A new design for pragmatic randomised controlled trials : a 'Patient Cohort' RCT of treatment by a homeopath for menopausal hot flushes

• Main Author: Relton, Clare
• Other Authors: Nicholl, Jon ; O'Cathain, Alicia
• Published: University of Sheffield 2009
• Subjects: 615.5
• Online Access: http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.505550

There is debate regarding the effectiveness of homeopathy and its continuing provision in the NHS, and despite 150+ clinical trials there are conflicting opinions as to what can be concluded from these trials. This thesis addresses the question: “What type of clinical trial design can provide the information needed to make decisions about the provision of homeopathy in a publicly funded healthcare system?” A critique of the methods used in existing clinical trial designs was undertaken which identified twelve key criteria for appropriate clinical trial design; methods from existing standard and alternative clinical trial designs were adapted in order to derive a new clinical trial design that has the potential to meet all twelve key criteria (the ‘Patient Cohort’ RCT design). A current clinical question was identified: ‘What is the clinical & cost effectiveness of treatment by a homeopath for women with menopausal hot flushes?” and a population based survey confirmed the importance of this question. The ‘Patient Cohort’ RCT design was piloted in an NHS setting in order to address this current clinical question. Seventy ‘with need’ women were recruited to the Hot Flush Cohort of whom forty-eight were eligible for the treatment, a proportion of whom were randomly selected to be offered the treatment. 70.8% of those offered treatment accepted the offer and completion of outcome measures was high (93.7%). The results indicate that a full trial of this treatment for this condition may be worthwhile conducting. A full RCT using this design would be an appropriate clinical trial design to provide answers as to the provision of homeopathy and other clinician delivered interventions in publicly funded healthcare system such as the NHS. The ‘Patient Cohort’ RCT design can be usefully applied to clinical questions that require very pragmatic approaches yet need the scientific rigour of randomisation.