News
CONSORT extensions
02 November 2011
News
Are you reporting a randomised controlled trial that differs from the standard two group parallel trial design?
Did you know that there are several extensions to the CONSORT Statement to help you address crucial features of your trial in your manuscript if it involves particular methodological designs (e.g., cluster trial), interventions (e.g., herbal medicines) or types of data (e.g., harms)?
You can find out more about the available extensions that may be useful for you on the CONSORT website http://www.consort-statement.org/extensions/. The website also provides information about revisions or updates to the existing extensions and alerts researchers to new extensions under development. Following the 2010 update to the main CONSORT Statement [1] the prime focus is to update the various extensions in line with this.
For each available extension the CONSORT group briefly describes the rationale for the particular modification and outlines how the guideline was developed. Development usually involves other stakeholders in the particular field participating in face to face consensus meetings to identify the crucial reporting items. For each extension the relevant publication(s) is (are) referenced, pdfs provided and also stand-alone checklists and flow-diagrams are often available to be used as tools to assist in the writing or peer review of manuscripts.
| Design extensions | Rationale for extension | Main reporting issue(s) | Updated to; 2010 CONSORT? Other languages? |
|---|---|---|---|
| Cluster randomised trials |
Randomises groups rather than individuals to minimise threats of contamination of the intervention and/or group randomisation is more practical in the situation. |
Must address 2 levels of inference: cluster and individual. |
Update publication due Chinese, Spanish available |
| Non- inferiority/ equivalence trials |
To establish whether a new intervention is at least as efficacious as the standard because it may have other advantages e.g., lower cost or simpler administration. |
Are participants similar to those in trials establishing efficacy of reference treatment? Are outcome measures similar to those used to establish efficacy? |
Update underway |
| Pragmatic trials |
To assess the effectiveness of an intervention in the real world in usual care settings – particularly to aid healthcare policy making. |
Generalisability? to inform real world choices readers need to have sufficient details to be able to evaluate validity of results, applicability and feasibility of interventions in their own settings. |
Update planned |
| Intervention extensions | Rationale for extension | Main reporting issue(s) | Updated to; 2010 CONSORT? Other languages? |
|---|---|---|---|
| Herbal medicinal products | Widely used products with variable content and quality and administration. |
Needs extensive elaboration of the item about the intervention itself. |
Update planned |
| Non- pharmacological interventions (NPT) |
Wide variety of NPTs where efficacy may be dependent on therapist (e.g., surgery), participant (e.g., exercise rehabilitation,) or devices (e.g., orthoses). |
Need to address issues of complexity of intervention, comparability of placebo, adequate blinding, the clustering effect of care providers/centres. Includes an additional level in flow diagram. |
Update planned |
| Acupuncture (STRICTA) |
To ensure acupuncture trials are better replicated and interpreted. |
Needs extensive elaboration of items about treatment details, practitioner details and comparator intervention. |
Updated 2010 Chinese, Korean available Russian, Japanese translations planned |
| Data extensions | Rationale for extension | Main reporting issue(s) | Updated to; 2010 CONSORT? Other languages? |
|---|---|---|---|
| Harms |
Very poor reporting of harms making it difficult to make clinical decisions about treatment options. |
Includes 10 additional specific recommendations about reporting harms-related issues further to the main CONSORT checklist. |
Update planned |
| Abstracts |
Journal and conference abstracts may provide the basis of clinical decisions. Many abstracts are unreliable and inaccurate when compared with full report. |
Extension identifies essential items to include in an abstract in a structured format to accommodate space limitations, e.g., “for the primary outcome, a result for each group and the estimated effect size and its precision”. To enable readers to use abstracts more effectively and to aid assessment of the validity of the research. |
Update planned Chinese available |
Overview of new CONSORT extensions being developed:
There are a number of CONSORT extensions in development by the CONSORT group for other types of trial designs including for multi-arm parallel group trials, crossover trials, factorial trials, within-person and N=1 trials.
There is also a new extension being developed for reporting quality of life data from clinical trials to facilitate the provision of robust evidence to inform patient choice, aid clinical decision making, and inform health policy. This is a collaboration between the International Society for Quality of Life Research (ISOQOL), the CONSORT Executive, the Midland and COnDuCT Medical Research Council Hubs for Trials Methodology Research (MRC MHTMR), journal editors, policy makers and patient representatives. A Delphi exercise is currently in progress with the consensus meeting planned in London, UK in January 2012. For further information please contact consortqol@contacts.bham.ac.uk
Overview of “unofficial” CONSORT extensions:
In addition to these official CONSORT extensions developed by or with the CONSORT group several independent initiatives have created CONSORT-style guidance in a number of diverse fields. Such extensions include RedHot for homeopathy, REFLECT for livestock trials, CONSORT-C for paediatric trials and others in e-health and allergen-specific immunotherapy (GA2LEN). The EQUATOR Network library of health research http://www.equator-network.org/resource-centre/library-of-health-research-reporting/reporting-guidelines/experimental-studies/ lists many of these unofficial extensions. However it must be noted that the methods of their development may differ from those used by the CONSORT group.
1. Schulz, K.F., D.G. Altman, and D. Moher, CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ, 2010. 340: p. c332.
Page last edited: 08 May 2012
