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Reporting Transparency and Completeness in Trials : Paper 2 - Reporting of randomised trials using registries was often inadequate and hindered the interpretation of results

Cord, Kimberly A. Mc. (författare)
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland
Imran, Mahrukh (författare)
Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada
Rice, Danielle B. (författare)
Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada
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McCall, Stephen J. (författare)
National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Center for Research on Population and Health, Faculty of Health Sciences, American University of Beirut, Ras Beirut, Lebanon
Kwakkenbos, Linda (författare)
Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands
Sampson, Margaret (författare)
Library Services, Children's Hospital of Eastern Ontario, Ottawa, Canada
Fröbert, Ole, 1964- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,Department of Cardiology
Gale, Chris (författare)
Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK
Langan, Sinéad M. (författare)
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK
Moher, David (författare)
Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Relton, Clare (författare)
Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK
Zwarenstein, Merrick (författare)
Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada
Juszczak, Edmund (författare)
National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Nottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, United Kingdom
Thombs, Brett D. (författare)
Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Departments of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada.; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada
Hemkens, Lars G. (författare)
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland; Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA
CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group, - (bidragsgivare)
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland; Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA
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 (creator_code:org_t)
Pergamon Press, 2022
2022
Engelska.
Ingår i: Journal of Clinical Epidemiology. - : Pergamon Press. - 0895-4356 .- 1878-5921. ; 141, s. 175-186
Relaterad länk:
https://doi.org/10.1...
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http://www.jclinepi....
https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • OBJECTIVE: Registries are important data sources for randomised controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries.STUDY DESIGN AND SETTING: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed.RESULTS: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate).CONCLUSION: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap -- Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Health Sciences -- Health Care Service and Management, Health Policy and Services and Health Economy (hsv//eng)

Nyckelord

CONSORT
CONSORT-ROUTINE
randomised controlled trials
registries
reporting guideline
routinely collected data

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