Centre Selection for Clinical Trials and the Generalisability of Results: A Mixed Methods Study

PLoS ONE

Volumn 8, Issue 2, 2013, Pages

  Gheorghe, Adrian ^a   Roberts, Tracy E ^a   Ives, Jonathan C ^a   Fletcher, Benjamin R ^a   Calvert, Melanie ^a  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PRACTICE; CLINICAL PROTOCOL; CLINICAL RESEARCH; EXTERNAL VALIDITY; FEASIBILITY STUDY; HUMAN; INFORMATION PROCESSING; META ANALYSIS (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); STUDY DESIGN; SYSTEMATIC REVIEW (TOPIC); UNITED KINGDOM;

COST-BENEFIT ANALYSIS; HEALTH FACILITIES; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84874338510     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0056560     Document Type: Article

References (42)

1. Black N (1996) Why we need observational studies to evaluate the effectiveness of health care. BMJ 312: 1215. doihttp://dx.doi.org/10.1136/bmj.312.7040.1215.
2. Rothwell PM, (2005) Treating Individuals 1- External validity of randomised controlled trials: "To whom do the results of this trial apply?". Lancet 365: 82-93.
3. Silverman SL, (2009) From randomized controlled trials to observational studies. American Journal of Medicine 122: 114-120.
4. Moore DA, Goodall RL, Ives NJ, Hooker M, Gazzard BG, et al. (2000) How generalizable are the results of large randomized controlled trials of antiretroviral therapy? HIV Medicine 1: 149-154.
5. Hoel AW, Kayssi A, Brahmanandam S, Belkin M, Conte MS, et al. (2009) Under-representation of women and ethnic minorities in vascular surgery randomized controlled trials. Journal of Vascular Surgery 50: 349-354.
6. Kalata P, Martus P, Zettl H, Rodel C, Hohenberger W, et al. (2009) Differences between clinical trial participants and patients in a population-based registry: the German Rectal Cancer Study vs. the Rostock Cancer Registry. Diseases of the Colon & Rectum 52: 425-437.
7. Maasland L, van Oostenbrugge RJ, Franke CF, Scholte Op Reimer WJ, Koudstaal PJ, et al. (2009) Patients enrolled in large randomized clinical trials of antiplatelet treatment for prevention after transient ischemic attack or ischemic stroke are not representative of patients in clinical practice: the Netherlands Stroke Survey. Stroke 40: 2662-2668.
8. Costa DJ, Amouyal M, Lambert P, Ryan D, Schunemann HJ, et al. (2011) How representative are clinical study patients with allergic rhinitis in primary care? Journal of Allergy & Clinical Immunology 127: 920-926.
9. Falagas ME, Vouloumanou EK, Sgouros K, Athanasiou S, Peppas G, et al. (2010) Patients included in randomised controlled trials do not represent those seen in clinical practice: focus on antimicrobial agents. International Journal of Antimicrobial Agents 36: 1-13.
10. Bartlett C, Doyal L, Ebrahim S, Davey P, Bachmann M, et al. (2005) The causes and effects of socio-demographic exclusions from clinical trials. Health Technology Assessment 9: 1-152.
11. Tunis SR, Stryer DB, Clancy CM, (2003) Practical Clinical Trials. JAMA: The Journal of the American Medical Association 290: 1624-1632.
12. Glasgow RE, Magid DJ, Beck A, Ritzwoller D, Estabrooks PA, (2005) Practical clinical trials for translating research to practice: design and measurement recommendations. Medical Care 43: 551-557.
13. Devereaux PJ, Mohit B, Mike C, Victor MM, Deborah JC, et al. (2005) Need for expertise based randomised controlled trials. BMJ 330: 88. doihttp://dx.doi.org/10.1136/bmj.330.7482.88.
14. Calvert M, Wood J, Freemantle N, (2011) Designing "Real-World" trials to meet the needs of health policy makers at marketing authorization. Journal of Clinical Epidemiology 64: 711-717.
15. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, et al. (2009) A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Canadian Medical Association Journal 180: E47-E57.
16. Halm EA, Lee C, Chassin MR, (2002) Is Volume Related to Outcome in Health Care? A Systematic Review and Methodologic Critique of the Literature. Annals of Internal Medicine 137: 511-520.
17. NICE (2009) IPG322 Negative pressure wound therapy for the open abdomen: guidance. London: National Institute for Health and Clinical Excellence.
18. Britton A, McKee M, Black N, McPherson K, Sanderson C, et al. (1999) Threats to applicability of randomised trials: exclusions and selective participation. Journal of Health Services & Research Policy 4: 112-121.
19. DeLong ER, Coombs LP, Ferguson TB, Peterson ED, (2005) The Evaluation of Treatment When Center-Specific Selection Criteria Vary with Respect to Patient Risk. Biometrics 61: 942-949.
20. Kravitz RL, Duan N, Braslow J, (2004) Evidence-Based Medicine, Heterogeneity of Treatment Effects, and the Trouble with Averages. Milbank Quarterly 82: 661-687.
21. Kraemer Hc FEKDJ, (2006) Moderators of treatment outcomes: Clinical, research, and policy importance. JAMA: The Journal of the American Medical Association 296: 1286-1289.
22. O'Brien BJ, (1997) A tale of two (or more) cities: Geographic transferability of pharmacoeconomic data. American Journal of Managed Care 3: S33-S39.
23. Drummond MF, Bloom BS, Carrin G, Hillman AL, Hutchings HC, et al. (1992) Issues in the Cross-National Assessment of Health Technology. International Journal of Technology Assessment in Health Care 8: 670-682.
24. Manca A, Rice N, Sculpher MJ, Briggs AH, (2005) Assessing generalisability by location in trial-based cost-effectiveness analysis: the use of multilevel models. Health Economics 14: 471-485.
25. Manca A, Lambert PC, Sculpher M, Rice N, (2007) Cost-effectiveness analysis using data from multinational trials: the use of bivariate hierarchical modeling. Medical Decision Making 27: 471-490.
26. Manca A, Sculpher MJ, Goeree R, (2010) The analysis of multinational cost-effectiveness data for reimbursement decisions: a critical appraisal of recent methodological developments. Pharmacoeconomics 28: 1079-1096.
27. Ramsey SD, McIntosh M, Sullivan SD, (2001) Design issues for conducting cost-effectiveness analyses alongside clinical trials. Annual Review of Public Health 22: 129-141.
28. Drummond M, Barbieri M, Cook J, Glick HA, Lis J, et al. (2009) Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report. Value in Health 12: 409-418.
29. Braslow JT, Duan N, Starks SL, Polo A, Bromley E, et al. (2005) Generalizability of studies on mental health treatment and outcomes, 1981 to 1996. Psychiatric Services 56: 1261-1268.
30. Ahmad N, Boutron I, Dechartres A, Durieux P, Ravaud P (2010) Applicability and generalisability of the results of systematic reviews to public health practice and policy: a systematic review. Trials 11. doi10.1186/1745-6215-11-20.
31. Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G, (2008) Internal and external validity of cluster randomised trials: systematic review of recent trials. BMJ 336: 876-880.
32. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, et al. (2008) Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration. Annals of Internal Medicine 148: 295-309.
33. Smyth RMD, Kirkham JJ, Jacoby A, Altman DG, Gamble C, et al. (2011) Frequency and reasons for outcome reporting bias in clinical trials: Interviews with trialists. BMJ 342: c7153 doihttp://dx.doi.org/10.1136/bmj.c7153.
34. Al-Marzouki S, Roberts I, Evans S, Marshall T, (2008) Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet. The Lancet 372: 201.
35. Sandelowski M, Barroso J, (2003) Creating Metasummaries of Qualitative Findings. Nursing Research 52: 226-233.
36. Liamputtong P (2011) Focus Group Methodology: Principles and Practice. Bodmin: Sage.
37. Krueger RA, Casey MA (2000) Focus groups: A practical guide for applied research. Thousand Oaks, CA: Sage Publications, Inc.
38. Hsieh HF, Shannon SE, (2005) Three Approaches to Qualitative Content Analysis. Qualitative Health Research 15: 1277-1288.
39. Jacquier I, Boutron I, Moher D, Roy C, Ravaud P, (2006) The Reporting of Randomized Clinical Trials Using a Surgical Intervention Is in Need of Immediate Improvement: A Systematic Review. Annals of Surgery 244: 677-683.
40. Schulz KF, Altman DG, Moher D (2010) CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 340: c322. doihttp://dx.doi.org/10.1136/bmj.c332.
41. Campbell MK, Elbourne DR, Altman DG (2004) CONSORT statement: extension to cluster randomised trials. BMJ 328: 702. doihttp://dx.doi.org/10.1136/bmj.328.7441.702.
42. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, et al. (2013) SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Annals of Internal Medicine. doi10.7326/000348191583-20130205000583.