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Journal of Clinical Epidemiology

Rooshenas L, Scott Lj, Blazeby Jm, Rogers Ca, Tilling Km, Husbands S, Conefrey C, Mills N, Stein Rc, Metcalfe C, Carr Aj, Beard Dj, Davis T, Paramasivan S, Jepson M, Avery K, Elliott D, Wilson C, Donovan Jl
OBJECTIVE: To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties, and then implements 'QRI-actions' to address these as recruitment proceeds. STUDY DESIGN AND SETTING: A mixed-methods study, comprising: a) before-and-after comparisons of recruitment rates and numbers of patients approached, and b) qualitative case studies, including documentary analysis and interviews with RCT investigators...
October 16, 2018: Journal of Clinical Epidemiology
Konstantinos I Bougioukas, Emmanouil Bouras, Fani Apostolidou-Kiouti, Stamatia Kokkali, Malamatenia Arvanitidou, Anna-Bettina Haidich
OBJECTIVE: An overview of systematic reviews (OoSRs) is a study designed to offer a broad view of evidence from existing systematic reviews (SRs). The abstract is an important part of an OoSRs as it can determine whether reading the full text is of interest. The aim of this paper is to offer guidelines to promote transparent and sufficient reporting in abstracts of OoSRs of health care interventions. STUDY DESIGN AND SETTING: The items were developed by combining key features from abstracts of OoSRs, PRISMA for abstracts and our published reporting guidelines for OoSRs...
October 15, 2018: Journal of Clinical Epidemiology
Ivana Propadalo, Mia Tranfic, Ivana Vuka, Ognjen Barcot, Tina Poklepovic Pericic, Livia Puljak
AIM: To analyze whether the risk of bias (RoB) judgments for allocation concealment in Cochrane systematic reviews (CSRs) were in line with recommendations from the Cochrane Handbook. METHODS: From CSR we extracted data about judgments and supporting comments about allocation concealment for each included RCT. We compared whether judgments for supporting comments were in line with Cochrane Handbook recommendations. RESULTS: We analyzed judgments and comments of 721 CSRs in which 10280 RCTs were included...
October 9, 2018: Journal of Clinical Epidemiology
Reid C Robson, Ba' Pham, Jeremiah Hwee, Sonia M Thomas, Patricia Rios, Matthew J Page, Andrea C Tricco
OBJECTIVE: To identify and summarize studies assessing methodologies for study selection, data abstraction, or quality appraisal in systematic reviews. STUDY DESIGN AND SETTING: A systematic review was conducted, searching MEDLINE, EMBASE, and the Cochrane Library from inception to Sept 1, 2016. Quality appraisal of included studies was undertaken using a modified QUADAS-2 and key results on accuracy, reliability, or efficiency of a methodology, or impact on results and conclusions were extracted...
October 9, 2018: Journal of Clinical Epidemiology
Lara A Kahale, Batoul Diab, Assem M Khamis, Yaping Chang, Luciane Cruz Lopes, Arnav Agarwal, Ling Li, Reem Mustafa, Serge Koujanian, Reem Waziry, Jason W Busse, Abeer Dakik, Gordon Guyatt, Elie A Akl
BACKGROUND: Missing data for the outcomes of participants in randomized controlled trials (RCTs) are a key element of risk of bias assessment. However, it is not always clear from RCT reports whether some categories of participants were followed-up or not (i.e., do or do not have missing data) nor how the RCT authors dealt with missing data in their analyses. OBJECTIVE: Our objectives were to describe how RCT authors: (1) report on different categories of participants that might have missing data; (2) handle these categories in the analysis; and (3) judge the risk of bias associated with missing data...
October 6, 2018: Journal of Clinical Epidemiology
Brian H Willis, Dyuti Coomar, Mohammed Baragilly
BACKGROUND: Meta-analysis may produce estimates that are unrepresentative of a test's performance in practice. Tailored meta-analysis (TMA) circumvents this by deriving an applicable region for the practice and selecting the studies compatible with the region. It requires the test positive rate, r and prevalence, p being estimated for the setting but previous studies have assumed their independence. The aim is to investigate the effects a correlation between r and p has on estimating the applicable region and how this affects TMA...
September 29, 2018: Journal of Clinical Epidemiology
Ling Li, Chang Xu, Ke Deng, Xu Zhou, Zhibin Liu, Jason W Busse, Yan Ren, Kang Zou, Xin Sun
OBJECTIVES: To examine, through a cross-sectional survey, how well safety information was reported among drug systematic reviews predating PRISMA harms checklist, and explore factors associated with better reporting. STUDY DESIGN AND SETTING: We searched PubMed to identify all systematic reviews published in the Cochrane Database of Systematic Review or the Core Clinical Journals in 2015, one year before the PRISMA harms checklist was published. We randomly selected, in a 1:1 ratio, Cochrane and non-Cochrane systematic reviews assessing drug effects (including both efficacy and safety)...
September 29, 2018: Journal of Clinical Epidemiology
James Griffin, Ranjit Lall, Julie Bruce, Emma Withers, Susanne Finnegan, Sarah E Lamb
BACKGROUND: Prospective, monthly diaries are recommended for collecting falls data but are burdensome and expensive. OBJECTIVE: To compare characteristics of fallers and estimates of fall rates by method of data collection. DESIGN: and Setting: A methodology study nested within a large cluster RCT. We randomised 9803 older adults from 63 general practices across England to receive one of three fall prevention interventions. Participants provided a retrospective report of falls in postal questionnaires mailed every four months...
September 25, 2018: Journal of Clinical Epidemiology
Tim Mathes, Pauline Klaßen, Dawid Pieper
OBJECTIVE: The study aims to assess whether the results from registry-based randomized trials (RRCTs) systematically differ from the results of conventional randomized controlled trials (CRCTs). STUDY DESIGN: Meta-epidemiological study. We identified RRCTs (02/2016) and subsequent systematic reviews (SRs) that included one RRCT (04/2017). We calculated pooled odds ratios for RRCTs and CRCTs for mortality and other incidence measures (e.g., cardiovascular events)...
September 23, 2018: Journal of Clinical Epidemiology
Richeek Pradhan, David C Hoaglin, Matthew Cornell, Weisong Liu, Victoria Wang, Hong Yu
OBJECTIVE: Systematic reviews and meta-analyses are labor-intensive and time-consuming. Automated extraction of quantitative data from primary studies can accelerate this process., launched in 2000, is the world's largest trial repository of results data from clinical trials; it has been used as a source instead of journal articles. We have developed a web application called EXACT that allows users without advanced programming skills to automatically extract data from ClinicalTrials...
September 23, 2018: Journal of Clinical Epidemiology
Shelly-Anne Li, Paul E Alexander, Tea Reljic, Adam Cuker, Robby Nieuwlaat, Wojtek Wiercioch, Gordon Guyatt, Holger J Schünemann, Benjamin Djulbegovic
OBJECTIVE: It is unclear how guidelines panelists discuss and consider factors (criteria) that are formally and not formally included in the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. To describe the use of decision criteria, we explored how panelists adhered to GRADE criteria, and sought to identify any emerging non-GRADE criteria when panelists used the Evidence to Decision (EtD) framework as part of GRADE application. STUDY DESIGN AND SETTING: We used conventional and summative qualitative analyses to identify themes emerging from face-to-face, panel meeting discussions...
September 22, 2018: Journal of Clinical Epidemiology
Edgar Gerardo Dorsey-Treviño, Neri Álvarez-Villalobos, José Gerardo González-González, Alejandro Díaz González-Colmenero, Francisco Jesús Barrera-Flores, Rozalina G McCoy, Juan P Brito, Alejandro Salcido-Montenegro, Victor M Montori, René Rodríguez-Gutiérrez
No abstract text is available yet for this article.
September 22, 2018: Journal of Clinical Epidemiology
Femke Abma, Jakob Bue Bjorner, Benjamin C Amick, Ute Bültmann
OBJECTIVE: The study aims to develop and validate short versions of the Work Role Functioning Questionnaire v2.0 (WRFQ) that retain the measurement properties of the full-length 27-item questionnaire. STUDY DESIGN AND SETTING: Six cross-sectional Dutch samples (N=2433) were used, containing data on gender, self-rated health, job type and WRFQ scores. Indicators from classical test theory and item response theory methods were used along with evaluation of translatability and conceptual considerations to identify short version candidate items...
September 22, 2018: Journal of Clinical Epidemiology
Nadine Binder, Anette Blümle, James Balmford, Edith Motschall, Patrick Oeller, Martin Schumacher
OBJECTIVE: In epidemiological cohort studies with missing disease information due to death (MDID), conventional analyses right-censoring death cases at last observation or at death may yield significant bias in relative risk and hazard ratio estimates. The aim of this study was to investigate susceptibility to this bias and to assess its potential direction and magnitude. STUDY DESIGN AND SETTING: Literature review of selected epidemiological, geriatric and environmental journals in 2011-2012, and simulation study of various conventional approaches to handling missing disease data...
September 22, 2018: Journal of Clinical Epidemiology
Romina Brignardello-Petersen, M Hassan Murad, Stephen D Walter, Shelley McLeod, Alonso Carrasco-Labra, Bram Rochwerg, Holger J Schünemann, George Tomlinson, Gordon H Guyatt
When direct and indirect estimates of treatment effects are coherent, network meta-analysis (NMA) estimates should have increased precision (narrower confidence or credible intervals compared with relying on direct estimates alone), a benefit of NMA. We have, however, observed cases of sparse networks in which combining direct and indirect estimates results in marked widening of the confidence intervals. In many cases, the assumption of common between-study heterogeneity across the network seems to be responsible for this counterintuitive result...
September 22, 2018: Journal of Clinical Epidemiology
R Quinzler, M H Freitag, B Wiese, M Beyer, H Brenner, A Dahlhaus, A Döring, T Freund, M Heier, H Knopf, M Luppa, J Prokein, S Riedel-Heller, I Schäfer, C Scheidt-Nave, M Scherer, B Schöttker, J Szecsenyi, P Thürmann, H van den Bussche, J Gensichen, W E Haefeli
OBJECTIVE: On the basis of current treatment guidelines, we developed and validated a medication-based chronic disease score (medCDS) and tested its association with all-cause mortality of older outpatients. STUDY DESIGN AND SETTING: Considering the most prevalent chronic diseases in the elderly German population, we compiled a list of evidence-based medicines used to treat these disorders. Based on this list, a score (medCDS) was developed to predict mortality using data of a large longitudinal cohort of older outpatients (training sample; MultiCare Cohort Study)...
September 22, 2018: Journal of Clinical Epidemiology
Kathryn Nicholson, Tatjana T Makovski, Lauren E Griffith, Parminder Raina, Saverio Stranges, Marjan van den Akker
No abstract text is available yet for this article.
September 22, 2018: Journal of Clinical Epidemiology
Michael Anderson, Huseyin Naci, Deborah Morrison, Leeza Osipenko, Elias Mossialos
OBJECTIVE: To identify and assess the methods for estimating comparative clinical effectiveness for novel pharmaceutical products licensed on the basis of non-RCT data and to evaluate the corresponding NICE recommendations. METHODS: Our identification strategy was two-fold. First, we reviewed all NICE appraisals between 2010 and 2016 and identified technologies where comparative clinical effectiveness estimates were calculated using non-RCT data. Second, we checked if NICE appraisals completed from 2000 to 2010 had included pharmaceuticals that were granted EMA marketing authorisation without RCT data between 1999-2014...
September 17, 2018: Journal of Clinical Epidemiology
R Pajouheshnia, M van Smeden, L M Peelen, R H H Groenwold
BACKGROUND AND OBJECTIVE: Diagnostic and prognostic prediction models often perform poorly when externally validated. We investigate how differences in the measurement of predictors across settings affect the discriminative power and transportability of a prediction model. METHODS: Differences in predictor measurement between data sets can be described formally using a measurement error taxonomy. Using this taxonomy, we derive an expression relating variation in the measurement of a continuous predictor to the area under the receiver operating characteristic curve (AUC) of a logistic regression prediction model...
September 14, 2018: Journal of Clinical Epidemiology
Loukia M Spineli
OBJECTIVES: To elaborate on the conceptual evaluation of transitivity assumption in the context of binary missing participant outcome data (MOD) in network meta-analysis (NMA) and to emphasize on the importance of statistical modeling as a mean to address MOD. STUDY DESIGN AND SETTING: We designate the notion of transitivity assumption in the context of binary MOD and indicate scenarios that compromise transitivity in complex networks. We propose a modification of these scenarios that preserves transitivity assumption...
September 14, 2018: Journal of Clinical Epidemiology
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