Methodological Issues Relevant to Blinding in Physical Medicine and Rehabilitation Research.
Journal
American journal of physical medicine & rehabilitation
ISSN: 1537-7385
Titre abrégé: Am J Phys Med Rehabil
Pays: United States
ID NLM: 8803677
Informations de publication
Date de publication:
01 07 2023
01 07 2023
Historique:
medline:
16
6
2023
pubmed:
11
3
2023
entrez:
10
3
2023
Statut:
ppublish
Résumé
Blinding in research is important, and the field of physical medicine and rehabilitation poses special consideration owing to the patient populations and treatment methodologies used. Historically, blinding has been increasingly relevant to conducting good-quality research. The main reason to blind is to reduce bias. There are several strategies to blinding. At times, when blinding is not possible, alternatives to blinding include sham control and description of study and control groups. Illustrative examples of blinding used in physical medicine and rehabilitation research are described in this article, along with how to assess success and fidelity of blinding.
Identifiants
pubmed: 36897811
doi: 10.1097/PHM.0000000000002228
pii: 00002060-202307000-00011
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
636-644Informations de copyright
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
Financial disclosure statements have been obtained, and no conflicts of interest have been reported by the authors or by any individuals in control of the content of this article.
Références
Reilly RP, Findley TW: Research in physical medicine and rehabilitation. IV. Some practical designs in applied research. Am J Phys Med Rehabil 1989;68:196–201
Lilienfeld AM: Ceteris paribus: The evolution of the clinical trial. Bull History Med 1982;56:1–8
Bull JP: The historical development of clinical therapeutic trials. J Chron Dis 1959;10:218–48
Rawlins MD: Development of a rational practice of therapeutics. BMJ 1990;301:729
Gaddum JH: Clinical pharmacology. Proc R Soc Med 1954;47:195–204
Bulpitt CJ: Randomized Controlled Clinical Trials . The Hague, Martinus Nijhoff, 1983
Karanicolas PJ, Farrokhyar F, Bhandari M: Blinding: Who, what, when, why, how? Can J Surg 2010;53:345
Schulz KF, Grimes DA: Blinding in randomised trials: Hiding who got what. Lancet 2002;359:696–700
Altman DG, Schulz KF, Moher D, et al.: The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Ann Intern Med 2001;134:663–94
Moher D, Schulz KF, Altman D; CONSORT Group: The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285:1987–91
Boutron I, Tubach F, Giraudeau B, et al.: Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials. J Clin Epidemiol 2004;57:543–50
Boutron I, Guittet L, Estellat C, et al.: Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med 2007;4:e61
Fregni F, Imamura M, Chien HF, et al.; International Placebo Symposium Working Group: Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: A report of the international placebo symposium working group. Am J Phys Med Rehabil 2010;89:160–72
Streitberger K, Kleinhenz J: Introducing a placebo needle into acupuncture research. Lancet 1998;352:364–5
Wartolowska K: The nocebo effect as a source of bias in the assessment of treatment effects. F1000Res 2019;8:5
Higgins JPT, Thomas J, Chandler J, et al.: Cochrane Handbook for Systematic Reviews of Interventions version 6.2 (updated February 2021) . London, Cochrane, 2021. Available at: www.training.cochrane.org/handbook . Accessed March 28, 2022
Wood L, Egger M, Gluud LL, et al.: Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: Meta-epidemiological study. BMJ 2008;336:601–5
Pozzi F, Dunning J, et al.Young IA: Immediate and short-term effects of thoracic spine manipulation in patients with cervical radiculopathy: A randomized controlled trial. J Orthop Sports Phys Ther 2019;49:299–309
Boutron I, Estellat C, Guittet L, et al.: Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: A systematic review. PLoS Med 2006;3:e425
Armijo-Olivo S, Fuentes J, da Costa BR, et al.: Blinding in physical therapy trials and its association with treatment effects: A meta-epidemiological study. Am J Phys Med Rehabil 2017;96:34–44
Ebadi S, Forogh B, Fallah E, et al.: Does ultrasound therapy add to the effects of exercise and mobilization in frozen shoulder? A pilot randomized double-blind clinical trial. J Bodyw Mov Ther 2017;21:781–7
Kacin A, Drobnič M, Marš T, et al.: Functional and molecular adaptations of quadriceps and hamstring muscles to blood flow restricted training in patients with ACL rupture. Scand J Med Sci Sports 2021;31:1636–46
Ilyas AM, Miller AJ, Graham JG, et al.: Pain management after carpal tunnel release surgery: A prospective randomized double-blinded trial comparing acetaminophen, ibuprofen, and oxycodone. J Hand Surg Am 2018;43:913–9
Friedberg JP, Lipsitz SR, Natarajan S: Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure. Patient Educ Couns 2010;78:5–11
Elmelund M, Biering-Sørensen F, Due U, et al.: The effect of both pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: An investigator-blinded parallel randomized clinical trial. Int Urogynecol J 2018;29:1597–606
Li T, Wilson CM, Basal Y: Reliability of an installed chair exit alarm system for fall prevention: A double-blind randomized controlled trial. J Acute Care Phys Ther 2017;8:141–52
Santus P, Radovanovic D, Di Marco F, et al.: Faster reduction in hyperinflation and improvement in lung ventilation inhomogeneity promoted by aclidinium compared to glycopyrronium in severe stable COPD patients. A randomized crossover study. Pulm Pharmacol Ther 2015;35:42–9
Cabitza P, Randelli P: Efficacy and safety of eperisone in patients with low back pain: A double blind randomized study. Eur Rev Med Pharmacol Sci 2008;12:229–35
MacDonald PB, Clark T, McRae S, et al.: Arthroscopic versus open lateral release for the treatment of lateral epicondylitis: A prospective randomized controlled trial. Arthroscopy 2018;34:3177–84
Pilloni G, Choi C, Shaw MT, et al.: Walking in multiple sclerosis improves with tDCS: A randomized, double-blind, sham-controlled study. Ann Clin Transl Neurol 2020;7:2310–9
Garcia LM, Birckhead BJ, Krishnamurthy P, et al.: An 8-week self-administered at-home behavioral skills-based virtual reality program for chronic low back pain: Double-blind, randomized, placebo-controlled trial conducted during COVID-19. J Med Internet Res 2021;23:e26292
Yeung LF, Ockenfeld C, Pang MK, et al.: Randomized controlled trial of robot-assisted gait training with dorsiflexion assistance on chronic stroke patients wearing ankle-foot-orthosis. J Neuroeng Rehabil 2018;15:51
Obeso JA, Olanow CW, Rodriguez-Oroz MC, et al.Deep-Brain Stimulation for Parkinson's Disease Study Group: Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med 2001;345:956–63
Elboim-Gabyzon M, Andrawus Najjar S, Shtarker H: Effects of transcutaneous electrical nerve stimulation (TENS) on acute postoperative pain intensity and mobility after hip fracture: A double-blinded, randomized trial. Clin Interv Aging 2019;14:1841–50
Yu B, Herman D, Preston J, et al.: Immediate effects of a knee brace with a constraint to knee extension on knee kinematics and ground reaction forces in a stop-jump task. Am J Sports Med 2004;32:1136–43
Louis E, Löfberg R, Reinisch W, et al.: Adalimumab improves patient-reported outcomes and reduces indirect costs in patients with moderate to severe Crohn's disease: Results from the CARE trial. J Crohns Colitis 2013;7:34–43
Quilty B, Tucker M, Campbell R, et al.: Physiotherapy, including quadriceps exercises and patellar taping, for knee osteoarthritis with predominant patello-femoral joint involvement: Randomized controlled trial. J Rheumatol 2003;30:1311–7
Scholtes VA, Nijman TH, van Beers L, et al.: Emerging designs in orthopaedics: Expertise-based randomized controlled trials. J Bone Joint Surg Am 2012;94(suppl 1):24–8
van Baar ME, Dekker J, Oostendorp RA, et al.: Effectiveness of exercise in patients with osteoarthritis of hip or knee: Nine months' follow up. Ann Rheum Dis 2001;60:1123–30
Mohammedi K, Potier L, François M, et al.: The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: Study design and rational. J Foot Ankle Res 2016;9:34
Meyer C, Mohr M, Falbriard M, et al.: Influence of footwear comfort on the variability of running kinematics. Footwear Sci 2018;10:29–38
Hauser SL, Bar-Or A, Cohen JA, et al.; ASCLEPIOS I and ASCLEPIOS II Trial Groups: Ofatumumab versus teriflunomide in multiple sclerosis. N Engl J Med 2020;383:546–57
Wang JC, Hsu PC, Wang KA, et al.: Ultrasound-guided triamcinolone acetonide hydrodissection for carpal tunnel syndrome: A randomized controlled trial. Front Med (Lausanne) 2021;8:742724
Boesen AP, Hansen R, Boesen MI, et al.: Effect of high-volume injection, platelet-rich plasma, and sham treatment in chronic midportion Achilles tendinopathy: A randomized double-blinded prospective study. Am J Sports Med 2017;45:2034–43
Wang JC, Chang KV, Wu WT, et al.: Ultrasound-guided standard vs dual-target subacromial corticosteroid injections for shoulder impingement syndrome: A randomized controlled trial. Arch Phys Med Rehabil 2019;100:2119–28
Zhang CS, Tan HY, Zhang GS, et al.: Placebo devices as effective control methods in acupuncture clinical trials: A systematic review. PLoS ONE 2015;10:e0140825
Freed CR, Greene PE, Breeze RE, et al.: Transplantation of embryonic dopamine neurons for severe Parkinson's disease. N Engl J Med 2001;344:710–9
Underwood MR, Morgan J: The use of a back class teaching extension exercises in the treatment of acute low back pain in primary care. Fam Pract 1998;15:9–15
Adamson J, Cockayne S, Puffer S, et al.: Review of randomised trials using the post-randomised consent (Zelen's) design. Contemp Clin Trials 2006;27:305–19
Portney L, Watkins M: Foundations of Clinical Research, 3e: Applications to Practice . Philadelphia, PA, F. A. Davis Company, 2015:115. ProQuest Ebook Central. Available at: https://ebookcentral-proquest-com.proxy.library.nyu.edu/lib/nyulibrary-ebooks/detail.action?docID=4392815 . Accessed March 28, 2022
Morris NB, Jay O: Aluminium salt-based antiperspirant coated prosthesis liners do not suppress local sweating during moderate intensity exercise in hot and temperate conditions. J Sci Med Sport 2020;23:1128–33
McNamara DG, Asher MI, Rubin BK, et al.: Heated humidification improves clinical outcomes, compared to a heat and moisture exchanger in children with tracheostomies. Respir Care 2014;59:46–53
Brown SA, Coimbra M, Coberly DM, et al.: Oral nutritional supplementation accelerates skin wound healing: A randomized, placebo-controlled, double-arm, crossover study. Plastic Reconstr Surg 2004;114:237–44
Kong X, Yang M, Cao Z, et al.: Tissue adhesive for wound closure in enhanced-recovery total hip arthroplasty: A prospective, randomized and controlled study. BMC Musculoskelet Disord 2020;21:1–7
Du J, Yang F, Hu J, et al.: Effects of high-and low-frequency repetitive transcranial magnetic stimulation on motor recovery in early stroke patients: Evidence from a randomized controlled trial with clinical, neurophysiological and functional imaging assessments. NeuroImage Clin 2019;21:101620
Vigneri S, Sindaco G, Zanella M, et al.: Electrocatheter-mediated high-voltage pulsed radiofrequency of the dorsal root ganglion in the treatment of chronic lumbosacral neuropathic pain: A randomized controlled study. Clin J Pain 2020;36:25–33
Oranchuk DJ, Flattery MR, Robinson TL: Superficial heat administration and foam rolling increase hamstring flexibility acutely; with amplifying effects. Phys Ther Sport 2019;40:213–7
Du Y, Zhang L, Liu W, et al.: Effect of acupuncture treatment on post-stroke cognitive impairment: A randomized controlled trial. Medicine 2020;99:e23803
Kamali F, Sinaei E, Morovati M: Comparison of upper trapezius and infraspinatus myofascial trigger point therapy by dry needling in overhead athletes with unilateral shoulder impingement syndrome. J Sport Rehab 2019;28:243–9
Desbiens NA: In randomized controlled trials, should subjects in both placebo and drug groups be expected to guess that they are taking drug 50% of the time? Med Hypotheses 2002;59:227–32
Kolahi J, Bang H, Park J: Towards a proposal for assessment of blinding success in clinical trials: Up-to-date review. Community Dent Oral Epidemiol 2009;37:477–84
James KE, Bloch DA, Lee KK, et al.: An index for assessing blindness in a multi-centre clinical trial: Disulfiram for alcohol cessation—A VA cooperative study. Stat Med 1996;15:1421–34
Bang H, Ni L, Davis CE: Assessment of blinding in clinical trials. Controlled Clinical Trials 2004;25:143–56
Sackett DL: Turning a blind eye: Why we don’t test for blindness at the end of our trials. BMJ 2004;328:1136