Blind outcome assessment: The development and use of procedures to maintain and describe blinding in a pragmatic physiotherapy rehabilitation trial

Clinical Rehabilitation

Volumn 25, Issue 3, 2011, Pages 264-274

  Lowe, C J Minns ^a,b   Wilson, M S ^a   Sackley, C M ^b   Barker, K L ^a  

^a OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COMPARATIVE STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; KNEE ARTHROPLASTY; KNEE OSTEOARTHRITIS; LONGITUDINAL STUDY; MALE; METHODOLOGY; PHYSIOTHERAPY; PROSPECTIVE STUDY; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REPRODUCIBILITY; SINGLE BLIND PROCEDURE; TREATMENT OUTCOME; UNITED KINGDOM;

ARTHROPLASTY, REPLACEMENT, KNEE; DOUBLE-BLIND METHOD; FEMALE; GREAT BRITAIN; HUMANS; LONGITUDINAL STUDIES; MALE; OSTEOARTHRITIS, KNEE; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); PHYSICAL THERAPY MODALITIES; PROSPECTIVE STUDIES; QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; SINGLE-BLIND METHOD;

EID: 79953890884     PISSN: 02692155     EISSN: 14770873     Source Type: Journal    
DOI: 10.1177/0269215510380824     Document Type: Article

References (28)

1. Davis Eyler F, Behnke M, Stewart N, Wobie K. Examiner masking in research of prenatal cocaine use. J Drug Issues 1999; 29: 215-24. (Pubitemid 29356697)
2. Sackett DL. Commentary: Measuring the success of blinding in RCTs: don't, must, can't or needn't? Int J Epidemiol 2007; 36: 664-65. (Pubitemid 47244572)
3. Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials 2004; 25: 143-56. (Pubitemid 38328755)
4. Altman DG, Schulz K F, Moher D, Egger M, Davidoff F, Elbourne D et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134: 663-94. (Pubitemid 32322245)
5. Montori VM, Bhandari M, Devereaux PJ, Manns BJ, Ghali WA, Guyatt GH. In the dark: the reporting of blinding status in randomized controlled trials. J Clin Epidemiol 2002; 55: 787-90.
6. Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet 2002; 359: 696-700. (Pubitemid 34203775)
7. Hróbjartsson A, Forfang E, Haahr MT, Als- Nielsen B, Brorson S. Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding. Int J Epidemiol 2007; 36: 654-63. (Pubitemid 47244571)
8. Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT et al. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess 1999; 3: 74.
9. Poolman RW, Struijs PAA, Krips R, Sierevelt IN, Marti RK, Farrokhyar F et al. Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter? J Bone Joint Surg Am 2007; 98-A: 550-58. (Pubitemid 46365355)
10. Fergusson D, Cranley Glass K, Waring D, Shapiro S. Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials. BMJ 2004; 328: 432-43.
11. Gluud LL. Bias in clinical intervention research. Am J Epidemiol 2006; 163: 493-501.
12. Schulz KF, Chalmers I, Altman DG. The landscape and the lexicon of blinding in randomized trials. Ann Intern Med 2002; 136: 254-59. (Pubitemid 34118130)
13. Boutron I, Estellat C, Guittet L, Dechartres A, Sackett DL, Hróbjartsson A et al. Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review. PLoS Med 2006; 3: 1931-39. (Pubitemid 44721832)
14. Turner JA, Jensen MP, Warms CA, Cardenas DD. Blinding effectiveness and association of pre-treatment expectations with pain improvement in a double blinded randomised controlled trial. Pain 2002; 99: 91-9. (Pubitemid 35247533)
15. Boutron I, Tubach F, Giraudeau B, Ravaud P. Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis. JAMA 2003; 290: 1062-70. (Pubitemid 37430447)
16. Forder PM, Gebski VJ, Keech AC. Allocation concealment and blinding: when ignorance is bliss. Med J Aust 2005; 182: 87-9.
17. Sackett DL. Turning a blind eye why we don't test for blindness at the end of our trials. BMJ 2004; 328: 1136.
18. Boutron I, Estellat C, Ravaud P. A review of blinding in randomized controlled trials found results inconsistent and questionable. J Clin Epidemiol 2005; 58: 1220-26. (Pubitemid 41608537)
19. Minns Lowe CJ. The effectiveness of physiotherapy following discharge from hospital after primary total knee arthroplasty for osteoarthritis. PhD thesis, University of Birmingham, 2009.
20. Berger VW, Exner DV. Detecting selection bias in randomized clinical trials. Control Clin Trials 1999; 20: 319-27. (Pubitemid 29320021)
21. Boutron I, Tubach F, Giraudeau B, Ravaud P. Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol 2004; 57: 543-50. (Pubitemid 38891491)
22. Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med 2007; 4: 0370-80. (Pubitemid 46354450)
23. Pope C, Ziebland S, Mays N. Qualitative research in health care analysing qualitative data. BMJ 2000; 320: 114-16.
24. Carroll KM, Rounsaville BJ, Nich C. Blind man's bluff: effectiveness and significance of psychotherapy and pharmacotherapy blinding procedures in a clinical trial. J Consult Clin Psychol 1994; 62: 276-80. (Pubitemid 24129505)
25. Rees JR, Wade TJ, Levy DA, Colford Jr JM, Hilton JF. Changes in beliefs identify unblinding in randomized controlled trials: a method to meet CONSORT guidelines. Contemp Clin Trials 2005; 26: 25-37. (Pubitemid 40693594)
26. Oppenheim AN. Questionnaire design, interviewing and attitude measurement, second edition. London: Pinter Publishers, 1992.
27. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008; 337: 1-8.
28. Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R. The impact of blinding on the results of a randomised placebo controlled multiple sclerosis clinical trial. Neurology 1994; 44: 16-20. (Pubitemid 24029420)