The Patient Deficit Model Overturned: A qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011)

Trials

Volumn 13, Issue , 2012, Pages

  Moynihan, Clare ^a   Lewis, Rebecca ^a   Hall, Emma ^a   Jones, Emma ^a   Birtle, Alison ^b   Huddart, Robert ^a  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^b LANCASHIRE TEACHING HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

Bladder cancer; Communication; Complex interventions; Confusion; Equipoise; Patient interviews; Qualitative methodology; Randomized controlled trials

Indexed keywords

AGED; ALIENATION; AMBIGUITY; ARTICLE; BLADDER CANCER; BLADDER SURGERY; CANCER INVASION; CLINICAL ARTICLE; CONSERVATIVE TREATMENT; FEASIBILITY STUDY; FEMALE; GEOGRAPHY; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; HUMAN; INFORMED CONSENT; MALE; MEDICAL ETHICS; MEDICAL INFORMATION; PATIENT ATTITUDE; PATIENT DECISION MAKING; PATIENT PARTICIPATION; QUALITATIVE RESEARCH; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEMI STRUCTURED INTERVIEW; UNITED KINGDOM;

AGED; ATTITUDE OF HEALTH PERSONNEL; CHEMOTHERAPY, ADJUVANT; COMMUNICATION; COMPREHENSION; CONFUSION; CYSTECTOMY; FEMALE; GREAT BRITAIN; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; INFORMED CONSENT; INTERVIEWS AS TOPIC; MALE; MIDDLE AGED; MODELS, PSYCHOLOGICAL; NEOADJUVANT THERAPY; NEOPLASM INVASIVENESS; ORGAN SPARING TREATMENTS; PATIENT ACCEPTANCE OF HEALTH CARE; PATIENT SELECTION; PERCEPTION; PROFESSIONAL-PATIENT RELATIONS; QUALITATIVE RESEARCH; RADIOTHERAPY, ADJUVANT; RESEARCH SUBJECTS; THERAPEUTIC EQUIPOISE; URINARY BLADDER; URINARY BLADDER NEOPLASMS;

EID: 84870063760     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-228     Document Type: Article

References (54)

1. Byar DP, Simon RM, Friedewald T, Schlesselman JJ, DeMets DL, Ellenberg JH, Gail MH, Ware JH. Randomized clinical trials: perspectives on some recent ideas. N Engl J Med 1976, 295:74-80. 10.1056/NEJM197607082950204, 775331.
2. Chalmers TC, Sacks H, Smith H. Historical versus randomised controls for clinical trials. J Control Clin Trials 1980, 1:177.
3. Tognoni G, Alkli C, Avanzini G, Bettelli G, Colombo F, Corso R, Marchioli R, Zussino A. Randomised clinical trials in general practice: lessons from a failure. BMJ 1991, 303:969-971. 10.1136/bmj.303.6808.969, 1671349, 1954424.
4. Earlam R. An MRC, prospective randomised trial of radiotherapy vs surgery for operable squamous cell carcinoma of the oesophagus. Ann R Coll Surg 1991, 73:8-12.
5. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol 1999, 52:1143-1156. 10.1016/S0895-4356(99)00141-9, 10580777.
6. Baum M. Reflections on randomised controlled trials in surgery. Lancet 1999, 353:6-8. 10.1016/S0140-6736(05)74876-5, 10023941.
7. Featherstone K. Experience of trial participation (editorial). J Rheumatol 2003, 30:646-647.
8. Wynne B. Knowledge in context. Sci Technol Hum Values 1991, 16:111-121.
9. Waggoner W, Mayo D. Who understands? A survey of 25 words or phrases commonly used in proposed clinical research consent forms. IRB 1995, 17:6-9.
10. Kerr C, Robinson E, Stevens A, Braunholtz D, Edwards S, Lilford R. Randomisation in trials: do potential trial participants understand it and find it acceptable?. J Med Ethics 2004, 30:80-84. 10.1136/jme.2002.001123, 1757143, 14872081.
11. Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, Frankel S, Neal D, Hamdy F. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ 2002, 325:766-770. 10.1136/bmj.325.7367.766, 1124277, 12364308.
12. Joffe S, Cook EF, Cleary PD, Clarke JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001, 358:1772-1777. 10.1016/S0140-6736(01)06805-2, 11734235.
13. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 1987, 17:20-24.
14. Spodick D. The randomized controlled clinical trial: scientific and ethical bases. Am J Med 1982, 73:420-425. 10.1016/0002-9343(82)90746-X, 7124768.
15. Kodish E, Lantos D, Siegler M. The ethics of randomization. Cancer J Clin 1991, 41:180-186.
16. Lynoe N, Sanlund M, Dahqvist G, Jacobsson L. Informed consent: study of quality of information given to participants in a clinical trial. BMJ 1991, 303:610-613. 10.1136/bmj.303.6803.610, 1671066, 1932901.
17. World Medical Association Declaration of Helsinki. Revised edition (1975). Contemporary Issues in Bioethics 1982, 511-512. Belmont, California: Wadsworth Publishing Company, Beauchamp TL, World Medical Association.
18. Mills N, Donovan JL, Smith M, Jacoby A, Neal DE, Hamdy FC. Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. Control Clin Trials 2003, 24:272-282. 10.1016/S0197-2456(03)00020-5, 12757993.
19. Featherstone K, Donovan J. "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, 55:709-719. 10.1016/S0277-9536(01)00197-6, 12190265.
20. Featherstone K, Donovan J. Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial. BMJ 1998, 317:1177-1180. 10.1136/bmj.317.7167.1177, 28698, 9794849.
21. Hall A. The role of effective communication in obtaining informed consent. Informed Consent in Medical Research 2001, 290-298. London: BMJ Books, Loyal L, Tobias J.
22. Snowdon C, Garcia J, Elbourne D. Reactions of participants to the results of a randomised controlled trial: exploratory study. BMJ 1998, 317:21-26. 10.1136/bmj.317.7150.21, 28597, 9651262.
23. Taylor K. Integrating conflicting professional roles: physician participation in randomised clinical trials. Soc Sci Med 1992, 35:217-224. 10.1016/0277-9536(92)90169-Q, 1509310.
24. Pregler JP, Bean JA, Rademaker AW, Eshler B, Anderson K, Benson AB. Oncologists' reluctance to accrue patients onto clinical trials: an Illinois Cancer Centre study. J Clin Oncol 1991, 9:2067-2975.
25. Taylor KM, Margolese RG, Soskolne CL. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med 1984, 310:1363-1367. 10.1056/NEJM198405243102106, 6717508.
26. Shuhatovich OM, Sharman MP, Mirabal YN, Earle NR, Follen M, Basen-Engquist K. Participant recruitment and motivation for participation in optical technology for cervical cancer screening research trials. Gynecol Oncol 2005, 99(3 Suppl 1):226-231.
27. McPherson K, Britton A, Wennbert J. Are randomised trials controlled? Patient preferences and unblind trials. J Roy Soc Med 1997, 90:652-656. 1296732, 9496288.
28. Simes RJ, Tattersall MH, Coates AS, Raghavan D, Solomon HJ, Smartt H. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. BMJ 1986, 293:1065-1068. 10.1136/bmj.293.6554.1065, 1341916, 3094776.
29. Lowton K. Trials and tribulations: understanding motivations for clinical research participation amongst adults with cystic fibrosis. Soc Sci Med 2005, 61:1854-1865. 10.1016/j.socscimed.2005.03.039, 15913858.
30. Verheggen F, Nieman F, Jonkers R. Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial. Patient Educ Couns 1998, 35:111-125. 10.1016/S0738-3991(98)00060-3, 10026554.
31. Ritchie J, Spencer L. Qualitative data analysis for applied policy research. Analyzing Qualitative Data 1994, 173-194. London: Sage Publications, Bryman A, Burgess R.
32. Pope C, Mays N. Qualitative Research in Health Care 1996, London: BMJ Books. Blackwell Publishing.
33. Huddart R, Hall E, Lewis R, Birtle A, . on behalf of the SPARE Trial Management Group Life and death of SPARE (selective bladder preservation against radical excision): reflections on why the SPARE trial closed. BJU Int 2010, 106:753-755. 10.1111/j.1464-410X.2010.09537.x, 20707796, on behalf of the SPARE Trial Management Group.
34. Ellis P, Butow P. Focus group interviews examining attitudes to randomised trials among breast cancer patients and the general community. Aust N Z J Public Health 1998, 22:528-531. 10.1111/j.1467-842X.1998.tb01432.x, 9744203.
35. Titus S, Keane M. Do you understand? An ethical assessment of researchers' description of the ethical process. J Clin Ethics 1996, 7:60-68.
36. Robinson EJ, 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. 10.1016/S0277-9536(03)00255-7, 14672595.
37. Michael M. Knowing ignorance and ignoring knowledge: discourses of ignorance in the public understanding of science. Misunderstanding Science? The Public Reconstruction of Science and Technology 1996, 107-126. Cambridge, UK: Cambridge University Press, Irwin A, Wynne B.
38. Hopwood P, Harvey A, Davies J, Stephens RJ, Girling DJ, Gibson D, Parmar MK. Survey of the Administration of quality of life (QL) questionnaires in three multicentre randomised trials in cancer. The Medical Research Council Lung Cancer Working Party the CHART Steering Committee. Eur J Cancer 1998, 34:49-57. 10.1016/S0959-8049(97)00347-X, 9624237.
39. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996, 313:36-39. 10.1136/bmj.313.7048.36, 2351444, 8664772.
40. Tattersall M. Examining informed consent to cancer clinical trials. Lancet 2001, 358:1742-1743. 10.1016/S0140-6736(01)06838-6, 11734224.
41. Salmon P, Young B. Core assumptions and research opportunities in clinical communication. Patient Educ Couns 2005, 58:225-234. 10.1016/j.pec.2005.05.018, 16024210.
42. Salander P, Moynihan C. Patients' 'hope work' is facilitated through relationship - a critique of the 'Discourse of Autonomy'. Configuring Health Consumers. Health Work and the Imperative of Personal Responsibility 2010, Basingstoke: Palgrave Macmillan, Harris R, Wathen N, Wyatt S.
43. Fallowfield L, Jenkins V. Communicating sad, bad and difficult news in medicine. Lancet 2004, 363:312-319. 10.1016/S0140-6736(03)15392-5, 14751707.
44. James N. Care=Organisation+physical labour+emotional labour. Sociol Health Ill 1992, 14:488-509.
45. Dodds W, Morgan M, Wolfe C, Raju K. Implementing the 2-week wait rule for cancer referral in the UK: general practitioners' views and practices. Eur J Cancer Care (Engl) 2004, 13:82-87.
46. Department of Health (National Cancer Waits Project) Cancer Waiting Targets: A Guide (Version 5) 2006, London: Department of Health, Department of Health (National Cancer Waits Project).
47. Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials 2011, 15:12-78.
48. Moynihan C. Patient 'non-compliance' and 'missing data' in quality of life research: where does the problem lie?. Eur J Cancer 1998, 34:9-11.
49. Silverman D. Communications and Medical Practice 1987, London: Sage Publications.
50. Donovan J, Blake D. Qualitative study of interpretation of reassurance among patients attending a rheumatology clinic: " just a touch of arthritis doctor" ?. BMJ 2000, 320:541-544. 10.1136/bmj.320.7234.541, 27296, 10688559.
51. Turner BS. Medical Power and Social Knowledge (Chapter 3) 1995, London: Sage Publications.
52. Cox A, Fallowfield L, Jenkins V. Communication and informed consent in phase 1 trials: a review of the literature. Support Care Cancer 2006, 14:303-309. 10.1007/s00520-005-0916-2, 16633840.
53. Bowlby J. Attachment theory and its therapeutic implications. Adolesc Psychiatry 1978, 6:5-33.
54. Brennan J, Moynihan C. Cancer in Context 2004, Oxford, UK: Oxford University Press.