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

Social Science and Medicine

Volumn 68, Issue 11, 2009, Pages 2018-2028

  Wade, Julia ^a   Donovan, Jenny L ^a   Athene Lane, J ^a   Neal, David E ^b   Hamdy, Freddie C ^c  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^c UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Conversation analysis; Informed consent; Prostate cancer; Randomised controlled trial (RCT); Recruitment; Shared decision making; UK

Indexed keywords

CANCER; DECISION MAKING; HEALTH CARE; QUALITATIVE ANALYSIS; STRATEGIC APPROACH;

ADULT; AGED; ARTICLE; CLINICAL ARTICLE; EXTERNAL VALIDITY; HEALTH CARE DELIVERY; HUMAN; INFORMATION DISSEMINATION; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MALE; MEDICAL INFORMATION; PARTICIPANT OBSERVATION; PATIENT DECISION MAKING; QUALITATIVE RESEARCH; RANDOMIZED CONTROLLED TRIAL; STANDARD; THEMATIC ANALYSIS; UNITED KINGDOM;

AGED; COMMUNICATION; GREAT BRITAIN; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; PATIENT PARTICIPATION; PATIENT SELECTION; PROSTATIC NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TAPE RECORDING;

EURASIA; EUROPE; UNITED KINGDOM; WESTERN EUROPE;

EID: 65749084314     PISSN: 02779536     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.socscimed.2009.02.023     Document Type: Article

References (47)

1. Albrecht T.L., Blanchard C., Ruckdeschel J.C., Coovert M., and Strongbow R. Strategic physician communication & oncology clinical trials. Journal of Clinical Oncology 17 10 (1999) 3324-3332
2. Arora N.K. Interacting with cancer patients: the significance of physicians' communication behaviour. Social Science & Medicine 57 (2003) 791-806
3. Atkinson J.M., and Heritage J. Structures of Social Action: Studies in Conversation Analysis (1984), Cambridge University Press, London
4. Boulton M., and Parker M. Informed consent in a changing environment. Social Science & Medicine 65 (2007) 2187-2198
5. Bower P., King M., Nazareth I., Lampe F., and Sibbald B. Patient preferences in randomised controlled trials: conceptual framework and implications for research. Social Science & Medicine 61 (2005) 685-695
6. Britton A., McKee M., Black N., McPherson K., Sanderson C., and Bain C. Choosing between randomised and non-randomised studies: a systematic review. Health Technology Assessment 2 13 (1998)
7. Brown R.F., Butow P.N., Butt D.G., Moore A.R., and Tattersall M.H.N. Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials. Social Science & Medicine 58 (2004) 379-390
8. Brown R.F., Butow P.N., Ellis P., Boyle F., and Tattersall M.H.N. Seeking informed consent to cancer clinical trials: describing current practice. Social Science & Medicine 58 (2004) 2445-2457
9. Chard J.A., and Lilford R.J. The use of equipoise in clinical trials. Social Science & Medicine 47 7 (1998) 891-898
10. Charles C., Gafni A., and Whelan T. Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Social Science & Medicine 49 (1999) 651-661
11. Degner L.F., and Sloan J.A. Decision making during serious illness: what role do patients really want to play?. Journal of Clinical Epidemiology 45 (1992) 941-950
12. De Salis I., Tomlin Z., Toerien M., and Donovan J. Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations. Contemporary Clinical Trials 29 (2008) 663-670
13. Dixon-Woods M., Ashcroft R.E., Jackson C.J., Tobin M.D., Kivits J., Burton P.R., et al. Beyond "misunderstanding": written information and decisions about taking part in a genetic epidemiology study. Social Science & Medicine 65 (2007) 2212-2222
14. Donovan J., Hamdy F., Neal D., Peters T., Oliver S., Brindle L., et al. Prostate testing for cancer and treatment (ProtecT) feasibility study. Health Technology Assessment 7 14 (2003)
15. Donovan J., Lane A., Peters T., Brindle L., Salter E., Gillatt D., et al. Development of a complex intervention improved randomisation and informed consent in a randomized controlled trial. Journal of Clinical Epidemiology (2008)
16. Donovan J., Mills N., Smith M., Brindle L., Jacoby A., Peters T., et al. Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ 325 (2002) 766-770
17. Drew P., and Heritage J. Analyzing talk at work: an introduction. In: Drew P., and Heritage J. (Eds). Talk at work: Interaction in institutional settings (1992), Cambridge University Press, Cambridge 3-65
18. Dunn L.B., and Jeste D.V. Enhancing informed consent for research and treatment. Neuropsychopharmacology 24 6 (2001) 595-607
19. Edwards S.J.L., Lilford R.J., Thornton J., and Hewison J. Informed consent for clinical trials: in search of the 'best' method. Social Science & Medicine 47 11 (1998) 1825-1840
20. Featherstone K., and Donovan J.L. Why don't they just tell me it straight, why allocate it? The struggle to make sense of participating in a randomised controlled trial. Social Science & Medicine 55 (2002) 709-719
21. Featherstone K., and Donovan J.L. Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial. BMJ 317 (1998) 1177-1180
22. Freedman B. Equipoise and ethics of clinical research. New England Journal of Medicine 317 3 (1987) 141-145
23. Gatellari M., Butow O.N., and Tattersall M.H.N. Sharing decisions in cancer care. Social Science & Medicine 52 (2001) 1865-1878
24. General Medical Council. Consent: Patients and doctors making decisions together (2008), GMC, London
25. Glaser B., and Strauss A. The discovery of grounded theory: Strategies for qualitative research (1967), Aldine, New York
26. Grossman S.A., Piantadosi S., and Cohavey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families?. Journal of Clinical Oncology 12 (1994) 2211-2215
27. Heritage J., and Robinson J.D. The structure of patients' presenting concerns: physicians' opening questions. Health Communication 19 2 (2006) 89-102
28. Heritage J., and Sefi S. Dilemmas of advice: aspects of the delivery and reception of advice in interactions between health visitors and first-time mothers. In: Drew P., and Heritage J. (Eds). Talk at work: Interaction in institutional settings (1992), CUP, Cambridge 359-417
29. Hietanen P., Aro A.R., Holli K., and Absetz P. Information and communication in the context of a clinical trial. European Journal of Cancer 36 (2000) 2096-2104
30. ICH harmonised tripartite guideline for good clinical practice for research E6 (R1) (1996).
31. Jenkins V.A., Fallowfield L.J., Shouhami A., and Sawtell M. How do doctors explain randomised clinical trials to their patients?. European Journal of Cancer 35 8 (1999) 1187-1193
32. Krippendorff K. Content analysis: An introduction to its methodology. 2nd ed. (2004), Sage Publications, Thousand Oaks, CA
33. Maynard D.W., and Heritage J. Conversation analysis, doctor-patient interaction and medical communication. Medical Education 39 (2005) 428-435
34. Miles M.B., and Huberman A.M. Qualitative data analysis: An expanded sourcebook (1994), Sage Publications, London
35. Mills E.J., Seely D., Rachlis B., Griffith L., Wu P., Wilson, et al. Barriers to participation in clinical trials of cancer: a meta-analysis & systematic review of patient-reported factors. Lancet Oncology 7 (2006) 141-148
36. Mills N., Donovan J.L., Smith M., Jacoby A., Neal D.E., and Hamdy F.C. Patients' perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. Controlled Clinical Trials 24 (2003) 272-282
37. Neuendorf K.A. The content analysis guidebook (2002), Sage Publications, Thousand Oaks, CA
38. NRES. Information sheets and consent forms, guidance for researchers and reviewers. Version 3.2 (2005), National Research Ethics Service, National Patient Safety Agency. http://www.nres.npsa.nhs.uk/docs/guidance/Info_sheet_and_consent_form_guidance.pdf Accessed 22.10.07
39. Ong L.M.L., de Haes J.C.J.M., Hoos A.M., and Lammes F.B. Doctor-patient communication: a review of the literature. Social Science & Medicine 40 (1995) 903-918
40. Robinson E., Kerr C., Stevens A., Lilford R., Braunholtz D., and Edwards S. Lay conceptions of the ethical and scientific justifications for random allocation in clinical trials. Social Science & Medicine 58 (2004) 811-824
41. Ross S., Grant A., Counsell C., Gillespie W., Russell I., and Prescott R. Barriers to participation in randomised controlled trials: a systematic review. Journal of Clinical Epidemiology 52 12 (1999) 1143-1156
42. Schegloff E.A. Overlapping talk and the organization of turn-taking for conversation. Language in Society 29 1 (2000) 1-63
43. Schwabe M., Howell S.J., and Reuber M. Differential diagnosis of seizure disorders: a conversation analytic approach. Social Science & Medicine 65 (2007) 712-724
44. Silverman D. Doing qualitative research: A practical handbook (2000), Sage Publications, London
45. Silverman D. Interpreting qualitative data: Method for analyzing talk, text and interaction (2001), Sage Publications, London
46. Tomamichel M., Sessa C., Herzig S., de Jong J., Pagani O., Willems Y., et al. Informed consent for phase 1 studies: evaluation of the quantity and quality of information provided to patients. Annals of Oncology 6 (1995) 363-369
47. World Medical Association. Declaration of Helsinki, ethical principles for medical research involving human subjects (2004), World Medical Association General Assembly, Tokyo