A pilot 'cohort multiple randomised controlled trial' of treatment by a homeopath for women with menopausal hot flushes

Introduction: In order to address the limitations of the standard pragmatic RCT design, the innovative 'cohort multiple RCT' design was developed. The design was first piloted by addressing a clinical question What is the clinical and cost effectiveness of treatment by a homeopath for women with menopausal hot flushes?. Methods: A cohort with the condition of interest (hot flushes) was recruited through an observational study of women's midlife health and consented to provide observational data and have their data used comparatively. The 'Hot Flush' Cohort were then screened in order to identify patients eligible for a trial of the offer of treatment by a homeopath (Eligible Trial Group). A proportion of the Eligible Trial Group was then randomly selected to the Offer Group and offered treatment. A patient centred approach to information and consent was adopted. Patients were not (i) told about treatments that they would not be offered, and trial intervention information was only given to the Offer Group after random selection. Patients were not (ii) given prior information that their treatment would be decided by chance. Results: The 'cohort multiple RCT design was acceptable to the NHS Research Ethics Committee. The majority of patients completed multiple questionnaires. Acceptance of the offer was high (17/24). Discussion: This pilot identified the feasibility of an innovative design in practice. Further research is required to test the concept of undertaking multiple trials within a cohort of patients and to assess the acceptability of the patient centred approach to information and consent. (c) 2012 Elsevier Inc. All rights reserved.