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Journal of Clinical Epidemiology

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https://www.readbyqxmd.com/read/28728922/existing-reporting-guidelines-for-clinical-trials-are-not-completely-relevant-for-implantable-medical-devices-a-systematic-review
#1
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
#2
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/28716504/series-pragmatic-trials-and-real-world-evidence-paper-8-data-collection-and-management-data-collection-in-pragmatic-trials
#3
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
#4
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
#5
Mira G Zuidgeest, Paco Welsing, Ghislaine 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 to usual care and inform decision making earlier in development. This 5(th) 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 7, 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
#6
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
#7
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
https://www.readbyqxmd.com/read/28688922/use-of-family-relationships-improved-consistency-of-identification-of-aboriginal-people-in-linked-administrative-data
#8
Alison J Gibberd, Judy M Simpson, Sandra J Eades
BACKGROUND: Algorithms are often used to improve identification of Aboriginal Australians in linked datasets with inconsistent and incomplete recording of Aboriginal status. We compared how consistently some common algorithms identified family members, developed a new algorithm incorporating relatives' information, and assessed the effects of these algorithms on health estimates. METHODS: The sample was people born 1980-2011 recorded as Aboriginal at least once (or a relative) in four Western Australian datasets and their relatives (n=156,407)...
July 5, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28676426/important-difference-to-infer-changes-in-health-related-quality-of-life-a-systematic-review
#9
REVIEW
Ravishankar Jayadevappa, Ratna Cook, Sumedha Chhatre
OBJECTIVE: To assess the usability of Minimal Important Difference (MID) and minimal clinically important difference (MCID) for measuring meaningful changes in disease-specific and generic HRQoL outcomes in patient-centered care. STUDY DESIGN AND SETTING: We adopted a two-step literature review process. First, we used PubMed and Google scholar to identify a broad range search terms. Next, we searched OVID Medline, JSTOR, and PubMed for terms "MID," and "MCID." We excluded non-English language studies, articles older than 1995, those not related to generic and disease specific HRQoL measures, and protocols of future studies...
July 1, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28720513/ahrq-series-on-complex-intervention-systematic-reviews-paper-7-prisma-ci-elaboration-explanation
#10
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 called PRISMA-CI. RATIONALE: Following the EQUATOR Network guidance for PRISMA extensions, this Explanation and Elaboration document accompanies the PRISMA-CI checklist to promote consistency in reporting of systematic reviews of complex interventions...
June 30, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28720515/ahrq-series-on-complex-intervention-systematic-reviews-paper-4-selecting-analytic-approaches
#11
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...
June 29, 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
#12
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 multi-dimensional 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. Further it discusses the use of theory to help organize reviews of complex interventions...
June 29, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28720516/ahrq-series-on-complex-intervention-systematic-reviews-paper-6-prisma-ci-extension-statement-checklist
#13
Jeanne-Marie Guise, Mary E Butler, Christine Chang, Meera Viswanathan, Terri Pigott, Peter Tugwell
BACKGROUND: Complex interventions are widely used in health systems, public health, education, and communities and are increasingly the subject of systematic reviews. Oversimplification and inconsistencies in reporting about complex interventions can limit the usability of review findings. RATIONALE: While guidance exists to ensure that reports of individual studies and systematic reviews adhere to accepted scientific standards, their design-specific focus leaves important reporting gaps relative to complex interventions in health care...
June 28, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28720512/ahrq-series-on-complex-intervention-systematic-reviews-paper-5-advanced-analytic-methods
#14
Terri Pigott, Jane Noyes, Craig A Umscheid, Evan Myers, Sally C Morton, Rongwei Fu, Gillian D Sanders-Schmidler, Emily E Beth Devine, M Hassan Murad, Michael P Kelly, Chris Fonnesbeck, Mark Petticrew, Leila Kahwati, S Natasha Beretvas
BACKGROUND: Advanced analytic methods for synthesizing evidence about complex interventions continue to be developed. In this paper, we emphasize that the specific research question posed in the review should be used as a guide for choosing the appropriate analytic method. RATIONALE: We present advanced analytic approaches that address four common questions that guide reviews of complex interventions: 1) How effective is the intervention?; 2) For whom does the intervention work and in what contexts?; 3) What happens when the intervention is implemented?; and 4) What decisions are possible given the results of the synthesis? DISCUSSION: The analytic approaches presented in this paper are particularly useful when each primary study differs in components, mechanisms of action, context, implementation, timing, and many other domains...
June 27, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28720511/ahrq-series-on-complex-intervention-systematic-reviews-paper-1-an-introduction-to-a-series-of-papers-that-provide-guidance-and-tools-for-reviews-of-complex-interventions
#15
Jeanne-Marie Guise, Christine Chang, Mary E Butler, Meera Viswanathan, Peter Tugwell
No abstract text is available yet for this article.
June 27, 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
#16
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 as well as alternatives to traditional analytic frameworks...
June 27, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28652063/comparator-choice-in-caries-prevention-and-management-trials
#17
Falk Schwendicke, Nicola Innes, Colin Levey, Thomas Lamont, Gerd Göstemeyer
Comparator choice has been found one major factor impacting on the overall evidence supporting clinical interventions. We performed social network analysis on trials on the prevention/management of caries/carious lesions, hypothesizing that certain comparators are proportionally over-investigated, and others under-investigated, and that comparisons within comparator classes are preferred over comparisons between classes. A systematic review of randomized controlled trials on the prevention/management of caries/existing carious lesions was carried out...
June 23, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28648833/opportunities-for-personalized-n-of-1-trials-in-the-mobile-health-era-patient-and-primary-care-provider-perspectives
#18
LETTER
Ian M Kronish, Carmela Alcantara, Joan Duer-Hefele, Tara St Onge, Karina W Davidson, Eileen J Carter, Vivian Medina, Elizabeth Cohn, Nathalie Moise
No abstract text is available yet for this article.
June 22, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28648832/decisional-conflict-screening-for-a-diversity-of-primary-care-decisions-are-we-sure-yet
#19
LETTER
Simon Decary, Maxime Dion, Louis-Paul Rivest, Jean-Sebastien Renaud, Hubert Robitaille, France Légaré
No abstract text is available yet for this article.
June 22, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28629700/designing-pragmatic-trials-what-can-we-learn-from-lessons-learnt
#20
Rolf H H Groenwold, Olaf M Dekkers
No abstract text is available yet for this article.
June 16, 2017: Journal of Clinical Epidemiology
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