Illustrating problems faced by stroke researchers: A review of cluster-randomized controlled trials

International Journal of Stroke

Volumn 8, Issue 7, 2013, Pages 566-574

  Sutton, Christopher J ^a   Watkins, Caroline L ^a   Dey, Paola ^a  

^a UNIVERSITY OF CENTRAL LANCASHIRE   (United Kingdom)

Author keywords

Cluster randomized controlled trial; Prevention; Research reporting; Review; Stroke care

Indexed keywords

ANTICOAGULANT AGENT;

ANTICOAGULANT THERAPY; BRAIN ISCHEMIA; CEREBROVASCULAR ACCIDENT; HEALTH CARE ORGANIZATION; HUMAN; OCCUPATIONAL THERAPY; PATIENT POSITIONING; PRACTICE GUIDELINE; PREVENTION STUDY; PRIMARY MEDICAL CARE; PRIMARY PREVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REHABILITATION CARE; REVIEW; SAMPLE SIZE; SCIENTIST; SPEECH THERAPY; STROKE PATIENT; TOTAL QUALITY MANAGEMENT;

CLUSTER-RANDOMIZED CONTROLLED TRIAL; PREVENTION; RESEARCH REPORTING; REVIEW; STROKE CARE;

HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; STROKE;

EID: 84884317795     PISSN: 17474930     EISSN: 17474949     Source Type: Journal    
DOI: 10.1111/j.1747-4949.2012.00915.x     Document Type: Review

References (41)

1. Underwood M, Barnett A, Hajioff S. Cluster randomization: a trap for the unwary. Br J Gen Pract 1998; 48:1089-1090.
2. Donner A, Klar N. Pitfalls and controversies in cluster randomization trials. Am J Public Health 2004; 94:416-422.
3. Hahn S, Puffer S, Torgerson DJ, Watson J. Methodological bias in cluster randomised trials. BMC Med Res Methodol 2005; 5:10.
4. Puffer S, Torgerson DJ, Watson J. Cluster randomized controlled trials. J Eval Clin Pract 2005; 11:479-483.
5. Giraudeau B, Ravaud P. Preventing bias in cluster randomised trials. PLoS Med 2009; 6:e1000065.
6. Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G. Internal and external validity of cluster randomised trials: systematic review of recent trials. BMJ 2008; 336:876-880.
7. Bowater RJ, Abdelmalik SME, Lilford RJ. The methodological quality of cluster randomised controlled trials for managing tropical parasitic disease: a review of trials published from 1998 to 2007. Trans R Soc Trop Med Hyg 2009; 103:429-436.
8. Crespi CM, Maxwell AE, Wu S. Cluster randomized trials of cancer screening interventions: are appropriate statistical methods being used? Contemp Clin Trials 2011; 32:477-484.
9. Ivers NM, Taljaard M, Dixon S etal. Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8. BMJ 2011; 343:d5886.
10. Walleser S, Hill SR, Bero LA. Characteristics and quality of reporting of cluster randomized trials in children: reporting needs improvement. J Clin Epidemiol 2011; 64:1331-1340.
11. Campbell MK, Elbourne DR, Altman DG, for the CONSORT Group. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 328:702-708.
12. Moher D, Schultz KF, Altman DG, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001; 285:1987-1991.
13. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340:c332.
14. Prescription in Ischaemic Stroke Management (PRISM) Study Group. Cluster-randomized, controlled trial of computer-based decision support for selecting long-term anti-thrombotic therapy after acute stroke. Q J Med 2003; 96:143-153.
15. Jones A, Tilling K, Wilson-Barnett J, Newham DJ, Wolfe CDA. Effect of recommended positioning on stroke outcome at six months: a randomized controlled trial. Clin Rehabil 2005; 19:138-145.
16. Pennington L, Roddam H, Burton C, Russell I, Godfrey C, Russell D. Promoting research use in speech and language therapy: a cluster randomized controlled trial to compare the clinical effectiveness and costs of two training strategies. Clin Rehabil 2005; 19:387-397.
17. Wolfe CDA, Redfern J, Rudd AG, Grieve AP, Heuschmann PU, McKevitt C. Cluster randomized controlled trial of a patient and general practitioner intervention to improve the management of multiple risk factors after stroke: Stop Stroke. Stroke 2010; 41:2470-2476.
18. Sackley C, Wade DT, Mant D etal. Cluster randomized pilot controlled trial of an occupational therapy intervention for residents with stroke in UK care homes. Stroke 2006; 37:2336-2341.
19. Wright J, Bibby J, Eastham J etal. Multifaceted implementation of stroke prevention guidelines in primary care cluster-randomised evaluation of clinical and cost-effectiveness. Qual Saf Health Care 2007; 16:51-59.
20. Johnston SC, Sidney S, Hills NK etal. Standardized discharge orders after stroke: results of the Quality Improvement in Stroke Prevention (QUISP) cluster randomized trial. Ann Neurol 2010; 67:579-589.
21. Lakshminarayan K, Borbas C, McLaughlin B etal. A cluster-randomized trial to improve stroke care in hospitals. Neurology 2010; 74:1634-1642.
22. Ornstein S, Jenkins RG, Nietert PJ etal. A multimethod quality improvement intervention to improve preventive cardiovascular care: a cluster randomized trial. Ann Intern Med 2004; 141:523-532.
23. Strasser DC, Falconer JA, Stevens AB etal. Team training and stroke rehabilitation outcomes: a cluster randomized trial. Arch Phys Med Rehabil 2008; 89:10-15.
24. Muller-Nordhorn J, Wegscheider K, Nolte CH etal. Population-based intervention to reduce prehospital delays in patients with cerebrovascular events. Ann Intern Med 2009; 169:1484-1490.
25. Cappucio FP, Kerry SM, Micah FB, Plange-Rhule J, Eastwood JB. A community programme to reduce salt intake and blood pressure in Ghana [ISRCTN 88789643]. BMC Public Health 2006; 6:13.
26. McAlister FA, Man-Son-Hing A, Straus SE etal. Impact of a patient decision aid on care among patients with nonvalvular atrial fibrillation: a cluster randomized trial. CMAJ 2005; 173:496-501.
27. De Luca A, Toni D, Lauria L etal. An emergency clinical pathway for stroke patients - results of a cluster randomised trial (ISRCTN 41456865). BMC Health Serv Res 2009; 9:14.
28. Dirks M, Niessen LW, van Wijngaarden JDH etal. Promoting thrombolysis in acute ischemic stroke. Stroke 2011; 42:1325-1330.
29. Taljaard M, McGowan J, Grimshaw JM etal. Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to standards. BMC Med Res Methodol 2010; 10:15.
30. Lake S, Kammann E, Klar N, Betensky R. Sample size re-estimation in cluster randomisation trials. Stat Med 2002; 21:1337-1350.
31. Turner RM, Prevost AT, Thompson SG. Allowing for imprecision of the intracluster correlation coefficient in the design of cluster randomized trials. Stat Med 2004; 23:1195-1214.
32. Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and Statistics in Medicine. Stat Med 2007; 26:2-19.
33. Feng Z, Grizzle JE. Correlated binomial variates: properties of estimator of intraclass correlation and its effect on sample size calculation. Stat Med 1992; 11:1607-1614.
34. Kieser M, Wassmer G. On the use of the upper confidence limit for the variance from a pilot sample for sample size determination. Biom J 1996; 38:941-949.
35. Campbell MK, Fayers PM, Grimshaw JM. Determinants of the intracluster correlation coefficient in cluster randomized trials: the case of implementation research. Clin Trials 2005; 2:99-107.
36. Feng Z, Diehr P, Peterson A, McLerran D. Selected statistical issues in group randomized trials. Annu Rev Public Health 2001; 22:167-187.
37. Hade EM, Murray DM, Pennell ML etal. Intraclass correlation estimates for cancer screening outcomes: estimates and applications in the design of group-randomized cancer screening studies. J Natl Cancer Inst Monogr 2010; 40:97-103.
38. Higgins JPT, Green S (eds). Cochrane handbook for systematic reviews of interventions version 5.1.0 [updated March 2011]. The Cochrane Collaboration. 2008. Available at http://www.cochrane-handbook.org
39. Roberts C, Roberts S. Design and analysis of trials with clustering due to treatment. Clin Trials 2005; 2:152-162.
40. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials 2007; 28:182-191.
41. Medical Research Council (MRC). Developing and evaluating complex interventions: new guidance. 2008. Available at http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC004871