Participant demographics reported in "Table 1" of randomised controlled trials: A case of “inverse evidence"?

Furler, John, Magin, Parker, Pirotta, Marie and van Driel, Mieke (2012) Participant demographics reported in "Table 1" of randomised controlled trials: A case of “inverse evidence"?. International Journal for Equity in Health, 11 14.1-14.14. doi:10.1186/1475-9276-11-14

Author Furler, John
Magin, Parker
Pirotta, Marie
van Driel, Mieke
Title Participant demographics reported in "Table 1" of randomised controlled trials: A case of “inverse evidence"?
Journal name International Journal for Equity in Health   Check publisher's open access policy
ISSN 1475-9276
Publication date 2012-03-19
Sub-type Article (original research)
DOI 10.1186/1475-9276-11-14
Open Access Status DOI
Volume 11
Start page 14.1
End page 14.14
Total pages 4
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2013
Language eng
Formatted abstract
Data supporting external validity of trial results allows clinicians to assess the applicability of a study's findings to their practice population. Socio-economic status (SES) of trial participants may be critical to external validity given the relationship between social and economic circumstances and health. We explored how this is documented in reports of RCTs in four major general medical journals.


The contents lists of four leading general medical journals were hand searched to identify 25 consecutive papers reporting RCT results in each journal (n = 100). Data on demographic characteristics were extracted from each paper's Table 1 only (or equivalent).


Authors infrequently reported key demographic characteristics relating to SES of RCT participants. Age and gender of participants were commonly reported. Less than 10% reported occupational group, employment status, income or area based measures of disadvantage.

Without adequate reporting of key indicators of SES in trial participants it is unclear if lower SES groups are under-represented. If such groups are systematically under-recruited into trials, this may limit the external validity and applicability of study findings to these groups. This is in spite of the higher health-care need in more disadvantaged populations. Under-representation of low SES groups could underestimate the reported effect of an intervention for those with a higher baseline risk. The marginal benefit identified in a trial with poor or no representation of lower SES participants could significantly underestimate the potential benefit to a low SES community. More transparency in this reporting and greater attention to the impact of SES on intervention outcomes in clinical trials is needed. This could be considered in the next revision of the CONSORT statement.
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Article number 14

Document type: Journal Article
Sub-type: Article (original research)
Collections: Discipline of General Practice Publications
Official 2013 Collection
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 7 times in Thomson Reuters Web of Science Article | Citations
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Created: Wed, 18 Jul 2012, 12:38:38 EST by Shani Lamb on behalf of Discipline of General Practice