Audit Versus Actual Recruitment in Palliative Care Clinical Trials (#197)
Aim: The development of appropriate inclusion and exclusion criteria is necessary for recruiting patients suitable for a study and are likely to complete participation. Researchers commonly report difficulties with recruitment in randomised controlled clinical trials, it is therefore important to assess the reasons which lead to study ineligibility1 . The Palliative Care Clinical Studies Collaborative (PaCCSC) undertakes randomised clinical control trials to assess symptoms commonly associated with a life-limiting illness.
Method: The current recruitment numbers for 4 studies (risperidone for delirium, megestrol acetate for appetite, octreotide for bowel obstruction and Ketamine2 for pain) will be compared to previous audit findings3, based around inclusion and exclusion criteria obtained retrospectively from multiple palliative care services. The audit was conducted prior to the commencement of each study to determine the frequency of symptoms and the likely proportion of people who would meet general and study-specific eligibility criteria. Using the current data, did the audit accurately predict future recruitment?
Results: An audit can predict expected recruitment and dropout rate, by estimating the likely proportion of people who would meet the general and specific eligibility criteria, and then comparing the initial estimate with actual reasons for study exclusion. Frequency analyses have been performed to assess any statistical differences between the groups.
Conclusion: Performing an audit prior to a palliative care study appears to predict the actual rate of recruitment. Once a study commences, tracking the reasons for ineligibility is important for improving recruitment, especially in given the challenges in recruiting in palliative care populations.
- Designing Research With Hospice and Palliative Care Populations, Ashley M, Wohleber DS, Davis McKitrick, Davis SE. AM J Hosp Palliat Care, 2011, 29: 335.
- Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Toxicity of Subcutaneous Ketamine in the Management of Cancer Pain. Quinn S, Fazekas B, Plummer J, Eckermann S, Agar M, Spruyt O, Rowett D and Currow DC. Journal of Clinical Oncology Oct 10, 2012:3611-3617.
- Planning phase III multi-site clinical trials in palliative care: the role of consecutive cohort audits to identify potential participants populations, Currow DC, Shelby-James TM, Agar M, Plummer J, Rowett, Glare P, Spruyt O, Hardy J. Support Care Cancer 2010, 18: 1571-1579.