dc.contributor.author | Kwakkenbos, L | en_US |
dc.contributor.author | Imran, M | en_US |
dc.contributor.author | McCord, KA | en_US |
dc.contributor.author | Sampson, M | en_US |
dc.contributor.author | Fröbert, O | en_US |
dc.contributor.author | Gale, C | en_US |
dc.contributor.author | Hemkens, LG | en_US |
dc.contributor.author | Langan, SM | en_US |
dc.contributor.author | Moher, D | en_US |
dc.contributor.author | Relton, C | en_US |
dc.contributor.author | Zwarenstein, M | en_US |
dc.contributor.author | Benchimol, EI | en_US |
dc.contributor.author | Boutron, I | en_US |
dc.contributor.author | Campbell, MK | en_US |
dc.contributor.author | Erlinge, D | en_US |
dc.contributor.author | Jawad, S | en_US |
dc.contributor.author | Ravaud, P | en_US |
dc.contributor.author | Rice, DB | en_US |
dc.contributor.author | Sauve, M | en_US |
dc.contributor.author | van Staa, TP | en_US |
dc.contributor.author | Thabane, L | en_US |
dc.contributor.author | Uher, R | en_US |
dc.contributor.author | Verkooijen, HM | en_US |
dc.contributor.author | Juszczak, E | en_US |
dc.contributor.author | Thombs, BD | en_US |
dc.date.accessioned | 2019-11-14T15:50:24Z | |
dc.date.issued | 2018-08-05 | en_US |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/61374 | |
dc.description.abstract | INTRODUCTION: Randomised 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. | en_US |
dc.description.sponsorship | Canadian Institutes of Health Research (BDT, OF, EJ, LK, CR; Grant #PJT156172), and from the United Kingdom National Institute of Health Research (NIHR) Clinical Trials Unit Support Funding - Supporting efficient / innovative delivery of NIHR research (EJ, co-applicant CG). BDT is supported by a Fonds de recherche du Québec - Santé researcher salary award. CG is supported by the United Kingdom Medical Research Council through a Clinician Scientist Fellowship. SML is supported by a Wellcome Senior Clinical Fellowship in Science (205039/Z/16/Z). RU is supported by the Canada Research Chairs Program (Award #231397). EIB is supported by a New Investigator Award from the Canadian Institutes of Health Research, Canadian Association of Gastroenterology and Crohn’s and Colitis Canada, and the Career Enhancement Program of the Canadian Child Health Clinician Scientist Program. DBR is supported by a Vanier CIHR Graduate Scholarship. | en_US |
dc.format.extent | e025266 - ? | en_US |
dc.language | eng | en_US |
dc.language.iso | en | en_US |
dc.relation.ispartof | BMJ Open | en_US |
dc.rights | CC-BY-NC | |
dc.rights | Attribution-NonCommercial 3.0 United States | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/3.0/us/ | * |
dc.subject | cohort | en_US |
dc.subject | consort | en_US |
dc.subject | randomized controlled trials | en_US |
dc.subject | rcts | en_US |
dc.subject | reporting guideline | en_US |
dc.subject | routinely collected health data | en_US |
dc.subject | Administrative Claims, Healthcare | en_US |
dc.subject | Cohort Studies | en_US |
dc.subject | Electronic Health Records | en_US |
dc.subject | Guidelines as Topic | en_US |
dc.subject | Humans | en_US |
dc.subject | Randomized Controlled Trials as Topic | en_US |
dc.subject | Registries | en_US |
dc.subject | Research Design | en_US |
dc.subject | Review Literature as Topic | en_US |
dc.title | Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data. | en_US |
dc.type | Article | |
dc.rights.holder | Author(s) (or their employer(s)) 2018 | |
dc.identifier.doi | 10.1136/bmjopen-2018-025266 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/30082372 | en_US |
pubs.issue | 8 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published online | en_US |
pubs.volume | 8 | en_US |
rioxxterms.funder | Default funder | en_US |
rioxxterms.identifier.project | Default project | en_US |