Participant views on participating in a pragmatic randomised controlled trial: the Aboriginal and Torres Strait Islander Women’s Fitness Program

International Journal for Equity in Health

Margaret Cargo²  Robyn McDermott²  Karla Canuto¹ 

[1] Wardliparingga Aboriginal Health Unit, South Australia Health and Medical Research Institute, Adelaide, Australia;School of Population Health, University of South Australia, Adelaide, Australia

关键词: Randomisation;    Physical activity;    Aboriginal and Torres Strait Islander;    Qualitative research;    Pragmatic RCTs;   

Others  :  1146426
DOI  :  10.1186/s12939-014-0077-3

 received in 2014-01-13, accepted in 2014-08-27,  发布年份 2014

【 摘 要 】

Introduction

The inequity of randomising participants to control groups in randomised controlled trials (RCTs) is often considered inappropriate, especially for research trials that include vulnerable populations such as Indigenous peoples. The Aboriginal and Torres Strait Islander Women¿s Fitness Program conducted a trial that randomly assigned participants to `active¿ and `waitlisted¿ groups. This paper reports on participant views of the randomisation protocol.

Methods

A pragmatic RCT was conducted in an urban setting to assess the effectiveness of the 12-week Aboriginal and Torres Strait Islander Women¿s Fitness Program on metabolic health outcomes and waist circumference. Qualitative interviews were conducted at follow-up, one of the objectives was to explore participant perspectives on the research protocol, including participant randomisation to `Active¿ and `Waitlisted¿ groups.

Results

A total of 49 interviews were conducted (26 Active and 23 Waitlisted participants). Two key factors influenced participant views on the protocol: 1) group assignment; and 2) how well they understood the research design, including the justification for randomisation. `Active¿ participants were concerned about the inequity of the randomisation process but overall supported the study protocol. Although most Waitlisted participants were disappointed about having to wait 12-months for the program, some participants derived motivation from being waitlisted, whilst others lost motivation. Well-informed participants were more likely to express both support for the randomisation process and an understanding of the research benefits than participants not attending an information session prior to registration.

Conclusions

Participants were more accepting of the research protocol if it was clearly explained to them, if they understood the randomisation process and felt the randomisation was justified in terms of the potential for the results to benefit other Aboriginal and Torres Strait Islander women. Our study suggests that the time and resources required to adequately explain the research protocol in research trials should not be undervalued.

Trial registration

Australian New Zealand Clinical Trials Registry (ACTRN12610000224022 webcite).

【 授权许可】

   
2014 Canuto et al.; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]National Health and Medical Research Council: NHMRC additional levels of evidence and grades for recommendations for developers of guidelines. Edited by Council National Health and Medical Research. Canberra; 2009.
• [2]Patsopoulos NA: A pragmatic view on pragmatic trials.Dialogues Clin Neurosci 2011, 13(2):217.
• [3]Sanson-Fisher RW, Bonevski B, Green LW, D¿Este C: Limitations of the randomized controlled trial in evaluating population-based health interventions. Am J Prev Med 2007, 33(2):155-161.
• [4]Edwards SJL, Lilford RJ, Braunholtz DA, Jackson JC, Hewison J, Thornton J: Ethical issues in the design and conduct of randomised controlled trials.Health Technol Assess 1998, 2(15):1407.
• [5]McAuley KA, Murphy E, McLay RT, Chisholm A, Story G, Mann JI, Thomson R, Bell D, Williams SM, Goulding A, Wilson N: Implementation of a successful lifestyle intervention programme for New Zealand Maori to reduce the risk of type 2 diabetes and cardiovascular disease. Asia Pac J Clin Nutr 2003, 12(4):423-426.
• [6]Sibthorpe BM, Bailie RS, Brady MA, Ball SA, Sumner-Dodd P, Hall WD: The demise of a planned randomised controlled trial in an urban Aboriginal medical service. Med J Aust 2002, 176(6):273-276.
• [7]Canuto K, McDermott R, Cargo M, Esterman A: Study protocol: a pragmatic randomised controlled trial of a 12-week physical activity and nutritional education program for overweight Aboriginal and Torres Strait Islander women.BioMed Central Public Health 2011, 11(1):655.
• [8]Canuto KJ, Spagnoletti B, McDermott RA, Cargo M: Factors influencing attendance in a structured physical activity program for Aboriginal and Torres Strait Islander women in an urban setting: a mixed methods process evaluation. Int J Equity Health 2013, 12(1):1-11. BioMed Central Full Text
• [9]Chen HT: Practical program evaluation: assessing and improving planning, implementation, and effectiveness. Sage, Thousand Oaks, CA; 2005.
• [10]Miles MB, Huberman AM: Qualitative data analysis: an expanded sourcebook, 2nd ed. edn. Sage Publications, Thousand Oaks, CA; 1994.
• [11]StataCorp: Stata statistical software: Release 11. Edited by Station C. Texas: Stata Corporation; 2009.
• [12]NVivo qualitative data analysis software In Version 9. QSR International Pty Ltd, Australia; 2010.
• [13]Attride-Stirling J: Thematic networks: an analytic tool for qualitative research. Qual Res 2001, 1(3):385-405.
• [14]Canuto KJ, Cargo M, Li M, D'Onise K, Esterman A, McDermott R: Pragmatic randomised trial of a 12-week exercise and nutrition program for Aboriginal and Torres Strait Islander women: clinical results immediate post and 3 months follow-up.BioMed Central Public Health 2012, 12(933).
• [15]Skingley A, Bungay H, Clift S, Warden J: Experiences of being a control group: lessons from a UK-based randomized controlled trial of group singing as a health promotion initiative for older people.Health Promot Int 2013, dat026.