Reconceptualising the objectives of a pilot study for clinical research.
This is a methodological study in which a case report is used to retrospectively analyse the link between a successful pilot study and stalled main study to identify potential methodological weaknesses in the planning process. The analysis identified unanticipated influences related to hospital processes and discipline boundaries that adversely influenced participant recruitment and retention for a clinical trial. The findings of the study demonstrate that, whilst the pilot is an important step in research planning to confirm the design and operational processes for a study, a thorough analysis of the relevant health service environment is an important additional objective for the pilot study.
Gardner
Glenn
G
The Canberra Hospital and University of Canberra Research Centre for Nursing Practice, The Canberra Hospital, PO Box 11, Woden ACT 2606, Australia. glenn.gardner@act.gov.au
Gardner
Anne
A
MacLellan
Lorna
L
Osborne
Sonya
S
D035843:Biomedical Research / Q000379:methods*; D006040:Goals; D006801:Humans; D010146:Pain / Q000188:drug therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D014481:United States