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; Merrick Zwarenstein; Eric I. Benchimol; Isabelle Boutron; Marion K. Campbell; David Erlinge; Sena Jawad; Philippe Ravaud; Danielle B. Rice; Maureen Sauve; Tjeerd P. Van Staa; Lehana Thabane; Rudolf Uher; Helena M. Verkooijen; Edmund Juszczak; Brett D. Thombs

doi:10.1136/bmjopen-2018-025266

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, Merrick Zwarenstein, Eric I. Benchimol, Isabelle Boutron, Marion K. Campbell, David Erlinge, Sena Jawad, Philippe Ravaud, Danielle B. Rice, Maureen Sauve, Tjeerd P. Van StaaLehana Thabane, Rudolf Uher, Helena M. Verkooijen, Edmund Juszczak, Brett D. Thombs

Medicine

Medicine

Résultat de recherche: Article › examen par les pairs

11 Citations (Scopus)

Résumé

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.

Langue d'origine	English
Numéro d'article	e025266
Journal	BMJ Open
Volume	8
Numéro de publication	8
DOI	https://doi.org/10.1136/bmjopen-2018-025266
Statut de publication	Published - août 1 2018

Note bibliographique

Funding Information:
The development of this CONSORT extension has been funded by grants from the Canadian Institutes of Health Research (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 (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 Crohns 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.

Funding Information:
Funding The development of this CONSORT extension has been funded by grants from the Canadian Institutes of Health Research (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 (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.

Publisher Copyright:
© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

ASJC Scopus Subject Areas

General Medicine

Accès au document

10.1136/bmjopen-2018-025266

Autres fichiers et liens

Citer

Kwakkenbos, L., Imran, M., McCord, K. A., Sampson, M., Fröbert, O., Gale, C., Hemkens, L. G., Langan, S. M., Moher, D., Relton, C., Zwarenstein, M., Benchimol, E. I., Boutron, I., Campbell, M. K., Erlinge, D., Jawad, S., Ravaud, P., Rice, D. B., Sauve, M., ... Thombs, B. D. (2018). Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data. BMJ Open, 8(8), Article e025266. https://doi.org/10.1136/bmjopen-2018-025266

Kwakkenbos, L, Imran, M, McCord, KA, Sampson, M, Fröbert, O, Gale, C, Hemkens, LG, Langan, SM, Moher, D, Relton, C, Zwarenstein, M, Benchimol, EI, Boutron, I, Campbell, MK, Erlinge, D, Jawad, S, Ravaud, P, Rice, DB, Sauve, M, Van Staa, TP, Thabane, L, Uher, R, Verkooijen, HM, Juszczak, E & Thombs, BD 2018, 'Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data', BMJ Open, vol. 8, n° 8, e025266. https://doi.org/10.1136/bmjopen-2018-025266

@article{847a64f0d197495199fb98d3adeae846,

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

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.",

author = "Linda Kwakkenbos and Mahrukh Imran and McCord, {Kimberly A.} and Margaret Sampson and Ole Fr{\"o}bert and Chris Gale and Hemkens, {Lars G.} and Langan, {Sinead M.} and David Moher and Clare Relton and Merrick Zwarenstein and Benchimol, {Eric I.} and Isabelle Boutron and Campbell, {Marion K.} and David Erlinge and Sena Jawad and Philippe Ravaud and Rice, {Danielle B.} and Maureen Sauve and {Van Staa}, {Tjeerd P.} and Lehana Thabane and Rudolf Uher and Verkooijen, {Helena M.} and Edmund Juszczak and Thombs, {Brett D.}",

note = "Funding Information: The development of this CONSORT extension has been funded by grants from the Canadian Institutes of Health Research (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 (EJ, co-applicant CG). BDT is supported by a Fonds de recherche du Qu{\'e}bec - Sant{\'e} 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 Crohns 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. Funding Information: Funding The development of this CONSORT extension has been funded by grants from the Canadian Institutes of Health Research (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 (EJ, co-applicant CG). BDT is supported by a Fonds de recherche du Qu{\'e}bec - Sant{\'e} 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{\textquoteright}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. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2018",

month = aug,

day = "1",

doi = "10.1136/bmjopen-2018-025266",

language = "English",

volume = "8",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "8",

}

TY - JOUR

T1 - Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data

AU - Kwakkenbos, Linda

AU - Imran, Mahrukh

AU - McCord, Kimberly A.

AU - Sampson, Margaret

AU - Fröbert, Ole

AU - Gale, Chris

AU - Hemkens, Lars G.

AU - Langan, Sinead M.

AU - Moher, David

AU - Relton, Clare

AU - Zwarenstein, Merrick

AU - Benchimol, Eric I.

AU - Boutron, Isabelle

AU - Campbell, Marion K.

AU - Erlinge, David

AU - Jawad, Sena

AU - Ravaud, Philippe

AU - Rice, Danielle B.

AU - Sauve, Maureen

AU - Van Staa, Tjeerd P.

AU - Thabane, Lehana

AU - Uher, Rudolf

AU - Verkooijen, Helena M.

AU - Juszczak, Edmund

AU - Thombs, Brett D.

N1 - Funding Information: The development of this CONSORT extension has been funded by grants from the Canadian Institutes of Health Research (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 (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 Crohns 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. Funding Information: Funding The development of this CONSORT extension has been funded by grants from the Canadian Institutes of Health Research (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 (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. Publisher Copyright: © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2018/8/1

Y1 - 2018/8/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85053158143&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85053158143&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2018-025266

DO - 10.1136/bmjopen-2018-025266

M3 - Article

C2 - 30082372

AN - SCOPUS:85053158143

SN - 2044-6055

VL - 8

JO - BMJ Open

JF - BMJ Open

IS - 8

M1 - e025266

ER -

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

Résumé

Note bibliographique

ASJC Scopus Subject Areas

Accès au document

Autres fichiers et liens

Empreinte numérique

Citer