Challenges in palliative care research; recruitment, attrition and compliance: experience from a randomized controlled trial

Randomized controlled trials (RCTs) in palliative cancer care often experie nce methodological problems. In this paper we discuss issues of major conce rn, including recruitment, patient attrition and compliance, arising from a n RCT that compared comprehensive palliative care to conventional care. The main criteria for trial entry were incurable malignant disease and a su rvival expectancy of between 2 and 9 months. Patients' health-related quali ty of life (HRQL), self-assessed by multi-item questionnaires, was a define d endpoint. The planned number of patients was successfully recruited, alth ough the patients were referred late in the course of their disease so that follow-up tended to be short. Compliance in completing HRQL questionnaires was good up to 1 month before the patient's death; but in the final weeks it was found to drop substantially Based on our experience, recommendations are given for those planning simil ar research. Procedures for improving patient recruitment are suggested, st ressing the need for local data management, repeated information to referra l sources, extensive screening for potentially eligible patients and simple referral routines. Precise inclusion criteria, including prognostic factor s other than physicians' estimates of life expectancy, should be used to en sure a sufficient follow-up period. For HRQL assessment, multi-item questio nnaires can achieve excellent compliance up to 1 month before patients' dea th, but in order to evaluate the very final weeks of life we recommend the use of simpler methods.