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Journal of Clinical Epidemiology

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https://www.readbyqxmd.com/read/30081071/clinical-trials-on-drug-drug-interactions-registered-in-clinicaltrials-gov-reported-incongruent-safety-data-in-published-articles-an-observational-study
#1
Diana Jurić, Shelly Pranić, Ružica Tokalić, Ana Marija Milat, Ivana Mudnić, Ivančica Pavličević, Ana Marušić
OBJECTIVE: To assess safety data of trials on DDIs reported in ClinicalTrials.gov and published in journal articles, since drug-drug interactions (DDIs) are a growing concern. STUDY DESIGN AND SETTING: In an observational study of clinical trials retrieved by the search term "drug-drug interaction(s)", we collected the information on registration and on adverse events (AEs) from ClinicalTrials.gov and corresponding publications. Trials were included if they primarily investigated DDIs, had a National Clinical Trial identifier and were closed and completed by October 16, 2015...
August 3, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30077621/orchestrated-efforts-to-foster-responsible-research
#2
LETTER
Li Tang, Guangyuan Hu
No abstract text is available yet for this article.
August 2, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30076979/biomarker-discovery-study-of-inflammatory-proteins-for-colorectal-cancer-early-detection-demonstrated-importance-of-screening-setting-validation
#3
Jing Qian, Kaja Tikk, Simone Werner, Yesilda Balavarca, Maral Saadati, Marlene Hechtner, Hermann Brenner
OBJECTIVES: Most studies identifying inflammatory markers for early detection of colorectal cancer (CRC) were conducted using clinically manifest cases. We aimed to identify circulating inflammatory biomarkers for early detection of CRC and validate them in both a clinical setting and a true screening setting. STUDY DESIGN AND SETTING: A total of 92 inflammatory proteins were quantified in baseline plasma samples from individuals clinically diagnosed with CRC and neoplasm-free controls matched on age and sex (training set)...
August 1, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30075189/crowdsourcing-critical-appraisal-of-research-evidence-crowdcare-was-found-to-be-a-valid-approach-to-assessing-clinical-research-quality
#4
Michael J Pianta, Eve Makrai, Karin M Verspoor, Trevor A Cohn, Laura E Downie
PURPOSE: We developed a free, online tool (CrowdCARE: crowdcare.unimelb.edu.au) to crowdsource research critical appraisal. The aim was to examine the validity of this approach for assessing the methodological quality of systematic reviews. STUDY DESIGN AND SETTING: In this prospective, cross-sectional study, a sample of systematic reviews (n=71), of heterogeneous quality, was critically appraised using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) tool, in CrowdCARE, by five trained novice and two expert raters...
July 31, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30075188/unsuccessful-replication-is-not-a-sign-of-research-misconduct
#5
LETTER
Lex M Bouter
No abstract text is available yet for this article.
July 31, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30075187/a-cohort-study-of-mammography-screening-finds-that-comorbidity-measures-are-insufficient-for-controlling-selection-bias
#6
Jonas Czwikla, Klaus Giersiepen, Ingo Langner, Dirk Enders, Franziska Heinze, Heinz Rothgang, Ulrike Haug, Hajo Zeeb, Hans-Werner Hense
OBJECTIVE: To examine the potential of claims-based comorbidity measures for controlling selection bias in observational studies of mammography screening. STUDY DESIGN AND SETTING: Based on claims data of a large German Statutory Health Insurance fund, the single comorbidities considered by the Charlson, Elixhauser, MACSS and M3 comorbidity measures were identified for mammography screening participants and non-participants. Total death rates within four years after screening invitation were compared...
July 31, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30063955/controversy-and-debate-memory-based-dietary-assessment-methods-paper-3
#7
Edward Archer, Michael L Marlow, Carl J Lavie
No abstract text is available yet for this article.
July 28, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30063954/validation-in-prediction-research-the-waste-by-data-splitting
#8
Ewout W Steyerberg
No abstract text is available yet for this article.
July 28, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30055247/the-consensus-on-exercise-reporting-template-cert-applied-to-exercise-interventions-in-musculoskeletal-trials-demonstrated-good-rater-agreement-and-incomplete-reporting
#9
Slade Sc, Finnegan S, Dionne Ce, Underwood M, Buchbinder R
OBJECTIVE: To determine inter-rater agreement and utility of the Consensus on Exercise Reporting Template (CERT) for evaluating reporting of musculoskeletal exercise trials. STUDY DESIGN AND SETTING: Two independent reviewers applied the CERT to a random sample of 20 exercise trials published 2010 to 2015 identified from searches of PEDro, CENTRAL and PubMed. Reviewers recorded whether each item criterion was met, detailed missing data and appraisal time Percent agreement and the Prevalence and Bias Adjusted Kappa (PABAK) statistic were used to measure inter-rater agreement...
July 25, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30036677/guidance-was-developed-on-how-to-write-a-plain-language-summary-for-diagnostic-test-accuracy-reviews
#10
Penny Whiting, Mariska Leeflang, Isabel de Salis, Reem A Mustafa, Nancy Santesso, Gowri Gopalakrishna, Geraldine Cooney, Emily Jesper, Joanne Thomas, Clare Davenport
OBJECTIVE: To develop guidance for authors of diagnostic test accuracy (DTA) reviews to help them write a plain language summary (PLS) of the results of their review. STUDY DESIGN AND SETTING: We used a combination of focus groups, user testing and a web based survey. Participants included patient representatives, media representatives and health professionals. RESULTS: We present step-by-step guidance for authors of DTA reviews for writing a PLS...
July 20, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30031210/handling-the-reflective-formative-measurement-conundrum-a-practical-illustration-based-on-sustainable-employability
#11
Bram P I Fleuren, Ludovic G P M van Amelsvoort, Fred R H Zijlstra, Andries de Grip, IJmert Kant
OBJECTIVE: Constructs capturing health or functioning can have reflective and/or formative measurement models. Although a construct's measurement model has extensive implications on the construction, validation and use of a measurement instrument, measurement models are frequently wrongly or not explicitly specified. As this is likely due to a lack of guidelines, this study uses sustainable employability as an example to demonstrate a) the applicability of an adapted checklist for establishing a construct's measurement model; and b) the use of structural equation modelling to handle formative constructs...
July 18, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30016643/two-morbidity-indices-developed-in-a-nationwide-population-permitted-performant-outcome-specific-severity-adjustment
#12
Panayotis Constantinou, Philippe Tuppin, Anne Fagot-Campagna, Christelle Gastaldi-Ménager, François G Schellevis, Nathalie Pelletier-Fleury
OBJECTIVE: To develop and validate two outcome-specific morbidity indices in a population-based setting: the Mortality-Related Morbidity Index (MRMI) predictive of all-cause mortality and the Expenditure-Related Morbidity Index (ERMI) predictive of healthcare expenditure. STUDY DESIGN AND SETTING: A cohort including all beneficiaries of the main French health insurance scheme aged 65 years or older on December 31, 2013 (N=7,672,111) was randomly split into a development population for index elaboration and a validation population for predictive performance assessment...
July 14, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30012478/classical-test-theory-and-item-response-theory-produced-differences-on-estimation-of-reliable-clinical-index-in-whodas-2-0
#13
Oscar Lozano, Juan José Mancheño, Marcos Cupani, Elena Delgado Rico, Enrique Moraleda, Pilar Cáceres-Pachón, Fermín Fernández Calderón
OBJECTIVE: WHODAS 2.0 is currently one of the most used instruments in disability assessment. The objective of this study is to analyze the clinically reliable change of WHODAS 2.0 by applying both Classical Test Theory (CTT) and the Item Response Theory (IRT). STUDY DESIGN AND SETTING: The sample consisted of 179 patients with dual pathology. The standard error of measurement (SEM) was estimated using the CTT and the Rating Testlet Model. RESULTS: Reliability estimated by Cronbach's alpha provided acceptable values for all domains...
July 13, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30009942/the-development-of-an-icf-based-questionnaire-for-patients-with-chronic-conditions-in-primary-care
#14
S A E Postma, K van Boven, H Ten Napel, D L Gerritsen, W J J Assendelft, H Schers, T C Olde Hartman
We developed a self-reported questionnaire for patients in primary care with chronic conditions aged 50 years or older. The questionnaire supports a more person-centered approach by adopting a biopsychosocial focus on functional status instead of a focus on disease. Based on the International Classification of Functioning, Disability and Health (ICF), an ICF Primary Care set for patients with chronic conditions was constructed in three phases. In the first phase, we identified relevant ICF categories for the ICF Primary Care set by using existing ICF sets for chronic health conditions...
July 12, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30009941/using-a-single-non-inferiority-margin-or-preserved-fraction-for-an-entire-pharmacological-class-was-found-to-be-inappropriate
#15
Turki A Althunian, Anthonius de Boer, Rolf H H Groenwold, Olaf H Klungel
OBJECTIVE: To assess the impact on non-inferiority decisions when using a single margin or single preserved fraction (PF) for all non-inferiority trials within a pharmacological class. STUDY DESIGN AND SETTING: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (nine non-inferiority comparisons ) for treating hyperlipidemia. The impact of using a single margin was assessed by calculating whether this margin corresponds to different PFs among comparator statins which will demonstrate that the threshold of demonstrating non-inferiority (in terms of the PF) varies among comparator statins...
July 12, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/30009940/application-of-competing-risks-analysis-improved-prognostic-assessment-of-patients-with-decompensated-chronic-heart-failure-and-reduced-left-ventricular-ejection-fraction
#16
Domenico Scrutinio, Pietro Guida, Andrea Passantino, Enrico Ammirati, Fabrizio Oliva, Rocco Lagioia, Maria Frigerio
OBJECTIVE: Kaplan-Meier method may overestimate absolute mortality risk (AMR) in the presence of competing risks. Urgent heart transplantation (UHT) and ventricular assist device implantation (VADi) are important competing events in heart failure. We sought to quantify the extent of bias of Kaplan-Meier method in estimating AMR in the presence of competing events and to analyse the effect of covariates on the hazard for death and competing events in the clinical model of decompensated chronic heart failure with reduced ejection fraction (DCHFrEF)...
July 12, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29981872/extending-pubmed-searches-to-clinicaltrials-gov-through-a-machine-learning-approach-for-systematic-reviews
#17
Corrado Lanera, Clara Minto, Abhinav Sharma, Dario Gregori, Paola Berchialla, Ileana Baldi
AIMS: Despite their essential role in collecting and organizing published medical literature, indexed search engines are unable to cover all relevant knowledge. Hence, current literature recommends the inclusion of clinical trial registries in systematic reviews. This study aims to provide an automated approach to extend a search on PubMed to the ClinicalTrials.gov database, relying on text mining and machine learning techniques. STUDY DESIGN AND SETTING: The procedure starts from a literature search on PubMed...
July 5, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29981871/diagnostic-test-guidelines-based-on-high-quality-evidence-had-greater-rates-of-adherence-a-meta-epidemiological-study
#18
J W O'Sullivan, A Albasri, C Koshiaris, J K Aronson, C Heneghan, R Perera
OBJECTIVE: To determine the association between the quality of guidelines for diagnostic tests (both the quality and reporting and the quality of the evidence underpinning recommendations) and non-adherence. STUDY DESIGN AND SETTING: We conducted a meta-epidemiological study. We previously published a systematic review that quantified the percentage of test use that was non-adherent with guidelines. For the current study, we assessed these guidelines using the Appraisal of Guidelines for Research & Evaluation (AGREE) II tool...
July 5, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29981870/statistical-power-of-clinical-trials-increased-while-effect-size-remained-stable-an-empirical-analysis-of-136-212-clinical-trials-between-1975-2014
#19
Herm J Lamberink, Willem M Otte, Michel Rt Sinke, Daniël Lakens, Paul P Glasziou, Joeri K Tijdink, Christiaan H Vinkers
OBJECTIVE: To study the statistical power of randomized clinical trials and examine developments over time. STUDY DESIGN AND SETTING: We analysed the statistical power in 136,212 clinical trials between 1975 and 2014 extracted from meta-analyses from the Cochrane database of systematic reviews. We determined study power to detect standardized effect sizes, where power was based on the meta-analysed effect size. Average power, effect size and temporal patterns were examined for all meta-analyses and a subset of significant meta-analyses...
July 5, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29966732/patients-and-investigators-preferred-measures-of-absolute-risk-in-subgroups-for-pragmatic-randomized-trials
#20
Eleanor J Murray, Ellen C Caniglia, Sonja A Swanson, Sonia Hernández-Díaz, Miguel A Hernán
OBJECTIVES: Pragmatic randomized trials are important tools for shared decision-making, but no guidance exists on patients' preferences for types of causal information. We aimed to assess preferences of patients and investigators towards causal effects in pragmatic randomized trials. STUDY DESIGN AND SETTING: We: (a) held 3 focus groups with patients (n=23) in Boston, MA; (b) surveyed (n=12) and interviewed (n=5) investigators with experience conducting pragmatic trials; and (c) conducted a systematic literature review of pragmatic trials (n=63)...
June 29, 2018: Journal of Clinical Epidemiology
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