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

Kwakkenbos, Linda; Imran, Mahrukh; McCord, Kimberly A.; Sampson, Margaret; Fröbert, Ole; Gale, Chris; Hemkens, Lars G.; Langan, Sinead M.; Moher, David and Relton, Clare, et al. (2018) In BMJ Open 8(8).
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... (More)

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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cohort, consort, randomized controlled trials, rcts, reporting guideline, routinely collected health data
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BMJ Open
volume
8
issue
8
publisher
British Medical Journal Publishing Group
external identifiers
  • scopus:85053158143
ISSN
2044-6055
DOI
10.1136/bmjopen-2018-025266
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English
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yes
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10d52f01-3529-49ce-9a77-2bf9bf1536a8
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2018-10-18 12:28:08
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2019-02-20 11:31:54
@article{10d52f01-3529-49ce-9a77-2bf9bf1536a8,
  abstract     = {<p>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.</p>},
  articleno    = {e025266},
  author       = {Kwakkenbos, Linda and Imran, Mahrukh and McCord, Kimberly A. and Sampson, Margaret and Fröbert, Ole and Gale, Chris and Hemkens, Lars G. and Langan, Sinead M. and Moher, David and Relton, Clare and Zwarenstein, Merrick and Benchimol, Eric I. and Boutron, Isabelle and Campbell, Marion K. and Erlinge, David and Jawad, Sena and Ravaud, Philippe and Rice, Danielle B. and Sauve, Maureen and Van Staa, Tjeerd P. and Thabane, Lehana and Uher, Rudolf and Verkooijen, Helena M. and Juszczak, Edmund and Thombs, Brett D.},
  issn         = {2044-6055},
  keyword      = {cohort,consort,randomized controlled trials,rcts,reporting guideline,routinely collected health data},
  language     = {eng},
  number       = {8},
  publisher    = {British Medical Journal Publishing Group},
  series       = {BMJ Open},
  title        = {Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data},
  url          = {http://dx.doi.org/10.1136/bmjopen-2018-025266},
  volume       = {8},
  year         = {2018},
}