Designing and Reporting Pilot Studies

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. 

BMJ. 2013 Jan.

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group.

Pilot and Feasibility Studies. 2016 Oct.

Pilot trials in health-related behavioral intervention research: Problems, solutions, and recommendations

Freedland KE.

Health Psychology. 2020 Jul.

The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel.

Freedland KE, King AC, Ambrosius WT, Mayo-Wilson E, Mohr DC, Czajkowski SM, Thabane L, Collins LM, Rebok GW, Treweek SP, Cook TD, Edinger JD, Stoney CM, Campo RA, Young-Hyman D, Riley WT; National Institutes of Health Office of Behavioral and Social Sciences Research Expert Panel on Comparator Selection in Behavioral and Social Science Clinical Trials. 

Journal of Clinical Epidemiology. 2019 Feb.

Caution regarding the use of pilot studies to guide power calculations for study proposals.

Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA.

Archives of General Psychiatry. 2006 May.

A guide to the reporting of protocols of pilot and feasibility trials

Thabane, Lehana, and Gillian Lancaster.

Pilot and Feasibility Studies. 2019 Feb.

A tutorial on pilot studies: the what, why and how. BMC medical research methodology.

Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH.

BMC Med Res Methodol. 2010 Jan.

Intervention Development

The NIH Science of Behavior Change Program: Transforming the science through a focus on mechanisms of change - PubMed

Nielsen L, Riddle M, King JW; NIH Science of Behavior Change Implementation Team, Aklin WM, Chen W, Clark D, Collier E, Czajkowski S, Esposito L, Ferrer R, Green P, Hunter C, Kehl K, King R, Onken L, Simmons JM, Stoeckel L, Stoney C, Tully L, Weber W.

Behaviour Research and Therapy. 2018 Feb.

Reenvisioning Clinical Science: Unifying the Discipline to Improve the Public Health

Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M.

Clinical Psychological Science. 2014 Jan.

Fear-Based Mechanisms & Regimen Adherence After Acute Medical Events

Anxiety and Fear of Exercise in Cardiopulmonary Rehabilitation: PATIENT AND PRACTITIONER PERSPECTIVES.

Farris SG, Abrantes AM, Bond DS, Stabile LM, Wu WC.

Journal of Cardiopulmonary Rehabilitation and Prevention. 2019 Mar.