Acceptance Checklist for Clinical Effectiveness Pilot Trials: a systematic approach.

Article English OPEN
Charlesworth, G. ; Burnell, K. ; Hoe, J. ; Orrell, M. ; Russell, I. (2013)
  • Publisher: BioMed Central
  • Journal: BMC Medical Research Methodology, volume 13, pages 78-78 (eissn: 1471-2288)
  • Related identifiers: pmc: PMC3702517, doi: 10.1186/1471-2288-13-78
  • Subject: Feasibility | Epidemiology | SHIELD | R | Correspondence | Internal pilot | CONSORT | Carer supporter programme | Pilot trial | Randomized controlled trial | ACCEPT

Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity is key, greater flexibility is written into trial protocols to allow for 'real life' variation in procedures. We describe the development of a checklist for use in decision-making on whether pilot data can be carried forward to the main trial dataset without compromising trial integrity. We illustrate the use of the checklist using a pragmatic trial of psychosocial interventions for family carers of people with dementia as a case study.
  • References (19)
    19 references, page 1 of 2

    1. Van-Teijlingen ER, Hundley V: The importance of pilot studies. Soc Res Update 2001, 35. [http://sru.soc.surrey.ac.uk/SRU35.html.

    2. Leon AC, Davis LL, Kraemer HC: The role and interpretation of pilot studies in clinical research. J Psychiatr Res 2011, 45:626-629.

    3. Rounsaville BJ, Carroll KM: A stage model of behavioural therapies research: getting started and moving on from Stage I. Clin Psychol Sci Pract 2001, 8:133-142.

    4. Craig N, Dieppe P, Macintyre S, Michie S, Nazareth I, Pettigrew M: Developing and evaluating complex interventions: the new Medical Research Council guidance. Brit Med J 2008, 337:a1655.

    5. Arnold DM, Burns KEA, Adhikari NKJ, Kho ME, Meade MO, Cook DJ, for the McMaster Critical Care Interest Group: The design and interpretation of pilot trials in clinical research in critical care. Crit Care Med 2009, 37S:S69-S74.

    6. Lancaster GA, Dodd S, Williamson PR: Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract 2004, 10:307-312.

    7. NIHR Health Technology Assessment Programme (NETSCC): Feasibility and pilot studies. [www.netscc.ac.uk/glossary/index.asp#glos7]

    8. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios L, et al: A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol 2010, 10:1.

    9. Arain M, Campbell MJ, Cooper CL, Lancaster GA: What is a pilot or feasibility study? a review of current practice and editorial policy. BMC Med Res Methodol 2010, 10:67.

    10. Shanyinde M, Pickering RM, Weatherall M: Questions asked and answered in pilot and feasibility randomized controlled trials. BMC Med Res Methodol 2011, 11:117.

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