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Southampton Health Technology Assessments Centre

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.

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Southampton Health Technology Assessments Centre

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  1. 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

  2. Variation in asthma prevalence, morbidity and/or mortality Recommendations Geographical Racial/ethnic population groups Minorities and socio-economic status should be included in clinical trials Socioeconomic status But… 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 Background Southampton Health Technology Assessments Centre

  3. Objective To determine the extent to which minority populations, socioeconomic, demographic and genetic information are reported and analysed in asthma clinical trials Southampton Health Technology Assessments Centre

  4. Source of evidence: Systematic reviews of asthma drug effectiveness and safety (SHTAC and PenTAG) 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 extraction of demographic data Methods Southampton Health Technology Assessments Centre

  5. Total number of RCTs Number reporting race/ethnicity 14 12 10 8 6 4 2 J:\SHTAC\Projects\Research\Healthcare Associated Infections\Catheter education in critical care\Correspondence with experts 0 1981 1986 1991 1996 2001 2006 Results 87 randomized controlled trials (RCTs) published in 32 English language journals, 1985 to 2006 Southampton Health Technology Assessments Centre

  6. Analyzed or discussed with outcomes Baseline data reported Race/ethnicity 23 0 Socio-economic variables 1 0 1 / 9 UK-specific trials 0 US-specific trials 6 / 7 0 Genetic information 0 0 (P=0.009, Fisher’s Exact test) Country / countries of trial 64 4 Results Of the 87 randomized controlled trials… Southampton Health Technology Assessments Centre

  7. Barriers to placing demographic data in the public domain Generalizability 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) Mixed populations “Ecological fallacy” Discussion What are the implications of these findings ? Southampton Health Technology Assessments Centre

  8. Existing asthma evidence Healthcare goals Clinical trials hypotheses new evidence Asthma variation: Guidance Geographical Racial/ethnic population groups Socioeconomic status Genetic polymorphisms Discussion Among others… Reduce and ideally eliminate demographic disparities in asthma prevalence, morbidity, mortality and management Southampton Health Technology Assessments Centre

  9. Thank you for your attention! 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 Conclusions and recommendations 1. Include evidence-based hypotheses in asthma clinical trials 2. More critically consider clinical trial generalizability 3. Improve the guidance for clinical trials and its impact 4. Encourage the publication of demographic information Southampton Health Technology Assessments Centre

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