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Information on ethnic minorities and demographic data from asthma clinical trials does not reach the public domain
Evidence from a systematic review and implications for tackling health disparities
Geoff Frampton & Jonathan Shepherd
Southampton Health Technology Assessments Centre
Background
Southampton Health Technology Assessments Centre
Variation in asthma prevalence, morbidity and/or mortality
Geographical
Racial/ethnic population groups
Socioeconomic status
Abandon broad classes in favour of most precise population provenance data available and genetic information if appropriate
Broad groups lack clinical relevance
Genetic polymorphisms useful
But…
Minorities and socio-economic status should be included in clinical trials
Recommendations
Southampton Health Technology Assessments Centre
Objective
To determine the extent to which minority populations, socioeconomic, demographic and genetic information are reported and analysed in asthma clinical trials
Methods
Southampton Health Technology Assessments Centre
National Institute for Health and Clinical Excellence(NICE) review and update of guidelines on inhaled corticosteroids and long-acting beta agonists for management of asthma in adults and children
Systematic reviews of asthma drug effectiveness and safety (SHTAC and PenTAG)
Source of evidence:
Systematic extraction of demographic data
Southampton Health Technology Assessments Centre
Results
87 randomized controlled trials (RCTs) published in 32 English language journals, 1985 to 2006
0
2
4
6
8
10
12
14
1981 1986 1991 1996 2001 2006
Total number of RCTs
J:\SHTAC\Projects\Research\Healthcare Associated Infections\Catheter education in critical care\Correspondence with experts
Number reporting race/ethnicity
Southampton Health Technology Assessments Centre
Of the 87 randomized controlled trials…
Results
1 0Socio-economic variables
23 0
Baseline data reported
Analyzed or discussed with
outcomes
Race/ethnicity
0 0Genetic information
64 4Country / countries of trial
(P=0.009, Fisher’s Exact test)
UK-specific trials
US-specific trials
1 / 9
6 / 7
0
0
Southampton Health Technology Assessments Centre
What are the implications of these findings ?
Discussion
A) Population-specific trials (6 / 23)B) Multi-population trials, baseline data only (17 / 23)
C) Multi-population trials with sub-group analyses (0 / 23)
Barriers to placing demographic data in the public domain
Generalizability
“Ecological fallacy”Mixed populations
Southampton Health Technology Assessments Centre
hypotheses new evidence
Existing asthma
evidence
Healthcare goals
Clinical trials
Discussion
Asthma variation:
Geographical
Racial/ethnic population groups
Socioeconomic status
Genetic polymorphisms
Among others…
Reduce and ideally eliminate demographic disparities in asthma prevalence, morbidity, mortality and management
Guidance
Southampton Health Technology Assessments Centre
Conclusions and recommendations
2. More critically consider clinical trial generalizability
1. Include evidence-based hypotheses in asthma clinical trials
3. Improve the guidance for clinical trials and its impact
The views and opinions expressed in this presentation are those of the authors and do not necessarily reflect those of the UK Department of Health
Thank you for your attention!
4. Encourage the publication of demographic information