Evidence map›Paper›PMID 34525409›Full record

ArticleJournal of clinical epidemiology2022

Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records - room for improvement.

Stephen J McCall, Mahrukh Imran, Lars G Hemkens, Kimberly Mc Cord, Linda Kwakkenbos, Margaret Sampson, Sena Jawad, Merrick Zwarenstein, Clare Relton, Sinéad M Langan and 6 more

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In one paragraph

Article in Journal of clinical epidemiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Stephen J McCallNuffield Department of Population Health, National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford, United Kingdom; Center for Research on Population and Health, American University of Beirut, Ras Beirut, Lebanon.
Mahrukh ImranLady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.
Lars G HemkensBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Kimberly Mc CordBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Linda KwakkenbosBehavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands.
Margaret SampsonLibrary Services, Children's Hospital of Eastern Ontario, Ottawa, Canada.
Sena JawadNeonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.
Merrick ZwarensteinDepartment of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Canada.
Clare ReltonCentre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, United Kingdom.
Sinéad M LanganFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
David MoherCentre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Ole FröbertDepartment of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.
Brett D ThombsLady 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.
Chris GaleNeonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.
Edmund JuszczakNuffield Department of Population Health, National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford, United Kingdom; Nottingham Clinical Trials Unit, Applied Health Research Building, University of Nottingham, Nottingham, United Kingdom. Electronic address: ed.juszczak@nottingham.ac.uk.
CONSORT Extension for Trials Conducted Using Cohorts and RoutinelyCollected Data Group

Funding

Department of HealthMedical Research Council MR/N008405/1Medical Research Council MR/V036866/1Wellcome Trust 205039/Z/16/Z
6 · The paper itself

Abstract

objectiveTo describe characteristics of randomized 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

designMEDLINE 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.

resultsOf the 183 RCT publications 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 most 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.

conclusionAspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.

Indexed as

Randomized Controlled Trials as TopicResearch DesignElectronic Health RecordsElectronicsHumansCollectedCONSORT-ROUTINEDataExtensionHealthRoutinely

Identifiers

PMID34525409
PMCPMC8982641

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.