Recruitment to a clinical trial from the databases of specialists in Parkinson’s disease

Ashburn, Ann, Pickering, Ruth M., Fazakarley, Louise, Ballinger, Claire, McLellan, Lindsay D. and Fitton, Carolyn (2007) Recruitment to a clinical trial from the databases of specialists in Parkinson’s disease. Parkinsonism and Related Disorders, 13 (1), 35-39. (doi:10.1016/j.parkreldis.2006.06.004). (PMID:16928464)

Abstract

Background: Many clinical trials involving elderly people living at home suffer from low recruitment. We report our experience of recruiting people with Parkinson's disease (PD) from specialist clinical databases, to a randomised controlled trial of personalised exercise.

Methods: We aimed to recruit 200 repeat fallers with PD. Subjects were recruited through the clinical registers of specialists in PD in two NHS trusts. They had to have a confirmed diagnosis of PD, be independently mobile, live in the community, be a repeat faller, and were screened for cognitive impairment.

Results: Out of 1107 patients on the registers, 457 did not meet the eligibility criteria for the trial. A further 151 were excluded for other reasons. Four hundred and ninety-nine were approached to have a home screening visit: 405 replied and 305 agreed to be screened for the trial. Of those screened, 126 were non-repeat fallers and 22 failed other eligibility criteria. Out of the remaining 157 patients, 18 (11%) decided not to participate in the trial which left 139 recruited to the trial. Seven more were recruited from a second screen of previous non-repeat fallers. In total 146 patients were recruited: 142 to the main trial and four to the initial pilot phase.

Conclusion: The percentage of patients who participated in the main trial was only 13% (95% confidence interval 11% to 15%) of those on specialists’ registers, considerably less than estimated, although the proportion of fallers and repeat fallers was similar to that previously reported.

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