Evidence map›Paper›PMID 30082372›Full record

ArticleBMJ open2018

Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data.

Linda Kwakkenbos, Mahrukh Imran, Kimberly A McCord, Margaret Sampson, Ole Fröbert, Chris Gale, Lars G Hemkens, Sinead M Langan, David Moher, Clare Relton and 15 more

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 10% of its field
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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
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  8. 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

25 authors at 18 institutions in 6 countries.

Linda KwakkenbosBehavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Gelderland, Netherlands.
Mahrukh ImranLady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada.
Kimberly A McCordBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Margaret SampsonLibrary Services, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
Ole FröbertDepartment of Cardiology, Faculty of Health, Örebro University, Örebro, UK.
Chris GaleSection of Neonatal Medicine, Department of Medicine, Imperial College London, London, UK.
Lars G HemkensBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Sinead M LanganFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
David MoherCentre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Clare ReltonCentre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK.
Merrick ZwarensteinDepartment of Family Medicine, Western University, London, UK.
Eric I BenchimolDepartment of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
Isabelle BoutronSorbonne Paris Cité Epidemiology and Statistics Research Center, INSERM, UMR1153, Paris, France.
Marion K CampbellHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
David ErlingeDepartment of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
Sena JawadSection of Neonatal Medicine, Department of Medicine, Imperial College London, London, UK.
Philippe RavaudSorbonne Paris Cité Epidemiology and Statistics Research Center, INSERM, UMR1153, Paris, France.
Danielle B RiceLady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada.ORCID 0000-0001-5615-7005
Maureen SauveScleroderma Society of Ontario, Hamilton, Ontario, Canada.
Tjeerd P van StaaHealth e-Research Centre, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Lehana ThabaneDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Rudolf UherDepartment of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.
Helena M VerkooijenDepartment of Epidemiology, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID 0000-0001-9480-1623
Edmund JuszczakNPEU Clinical Trials Unit, National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Brett D ThombsLady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada.ORCID 0000-0002-5644-8432
Jewish General Hospital · CADélégation Paris 5 · FRImperial College London · GBUniversity of Basel · CHUtrecht University · NLChildren's Hospital of Eastern Ontario · CADalhousie University · CAImpact · CALondon School of Hygiene & Tropical Medicine · GBLund University · SEMultiple Sclerosis Society of Canada · CAOttawa Hospital · CAQueen Mary University of London · GBRadboud University Nijmegen · NLUniversity of Aberdeen · GBUniversity of Ottawa · CAUniversity of Oxford · GBWestern University · CA

Funding

CIHR PJT-156172Medical Research Council MR/N008405/1Wellcome TrustWellcome Trust 205039/Z/16/Z
6 · The paper itself

Abstract

introductionRandomised controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data is being undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. To develop this extension to the CONSORT statement, a scoping review will be conducted to identify potential modifications or clarifications of existing reporting guideline items, as well as additional items needed for reporting RCTs using cohorts and routinely collected health data. METHODS AND ANALYSIS: In separate searches, we will seek publications on methods or reporting or that describe protocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources will include Medline and the Cochrane Methodology Register. For each of the four main types of RCTs using cohorts and routinely collected health data, separately, two investigators will independently review included publications to extract potential checklist items. A potential item will either modify an existing CONSORT 2010, Strengthening the Reporting of Observational Studies in Epidemiology or REporting of studies Conducted using Observational Routinely collected health Data item or will be proposed as a new item. Additionally, we will identify examples of good reporting in RCTs using cohorts and routinely collected health data. ETHICS AND DISSEMINATION: The proposed scoping review will help guide the development of the CONSORT extension statement for RCTs conducted using cohorts and routinely collected health data.

Indexed as

Cohort StudiesGuidelines as TopicRandomized Controlled Trials as TopicResearch DesignAdministrative Claims, HealthcareElectronic Health RecordsHumansObservational Studies as TopicRegistriesScoping Reviews as Topiccohortconsortrandomized controlled trialsrctsreporting guidelineroutinely collected health data

Identifiers

PMID30082372
PMCPMC6078273
OpenAlexW2885245352

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.