dc.contributor.author | Kwakkenbos, L | en_US |
dc.contributor.author | Juszczak, E | en_US |
dc.contributor.author | Hemkens, LG | en_US |
dc.contributor.author | Sampson, M | en_US |
dc.contributor.author | Fröbert, O | en_US |
dc.contributor.author | Relton, C | en_US |
dc.contributor.author | Gale, C | en_US |
dc.contributor.author | Zwarenstein, M | en_US |
dc.contributor.author | Langan, SM | en_US |
dc.contributor.author | Moher, D | en_US |
dc.contributor.author | Boutron, I | en_US |
dc.contributor.author | Ravaud, P | en_US |
dc.contributor.author | Campbell, MK | en_US |
dc.contributor.author | Mc Cord, KA | 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 | Benchimol, EI | en_US |
dc.contributor.author | Erlinge, D | en_US |
dc.contributor.author | Sauvé, M | en_US |
dc.contributor.author | Torgerson, D | en_US |
dc.contributor.author | Thombs, BD | en_US |
dc.date.accessioned | 2018-12-17T14:59:57Z | |
dc.date.available | 2018-09-21 | en_US |
dc.date.issued | 2018 | en_US |
dc.date.submitted | 2018-12-05T12:22:37.998Z | |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/53823 | |
dc.description.abstract | Background: Randomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data. Methods: The development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial "long list" of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the "long list" and generate a "short list" of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline. Discussion: Development of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data. | en_US |
dc.format.extent | 9 - ? | en_US |
dc.language | eng | en_US |
dc.language.iso | en | en_US |
dc.relation.ispartof | Res Integr Peer Rev | en_US |
dc.rights | This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. | |
dc.subject | Administrative data | en_US |
dc.subject | CONSORT | en_US |
dc.subject | Cohort | en_US |
dc.subject | Electronic health records | en_US |
dc.subject | Electronic medical records | en_US |
dc.subject | Electronic patient records | en_US |
dc.subject | RCTs | en_US |
dc.subject | Randomized controlled trials | en_US |
dc.subject | Registries | en_US |
dc.subject | Reporting guideline | en_US |
dc.subject | Routinely collected health data | en_US |
dc.title | Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data. | en_US |
dc.type | Article | |
dc.rights.holder | © The Author(s) 2018 | |
dc.identifier.doi | 10.1186/s41073-018-0053-3 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/30397513 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published online | en_US |
pubs.volume | 3 | en_US |
dcterms.dateAccepted | 2018-09-21 | en_US |
rioxxterms.funder | Default funder | en_US |
rioxxterms.identifier.project | Default project | en_US |