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Journal of Clinical Epidemiology

Rolf H H Groenwold, Olaf M Dekkers
No abstract text is available yet for this article.
June 16, 2017: Journal of Clinical Epidemiology
Gordon Forbes, Kirsty Loudon, Shaun Treweek, Stephanie Jc Taylor, Sandra Eldridge
OBJECTIVE: To compare two approaches for trial teams to apply PRECIS-2 to pragmatic trials: independent scoring and scoring following a group discussion. STUDY DESIGN AND SETTING: We recruited multidisciplinary teams who were conducting or had conducted trials in primary care in collaboration with the Pragmatic Clinical Trials Unit, Queen Mary University of London. Each team carried out two rounds of scoring on the 9 PRECIS-2 domains: first independently using an online version of PRECIS-2 and secondly following a discussion...
June 16, 2017: Journal of Clinical Epidemiology
Maureen Rice, Muhammad Usman Ali, Donna Fitzpatrick-Lewis, Meghan Kenny, Parminder Raina, Diana Sherifali
OBJECTIVE: To test the overall effectiveness of a simplified search strategy (SSS) for updating systematic reviews. METHODS: We identified nine systematic reviews undertaken by our research group for which both comprehensive and simplified search strategy (SSS) updates were performed. Three relevant performance measures were estimated i.e. sensitivity, precision and number needed to read (NNR). RESULTS: The update reference searches for all nine included systematic reviews identified a total of 55,099 citations that were screened resulting in final inclusion of 163 RCTs...
June 15, 2017: Journal of Clinical Epidemiology
Bruno Kovic, Michael J Zoratti, Steven Michalopoulos, Camila Silvestre, Kristian Thorlund, Lehana Thabane
OBJECTIVE: To evaluate the current state of reporting and handling of effect modification in network meta-analyses (NMAs), as well as perform exploratory analyses to identify variables that are potentially associated with incomplete reporting of effect modifiers in NMAs. STUDY DESIGN AND SETTING: We conducted a meta-epidemiological survey utilizing a systematic review of NMAs published in 2013 and identified through MEDLINE and Embase databases. RESULTS: The review identified 77 NMAs...
June 8, 2017: Journal of Clinical Epidemiology
Ian Shrier, Menglan Pang, Robert W Platt
OBJECTIVE: To increase transparency in papers reporting propensity scores by using graphical methods that clearly illustrate 1) the number of participant exclusions that occur as a consequence of the analytic strategy, and 2) whether treatment effects are constant or heterogeneous across propensity scores. STUDY DESIGN AND SETTING: We applied graphical methods to a real-world pharmacoepidemiologic study that evaluated the effect of initiating statin medication on the 1-year all-cause mortality post-myocardial infarction...
June 8, 2017: Journal of Clinical Epidemiology
Bram Duyx, Miriam J E Urlings, Gerard M H Swaen, Lex M Bouter, Maurice P Zeegers
OBJECTIVE: Citation bias concerns the selective citation of scientific articles based on their results. We brought together all available evidence on citation bias across scientific disciplines and quantified its impact. STUDY DESIGN AND SETTING: An extensive search strategy was applied to the Web of Science Core Collection and Medline, yielding 52 studies in total. We classified these studies on scientific discipline, selection method and other variables. We also performed random effects meta-analyses to pool the effect of positive versus negative results on subsequent citations...
June 8, 2017: Journal of Clinical Epidemiology
Kirsty Loudon, Merrick Zwarenstein, Frank Sullivan, Peter Donnan, Ildikó Gágyor, Hans Hobbelen, Fernando Althabe, Jerry A Krishnan, Shaun Treweek
OBJECTIVE: PRECIS - 2 is a tool that could improve design insight for trialists. Our aim was to validate the PRECIS - 2 tool, unlike its predecessor, testing the discriminant validity and inter-rater reliability. STUDY DESIGN AND SETTING: Over 80 international trialists, methodologists, clinicians and policymakers created PRECIS - 2 helping to ensure face and content validity. The inter-rater reliability of PREC IS - 2 was measured using 19 experienced trialists who used PRECIS - 2 to score a diverse sample of 15 RCT protocols...
June 8, 2017: Journal of Clinical Epidemiology
Yuqing Zhang, Ivan D Flórez, Luis E Colunga Lozano, Fazila Abu Bakar Aloweni, Sean Alexander Kennedy, Aihua Li, Samantha Craigie, Shiyuan Zhang, Arnav Agarwal, Luciane C Lopes, Tahira Devji, Wojtek Wiercioch, John J Riva, Mengxiao Wang, Xuejing Jin, Yutong Fei, Paul Alexander, Gian Paolo Morgano, Yuan Zhang, Alonso Carrasco-Labra, Lara A Kahale, Elie A Akl, Holger J Schünemann, Lehana Thabane, Gordon Guyatt
OBJECTIVE: To assess analytic approaches randomized trial (RCT) authors use to address missing participant data (MPD) for patient-important continuous outcomes. STUDY DESIGN AND SETTINGS: We conducted a systematic survey of RCTs published in 2014 in the core clinical journals that reported at least one patient-important outcome analyzed as a continuous variable. RESULT: Among 200 studies, 187 (93.5%) trials explicitly reported whether MPD occurred...
June 2, 2017: Journal of Clinical Epidemiology
Anna Selva, Andrea Juliana Sanabria, Sandra Pequeño, Yuan Zhang, Ivan Solà, Héctor Pardo-Hernandez, Clara Selva, Holger Schünemann, Pablo Alonso-Coello
OBJECTIVE: To assess how guidance documents for developing clinical guidelines (CG) address the incorporation of patients' views in CG. STUDY DESIGN AND SETTING: Systematic review to identify the methodology provided in guidance documents for incorporating: a) patients or representatives and b) patients' views in the CG development process. The search was performed in 2017 in five databases. Two authors selected the studies and data extraction was double-checked...
June 1, 2017: Journal of Clinical Epidemiology
Yuqing Zhang, Akram Alyass, Thuva Vanniyasingam, Behnam Sadeghirad, Iván D Flórez, Sathish Chandra Pichika, Sean Alexander Kennedy, Ulviya Abdulkarimova, Yuan Zhang, Tzvia Iljon, Gian Paolo Morgano, Luis E Colunga Lozano, Fazila Abu Bakar Aloweni, Luciane C Lopes, Juan José Yepes-Nuñez, Yutong Fei, Li Wang, Lara A Kahale, David Meyre, Elie A Akl, Lehana Thabane, Gordon Guyatt
OBJECTIVE: To conduct 1) a systematic survey of the reporting quality of simulation studies dealing with how to handle missing participant data (MPD) in randomized control trials and 2) summarize the findings of these studies. STUDY DESIGN AND SETTINGS: We included simulation studies comparing statistical methods dealing with continuous MPD in RCTs addressing bias, precision, coverage, accuracy, power, type I error and overall ranking. For the reporting of simulation studies, we adapted previously developed criteria for reporting quality and applied them to eligible studies...
June 1, 2017: Journal of Clinical Epidemiology
L Martínez García, H Pardo-Hernandez, C Superchi, E Niño de Guzman, M Ballesteros, N Ibargoyen Roteta, E McFarlane, M Posso, M Roqué I Figuls, R Rotaeche Del Campo, A J Sanabria, A Selva, I Solà, R W M Vernooij, P Alonso-Coello
OBJECTIVE: To identify and describe strategies to prioritise the updating of systematic reviews (SRs), health technology assessments (HTAs), or clinical guidelines (CGs). STUDY DESIGN AND SETTING: We conducted a SR of studies describing one or more methods to prioritise SRs, HTAs, or CGs for updating. We searched MEDLINE (PubMed, from 1966 to August 2016) and The Cochrane Methodology Register (The Cochrane Library, Issue 8 2016). We handsearched abstract books, reviewed reference lists, and contacted experts...
May 23, 2017: Journal of Clinical Epidemiology
David Hajage, Florence Tubach, Yann De Rycke
No abstract text is available yet for this article.
May 23, 2017: Journal of Clinical Epidemiology
Mira Zuidgeest, Iris Goetz, Rolf Groenwold, Elaine Irving, Ghislaine van Thiel, Diederick E Grobbee
This is the introductory paper in a series of 8 papers (see box). In this series we integrate the theoretical design options with the practice of conducting pragmatic trials. For most new market-approved treatments the clinical evidence is insufficient to fully guide physicians and policy makers in choosing the optimal treatment for their patients. Pragmatic trials can fill this gap, by providing evidence on the relative effectiveness of a treatment strategy in routine clinical practice, already in an early phase of development, while maintaining the strength of randomized controlled trials...
May 23, 2017: Journal of Clinical Epidemiology
V Brueton, S P Stenning, F Stevenson, J Tierney, G Rait
OBJECTIVE: To develop best practice guidance for the use of retention strategies in randomised clinical trials (RCTs). DESIGN: Consensus development workshops. SETTING: Two UK Clinical Trials Units. PARTICIPANTS: 66 statisticians, clinicians, RCT coordinators, research scientists, research assistants, and data managers associated with RCTs. METHODS: The consensus development workshops were based on the consensus development conference method used to develop best practice for treatment of medical conditions...
May 22, 2017: Journal of Clinical Epidemiology
Cornelis A van den Bogert, Patrick C Souverein, Cecile Tm Brekelmans, Susan Wj Janssen, Gerard H Koëter, Hubert Gm Leufkens, Lex M Bouter
OBJECTIVE: To identify the occurrence and determinants of protocol-publication discrepancies in clinical drug trials. STUDY DESIGN AND SETTING: All published clinical drug trials reviewed by the Dutch Institutional Review Boards in 2007 were analyzed. Discrepancies between trial protocols and publications were measured among key reporting aspects. We evaluated the association of trial characteristics with discrepancies in primary endpoints by calculating the risk ratio (RR) and 95% confidence interval (CI)...
May 20, 2017: Journal of Clinical Epidemiology
Jamilla A Hussain, Martin Bland, Dean Langan, Miriam J Johnson, David C Currow, Ian R White
OBJECTIVES: Assess (i) the quality of reporting and handling missing data in palliative care trials against current guidance, (ii) whether there are differences in the reporting of criteria specified by the CONSORT 2010 statement compared to those not specified, (iii) the association of the reporting of missing data with journal impact factor and CONSORT endorsement status. STUDY DESIGN AND SETTING: Systematic review of palliative care randomised controlled trials...
May 19, 2017: Journal of Clinical Epidemiology
Gordon H Guyatt, Shanil Ebrahim, Pablo Alonso-Coello, Bradley C Johnston, Alexander G Mathioudakis, Matthias Briel, Reem A Mustafa, Xin Sun, Stephen D Walter, Diane Heels-Ansdell, Ignacio Neumann, Lara A Kahale, Alfonso Iorio, Joerg Meerpohl, Holger J Schünemann, Elie A Akl
OBJECTIVE: To provide GRADE guidance for assessing risk of bias across an entire body of evidence consequent on missing data for systematic reviews of both binary and continuous outcomes. STUDY DESIGN: Systematic survey of published methodological research, iterative discussions, testing in systematic reviews, and feedback from the GRADE Working Group. RESULTS: Approaches begin with a primary meta-analysis using a complete case analysis followed by sensitivity meta-analyses imputing, in each study, data for those with missing data, and then pooling across studies...
May 18, 2017: Journal of Clinical Epidemiology
Evan Mayo-Wilson, Nicole Fusco, Tianjing Li, Hwanhee Hong, Joseph K Canner, Kay Dickersin
OBJECTIVE: To identify variations in outcomes and results across reports of randomized clinical trials (RCTs). STUDY DESIGN AND SETTING: Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., journal articles) and non-public (e.g., clinical study reports) sources by 2015. We pre-specified outcome domains. From each source, we collected "outcomes" (i.e., domain, measure, metric, method of aggregation, and time-point); "treatment effect" (i...
May 18, 2017: Journal of Clinical Epidemiology
Tibor Schuster, Wilfrid Kouokam Lowe, Robert W Platt
No abstract text is available yet for this article.
May 18, 2017: Journal of Clinical Epidemiology
David S Riley, Melissa S Barber, Gunver S Kienle, Jeffry Aronson, Tido von Schoen-Angerer, Peter Tugwell, Helmut Kiene, Mark Helfand, Douglas G Altman, Harold Sox, Paul G Werthmann, David Moher, Richard A Rison, Larissa Shamseer, Christian A Koch, Gordon H Sun, Patrick Hanaway, Cleveland Clinic, Nancy L Sudak, Marietta Kaszkin-Bettag, Joel J Gagnier
Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines (CPGs), and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011-2012 a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist...
May 18, 2017: Journal of Clinical Epidemiology
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