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

Recruitment to a clinical trial from the databases of specialists in Parkinson’s disease
Recruitment to a clinical trial from the databases of specialists in Parkinson’s disease
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.
parkinson's disease, recruitment, clinical trials, fallers, clinical database
1353-8020
35-39
Ashburn, Ann
818b9ce8-f025-429e-9532-43ee4fd5f991
Pickering, Ruth M.
4a828314-7ddf-4f96-abed-3407017d4c90
Fazakarley, Louise
5645a250-43bd-4b69-b604-212a0e611e23
Ballinger, Claire
1495742c-90aa-4074-920e-95e6cc3d5380
McLellan, Lindsay D.
8784a06b-0727-4db4-8226-b4795df761ad
Fitton, Carolyn
6288734e-9b6e-470d-b420-33c16d65b879
Ashburn, Ann
818b9ce8-f025-429e-9532-43ee4fd5f991
Pickering, Ruth M.
4a828314-7ddf-4f96-abed-3407017d4c90
Fazakarley, Louise
5645a250-43bd-4b69-b604-212a0e611e23
Ballinger, Claire
1495742c-90aa-4074-920e-95e6cc3d5380
McLellan, Lindsay D.
8784a06b-0727-4db4-8226-b4795df761ad
Fitton, Carolyn
6288734e-9b6e-470d-b420-33c16d65b879

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)

Record type: Article

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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More information

Published date: 1 February 2007
Keywords: parkinson's disease, recruitment, clinical trials, fallers, clinical database
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 47930
URI: http://eprints.soton.ac.uk/id/eprint/47930
ISSN: 1353-8020
PURE UUID: 3a7743a9-49b9-420c-846a-c3041d3f16a1

Catalogue record

Date deposited: 10 Aug 2007
Last modified: 15 Mar 2024 09:40

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Contributors

Author: Ann Ashburn
Author: Louise Fazakarley
Author: Claire Ballinger
Author: Lindsay D. McLellan
Author: Carolyn Fitton

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