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

Institute of Applied Health Sciences

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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.

Original language	English
Pages (from-to)	e025266
Journal	BMJ Open
Volume	8
Issue number	8
DOIs	https://doi.org/10.1136/bmjopen-2018-025266
Publication status	Published - 5 Aug 2018

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Journal Article

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10.1136/bmjopen-2018-025266Licence: CC BY-NC

Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data
© 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. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Final published version, 207 KBLicence: CC BY-NC

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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), 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, no. 8, pp. e025266. https://doi.org/10.1136/bmjopen-2018-025266

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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

PY - 2018/8/5

Y1 - 2018/8/5

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.

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DO - 10.1136/bmjopen-2018-025266

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C2 - 30082372

SN - 2044-6055

VL - 8

SP - e025266

JO - BMJ Open

JF - BMJ Open

IS - 8

ER -

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

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