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.
| Original language | English |
|---|---|
| Article number | 9 |
| Journal | Research integrity and peer review |
| Volume | 3 |
| DOIs | |
| Publication status | Published - 29 Oct 2018 |
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Keywords
- administrative data
- cohort
- CONSORT
- electronic health records
- electronic medical records
- electronic patient records
- randomized controlled trials
- RCTs
- registries
- reporting guideline
- routinely collected health data
Cite this
Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data. / Kwakkenbos, Linda; Juszczak, Edmund; Hemkens, Lars G; Sampson, Margaret; Fröbert, Ole; Relton, Clare; Gale, Chris; Zwarenstein, Merrick; Langan, Sinéad M; Moher, David; Boutron, Isabelle; Ravaud, Philippe; Campbell, Marion K; Mc Cord, Kimberly A; van Staa, Tjeerd P; Thabane, Lehana; Uher, Rudolf; Verkooijen, Helena M; Benchimol, Eric I; Erlinge, David; Sauvé, Maureen; Torgerson, David; Thombs, Brett D.
In: Research integrity and peer review, Vol. 3, 9, 29.10.2018.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data
AU - Kwakkenbos, Linda
AU - Juszczak, Edmund
AU - Hemkens, Lars G
AU - Sampson, Margaret
AU - Fröbert, Ole
AU - Relton, Clare
AU - Gale, Chris
AU - Zwarenstein, Merrick
AU - Langan, Sinéad M
AU - Moher, David
AU - Boutron, Isabelle
AU - Ravaud, Philippe
AU - Campbell, Marion K
AU - Mc Cord, Kimberly A
AU - van Staa, Tjeerd P
AU - Thabane, Lehana
AU - Uher, Rudolf
AU - Verkooijen, Helena M
AU - Benchimol, Eric I
AU - Erlinge, David
AU - Sauvé, Maureen
AU - Torgerson, David
AU - Thombs, Brett D
N1 - The development of this CONSORT extension has been funded by grants from the Canadian Institutes of Health Research (PIs = BDT, OF, EJ, LK, CR; grant #PJT-156172) and from the United Kingdom National Institute of Health Research (NIHR) Clinical Trials Unit Support Funding-Supporting efficient/innovative delivery of NIHR research (PI EJ, co-applicant CG). Dr. Thombs is supported by a Fonds de recherche du Québec-Santé researcher salary award. Dr. Gale is supported by the United Kingdom Medical Research Council through a Clinician Scientist Fellowship. Dr. Langan is supported by a Wellcome Senior Clinical Fellowship in Science (205039/Z/16/Z). Dr. Uher is supported by the Canada Research Chairs Program (Award #231397). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care.
PY - 2018/10/29
Y1 - 2018/10/29
N2 - 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.
AB - 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.
KW - administrative data
KW - cohort
KW - CONSORT
KW - electronic health records
KW - electronic medical records
KW - electronic patient records
KW - randomized controlled trials
KW - RCTs
KW - registries
KW - reporting guideline
KW - routinely collected health data
U2 - 10.1186/s41073-018-0053-3
DO - 10.1186/s41073-018-0053-3
M3 - Article
C2 - 30397513
VL - 3
JO - Research integrity and peer review
JF - Research integrity and peer review
SN - 2058-8615
M1 - 9
ER -