title: The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma.
abstract: OBJECTIVE
  To test the feasibility of a pragmatic trial design with economic evaluation and nested qualitative study, comparing usual care (UC) with UC plus individualised homeopathy, in children requiring secondary care for asthma. This included recruitment and retention, acceptability of outcome measures patients' and health professionals' views and experiences and a power calculation for a definitive trial.
  
  
  METHODS
  In a pragmatic parallel group randomised controlled trial (RCT) design, children on step 2 or above of the British Thoracic Society Asthma Guidelines (BTG) were randomly allocated to UC or UC plus a five visit package of homeopathic care (HC). Outcome measures included the Juniper Asthma Control Questionnaire, Quality of Life Questionnaire and a resource use questionnaire. Qualitative interviews were used to gain families' and health professionals' views and experiences.
  
  
  RESULTS
  226 children were identified from hospital clinics and related patient databases. 67 showed an interest in participating, 39 children were randomised, 18 to HC and 21 to UC. Evidence in favour of adjunctive homeopathic treatment was lacking. Economic evaluation suggests that the cost of additional consultations was not offset by the reduced cost of homeopathic remedies and the lower use of primary care by children in the homeopathic group. Qualitative data gave insights into the differing perspectives of families and health care professionals within the research process.
  
  
  CONCLUSIONS
  A future study using this design is not feasible, further investigation of a potential role for homeopathy in asthma management might be better conducted in primary care with children with less severe asthma.
authors.affiliation: Bristol Homeopathic Hospital, University Hospitals Bristol Foundation Trust, Cotham Hill, Bristol BS6 6JU, England, UK. elizabeth.thompson@UHBristol.nhs.uk
authors.forename: E A
authors.initials: EA
authors.lastname: Thompson
authors.forename: A
authors.initials: A
authors.lastname: Shaw
authors.forename: J
authors.initials: J
authors.lastname: Nichol
authors.forename: S
authors.initials: S
authors.lastname: Hollinghurst
authors.forename: A J
authors.initials: AJ
authors.lastname: Henderson
authors.forename: T
authors.initials: T
authors.lastname: Thompson
authors.forename: D
authors.initials: D
authors.lastname: Sharp
mesh_terms: D001249:Asthma / Q000191:economics / Q000628:therapy*; D002648:Child; D002662:Child Health Services / Q000458:organization & administration; D005240:Feasibility Studies; D005260:Female; D006705:Homeopathy / Q000191:economics / Q000379:methods*; D006801:Humans; D008297:Male; D008419:Materia Medica / Q000191:economics / Q000627:therapeutic use*; D017063:Outcome Assessment, Health Care; D057285:Precision Medicine / Q000191:economics / Q000379:methods*; D011785:Quality Assurance, Health Care / Q000379:methods; D012720:Severity of Illness Index; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D008419:Materia Medica