CONSORT:  Consolidated Standards of Reporting Trials

References: The revised CONSORT statement for reporting randomized trials: explanation and elaboration (Altman et al. 2001); CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials (Moher et al. 2010)

Consort Extensions for RCTs – These guidelines involve adaptation of existing CONSORT 2010 guidelines, and inclusion of additional guidelines, to acknowledge the special features of particular kinds of studies involving RCTs, where these features might otherwise have been overlooked during the reporting process.

1. CONSORT Extension for Abstracts

2. CONSORT Extension for Harms-Related Data
   Reference: Better reporting of harms in randomized trials: an extension of the CONSORT statement (Ioannidis et al., 2004)
3. CONSORT Extension for Noninferiority and Equivalence Trials

Reference: Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement (Piaggio et al. 2012)

4. CONSORT Extension for Non-Pharmacologic Treatments
5. CONSORT Extension for Pragmatic Trials

6. CONSORT Extension for Quality of Life
   This extension has been under review since 2011

7. CONSORT Extension for Acupuncture Interventions
   Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA)

8. CONSORT Extension for Herbal-Medicinal Interventions

9. The CONSORT PRO extension: Reporting of Patient-Reported Outcomes in randomized trials

10. CONSORT Extension for cluster randomised controlled trials
    Reference: Consort 2010 statement: extension to cluster randomised trials. (Campbell et al. 2012)

11.  CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts

12. TIDieR (Template for Intervention Description and Replication)

Reference: Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide (Hoffman, et al., 2014)

13. Unofficial extensions of the CONSORT statement

These guidelines have been designed without the involvement or official approval of the CONSORT group. Therefore, in referencing these guidelines it is inappropriate to refer to them explicitly as CONSORT guidelines.

14. Occupational therapy randomized controlled trials

Nelson-Moberg Expanded CONSORT Instrument

Reference:  Evaluating the quality of reporting occupational therapy randomized controlled trials by expanding the CONSORT criteria. (Moberg-Mogren and Nelson, 2006)

15. Scoring the reporting of RCTs

Jadad Scale for reporting randomized trials

Assessing the quality of reports of randomized clinical trials: is blinding necessary? (Jadad et al. 1996)

The above paper reports on the systematic development of a 3-item scale – the Jadad Scale – for the evaluation of reporting of key elements of design within a RCT specifically within the context of studies evaluating pain relief.  The items address randomization, double-blinding and withdrawals and dropouts. The intention is to verify, not simply the recognition of these areas within the reporting of the trial but also, the adequacy of such reporting.  This instrument is recommended by the authors as of practical value in assessing the content of both the study protocol and the final report.

What’s missing?

There is “a need to develop a CONSORT extension with updated standards for social and psychological intervention trials.”  (Reference: Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications, Grant et al. 2013)

RANDOMIZED CONTROLLED TRIALS by Margaret MacDougall is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.