Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

Linda Kwakkenbos, Edmund Juszczak, Lars G Hemkens, Margaret Sampson, Ole Fröbert, Clare Relton, Chris Gale, Merrick Zwarenstein, Sinéad M Langan, David Moher, Isabelle Boutron, Philippe Ravaud, Marion K Campbell, Kimberly A Mc Cord, Tjeerd P van Staa, Lehana Thabane, Rudolf Uher, Helena M Verkooijen, Eric I Benchimol, David ErlingeMaureen Sauvé, David Torgerson, Brett D Thombs

Research output: Contribution to journalArticle

5 Downloads (Pure)

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 languageEnglish
Article number9
JournalResearch integrity and peer review
Volume3
DOIs
Publication statusPublished - 29 Oct 2018

Fingerprint

Randomized Controlled Trials
Health
Checklist
Guidelines
Electronic Health Records
Observational Studies
Registries
Publications
Epidemiology
Databases
Research

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 journalArticle

Kwakkenbos, L, Juszczak, E, Hemkens, LG, Sampson, M, Fröbert, O, Relton, C, Gale, C, Zwarenstein, M, Langan, SM, Moher, D, Boutron, I, Ravaud, P, Campbell, MK, Mc Cord, KA, van Staa, TP, Thabane, L, Uher, R, Verkooijen, HM, Benchimol, EI, Erlinge, D, Sauvé, M, Torgerson, D & Thombs, BD 2018, 'Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data', Research integrity and peer review, vol. 3, 9. https://doi.org/10.1186/s41073-018-0053-3
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. / Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data. In: Research integrity and peer review. 2018 ; Vol. 3.
@article{0e5a25add7df4db8b147f2523319de3b,
title = "Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data",
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.",
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",
author = "Linda Kwakkenbos and Edmund Juszczak and Hemkens, {Lars G} and Margaret Sampson and Ole Fr{\"o}bert and Clare Relton and Chris Gale and Merrick Zwarenstein and Langan, {Sin{\'e}ad M} and David Moher and Isabelle Boutron and Philippe Ravaud and Campbell, {Marion K} and {Mc Cord}, {Kimberly A} and {van Staa}, {Tjeerd P} and Lehana Thabane and Rudolf Uher and Verkooijen, {Helena M} and Benchimol, {Eric I} and David Erlinge and Maureen Sauv{\'e} and David Torgerson and Thombs, {Brett D}",
note = "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 Qu{\'e}bec-Sant{\'e} 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.",
year = "2018",
month = "10",
day = "29",
doi = "10.1186/s41073-018-0053-3",
language = "English",
volume = "3",
journal = "Research integrity and peer review",
issn = "2058-8615",

}

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 -