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Reporting Transpare...
Reporting Transparency and Completeness in Trials : Paper 4 - Reporting of randomised controlled trials conducted using routinely collected electronic records - room for improvement
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- McCall, Stephen J. (author)
- 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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- Imran, Mahrukh (author)
- Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada
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- Hemkens, Lars G. (author)
- Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland
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- Cord, Kimberly Mc. (author)
- Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland
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- Kwakkenbos, Linda (author)
- Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands
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- Sampson, Margaret (author)
- Library Services, Children's Hospital of Eastern Ontario, Ottawa, Canada
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- Jawad, Sena (author)
- Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom
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- Zwarenstein, Merrick (author)
- Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Canada
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- Relton, Clare (author)
- Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, United Kingdom
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- Langan, Sinéad M. (author)
- Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom
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- Moher, David (author)
- Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
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- Fröbert, Ole, 1964- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Department of Cardiology
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- Thombs, Brett D. (author)
- Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, 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 Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada
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- Gale, Chris (author)
- Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom
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- Juszczak, Edmund (author)
- 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, Building 42, University Park, Nottingham, United Kingdom
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CONSORT Extension for Trials Conducted Using Cohorts and RoutinelyCollected Data Group, - (contributor)
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(creator_code:org_t)
- Pergamon Press, 2022
- 2022
- English.
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In: Journal of Clinical Epidemiology. - : Pergamon Press. - 0895-4356 .- 1878-5921. ; 141, s. 198-209
- Related links:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- OBJECTIVE: To describe characteristics of randomised controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.STUDY DESIGN: MEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011-2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form.RESULTS: 183 RCT publications were identified; 122 (67%) used EHRs to identify eligible participants, 139 (76%) used the EHR as part of the intervention and 137 (75%) to ascertain outcomes. When 60 publications were evaluated against the CONSORT 2010 item and the corresponding extension for the 8 modified items, four items were 'adequately reported' for the majority of trials. Five new reporting items were identified for the CONSORT-ROUTINE extension; when evaluated, one was 'adequately reported', three were reported 'inadequately or not at all', the other 'partially'. There were, however, some encouraging signs with adequate and partial reporting of many important items, including descriptions of trial design, the consent process, outcome ascertainment and interpretation.CONCLUSION: Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.
Subject headings
- 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)
Keyword
- CONSORT-ROUTINE extension routinely collected data
Publication and Content Type
- ref (subject category)
- art (subject category)
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McCall, Stephen ...
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Imran, Mahrukh
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Hemkens, Lars G.
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Cord, Kimberly M ...
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Kwakkenbos, Lind ...
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Sampson, Margare ...
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show more...
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Jawad, Sena
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Zwarenstein, Mer ...
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Relton, Clare
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Langan, Sinéad M ...
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Moher, David
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Fröbert, Ole, 19 ...
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Thombs, Brett D.
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Gale, Chris
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Juszczak, Edmund
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CONSORT Extensio ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Health Sciences
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Örebro University