Women’s views and experiences of a patient preference trial in surgery: a qualitative study of the CARPET1 trial

Abstract

Background The randomized controlled trial (RCT) has a well-established role in assessing drug therapies, but its adoption in developing surgical interventions has been slow. Patients’ perspectives on surgical RCTs, especially those including a patient preference option, have received little attention.

Purpose To characterize participants’ experiences and views of recruitment to a pilot trial (CARPET1) of two surgical treatments for urinary incontinence and vaginal prolapse that included a patient preference option.

Methods Semi-structured qualitative interviews with 16 women who participated in the CARPET1 trial. Data analysis was based on the constant comparative method. Main outcome measures Women’s experiences of taking part in a patient preference trial.

Results Women’s motives for participating in CARPET1 focused on the possibility of additional care and, as a secondary motive, the wish to help with research. Most participants expressed a treatment preference rather than accepting randomization. Most were pleased with the information they received, and acknowledged the principle of equipoise, but there was substantial variability in their understanding of aspects of the trial, including randomization. Randomization was considered by women to be appropriate only when both treatments were equally suitable and they had no strong preference. Women suggested that the main influence on their willingness to be randomized was the recruiting clinician’s opinion. Importantly, despite the recruiting clinicians being heavily involved in conception of CARPET1, they did not seem to be in equipoise at the level of the individual patient. Limitations This being a small study it was not possible to interview women who declined trial participation or to observe consultations between surgeons and patients.

Conclusions CARPET1 appears to have been more a surgeon preference trial than a patient preference trial. Substantial challenges may remain in conducting RCTs in surgery, particularly where surgeons have preferences about what they perceive as the best option for an individual patient. Clinical Trials 2010; 7: 696—704. http://ctj.sagepub.com

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References

Marron JM , Siegler M. Ethical issues in innovative colorectal surgery. Dis Colon Rectum 2005; 48: 1109-13.

McKneally MF , Daar AS Introducing new technologies: protecting subjects of surgical innovation and research. World J Surg 2003; 27: 930-35.

The EC/IC Bypass Study Group. Failure of extracranialintracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. N Engl J Med 1985; 313: 191-200.

Reid SV , Parys BT Long-term 5-year followup of the results of the vesica procedure. J Urol 2005; 173: 1234-36.

Danjoux NM , Martin DK , Lehoux PN , et al. Adoption of an innovation to repair aortic aneurysms at a Canadian hospital: a qualitative case study and evaluation. BMC Health Serv Res 2007; 7: 182.

Wilson CB Adoption of new surgical technology. BMJ 2006 ; 332: 112-14.

Biffl WL , Spain DA , Reitsma AM , et al. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. J Am Coll Surg 2008; 206: 1204-09.

Barkun JS , Aronson JK , Feldman S. , et al. Evaluation and stages of surgical innovation. The Lancet 2009; 374: 1089-96.

Engina PL , Cook JA , Blazeby JM , et al. Challeges in evaluating surgical innovation. Lancet 2009; 374: 1097-104.

10.

Gurusamy KS , Gluud C. , Nikolova D. , Davidson BR Assessment of risk of bias in randomized clinical trials in surgery. Br J Surg 2009; 96: 342-49.

11.

Cook JA The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials 2009; 10: 9.

12.

Snowdon C. , Garcia J. , Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med 1997; 45: 1337-55.

13.

Featherstone K. , Donovan JL ‘‘Why don’t they just tell me straight, why allocate it?’’ The struggle to make sense of participating in a randomised controlled trial. Soc Sci Med 2002; 55: 709-19.

14.

Canvin K. , Jacoby A. Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial. Trials 2006; 7: 32.

15.

Madsen SM , Holm S. , Riis P. Attitudes towards clinical research among cancer trial participants and non-participants: an interview study using a Grounded Theory approach. J Med Ethics 2007; 33: 234-40.

16.

Tincello DG , Kenyon S. , Slack M. , et al. Colposuspension or TVT with anterior repair for urinary incontinence and prolapse: results of and lessons from a pilot randomised patient preference study (CARPET 1). BJOG 2009; 113: 1809-14.

17.

Torgerson DJ , Sibbald B.

Understanding controlled trials. What is a patient preference trial?

BMJ 1998; 316: 360.

18.

Preference Collaborative Review Group. Patients’ preferences within randomised trials: systematic review and patient level meta-analysis. BMJ 2008; 337.

19.

Grant AM , Wileman SM , Ramsay CR , et al. Minimal access surgery compared with medical management for chronic gastro-oesophagal reflex disease: UK collaborative randomised trial . BMJ 2008; 377: a2664.

20.

McPherson K. , Britton AR , Wennberg JE Are randomized controlled trials controlled? Patient preferences and unblind trials. J R Soc Med 1997; 90: 652-56.

21.

Bowling A. , Rowe G.

‘‘You decide doctor’’. What do patient preference arms in clinical trials really mean?

J Epidemiol Comm Health 2005; 59: 914-15.

22.

King M. , Nazareth I. , Lampe F. , et al. Impact of participant and physician intervention preferences on randomized trials: a systematic review. JAMA 2005; 293: 089-99.

23.

Glaser B. , Strauss A. Discovery of grounded theory. Aldine, Chicago, 1967.

24.

Dixon-Woods M. , Tarrant C. Why do people cooperate with medical research? Findings from three studies. Soc Sci Med 2009 ; 68: 2215-22.

25.

Snowdon C. , Garcia J. , Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med 1997; 45: 337-55.

26.

Bale RN , Van Stone WW , Kuldau JM , et al. Therapeutic communities vs methadone maintenance. A prospective controlled study of narcotic addiction treatment: design and one-year follow-up . Arch Gen Psych 1980; 37: 179-93.

27.

Eurich DT , Tsuyuki RT , Majumdar SR , et al. Metformin treatment in diabetes and heart failure: when academic equipoise meets clinical reality. Trials 2009 ; 10: 12.

28.

Ruddell M. , Spencer A. , Hill K. , House A. Fluoxetine vs placebo for depressive symptoms after stroke: failed randomised controlled trial. Int J Geriatr Psych 2007 ; 22: 963-65.

29.

Sugarman J. , Kass NE , Goodman SN , et al. What patients say about medical research . IRB: Ethics Human Res 1998; 20: 1-7.

30.

McCann S. , Campbell MK , Entwistle V. Reasons for participating in randomised controlled trials: conditional altruism and considerations for self. Trials 2010; 11: 3.

31.

Donovan J. , Mills N. , Smith M. , et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ 2002; 325: 766-70.

32.

Ziebland S. , Featherstone K. , Snowdon C. , et al. Does it matter if clinicians recruiting for a trial don’t understand what the trial is really about? Qualitative study of surgeons’ experiences of participation in a pragmatic multi-centre RCT. Trials 2007; 8: 4.

33.

Gross M. Innovations in surgery. A proposal for phased clinical trials. J Bone Joint Surg Br 1993; 75: 351-54.

34.

Morgenstern L.

Can surgical research be ethical?

Surg Innov 2008; 15: 57-60.

35.

Lumley J. , Lester A. , Renou P. , Wood C. A failed RCT to determine the best method of delivery for very low birth weight infants. Control Clin Trials 1985; 6: 20-27.

36.

Barkun JS , Barkun AN , Sampalis JS , et al. Randomised controlled trial of laparoscopic versus mini cholecystectomy. The McGill Gallstone Treatment Group. Lancet 1992; 340: 1116-19.