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Journal of Clinical Epidemiology

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https://www.readbyqxmd.com/read/28823649/if-there-is-only-one-author-or-only-one-database-was-searched-a-study-should-not-be-called-a-systematic-review
#1
LETTER
Livia Puljak
No abstract text is available yet for this article.
August 17, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28802676/instrumental-variable-meta-analysis
#2
LETTER
Stuart G Baker, Karen S Lindeman
No abstract text is available yet for this article.
August 9, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28802675/grade-equity-guidelines-4-guidance-on-how-to-assess-and-address-health-equity-within-the-evidence-to-decision-process
#3
Kevin Pottie, Vivian Welch, Rachael Morton, Elie A Akl, Javier H Eslava-Schmalbach, Vittal Katikireddi, Jasvinder Singh, Lorenzo Moja, Eddy Lang, Nicola Magrini, Lehana Thabane, Roger Stanev, Elizabeth Matovinovic, Alexandra Snellman, Matthias Briel, Beverly Shea, Peter Tugwell, Holger Schunemann, Gordon Guyatt, Pablo Alonso-Coello
OBJECTIVE: The aim of this paper is to provide detailed guidance on how to incorporate health equity within the GRADE (Grading Recommendations Assessment and Development Evidence) evidence to decision process. STUDY DESIGN AND SETTING: We developed this guidance based on the GRADE evidence to decision (EtD) framework, iteratively reviewing and modifying draft documents, in person discussion of project group members and input from other GRADE members. RESULTS: Considering the impact on health equity may be required, both in general guidelines, and guidelines that focus on disadvantaged populations...
August 9, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28802674/the-yusuf-peto-method-was-not-a-robust-method-for-meta-analyses-of-rare-events-data-from-antidepressant-trials
#4
Tarang Sharma, Peter C Gøtzsche, Oliver Kuss
OBJECTIVE: To identify the validity of effect estimates for serious rare adverse events in clinical study reports of antidepressants trials, across different meta-analysis methods. STUDY DESIGN AND SETTING: Four serious rare adverse events (all-cause mortality, suicidality, aggressive behaviour and akathisia) were meta-analysed using different methods. The Yusuf-Peto odds ignores studies with no events, was compared with the alternative approaches of generalised linear mixed models (GLMM), conditional logistic regression, a Bayesian approach using Markov Chain Monte Carlo (MCMC) and a beta-binomial regression model...
August 9, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28802673/quasi-experimental-study-designs-making-a-case-for-non-experimental-designs-in-the-spectrum
#5
LETTER
Anke Richters, René J F Melis
No abstract text is available yet for this article.
August 9, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28802672/congruence-between-patient-characteristics-and-interventions-may-partly-explain-medication-adherence-intervention-effectiveness-an-analysis-of-190-randomized-controlled-trials-from-a-cochrane-systematic-review
#6
REVIEW
Samuel S Allemann, Robby Nieuwlaat, Tamara Navarro, Brian Haynes, Kurt E Hersberger, Isabelle Arnet
BACKGROUND: Due to the negative outcomes of medication non-adherence, interventions to improve adherence have been the focus of countless studies. The congruence between adherence-related patient characteristics and interventions may partly explain the variability of effectiveness in medication adherence studies. In their latest update of a Cochrane review reporting inconsistent effects of adherence interventions, the authors offered access to their database for sub-analysis. We aimed to use this database to assess congruence between adherence-related patient characteristics and interventions and its association with intervention effects...
August 9, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28757261/searching-clinicaltrials-gov-did-not-change-the-conclusions-of-a-systematic-review
#7
Lisa M Wilson, Ritu Sharma, Sydney M Dy, Julie M Waldfogel, Karen A Robinson
OBJECTIVES: We assessed the effect of searching ClinicalTrials.gov on the conclusions of a systematic review. STUDY DESIGN AND SETTING: We conducted this case study concurrently with a systematic review. We searched ClinicalTrials.gov on March 9, 2016, to identify trial records eligible for inclusion in the review. Two independent reviewers screened ClinicalTrials.gov records. We compared conclusions and strength of evidence grade with and without ClinicalTrials...
July 27, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28757260/comparison-between-publicly-accessible-publications-registries-and-protocols-of-phase-iii-trials-indicated-persistence-of-selective-outcome-reporting
#8
Sheng Zhang, Fei Liang, Wenfeng Li
OBJECTIVES: The decision to make protocols of phase III randomized clinical trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here we compared primary outcomes defined in protocols with those in publications describing the trials, and in trial registration. STUDY DESIGN AND SETTING: We identified phase III RCTs published between January 1, 2012 and June 30, 2015 in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association and The BMJ with available protocols...
July 27, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28750849/heterogeneity-in-application-design-and-analysis-characteristics-was-found-for-controlled-before-after-cba-and-interrupted-time-series-its-studies-included-in-cochrane-reviews
#9
Stephanie Polus, Dawid Pieper, Jacob Burns, Atle Fretheim, Craig Ramsay, Julian Pt Higgins, Tim Mathes, Lisa M Pfadenhauer, Eva A Rehfuess
OBJECTIVE: To examine the application, design and analysis characteristics of controlled before-after (CBA) and interrupted time series (ITS) studies and their use in Cochrane reviews. STUDY DESIGN AND SETTING: We searched the Cochrane library for reviews including these study designs from May 2012 - March 2015 and purposively selected, where available, two reviews each across ten pre-specified intervention types. We randomly selected two CBA and two ITS studies from each review...
July 24, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28728922/existing-reporting-guidelines-for-clinical-trials-are-not-completely-relevant-for-implantable-medical-devices-a-systematic-review
#10
REVIEW
Anne-France Motte, Stéphanie Diallo, Hélène van den Brink, Constance Châteauvieux, Carole Serrano, Carole Naud, Julie Steelandt, Jean-Marc Alsac, Pierre Aubry, Florence Cour, Olivier Pellerin, Judith Pineau, Patrice Prognon, Isabelle Borget, Brigitte Bonan, Nicolas Martelli
OBJECTIVE: The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices and to identify reporting guidelines which include these items. STUDY DESIGN AND SETTING: A panel of experts identified the most relevant items for evaluating implantable medical devices from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting...
July 17, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28728921/web-based-questionnaires-to-assess-perinatal-outcome-proved-to-be-valid
#11
Marleen M H J van Gelder, Saskia Vorstenbosch, Lineke Derks, Bernke Te Winkel, Eugène P van Puijenbroek, Nel Roeleveld
OBJECTIVE: To validate a Web-based questionnaire completed by the mother to assess perinatal outcome used in a prospective cohort study. STUDY DESIGN AND SETTING: For 882 women with an estimated date of delivery between February 2012 and February 2015 who participated in the PRegnancy and Infant DEvelopment (PRIDE) Study, we compared data on pregnancy outcome, including mode of delivery, plurality, gestational age, birth weight and length, head circumference, birth defects, and infant sex from Web-based questionnaires administered to the mothers 2 months after delivery with data from obstetric records...
July 17, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28720515/ahrq-series-on-complex-intervention-systematic-reviews-paper-4-selecting-analytic-approaches
#12
Meera Viswanathan, Melissa L McPheeters, M Hassan Murad, Mary E Butler, Emily E Beth Devine, Michele P Dyson, Jeanne-Marie Guise, Leila C Kahwati, Jeremy N V Miles, Sally C Morton
BACKGROUND: Systematic reviews of complex interventions can vary widely in purpose, data availability and heterogeneity, and stakeholder expectations. RATIONALE: This article addresses the uncertainty that systematic reviewers face in selecting methods for reviews of complex interventions. Specifically, it lays out parameters for systematic reviewers to consider when selecting analytic approaches that best answer the questions at hand and suggests analytic techniques that may be appropriate in different circumstances...
July 15, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28720514/ahrq-series-on-complex-intervention-systematic-reviews-paper-2-defining-complexity-formulating-scope-and-questions
#13
Michael P Kelly, Jane Noyes, Robert L Kane, Christine Chang, Stacey Uhl, Karen A Robinson, Stacey Springs, Mary E Butler, Jeanne-Marie Guise
BACKGROUND: The early stages of a systematic review set the scope and expectations. This can be particularly challenging for complex interventions given their multidimensional and dynamic nature. RATIONALE: This paper builds on concepts introduced in paper 1 of this series. It describes the methodological, practical, and philosophical challenges and potential approaches for formulating the questions and scope of systematic reviews of complex interventions. Furthermore, it discusses the use of theory to help organize reviews of complex interventions...
July 15, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28720513/ahrq-series-on-complex-intervention-systematic-reviews-paper-7-prisma-ci-elaboration-and-explanation
#14
Jeanne-Marie Guise, Mary Butler, Christine Chang, Meera Viswanathan, Terri Pigott, Peter Tugwell
BACKGROUND: Complex interventions are widely used in health care, public health, education, criminology, social work, business, and welfare. They have increasingly become the subject of systematic reviews and are challenging to effectively report. The Complex Interventions Methods Workgroup developed an extension to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Complex Interventions (PRISMA-CI). RATIONALE: Following the EQUATOR Network guidance for Preferred Reporting Items for Systematic Reviews and Meta-Analysis extensions, this Explanation and Elaboration (EE) document accompanies the PRISMA-CI checklist to promote consistency in reporting of systematic reviews of complex interventions...
July 15, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28720510/ahrq-series-on-complex-intervention-systematic-reviews-paper-3-adapting-frameworks-to-develop-protocols
#15
Mary Butler, Richard A Epstein, Annette Totten, Evelyn P Whitlock, Mohammed T Ansari, Laura J Damschroder, Ethan Balk, Eric B Bass, Nancy D Berkman, Susanne Hempel, Suchitra Iyer, Karen Schoelles, Jeanne-Marie Guise
BACKGROUND: Once a proposed topic has been identified for a systematic review and has undergone a question formulation stage, a protocol must be developed that specifies the scope and research questions in detail and outlines the methodology for conducting the systematic review. RATIONALE: Framework modifications are often needed to accommodate increased complexity. We describe and give examples of adaptations and alternatives to traditional analytic frameworks...
July 15, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28716504/data-collection-in-pragmatic-trials
#16
Anna-Katharina Meinecke, Paco Welsing, George Kafatos, Des Burke, Sven Trelle, Maria Kubin, Gaelle Nachbaur, Matthias Egger, Mira Zuidgeest
Pragmatic trials can improve our understanding of how treatments will perform in routine practice. In a series of eight papers, the GetReal Consortium has evaluated the challenges in designing and conducting pragmatic trials and their specific methodological, operational, regulatory, and ethical implications. The present final paper of the series discusses the operational and methodological challenges of data collection in pragmatic trials. A more pragmatic data collection needs to balance the delivery of highly accurate and complete data with minimizing the level of interference that data entry and verification induce with clinical practice...
July 14, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28709997/methodological-challenges-identified-for-the-evaluation-of-clinical-effectiveness-in-the-context-of-accelerated-regulatory-approval-an-overview
#17
REVIEW
Nerys Woolacott, Mark Corbett, Julie Jones-Diette, Robert Hodgson
BACKGROUND: Regulatory authorities are approving innovative therapies with limited evidence. Whilst this level of data is sufficient for the regulator to establish an acceptable risk-benefit balance, it is problematic for downstream health technology assessment, where assessment of cost-effectiveness requires reliable estimates of effectiveness relative to existing clinical practice. Some key issues associated with a limited evidence base include using data, from non-randomised studies, from small single-arm trials, or from single-centre trials; and using surrogate endpoints...
July 11, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28694123/pragmatic-trials-defining-questions-choosing-comparators-allocating-treatments
#18
Mira G P Zuidgeest, Paco M J Welsing, Ghislaine J M W van Thiel, Antonio Ciaglia, Rafael Alfonso-Cristancho, Laurent Eckert, Marinus J C Eijkemans, Matthias Egger
Pragmatic trials may deliver real-world evidence on the added value of new medications compared with usual care and inform decision making earlier in development. This fifth paper in a series on pragmatic trials in the Journal discusses usual care as a comparator and the allocation of treatment strategies. The allocation and implementation of treatment strategies should resemble clinical practice as closely as possible. Randomization at the level of the site, as opposed to at the individual level, may be preferred...
July 8, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28694122/the-risk-of-bias-in-systematic-reviews-robis-tool-showed-fair-reliability-and-good-construct-validity
#19
Stefanie Bühn, Tim Mathes, Peggy Prengel, Uta Wegewitz, Thomas Ostermann, Sibylle Robens, Dawid Pieper
OBJECTIVE: There is a movement from generic quality checklists towards a more domain based approach in critical appraisal tools. This study aims to report on a first experience with the newly developed risk of bias in systematic reviews (ROBIS) tool and compare it with A Measurement Tool to Assess Systematic Reviews (AMSTAR) that is the most common used tool to assess methodological quality of systematic reviews while assessing validity, reliability and applicability. STUDY DESIGN AND SETTING: Validation study with four reviewers based on 16 systematic reviews in the field of occupational health...
July 7, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28694121/quasi-experimental-study-designs-series-paper-1-history-and-introduction
#20
Till Bärnighausen, John-Arne Røttingen, Peter Rockers, Ian Shemilt, Peter Tugwell
OBJECTIVE: To contrast the historical development of experiments and quasi-experiments and provide the motivation for a journal series on quasi-experimental designs in health research STUDY DESIGN: A short historical narrative, with concrete examples, and arguments based on an understanding of the practice of health research and evidence synthesis RESULTS: Health research has played a key role in developing today's gold standard for causal inference - the randomized controlled multiply blinded trial...
July 7, 2017: Journal of Clinical Epidemiology
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