwards. 26 students, seven males, were enrolled in the survey. On average, graduates scored higher in differential-diagnostic questioning and time management but showed deficiencies in taking systematic and complete symptom-oriented histories, in communication techniques, in structuring consultations and in gathering the patients' perspectives. Patient-centeredness and empathy were rather low at graduation. Individual deficiencies could barely be eliminated. Medical students were able to enhance their clinical reasoning skills and their time management. Still, various communication deficiencies in final year students became evident regarding appropriate history taking, communication skills, empathy and patient-centeredness. The necessity of developing a longitudinal communication curriculum with enhanced communication trainings and assessments became evident. A curriculum should ensure that students' communication competencies are firmly achieved at graduation. Copyright © 2017. Published by Elsevier B.V.

The impact of a chest tube management protocol on the outcome of trauma patients with tube thoracostomy.

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de Abreu, Emanuelle Maria Sávio; Machado, Carla Jorge; Pastore Neto, Mario; de Rezende Neto, João Baptista; Sanches, Marcelo Dias

2015-01-01

to investigate the effect of standardized interventions in the management of tube thoracostomy patients and to assess the independent effect of each intervention. A chest tube management protocol was assessed in a retrospective cohort study. The tube thoracostomy protocol (TTP) was implemented in August 2012, and consisted of: antimicrobial prophylaxis, chest tube insertion in the operating room (OR), admission post chest tube thoracostomy (CTT) in a hospital floor separate from the emergency department (ED), and daily respiratory therapy (RT) sessions post-CTT. The inclusion criteria were, hemodynamic stability, patients between the ages of 15 and 59 years, and injury severity score (ISS) chest wall, lung, and pleura. During the study period 92 patients were managed according to the standardized protocol. The outcomes of those patients were compared to 99 patients treated before the TTP. Multivariate logistic regression analysis was performed to assess the independent effect of each variable of the protocol on selected outcomes. Demographics, injury severity, and trauma mechanisms were similar among the groups. As expected, protocol compliance increased after the implementation of the TTP. There was a significant reduction (pchest tube days. Respiratory therapy was independently linked to significant reduction (pchest tube insertion was associated with significant (ptrauma patients.

Post-treatment surveillance testing of patients with colorectal cancer and the association with survival: protocol for a retrospective cohort study of the Surveillance, Epidemiology, and End Results (SEER)-Medicare database.

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Hines, Robert B; Jiban, Md Jibanul Haque; Choudhury, Kanak; Loerzel, Victoria; Specogna, Adrian V; Troy, Steven P; Zhang, Shunpu

2018-04-28

Although the colorectal cancer (CRC) mortality rate has significantly improved over the past several decades, many patients will have a recurrence following curative treatment. Despite this high risk of recurrence, adherence to CRC surveillance testing guidelines is poor which increases cancer-related morbidity and potentially, mortality. Several randomised controlled trials (RCTs) with varying surveillance strategies have yielded conflicting evidence regarding the survival benefit associated with surveillance testing. However, due to differences in study protocols and limitations of sample size and length of follow-up, the RCT may not be the best study design to evaluate this relationship. An observational comparative effectiveness research study can overcome the sample size/follow-up limitations of RCT designs while assessing real-world variability in receipt of surveillance testing to provide much needed evidence on this important clinical issue. The gap in knowledge that this study will address concerns whether adherence to National Comprehensive Cancer Network CRC surveillance guidelines improves survival. Patients with colon and rectal cancer aged 66-84 years, who have been diagnosed between 2002 and 2008 and have been included in the Surveillance, Epidemiology, and End Results-Medicare database, are eligible for this retrospective cohort study. To minimise bias, patients had to survive at least 12 months following the completion of treatment. Adherence to surveillance testing up to 5 years post-treatment will be assessed in each year of follow-up and overall. Binomial regression will be used to assess the association between patients' characteristics and adherence. Survival analysis will be conducted to assess the association between adherence and 5-year survival. This study was approved by the National Cancer Institute and the Institutional Review Board of the University of Central Florida. The results of this study will be disseminated by publishing in

Clinical benefits after the implementation of a multimodal perioperative protocol in elderly patients.

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Aguilar-Nascimento, José Eduardo de; Salomão, Alberto Bicudo; Caporossi, Cervantes; Diniz, Breno Nadaf

2010-01-01

Multimodal protocol of perioperative care may enhance recovery after surgery. Based on evidence these new routines of perioperative care changed conventional prescriptions in surgery. To evaluate the results of a multimodal protocol (ACERTO protocol) in elderly patients. Non-randomized historical cohort study was performed at the surgical ward of a tertiary university hospital. One hundred seventeen patients aged 60 and older were submitted to elective abdominal operations under either conventional (n = 42; conventional group, January 2004-June 2005) or a fast-track perioperative protocol named ACERTO (n = 75; ACERTO group, July 2005-December 2007). Main endpoints were preoperative fasting time, postoperative day of re-feeding, volume of intravenous fluids, length of hospital stay and morbidity. The implantation of the ACERTO protocol was followed by a decrease in both preoperative fasting (15 [8-20] vs 4 [2-20] hours, P<0.001) and postoperative day of refeeding (1st [1st-10th] vs 0 [0-5th] PO day; P<0.01), and intravenous fluids (10.7 [2.5-57.5] vs 2.5 [0.5-82] L, P<0.001). The changing of protocols reduced the mean length of hospital stay by 4 days (6[1-43] vs 2[1-97] days; P = 0.002) and surgical site infection rate by 85.7% (19%; 8/42 vs 2.7%; 2/75, P<0.001; relative risk = 1.20; 95% confidence interval = 1.03-1.39). Per-protocol analysis showed that hospital stay in major operations diminished only in patients who completed the protocol (P<0.01). The implementation of multidisciplinary routines of the ACERTO protocol diminished both hospitalization and surgical site infection in elderly patients submitted to abdominal operations.

The cumulative effect of multiple critical care protocols on length of stay in a geriatric trauma population.

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Frederickson, Tiffany A; Renner, Catherine Hackett; Swegle, James R; Sahr, Sheryl M

2013-01-01

The elderly individuals are the most rapidly growing cohort within the US population, and a corresponding increase is being seen in elderly trauma patients. Elderly patients are more likely to have a hospital length of stay (LOS) in excess of 10 days. They account for 60% of total ICU days. Length of stay is frequently used as a proxy measure for improvement in injury outcomes, changes in quality of care, and hospital outcomes. Patient care protocols are typically created from evidence-based guidelines that serve to reduce variation in care from patient to patient. Patient care protocols have been found to positively impact patient care with reduced duration of mechanical ventilation, shorter LOS in the ICU and shorter overall hospitalization time, reduced mortality, and reduced health care costs. The following study was designed to assess the impact of the implementation of 4 patient care protocols within an elderly trauma population. We hypothesized that the implementation of these protocols would have a beneficial impact on patient care that could be measured by a decrease in hospital LOS. An archival, retrospective pretest/posttest study was performed on elderly trauma patients. The new protocols helped guide practical changes in care that resulted in a 32% decrease in LOS for our elderly trauma patients which exceeds the 25% decrease found in other studies. Additionally, the "Other" category for each variable was less frequently used in the post-protocol phase than in the pre-protocol phase, suggesting a spillover effect on the level of detail recorded in the patient chart. With less variation in practices in the post-protocol phase, Injury Severity score, and admission systolic blood pressure emerged as significant predictors of LOS.

Analysis of 1:1 Matched Cohort Studies and Twin Studies, with Binary Exposures and Binary Outcomes

OpenAIRE

Sjölander, Arvid; Johansson, Anna L. V.; Lundholm, Cecilia; Altman, Daniel; Almqvist, Catarina; Pawitan, Yudi

2012-01-01

To improve confounder adjustments, observational studies are often matched on potential confounders. While matched case-control studies are common and well covered in the literature, our focus here is on matched cohort studies, which are less common and sparsely discussed in the literature. Matched data also arise naturally in twin studies, as a cohort of exposure–discordant twins can be viewed as being matched on a large number of potential confounders. The analysis of twin studies will be g...

A prospective cohort study to investigate parental stress and child health in low-income Chinese families: protocol paper.

Science.gov (United States)

Wong, Rosa Sze Man; Yu, Esther Yee Tak; Guo, Vivian Yawei; Wan, Eric Yuk-Fai; Chin, Weng-Yee; Wong, Carlos King Ho; Fung, Colman Siu Cheung; Tung, Keith Tsz Suen; Wong, Wilfred Hing-Sang; Ip, Patrick; Tiwari, Agnes Fung Yee; Lam, Cindy Lo Kuen

2018-02-22

Chronic stress has adverse effects on health. Adults and children from low-income families are subject to multiple sources of stress. Existing literature about economic hardship mostly focuses on either adults or children but not both. Moreover, there is limited knowledge on the relationship between parental generalised stress and child health problems. This study aims to explore the bidirectional relationship between parental stress and child health in Chinese low-income families and to identify other modifiable factors influencing this relationship. This prospective cohort study will sample 254 low-income parent-child pairs and follow them up for 24 months with assessments at three time points (baseline, 12 and 24 months) on parental stress, health-related quality of life (HRQOL) and child health and behaviour using both subjective measures and objective physiological parameters. This study will collect data using standardised measures on HRQOL and behaviours of children as well as on HRQOL, mental health and stress levels of parents along with physiological tests of allostatic load and telomere length. The mediating or moderating effect of family harmony, parenting style and neighbourhood conditions will also be assessed. Data will be analysed using latent growth modelling and cross-lagged path analysis modelling to examine the bidirectional effect of parental stress and child health over time. Mediation and moderation analysis will also be conducted to examine the mechanism by which the variables relate. This study was approved by the institutional review board of the University of Hong Kong-the Hospital Authority Hong Kong West Cluster, reference no: UW 16-415. The study findings will be disseminated through peer-reviewed publications and international conferences. NCT03185273; 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

Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews.

Science.gov (United States)

Saini, Pooja; Loke, Yoon K; Gamble, Carrol; Altman, Douglas G; Williamson, Paula R; Kirkham, Jamie J

2014-11-21

To determine the extent and nature of selective non-reporting of harm outcomes in clinical studies that were eligible for inclusion in a cohort of systematic reviews. Cohort study of systematic reviews from two databases. Outcome reporting bias in trials for harm outcomes (ORBIT II) in systematic reviews from the Cochrane Library and a separate cohort of systematic reviews of adverse events. 92 systematic reviews of randomised controlled trials and non-randomised studies published in the Cochrane Library between issue 9, 2012 and issue 2, 2013 (Cochrane cohort) and 230 systematic reviews published between 1 January 2007 and 31 December 2011 in other publications, synthesising data on harm outcomes (adverse event cohort). A 13 point classification system for missing outcome data on harm was developed and applied to the studies. 86% (79/92) of reviews in the Cochrane cohort did not include full data from the main harm outcome of interest of each review for all of the eligible studies included within that review; 76% (173/230) for the adverse event cohort. Overall, the single primary harm outcome was inadequately reported in 76% (705/931) of the studies included in the 92 reviews from the Cochrane cohort and not reported in 47% (4159/8837) of the 230 reviews in the adverse event cohort. In a sample of primary studies not reporting on the single primary harm outcome in the review, scrutiny of the study publication revealed that outcome reporting bias was suspected in nearly two thirds (63%, 248/393). The number of reviews suspected of outcome reporting bias as a result of missing or partially reported harm related outcomes from at least one eligible study is high. The declaration of important harms and the quality of the reporting of harm outcomes must be improved in both primary studies and systematic reviews. © Saini et al 2014.

An inventory of Canadian pregnancy and birth cohort studies: research in progress

Directory of Open Access Journals (Sweden)

Joly Marie-Pier

2012-10-01

Full Text Available Abstract Background A web-based inventory was developed as a voluntary registry of Canadian pregnancy and birth cohort studies, with the objective to foster collaboration and sharing of research tools among cohort study groups as a means to enrich research in maternal and child health across Canada. Description Information on existing birth cohort studies conducted in Canada exclusively or as part of broader international initiatives was accessed by searching the literature in PubMed and PsychInfo databases. Additional studies were identified by enquiring about the research activities of researchers at Canadian universities or working in affiliated hospitals or research centres or institutes. Of the fifty-eight birth cohort studies initially identified, forty-six were incorporated into the inventory if they were of a retrospective and/or prospective longitudinal design and with a minimum of two phases of data collection, with the first period having occurred before, during, or shortly after pregnancy and had an initial study sample size of a minimum of 200 participants. Information collected from each study was organized into four main categories: basic information, data source and period of collection, exposures, and outcome measures and was coded and entered into an Excel spreadsheet. The information incorporated into the Excel spreadsheet was double checked, completed when necessary, and verified for completeness and accuracy by contacting the principal investigator or research coordinator. All data collected were then uploaded onto the website of the Institute of Human Development Child and Youth Health of the Canadian Institutes of Health Research. Subsequently, the database was updated and developed as an online searchable inventory on the website of the Maternal, Infant, Child and Youth Research Network. Conclusions This inventory is unique, as it represents detailed information assembled for the first time on a large number of Canadian

Molecular and clinical study of a cohort of 110 Algerian patients with autosomal recessive ataxia.

Science.gov (United States)

Hamza, Wahiba; Ali Pacha, Lamia; Hamadouche, Tarik; Muller, Jean; Drouot, Nathalie; Ferrat, Farida; Makri, Samira; Chaouch, Malika; Tazir, Meriem; Koenig, Michel; Benhassine, Traki

2015-06-12

Autosomal recessive cerebellar ataxias (ARCA) are a complex group of neurodegenerative disorders with great genetic and phenotypic heterogeneity, over 30 genes/loci have been associated with more than 20 different clinical forms of ARCA. Genetic heterogeneity combined with highly variable clinical expression of the cerebellar symptoms and overlapping features complicate furthermore the etiological diagnosis of ARCA. The determination of the most frequent mutations and corresponding ataxias, as well as particular features specific to a population, are mandatory to facilitate and speed up the diagnosis process, especially when an appropriate treatment is available. We explored 166 patients (115 families) refered to the neurology units of Algiers central hospitals (Algeria) with a cerebellar ataxia phenotype segregating as an autosomal recessive pattern of inheritance. Genomic DNA was extracted from peripheral blood samples and mutational screening was performed by PCR and direct sequencing or by targeted genomic capture and massive parallel sequencing of 57 genes associated with inherited cerebellar ataxia phenotypes. In this work we report the clinical and molecular results obtained on a large cohort of Algerian patients (110 patients/76 families) with genetically determined autosomal recessive ataxia, representing 9 different types of ARCA and 23 different mutations, including 6 novel ones. The five most common ARCA in this cohort were Friedreich ataxia, ataxia with isolated vitamin E deficiency, ataxia with oculomotor apraxia type 2, autosomal recessive spastic ataxia of Charlevoix-Saguenay and ataxia with oculomotor apraxia type 1. We report here a large cohort of patients with genetically determined autosomal recessive ataxia and the first study of the genetic context of ARCA in Algeria. This study showed that in Algerian patients, the two most common types of ataxia (Friedreich ataxia and ataxia with isolated vitamin E deficiency) coexist with forms that may be

Born in Bradford’s Better Start: an experimental birth cohort study to evaluate the impact of early life interventions

Directory of Open Access Journals (Sweden)

Josie Dickerson

2016-08-01

Full Text Available Abstract Background Early interventions are recognised as key to improving life chances for children and reducing inequalities in health and well-being, however there is a paucity of high quality research into the effectiveness of interventions to address childhood health and development outcomes. Planning and implementing standalone RCTs for multiple, individual interventions would be slow, cumbersome and expensive. This paper describes the protocol for an innovative experimental birth cohort: Born in Bradford’s Better Start (BiBBS that will simultaneously evaluate the impact of multiple early life interventions using efficient study designs. Better Start Bradford (BSB has been allocated £49 million from the Big Lottery Fund to implement 22 interventions to improve outcomes for children aged 0–3 in three key areas: social and emotional development; communication and language development; and nutrition and obesity. The interventions will be implemented in three deprived and ethnically diverse inner city areas of Bradford. Method The BiBBS study aims to recruit 5000 babies, their mothers and their mothers’ partners over 5 years from January 2016-December 2020. Demographic and socioeconomic information, physical and mental health, lifestyle factors and biological samples will be collected during pregnancy. Parents and children will be linked to their routine health and local authority (including education data throughout the children’s lives. Their participation in BSB interventions will also be tracked. BiBBS will test interventions using the Trials within Cohorts (TwiCs approach and other quasi-experimental designs where TwiCs are neither feasible nor ethical, to evaluate these early life interventions. The effects of single interventions, and the cumulative effects of stacked (multiple interventions on health and social outcomes during the critical early years will be measured. Discussion The focus of the BiBBS cohort is on

A comparison between r-LH and urinary supplements containing LH activity in patients undergoing the microdose GnRH agonist flare protocol for in-vitro fertilization: a pilot study.

Science.gov (United States)

Shavit, Tal; Agdi, Mohammed; Son, Weon Y; Hasson, Josseph; Dahan, Michael H

2016-08-01

The aim of this study was to compare pregnancy rates and stimulation parameters in patients with diminished ovarian reserve, who were treated with recombinant human luteinizing hormone (r-LH) or menopausal gonadotropins (hMG), as part of a microdose flare protocol. A retrospective cohort study was performed. Comparisons between the group that was stimulated with r-LH plus follicle stimulating hormone (FSH) to those treated with hMG and FSH, were performed. Measurements included: medication doses, number of oocyte collected, number of embryos obtained, pregnancy and clinical pregnancy rates. Patients in the r-LH group (N.=40) had significant higher clinical pregnancy rates (33% vs. 14%; P=0.04) and used lower dose of LH (1938 IU vs. 2807 IU; P=0.02) compared to patients that were stimulated with hMG (N.=39). r-LH may offer advantages for the treatment of diminished ovarian reserve when performing a microdose flare protocol when compared to hMG. Both larger and prospective studies should be carried out to confirm these findings.

Discovering biomarkers for antidepressant response: protocol from the Canadian biomarker integration network in depression (CAN-BIND) and clinical characteristics of the first patient cohort.

Science.gov (United States)

Lam, Raymond W; Milev, Roumen; Rotzinger, Susan; Andreazza, Ana C; Blier, Pierre; Brenner, Colleen; Daskalakis, Zafiris J; Dharsee, Moyez; Downar, Jonathan; Evans, Kenneth R; Farzan, Faranak; Foster, Jane A; Frey, Benicio N; Geraci, Joseph; Giacobbe, Peter; Feilotter, Harriet E; Hall, Geoffrey B; Harkness, Kate L; Hassel, Stefanie; Ismail, Zahinoor; Leri, Francesco; Liotti, Mario; MacQueen, Glenda M; McAndrews, Mary Pat; Minuzzi, Luciano; Müller, Daniel J; Parikh, Sagar V; Placenza, Franca M; Quilty, Lena C; Ravindran, Arun V; Salomons, Tim V; Soares, Claudio N; Strother, Stephen C; Turecki, Gustavo; Vaccarino, Anthony L; Vila-Rodriguez, Fidel; Kennedy, Sidney H

2016-04-16

Major Depressive Disorder (MDD) is among the most prevalent and disabling medical conditions worldwide. Identification of clinical and biological markers ("biomarkers") of treatment response could personalize clinical decisions and lead to better outcomes. This paper describes the aims, design, and methods of a discovery study of biomarkers in antidepressant treatment response, conducted by the Canadian Biomarker Integration Network in Depression (CAN-BIND). The CAN-BIND research program investigates and identifies biomarkers that help to predict outcomes in patients with MDD treated with antidepressant medication. The primary objective of this initial study (known as CAN-BIND-1) is to identify individual and integrated neuroimaging, electrophysiological, molecular, and clinical predictors of response to sequential antidepressant monotherapy and adjunctive therapy in MDD. CAN-BIND-1 is a multisite initiative involving 6 academic health centres working collaboratively with other universities and research centres. In the 16-week protocol, patients with MDD are treated with a first-line antidepressant (escitalopram 10-20 mg/d) that, if clinically warranted after eight weeks, is augmented with an evidence-based, add-on medication (aripiprazole 2-10 mg/d). Comprehensive datasets are obtained using clinical rating scales; behavioural, dimensional, and functioning/quality of life measures; neurocognitive testing; genomic, genetic, and proteomic profiling from blood samples; combined structural and functional magnetic resonance imaging; and electroencephalography. De-identified data from all sites are aggregated within a secure neuroinformatics platform for data integration, management, storage, and analyses. Statistical analyses will include multivariate and machine-learning techniques to identify predictors, moderators, and mediators of treatment response. From June 2013 to February 2015, a cohort of 134 participants (85 outpatients with MDD and 49 healthy participants

Family Structure and Childhood Obesity, Early Childhood Longitudinal Study ? Kindergarten Cohort

OpenAIRE

Chen, Alex Y.; Escarce, Jos? J.

2010-01-01

Introduction Little is known about the effect of family structure on childhood obesity among US children. This study examines the effect of number of parents and number of siblings on children's body mass index and risk of obesity. Methods We conducted a secondary data analysis of the Early Childhood Longitudinal Study ? Kindergarten Cohort (ECLS-K), which consists of a nationally representative cohort of children who entered kindergarten during 1998-1999. Our analyses included 2 cross-sectio...

Standardization of a Videofluoroscopic Swallow Study Protocol to Investigate Dysphagia in Dogs.

Science.gov (United States)

Harris, R A; Grobman, M E; Allen, M J; Schachtel, J; Rawson, N E; Bennett, B; Ledyayev, J; Hopewell, B; Coates, J R; Reinero, C R; Lever, T E

2017-03-01

Videofluoroscopic swallow study (VFSS) is the gold standard for diagnosis of dysphagia in veterinary medicine but lacks standardized protocols that emulate physiologic feeding practices. Age impacts swallow function in humans but has not been evaluated by VFSS in dogs. To develop a protocol with custom kennels designed to allow free-feeding of 3 optimized formulations of contrast media and diets that address limitations of current VFSS protocols. We hypothesized that dogs evaluated by a free-feeding VFSS protocol would show differences in objective swallow metrics based on age. Healthy juvenile, adult, and geriatric dogs (n = 24). Prospective, experimental study. Custom kennels were developed to maintain natural feeding behaviors during VFSS. Three food consistencies (thin liquid, pureed food, and dry kibble) were formulated with either iohexol or barium to maximize palatability and voluntary prehension. Dogs were evaluated by 16 swallow metrics and compared across age groups. Development of a standardized VFSS protocol resulted in successful collection of swallow data in healthy dogs. No significant differences in swallow metrics were observed among age groups. Substantial variability was observed in healthy dogs when evaluated under these physiologic conditions. Features typically attributed to pathologic states, such as gastric reflux, were seen in healthy dogs. Development of a VFSS protocol that reflects natural feeding practices may allow emulation of physiology resulting in clinical signs of dysphagia. Age did not result in significant changes in swallow metrics, but additional studies are needed, particularly in light of substantial normal variation. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Antibiotic prophylaxis adequacy in knee arthroplasty and surgical wound infection: Prospective cohort study.

Science.gov (United States)

Del-Moral-Luque, J A; Checa-García, A; López-Hualda, Á; Villar-Del-Campo, M C; Martínez-Martín, J; Moreno-Coronas, F J; Montejo-Sancho, J; Rodríguez-Caravaca, G

Antibiotic prophylaxis is the most suitable tool for preventing surgical wound infection. This study evaluated adequacy of antibiotic prophylaxis in surgery for knee arthroplasty and its effect on surgical site infection. Prospective cohort study. We assessed the degree of adequacy of antibiotic prophylaxis, the causes of non-adequacy, and the effect of non-adequacy on surgical site infection. Incidence of surgical site infection was studied after a maximum incubation period of a year. To assess the effect of prophylaxis non-adequacy on surgical site infection we used the relative risk adjusted with the aid of a logistic regression model. The study covered a total of 1749 patients. Antibiotic prophylaxis was indicated in all patients and administered in 99.8% of cases, with an overall protocol adequacy of 77.6%. The principal cause of non-compliance was the duration of prescription of the antibiotics (46.5%). Cumulative incidence of surgical site infection was 1.43%. No relationship was found between prophylaxis adequacy and surgical infection (RR=1.15; 95% CI: .31-2.99) (P>.05). Surveillance and infection control programs enable risk factors of infection and improvement measures to be assessed. Monitoring infection rates enables us to reduce their incidence. Adequacy of antibiotic prophylaxis was high but could be improved. We did not find a relationship between prophylaxis adequacy and surgical site infection rate. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Toenail selenium status and the risk of Barrett's esophagus: The Netherlands Cohort Study

NARCIS (Netherlands)

Steevens, J.; Schouten, L.J.; Driessen, A.L.C.; Huysentruyt, C.J.R.; Keulemans, Y.C.A.; Goldbohm, R.A.; Brandt, P.A. van den

2010-01-01

Objective: To investigate the association between selenium and the risk of Barrett's esophagus (BE), the precursor lesion of esophageal adenocarcinoma. Methods: Data from the prospective Netherlands Cohort Study were used. This cohort study was initiated in 1986, when 120,852 subjects aged 55-69

Understanding barriers and outcomes of unspecified (non-directed altruistic) kidney donation from both professional's and patient's perspectives: research protocol for a national multicentre mixed-methods prospective cohort study.

Science.gov (United States)

Gare, Rebecca; Gogalniceanu, Petrut; Maple, Hannah; Burnapp, Lisa; Clarke, Alexis; Williams, Lynsey; Norton, Sam; Chilcot, Joseph; Gibbs, Paul; Mitchell, Annie; McCrone, Paul; Draper, Heather; Mamode, Nizam

2017-09-21

Living donation accounts for over one-third of all kidney transplants taking place in the UK. 1 The concept of anonymously donating a kidney to a stranger (non-directed altruistic or unspecified kidney donation (UKD)) remains uncomfortable for some clinicians, principally due to concerns about the motivations and long-term physical and psychological outcomes in this donor group. The research programme aims to provide a comprehensive assessment of the unspecified donor programme in the UK. It aims to identify reasons for variations in practice across centres, explore outcomes for donors and ascertain barriers and facilitators to UKD, as well as assess the economic implications of unspecified donation. The research programme will adopt a mixed-methods approach to assessing UKD nationally using focus groups, interviews and questionnaires. Two study populations will be investigated. The first will include transplant professionals involved in unspecified kidney donation. The second will include a 5-year prospective cohort of individuals who present to any of the 23 UK transplant centres as a potential unspecified living kidney donor. Physical and psychological outcomes will be followed up to 1 year following donation or withdrawal from the donation process. A matched sample of specified donors (those donating to someone they know) will be recruited as a control group. Further qualitative work consisting of interviews will be performed on a purposive sample of unspecified donors from both groups (those who do and do not donate). The findings will be reported to NHS Blood and Transplant and the British Transplant Society with a view to developing national guidelines and a protocol for the management of those presenting for unspecified donation. ISRCTN23895878, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cohort Profile: Antiretroviral Therapy Cohort Collaboration (ART-CC)

Science.gov (United States)

May, Margaret T; Ingle, Suzanne M; Costagliola, Dominique; Justice, Amy C; de Wolf, Frank; Cavassini, Matthias; D’Arminio Monforte, Antonella; Casabona, Jordi; Hogg, Robert S; Mocroft, Amanda; Lampe, Fiona C; Dabis, François; Fätkenheuer, Gerd; Sterling, Timothy R; del Amo, Julia; Gill, M John; Crane, Heidi M; Saag, Michael S; Guest, Jodie; Brodt, Hans-Reinhard; Sterne, Jonathan AC

2014-01-01

The advent of effective combination antiretroviral therapy (ART) in 1996 resulted in fewer patients experiencing clinical events, so that some prognostic analyses of individual cohort studies of human immunodeficiency virus-infected individuals had low statistical power. Because of this, the Antiretroviral Therapy Cohort Collaboration (ART-CC) of HIV cohort studies in Europe and North America was established in 2000, with the aim of studying the prognosis for clinical events in acquired immune deficiency syndrome (AIDS) and the mortality of adult patients treated for HIV-1 infection. In 2002, the ART-CC collected data on more than 12,000 patients in 13 cohorts who had begun combination ART between 1995 and 2001. Subsequent updates took place in 2004, 2006, 2008, and 2010. The ART-CC data base now includes data on more than 70 000 patients participating in 19 cohorts who began treatment before the end of 2009. Data are collected on patient demographics (e.g. sex, age, assumed transmission group, race/ethnicity, geographical origin), HIV biomarkers (e.g. CD4 cell count, plasma viral load of HIV-1), ART regimen, dates and types of AIDS events, and dates and causes of death. In recent years, additional data on co-infections such as hepatitis C; risk factors such as smoking, alcohol and drug use; non-HIV biomarkers such as haemoglobin and liver enzymes; and adherence to ART have been collected whenever available. The data remain the property of the contributing cohorts, whose representatives manage the ART-CC via the steering committee of the Collaboration. External collaboration is welcomed. Details of contacts are given on the ART-CC website (www.art-cohort-collaboration.org). PMID:23599235

Cohort profile: LIFEWORK, a prospective cohort study on occupational and environmental risk factors and health in the Netherlands.

Science.gov (United States)

Reedijk, Marije; Lenters, Virissa; Slottje, Pauline; Pijpe, Anouk; Peeters, Petra H; Korevaar, Joke C; Bueno-de-Mesquita, Bas; Verschuren, W M Monique; Verheij, Robert A; Pieterson, Inka; van Leeuwen, Flora E; Rookus, Matti A; Kromhout, Hans; Vermeulen, Roel C H

2018-02-03

LIFEWORK is a large federated prospective cohort established in the Netherlands to quantify the health effects of occupational and environmental exposures. This cohort is also the Dutch contribution to the international Cohort Study of Mobile Phone Use and Health (COSMOS). In this paper, we describe the study design, ongoing data collection, baseline characteristics of participants and the repeatability of key questionnaire items. 88 466 participants were enrolled in three cohort studies in 2011-2012. Exposure information was collected by a harmonised core questionnaire, or modelled based on occupational and residential histories; domains include air pollution (eg, nitrogen dioxide (NO 2 ), particulate matter with diameter ≤2.5 µm (PM 2.5 )), noise, electromagnetic fields (EMF), mobile phone use, shift work and occupational chemical exposures. Chronic and subacute health outcomes are assessed by self-report and through linkage with health registries. Participants had a median age of 51 years at baseline (range 19-87), and the majority are female (90%), with nurses being over-represented. Median exposure levels of NO 2 , PM 2.5 , EMF from base stations and noise at the participants' home addresses at baseline were 22.9 µg/m 3 , 16.6 µg/m 3 , 0.003 mWm 2 and 53.1 dB, respectively. Twenty-two per cent of participants reported to have started using a mobile phone more than 10 years prior to baseline. Repeatability for self-reported exposures was moderate to high (weighted kappa range: 0.69-1) for a subset of participants (n=237) who completed the questionnaire twice. We are actively and passively observing participants; we plan to administer a follow-up questionnaire every 4-5 years-the first follow-up will be completed in 2018-and linkage to cause-of-death and cancer registries occurs on a (bi)annual basis. This prospective cohort offers a unique, large and rich resource for research on contemporary occupational and environmental health risks and will

Non-cancer morbidity among Estonian Chernobyl cleanup workers: a register-based cohort study.

Science.gov (United States)

Rahu, Kaja; Bromet, Evelyn J; Hakulinen, Timo; Auvinen, Anssi; Uusküla, Anneli; Rahu, Mati

2014-05-14

To examine non-cancer morbidity in the Estonian Chernobyl cleanup workers cohort compared with the population sample with special attention to radiation-related diseases and mental health disorders. Register-based cohort study. Estonia. An exposed cohort of 3680 men (cleanup workers) and an unexposed cohort of 7631 men (population sample) were followed from 2004 to 2012 through the Population Registry and Health Insurance Fund database. Morbidity in the exposed cohort compared with the unexposed controls was estimated in terms of rate ratio (RR) with 95% CIs using Poisson regression models. Elevated morbidity in the exposed cohort was found for diseases of the nervous system, digestive system, musculoskeletal system, ischaemic heart disease and for external causes. The most salient excess risk was observed for thyroid diseases (RR=1.69; 95% CI 1.38 to 2.07), intentional self-harm (RR=1.47; 95% CI 1.04 to 2.09) and selected alcohol-related diagnoses (RR=1.25; 95% CI 1.12 to 1.39). No increase in morbidity for stress reactions, depression, headaches or sleep disorders was detected. No obvious excess morbidity consistent with biological effects of radiation was seen in the exposed cohort, with the possible exception of benign thyroid diseases. Increased alcohol-induced morbidity may reflect alcohol abuse, and could underlie some of the higher morbidity rates. Mental disorders in the exposed cohort were probably under-reported. The future challenge will be to study mental and physical comorbidities in the Chernobyl cleanup workers cohort. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Primary Sjogren's syndrome and the risk of acute pancreatitis: a nationwide cohort study.

Science.gov (United States)

Chang, Chi-Ching; Chang, Yu-Sheng; Wang, Shu-Hung; Lin, Shyr-Yi; Chen, Yi-Hsuan; Chen, Jin Hua

2017-08-11

Studies on the risk of acute pancreatitis in patients with primary Sjogren's syndrome (pSS) are limited. We evaluated the effects of pSS on the risk of acute pancreatitis in a nationwide, population-based cohort in Taiwan. Population-based retrospective cohort study. We studied the claims data of the >97% Taiwan population from 2002 to 2012. We identified 9468 patients with pSS by using the catastrophic illness registry of the National Health Insurance Database in Taiwan. We also selected 37 872 controls that were randomly frequency matched by age (in 5 year bands), sex and index year from the general population. We analysed the risk of acute pancreatitis by using Cox proportional hazards regression models including sex, age and comorbidities. From 23.74 million people in the cohort, 9468 patients with pSS (87% women, mean age=55.6 years) and 37 872 controls were followed-up for 4.64 and 4.74 years, respectively. A total of 44 cases of acute pancreatitis were identified in the pSS cohort versus 105 cases in the non-pSS cohort. Multivariate Cox regression analysis indicated that the incidence rate of acute pancreatitis was significantly higher in the pSS cohort than in the non-pSS cohort (adjusted HR (aHR) 1.48, 95% CI 1.03 to 2.12). Cyclophosphamide use increased the risk of acute pancreatitis (aHR 5.27, 95% CI 1.16 to 23.86). By contrast, hydroxychloroquine reduced the risk of acute pancreatitis (aHR 0.23, 95% CI 0.09 to 0.55). This nationwide, retrospective cohort study demonstrated that the risk of acute pancreatitis was significantly higher in patients with pSS than in the general population. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Opportunities and Challenges in Establishing a Cohort Study: An Example From Cleft Lip/Palate Research in the United Kingdom.

Science.gov (United States)

Stock, Nicola Marie; Humphries, Kerry; Pourcain, Beate St; Bailey, Maggie; Persson, Martin; Ho, Karen M; Ring, Susan; Marsh, Cathy; Albery, Liz; Rumsey, Nichola; Sandy, Jonathan

2016-05-01

Cleft lip and/or palate (CL/P) is one of the most common birth conditions in the world, but little is known about its causes. Professional opinion remains divided as to which treatments may be the most beneficial for patients with CL/P, and the factors that contribute to psychological adjustment are poorly understood. The use of different methodological approaches and tools plays a key role in hampering efforts to address discrepancies within the evidence base. A new UK-wide program of research, The Cleft Collective, was established to combat many of these methodological challenges and to address some of the key research questions important to all CL/P stakeholders. To describe the establishment of CL/P cohort studies in the United Kingdom and to consider the many opportunities this resource will generate. To date, protocols have been developed and implemented within most UK cleft teams. Biological samples, environmental information, and data pertaining to parental psychological well-being and child development are being collected successfully. Recruitment is currently on track to meet the ambitious target of approximately 9800 individuals from just more than 3000 families. The Cleft Collective cohort studies represent a significant step forward for research in the field of CL/P. The data collected will form a comprehensive resource of information about individuals with CL/P and their families. This resource will provide the basis for many future projects and collaborations, both in the United Kingdom and around the world.

Establishing integrated rural–urban cohorts to assess air pollution-related health effects in pregnant women, children and adults in Southern India: an overview of objectives, design and methods in the Tamil Nadu Air Pollution and Health Effects (TAPHE) study

Science.gov (United States)

Balakrishnan, Kalpana; Sambandam, Sankar; Ramaswamy, Padmavathi; Ghosh, Santu; Venkatesan, Vettriselvi; Thangavel, Gurusamy; Mukhopadhyay, Krishnendu; Johnson, Priscilla; Paul, Solomon; Puttaswamy, Naveen; Dhaliwal, Rupinder S; Shukla, D K

2015-01-01

Introduction In rapidly developing countries such as India, the ubiquity of air pollution sources in urban and rural communities often results in ambient and household exposures significantly in excess of health-based air quality guidelines. Few efforts, however, have been directed at establishing quantitative exposure–response relationships in such settings. We describe study protocols for The Tamil Nadu Air Pollution and Health Effects (TAPHE) study, which aims to examine the association between fine particulate matter (PM2.5) exposures and select maternal, child and adult health outcomes in integrated rural–urban cohorts. Methods and analyses The TAPHE study is organised into five component studies with participants drawn from a pregnant mother–child cohort and an adult cohort (n=1200 participants in each cohort). Exposures are assessed through serial measurements of 24–48 h PM2.5 area concentrations in household microenvironments together with ambient measurements and time-activity recalls, allowing exposure reconstructions. Generalised additive models will be developed to examine the association between PM2.5 exposures, maternal (birth weight), child (acute respiratory infections) and adult (chronic respiratory symptoms and lung function) health outcomes while adjusting for multiple covariates. In addition, exposure models are being developed to predict PM2.5 exposures in relation to household and community level variables as well as to explore inter-relationships between household concentrations of PM2.5 and air toxics. Finally, a bio-repository of peripheral and cord blood samples is being created to explore the role of gene–environment interactions in follow-up studies. Ethics and dissemination The study protocols have been approved by the Institutional Ethics Committee of Sri Ramachandra University, the host institution for the investigators in this study. Study results will be widely disseminated through peer-reviewed publications and

Establishing integrated rural-urban cohorts to assess air pollution-related health effects in pregnant women, children and adults in Southern India: an overview of objectives, design and methods in the Tamil Nadu Air Pollution and Health Effects (TAPHE) study.

Science.gov (United States)

Balakrishnan, Kalpana; Sambandam, Sankar; Ramaswamy, Padmavathi; Ghosh, Santu; Venkatesan, Vettriselvi; Thangavel, Gurusamy; Mukhopadhyay, Krishnendu; Johnson, Priscilla; Paul, Solomon; Puttaswamy, Naveen; Dhaliwal, Rupinder S; Shukla, D K

2015-06-10

In rapidly developing countries such as India, the ubiquity of air pollution sources in urban and rural communities often results in ambient and household exposures significantly in excess of health-based air quality guidelines. Few efforts, however, have been directed at establishing quantitative exposure-response relationships in such settings. We describe study protocols for The Tamil Nadu Air Pollution and Health Effects (TAPHE) study, which aims to examine the association between fine particulate matter (PM2.5) exposures and select maternal, child and adult health outcomes in integrated rural-urban cohorts. The TAPHE study is organised into five component studies with participants drawn from a pregnant mother-child cohort and an adult cohort (n=1200 participants in each cohort). Exposures are assessed through serial measurements of 24-48 h PM2.5 area concentrations in household microenvironments together with ambient measurements and time-activity recalls, allowing exposure reconstructions. Generalised additive models will be developed to examine the association between PM2.5 exposures, maternal (birth weight), child (acute respiratory infections) and adult (chronic respiratory symptoms and lung function) health outcomes while adjusting for multiple covariates. In addition, exposure models are being developed to predict PM2.5 exposures in relation to household and community level variables as well as to explore inter-relationships between household concentrations of PM2.5 and air toxics. Finally, a bio-repository of peripheral and cord blood samples is being created to explore the role of gene-environment interactions in follow-up studies. The study protocols have been approved by the Institutional Ethics Committee of Sri Ramachandra University, the host institution for the investigators in this study. Study results will be widely disseminated through peer-reviewed publications and scientific presentations. In addition, policy-relevant recommendations are also

Anthropometry, physical activity, and endometrial cancer risk: Results from the Netherlands Cohort Study

NARCIS (Netherlands)

Schouten, L.J.; Goldbohm, R.A.; Brandt, P.A. van den

2004-01-01

Although obesity is an established risk factor for endometrial cancer, evidence linking risk to height, weight change since age 20, and physical activity is limited. In this case-cohort study, 62 573 women from The Netherlands Cohort Study on Diet and Cancer were followed up from 1986 to 1995, and

End Stage Renal Disease: Not a Contraindication for Minor Oral Surgery-Protocol for the Management of Oral Surgery patients with ESRD on Hemodialysis.

Science.gov (United States)

Pendem, Sneha; Lakshmi Narayana, G; Ravi, Poornima

2017-06-01

To describe a safe and effective protocol for the management of patients with end stage renal disease (ESRD) undergoing minor oral surgery. A prospective cohort study was conducted on all patients with ESRD who were referred for dental consultation. A definite protocol was designed in consultation with the nephrologist to minimize the risk of bleeding and wound healing complications during and after the minor surgical procedures. 36 patients consented for the protocol to be followed while 4 patients did not comply with the protocol and in 2 cases the protocol could be followed. The intra operative, post operative bleeding, and the wound healing were assessed in these patients. 36 patients had uneventful extractions as the blood pressure was brought down to pre hypertensive stage following the protocol. 4 patients who did not comply with the protocol had episodes of bleeding in the post operative period. There were two special scenarios where additional precautions had to be taken have been discussed. The wound healing was satisfactory in all these patients. The protocol discussed in this article helps us provide safe minor oral surgical treatment in patients with ESRD.

Pregnancy outcome of “delayed start” GnRH antagonist protocol versus GnRH antagonist protocol in poor responders: A clinical trial study

Directory of Open Access Journals (Sweden)

Abbas Aflatoonian

2017-08-01

Full Text Available Background: Management of poor-responding patients is still major challenge in assisted reproductive techniques (ART. Delayed-start GnRH antagonist protocol is recommended to these patients, but little is known in this regards. Objective: The goal of this study was assessment of delayed-start GnRH antagonist protocol in poor responders, and in vitro fertilization (IVF outcomes. Materials and Methods: This randomized clinical trial included sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF. In case group (n=30, delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin. Control group (n=30 treated with estrogen priming antagonist protocol. Finally, endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy were compared between two groups. Results: Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles were higher although was not statistically significant. Endometrial thickness was significantly higher in case group. There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups. Conclusion: There is no significant difference between delayed-start GnRH antagonist protocol versus GnRH antagonist protocol.

A Performance Study of LEACH and Direct Diffusion Routing Protocols in Wireless Sensor Network

International Nuclear Information System (INIS)

Fakher, S.; Sharshar, K.; Moawad, M.I.; Shokair, M.

2016-01-01

The Wireless Sensor Network (WSN) is composed of a large number of sensor nodes with limited computation communication, and battery facilities. One of the common applications of this network is environment monitoring through sensing motion, measuring temperature, humidity and radiation. One of the basic activities in WSN is data gathering which represents a great challenge. Many routing protocols are proposed for that network to collect and aggregate the data. The most popular ones are hierarchy and data centric routing protocols. The main goal of this study is to identify the most preferable routing protocol, to be used in each mobility model. This paper studies the performance of LEACH (Low Energy Adaptive Clustering Hierarchy) from hierarchy routing protocol and direct diffusion from data centric routing protocol which is not clarified until now. Moreover, a comparison between LEACH and direct diffusion protocol using NS2 simulator will be made, and an analysis of these protocols will be conducted. The comparison includes packet delivery ratio, throughput, average energy ratio, average delay, network lifetime, and routing overhead. The performance is evaluated by varying the number of sensor nodes under three mobility models Reference Point Group Mobility Model (RPGM), Manhattan and random waypoint mobility model. Simulation results show that LEACH routing protocol has a good performance in RPGM and Manhattan than random waypoint mobility model. Direct diffusion has a good performance in random waypoint mobility model than in RPGM and Manhattan mobility model

Incense use and respiratory tract carcinomas: a prospective cohort study

DEFF Research Database (Denmark)

Yuan, J.M.; Wang, R.; Koh, W.P.

2008-01-01

of cancer and ages 45 to 74 years completed a comprehensive interview regarding living conditions and dietary and lifestyle factors. Through linkage to population-based registries, the cohort was followed through 2005 and cancer occurrence determined. The relative risk for these cancers associated......BACKGROUND: Incense use is an integral part of daily life in large parts of Asia. The burning of incense is a powerful producer of particulate matter and the smoke contains a multitude of well-characterized carcinogens. However, to the authors' knowledge, no convincing association has been reported...... between exposure to incense smoke and the development of cancer. Therefore, the relation between incense use and the risk of respiratory tract carcinomas was analyzed in a prospective cohort study. METHODS: Between 1993 and 1998, a population-based cohort of 61,320 Singapore Chinese who were free...

A Cohort Study on Meniscal Lesions among Airport Baggage Handlers

DEFF Research Database (Denmark)

Mikkelsen, Sigurd; Brauer, Charlotte; Pedersen, Ellen Bøtker

2016-01-01

socioeconomic background and less knee-straining work. Baggage handlers lifted suitcases with an average weight of approximately 15 kg, in total approximately five tonnes during a 9-hour workday. The cohort was followed in the National Patient Register and Civil Registration System. The outcome was a first time......Meniscal lesions are common and may contribute to the development of knee arthrosis. A few case-control and cross-sectional studies have identified knee-straining work as risk factors for meniscal lesions, but exposure-response relations and the role of specific exposures are uncertain...... of unskilled men employed at Copenhagen Airport or in other companies in the metropolitan Copenhagen area from 1990 to 2012 (the Copenhagen Airport Cohort). The cohort at risk included 3,307 airport baggage handlers with heavy lifting and kneeling or squatting work tasks and 63,934 referents with a similar...

Efficacy of a tool to predict short-term mortality in older people presenting at emergency departments: Protocol for a multi-centre cohort study.

Science.gov (United States)

Cardona, Magnolia; Lewis, Ebony T; Turner, Robin M; Alkhouri, Hatem; Asha, Stephen; Mackenzie, John; Perkins, Margaret; Suri, Sam; Holdgate, Anna; Winoto, Luis; Chang, Chan-Wei; Gallego-Luxan, Blanca; McCarthy, Sally; Kristensen, Mette R; O'Sullivan, Michael; Skjøt-Arkil, Helene; Ekmann, Anette A; Nygaard, Hanne H; Jensen, Jonas J; Jensen, Rune O; Pedersen, Jonas L; Breen, Dorothy; Petersen, John A; Jensen, Birgitte N; Mogensen, Christian Backer; Hillman, Ken; Brabrand, Mikkel

Prognostic uncertainty inhibits clinicians from initiating timely end-of-life discussions and advance care planning. This study evaluates the efficacy of the CriSTAL (Criteria for Screening and Triaging to Appropriate aLternative care) checklist in emergency departments. Prospective cohort study of patients aged ≥65 years with any diagnosis admitted via emergency departments in ten hospitals in Australia, Denmark and Ireland. Electronic and paper clinical records will be used to extract risk factors such as nursing home residency, physiological deterioration warranting a rapid response call, personal history of active chronic disease, history of hospitalisations or intensive care unit admission in the past year, evidence of proteinuria or ECG abnormalities, and evidence of frailty to be concurrently measured with Fried Score and Clinical Frailty Scale. Patients or their informal caregivers will be contacted by telephone around three months after initial assessment to ascertain survival, self-reported health, post-discharge frailty and health service utilisation since discharge. Logistic regression and bootstrapping techniques and AUROC curves will be used to test the predictive accuracy of CriSTAL for death within 90 days of admission and in-hospital death. The CriSTAL checklist is an objective and practical tool for use in emergency departments among older patients to determine individual probability of death in the short-term. Its validation in this cohort is expected to reduce clinicians' prognostic uncertainty on the time to patients' death and encourage timely end-of-life conversations to support clinical decisions with older frail patients and their families about their imminent or future care choices. Copyright © 2018 Elsevier B.V. All rights reserved.

Performance of a multi-disciplinary emergency department observation protocol for acetaminophen overdose.

Science.gov (United States)

Beauchamp, Gillian A; Hart, Kimberly W; Lindsell, Christopher J; Lyons, Michael S; Otten, Edward J; Smith, Carol L; Ward, Michael J; Wright, Stewart W

2013-09-01

The availability of 20-h N-acetylcysteine (NAC) infusion for low-risk acetaminophen (APAP) overdose enabled our center to implement an Emergency Department observation unit (OU) protocol as an alternative to hospitalization. Our objective was to evaluate our early experience with this protocol. This retrospective cohort study included all patients treated for low-risk APAP overdose in our academic hospital between 2006 and 2011. Cases were identified using OU and pharmacy records. Successful OU discharge was defined as disposition with no inpatient admission. Differences in medians with 95 % confidence intervals were used for comparisons. One hundred ninety-six patients received NAC for APAP overdose with a mean age of 35 years (SD 14); 73 % were white, and 43 % were male. Twenty (10 %) received care in the OU; 3/20(15 %) met criteria for inclusion in the OU protocol and 13/20(65 %) were discharged successfully. Out of the 196 patients, 10 met criteria for inclusion in the OU protocol but instead received care in the inpatient setting. The median total length of stay from presentation to ED discharge was 41 h for all patients treated in the OU, compared to 68 h for ten patients who met criteria for inclusion in the OU protocol but who were admitted (difference 27 h, 95 % CI 18-72 h). ED observation for APAP overdose can be a viable alternative to inpatient admission. Most patients were successfully discharged from the OU. This evaluation identified both over- and under-utilization of the OU. OU treatment resulted in shorter median length of stay than inpatient admission.

Analysis of the Relation Between Exposure to Ionising Radiation from Computed Tomography Scans in Childhood and Cancer Incidence within the 'Cohorte Enfant Scanner' Study

International Nuclear Information System (INIS)

Journy, Neige

2014-01-01

Computed tomography (CT) is a powerful imaging technique that provides great benefits for diagnosis and medical management of patients. Nonetheless, the widespread use of this procedure raises many concerns about the potential adverse effects induced by X-rays exposure, both in clinical practice and in terms of public health. First epidemiological studies have suggested an increased risk of cancer associated with CT scan exposures in childhood or adolescence. The interpretation of these results is, however, controversial, and evidence about radiation-induced risks of cancer is still limited at this level of exposure and during childhood. In France, the 'Enfant Scanner' cohort was set up by IRSN to study the incidence of cancer among more than 100,000 children who received CT scans before the age of 10 in 21 university hospitals. This study is part of the European Epi-CT project - coordinated by the International Agency for Research on Cancer - which includes nine national cohorts set up on the basis of a common protocol. The current thesis, based on the French cohort, focuses on characterizing the exposure of children receiving diagnostic CT scans and quantifying the risk of cancer associated with these exposures. Dosimetric assessment was performed from the radiological protocols used in paediatrics between 2000 and 2011 in the participating hospitals. This study presents the evolution of the exposures during the period and the variability of practices in the radiology departments. The results show that there is a leeway for optimizing the procedures and limiting the exposure of patients, especially for scans of the head that account for most of the examinations in paediatrics. A quantitative assessment of cancer risk potentially induced by CT scans in paediatrics was performed - on the basis of estimates of risk in other contexts of ionizing radiation exposure. The results show that each CT scan could be associated with an excess risk of tumours of the

Study Application of RADIUS Protocol on Ethernet

Institute of Scientific and Technical Information of China (English)

GUO Fang; YANG Huan-yu; LI Hong

2004-01-01

This paper presents how to apply the RADIUS (Remote Authentication Dial In User Service)protocol ,which is generally applied to dial-up network, to the authentication & charge of Broad Band accessing control system on Ethernet. It is provided that the Broad Band accessing control system included a self-designed communication protocol is used in communicating between an terminal user and Network Access Server .The interface module on the servers side and the Radius system is also given in this article.

The value of a rapid contrast-enhanced angio-MRI protocol in the detection of head and neck paragangliomas in SDHx mutations carriers: a retrospective study on behalf of the PGL.EVA investigators*

International Nuclear Information System (INIS)

Gravel, Guillaume; Hernigou, Anne; Niccoli, Patricia; Rohmer, Vincent; Moulin, Guy; Borson-Chazot, Francoise; Rousset, Pascal; Pasco-Papon, Anne; Marcus, Claude; Dubrulle, Frederique; Gouya, Herve; Bidault, Francois; Dupas, Benoit; Gabrillargues, Jean; Caumont-Prim, Aurore; Gimenez-Roqueplo, Anne-Paule; Halimi, Philippe

2016-01-01

To assess the performance of a simplified MRI protocol consisting of a contrast-enhanced three-dimensional MR angiography (CE-MRA) in association with a post-contrast T1-weighted sequence (T1WIV) for the detection of HNPGLs in SDHx mutation carriers. This retrospective sub-study is based on the multicenter PGL.EVA cohort, which prospectively enrolled SDHx mutation carriers from 2005 to 2009; 157 index cases or relatives were included. CE-MRA and the T1WIV images were read solely with knowledge of the clinical data but blind to the diagnosis. Sensitivity, specificity and likelihood ratios for the simplified MRI protocol were compared to the full MRI protocol reading results and to the gold standard status obtained through the consensus of an expert committee. The sensitivity and specificity of the readings of the simplified MRI protocol were, respectively, 88.7 % (95 % CI = 78.1-95.3) and 93.7 % (95 % CI = 86.8-97.7) versus 80.7 % (95 % CI = 68.6-89.6) and 94.7 % (95 % CI = 88.1-98.3) for the readings of the full MRI protocol. The simplified post-contrast MRI with shorter duration (5 to 10 minutes) showed no performance difference compared to the lengthy standard full MRI and can be proposed for the detection of head and neck paragangliomas (HNPGLs) in SDHx mutation carriers. (orig.)

The value of a rapid contrast-enhanced angio-MRI protocol in the detection of head and neck paragangliomas in SDHx mutations carriers: a retrospective study on behalf of the PGL.EVA investigators*

Energy Technology Data Exchange (ETDEWEB)

Gravel, Guillaume; Hernigou, Anne [Hopital Europeen Georges Pompidou, Assistance Publique-Hopitaux de Paris, Service de Radiologie, Paris (France); Niccoli, Patricia [Centre Hospitalier Universitaire la Timone, Assistance Publique-Hopitaux de Marseille, Service d' Endocrinologie, Diabete et Maladies Metaboliques, Marseille (France); Rohmer, Vincent [Centre Hospitalier Universitaire d' Angers, Service d' Endocrinologie, Diabetologie, Nutrition, Angers (France); LUNAM Universite, INSERM, U1063, Angers (France); Moulin, Guy [Centre Hospitalier Universitaire la Timone, Assistance Publique-Hopitaux de Marseille, Service de Radiologie, Marseille (France); Borson-Chazot, Francoise [Federation d' Endocrinologie, Hospices civils de Lyon, Groupement Hospitalier Est, Lyon (France); Universite de Lyon, Faculte de Medecine Lyon-Est, Lyon (France); Cancer Research Center of Lyon, INSERM UMR1052, UMR CNRS 5286, Lyon (France); Rousset, Pascal [Hospices civils de Lyon, Groupement Hospitalier Est, Service de Radiologie, Lyon (France); Pasco-Papon, Anne [Centre Hospitalier Universitaire d' Angers, Service de Radiologie, Angers (France); Marcus, Claude [Centre Hospitalo-Universitaire de Reims, Service de Radiologie, Reims (France); Dubrulle, Frederique [Centre Hospitalo-Universitaire de Lille, Service de Radiologie, Lille (France); Gouya, Herve [Hopital Cochin, Assistance Publique-Hopitaux de Paris, Service de Radiologie, Paris (France); Bidault, Francois [Institut Gustave Roussy, Service de Radiologie, Villejuif (France); Dupas, Benoit [Centre Hospitalo-Universitaire de Nantes, Service de Radiologie, Nantes (France); Gabrillargues, Jean [Centre Hospitalo-Universitaire de Clermont-Ferrand, Service de Neuroradiologie, Clermont Ferrand (France); Caumont-Prim, Aurore [Unite d' Epidemiologie et de Recherche Clinique, Assistance Publique-Hopitaux de Paris, Hopital Europeen Georges Pompidou, Paris (France); Centre d' investigation Epidemiologique 4, INSERM, Paris (France); Gimenez-Roqueplo, Anne-Paule [Hopital Europeen Georges Pompidou, Assistance Publique-Hopitaux de Paris, Service de Genetique, Paris (France); Paris Cardiovascular Research Center, INSERM, UMR970, Paris (France); Universite Paris Descartes, Sorbonne Paris Cite, Faculte de Medecine, Paris (France); Halimi, Philippe [Hopital Europeen Georges Pompidou, Assistance Publique-Hopitaux de Paris, Service de Radiologie, Paris (France); Universite Paris Descartes, Sorbonne Paris Cite, Faculte de Medecine, Paris (France)

2016-06-15

To assess the performance of a simplified MRI protocol consisting of a contrast-enhanced three-dimensional MR angiography (CE-MRA) in association with a post-contrast T1-weighted sequence (T1WIV) for the detection of HNPGLs in SDHx mutation carriers. This retrospective sub-study is based on the multicenter PGL.EVA cohort, which prospectively enrolled SDHx mutation carriers from 2005 to 2009; 157 index cases or relatives were included. CE-MRA and the T1WIV images were read solely with knowledge of the clinical data but blind to the diagnosis. Sensitivity, specificity and likelihood ratios for the simplified MRI protocol were compared to the full MRI protocol reading results and to the gold standard status obtained through the consensus of an expert committee. The sensitivity and specificity of the readings of the simplified MRI protocol were, respectively, 88.7 % (95 % CI = 78.1-95.3) and 93.7 % (95 % CI = 86.8-97.7) versus 80.7 % (95 % CI = 68.6-89.6) and 94.7 % (95 % CI = 88.1-98.3) for the readings of the full MRI protocol. The simplified post-contrast MRI with shorter duration (5 to 10 minutes) showed no performance difference compared to the lengthy standard full MRI and can be proposed for the detection of head and neck paragangliomas (HNPGLs) in SDHx mutation carriers. (orig.)

Development of a Health Empowerment Programme to improve the health of working poor families: protocol for a prospective cohort study in Hong Kong.

Science.gov (United States)

Fung, Colman Siu Cheung; Yu, Esther Yee Tak; Guo, Vivian Yawei; Wong, Carlos King Ho; Kung, Kenny; Ho, Sin Yi; Lam, Lai Ying; Ip, Patrick; Fong, Daniel Yee Tak; Lam, David Chi Leung; Wong, William Chi Wai; Tsang, Sandra Kit Man; Tiwari, Agnes Fung Yee; Lam, Cindy Lo Kuen

2016-02-03

People from working poor families are at high risk of poor health partly due to limited healthcare access. Health empowerment, a process by which people can gain greater control over the decisions affecting their lives and health through education and motivation, can be an effective way to enhance health, health-related quality of life (HRQOL), health awareness and health-seeking behaviours of these people. A new cohort study will be launched to explore the potential for a Health Empowerment Programme to enable these families by enhancing their health status and modifying their attitudes towards health-related issues. If proven effective, similar empowerment programme models could be tested and further disseminated in collaborations with healthcare providers and policymakers. A prospective cohort study with 200 intervention families will be launched and followed up for 5 years. The following inclusion criteria will be used at the time of recruitment: (1) Having at least one working family member; (2) Having at least one child studying in grades 1-3; and (3) Having a monthly household income that is less than 75% of the median monthly household income of Hong Kong families. The Health Empowerment Programme that will be offered to intervention families will comprise four components: health assessment, health literacy, self-care enablement and health ambassador. Their health status, HRQOL, lifestyle and health service utilisation will be assessed and compared with 200 control families with matching characteristics but will not receive the health empowerment intervention. This project was approved by the University of Hong Kong-the Hospital Authority Hong Kong West Cluster IRB, Reference number: UW 12-517. The study findings will be disseminated through a series of peer-reviewed publications and conference presentations, as well as a yearly report to the philanthropic funding body-Kerry Group Kuok Foundation (Hong Kong) Limited. Published by the BMJ Publishing Group

Feasibility of a cohort study on health risks caused by occupational exposure to radiofrequency electromagnetic fields

DEFF Research Database (Denmark)

Breckenkamp, Jürgen; Berg-Beckhoff, Gabriele; Münster, Eva

2009-01-01

, in addition, a cohort of amateur radio operators were considered. Based on expert ratings, literature reviews and our set of predefined criteria, three of the cohorts were identified as promising for further evaluation: the personnel (technicians) of medium/short wave broadcasting stations, amateur radio......BACKGROUND: The aim of this study was to examine the feasibility of performing a cohort study on health risks from occupational exposure to radiofrequency electromagnetic fields (RF-EMF) in Germany. METHODS: A set of criteria was developed to evaluate the feasibility of such a cohort study...... and mixture of exposures, e.g. plastic vapours), although exposure was highest in this occupational setting. The advantage of the cohort of amateur radio operators was the large number of persons it includes, while the advantage of the cohort of personnel working at broadcasting stations was the quality...

Chocolate consumption and risk of atrial fibrillation: Two cohort studies and a meta-analysis.

Science.gov (United States)

Larsson, Susanna C; Drca, Nikola; Jensen-Urstad, Mats; Wolk, Alicja

2018-01-01

Chocolate consumption has been inconsistently associated with risk of atrial fibrillation (AF). We investigated the association between chocolate consumption and risk of AF in Swedish adults from two cohort studies and conducted a meta-analysis to summarize available evidence from cohort studies on this topic. Our study population comprised 40,009 men from the Cohort of Swedish Men and 32,486 women from the Swedish Mammography Cohort. Incident AF cases were ascertained through linkage with the Swedish National Patient Register. Published cohort studies of chocolate consumption in relation to risk of AF were identified by a PubMed search through September 14, 2017. During a mean follow-up of 14.6 years, AF was diagnosed in 9978 Swedish men and women. Compared with non-consumers, the multivariable hazard ratio of AF for those in the highest category of chocolate consumption (≥3-4 servings/week) was 0.96 (95% CI 0.88-1.04). In a random-effects meta-analysis of 5 cohort studies, including 180,454 participants and 16,356 AF cases, the hazard ratios of AF were 0.97 (95% CI 0.94-1.01) per 2 servings/week increase in chocolate consumption and 0.96 (95% CI 0.90-1.03) for the highest versus lowest category of chocolate consumption. Available data provide no evidence of an association of chocolate consumption with risk of AF. Copyright © 2017 Elsevier Inc. All rights reserved.

Opium use and mortality in Golestan Cohort Study: prospective cohort study of 50,000 adults in Iran.

Science.gov (United States)

Khademi, Hooman; Malekzadeh, Reza; Pourshams, Akram; Jafari, Elham; Salahi, Rasool; Semnani, Shahryar; Abaie, Behrooz; Islami, Farhad; Nasseri-Moghaddam, Siavosh; Etemadi, Arash; Byrnes, Graham; Abnet, Christian C; Dawsey, Sanford M; Day, Nicholas E; Pharoah, Paul D; Boffetta, Paolo; Brennan, Paul; Kamangar, Farin

2012-04-17

To investigate the association between opium use and subsequent risk of death. Prospective cohort study. The Golestan Cohort Study in north-eastern Iran collected detailed validated data on opium use and other exposures at baseline. Participants were enrolled between January 2004 and June 2008 and were followed to May 2011, with a follow-up success rate of over 99%. 50,045 participants aged 40-75 at baseline. Mortality, all cause and major subcategories. 17% (n = 8487) of the participants reported opium use, with a mean duration of 12.7 years. During the follow-up period 2145 deaths were reported. The adjusted hazard ratio for all cause mortality associated with ever use of opium was 1.86 (95% confidence interval 1.68 to 2.06). Opium consumption was significantly associated with increased risks of deaths from several causes including circulatory diseases (hazard ratio 1.81) and cancer (1.61). The strongest associations were seen with deaths from asthma, tuberculosis, and chronic obstructive pulmonary disease (11.0, 6.22, and 5.44, respectively). After exclusion of people who self prescribed opium after the onset of major chronic illnesses, the associations remained strong with a dose-response relation. Opium users have an increased risk of death from multiple causes compared with non-users. Increased risks were also seen in people who used low amounts of opium for a long period and those who had no major illness before use.

No benefit to surgical fixation of flail chest injuries compared with modern comprehensive management: results of a retrospective cohort study.

Science.gov (United States)

Farquhar, Jaclyn; Almarhabi, Yahya; Slobogean, Gerard; Slobogean, Bronwyn; Garraway, Naisan; Simons, Richard K; Hameed, S Morad

2016-09-01

Chest wall trauma is a common cause of morbidity and mortality. Recent technological advances and scientific publications have created a renewed interest in surgical fixation of flail chest. However, definitive data supporting surgical fixation are lacking, and its virtues have not been evaluated against modern, comprehensive management protocols. Consecutive patients undergoing rib fracture fixation with rib-specific locking plates at 2 regional trauma centres between July 2010 and August 2012 were matched to historical controls with similar injury patterns and severity who were managed nonoperatively with modern, multidisciplinary protocols. We compared short- and long-term outcomes between these cohorts. Our patient cohorts were well matched for age, sex, injury severity scores and abbreviated injury scores. The nonoperatively managed group had significantly better outcomes than the surgical group in terms of ventilator days (3.1 v. 6.1, p = 0.012), length of stay in the intensive care unit (3.7 v. 7.4 d, p = 0.009), total hospital length of stay (16.0 v. 21.9 d, p = 0.044) and rates of pneumonia (22% v. 63%, p = 0.004). There were no significant differences in long-term outcomes, such as chest pain or dyspnea. Although considerable enthusiasm surrounds surgical fixation of flail chest injuries, our analysis does not immediately validate its universal implementation, but rather encourages the use of modern, multidisciplinary, nonoperative strategies. The role of rib fracture fixation in the modern era of chest wall trauma management should ultimately be defined by prospective, randomized trials.

Trends in Dementia Incidence in a Birth Cohort Analysis of the Einstein Aging Study.

Science.gov (United States)

Derby, Carol A; Katz, Mindy J; Lipton, Richard B; Hall, Charles B

2017-11-01

Trends in dementia incidence rates have important implications for planning and prevention. To better understand incidence trends over time requires separation of age and cohort effects, and few prior studies have used this approach. To examine trends in dementia incidence and concomitant trends in cardiovascular comorbidities among individuals aged 70 years or older who were enrolled in the Einstein Aging Study between 1993 and 2015. In this birth cohort analysis of all-cause dementia incidence in persons enrolled in the Einstein Aging Study from October 20, 1993, through November 17, 2015, a systematically recruited, population-based sample of 1348 participants from Bronx County, New York, who were 70 years or older without dementia at enrollment and at least one annual follow-up was studied. Poisson regression was used to model dementia incidence as a function of age, sex, educational level, race, and birth cohort, with profile likelihood used to identify the timing of significant increases or decreases in incidence. Birth year and age. Incident dementia defined by consensus case conference based on annual, standardized neuropsychological and neurologic examination findings, using criteria from the DSM-IV. Among 1348 individuals (mean [SD] baseline age, 78.5 [5.4] years; 830 [61.6%] female; 915 [67.9%] non-Hispanic white), 150 incident dementia cases developed during 5932 person-years (mean [SD] follow-up, 4.4 [3.4] years). Dementia incidence decreased in successive birth cohorts. Incidence per 100 person-years was 5.09 in birth cohorts before 1920, 3.11 in the 1920 through 1924 birth cohorts, 1.73 in the 1925 through 1929 birth cohorts, and 0.23 in cohorts born after 1929. Change point analyses identified a significant decrease in dementia incidence among those born after July 1929 (95% CI, June 1929 to January 1930). The relative rate for birth cohorts before July 1929 vs after was 0.13 (95% CI, 0.04-0.41). Prevalence of stroke and myocardial infarction

Cohort study of atypical pressure ulcers development.

Science.gov (United States)

Jaul, Efraim

2014-12-01

Atypical pressure ulcers (APU) are distinguished from common pressure ulcers (PU) with both unusual location and different aetiology. The occurrence and attempts to characterise APU remain unrecognised. The purpose of this cohort study was to analyse the occurrence of atypical location and the circumstances of the causation, and draw attention to the prevention and treatment by a multidisciplinary team. The cohort study spanned three and a half years totalling 174 patients. The unit incorporates two weekly combined staff meetings. One concentrates on wound assessment with treatment decisions made by the physician and nurse, and the other, a multidisciplinary team reviewing all patients and coordinating treatment. The main finding of this study identified APU occurrence rate of 21% within acquired PU over a three and a half year period. Severe spasticity constituted the largest group in this study and the most difficult to cure wounds, located in medial aspects of knees, elbows and palms. Medical devices caused the second largest occurrence of atypical wounds, located in the nape of the neck, penis and nostrils. Bony deformities were the third recognisable atypical wound group located in shoulder blades and upper spine. These three categories are definable and time observable. APU are important to be recognisable, and can be healed as well as being prevented. The prominent role of the multidisciplinary team is primary in identification, prevention and treatment. © 2013 The Authors. International Wound Journal © 2013 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Study protocol of the B-CAST study: a multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer

International Nuclear Information System (INIS)

Ishiguro, Megumi; Mori, Masaki; Kakeji, Yoshihiro; Kanazawa, Akiyoshi; Kobayashi, Michiya; Okajima, Masazumi; Hyodo, Ichinosuke; Miyakoda, Keiko; Sugihara, Kenichi; Kotake, Kenjiro; Nishimura, Genichi; Tomita, Naohiro; Ichikawa, Wataru; Takahashi, Keiichi; Watanabe, Toshiaki; Furuhata, Tomohisa; Kondo, Ken

2013-01-01

Adjuvant chemotherapy for stage III colon cancer is internationally accepted as standard treatment with established efficacy. Several oral fluorouracil (5-FU) derivatives with different properties are available in Japan, but which drug is the most appropriate for each patient has not been established. Although efficacy prediction of 5-FU derivatives using expression of 5-FU activation/metabolism enzymes in tumors has been studied, it has not been clinically applied. The B-CAST study is a multicenter, prospective cohort study aimed to identify the patients who benefit from adjuvant chemotherapy with each 5-FU regimen, through evaluating the relationship between tumor biomarker expression and treatment outcome. The frozen tumor specimens of patients with stage III colon cancer who receives postoperative adjuvant chemotherapy are examined. Protein expression of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), epidermal growth factor receptor (EGFR), and vascular endothelial growth factor (VEGF) are evaluated using enzyme-linked immunosorbent assay (ELISA). mRNA expression of TP, DPD, thymidylate synthase (TS) and orotate phosphoribosyl transferase (OPRT) are evaluated using reverse transcription polymerase chain reaction (RT-PCR). The patients’ clinical data reviewed are as follow: demographic and pathological characteristics, regimen, drug doses and treatment duration of adjuvant therapy, types and severity of adverse events, disease free survival, relapse free survival and overall survival. Then, relationships among the protein/mRNA expression, clinicopathological characteristics and the treatment outcomes are analyzed for each 5-FU derivative. A total of 2,128 patients from the 217 institutions were enrolled between April 2009 and March 2012. The B-CAST study demonstrated that large-scale, multicenter translational research using frozen samples was feasible when the sample shipment and Web-based data collection were well organized. The results

The Danish National Birth Cohort

DEFF Research Database (Denmark)

Andersen, Anne-Marie Nybo; Olsen, Jørn

2011-01-01

, physical exercise, working conditions, medication and infections during pregnancy, and environmental possible toxins. The study designs cover straightforward cohort analyses, case-control studies and sub-cohort analyses with enriched data collection. CONCLUSION: So far, the Danish National Birth Cohort has......INTRODUCTION: In this review a selection of studies published during the period 2002-2010, based on data from the Danish National Birth Cohort linked with other health registers, is described. Illustrative examples of studies addressing perinatal health outcomes (pregnancy complications and fetal...... that this investment in epidemiologic infrastructure was well spent. The existence of the Danish National Birth Cohort together with other cohorts and national registers has given Denmark a leading position in reproductive epidemiology....

Sensor, a population-based cohort study on gastroenteritis in the Netherlands: incidence and etiology.

NARCIS (Netherlands)

Wit, M.A.S. de; Koopmans, M.P.G.; Kortbeek, L.M.; Wannet, W.J.B.; Vinje, J; Leusden, F. van; Bartelds, A.I.M.; Duynhoven, Y.T.H.P. van

2001-01-01

A prospective population-based cohort study with a nested case- control study was conducted to estimate the incidence of gastroenteritis and the associated pathogens in the general Dutch population. Follow-up of two consecutive cohorts was performed by weekly reporting cards from december 1998 to

Feasibility of a cohort study on health risks caused by occupational exposure to radiofrequency electromagnetic fields

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Wahrendorf Jürgen

2009-05-01

Full Text Available Abstract Background The aim of this study was to examine the feasibility of performing a cohort study on health risks from occupational exposure to radiofrequency electromagnetic fields (RF-EMF in Germany. Methods A set of criteria was developed to evaluate the feasibility of such a cohort study. The criteria aimed at conditions of exposure and exposure assessment (level, duration, preferably on an individual basis, the possibility to assemble a cohort and the feasibility of ascertaining various disease endpoints. Results Twenty occupational settings with workers potentially exposed to RF-EMF and, in addition, a cohort of amateur radio operators were considered. Based on expert ratings, literature reviews and our set of predefined criteria, three of the cohorts were identified as promising for further evaluation: the personnel (technicians of medium/short wave broadcasting stations, amateur radio operators, and workers on dielectric heat sealers. After further analyses, the cohort of workers on dielectric heat sealers seems not to be feasible due to the small number of exposed workers available and to the difficulty of assessing exposure (exposure depends heavily on the respective working process and mixture of exposures, e.g. plastic vapours, although exposure was highest in this occupational setting. The advantage of the cohort of amateur radio operators was the large number of persons it includes, while the advantage of the cohort of personnel working at broadcasting stations was the quality of retrospective exposure assessment. However, in the cohort of amateur radio operators the exposure assessment was limited, and the cohort of technicians was hampered by the small number of persons working in this profession. Conclusion The majority of occupational groups exposed to RF-EMF are not practicable for setting up an occupational cohort study due to the small numbers of exposed subjects or due to exposure levels being only marginally higher

Feasibility of a cohort study on health risks caused by occupational exposure to radiofrequency electromagnetic fields

Science.gov (United States)

2009-01-01

Background The aim of this study was to examine the feasibility of performing a cohort study on health risks from occupational exposure to radiofrequency electromagnetic fields (RF-EMF) in Germany. Methods A set of criteria was developed to evaluate the feasibility of such a cohort study. The criteria aimed at conditions of exposure and exposure assessment (level, duration, preferably on an individual basis), the possibility to assemble a cohort and the feasibility of ascertaining various disease endpoints. Results Twenty occupational settings with workers potentially exposed to RF-EMF and, in addition, a cohort of amateur radio operators were considered. Based on expert ratings, literature reviews and our set of predefined criteria, three of the cohorts were identified as promising for further evaluation: the personnel (technicians) of medium/short wave broadcasting stations, amateur radio operators, and workers on dielectric heat sealers. After further analyses, the cohort of workers on dielectric heat sealers seems not to be feasible due to the small number of exposed workers available and to the difficulty of assessing exposure (exposure depends heavily on the respective working process and mixture of exposures, e.g. plastic vapours), although exposure was highest in this occupational setting. The advantage of the cohort of amateur radio operators was the large number of persons it includes, while the advantage of the cohort of personnel working at broadcasting stations was the quality of retrospective exposure assessment. However, in the cohort of amateur radio operators the exposure assessment was limited, and the cohort of technicians was hampered by the small number of persons working in this profession. Conclusion The majority of occupational groups exposed to RF-EMF are not practicable for setting up an occupational cohort study due to the small numbers of exposed subjects or due to exposure levels being only marginally higher than those of the general

Vegetarianism, low meat consumption and the risk of colorectal cancer in a population based cohort study

NARCIS (Netherlands)

Gilsing, A.M.J.; Schouten, L.J.; Goldbohm, R.A.; Dagnelie, P.C.; Brandt, P.A. van den; Weijenberg, M.P.

2015-01-01

To study how a vegetarian or low meat diet influences the risk of colorectal cancer compared to a high meat diet, and to assess the explanatory role of factors associated with these diets. In the Netherlands Cohort Study – Meat Investigation Cohort (NLCS-MIC) (cohort of 10,210 individuals including

The effect of gender medicine education in GP training: a prospective cohort study.

Science.gov (United States)

Dielissen, Patrick; Verdonk, Petra; Waard, Magreet Wieringa-de; Bottema, Ben; Lagro-Janssen, Toine

2014-11-01

The purpose of this study is to compare the change in general practitioner (GP) trainees' gender awareness following a modular gender medicine programme or a mainstream gender medicine programme. In 2007, a prospective study was conducted in three cohorts of in total 207 GP trainees who entered GP training in the Netherlands. The outcome measure was the Nijmegen Gender Awareness in Medicine Scale and a 16-item gender knowledge questionnaire. Two gender medicine teaching methods were compared: a modular approach (n = 75) versus a mainstream approach (n = 72). Both strategies were compared with a control cohort (n = 60). Statistical analysis included analysis of variance and t-tests. The overall response rates for the modular, mainstream and control cohort were 78, 72 and 82 %, respectively. There was a significant difference in change in gender knowledge scores between the modular cohort compared with the mainstream and control cohort (p = 0.049). There were no statistical differences between the cohorts on gender sensitivity and gender role ideology. At entry and end, female GP trainees demonstrated significantly higher gender awareness than male GP trainees. A modular teaching method is not a more favourable educational method to teach gender medicine in GP training. Female GP trainees are more gender aware, but male GP trainees are not unaware of gender-related issues.

The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people.

Science.gov (United States)

Cockayne, Sarah; Adamson, Joy; Corbacho Martin, Belen; Fairhurst, Caroline; Hewitt, Catherine; Hicks, Kate; Hull, Robin; Keenan, Anne Maree; Lamb, Sarah E; Loughrey, Lorraine; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Rodgers, Sara; Vernon, Wesley; Watson, Judith; Torgerson, David

2014-12-17

Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting. This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale-International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists. The trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations. Current Controlled Trials ISRCTN68240461 assigned 01/07/2011. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

Adaptation During a Great Economic Recession: A Cohort Study of Greek and Immigrant Youth.

Science.gov (United States)

Motti-Stefanidi, Frosso; Asendorpf, Jens B

2017-07-01

This study examined how Greek and immigrant youth adapted to school life during the economic recession in Greece. Two cohorts of adolescents (M age  = 12.6 years) were compared, one assessed before the crisis and the other during the crisis (N = 1,057 and 1,052, respectively). Cohort findings were disaggregated by immigrant status, generation, and ethnic group. Crisis-cohort youth experienced more economic problems, displayed worse conduct, higher levels of absenteeism, and lower self-efficacy than precrisis youth. The cohorts did not differ in well-being, school engagement, and academic achievement. Most crisis-cohort groups showed a pervasive increase in conduct problems compared to the precrisis cohort. However, some of these groups also showed an increase in academic achievement. © 2017 The Authors. Child Development © 2017 Society for Research in Child Development, Inc.

Case series and descriptive cohort studies in neurosurgery: the confusion and solution.

Science.gov (United States)

Esene, Ignatius N; Ngu, Julius; El Zoghby, Mohamed; Solaroglu, Ihsan; Sikod, Anna M; Kotb, Ali; Dechambenoit, Gilbert; El Husseiny, Hossam

2014-08-01

Case series (CS) are well-known designs in contemporary use in neurosurgery but are sometimes used in contexts that are incompatible with their true meaning as defined by epidemiologists. This inconsistent, inappropriate and incorrect use, and mislabeling impairs the appropriate indexing and sorting of evidence. Using PubMed, we systematically identified published articles that had "case series" in the "title" in 15 top-ranked neurosurgical journals from January 2008 to December 2012. The abstracts and/or full articles were scanned to identify those with descriptions of the principal method as being "case series" and then classified as "true case series" or "non-case series" by two independent investigators with 100 % inter-rater agreement. Sixty-four articles had the label "case series" in their "titles." Based on the definition of "case series" and our appraisal of the articles using Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, 18 articles (28.13 %) were true case series, while 46 (71.87 %) were mislabeled. Thirty-five articles (54.69 %) mistook retrospective (descriptive) cohorts for CS. CS are descriptive with an outcome-based sampling, while "descriptive cohorts" have an exposure-based sampling of patients, followed over time to assess outcome(s). A comparison group is not a defining feature of a cohort study and distinguishes descriptive from analytic cohorts. A distinction between a case report, case series, and descriptive cohorts is absolutely necessary to enable the appropriate indexing, sorting, and application of evidence. Researchers need better training in methods and terminology, and editors and reviewers should scrutinize more carefully manuscripts claiming to be "case series" studies.

New architectural design of delivery room reduces morbidity in preterm neonates: a prospective cohort study.

Science.gov (United States)

Terrin, Gianluca; Conte, Francesca; Scipione, Antonella; Aleandri, Vincenzo; Di Chiara, Maria; Bacchio, Erica; Messina, Francesco; De Curtis, Mario

2016-03-23

A multidisciplinary committee composed of a panel of experts, including a member of the American Academy of Pediatrics and American Institute of Architects, has suggested that the delivery room (DR) and the neonatal intensive care units (NICU) room should be directly interconnected. We aimed to investigate the impact of the architectural design of the DR and the NICU on neonatal outcome. Two cohorts of preterm neonates born at architectural renovation of the DR realized in accordance with specific standards (Cohort 2: "new concept of DR"). In Cohort 1, neonates were initially cared for a conventional resuscitation area, situated in the DR, and then transferred to the NICU, located on a separate floor of the same hospital. In Cohort 2 neonates were assisted at birth directly in the NICU room, which was directly connected to the DR via a pass-through door. The primary outcome of the study was morbidity, defined by the proportion of neonates with at least one complication of prematurity (i.e., late-onset sepsis, patent ductus arteriosus, intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis). Secondary outcomes were mortality and duration of hospitalization. Statistical analysis was performed using standard methods by SPSS software. We enrolled 106 neonates (56 in Cohort 1 and 50 in Cohort 2). The main clinical and demographic characteristics of the 2 cohorts were similar. Moderate hypothermia (body temperature ≤ 35.9 °C) was more frequent in Cohort 1 (57%) compared with Cohort 2 (24%, p = 0.001). Morbidity was increased in Cohort 1 (73%) compared with Cohort 2 (44%, p = 0.002). No statistically significant differences in mortality and median duration of hospitalization were observed between the 2 cohorts of the study. If realized according to the proposed architectural standards, renovation of DR and NICU may represent an opportunity to reduce morbidity in preterm neonates.

Comparison of carboplatin and doxorubicin-based chemotherapy protocols in 470 dogs after amputation for treatment of appendicular osteosarcoma.

Science.gov (United States)

Selmic, L E; Burton, J H; Thamm, D H; Withrow, S J; Lana, S E

2014-01-01

Many chemotherapy protocols have been reported for treatment of canine appendicular osteosarcoma (OSA), but outcome comparisons in a single population are lacking. To evaluate the effects of protocol and dose intensity (DI) on treatment outcomes for carboplatin and doxorubicin-based chemotherapy protocols. Four hundred and seventy dogs with appendicular OSA. A retrospective cohort study was performed comprising consecutive dogs treated (1997-2012) with amputation followed by 1 of 5 chemotherapy protocols: carboplatin 300 mg/m(2) IV q21d for 4 or 6 cycles (CARBO6), doxorubicin 30 mg/m(2) IV q14d or q21d for 5 cycles, and alternating carboplatin 300 mg/m(2) IV and doxorubicin 30 mg/m(2) IV q21d for 3 cycles. Adverse events (AE) and DI were evaluated. Kaplan-Meier survival curves and Cox proportional hazards regression were used to compare disease-free interval (DFI) and survival time (ST) among protocols. The overall median DFI and ST were 291 days and 284 days, respectively. A lower proportion of dogs prescribed CARBO6 experienced AEs compared to other protocols (48.4% versus 60.8-75.8%; P = .001). DI was not associated with development of metastases or death. After adjustment for baseline characteristics and prognostic factors, none of the protocols provided a significant reduction in risk of development of metastases or death. Although choice of protocol did not result in significant differences in DFI or ST, the CARBO6 protocol resulted in a lower proportion of dogs experiencing AEs, which could be advantageous in maintaining high quality of life during treatment. DI was not a prognostic indicator in this study. Copyright © 2014 by the American College of Veterinary Internal Medicine.

Urban Adolescents Readily Comply with a Complicated Asthma Research Protocol

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Stephanie Lovinsky-Desir

2014-01-01

Full Text Available Purpose Adolescents are often cited as having poor rates of compliance with medical regimens and research protocols. We quantified compliance in a cohort of urban adolescents participating in a complex research protocol in which measures were obtained without direct supervision by research personnel. Methods A total of 54 early adolescents ages 10-13 were asked to wear a vest containing a personal air pollutant exposure monitor for two 24-hour periods and to perform daily peak expiratory flow (PEF for six consecutive days. Compliance with wearing the vest was measured by comparing accelerometer data from a device within the vest to one worn continuously on the child's wrist. Daily PEF data were recorded using an electronic meter. Results A priori definition of compliance was met by 85% of the adolescents by wearing the exposure monitoring vest and 72% by performing PEF. Conclusions These findings suggest that early adolescents can be compliant with complex research protocols that are needed to help bridge gaps in pediatric asthma research.

Statistical principles for prospective study protocols:

DEFF Research Database (Denmark)

Christensen, Robin; Langberg, Henning

2012-01-01

In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research...... to quantify relationships in data. Despite an increased focus on statistical content and complexity of biomedical research these topics remain difficult for most researchers. Statistical methods enable researchers to condense large spreadsheets with data into means, proportions, and difference between means...... the statistical principles for trial protocols in terms of design, analysis, and reporting of findings....

The Danish National Cohort Study (DANCOS)

DEFF Research Database (Denmark)

Helweg-Larsen, Karin; Kjøller, Mette; Davidsen, Michael

2003-01-01

This article gives an overview of a nationally representive public health research database in Denmark, the Danish National Cohort Study (DANCOS). DANCOS combines baseline data from health interview surveys with both pre- and post-baseline data from national health registries with date from a re...... and administrative registries. All respondents and non-respondents were followed through 2002, a total of 3,796 had died and 249 had emigrated. The specific cause of death for 2,485 people was recorded in the Danish Register of Causes of Death, updated through 1998. For 1978-1977, the Danish National Hospital...

Nordic registry-based cohort studies: Possibilities and pitfalls when combining Nordic registry data.

Science.gov (United States)

Maret-Ouda, John; Tao, Wenjing; Wahlin, Karl; Lagergren, Jesper

2017-07-01

All five Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) have nationwide registries with similar data structure and validity, as well as personal identity numbers enabling linkage between registries. These resources provide opportunities for medical research that is based on large registry-based cohort studies with long and complete follow-up. This review describes practical aspects, opportunities and challenges encountered when setting up all-Nordic registry-based cohort studies. Relevant articles describing registries often used for medical research in the Nordic countries were retrieved. Further, our experiences of conducting this type of study, including planning, acquiring permissions, data retrieval and data cleaning and handling, and the possibilities and challenges we have encountered are described. Combining data from the Nordic countries makes it possible to create large and powerful cohorts. The main challenges include obtaining all permissions within each country, usually in the local language, and retrieving the data. These challenges emphasise the importance of having experienced collaborators within each country. Following the acquisition of data, data management requires the understanding of the differences between the variables to be used in the various countries. A concern is the long time required between initiation and completion. Nationwide Nordic registries can be combined into cohorts with high validity and statistical power, but the considerable expertise, workload and time required to complete such cohorts should not be underestimated.

Implementation of a Rapid, Protocol-based TIA Management Pathway

Directory of Open Access Journals (Sweden)

Susann J. Jarhult

2018-02-01

Full Text Available Introduction: Our goal was to assess whether use of a standardized clinical protocol improves efficiency for patients who present to the emergency department (ED with symptoms of transient ischemic attack (TIA. Methods: We performed a structured, retrospective, cohort study at a large, urban, tertiary care academic center. In July 2012 this hospital implemented a standardized protocol for patients with suspected TIA. The protocol selected high-risk patients for admission and low/intermediate-risk patients to an ED observation unit for workup. Recommended workup included brain imaging, vascular imaging, cardiac monitoring, and observation. Patients were included if clinical providers determined the need for workup for TIA. We included consecutive patients presenting during a six-month period prior to protocol implementation, and those presenting between 6–12 months after implementation. Outcomes included ED length of stay (LOS, hospital LOS, use of neuroimaging, and 90-day risk of stroke or TIA. Results: From 01/2012 to 06/2012, 130 patients were evaluated for TIA symptoms in the ED, and from 01/2013 to 06/2013, 150 patients. The final diagnosis was TIA or stroke in 45% before vs. 41% after (p=0.18. Following the intervention, the inpatient admission rate decreased from 62% to 24% (p<0.001, median ED LOS decreased by 1.2 hours (5.7 to 4.9 hours, p=0.027, and median total hospital LOS from 29.4 hours to 23.1 hours (p=0.019. The proportion of patients receiving head computed tomography (CT went from 68% to 58% (p=0.087; brain magnetic resonance (MR imaging from 83% to 88%, (p=0.44 neck CT angiography from 32% to 22% (p=0.039; and neck MR angiography from 61% to 72% (p=0.046. Ninety-day stroke or recurrent TIA among those with final diagnosis of TIA was 3% for both periods. Conclusion: Implementation of a TIA protocol significantly reduced ED LOS and total hospital LOS.

Adherence to, and outcomes of, a galactomannan screening protocol in high-risk hematology patients.

Science.gov (United States)

Harricharan, S; Biederman, K; Bombassaro, A M; Lazo-Langner, A; Elsayed, S; Fulford, A; Delport, J A; Xenocostas, A

2018-04-01

A twice-weekly galactomannan (gm) screening protocol was implemented in high-risk hematology inpatients. Study objectives were to determine adherence to the protocol, use of selected resources, and patient outcomes. This retrospective cohort study compared outcomes of interest before and after implementation of gm screening. Adults undergoing matched related allogeneic hematopoietic stem-cell transplantation or induction chemotherapy for acute leukemia were eligible. Patients could be enrolled more than once and were evaluated as episodes. Adherence to the gm protocol was assessed in post-implementation episodes. Use of broad-spectrum antifungals (bsafs), consultations (infectious diseases, respirology), and diagnostic procedures (computed tomography imaging, bronchoalveolar lavage) were compared between phases, as were the patient outcomes of all-cause mortality and clinical success (alive and not taking a bsaf). Of 182 episodes consecutively screened, 70 per phase were enrolled. Clinical characteristics and duration of assessment were similar for the phases. Full or partial adherence to the protocol was observed in 61 post-implementation episodes (87%), with full adherence in 40 episodes (57%). More episodes in the pre-implementation phase than in the post-implementation phase involved receipt of bsafs, consultations, and diagnostics (27% vs. 7%, p = 0.02; 46% vs. 26%, p = 0.014; and 46% vs. 31%, p = 0.083 respectively). Although mortality was similar in the two phases, clinical success at the final assessment was observed in fewer pre-implementation than post-implementation episodes (79% vs. 98%, p < 0.001). Implementation of a gm screening protocol was feasible and associated with significantly fewer episodes involving receipt of bsafs and consultations, and with significantly more episodes showing clinical success.

Carboplatin Hypersensitivity Reactions in Pediatric Low Grade Glioma Are Protocol Specific and Desensitization Shows Poor Efficacy.

Science.gov (United States)

Dodgshun, Andrew J; Hansford, Jordan R; Cole, Theresa; Choo, Sharon; Sullivan, Michael J

2016-01-01

The use of carboplatin for the treatment of pediatric low grade gliomas (PLGG) is often limited by the development of carboplatin hypersensitivity. Reported rates of carboplatin hypersensitivity reactions vary between 6% and 32% in these patients. Here we report the frequency of carboplatin hypersensitivity reactions depending on the treatment regimen used, and outcomes of carboplatin desensitization. The records of all patients in a single institution who were treated with carboplatin for PLGG were accessed and all patients receiving more than one dose of carboplatin are reported. Thirty four patients with PLGG were treated with carboplatin according to one of the two different regimens. Carboplatin hypersensitivity was documented in 47% of patients, but the frequency differed by treatment protocol. Those patients treated with 4-weekly single agent carboplatin had carboplatin allergy in 8% of cases whereas 68% of those treated with combined carboplatin and vincristine (every three weeks, according to the SIOP 2004 low grade glioma protocol) had carboplatin reactions (OR 23.6, P Desensitization was only successful in two out of 10 patients in whom it was attempted. Hypersensitivity reactions to carboplatin are more common in this cohort than previously reported and rates are protocol-dependent. Desensitization showed limited effectiveness in this cohort. © 2015 Wiley Periodicals, Inc.

Cohort profile: cerebral palsy in the Norwegian and Danish birth cohorts (MOBAND-CP)

Science.gov (United States)

Tollånes, Mette C; Strandberg-Larsen, Katrine; Forthun, Ingeborg; Petersen, Tanja Gram; Moster, Dag; Andersen, Anne-Marie Nybo; Stoltenberg, Camilla; Olsen, Jørn; Wilcox, Allen J

2016-01-01

Purpose The purpose of MOthers and BAbies in Norway and Denmark cerebral palsy (MOBAND-CP) was to study CP aetiology in a prospective design. Participants MOBAND-CP is a cohort of more than 210 000 children, created as a collaboration between the world's two largest pregnancy cohorts—the Norwegian Mother and Child Cohort study (MoBa) and the Danish National Birth Cohort. MOBAND-CP includes maternal interview/questionnaire data collected during pregnancy and follow-up, plus linked information from national health registries. Findings to date Initial harmonisation of data from the 2 cohorts has created 140 variables for children and their mothers. In the MOBAND-CP cohort, 438 children with CP have been identified through record linkage with validated national registries, providing by far the largest such sample with prospectively collected detailed pregnancy data. Several studies investigating various hypotheses regarding CP aetiology are currently on-going. Future plans Additional data can be harmonised as necessary to meet requirements of new projects. Biological specimens collected during pregnancy and at delivery are potentially available for assay, as are results from assays conducted on these specimens for other projects. The study size allows consideration of CP subtypes, which is rare in aetiological studies of CP. In addition, MOBAND-CP provides a platform within the context of a merged birth cohort of exceptional size that could, after appropriate permissions have been sought, be used for cohort and case-cohort studies of other relatively rare health conditions of infants and children. PMID:27591025

Locoregional first recurrence after mastectomy: prospective cohort studies with and without immediate chemotherapy

International Nuclear Information System (INIS)

Haylock, Brian J.; Coppin, Chris M.L.; Jackson, Jeremy; Basco, Vivien E.; Wilson, Kenneth S.

2000-01-01

Purpose: To evaluate prospectively the impact of combination chemotherapy in the combined modality treatment of isolated first locoregional recurrence (LRR) following mastectomy for breast cancer. Methods and Materials: Between 1979 and 1989, 120 chemotherapy-naive women with isolated LRR as first failure after mastectomy were prospectively identified, uniformly staged, and systematically followed. Treatment consisted of excision if feasible, radical locoregional radiotherapy, and a hormonal maneuver (unless estrogen receptor negative). The initial chemotherapy cohort also received 8 cycles of doxorubicin and cyclophosphamide. This was compared to a subsequent control cohort. Results: For all patients, the 10-year actuarial relapse-free survival ± 95% confidence interval was 42.1 ± 9.2%, and overall survival was 56.8 ± 9.1%. No difference was seen in locoregional control between cohorts. At 5 years, distant recurrence-free survival for chemotherapy and control cohort respectively was 75.4 ± 10.8% and 60.7 ±12.5% (p = 0.33) and overall survival was 81.9% ± 9.6 and 74.3% ± 11.2 (p = 0.24). Univariate analysis showed no prognostic importance for any imbalance between cohorts. Cox modeling confirmed that complete resection was strongly associated with fewer LRR (hazard ratio [HR] 0.32, p = 0.001) and also with better overall survival (HR 1.82, p = 0.019). Chemotherapy produced a substantial reduction in risk of death (HR 0.72 CI 0.421-1.235, p = 0.23). Conclusions: In this prospective but nonrandomized study of treatment for first LRR, the risk of death in the later control cohort was 1.39 times the risk in the chemotherapy cohort but failed to reach statistical significance. The results justify further study

The impact of attrition on the representativeness of cohort studies of older people

Directory of Open Access Journals (Sweden)

Brilleman Samuel L

2010-08-01

Full Text Available Abstract Background There are well-established risk factors, such as lower education, for attrition of study participants. Consequently, the representativeness of the cohort in a longitudinal study may deteriorate over time. Death is a common form of attrition in cohort studies of older people. The aim of this paper is to examine the effects of death and other forms of attrition on risk factor prevalence in the study cohort and the target population over time. Methods Differential associations between a risk factor and death and non-death attrition are considered under various hypothetical conditions. Empirical data from the Australian Longitudinal Study on Women's Health (ALSWH for participants born in 1921-26 are used to identify associations which occur in practice, and national cross-sectional data from Australian Censuses and National Health Surveys are used to illustrate the evolution of bias over approximately ten years. Results The hypothetical situations illustrate how death and other attrition can theoretically affect changes in bias over time. Between 1996 and 2008, 28.4% of ALSWH participants died, 16.5% withdrew and 10.4% were lost to follow up. There were differential associations with various risk factors, for example, non-English speaking country of birth was associated with non-death attrition but not death whereas being underweight (body mass index Conclusions Deaths occur in both the target population and study cohort, while other forms of attrition occur only in the study cohort. Therefore non-death attrition may cause greater bias than death in longitudinal studies. However although more than a quarter of the oldest participants in the ALSWH died in the 12 years following recruitment, differences from the national population changed only slightly.

Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya

DEFF Research Database (Denmark)

Bailey, Jeanette; Lelijveld, Natasha; Marron, Bethany

2018-01-01

Background: Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The Combined Protocol for Acute Malnutrition Study (ComPAS) aims to simplify and unify...... the treatment of uncomplicated severe and moderate acute malnutrition (SAM and MAM) for children 6-59 months into one protocol in order to improve the global coverage, quality, continuity of care and cost-effectiveness of acute malnutrition treatment in resource-constrained settings.  Methods/design: This study...... is a multi-site, cluster randomized non-inferiority trial with 12 clusters in Kenya and 12 clusters in South Sudan. Participants are 3600 children aged 6-59 months with uncomplicated acute malnutrition. This study will evaluate the impact of a simplified and combined protocol for the treatment of SAM and MAM...

Influence of motor skills training on children's development evaluated in the Motor skills in PreSchool (MiPS) study-DK: study protocol for a randomized controlled trial, nested in a cohort study.

Science.gov (United States)

Hestbaek, Lise; Andersen, Sarah Thurøe; Skovgaard, Thomas; Olesen, Line Groenholt; Elmose, Mette; Bleses, Dorthe; Andersen, Simon Calmar; Lauridsen, Henrik Hein

2017-08-29

Good motor skills are considered important for children's physical, social, and psychological development, but the relationship is still poorly understood. Preschool age seems to be decisive for the development of motor skills and probably the most promising time-window in relation to preventive strategies based on improved motor skills. This research program has four overall aims: (1) investigation of the effect of a structured program aimed at improving motor skills in 3-6-year-old children on current and future motor skills, health, cognition, and wellbeing; (2) establish reference data on motor skills in 3-6-year-olds; (3) description of early development of musculoskeletal problems; and (4) establishment of a population-based cohort of 3-6-year-olds. Over a four-year period, all preschools in a Danish municipality, Svendborg, will implement a new program aimed at optimizing children's motor skills. By introducing the program into a subset of the preschools at onset and comparing these children to another subset (control) that will not receive the intervention the first three years, it is possible to document a potential effect of the intervention. At the same time, a cohort will be established including all children attending preschools in the municipality with extensive baseline data collection: gross and fine motor skills; movement patterns; musculoskeletal complaints; physical activity; anthropometry; general wellbeing; cognitive abilities; language status; medical history; demographic background; and more. The children are aged 3-6 years at baseline. A total of 1461 children have been invited into the cohort, 368 to the intervention arm and 359 to the control arm. Follow-up time for the trial is 2.5 years. The cohort is planned to run at least until the children leave school at age 15-16 years. Longer follow-up will depend on future funding. If the results of the trial are positive, the intervention can be implemented in other similar settings with

Investing in Prospective Cohorts for Etiologic Study of Occupational Exposures

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Prospective cohorts have played a major role in understanding the role of diet, physical activity, medical conditions, and genes in the development of many diseases, but have not been widely used in the study of occupational exposures. Studies in agriculture are an exception. W...

Assessment of participation bias in cohort studies: systematic review and meta-regression analysis

Directory of Open Access Journals (Sweden)

Sérgio Henrique Almeida da Silva Junior

2015-11-01

Full Text Available Abstract The proportion of non-participation in cohort studies, if associated with both the exposure and the probability of occurrence of the event, can introduce bias in the estimates of interest. The aim of this study is to evaluate the impact of participation and its characteristics in longitudinal studies. A systematic review (MEDLINE, Scopus and Web of Science for articles describing the proportion of participation in the baseline of cohort studies was performed. Among the 2,964 initially identified, 50 were selected. The average proportion of participation was 64.7%. Using a meta-regression model with mixed effects, only age, year of baseline contact and study region (borderline were associated with participation. Considering the decrease in participation in recent years, and the cost of cohort studies, it is essential to gather information to assess the potential for non-participation, before committing resources. Finally, journals should require the presentation of this information in the papers.

Multiple sclerosis risk sharing scheme: two year results of clinical cohort study with historical comparator.

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Boggild, Mike; Palace, Jackie; Barton, Pelham; Ben-Shlomo, Yoav; Bregenzer, Thomas; Dobson, Charles; Gray, Richard

2009-12-02

To generate evidence on the longer term cost effectiveness of disease modifying treatments in patients with relapsing-remitting multiple sclerosis. Prospective cohort study with historical comparator. Specialist multiple sclerosis clinics in 70 centres in the United Kingdom. Patients with relapsing-remitting multiple sclerosis who started treatment from May 2002 to April 2005 under the UK risk sharing scheme. Treatment with interferon beta or glatiramer acetate in accordance with guidelines of the UK Association of British Neurologists. Observed utility weighted progression in disability at two years' follow-up assessed on the expanded disability status scale (EDSS) compared with that expected by applying the progression rates in a comparator dataset, modified for patients receiving treatment by multiplying by the hazard ratio derived separately for each disease modifying treatment from the randomised trials. In the primary per protocol analysis, progression in disability was worse than that predicted and worse than that in the untreated comparator dataset ("deviation score" of 113%; excess in mean disability status scale 0.28). In sensitivity analyses, however, the deviation score varied from -72% (using raw baseline disability status scale scores, rather than applying a "no improvement" algorithm) to 156% (imputing missing data for year two from progression rates for year one). It is too early to reach any conclusion about the cost effectiveness of disease modifying treatments from this first interim analysis. Important methodological issues, including the need for additional comparator datasets, the potential bias from missing data, and the impact of the "no improvement" rule, will need to be addressed and long term follow-up of all patients is essential to secure meaningful results. Future analyses of the cohort are likely to be more informative, not least because they will be less sensitive to short term fluctuations in disability.

Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol.

Science.gov (United States)

Röösli, Martin; Frei, Patrizia; Bolte, John; Neubauer, Georg; Cardis, Elisabeth; Feychting, Maria; Gajsek, Peter; Heinrich, Sabine; Joseph, Wout; Mann, Simon; Martens, Luc; Mohler, Evelyn; Parslow, Roger C; Poulsen, Aslak Harbo; Radon, Katja; Schüz, Joachim; Thuroczy, György; Viel, Jean-François; Vrijheid, Martine

2010-05-20

The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF) is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas.

The Shozu Herpes Zoster (SHEZ) Study: Rationale, Design, and Description of a Prospective Cohort Study

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Takao, Yukiko; Miyazaki, Yoshiyuki; Onishi, Fumitake; Kumihashi, Hideaki; Gomi, Yasuyuki; Ishikawa, Toyokazu; Okuno, Yoshinobu; Mori, Yasuko; Asada, Hideo; Yamanishi, Koichi; Iso, Hiroyasu

2012-01-01

Background The incidence and risk factors for herpes zoster have been studied in cross-sectional and cohort studies, although most such studies have been conducted in Western countries. Evidence from Asian populations is limited, and no cohort study has been conducted in Asia. We are conducting a 3-year prospective cohort study in Shozu County in Kagawa Prefecture, Japan to determine the incidence and predictive and immunologic factors for herpes zoster among Japanese. Methods The participants are followed for 3 years, and a telephone survey is conducted every 4 weeks. The participants were assigned to 1 of 3 studies. Participants in study A gave information on past history of herpes zoster and completed health questionnaires. Study B participants additionally underwent varicella-zoster virus (VZV) skin testing, and study C participants additionally underwent blood testing. If the participants develop herpes zoster, we evaluate clinical symptoms, measure cell-mediated immunity and humoral immunity using venous blood sampling, photograph skin areas with rash, conduct virus identification testing by polymerase chain reaction (PCR) and virus isolation from crust sampling, and evaluate postherpetic pain. Results We recruited 12 522 participants aged 50 years or older in Shozu County from December 2009 through November 2010. The participation rate was 65.7% of the target population. Conclusions The present study is likely to provide valuable data on the incidence and predictive and immunologic factors for herpes zoster in a defined community-based population of Japanese. PMID:22343323

Comparison of four measures in reducing length of stay in burns: An Asian centre's evolved multimodal burns protocol.

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Chong, Si Jack; Kok, Yee Onn; Choke, Abby; Tan, Esther W X; Tan, Kok Chai; Tan, Bien-Keem

2017-09-01

Multidisciplinary burns care is constantly evolving to improve outcomes given the numerous modalities available. We examine the use of Biobrane, micrografting, early renal replacement therapy and a strict target time of surgery within 24h of burns on improving outcomes of length of stay, duration of surgery, mean number of surgeries and number of positive tissue cultures in a tertiary burns centre. A post-implementation prospective cohort of inpatient burns patients from 2014 to 2015 (n=137) was compared against a similar pre-implementation cohort from 2013 to 2014 (n=93) using REDCAP, an electronic database. There was no statistically significant difference for comorbidities, age and percentage (%) TBSA between the new protocol and control groups. The protocol group had shorter mean time to surgery (23.5-38.5h) (pburns protocol improved burns care and validated the collective effort of a multi-disciplinary, multipronged burns management supported by surgeons, anesthetists, renal physicians, emergency physicians, nurses, and allied healthcare providers. Biobrane, single stage onlay micrograft/allograft, early CRRT and surgery within 24h were successfully introduced. These are useful adjuncts in the armamentarium to be considered for any burns centre. Copyright © 2017. Published by Elsevier Ltd.

Security Protocols in a Nutshell

OpenAIRE

Toorani, Mohsen

2016-01-01

Security protocols are building blocks in secure communications. They deploy some security mechanisms to provide certain security services. Security protocols are considered abstract when analyzed, but they can have extra vulnerabilities when implemented. This manuscript provides a holistic study on security protocols. It reviews foundations of security protocols, taxonomy of attacks on security protocols and their implementations, and different methods and models for security analysis of pro...

An investigation into the nutritional status of patients receiving an Enhanced Recovery After Surgery (ERAS) protocol versus standard care following Oesophagectomy.

Science.gov (United States)

Benton, Katie; Thomson, Iain; Isenring, Elisabeth; Mark Smithers, B; Agarwal, Ekta

2018-06-01

Enhanced Recovery After Surgery (ERAS) protocols have been effectively expanded to various surgical specialities including oesophagectomy. Despite nutrition being a key component, actual nutrition outcomes and specific guidelines are lacking. This cohort comparison study aims to compare nutritional status and adherence during implementation of a standardised post-operative nutritional support protocol, as part of ERAS, compared to those who received usual care. Two groups of patients undergoing resection of oesophageal cancer were studied. Group 1 (n = 17) underwent oesophagectomy between Oct 2014 and Nov 2016 during implementation of an ERAS protocol. Patients in group 2 (n = 16) underwent oesophagectomy between Jan 2011 and Dec 2012 prior to the implementation of ERAS. Demographic, nutritional status, dietary intake and adherence data were collected. Ordinal data was analysed using independent t tests, and categorical data using chi-square tests. There was no significant difference in nutrition status, dietary intake or length of stay following implementation of an ERAS protocol. Malnutrition remained prevalent in both groups at day 42 post surgery (n = 10, 83% usual care; and n = 9, 60% ERAS). A significant difference was demonstrated in adherence with earlier initiation of oral free fluids (p nutrition protocol, within an ERAS framework, results in earlier transition to oral intake; however, malnutrition remains prevalent post surgery. Further large-scale studies are warranted to examine individualised decision-making regarding nutrition support within an ERAS protocol.

Adjustment of Cell-Type Composition Minimizes Systematic Bias in Blood DNA Methylation Profiles Derived by DNA Collection Protocols.

Science.gov (United States)

Shiwa, Yuh; Hachiya, Tsuyoshi; Furukawa, Ryohei; Ohmomo, Hideki; Ono, Kanako; Kudo, Hisaaki; Hata, Jun; Hozawa, Atsushi; Iwasaki, Motoki; Matsuda, Koichi; Minegishi, Naoko; Satoh, Mamoru; Tanno, Kozo; Yamaji, Taiki; Wakai, Kenji; Hitomi, Jiro; Kiyohara, Yutaka; Kubo, Michiaki; Tanaka, Hideo; Tsugane, Shoichiro; Yamamoto, Masayuki; Sobue, Kenji; Shimizu, Atsushi

2016-01-01

Differences in DNA collection protocols may be a potential confounder in epigenome-wide association studies (EWAS) using a large number of blood specimens from multiple biobanks and/or cohorts. Here we show that pre-analytical procedures involved in DNA collection can induce systematic bias in the DNA methylation profiles of blood cells that can be adjusted by cell-type composition variables. In Experiment 1, whole blood from 16 volunteers was collected to examine the effect of a 24 h storage period at 4°C on DNA methylation profiles as measured using the Infinium HumanMethylation450 BeadChip array. Our statistical analysis showed that the P-value distribution of more than 450,000 CpG sites was similar to the theoretical distribution (in quantile-quantile plot, λ = 1.03) when comparing two control replicates, which was remarkably deviated from the theoretical distribution (λ = 1.50) when comparing control and storage conditions. We then considered cell-type composition as a possible cause of the observed bias in DNA methylation profiles and found that the bias associated with the cold storage condition was largely decreased (λ adjusted = 1.14) by taking into account a cell-type composition variable. As such, we compared four respective sample collection protocols used in large-scale Japanese biobanks or cohorts as well as two control replicates. Systematic biases in DNA methylation profiles were observed between control and three of four protocols without adjustment of cell-type composition (λ = 1.12-1.45) and no remarkable biases were seen after adjusting for cell-type composition in all four protocols (λ adjusted = 1.00-1.17). These results revealed important implications for comparing DNA methylation profiles between blood specimens from different sources and may lead to discovery of disease-associated DNA methylation markers and the development of DNA methylation profile-based predictive risk models.

Adjustment of Cell-Type Composition Minimizes Systematic Bias in Blood DNA Methylation Profiles Derived by DNA Collection Protocols.

Directory of Open Access Journals (Sweden)

Yuh Shiwa

Full Text Available Differences in DNA collection protocols may be a potential confounder in epigenome-wide association studies (EWAS using a large number of blood specimens from multiple biobanks and/or cohorts. Here we show that pre-analytical procedures involved in DNA collection can induce systematic bias in the DNA methylation profiles of blood cells that can be adjusted by cell-type composition variables. In Experiment 1, whole blood from 16 volunteers was collected to examine the effect of a 24 h storage period at 4°C on DNA methylation profiles as measured using the Infinium HumanMethylation450 BeadChip array. Our statistical analysis showed that the P-value distribution of more than 450,000 CpG sites was similar to the theoretical distribution (in quantile-quantile plot, λ = 1.03 when comparing two control replicates, which was remarkably deviated from the theoretical distribution (λ = 1.50 when comparing control and storage conditions. We then considered cell-type composition as a possible cause of the observed bias in DNA methylation profiles and found that the bias associated with the cold storage condition was largely decreased (λ adjusted = 1.14 by taking into account a cell-type composition variable. As such, we compared four respective sample collection protocols used in large-scale Japanese biobanks or cohorts as well as two control replicates. Systematic biases in DNA methylation profiles were observed between control and three of four protocols without adjustment of cell-type composition (λ = 1.12-1.45 and no remarkable biases were seen after adjusting for cell-type composition in all four protocols (λ adjusted = 1.00-1.17. These results revealed important implications for comparing DNA methylation profiles between blood specimens from different sources and may lead to discovery of disease-associated DNA methylation markers and the development of DNA methylation profile-based predictive risk models.

Opium use and mortality in Golestan Cohort Study: prospective cohort study of 50 000 adults in Iran

Science.gov (United States)

Khademi, Hooman; Pourshams, Akram; Jafari, Elham; Salahi, Rasool; Semnani, Shahryar; Abaie, Behrooz; Islami, Farhad; Nasseri-Moghaddam, Siavosh; Etemadi, Arash; Byrnes, Graham; Abnet, Christian C; Dawsey, Sanford M; Day, Nicholas E; Pharoah, Paul D; Boffetta, Paolo; Kamangar, Farin

2012-01-01

Objectives To investigate the association between opium use and subsequent risk of death. Design Prospective cohort study. Setting The Golestan Cohort Study in north-eastern Iran collected detailed validated data on opium use and other exposures at baseline. Participants were enrolled between January 2004 and June 2008 and were followed to May 2011, with a follow-up success rate of over 99%. Participants 50 045 participants aged 40-75 at baseline. Main outcomes Mortality, all cause and major subcategories. Results 17% (n=8487) of the participants reported opium use, with a mean duration of 12.7 years. During the follow-up period 2145 deaths were reported. The adjusted hazard ratio for all cause mortality associated with ever use of opium was 1.86 (95% confidence interval 1.68 to 2.06). Opium consumption was significantly associated with increased risks of deaths from several causes including circulatory diseases (hazard ratio 1.81) and cancer (1.61). The strongest associations were seen with deaths from asthma, tuberculosis, and chronic obstructive pulmonary disease (11.0, 6.22, and 5.44, respectively). After exclusion of people who self prescribed opium after the onset of major chronic illnesses, the associations remained strong with a dose-response relation. Conclusion Opium users have an increased risk of death from multiple causes compared with non-users. Increased risks were also seen in people who used low amounts of opium for a long period and those who had no major illness before use. PMID:22511302

Design and conduct of an internet-based preconception cohort study in North America: Pregnancy Study Online (PRESTO)

Science.gov (United States)

Wise, Lauren A; Rothman, Kenneth J.; Mikkelsen, Ellen M.; Stanford, Joseph B.; Wesselink, Amelia K.; McKinnon, Craig; Gruschow, Siobhan M.; Horgan, Casie E.; Wiley, Aleta S.; Hahn, Kristen A.; Sørensen, Henrik Toft; Hatch, Elizabeth E.

2015-01-01

Background We launched the Boston University Pregnancy Study Online (PRESTO) to assess the feasibility of carrying out an internet-based preconception cohort study in the U.S. and Canada. Methods We recruited female participants age 21–45 and their male partners through internet advertisements, word of mouth, and flyers. Female participants were randomized with 50% probability to receive a subscription to FertilityFriend.com (FF), a web-based program that collects real-time data on menstrual characteristics. We compared recruitment methods within PRESTO, assessed the cost-efficiency of PRESTO relative to its Danish counterpart (Snart-Gravid), and validated retrospectively-reported date of last menstrual period (LMP) against FF data. Results After 99 weeks of recruitment (2013–2015), 2,421 women enrolled; 1,384 (57%) invited their male partners to participate, of whom 693 (50%) enrolled. Baseline characteristics were balanced across randomization groups. Cohort retention was similar among those randomized vs. not randomized to FF (84% vs. 81%). At study enrollment, 56%, 22%, and 22% couples had been trying to conceive for cost per subject enrolled was $146 (2013 $US), which was similar to our companion Danish study and half that of a traditional cohort study. Among FF users who conceived, >97% reported their LMP on the PRESTO questionnaire within 1 day of the LMP recorded via FF. Conclusions Use of the internet as a method of recruitment and follow-up in a North American preconception cohort study was feasible and cost-effective. PMID:26111445

Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review.

Science.gov (United States)

Gillman, Anna; Winkler, Renata; Taylor, Nicholas F

2017-06-01

The Frazier Free Water Protocol was developed with the aim of providing patients with dysphagia an option to consume thin (i.e. unthickened) water in-between mealtimes. A systematic review was conducted of research published in peer-reviewed journals. An electronic search of the EMBASE, CINAHL and MEDLINE databases was completed up to July 2016. A total of 8 studies were identified for inclusion: 5 randomised controlled trials, 2 cohort studies with matched cases and 1 single group pre-post intervention prospective study. A total of 215 rehabilitation inpatients and 30 acute patients with oropharyngeal dysphagia who required thickened fluids or were to remain 'nil by mouth', as determined by bedside swallow assessment and/or videofluoroscopy/fiberoptic endoscopic evaluation of swallowing, were included. Meta-analyses of the data from the rehabilitation studies revealed (1) low-quality evidence that implementing the protocol did not result in increased odds of having lung complications and (2) low-quality evidence that fluid intake may increase. Patients' perceptions of swallow-related quality of life appeared to improve. This review has found that when the protocol is closely adhered to and patients are carefully selected using strict exclusion criteria, including an evaluation of their cognition and mobility, adult rehabilitation inpatients with dysphagia to thin fluids can be offered the choice of implementing the Free Water Protocol. Further research is required to determine if the Free Water Protocol can be implemented in settings other than inpatient rehabilitation.

Dropout from exercise programs for seniors: A prospective cohort study

NARCIS (Netherlands)

Stiggelbout, M.; Hopman-Rock, M.; Tak, E.; Lechner, L.; Mechelen, W. van

2005-01-01

This study examines dropout incidence, moment of dropout, and switching behavior in organized exercise programs for seniors in the Netherlands, as determined in a prospective cohort study (with baseline measurements at the start of the exercise program and follow-up after 6 months; N = 1,725,

Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance.

Science.gov (United States)

Layton, Deborah; Shakir, Saad A W

2015-02-01

The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for 'real-world' post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pattern of drug utilization, but also satisfy key regulatory requirements for marketing authorization holder risk management planning and execution needs. There is a need for data capture across the primary care and secondary care interface, or for exploring use of new medicines in secondary care to support conducting PASS. To fulfil this need, event monitoring has evolved. The Specialist Cohort Event Monitoring (SCEM) study is a new application that enables a cohort of patients prescribed a medicine in the hospital and secondary care settings to be monitored. The method also permits the inclusion of a comparator cohort of patients receiving standard care, or another counterfactual comparator group, to be monitored concurrently, depending on the study question. The approach has been developed in parallel with the new legislative requirement for pharmaceutical companies to undertake a risk management plan as part of post-authorization safety monitoring. SCEM studies recognize that the study population comprises those patients who may have treatment initiated under the care of specialist health care professionals and who are more complex in terms of underlying disease, co-morbidities and concomitant medications than the general disease population treated in primary care. The aims of this paper are to discuss the SCEM new-user study design, rationale and features that aim to address possible bias (such as selection bias) and current applications.

The Siblings With Ischemic Stroke Study (SWISS Protocol

Directory of Open Access Journals (Sweden)

Hardy John

2002-02-01

Full Text Available Abstract Background Family history and twins studies suggest an inherited component to ischemic stroke risk. Candidate gene association studies have been performed but have limited capacity to identify novel risk factor genes. The Siblings With Ischemic Stroke Study (SWISS aims to conduct a genome-wide scan in sibling pairs concordant or discordant for ischemic stroke to identify novel genetic risk factors through linkage analysis. Methods Screening at multiple clinical centers identifies patients (probands with radiographically confirmed ischemic stroke and a family history of at least 1 living full sibling with stroke. After giving informed consent, without violating privacy among other family members, the proband invites siblings concordant and discordant for stroke to participate. Siblings then contact the study coordinating center. The diagnosis of ischemic stroke in potentially concordant siblings is confirmed by systematic centralized review of medical records. The stroke-free status of potentially discordant siblings is confirmed by validated structured telephone interview. Blood samples for DNA analysis are taken from concordant sibling pairs and, if applicable, from 1 discordant sibling. Epstein-Barr virus-transformed lymphoblastoid cell lines are created, and a scan of the human genome is planned. Discussion Conducting adequately powered genomics studies of stroke in humans is challenging because of the heterogeneity of the stroke phenotype and the difficulty of obtaining DNA samples from clinically well-characterized members of a cohort of stroke pedigrees. The multicentered design of this study is intended to efficiently assemble a cohort of ischemic stroke pedigrees without invoking community consent or using cold-calling of pedigree members.

Prevalence and predictors of alcohol use during pregnancy: findings from international multicentre cohort studies.

Science.gov (United States)

O'Keeffe, Linda M; Kearney, Patricia M; McCarthy, Fergus P; Khashan, Ali S; Greene, Richard A; North, Robyn A; Poston, Lucilla; McCowan, Lesley M E; Baker, Philip N; Dekker, Gus A; Walker, James J; Taylor, Rennae; Kenny, Louise C

2015-07-06

To compare the prevalence and predictors of alcohol use in multiple cohorts. Cross-cohort comparison of retrospective and prospective studies. Population-based studies in Ireland, the UK, Australia and New Zealand. 17,244 women of predominantly Caucasian origin from two Irish retrospective studies (Growing up in Ireland (GUI) and Pregnancy Risk Assessment Monitoring System Ireland (PRAMS Ireland)), and one multicentre prospective international cohort, Screening for Pregnancy Endpoints (SCOPE) study. Prevalence of alcohol use pre-pregnancy and during pregnancy across cohorts. Sociodemographic factors associated with alcohol consumption in each cohort. Alcohol consumption during pregnancy in Ireland ranged from 20% in GUI to 80% in SCOPE, and from 40% to 80% in Australia, New Zealand and the UK. Levels of exposure also varied substantially among drinkers in each cohort ranging from 70% consuming more than 1-2 units/week in the first trimester in SCOPE Ireland, to 46% and 15% in the retrospective studies. Smoking during pregnancy was the most consistent predictor of gestational alcohol use in all three cohorts, and smokers were 17% more likely to drink during pregnancy in SCOPE, relative risk (RR)=1.17 (95% CI 1.12 to 1.22), 50% more likely to drink during pregnancy in GUI, RR=1.50 (95% CI 1.36 to 1.65), and 42% more likely to drink in PRAMS, RR=1.42 (95% CI 1.18 to 1.70). Our data suggest that alcohol use during pregnancy is prevalent and socially pervasive in the UK, Ireland, New Zealand and Australia. New policy and interventions are required to reduce alcohol prevalence both prior to and during pregnancy. Further research on biological markers and conventions for measuring alcohol use in pregnancy is required to improve the validity and reliability of prevalence estimates. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Risk of thyroid cancer in patients with thyroiditis: a population-based cohort study.

Science.gov (United States)

Liu, Chien-Liang; Cheng, Shih-Ping; Lin, Hui-Wen; Lai, Yuen-Liang

2014-03-01

The causative relationship between autoimmune thyroiditis and thyroid cancer remains a controversial issue. The aim of this population-based study was to investigate the risk of thyroid cancer in patients with thyroiditis. From the Longitudinal Health Insurance Database 2005 (LHID2005) of Taiwan, we identified adult patients newly diagnosed with thyroiditis between 2004 and 2009 (n = 1,654). The comparison cohort (n = 8,270) included five randomly selected age- and sex-matched controls for each patient in the study cohort. All patients were followed up from the date of cohort entry until they developed thyroid cancer or to the end of 2010. Multivariate Cox regression was used to assess the risk of developing thyroid cancer. A total of 1,000 bootstrap replicates were created for internal validation. A total of 35 patients developed thyroid cancer during the study period, of whom 24 were from the thyroiditis cohort and 11 were from the comparison cohort (incidence 353 and 22 per 100,000 person-years, respectively). After adjusting for potential confounding factors, the hazard ratio (HR) for thyroid cancer in patients with thyroiditis was 13.24 (95 % CI 6.40-27.39). Excluding cancers occurring within 1 year of follow-up, the HR remained significantly increased (6.64; 95 % CI 2.35-18.75). Hypothyroidism was not an independent factor associated with the occurrence of thyroid cancer. We found an increased risk for the development of thyroid cancer after a diagnosis of thyroiditis, independent of comorbidities.

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

Science.gov (United States)

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-05-15

To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

Fish intake during pregnancy, fetal growth, and gestational length in 19 European birth cohort studies.

Science.gov (United States)

Leventakou, Vasiliki; Roumeliotaki, Theano; Martinez, David; Barros, Henrique; Brantsaeter, Anne-Lise; Casas, Maribel; Charles, Marie-Aline; Cordier, Sylvaine; Eggesbø, Merete; van Eijsden, Manon; Forastiere, Francesco; Gehring, Ulrike; Govarts, Eva; Halldórsson, Thorhallur I; Hanke, Wojciech; Haugen, Margaretha; Heppe, Denise H M; Heude, Barbara; Inskip, Hazel M; Jaddoe, Vincent W V; Jansen, Maria; Kelleher, Cecily; Meltzer, Helle Margrete; Merletti, Franco; Moltó-Puigmartí, Carolina; Mommers, Monique; Murcia, Mario; Oliveira, Andreia; Olsen, Sjúrður F; Pele, Fabienne; Polanska, Kinga; Porta, Daniela; Richiardi, Lorenzo; Robinson, Siân M; Stigum, Hein; Strøm, Marin; Sunyer, Jordi; Thijs, Carel; Viljoen, Karien; Vrijkotte, Tanja G M; Wijga, Alet H; Kogevinas, Manolis; Vrijheid, Martine; Chatzi, Leda

2014-03-01

Fish is a rich source of essential nutrients for fetal development, but in contrast, it is also a well-known route of exposure to environmental pollutants. We assessed whether fish intake during pregnancy is associated with fetal growth and the length of gestation in a panel of European birth cohort studies. The study sample of 151,880 mother-child pairs was derived from 19 population-based European birth cohort studies. Individual data from cohorts were pooled and harmonized. Adjusted cohort-specific effect estimates were combined by using a random- and fixed-effects meta-analysis. Women who ate fish >1 time/wk during pregnancy had lower risk of preterm birth than did women who rarely ate fish (≤ 1 time/wk); the adjusted RR of fish intake >1 but 1 but <3 times/wk and 15.2 g (95% CI: 8.9, 21.5 g) for ≥ 3 times/wk independent of gestational age. The association was greater in smokers and in overweight or obese women. Findings were consistent across cohorts. This large, international study indicates that moderate fish intake during pregnancy is associated with lower risk of preterm birth and a small but significant increase in birth weight.

pilot studies to test the feasibility of a birth cohort study investigating ...

African Journals Online (AJOL)

1991-04-20

Apr 20, 1991 ... of a birth cohort study investigating the effects of urbanisation in South Africa. S. FONN, M. DE ... is to determine the biological, environmental, economic and psychological factors that are associated with ... the South African Medical Research Council, Parowvallei,. CP. S. FONN, M.B. B.CH., D.O.H., D.EPL, ...

Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project-study protocol for a nationwide prospective cohort study.

Science.gov (United States)

Kortram, Kirsten; Spoon, Emerentia Q W; Ismail, Sohal Y; d'Ancona, Frank C H; Christiaans, Maarten H L; van Heurn, L W Ernest; Hofker, H Sijbrand; Hoksbergen, Arjan W J; Homan van der Heide, Jaap J; Idu, Mirza M; Looman, Caspar W N; Nurmohamed, S Azam; Ringers, Jan; Toorop, Raechel J; van de Wetering, Jacqueline; Ijzermans, Jan N M; Dor, Frank J M F

2016-04-01

Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. Outcome will be published in a

Impact of a Newly Implemented Burn Protocol on Surgically Managed Partial Thickness Burns at a Specialized Burns Center in Singapore.

Science.gov (United States)

Tay, Khwee-Soon Vincent; Chong, Si-Jack; Tan, Bien-Keem

2016-03-01

This study evaluated the impact of a newly implemented protocol for superficial to mid-dermal partial thickness burns which involves early surgery and rapid coverage with biosynthetic dressing in a specialized national burns center in Singapore. Consecutive patients with 5% or greater total body surface area (TBSA) superficial to mid-dermal partial thickness burns injury admitted to the Burns Centre at the Singapore General Hospital between August and December 2014 for surgery within 48 hours of injury were prospectively recruited into the study to form the protocol group. Comparable historical cases from the year 2013 retrieved from the burns center audit database were used to form the historical control group. Demographics (age, sex), type and depth of burns, %TBSA burnt, number of operative sessions, and length of stay were recorded for each patient of both cohorts. Thirty-nine burns patients managed under the new protocol were compared with historical control (n = 39) comparable in age and extensiveness of burns. A significantly shorter length of stay (P burns was observed in the new protocol group (0.74 day/%TBSA) versus historical control (1.55 day/%TBSA). Fewer operative sessions were needed under the new protocol for burns 10% or greater TBSA burns (P protocol for surgically managed burns patients which involves early surgery and appropriate use of biosynthetic dressing on superficial to mid-dermal partial thickness burns. Clinically, shorter lengths of stay, fewer operative sessions, and decreased need for skin grafting of burns patient were observed.

Reduction in Wound Complications After Total Ankle Arthroplasty Using a Compression Wrap Protocol.

Science.gov (United States)

Schipper, Oliver N; Hsu, Andrew R; Haddad, Steven L

2015-12-01

The purpose of this study was to evaluate the clinical differences in wound complications after total ankle arthroplasty (TAA) between a cohort of patients that received a compression wrap protocol and a historical control group treated with cast immobilization. Patient charts and postoperative wound pictures were reviewed for 42 patients who underwent a compression wrap protocol and 50 patients who underwent circumferential casting after primary TAA from 2008 to 2013. A blinded reviewer graded each wound using a novel postoperative wound classification system, and recorded whether the wound was completely healed by or after 3 months. A second blinded review was performed to determine intraobserver reliability. Mean patient age was 55 years (range, 24-80) and all patients had at least 6-month follow-up. There were significantly more total wound complications (P = .02) and mild wound complications (P = .02) in the casted group compared to the compression wrap group. There were no significant differences in the number of moderate and severe complications between each group. A significantly higher proportion of TAA incisions took longer than 3 months to heal in the casted group (P = .02). Based on our clinical experience with postoperative wound care after TAA, use of a compression wrap protocol was safe and effective at reducing wound-related complications, and well tolerated by patients. Further prospective, randomized clinical trials are warranted to evaluate the utility and cost-effectiveness of a compression wrap protocol after TAA. © The Author(s) 2015.

Results from a Nationwide Cohort Temporary Utilization Authorization (ATU) survey of patients in france treated with Pheburane(®) (Sodium Phenylbutyrate) taste-masked granules.

Science.gov (United States)

Kibleur, Yves; Dobbelaere, Dries; Barth, Magalie; Brassier, Anaïs; Guffon, Nathalie

2014-10-01

The aim of this study was to describe a nationwide system for pre-marketing follow-up (cohort temporary utilization authorization [ATU] protocol; i.e., 'therapeutic utilization') of a new taste-masked formulation of sodium phenylbutyrate (NaPB) granules (Pheburane(®)) in France and to analyze safety and efficacy in this treated cohort of patients with urea cycle disease (UCD). In October 2012, a cohort ATU was established in France to monitor the use of Pheburane(®) on a named-patient basis. All treated UCD patients were included in a follow-up protocol developed by the Laboratory (Lucane Pharma) and the French Medicines Agency (ANSM), which recorded demographics, dosing characteristics of NaPB, concomitant medications, adverse events, and clinical outcome during the period of treatment. Following the granting of the Marketing Authorization in Europe, the cohort ATU was terminated approximately 1 year after its initiation, as the product was launched on the French market. The ease of administration and acceptability were much better with the new taste-masked formulation than with the previous treatment. No episodes of metabolic decompensation were observed over a treatment period ranging from 3 to 11 months with Pheburane(®) and the range of ammonia and glutamine plasma levels improved and remained within the normal range. In all, no adverse events were reported with Pheburane(®) treatment. The recently developed taste-masked formulation of NaPB granules improved the quality of life for UCD patients. This may translate into improved compliance, efficacy, and safety, which may be demonstrated either in further studies or in the post-marketing use of the product.

Does the age of acute care physicians impact their (1) crisis management performance and (2) learning after simulation-based education? A protocol for a multicentre prospective cohort study in Toronto and Ottawa, Canada.

Science.gov (United States)

Alam, Fahad; LeBlanc, Vicki R; Baxter, Alan; Tarshis, Jordan; Piquette, Dominique; Gu, Yuqi; Filipkowska, Caroline; Krywenky, Ashley; Kester-Greene, Nicole; Cardinal, Pierre; Au, Shelly; Lam, Sandy; Boet, Sylvain; Clinical Trials Group, Perioperative Anesthesia

2018-04-21

The proportion of older acute care physicians (ACPs) has been steadily increasing. Ageing is associated with physiological changes and prospective research investigating how such age-related physiological changes affect clinical performance, including crisis resource management (CRM) skills, is lacking. There is a gap in the literature on whether physician's age influences baseline CRM performance and also learning from simulation. We aim to investigate whether ageing is associated with baseline CRM skills of ACPs (emergency, critical care and anaesthesia) using simulated crisis scenarios and to assess whether ageing influences learning from simulation-based education. This is a prospective cohort multicentre study recruiting ACPs from the Universities of Toronto and Ottawa, Canada. Each participant will manage an advanced cardiovascular life support crisis-simulated scenario (pretest) and then be debriefed on their CRM skills. They will then manage another simulated crisis scenario (immediate post-test). Three months after, participants will return to manage a third simulated crisis scenario (retention post-test). The relationship between biological age and chronological age will be assessed by measuring the participants CRM skills and their ability to learn from high-fidelity simulation. This protocol was approved by Sunnybrook Health Sciences Centre Research Ethics Board (REB Number 140-2015) and the Ottawa Health Science Network Research Ethics Board (#20150173-01H). The results will be disseminated in a peer-reviewed journal and at scientific meetings. NCT02683447; 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.

Birth cohorts in Asia: The importance, advantages, and disadvantages of different-sized cohorts.

Science.gov (United States)

Kishi, Reiko; Araki, Atsuko; Minatoya, Machiko; Itoh, Sachiko; Goudarzi, Houman; Miyashita, Chihiro

2018-02-15

Asia contains half of the world's children, and the countries of Asia are the most rapidly industrializing nations on the globe. Environmental threats to the health of children in Asia are myriad. Several birth cohorts were started in Asia in early 2000, and currently more than 30 cohorts in 13 countries have been established for study. Cohorts can contain from approximately 100-200 to 20,000-30,000 participants. Furthermore, national cohorts targeting over 100,000 participants have been launched in Japan and Korea. The aim of this manuscript is to discuss the importance of Asian cohorts, and the advantages and disadvantages of different-sized cohorts. As for case, one small-sized (n=514) cohort indicate that even relatively low level exposure to dioxin in utero could alter birth size, neurodevelopment, and immune and hormonal functions. Several Asian cohorts focus prenatal exposure to perfluoroalkyo substances and reported associations with birth size, thyroid hormone levels, allergies and neurodevelopment. Inconsistent findings may possibly be explained by the differences in exposure levels and target chemicals, and by possible statistical errors. In a smaller cohort, novel hypotheses or preliminary examinations are more easily verifiable. In larger cohorts, the etiology of rare diseases, such as birth defects, can be analyzed; however, they require a large cost and significant human resources. Therefore, conducting studies in only one large cohort may not always be the best strategy. International collaborations, such as the Birth Cohort Consortium of Asia, would cover the inherent limitation of sample size in addition to heterogeneity of exposure, ethnicity, and socioeconomic conditions. Copyright © 2017 Elsevier B.V. All rights reserved.

Validity of partial protocols to assess the prevalence of periodontal outcomes and associated sociodemographic and behavior factors in adolescents and young adults.

Science.gov (United States)

Peres, Marco A; Peres, Karen G; Cascaes, Andreia M; Correa, Marcos B; Demarco, Flávio F; Hallal, Pedro C; Horta, Bernardo L; Gigante, Denise P; Menezes, Ana B

2012-03-01

Most studies comparing prevalence of periodontal disease and risk factors by using partial protocols were performed in adult populations, with several studies being conducted in clinical settings. The aim of this study is to assess the accuracy of partial protocols in estimating the prevalence of periodontal outcomes in adolescents and young adults from two population-based birth cohorts from Pelotas, Brazil, and to assess differences in the estimation and strength of the effect measures when partial protocols are adopted compared to full-mouth examination. Gingival bleeding at probing among adolescents (n = 339) and young adults (n = 720) and dental calculus and periodontal probing depth among young adults were assessed using full-mouth examinations and four partial protocols: Ramfjord teeth (RT), community periodontal index (CPI), and two random diagonal quadrants (1 and 3, 2 and 4). Socioeconomic, demographic, and periodontal health-related variables were also collected. Sensitivity, absolute and relative bias, and inflation factors were calculated. Prevalence ratio for each periodontal outcome for the risk factors was estimated. Two diagonal quadrants showed better accuracy; RT had the worst, whereas CPI presented an intermediate pattern when compared to full-mouth examination. For bleeding assessment in adolescence, RT and CPI underestimated by 18.4% and 16.2%, respectively, the true outcome prevalence, whereas among young adults, all partial protocols underestimated the prevalence. All partial protocols presented similar magnitude of association measures for all investigated periodontal potential risk factors. Two diagonal quadrants protocol may be effective in identifying the risk factors for the most relevant periodontal outcomes in adolescence and in young adulthood.

Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol

Directory of Open Access Journals (Sweden)

Radon Katja

2010-05-01

Full Text Available Abstract Background The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. Methods The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. Results We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Conclusion Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas.

Hyperthyroidism and female urinary incontinence: a population-based cohort study.

Science.gov (United States)

Chung, Shiu-Dong; Chen, Yi-Kuang; Chen, Yi-Hua; Lin, Herng-Ching

2011-11-01

The imbalanced autonomic nervous system present in hyperthyroidism may cause lower urinary tract symptoms. Urinary incontinence (UI) is the most bothersome lower urinary tract symptom; however, in the literature, reports regarding urinary dysfunction and/or incontinence among hyperthyroid patients are scarce. This population-based cohort study aimed to examine the relationship between hyperthyroidism in women and the risk of developing UI in Taiwan. This study used data from the Longitudinal Health Insurance Database. For this study, 10,817 female patients diagnosed with hyperthyroidism from 2001 to 2005 were recruited together with a comparison cohort of 54,085 matched enrollees who did not have a history of hyperthyroidism. All patients were tracked for a 3-year period from their index date to identify those who had a subsequent UI. The stratified Cox proportional hazards models were used to compute the risk of UI between study and comparison cohorts. During the follow-up period, of 64,169 patients, 173 (1·60%) from the hyperthyroidism group and 560 (1·04%) from the comparison group, had a diagnosis of UI. The regression analysis showed that, after adjusting for monthly income, geographic region, urbanization level of the community in which the patient resided, obesity and hysterectomy, patients with hyperthyroidism were more likely to have UI during the 3-year follow-up period than the comparison patients (hazard ratio = 1·54; 95% CI = 1·30-1·83; P hyperthyroidism at the 3-year follow-up. © 2011 Blackwell Publishing Ltd.

Efficient secure two-party protocols

CERN Document Server

Hazay, Carmit

2010-01-01

The authors present a comprehensive study of efficient protocols and techniques for secure two-party computation -- both general constructions that can be used to securely compute any functionality, and protocols for specific problems of interest. The book focuses on techniques for constructing efficient protocols and proving them secure. In addition, the authors study different definitional paradigms and compare the efficiency of protocols achieved under these different definitions.The book opens with a general introduction to secure computation and then presents definitions of security for a

Constant round group key agreement protocols: A comparative study

NARCIS (Netherlands)

Makri, E.; Konstantinou, Elisavet

2011-01-01

The scope of this paper is to review and evaluate all constant round Group Key Agreement (GKA) protocols proposed so far in the literature. We have gathered all GKA protocols that require 1,2,3,4 and 5 rounds and examined their efficiency. In particular, we calculated each protocol’s computation and

Understanding the role of contrasting urban contexts in healthy aging: an international cohort study using wearable sensor devices (the CURHA study protocol).

Science.gov (United States)

Kestens, Yan; Chaix, Basile; Gerber, Philippe; Desprès, Michel; Gauvin, Lise; Klein, Olivier; Klein, Sylvain; Köppen, Bernhard; Lord, Sébastien; Naud, Alexandre; Payette, Hélène; Richard, Lucie; Rondier, Pierre; Shareck, Martine; Sueur, Cédric; Thierry, Benoit; Vallée, Julie; Wasfi, Rania

2016-05-05

Given the challenges of aging populations, calls have been issued for more sustainable urban re-development and implementation of local solutions to address global environmental and healthy aging issues. However, few studies have considered older adults' daily mobility to better understand how local built and social environments may contribute to healthy aging. Meanwhile, wearable sensors and interactive map-based applications offer novel means for gathering information on people's mobility, levels of physical activity, or social network structure. Combining such data with classical questionnaires on well-being, physical activity, perceived environments and qualitative assessment of experience of places opens new opportunities to assess the complex interplay between individuals and environments. In line with current gaps and novel analytical capabilities, this research proposes an international research agenda to collect and analyse detailed data on daily mobility, social networks and health outcomes among older adults using interactive web-based questionnaires and wearable sensors. Our study resorts to a battery of innovative data collection methods including use of a novel multisensor device for collection of location and physical activity, interactive map-based questionnaires on regular destinations and social networks, and qualitative assessment of experience of places. This rich data will allow advanced quantitative and qualitative analyses in the aim to disentangle the complex people-environment interactions linking urban local contexts to healthy aging, with a focus on active living, social networks and participation, and well-being. This project will generate evidence about what characteristics of urban environments relate to active mobility, social participation, and well-being, three important dimensions of healthy aging. It also sets the basis for an international research agenda on built environment and healthy aging based on a shared and comprehensive

Developing an Anti-Xa-Based Anticoagulation Protocol for Patients with Percutaneous Ventricular Assist Devices.

Science.gov (United States)

Sieg, Adam; Mardis, B Andrew; Mardis, Caitlin R; Huber, Michelle R; New, James P; Meadows, Holly B; Cook, Jennifer L; Toole, J Matthew; Uber, Walter E

2015-01-01

Because of the complexities associated with anticoagulation in temporary percutaneous ventricular assist device (pVAD) recipients, a lack of standardization exists in their management. This retrospective analysis evaluates current anticoagulation practices at a single center with the aim of identifying an optimal anticoagulation strategy and protocol. Patients were divided into two cohorts based on pVAD implanted (CentriMag (Thoratec; Pleasanton, CA) / TandemHeart (CardiacAssist; Pittsburgh, PA) or Impella (Abiomed, Danvers, MA)), with each group individually analyzed for bleeding and thrombotic complications. Patients in the CentriMag/TandemHeart cohort were subdivided based on the anticoagulation monitoring strategy (activated partial thromboplastin time (aPTT) or antifactor Xa unfractionated heparin (anti-Xa) values). In the CentriMag/TandemHeart cohort, there were five patients with anticoagulation titrated based on anti-Xa values; one patient developed a device thrombosis and a major bleed, whereas another patient experienced major bleeding. Eight patients received an Impella pVAD. Seven total major bleeds in three patients and no thrombotic events were detected. Based on distinct differences between the devices, anti-Xa values, and outcomes, two protocols were created to guide anticoagulation adjustments. However, anticoagulation in patients who require pVAD support is complex with constantly evolving anticoagulation goals. The ideal level of anticoagulation should be individually determined using several coagulation laboratory parameters in concert with hemodynamic changes in the patient's clinical status, the device, and the device cannulation.

Association between diverticular disease and Ehlers-Danlos syndrome: a 13-year nationwide population-based cohort study.

Science.gov (United States)

Leganger, Julie; Søborg, Marie-Louise Kulas; Mortensen, Laura Quitzau; Gregersen, Rasmus; Rosenberg, Jacob; Burcharth, Jakob

2016-12-01

The aim of this study was to examine occurrence and consequences of diverticular disease in patients with Ehlers-Danlos syndrome (EDS) compared with a matched cohort. This nationwide population-based cohort study was conducted using data from medical registers in Denmark from year 2000 to 2012. The EDS cohort was identified using the specific diagnosis code for EDS and was randomly matched in a ratio of 1:20 by sex and date of birth (±1 year) with persons from the Danish general population. The occurrence of diverticular disease and the clinical characteristics of the initial diverticular event were compared between the EDS cohort and the comparison cohort. The first admission with diverticulitis was identified, and severity of diverticulitis, treatment, colonoscopies, length of stay, and 30-day mortality were investigated. We identified 1336 patients with EDS and matched a control cohort of 26,720 patients. The occurrence of diverticular disease in the EDS cohort (2.0 %) and the comparison cohort (0.68 %) differed significantly (p < 0.001). At the first diverticular event, the majority of patients were women (85 % for EDS and 87 % for the comparison cohort). Mean age, localization, and type of contact did not differ significantly. Admission with diverticulitis (1.0 % for EDS and 0.34 % for the comparison cohort) differed significantly (p < 0.001). We found no significant difference in severity of diverticulitis, treatment, length of stay, or 30-day mortality between the EDS and the comparison cohorts. Patients with EDS had an increased occurrence of overall diverticular events and admissions with diverticulitis compared with the general population.

Cohort-Sequential Study of Conflict Inhibition during Middle Childhood

Science.gov (United States)

Rollins, Leslie; Riggins, Tracy

2017-01-01

This longitudinal study examined developmental changes in conflict inhibition and error correction in three cohorts of children (5, 7, and 9 years of age). At each point of assessment, children completed three levels of Luria's tapping task (1980), which requires the inhibition of a dominant response and maintenance of task rules in working…

Workplace bullying, sleep problems and leisure-time physical activity: a prospective cohort study

DEFF Research Database (Denmark)

Hansen, Åse Marie; Gullander, Maria; Hogh, Annie

2015-01-01

and Harassment (WBH) cohort (N=3278) or the Psychosocial Risk Factors for Stress and Mental Disease (PRISME) cohort (N=4455). We measured workplace bullying using one question that was preceded by a definition of bullying. We used the Karolinska sleep questionnaire to assess sleep problems. The number of hours......OBJECTIVES: Workplace bullying is a potent stressor that may increase sleep problems. Since physical fitness improves resilience to stress, it seems plausible that recreational physical activities may moderate the association between bullying and sleep. The study aimed to examine prospectively...... whether (i) bullying increases the risk of sleep problems, and (ii) the association between bullying and sleep problems is moderated by leisure-time physical activity (LTPA). METHODS: The study sample comprised a cohort of public and private sector employees, who were enrolled into the Work Bullying...

Data linkage in an established longitudinal cohort: the Western Australian Pregnancy Cohort (Raine) Study.

Science.gov (United States)

Mountain, Jenny A; Nyaradi, Anett; Oddy, Wendy H; Glauert, Rebecca A; de Klerk, Nick H; Straker, Leon M; Stanley, Fiona J

2016-07-15

The Western Australian Data Linkage System is one of a few comprehensive, population-based data linkage systems worldwide, creating links between information from different sources relating to the same individual, family, place or event, while maintaining privacy. The Raine Study is an established cohort study with more than 2000 currently active participants. Individual consent was obtained from participants for information in publicly held databases to be linked to their study data. A waiver of consent was granted where it was impracticable to obtain consent. Approvals to link the datasets were obtained from relevant ethics committees and data custodians. The Raine Study dataset was subsequently linked to academic testing data collected by the Western Australian Department of Education. Examination of diet and academic performance showed that children who were predominantly breastfed for at least 6 months scored higher academically at age 10 than children who were breastfed for less than 6 months. A further study found that better diet quality at ages 1, 2 and 3 years was associated with higher academic scores at ages 10 and 12 years. Examination of nutritional intake at 14 years of age found that a better dietary pattern was associated with higher academic performance. The detailed longitudinal data collected in the Raine Study allowed for adjustment for multiple covariates and confounders. Data linkage reduces the burden on cohort participants by providing additional information without the need to contact participants. It can give information on participants who have been lost to follow-up; provide or complement missing data; give the opportunity for validation studies comparing recall of participants with administrative records; increase the population sample of studies by adding control participants from the general population; and allow for the adjustment of multiple covariates and confounders. The Raine Study dataset is extensive and detailed, and can be

Comparative Study on Various Authentication Protocols in Wireless Sensor Networks.

Science.gov (United States)

Rajeswari, S Raja; Seenivasagam, V

2016-01-01

Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated.

Comparative Study on Various Authentication Protocols in Wireless Sensor Networks

Science.gov (United States)

Rajeswari, S. Raja; Seenivasagam, V.

2016-01-01

Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated. PMID:26881272

The epidemiology of mild cognitive impairment (MCI and Alzheimer’s disease (AD in community-living seniors: protocol of the MemoVie cohort study, Luxembourg

Directory of Open Access Journals (Sweden)

Perquin Magali

2012-07-01

Full Text Available Abstract Background Cognitive impairment and Alzheimer’s disease (AD are increasingly considered a major public health problem. The MemoVie cohort study aims to investigate the living conditions or risk factors under which the normal cognitive capacities of the senior population in Luxembourg (≥ 65 year-old evolve (1 to mild cognitive impairment (MCI – transitory non-clinical stage – and (2 to AD. Identifying MCI and AD predictors undeniably constitutes a challenge in public health in that it would allow interventions which could protect or delay the occurrence of cognitive disorders in elderly people. In addition, the MemoVie study sets out to generate hitherto unavailable data, and a comprehensive view of the elderly population in the country. Methods/design The study has been designed with a view to highlighting the prevalence in Luxembourg of MCI and AD in the first step of the survey, conducted among participants selected from a random sample of the general population. A prospective cohort is consequently set up in the second step, and appropriate follow-up of the non-demented participants allows improving the knowledge of the preclinical stage of MCI. Case-control designs are used for cross-sectional or retrospective comparisons between outcomes and biological or clinical factors. To ensure maximal reliability of the information collected, we decided to opt for structured face to face interviews. Besides health status, medical and family history, demographic and socio-cultural information are explored, as well as education, habitat network, social behavior, leisure and physical activities. As multilingualism is expected to challenge the cognitive alterations associated with pathological ageing, it is additionally investigated. Data relative to motor function, including balance, walk, limits of stability, history of falls and accidents are further detailed. Finally, biological examinations, including ApoE genetic polymorphism are

Diagnostic and economic evaluation of new biomarkers for Alzheimer’s disease: the research protocol of a prospective cohort study

Directory of Open Access Journals (Sweden)

Handels Ron LH

2012-08-01

Full Text Available Abstract Background New research criteria for the diagnosis of Alzheimer’s disease (AD have recently been developed to enable an early diagnosis of AD pathophysiology by relying on emerging biomarkers. To enable efficient allocation of health care resources, evidence is needed to support decision makers on the adoption of emerging biomarkers in clinical practice. The research goals are to 1 assess the diagnostic test accuracy of current clinical diagnostic work-up and emerging biomarkers in MRI, PET and CSF, 2 perform a cost-consequence analysis and 3 assess long-term cost-effectiveness by an economic model. Methods/design In a cohort design 241 consecutive patients suspected of having a primary neurodegenerative disease are approached in four academic memory clinics and followed for two years. Clinical data and data on quality of life, costs and emerging biomarkers are gathered. Diagnostic test accuracy is determined by relating the clinical practice and new research criteria diagnoses to a reference diagnosis. The clinical practice diagnosis at baseline is reflected by a consensus procedure among experts using clinical information only (no biomarkers. The diagnosis based on the new research criteria is reflected by decision rules that combine clinical and biomarker information. The reference diagnosis is determined by a consensus procedure among experts based on clinical information on the course of symptoms over a two-year time period. A decision analytic model is built combining available evidence from different resources among which (accuracy results from the study, literature and expert opinion to assess long-term cost-effectiveness of the emerging biomarkers. Discussion Several other multi-centre trials study the relative value of new biomarkers for early evaluation of AD and related disorders. The uniqueness of this study is the assessment of resource utilization and quality of life to enable an economic evaluation. The study results

Dietary Fat Intake and Fecundability in 2 Preconception Cohort Studies

DEFF Research Database (Denmark)

Wise, Lauren A; Wesselink, Amelia K; Tucker, Katherine L

2018-01-01

American preconception cohort studies. Women who were attempting to become pregnant completed a validated food frequency questionnaire at baseline. Pregnancy status was updated bimonthly for 12 months or until pregnancy. Fecundability ratios (FR) and 95% confidence intervals were estimated using...

Protocol: using virus-induced gene silencing to study the arbuscular mycorrhizal symbiosis in Pisum sativum

DEFF Research Database (Denmark)

Grønlund, Mette; Olsen, Anne; Johansen, Elisabeth

2010-01-01

, the available PEBV-VIGS protocols are inadequate for studying genes involved in the symbiosis with arbuscular mycorrhizal fungi (AMF). Here we describe a PEBV-VIGS protocol suitable for reverse genetics studies in pea of genes involved in the symbiosis with AMF and show its effectiveness in silencing genes...... involved in the early and late stages of AMF symbiosis....

Hyperthyroidism and thyroid cancer risk: a population-based cohort study.

Science.gov (United States)

Yeh, N-C; Chou, C-W; Weng, S-F; Yang, C-Y; Yen, F-C; Lee, S-Y; Wang, J-J; Tien, K-J

2013-07-01

Thyroid hormones regulate the rate of metabolism and affect the differentiation and growth of many tissues in the body. We investigated the association between hyperthyroidism and cancer risk in Taiwan. A random sample of 1 000 000 individuals from Taiwan's National Health Insurance database was enrolled. We found 17 033 patients to have newly diagnosed hyperthyroidism between 2000 and 2005. These patients were recruited along with a match cohort of 34 066 patients without hyperthyroidism. Starting from index date, we followed up all patients for 4 years to identify those who developed cancer. During the 4-year follow-up study, cancer was diagnosed in 1.23% of patients with hyperthyroidism and 1.02% of the member of the comparison cohort. Regression analysis showed that patients with hyperthyroidism were at greater risk of cancer incidence, especially thyroid cancer, compared the comparison cohort (HR: 1.213; 95% CI: 1.022-1.440; phyperthyroidism remained at increased risk of cancer incidence and thyroid cancer (Adjusted HR: 1.206; 95% CI: 1.015-1.433 and 6.803; 95% CI: 3.584-12.91, respectively) (both phyperthyroidism, the greater the risk of thyroid cancer. This 4-year follow up study suggests that patients with hyperthyroidism are at increased risk of cancer, especially thyroid cancer. © J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York.

Knee disarticulation : Survival, wound healing and ambulation. A historic cohort study

NARCIS (Netherlands)

Ten Duis, K.; Bosmans, J. C.; Voesten, H. G. J.; Geertzen, J. H. B.; Dijkstra, P. U.

2009-01-01

The aim of this study was to analyze survival, wound healing and ambulation after knee disarticulation (KD). A historic cohort study using medical records and nursing home records was performed. Data included demographics, reason for amputation, concomitant diseases, survival, wound healing,

Risk of Nephrotic Syndrome following Enteroviral Infection in Children: A Nationwide Retrospective Cohort Study.

Science.gov (United States)

Lin, Jiun-Nong; Lin, Cheng-Li; Yang, Chi-Hui; Lin, Ming-Chia; Lai, Chung-Hsu; Lin, Hsi-Hsun; Kao, Chia-Hung

2016-01-01

Nephrotic syndrome is a common chronic illness encountered during childhood. Infections have been identified as a cause of nephrotic syndrome. The aim of this study was to evaluate the association between enteroviral infection and nephrotic syndrome. A nationwide retrospective cohort study was conducted by analyzing data from the National Health Insurance Research Database in Taiwan. Children aged children were randomly selected as the comparison cohort. The primary endpoint was the occurrence of nephrotic syndrome. This study included 280,087 enterovirus-infected children and 280,085 non-enterovirus-infected children. The mean age of the enterovirus-infected children was 2.38 years, and 53.7% of these children were boys. The overall incidence densities of nephrotic syndrome for enterovirus- and non-enterovirus-infected children were 2.65 and 2.21 per 10,000 person-years, respectively. The enterovirus-infected cohort had a higher cumulative incidence of nephrotic syndrome than did the non-enterovirus-infected cohort (log-rank test, p = 0.01). Multivariable analyses revealed that children with enteroviral infection were significantly associated with an increased risk of nephrotic syndrome compared with those without enteroviral infection (adjusted hazard ratio, 1.20; 95% confidence interval, 1.04-1.39; p = 0.01), particularly in children infected with coxsackievirus. Subgroup analyses revealed that enterovirus-infected girls, children of blue-collar workers, and children without allergies had a higher risk of nephrotic syndrome than did children in the non-enterovirus-infected cohort. This study revealed a significant association between enteroviral infection and nephrotic syndrome. Additional studies elucidating the role and pathogenesis of enterovirus in nephrotic syndrome are warranted.

Malignant transformation of Taiwanese patients with oral leukoplakia: A nationwide population-based retrospective cohort study

Directory of Open Access Journals (Sweden)

Tung-Yuan Wang

2018-05-01

Full Text Available Background/Purpose: Oral leukoplakia (OL is one of the clinically diagnosed oral potentially malignant disorders (OPMDs with an increased risk of oral cancer development. In this study, we investigated the malignant transformation of OL in Taiwanese population. Methods: A retrospective cohort study was analyzed from Taiwan's National Health Insurance Research Database. A comparison cohort was randomly frequency-matched with the OL cohort according to age, sex, and index year. Oral submucous fibrosis (OSF and oral lichen planus (OLP were further stratified to evaluate the possible synergistic effects for OL-associated malignant transformation. Results: In this cohort, 102 (5.374% of 1898 OL patients were observed to transform into oral cancer. The malignant transformation rate was 26.40-fold in the OL cohort than in the comparison cohort after adjustment (95% confidence intervals 18.46–37.77. To further stratify with OSF and OLP, OL with OSF (58.38; 95% confidence intervals 34.61–98.50 and OL with OLP (36.88; 95% confidence intervals 8.90–152.78 had higher risk of malignant transformation rate than OL alone (27.01; 95% confidence intervals 18.91–38.59. The Kaplan–Meier plot revealed the free of malignant transformation rate was significant over the 13 years follow-up period (log-rank test, p < 0.001. Conclusion: OL patients exhibited a significantly higher risk of malignant transformation than those without OL. In addition, both OSF and OLP could enhance malignant transformation in patients with OL. However, further studies are required to identify the histopathological and clinical parameters in the pathogenesis of malignant transformation among OPMDs. Keywords: Oral leukoplakia, Oral submucous fibrosis, Oral lichen planus, Malignant transformation, Nationwide population, Cohort study, Taiwan

Is Child Abuse Associated with Adolescent Obesity? A Population Cohort Study.

Science.gov (United States)

Hawton, Katherine; Norris, Tom; Crawley, Esther; Shield, Julian P H

Child abuse is associated with obesity in adulthood through multiple mechanisms. However, little is known about the relationship between abuse and obesity during adolescence. The aim of this study was to investigate, using a birth cohort, whether there is an association between child abuse and overweight or obesity in adolescence. This study utilizes data from the Avon Longitudinal Study of Parents and Children, a prospective cohort study based in South West England. Using data from the 4205 children with complete data at 13 and 16 years, we analyzed body mass index (BMI) and anonymous parental report of abuse. Abuse was categorized as emotional, physical, or sexual. A sub-sample of 3429 had BMI recorded at 18 years, enabling a longitudinal analysis of BMI trajectories. Using linear and logistic regression analysis, adjusting for sex and family adversity, no association was found between child abuse and BMI, BMI Z-scores, overweight, or obesity, at 13 or 16 years, with all confidence intervals straddling the null. There was weak evidence of a negative association between physical and emotional abuse and BMI trajectories between 13 and 18 years. No relationship was found between child abuse and adolescent obesity in this cohort. This challenges the assumption that adolescent obesity is linked to previous child abuse, as demonstrated for obesity in adult life. A further longitudinal study utilizing both parental and child reports with data record linkage, to improve reporting of abuse, and including neglect as an abuse category, would be desirable.

The LifeLines Cohort Study: Prevalence and treatment of cardiovascular disease and risk factors

OpenAIRE

van der Ende, M. Yldau; Hartman, Minke H. T.; Hagemeijer, Yanick; Meems, Laura M. G.; de Vries, Hendrik Sierd; Stolk, Ronald P.; de Boer, Rudolf A.; Sijtsma, Anna; van der Meer, Peter; Rienstra, Michiel; van der Harst, Pim

2017-01-01

Background: The LifeLines Cohort Study is a large three-generation prospective study and Biobank. Recruitment and data collection started in 2006 and follow-up is planned for 30 years. The central aim of LifeLines is to understand healthy ageing in the 21st century. Here, the study design, methods, baseline and major cardiovascular phenotypes of the LifeLines Cohort Study are presented. Methods and results: Baseline cardiovascular phenotypeswere defined in 9700 juvenile (8-18 years) and 152,1...

Mother's education and offspring asthma risk in 10 European cohort studies.

Science.gov (United States)

Lewis, Kate Marie; Ruiz, Milagros; Goldblatt, Peter; Morrison, Joana; Porta, Daniela; Forastiere, Francesco; Hryhorczuk, Daniel; Zvinchuk, Oleksandr; Saurel-Cubizolles, Marie-Josephe; Lioret, Sandrine; Annesi-Maesano, Isabella; Vrijheid, Martine; Torrent, Maties; Iniguez, Carmen; Larranaga, Isabel; Harskamp-van Ginkel, Margreet W; Vrijkotte, Tanja G M; Klanova, Jana; Svancara, Jan; Barross, Henrique; Correia, Sofia; Jarvelin, Marjo-Riitta; Taanila, Anja; Ludvigsson, Johnny; Faresjo, Tomas; Marmot, Michael; Pikhart, Hynek

2017-09-01

Highly prevalent and typically beginning in childhood, asthma is a burdensome disease, yet the risk factors for this condition are not clarified. To enhance understanding, this study assessed the cohort-specific and pooled risk of maternal education on asthma in children aged 3-8 across 10 European countries. Data on 47,099 children were obtained from prospective birth cohort studies across 10 European countries. We calculated cohort-specific prevalence difference in asthma outcomes using the relative index of inequality (RII) and slope index of inequality (SII). Results from all countries were pooled using random-effects meta-analysis procedures to obtain mean RII and SII scores at the European level. Final models were adjusted for child sex, smoking during pregnancy, parity, mother's age and ethnicity. The higher the score the greater the magnitude of relative (RII, reference 1) and absolute (SII, reference 0) inequity. The pooled RII estimate for asthma risk across all cohorts was 1.46 (95% CI 1.26, 1.71) and the pooled SII estimate was 1.90 (95% CI 0.26, 3.54). Of the countries examined, France, the United Kingdom and the Netherlands had the highest prevalence's of childhood asthma and the largest inequity in asthma risk. Smaller inverse associations were noted for all other countries except Italy, which presented contradictory scores, but with small effect sizes. Tests for heterogeneity yielded significant results for SII scores. Overall, offspring of mothers with a low level of education had an increased relative and absolute risk of asthma compared to offspring of high-educated mothers.

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.

The WISTAH hand study: A prospective cohort study of distal upper extremity musculoskeletal disorders

Directory of Open Access Journals (Sweden)

Garg Arun

2012-06-01

Full Text Available Abstract Background Few prospective cohort studies of distal upper extremity musculoskeletal disorders have been performed. Past studies have provided somewhat conflicting evidence for occupational risk factors and have largely reported data without adjustments for many personal and psychosocial factors. Methods/design A multi-center prospective cohort study was incepted to quantify risk factors for distal upper extremity musculoskeletal disorders and potentially develop improved methods for analyzing jobs. Disorders to analyze included carpal tunnel syndrome, lateral epicondylalgia, medial epicondylalgia, trigger digit, deQuervain’s stenosing tenosynovitis and other tendinoses. Workers have thus far been enrolled from 17 different employment settings in 3 diverse US states and performed widely varying work. At baseline, workers undergo laptop administered questionnaires, structured interviews, two standardized physical examinations and nerve conduction studies to ascertain demographic, medical history, psychosocial factors and current musculoskeletal disorders. All workers’ jobs are individually measured for physical factors and are videotaped. Workers are followed monthly for the development of musculoskeletal disorders. Repeat nerve conduction studies are performed for those with symptoms of tingling and numbness in the prior six months. Changes in jobs necessitate re-measure and re-videotaping of job physical factors. Case definitions have been established. Point prevalence of carpal tunnel syndrome is a combination of paraesthesias in at least two median nerve-served digits plus an abnormal nerve conduction study at baseline. The lifetime cumulative incidence of carpal tunnel syndrome will also include those with a past history of carpal tunnel syndrome. Incident cases will exclude those with either a past history or prevalent cases at baseline. Statistical methods planned include survival analyses and logistic regression. Discussion A

Recipient Age and Mortality Risk after Liver Transplantation: A Population-Based Cohort Study.

Science.gov (United States)

Chen, Hsiu-Pin; Tsai, Yung-Fong; Lin, Jr-Rung; Liu, Fu-Chao; Yu, Huang-Ping

2016-01-01

The aim of the present large population-based cohort study is to explore the risk factors of age-related mortality in liver transplant recipients in Taiwan. Basic information and data on medical comorbidities for 2938 patients who received liver transplants between July 1, 1998, and December 31, 2012, were extracted from the National Health Insurance Research Database on the basis of ICD-9-codes. Mortality risks were analyzed after adjusting for preoperative comorbidities and compared among age cohorts. All patients were followed up until the study endpoint or death. This study finally included 2588 adults and 350 children [2068 (70.4%) male and 870 (29.6%) female patients]. The median age at transplantation was 52 (interquartile range, 43-58) years. Recipients were categorized into the following age cohorts: recipients (≥60 years), especially dialysis patients, have a higher mortality rate, possibly because they have more medical comorbidities. Our findings should make clinicians aware of the need for better risk stratification among elderly liver transplantation candidates.

European birth cohort studies on asthma and atopic diseases I

DEFF Research Database (Denmark)

Keil, T; Kulig, M; Simpson, A

2006-01-01

, recruitment process and follow-up rates. A subsequent review (part II) will compare outcome and exposure parameters. METHODS: For each birth cohort, we collected detailed information regarding recruitment process, study setting, baseline data (pregnancy, birth, parents/siblings) as well as follow-up rates...

Long working hours and cancer risk: a multi-cohort study

NARCIS (Netherlands)

Heikkila, K.; Nyberg, S.T.; Madsen, I.E.; Vroome, E. de; Alfredsson, L.; Bjorner, J.B.; Borritz, M.; Burr, H.; Erbel, R.; Ferrie, J.E.; Fransson, E.; Geuskens, G.A.; Hooftman, W.E.; Houtman, I.L.; Jöckel, K.H.; Knutsson, A.; Koskenvuo, M.; Lunau, T.; Nielsen, M.L.; Nordin, M.; Oksanen, T.; Pejtersen, J.H.; Pentti, J.; Shipley, M.J.; Steptoe, A.; Suominen, S.B.; Theorell, T.; Vahtera, J.; Westerholm, P.J.M.; Westerlund, H.; Dragano, N.; Rugulies, R.; Kawachi, I.; Batty, G.D.; Singh-Manoux, A.; Virtanen, M.; Kivimäki, M.

2016-01-01

Background: Working longer than the maximum recommended hours is associated with an increased risk of cardiovascular disease, but the relationship of excess working hours with incident cancer is unclear. Methods: This multi-cohort study examined the association between working hours and cancer risk

Studying variability in human brain aging in a population-based German cohort – Rationale and design of 1000BRAINS

Directory of Open Access Journals (Sweden)

Svenja eCaspers

2014-07-01

Full Text Available The ongoing 1000 brains study (1000BRAINS is an epidemiological and neuroscientific investigation of structural and functional variability in the human brain during aging. The two recruitment sources are the 10-year follow-up cohort of the German Heinz Nixdorf Recall (HNR Study, and the HNR MultiGeneration Study cohort, which comprises spouses and offspring of HNR subjects. The HNR is a longitudinal epidemiological investigation of cardiovascular risk factors, with a comprehensive collection of clinical, laboratory, socioeconomic, and environmental data from population-based subjects aged 45-75 years on inclusion. HNR subjects underwent detailed assessments in 2000, 2006, and 2011, and completed annual postal questionnaires on health status. 1000BRAINS accesses these HNR data and applies a separate protocol comprising: neuropsychological tests of attention, memory, executive functions & language; examination of motor skills; ratings of personality, life quality, mood & daily activities; analysis of laboratory and genetic data; and state-of-the-art magnetic resonance imaging (MRI, 3 Tesla of the brain. The latter includes (i 3D-T1- and 3D-T2-weighted scans for structural analyses and myelin mapping; (ii three diffusion imaging sequences optimized for diffusion tensor imaging, high-angular resolution diffusion imaging for detailed fibre tracking and for diffusion kurtosis imaging; (iii resting-state and task-based functional MRI; and (iv fluid-attenuated inversion recovery and MR angiography for the detection of vascular lesions and the mapping of white matter lesions. The unique design of 1000BRAINS allows: (i comprehensive investigation of various influences including genetics, environment and health status on variability in brain structure and function during aging; and (ii identification of the impact of selected influencing factors on specific cognitive subsystems and their anatomical correlates.

Necessary accuracy of dose estimation during cohort epidemiologic study after irradiation

International Nuclear Information System (INIS)

Orlov, M.Yu.; Stepanenko, V.F.; Khoshi, M.; Takada, Dzh.

2003-01-01

Effect of breadth of dose ranges on values of radiation risk was estimated. Ratios of observed numbers of mortalities because of leukemia in the cohort in 1950 - 1974 under deferent radiation dose to expected number of mortalities in this cohort only under background radiation were used as degree of risk. Data of cooperative Japan-American Program LSS (Life Span Study) were applied in the researches. It is established that required for the risk assessment with uncertainty 20 - 30 % the accuracy of dose estimation comprises 30 - 35 % in the range 1 - 5 rad and 5 - 10 % in the range 5 - 30 rad [ru

Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

Science.gov (United States)

Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

2018-01-01

The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and

Copenhagen Airport Cohort

DEFF Research Database (Denmark)

Møller, Karina Lauenborg; Brauer, Charlotte; Mikkelsen, Sigurd

2017-01-01

PURPOSE: Copenhagen Airport Cohort 1990-2012 presents a unique data source for studies of health effects of occupational exposure to air pollution (ultrafine particles) and manual baggage handling among airport employees. We describe the extent of information in the cohort and in the follow...... covers 69 175 men in unskilled positions. The exposed cohort includes men in unskilled jobs employed at Copenhagen Airport in the period 1990-2012 either as baggage handlers or in other outdoor work. The reference cohort includes men in unskilled jobs working in the greater Copenhagen area. FINDINGS...... TO DATE: The cohort includes environmental Global Positioning System (GPS) measurements in Copenhagen Airport, information on job function/task for each calendar year of employment between 1990 and 2012, exposure to air pollution at residence, average weight of baggage lifted per day and lifestyle...

Cohort changes in cognitive function among Danish centenarians. A comparative study of 2 birth cohorts born in 1895 and 1905

DEFF Research Database (Denmark)

Engberg, Henriette; Christensen, Kaare; Andersen-Ranberg, Karen

2008-01-01

of 276 persons participated (75%). The Danish 1905 Cohort Survey includes all individuals born in 1905. In total, 225 out of 364 persons who reached the age of 100 in the cohort participated in the most recent 2005 follow-up (62%). In both cohorts, cognitive function was assessed using the Mini-Mental...

Comparison between stress myocardial perfusion SPECT recorded with cadmium-zinc-telluride and Anger cameras in various study protocols

International Nuclear Information System (INIS)

Verger, Antoine; Karcher, Gilles; Djaballah, Wassila; Fourquet, Nicolas; Rouzet, Francois; Le Guludec, Dominique; Koehl, Gregoire; Roch, Veronique; Imbert, Laetitia; Poussier, Sylvain; Fay, Renaud; Marie, Pierre-Yves

2013-01-01

The results of stress myocardial perfusion SPECT could be enhanced by new cadmium-zinc-telluride (CZT) cameras, although differences compared to the results with conventional Anger cameras remain poorly known for most study protocols. This study was aimed at comparing the results of CZT and Anger SPECT according to various study protocols while taking into account the influence of obesity. The study population, which was from three different institutions equipped with identical CZT cameras, comprised 276 patients referred for study using protocols involving 201 Tl (n = 120) or 99m Tc-sestamibi injected at low dose at stress ( 99m Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ( 99m Tc-High; rest/stress 1-day or 2-day protocol; n = 46). Each Anger SPECT scan was followed by a high-speed CZT SPECT scan (2 to 4 min). Agreement rates between CZT and Anger SPECT were good irrespective of the study protocol (for abnormal SPECT, 201 Tl 92 %, 99m Tc-Low 86 %, 99m Tc-High 98 %), although quality scores were much higher for CZT SPECT with all study protocols. Overall correlations were high for the extent of myocardial infarction (r = 0.80) and a little lower for ischaemic areas (r = 0.72), the latter being larger on Anger SPECT (p 201 Tl or 99m Tc-Low group and in whom stress myocardial counts were particularly low with Anger SPECT (228 ± 101 kcounts) and dramatically enhanced with CZT SPECT (+279 ± 251 %). Concordance between the results of CZT and Anger SPECT is good regardless of study protocol and especially when excluding obese patients who have low-count Anger SPECT and for whom myocardial counts are dramatically enhanced on CZT SPECT. (orig.)

Ancestors protocol for scalable key management

Directory of Open Access Journals (Sweden)

Dieter Gollmann

2010-06-01

Full Text Available Group key management is an important functional building block for secure multicast architecture. Thereby, it has been extensively studied in the literature. The main proposed protocol is Adaptive Clustering for Scalable Group Key Management (ASGK. According to ASGK protocol, the multicast group is divided into clusters, where each cluster consists of areas of members. Each cluster uses its own Traffic Encryption Key (TEK. These clusters are updated periodically depending on the dynamism of the members during the secure session. The modified protocol has been proposed based on ASGK with some modifications to balance the number of affected members and the encryption/decryption overhead with any number of the areas when a member joins or leaves the group. This modified protocol is called Ancestors protocol. According to Ancestors protocol, every area receives the dynamism of the members from its parents. The main objective of the modified protocol is to reduce the number of affected members during the leaving and joining members, then 1 affects n overhead would be reduced. A comparative study has been done between ASGK protocol and the modified protocol. According to the comparative results, it found that the modified protocol is always outperforming the ASGK protocol.

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

A study protocol to evaluate the relationship between outdoor air pollution and pregnancy outcomes.

Science.gov (United States)

Ribeiro, Manuel C; Pereira, Maria J; Soares, Amílcar; Branquinho, Cristina; Augusto, Sofia; Llop, Esteve; Fonseca, Susana; Nave, Joaquim G; Tavares, António B; Dias, Carlos M; Silva, Ana; Selemane, Ismael; de Toro, Joaquin; Santos, Mário J; Santos, Fernanda

2010-10-15

The present study protocol is designed to assess the relationship between outdoor air pollution and low birth weight and preterm births outcomes performing a semi-ecological analysis. Semi-ecological design studies are widely used to assess effects of air pollution in humans. In this type of analysis, health outcomes and covariates are measured in individuals and exposure assignments are usually based on air quality monitor stations. Therefore, estimating individual exposures are one of the major challenges when investigating these relationships with a semi-ecologic design. Semi-ecologic study consisting of a retrospective cohort study with ecologic assignment of exposure is applied. Health outcomes and covariates are collected at Primary Health Care Center. Data from pregnant registry, clinical record and specific questionnaire administered orally to the mothers of children born in period 2007-2010 in Portuguese Alentejo Litoral region, are collected by the research team. Outdoor air pollution data are collected with a lichen diversity biomonitoring program, and individual pregnancy exposures are assessed with spatial geostatistical simulation, which provides the basis for uncertainty analysis of individual exposures. Awareness of outdoor air pollution uncertainty will improve validity of individual exposures assignments for further statistical analysis with multivariate regression models. Exposure misclassification is an issue of concern in semi-ecological design. In this study, personal exposures are assigned to each pregnant using geocoded addresses data. A stochastic simulation method is applied to lichen diversity values index measured at biomonitoring survey locations, in order to assess spatial uncertainty of lichen diversity value index at each geocoded address. These methods assume a model for spatial autocorrelation of exposure and provide a distribution of exposures in each study location. We believe that variability of simulated exposure values at

A study protocol to evaluate the relationship between outdoor air pollution and pregnancy outcomes

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Selemane Ismael

2010-10-01

Full Text Available Abstract Background The present study protocol is designed to assess the relationship between outdoor air pollution and low birth weight and preterm births outcomes performing a semi-ecological analysis. Semi-ecological design studies are widely used to assess effects of air pollution in humans. In this type of analysis, health outcomes and covariates are measured in individuals and exposure assignments are usually based on air quality monitor stations. Therefore, estimating individual exposures are one of the major challenges when investigating these relationships with a semi-ecologic design. Methods/Design Semi-ecologic study consisting of a retrospective cohort study with ecologic assignment of exposure is applied. Health outcomes and covariates are collected at Primary Health Care Center. Data from pregnant registry, clinical record and specific questionnaire administered orally to the mothers of children born in period 2007-2010 in Portuguese Alentejo Litoral region, are collected by the research team. Outdoor air pollution data are collected with a lichen diversity biomonitoring program, and individual pregnancy exposures are assessed with spatial geostatistical simulation, which provides the basis for uncertainty analysis of individual exposures. Awareness of outdoor air pollution uncertainty will improve validity of individual exposures assignments for further statistical analysis with multivariate regression models. Discussion Exposure misclassification is an issue of concern in semi-ecological design. In this study, personal exposures are assigned to each pregnant using geocoded addresses data. A stochastic simulation method is applied to lichen diversity values index measured at biomonitoring survey locations, in order to assess spatial uncertainty of lichen diversity value index at each geocoded address. These methods assume a model for spatial autocorrelation of exposure and provide a distribution of exposures in each study location