Pilot and feasibility studies come of age!

Gillian A Lancaster, Gillian A Lancaster

Abstract

This editorial introduces the new, online, open-access journal Pilot and Feasibility Studies. The journal considers manuscripts on any aspect of the design and analysis of pilot and feasibility studies, as well as protocols for pilot and feasibility studies, and discussions and reviews of methodological issues around the planning and reporting of such studies. These studies are generally carried out in preparation for future large-scale definitive randomised controlled trials or observational studies and address key issues of uncertainty. Objectives for conducting pilot and feasibility studies therefore differ from those of the future large-scale study and should be clearly expressed. The journal provides a dedicated place for publication of this important work as well as a forum for discussion of methodological issues that will lead to increased scientific rigour in this area.

Lancaster; licensee BioMed Central. 2015

References

    1. Dyer C. UK clinical trials must be registered to win ethics committee approval. BMJ. 2013;347:f5614. doi: 10.1136/bmj.f5614.
    1. Altman DG, Furberg CD, Grimshaw JM, Rothwell PM. Lead editorial – using the opportunities of electronic publishing to improve the reporting of randomised trials. Trials. 2006;7:6. doi: 10.1186/1745-6215-7-6.
    1. Mays N, Pope C. Qualitative research in health care: assessing quality in qualitative research. BMJ. 2000;320:50–52. doi: 10.1136/bmj.320.7226.50.
    1. Eldridge S, Spencer A, Cryer C, Parsons S, Underwood M, Feder G. Why modelling a complex intervention is an important precursor to trial design: lessons from studying an intervention to reduce falls-related injuries in older people. J Health Serv Res Pol. 2005;10:133–142. doi: 10.1258/1355819054338942.
    1. Craig P, Dieppe P, Macintyre S, Mitchie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new medical research council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655.
    1. Tickle-Degnen L. Nuts and bolts of conducting feasibility studies. Am J Occup Ther. 2013;67:171–176. doi: 10.5014/ajot.2013.006270.
    1. Arnold DM, Burns KE, Adhikari NK, Kho ME, Meade MO, Cook DJ. The design and interpretation of pilot trials in clinical research in critical care. Crit Care Med. 2009;37(Suppl 1):69–74. doi: 10.1097/CCM.0b013e3181920e33.
    1. McGrath JM. Not all studies with small samples are pilot studies. J Perinat Neonatal Nurs. 2013;27:281–283. doi: 10.1097/01.JPN.0000437186.01731.bc.
    1. Morin KH. Value of a pilot study. J Nurs Educ. 2013;52:547–548. doi: 10.3928/01484834-20130920-10.
    1. Leon AC, Davies LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011;45:626–629. doi: 10.1016/j.jpsychires.2010.10.008.
    1. Van Teijlingen ER, Hundley V. The importance of pilot studies. 2001.
    1. Schulz KF, Altman DG, Moher D, for the CONSORT Group CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi: 10.1136/bmj.c332.
    1. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomized trials. BMJ. 2004;328:707–708.
    1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi: 10.1136/bmj.a2390.
    1. Lancaster GA, Dodd SR, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–312. doi: 10.1111/j..2002.384.doc.x.
    1. Teare D, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014;15:264. doi: 10.1186/1745-6215-15-264.
    1. Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006;63:484–489. doi: 10.1001/archpsyc.63.5.484.
    1. Lancaster GA, Campbell MC, Eldridge SE, Farrin A, Marchant M, Muller S, et al. Trials in primary care: statistical issues in the design, conduct and evaluation of complex interventions. Stat Methods Med Res. 2010;19:349–377. doi: 10.1177/0962280209359883.
    1. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1. doi: 10.1186/1471-2288-10-1.
    1. Arain M, Campbell MC, 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. doi: 10.1186/1471-2288-10-67.
    1. Shanyinde M, Pickering R, Weatherall M. Questions asked and answered in pilot and feasibility randomised controlled trials. BMC Med Res Methodol. 2011;11:117. doi: 10.1186/1471-2288-11-117.
    1. Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, et al. A process for decision-making after pilot and feasibility trials (ADEPT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013;14:353. doi: 10.1186/1745-6215-14-353.
    1. Charlesworth G, Burnell K, Hoe J, Orrell M, Russell I. Acceptance checklist for clinical effectiveness pilot trials: a systematic approach. BMC Med Res Methodol. 2013;13:78. doi: 10.1186/1471-2288-13-78.

Source: PubMed

3
Abonnieren