Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial

Meriel Norris, Leon Poltawski, Raff Calitri, Anthony I Shepherd, Sarah G Dean, ReTrain Team, Meriel Norris, Leon Poltawski, Raff Calitri, Anthony I Shepherd, Sarah G Dean, ReTrain Team

Abstract

Background: Unanticipated responses by research participants can influence randomised controlled trials (RCTs) in multiple ways, many of which are poorly understood. This study used qualitative interviews as part of an embedded process evaluation to explore the impact participants may have on the study, but also unintended impacts the study may have on them.

Aim: The aim of the study was to explore participants' experiences and the impact of trial involvement in a pilot RCT in order to inform the designing and delivery of a definitive RCT.

Methods: In-depth interviews with 20 participants (10 in the intervention and 10 in the control group) enrolled in a stroke rehabilitation pilot trial. A modified framework approach was used to analyse transcripts.

Results: Participation in the study was motivated partly by a desperation to receive further rehabilitation after discharge. Responses to allocation to the control group included an increased commitment to self-treatment, and negative psychological consequences were also described. Accounts of participants in both control and intervention groups challenge the presumption that they were neutral, or in equipoise, regarding group allocation prior to consenting to randomisation.

Conclusions: Considering and exploring participant and participation effects, particularly in the control group, highlights numerous issues in the interpretation of trial studies, as well as the in ethics of RCTs more generally. While suggestions for a definitive trial design are given, further research is required to investigate the significant implications these findings may have for trial design, monitoring and funding.

Trial registration: ClinicalTrials.gov, NCT02429180 . Registered on 29 April/2015.

Keywords: Equipoise; Qualitative; Randomisation; Rehabilitation; Stroke; Trial design.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Phases in Framework Analysis [24]

References

    1. O’Connell N, Moseley G, McAuley J, Wand B, Herbert R. Interpreting effectiveness evidence in pain: short tour of contemporary issues. Phys Ther. 2015;95(8):1087–1094. doi: 10.2522/ptj.20140480.
    1. Oakley A, Strange V, Bonell C, Allen E, Stephenson J, Team R. Process evaluation in randomised controlled trials of complex interventions. Br Med J. 2006;332(7538):413–416. doi: 10.1136/bmj.332.7538.413.
    1. Poltawski L, Norris M, Dean S. Intervention fidelity: developing an experience based model for rehabilitation research. J Rehabil Med. 2014;46:609–615. doi: 10.2340/16501977-1848.
    1. McCambridge J, Kypri K, Elbourne D. Research participation effects: a skeleton in the methodological cupboard. J Clin Epidemiol. 2014;67:845–849. doi: 10.1016/j.jclinepi.2014.03.002.
    1. McCambridge J, Sorhaindo A, Quirk A, Nanchahal K. Patient preferences and performance bias in a weight loss trial with a usual care arm. Patient Educ Couns. 2014;95:243–247. doi: 10.1016/j.pec.2014.01.003.
    1. Preference Collaborative Review Group Patients’ preferences within randomised trials: systematic review and patient level meta-analysis. Br Med J. 2008;337:a1864. doi: 10.1136/bmj.a1864.
    1. King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M. Impact of participant and physician intervention preferences on randomised trials: a systematic review. J Am Med Assoc. 2005;293:1089–1099. doi: 10.1001/jama.293.9.1089.
    1. Appelbaum P, Roth L, Lidz C, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconcenption. Hast Cent Rep. 1987;7(2):20–24. doi: 10.2307/3562038.
    1. Robinson E, Kerr C, Stevens A, Lilford R, Braunholtz D, Edwards S. Lay conceptions of the ethical and scientific justifications for random allocation in clinical trials. Soc Sci Med. 2004;58:811–824. doi: 10.1016/S0277-9536(03)00255-7.
    1. World Medical Association WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects 2013 available at . Accessed Dec 2017.
    1. Bower P, King M, Nazareth I, Lampe F, Sibbald B. Patient preferences in randomised controlled trials: conceptual framework and implications for research. Soc Sci Med. 2005;61:685–695. doi: 10.1016/j.socscimed.2004.12.010.
    1. Chard J, Lilford R. The use of equipoise in clinical trials. Soc Sci Med. 1998;47(7):891–898. doi: 10.1016/S0277-9536(98)00153-1.
    1. Wade J, Donovana J, Lanea J, Nealb D, Hamdy F. It’s not just what you say, it’s also how you say it: opening the ‘black box’ of informed consent appointments in randomised controlled trials. Soc Sci Med. 2009;68:2018–2028. doi: 10.1016/j.socscimed.2009.02.023.
    1. Brown R, Butow P, Ellis P, Boyle F, Tattersall M. Seeking informed consent to cancer clinical trials: describing current practice. Soc Sci Med. 2004;58:2445–2457. doi: 10.1016/j.socscimed.2003.09.007.
    1. Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T. Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Br Med J. 2002;325:766–770. doi: 10.1136/bmj.325.7367.766.
    1. Harrop E, Noble S, Edwards M, Sivell S, Moore B, Nelson A. “I didn’t really understand it, I just thought it’d help”: exploring the motivations, understandings and experiences of patients with advanced lung cancer participating in a non-placebo clinical IMP trial. Trials. 2016;17:329–340. doi: 10.1186/s13063-016-1460-8.
    1. Toye F, Williamson E, Williams M, Fairbank J, Lamb S. What value can qualitative research add to quantitative research design? An example from an adolescent idiopathic scoliosis trail feasibility study. Qual Health Res. 2016;26(13):1838–1850. doi: 10.1177/1049732316662446.
    1. Dean S, Poltawski L, Forster A, Taylor R, Spencer A, James M, Allison R, Stevens S, Norris M, Shepherd A, Calitri R. Community-based rehabilitation training after stroke: protocol of a pilot randomised controlled trial (ReTrain) BMJ Open. 2016;6:e012375. doi: 10.1136/bmjopen-2016-012375.
    1. Dean S, Poltawski L, Forster A, Taylor R, Spencer A, James M, Allison R, Stevens S, Norris M, Shepherd A, Calitri R. Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility. BMJ. Open in press.
    1. Stroke Association. Exercise and stroke. London: Stroke association resources 7, version 1, 2013.
    1. Balchin T. The successful stroke survivor: a new guide to functional recovery from stroke. Lingfield: ARNI Trust; 2011.
    1. Norris M, Poltawski L, Calitri R, Shepherd A, Dean S. The acceptability and experience of a functional training programme (ReTrain) in community dwelling stroke survivors in South West England: a qualitative study. BMJ Open. 2018;8:e022175. doi: 10.1136/bmjopen-2018-022175.
    1. Packer M. The science of qualitative research. Cambridge: Cambridge University Press; 2011.
    1. Ritchie J, Lewis J. Qualitative research practice: a guide for social science students and researchers. London: SAGE Publications; 2009.
    1. Greenhalgh T. Papers that go beyond numbers (qualitative research) 5. Chichester: Wiley, BMJ Books; 2014. How to read a paper: the basics of evidenced based medicine; pp. 164–177.
    1. Scott C, Walker J, White P, Lewith G. Forging convictions: the effects of active participation in a clinical trial. Soc Sci Med. 2011;72:2041–2048. doi: 10.1016/j.socscimed.2011.04.021.
    1. McCann S, Campbell M, Entwistle V. Reasons for participating in randomised controlled trials: conditional altruism and considerations for self. Trials. 2010;11:31–41. doi: 10.1186/1745-6215-11-31.
    1. MacNeill V, Foley M, Quirk A, McCambridge J. Shedding light on research participation effects in behaviour change trials: a qualitative study examining research participant experiences. BMC Public Health. 2016;16:91–98. doi: 10.1186/s12889-016-2741-6.
    1. Mills N, Donovan J, Smith M, Jacoby A, Neal D, Hamdy F. Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. Control Clin Trials. 2003;24:272–282. doi: 10.1016/S0197-2456(03)00020-5.
    1. Doherty C, Stavropoulou C, Saunders M, Brown T. The consent process: enabling or disabling patients’ active participation? Health. 2015;21(2):205–222. doi: 10.1177/1363459315611870.
    1. Joseph-Williams N, Elwyn G, Edwards A. Knowledge is not power for patients: a systematic review and thematic synthesis of patient-reported barriers and facilitators to shared decision making. Patient Educ Couns. 2014;94(3):291–309. doi: 10.1016/j.pec.2013.10.031.
    1. Murray J, Young J, Forster A, Ashworth R. Developing a primary care-based stroke model: the prevalence of longer-term problems experienced by patients and carers. Br J Gen Pract. 2003;53(495):803–807.
    1. Ch’ng A, French D, Mclean N. Coping with the challenges of recovery from stroke. J Health Psychol. 2008;13(8):1136–1146. doi: 10.1177/1359105308095967.
    1. Townend S, Whyte S, Desborough T, Crimmins D, Markus R, Levi C, Sturm J. Longitudinal prevalence and determinants of early mood disorder post-stroke. J Clin Neurosci. 2007;14:429–434. doi: 10.1016/j.jocn.2006.01.025.
    1. Lindström D, Sundberg-Petersson I, Adami J, Tönnesen H. Disappointment and drop-out rate after being allocated to control group in a smoking cessation trial. Contemp Clin Trials. 2010;31:22–26. doi: 10.1016/j.cct.2009.09.003.
    1. Vist G, Hagen K, Devereaux P, Bryant D, Kristoffersen D, Oxman A. Systematic review to determine whether participation in a trial influences outcome. BMJ. 2005;330:1175. doi: 10.1136/bmj.330.7501.1175.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe