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Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials
Abstract
Objective To compare the feasibility of blinding and the perceived risk of unblinding in trials evaluating pharmacologic (PT) and nonpharmacologic treatments (NPT) of hip or knee osteoarthritis.Study design and setting Two independent reviewers assessed the feasibility of blinding patients, care providers, and outcome assessors, the perceived risk of unblinding, and whether blinding was reported in 110 reports of randomized controlled trials (RCTs) evaluating PT and NPT in patients with hip or knee osteoarthritis.Results Blinding was considered to be possible less often in NPT trials than in PT trials for patients (42 vs. 96%; P <.001), care providers (12 vs. 96%; P <.001), and outcome assessors (34 vs. 98%; P <.001). When blinding was judged feasible, the perceived risk of unblinding was more often considered moderate or important in NPT than PT trials for patients (35 vs. 14%, P=.02) and outcome assessors (44 vs. 10%, P=.0004). When blinding was judged feasible, it was reported less often in NPT reports than in PT reports for patients (46 vs. 98%, P <.001), care providers (43 vs. 83%, P=.03), and outcome assessors (72 vs. 98%, P=.0006).Conclusion Blinding appears to be more difficult to achieve and unblinding may occur more often in NPT than PT trials.
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“In general, low rates of reported blinding checks are a known issue in nonpharmacologic treatments which DTx (58).”
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Selecting and measuring optimal outcomes for randomised controlled trials in surgery
Macefield, R. C., Boulind, C. E., & Blazeby, J. M. (2013) · Langenbeck s Archives of Surgery · doi:10.1007/s00423-013-1136-8 · Cited by 51
“In the case of surgical trials, however, using a placebo or sham surgery is often difficult or impossible because it may be considered unethical to subject patients to general anaesthesia and a mock operation for solely research purposes, although such examples exist [45–51].”
BackgroundQuality of Randomized Controlled Trials Reporting in the Treatment of Sarcomas
Toulmonde, M., Bellera, C. A., Mathoulin‐Pélissier, S., Debled, M., Bui, B., & Italiano, A. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2010.30.9369 · Cited by 50
“Indeed, nonpharmacologic trials (ie, radiotherapy, surgery) have specific issues, such as blinding, which is more difficult to achieve in surgery or radiotherapy trials and often not feasible.(18) Altogether, our results are in agreement with similar recent studies assessing reporting quality of RCTs in brain tumors,(…”
ResultVillamar, M. F., Contreras, V., Kuntz, R. E., & Fregni, F. (2013) · Journal of Rehabilitation Medicine · doi:10.2340/16501977-1071 · Cited by 50
Wyse, R., Wolfenden, L., Campbell, E. M., Campbell, K. J., Wiggers, J. H., Brennan, L., Fletcher, A., Bowman, J., & Heard, T. R. (2012) · American Journal of Clinical Nutrition · doi:10.3945/ajcn.111.030585 · Cited by 50
“As is common in trials of behavioral interventions (47), parent participants in this trial were unblinded, and the primary outcome measure was subjectively assessed by parent report, which increased the risk of a biased assessment of intervention effect (48).”
BackgroundEarly add‐on treatmentvsalternative monotherapy in patients with partial epilepsy
Semah, F., Thomas, P., Coulbaut, S., & Derambure, P. (2014) · Epileptic Disorders · doi:10.1684/epd.2014.0650 · Cited by 50
Current role for spa therapy in rheumatology
Forestier, R. J., Forestıer, F. B. E., & Françon, A. (2016) · Joint Bone Spine · doi:10.1016/j.jbspin.2016.05.003 · Cited by 49
Robinson, A. G., Dennett, A. M., & Snowdon, D. A. (2018) · Physiotherapy · doi:10.1016/j.physio.2018.11.007 · Cited by 48
Blinding Strategies in Dry Needling Trials: Systematic Review and Meta-Analysis
BRAITHWAITE, F., Walters, J. L., Li, L. S. K., Moseley, G. L., Williams, M., & McEvoy, M. P. (2019) · Physical Therapy · doi:10.1093/ptj/pzz111 · Cited by 48
Statins for multiple sclerosis
Wang, J., Xiao, Y., Luo, M., & Luo, H. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008386.pub3 · Cited by 47
Methodological choices for the clinical development of medical devices
Bernard, A., Vaneau, M., Fournel, I., Galmiche, H., Nony, P., & Dubernard, J. M. (2014) · Medical Devices Evidence and Research · doi:10.2147/mder.s63869 · Cited by 47
“Blinding is impossible more often in non-pharmacological studies (16), for ethical or practical reasons (3).”
BackgroundHohenschurz‐Schmidt, D., Draper‐Rodi, J., Vase, L., Scott, W., McGregor, A. H., Soliman, N., MacMillan, A., Olivier, A., Cherian, C. A., Corcoran, D., et al. (2022) · Pain · doi:10.1097/j.pain.0000000000002723 · Cited by 50
“This lack of highquality data is partly because of methodological difficulties specific to efficacy and mechanistic trials of PPS for pain, mainly centred around issues of placebo control and blinding.(32,33,103) Placebo interventions in clinical trials are conceptualised as “a”
BackgroundBlinding in Rehabilitation Research
Armijo-Olivo, S. L., Dennett, L., Arienti, C., Dahchi, M., Arokoski, J. P., Heinemann, A. W., & Malmivaara, A. O. V. (2020) · American Journal of Physical Medicine & Rehabilitation · doi:10.1097/phm.0000000000001377 · Cited by 47
Disentangling contextual effects from musculoskeletal treatments
Cashin, A. G., McAuley, J. H., Lamb, S. E., & Lee, H. (2021) · Osteoarthritis and Cartilage · doi:10.1016/j.joca.2020.12.011 · Cited by 50
Camenzind, E., Wijns, W. C., Mauri, L., Boersma, E. H., Parikh, K. H., Kurowski, V., Gao, R., Bode, C., Greenwood, J. P., Gershlick, A., et al. (2009) · American Heart Journal · doi:10.1016/j.ahj.2009.10.002 · Cited by 45
Ouldamer, L., Bonastre, J., Brunet-Houdard, S., Body, G., Giraudeau, B., & Caille, A. (2016) · BMJ Open · doi:10.1136/bmjopen-2015-009903 · Cited by 45
“interventions.(34) 35 Moreover, blinding of outcome assessor is not feasible for the primary outcome: seroma that require aspiration or surgical evacuation within 21 days following mastectomy.”
BackgroundSelf-citationBello, S., Moustgaard, H., & Hróbjartsson, A. (2014) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2014.05.007 · Cited by 45
BRAITHWAITE, F., Walters, J. L., Li, L. S. K., Moseley, G. L., Williams, M., & McEvoy, M. P. (2018) · PeerJ · doi:10.7717/peerj.5318 · Cited by 44
“The complex nature of physical interventions means that blinding of relevant parties, particularly participants and therapists, is often extremely difficult (Boutron et al., 2004).”
BackgroundOutcomes Assessment in Fracture Healing Trials: A Primer
Dr. Bauke Kooistra, O. S., Sprague, S., Bhandari, M., & Schemitsch, E. H. (2010) · Journal of Orthopaedic Trauma · doi:10.1097/bot.0b013e3181ca3fbd · Cited by 43
di Ruffano, L. F., Dinnes, J., Sitch, A. J., Hyde, C., & Deeks, J. J. (2017) · BMC Medical Research Methodology · doi:10.1186/s12874-016-0287-z · Cited by 43
Brand, P. L. P., Vlieg‐Boerstra, B., & Dubois, A. E. J. (2007) · Pediatric Allergy and Immunology · doi:10.1111/j.1399-3038.2007.00541.x · Cited by 43
“In studies in which patients or parents know what treatment (or formula) is being received but the examiner does not ( single blind design), the odds of unblinding of the examiner by inadvertent disclosure by patient or parent are high (11).”
BackgroundLemans, J. V. C., Wijdicks, S. P. J., Boot, W., Govaert, G. A. M., Houwert, R. M., Öner, F. C., & Kruyt, M. C. (2018) · Global Spine Journal · doi:10.1177/2192568218786252 · Cited by 42
“For example, double blinding is difficult or impossible.(52) Furthermore, surgical RCTs often have very low recruitment rates, which make them less representative of usual practice.”
BackgroundIsmail, A., Moore, C., Alshishani, N., Yaseen, K. M., & Alshehri, M. A. (2017) · Journal of Physical Therapy Science · doi:10.1589/jpts.29.2228 · Cited by 42
Perceptions and Competence in Evidence-Based Medicine
Poolman, R. W., Farrokhyar, F., Bhandari, M., Sierevelt, I. N., Blankevoort, L., & Mazel, J. A. (2007) · Journal of Bone and Joint Surgery · doi:10.2106/00004623-200701000-00028 · Cited by 39
Blinding during the analysis of research data
Polit, D. F. (2011) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2011.02.010 · Cited by 38
“It is typically impossible to avoid having participants know which treatment group they were in, or to have interventionists blinded as to who received the experimental treatment (Boutron et al., 2004).”
BackgroundRealignment treatment for medial tibiofemoral osteoarthritis: randomised trial
Hunter, D. J., Gross, K. D., McCree, P., Li, L., Hirko, K. A., & Harvey, W. F. (2012) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2011-200728 · Cited by 38
Non-drug care for RA is the era of evidence-based practice approaching?
Vlieland, T. P. M. V. (2007) · Lara D. Veeken · doi:10.1093/rheumatology/kem149 · Cited by 38
Metadata
- Authors
- Boutron, I., Tubach, F., Giraudeau, B., & Ravaud, P.
- Affiliations
- Inserm (FR)
- Corresponding author
- Boutron, Isabelle
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2004-06
- Volume
- 57
- Issue
- 6
- Pages
- 543-550
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W1996966348
- Cited by
- 300
- References
- 28
- Citations by year
- 2026: 12 · 2025: 17 · 2024: 13 · 2023: 16 · 2022: 19 · 2021: 17 · 2020: 16 · 2019: 21 · 2018: 28 · 2017: 14 · 2016: 22 · 2015: 8 · 2014: 14 · 2013: 12 · 2012: 12
- FWCI
- 8.89
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Assistance Publique - Hôpitaux de Paris
- Assistance publique-Hôpitaux de Paris
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- blinding, unblinding, non-pharmacological treatment, pharmacotherapy, hip osteoarthritis, knee osteoarthritis, randomized controlled trials, trial reporting quality, care providers
- MeSH terms
- Double-Blind Method, Drug Therapy, Feasibility Studies, Humans, Osteoarthritis, Hip, Epidemiologic Research Design, Randomized Controlled Trials as Topic, Single-Blind Method, Treatment Outcome, Osteoarthritis, Knee
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