The importance of piloting an RCT intervention.
The pilot study provides a unique opportunity to identify and prepare for the challenges of evaluating an intervention. Ultimately, it will enhance the scientific rigour and value of the full-scale study. Although some journals publish reports of pilot studies, little attention has been given to the types of research questions and issues specific to these studies. This article focuses on the utility of a pilot randomized controlled trial (RCT) as a first step towards conducting an RCT. Three major objectives of a pilot RCT are discussed: assessing the feasibility and acceptability of the intervention, assessing the feasibility and acceptability of the design and procedures, and facilitating the determination of effect sizes for use in sample-size calculations.
Feeley
Nancy
N
Centre for Nursing Research, Sir Mortimer B. Davis Jewish General Hospital, School of Nursing, McGill University, Montreal, Quebec, Canada.
Cossette
Sylvie
S
Côté
José
J
Héon
Marjolaine
M
Stremler
Robyn
R
Martorella
Geraldine
G
Purden
Margaret
M
D019985:Benchmarking; D003625:Data Collection; D015987:Effect Modifier, Epidemiologic; D055317:Evidence-Based Practice; D005240:Feasibility Studies; D006801:Humans; D020380:Needs Assessment; D015399:Nursing Research / Q000458:organization & administration; D009937:Organizational Objectives; D010865:Pilot Projects; D010934:Planning Techniques; D011643:Publishing / Q000458:organization & administration; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000451:nursing; D012107:Research Design; D018401:Sample Size