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New CONSORT extension for trials using cohorts and routinely collected data: CONSORT-ROUTINE

Cohort and routinely collected data are being increasingly used in randomised controlled trials (RCTs) to identify eligible participants, collect patient or outcome data, or implement interventions. The original Consolidated Standards of Reporting Trials (CONSORT) 2010 statement helps improve reporting of RCTs through transparency and completeness. Details of an extension to CONSORT for RCTs conducted using cohorts or routinely collected data, CONSORT-ROUTINE, have been recently published in the British Medical Journal.

Routinely collected data are data that are not initially collected with research purposes in mind, and include registries, databases (such as private health insurance databases) and electronic health records. Cohorts are groups of individuals from whom data are collected for research purposes. Although cohort and routinely collected data can make RCTs more efficient (eg, by reducing time and money spent on recruitment) and more representative of real world patient populations, current reporting guidelines do not cover their unique methodology in a standardised way.

Although cohort and routinely collected data can make RCTs more efficient and more representative of real world patient populations, current reporting guidelines do not cover their unique methodology in a standardised way.

Along with several modifications to the original checklist, the CONSORT-ROUTINE extension includes 5 new items specific to RCTs conducted using cohorts or routinely collected data:

  • ROUTINE-1 on the description of the cohort or routinely collected database(s)
  • ROUTINE-2 on the eligibility criteria for participants in the cohort or routinely collected database(s)
  • ROUTINE-3 on data linkage across 2 or more databases
  • ROUTINE-4 on consent for use of cohort or routinely collected data and trial participation
  • ROUTINE-5 on codes and algorithms used to define or derive the outcomes from the cohort or routinely collected database(s).

It is hoped that this new extension will improve the transparency and reporting of RCTs using cohort and routinely collected data, thereby helping to reduce wastage in research.

After reading the article, click here for a brief survey and to receive your authorization code for your Credit Tracker. This serves as documentation for the activity.

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