Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences

Trials

Volumn 15, Issue 1, 2014, Pages

  Mills, Nicola ^a   Blazeby, Jane M ^a   Hamdy, Freddie C ^b   Neal, David E ^c   Campbell, Bruce ^d   Wilson, Caroline ^a   Paramasivan, Sangeetha ^a   Donovan, Jenny L ^a  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c ADDENBROOKE S HOSPITAL   (United Kingdom)

^d UNIVERSITY OF EXETER MEDICAL SCHOOL   (United Kingdom)

Author keywords

Informed consent; ProtecT study; Qualitative research methods; Randomized controlled trials; Recruitment to randomized controlled trials; Treatment preferences

Indexed keywords

ARTICLE; HUMAN; INFORMED CONSENT; MALE GENITAL SYSTEM EXAMINATION; MEDICAL EDUCATION; PATIENT DECISION MAKING; PATIENT PREFERENCE; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT PLANNING; ADULT; AGED; FEMALE; MALE; MIDDLE AGED; PATIENT SELECTION;

ADULT; AGED; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; PATIENT PREFERENCE; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84908079255     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-323     Document Type: Article

References (45)

1. Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan F, Wilson S, Jackson C, Jones R, Lockhart P. Strategies to improve recruitment to randomized controlled trials. Cochrane Database Syst Rev 2010, MR000013.
2. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomized controlled trials: a systematic review. J Clin Epidemiol 1999, 52:1143-1156.
3. Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K, Ellis P, Wright JR. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol 2006, 7:141-148.
4. King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M, Sibbald B, Lai R. Impact of participant and physician intervention preferences on randomized trials: a systematic review. JAMA 2005, 293:1089-1099.
5. Fayter D, McDaid C, Eastwood A. A systematic review highlights threats to validity in studies of barriers to cancer trial participation. J Clin Epidemiol 2007, 60:990-1001.
6. Taylor KM. Physician participation in a randomized clinical trial for ocular melanoma. Ann Ophthalmol 1992, 24:337-344.
7. Langley C, Gray S, Selley S, Bowie C, Price C. Clinicians' attitudes to recruitment to randomized trials in cancer care: a qualitative study. J Health Serv Res Policy 2000, 5:164-169.
8. Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomized controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial. Trials 2011, 12:78.
9. Donovan JL, Paramasivan S, de Salis I, Toerien M. Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomized controlled trials. Trials 2014, 15:5.
10. Preference Collaborative Review Group Patients' preferences within randomized trials: systematic review and patient level meta-analysis. BMJ 2008, 337:a1864. Preference Collaborative Review Group.
11. Bowling A, Rowe G. "You decide doctor": What do patient preference arms in clinical trials really mean?. J Epidemiol Community Health 2005, 59:914-915.
12. Rowe G, Lambert N, Bowling A, Ebrahim S, Wakeling I, Thomson R. Assessing patients' preferences for treatments for angina using a modified repertory grid method. Soc Sci Med 2005, 60:2585-2595.
13. Stiggelbout AM, de Haes JCJM. Patient preference for cancer therapy: an overview of measurement approaches. J Clin Oncol 2001, 19:220-230.
14. Donovan JL, Lane JA, Peters TJ, Brindle L, Salter E, Gillatt D, Powell P, Bollina P, Neal DE, Hamdy FC, . for the ProtecT Study Group Development of a complex intervention to improve randomization and informed consent in randomized controlled trials. J Clin Epidemiol 2009, 62:29-36. for the ProtecT Study Group.
15. Mills N, Donovan JL, Wade J, Hamdy FC, Neal DE, Lane JA. Exploring treatment preferences facilitated recruitment to randomized controlled trials. J Clin Epidemiol 2011, 64:1127-1136.
16. Bower P, King M, Nazareth I, Lampe F, Sibbald B. Patient preferences in randomized controlled trials: conceptual framework and implications for research. Soc Sci Med 2005, 61:685-695.
17. Wade J, Donovan JL, Lane JA, Neal DE, Hamdy FC. It's not just what you say, it's also how you say it: opening the 'black box' of informed consent appointments in randomized controlled trials. Soc Sci Med 2009, 68:2018-2028.
18. Edwards A, Elwyn G. Understanding risk and lessons for clinical risk communication about treatment preferences. Qual Health Care 2001, 10:i9-i13.
19. Donovan JL, Mills N, Smith M, Brindle L, Jacoby A, Peters T, Frankel S, Neal D, Hamdy F. Improving design and conduct of randomized trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ 2002, 325:766-770.
20. Wragg JA, Robinson EJ, Lilford RJ. Information presentation and decisions to enter clinical trials: a hypothetical trial of hormone replacement therapy. Soc Sci Med 2000, 51:453-462.
21. Marteau TM. Framing of information: its influence upon decisions of doctors and patients. Br J Soc Psychol 1989, 28:89-94.
22. 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, 45:1337-1355.
23. McQuellon RP, Muss HB, Hoffman SL, Russell G, Craven B, Yellen SB. Patient preferences for treatment of metastatic breast cancer: a study of women with early-stage breast cancer. J Clin Oncol 1995, 13:858-868.
24. Silvestri G, Pritchard R, Welch HG. Preferences for chemotherapy in patients with advanced non-small cell lung cancer: descriptive study based on scripted interviews. BMJ 1998, 317:771-775.
25. Yellen SB, Cella DF. Someone to live for: social well-being, parenthood status, and decision-making in oncology. J Clin Oncol 1995, 13:1255-1264.
26. Braddock CH, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed decision making in outpatient practice - time to get back to basics. JAMA 1999, 282:2313-2320.
27. Stiggelbout AM, Van der Weijden T, De Wit MPT, Frosch D, Legare F, Montori VM, Trevena L, Elwyn G. Shared decision making: really putting patients at the centre of healthcare. BMJ 2012, 344:e256.
28. World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects 2004, Tokyo: World Medial Association General Assembly, World Medical Association.
29. Lane JA, Hamdy FC, Martin RM, Turner EL, Neal DE, Donovan JL. Latest results from the UK trials evaluating prostate cancer screening and treatment: The CAP and ProtecT studies. European J Cancer 2010, 46:3095-3101.
30. Krippendorff K. Content Analysis: an Introduction to its Methodology 2004, Thousand Oaks, CA: Sage Publications.
31. Glaser BG, Strauss AL. The Discovery of Grounded Theory 1967, Chicago: Aldine Publishing Company.
32. Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomized controlled trials: a systematic review. BMJ Open 2012, 2:e000496.
33. Kaur G, Smyth RL, Williamson P. Developing a survey of barriers and facilitators to recruitment in randomized controlled trials. Trials 2012, 13:218.
34. Donovan JL, de Salis I, Toerien M, Paramasivan S, Hamdy FC, Blazeby JM. The intellectual challenges and emotional consequences of equipoise contributed to the fragility or recruitment in six randomized controlled trials. J Clin Epidemiol 2014, 67:912-920.
35. Fayter D, McDaid C, Ritchie G, Stirk L, Eastwood A. Systematic Review of Barriers, Modifiers and Benefits Involved in Participation in Cancer Clinical Trials 2006, York: Centre for Reviews and Dissemination, University of York.
36. Little P. Improving design and conduct of randomized trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult [see comment]. BMJ 2002, 325:766-770.
37. Tomlin Z, DeSalis I, Toerien M, Donovan JL. Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent. Health Expect 2012, doi:10.1111/j.1369-7625.2012.00792.x.
38. Jenkins VA, Fallowfield LJ, Souhami A, Sawtell M. How do doctors explain randomized clinical trials to their patients?. Eur J Cancer 1999, 35:1187-1193.
39. Howard L, DeSalis I, Tomlin Z, Thornicroft G, Donovan J. Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness. Contemp Clin Trials 2008, 30:40-46.
40. Brown RF, Butow PN, Ellis P, Boyle F, Tattersall MHN. Seeking informed consent to cancer clinical trials: describing current practice. Soc Sci Med 2004, 58:2445-2457.
41. McCann SK, Campbell MK, Entwistle VA. Reasons for participating in randomized controlled trials: conditional altruism and considerations for self. Trials 2010, 11:31.
42. 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, 8:811-824.
43. Donovan JL, Peters TJ, Noble S, Powell P, Gillatt D, Oliver SE, Lane JL, Neal DE, Hamdy FC, . for the ProtecT Study Group Who can best recruit to randomized trials?: Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study). J Clin Epidemiol 2003, 56:605-609. for the ProtecT Study Group.
44. Albrecht TL, Blanchard C, Ruckdeschel JC, Coovert M, Strongbow R. Strategic physician communication and oncology clinician trials. J Clin Oncol 1999, 17:3324-3332.
45. Mulley AG, Trimble C, Elwyn G. Stop the silent misdiagnosis: patients' preferences matter. BMJ 2012, 345:e6572.