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Reporting Transparency and Completeness in Trials : Paper 3 - Trials conducted using administrative databases do not adequately report elements related to use of databases

Imran, Mahrukh (författare)
Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada
Cord, Kimberly Mc. (författare)
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland
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
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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, United Kingdom
Hemkens, Lars G. (författare)
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland
Langan, Sinéad M. (författare)
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom
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, United Kingdom
Zwarenstein, Merrick (författare)
Department of Family Medicine, 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 Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada
Consort Extension For Trials Conducted Using Cohorts And Routinely Collected Data Group, - (bidragsgivare)
Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada
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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. 187-197
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: We evaluated reporting completeness and transparency in randomised controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.STUDY DESIGN AND SETTING: MEDLINE and the Cochrane Methodology Register were searched (2011 and 2018). Eligible RCTs used administrative databases for identifying eligible participants or collecting outcomes. We evaluated reporting based on CONSORT-ROUTINE, which modified eight items from CONSORT 2010 and added five new items.RESULTS: Of 33 included trials (76% used administrative databases for outcomes, 3% for identifying participants, 21% both), most were conducted in the United States (55%), Canada (18%), or the United Kingdom (12%). Of eight items modified in the extension; six were adequately reported in a majority (>50%) of trials. For the CONSORT-ROUTINE modification portion of those items, three items were reported adequately in >50% of trials, two in <50%, two only applied to some trials, and one only had wording modifications and was not evaluated. For five new items, four that address use of routine data in trials were reported inadequately in most trials.CONCLUSION: How administrative data are used in trials is often sub-optimally reported. CONSORT-ROUTINE uptake may improve reporting.

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
administrative data
randomised controlled trials
reporting guideline
routinely collected data

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