Understanding the outcomes of multi-centre clinical trials: A qualitative study of health professional experiences and views

Social Science and Medicine

Volumn 74, Issue 4, 2012, Pages 574-581

  Lawton, Julia ^a   Jenkins, Nicholas ^a   Darbyshire, Julie ^b   Farmer, Andrew ^b   Holman, Rury ^b   Hallowell, Nina ^c  

^a UNIVERSITY OF EDINBURGH   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c NEWCASTLE UNIVERSITY   (United Kingdom)

Author keywords

Mutli centre study; Qualitative; Staff perspectives; Trial delivery; Type 2 diabetes; UK

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN;

BLOOD; DIABETES; DRUG; GLUCOSE; HEALTH CARE; QUALITATIVE ANALYSIS;

ARTICLE; CLINICAL PRACTICE; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); DIABETES MELLITUS; FUNDING; GLUCOSE BLOOD LEVEL; HEALTH CARE QUALITY; HEALTH PERSONNEL ATTITUDE; HUMAN; MEDICAL STAFF; MULTICENTER STUDY (TOPIC); PATIENT CARE; PATIENT PARTICIPATION; QUALITATIVE RESEARCH; TREATMENT OUTCOME; UNITED KINGDOM;

ATTITUDE OF HEALTH PERSONNEL; GREAT BRITAIN; HUMANS; MULTICENTER STUDIES AS TOPIC; NURSES; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); PATIENT SELECTION; PHYSICIANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH PERSONNEL; RESEARCH SUPPORT AS TOPIC;

UNITED KINGDOM;

EID: 84856378107     PISSN: 02779536     EISSN: 18735347     Source Type: Journal    
DOI: 10.1016/j.socscimed.2011.11.012     Document Type: Article

References (40)

1. Abadie R. The professional Guinea pig: Big pharma and the risky world of human subjects 2010, Duke University Press, London.
2. Cambrosio A., Keating P., Schlich T., Weisz G. Regulatory objectivity and the generation and management of evidence in medicine. Social Science & Medicine 2006, 63:189-199.
3. Cambrosio A., Keating P., Schlich T., Weisz G. Biomedical conventions and regulatory objectivity: a few introductory remarks. Social Studies of Science 2009, 39:651-664.
4. 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.
5. Carsten J. Cooking money: gender and the symbolic transformation of means of exchange in a Malay fishing community. Money & the morality of exchange 1989, Cambridge University Press, Cambridge. J. Parry, M. Block (Eds.).
6. Chen D., Miller F., Rosenstein D. Clinical research and the physician-patient relationship. Annals of Internal Medicine 2003, 138:669-672.
7. Del Bianco P., Borgoni R. Handling dropout and clustering in longitudinal multi-centre clinical trials. Statistical Modelling 2006, 6:141-157.
8. Dixon J. The international conference on harmonization good clinical practice guideline. Quality Assurance 1998, 6:65-74.
9. Donovan J., Mills N., Smith M., Brindle L., Jacoby A., Peters T., et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. British Medical Journal 2002, 325:766-770.
10. Easter M., Henderson G., Davis A., Churchill L., King N. The many meanings of care in clinical research. Sociology of Health & Illness 2006, 28:695-712.
11. 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. Social Science & Medicine 2002, 55:709-719.
12. Fisher J. Co-ordinating 'ethical' clinical trials: the role of research coordinators in the contract research industry. Sociology of Health & Illness 2006, 28:678-694.
13. Flynn R. Clinical governance and governmentality. Health Risk & Society 2002, 4:155-173.
14. Glaser B., Strauss A. The discovery of grounded theory 1967, Aldine, Chicago.
15. Gray R. A Bayesian analysis of institutional effects in a multicenter cancer clinical trial. Biometrics 1994, 50:244-253.
16. Hallowell N., Cooke S., Crawford G., Parker M., Lucassen A. Healthcare professionals' and researchers' understanding of cancer genetics activities: a qualitative interview study. Journal of Medical Ethics 2009, 35:113-119.
17. Hallowell N., Cooke S., Crawford G., Lucassen A., Parker M. Distinguishing research from clinical care in cancer genetics: theoretical justifications and practical strategies. Social Science & Medicine 2009, 68:2010-2017.
18. Heaven B. Bridging the ontological divide: different social worlds in the conduct of a pilot study. Medical proofs, social experiments: Clinical trials in shifting contexts 2010, Ashgate, Aldershot. C. Will, T. Moreira (Eds.).
19. Holman R., Thorne K., Farmer A., Davies M., Keenan J., Paul S., et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. The New England Journal of Medicine 2007, 357:1716-1730.
20. Holman R., Farmer A., Davies M., Levy J., Darbyshire J., Keenan J., et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. The New England Journal of Medicine 2009, 361:1736-1747.
21. Jenkins N., Hallowell N., Farmer A., Holman R., Lawton J. Initiating insulin as part of the treating to target in type 2 diabetes (4-T) trial: a interview study of patients' and health professionals' experiences. Diabetes Care 2010, 33:2178-2180.
22. Jenkins N., Hallowell N., Farmer A., Holman R., Lawton J. Participants' experiences of intensifying insulin therapy during the treating to target in type 2 diabetes (4-T) trial: qualitative interview study. Diabetic Medicine 2011, 28:543-548.
23. Krein S., Damschroder L., Kowalski C., Forman J., Hofer T., Saint S. The influence of organizational context on quality improvement and patient safety efforts in infection prevention: a multi-centre qualitative study. Social Science & Medicine 2010, 71:1692-1701.
24. Lawton J., Jenkins N., Darbyshire J., Farmer A., Hollman R., Hallowell N. Challenges of maintaining research protocol fidelity in a clinical care setting: a qualitative study of the experiences and views of patients and staff participating in a randomised controlled trial. Trials 2011, 12:108.
25. Legrand C., Ducrocq V., Janssen P., Sylvester R., Duchateau L. A Bayesian approach to jointly estimate centre and treatment by centre heterogeneity in a proportional hazards model. Statistics in Medicine 2005, 24:3789-3804.
26. Lewin S., Glenton C., Oxman A. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. British Medical Journal 2009, 339. 10.1136/bmj.b3496.
27. Lowton K. Trials and tribulations: understanding motivations for clinical research participation amongst adults with cystic fibrosis. Social Science & Medicine 2005, 61:1854-1865.
28. Manda S. A Bayesian ordinal model for heterogeneity in a multi-centre myocardial infarction clinical trial. Statistics in Medicine 2002, 21:3011-3022.
29. Medical Research Council (MRC) A framework for development and evaluation of RCTs for complex interventions to improve health 2000.
30. Petryna A. When experiments travel: Clinical trials and the global search for human subjects 2009, Princeton University Press, Princeton.
31. Ruston A. Interpreting and managing risk in a machine bureaucracy: professional decision-making in NHS direct. Health, Risk & Society 2006, 8:257-271.
32. 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. Social Science & Medicine 1997, 45:1337-1355.
33. Strauss A., Corbin J. Basics of qualitative research: Grounded theory procedures and techniques 1990, Sage, London.
34. Taylor K. Integrating conflicting professional roles: physician participation in randomized clinical trials. Social Science & Medicine 1992, 35:217-224.
35. Timmermans S. Reconciling research with medical care in RCTS. Medical proofs, social experiments: Clinical trials in shifting contexts 2010, Ashgate, Aldershot. C. Will, T. Moreira (Eds.).
36. Timmermans S., Berg M. The gold standard: The challenge of evidence-based medicine and standardization in health care 2003, Temple University Press, Philadelphia.
37. Timmermans S., McKay T. Clinical trials as treatment option: bioethics and health care disparities in substance dependency. Social Science & Medicine 2009, 69. 1784-1709.
38. Will C. Mutual benefit, multiple value? Doing research in the national health service. Journal of Cultural Economy 2011, 4:11-26.
39. Yamaguchi T., Ohashi Y. Investigating centre effects in a multi-centre clinical trial of superficial bladder cancer. Statistics in Medicine 1999, 18:1961-1971.
40. Ziebland S., Featherstone K., Snowdon C., Barker K., Frost H., Fairbank J. 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.