Cited by 300Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsAdvanced Causal Inference Techniques

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Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials

Boutron, Isabelle, Tubach, Florence, Giraudeau, Bruno, Ravaud, Philippe·2004·Journal of Clinical Epidemiology

DOI 10.1016/j.jclinepi.2003.12.010

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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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Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one)
Gay, C., Guiguet‐Auclair, C., Pereira, B., Goldstein, A., Bareyre, L., Coste, N., & Coudeyre, E. (2018) · BMC Complementary and Alternative Medicine · doi:10.1186/s12906-018-2339-x · Cited by 14
Conclusiveness of Cochrane Reviews in physiotherapy: a systematic search and analytical review
Momosaki, R., Tsuboi, M., Yasufuku, Y., Furudate, K., Kamo, T., Uda, K., Tanaka, Y., & Abo, M. (2019) · International Journal of Rehabilitation Research · doi:10.1097/mrr.0000000000000338 · Cited by 14
“Blind RCTs in physiotherapy pose particular difficulties compared with those conducted in other fields of medicine, as successful blinding is often hard to achieve (Boutron et al., 2004; Wood et al., 2008).”
Background
Limit Allogeneic Blood Use with Routine Re-use of Patient's Own Blood: A Prospective, Randomized, Controlled Trial in Total Hip Surgery
Thomassen, B. J. W., Pilot, P., Scholtes, V. A., Grohs, J. G., Holen, K. J., Bisbe, E., & Poolman, R. W. (2012) · PLoS ONE · doi:10.1371/journal.pone.0044503 · Cited by 13
“However, blinding patients, care providers and outcome assessors is difficult to achieve when surgery techniques are being studied, and unblinding may thus occur more often in such studies [31].”
Recommendations for primary studies evaluating therapeutic medical devices were identified and systematically reported through reviewing existing guidance
Schnell‐Inderst, P., Hunger, T., Conrads‐Frank, A., Arvandi, M., & Siebert, U. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.10.007 · Cited by 13
Feasibility, acceptability, and effects of behavior change interventions for improving multiple dietary behaviors among cancer survivors: a systematic review
Gan, T., Cheng, H., & Tse, M. Y. M. (2021) · Supportive Care in Cancer · doi:10.1007/s00520-021-06582-2 · Cited by 11
“The lack of blinding has been a common issue for RCTs that examined behavioral interventions predominantly because they are typically complex involving multiple behavioral, psychosocial, and educational components [35].”
Background
Comparison of Flap Fixation to Its Bed and Conventional Wound Closure with Drainage in Preventing Seroma Formation Following Mastectomy for Breast Cancer: Systematic Review and Meta-analysis
Rao, D., Xie, J., Xia, Y., & Cao, D. (2022) · Aesthetic Plastic Surgery · doi:10.1007/s00266-022-02814-w · Cited by 14
“First, due to the nature of the studied surgical intervention and the existence of other nonpharmacological interventions, it was difficult to blind patients in these studies, which had a great impact on the outcomes [35].”
Background
Future Directions for Surgical Trial Designs in Trigeminal Neuralgia
Zakrzewska, J. M., & Relton, C. (2016) · Neurosurgery Clinics of North America · doi:10.1016/j.nec.2016.02.011 · Cited by 11
Risk of bias assessments in systematic reviews and meta-analyses of behavioral interventions for substance use outcomes
Bo, A., Hai, A. H., Chen, D., & Hammock, K. (2021) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2021.06.012 · Cited by 12
Number and quality of randomized controlled trials in obstetrics published in the top general medical and obstetrics and gynecology journals
Doulaveris, G., Vani, K., Saccone, G., Chauhan, S. P., & Berghella, V. (2021) · American Journal of Obstetrics & Gynecology MFM · doi:10.1016/j.ajogmf.2021.100509 · Cited by 12
Navigating blinding challenges in complex intervention trials: insights from a UK researcher survey
Yonis, A., Dean, S. G., Warren, F. C., Taylor, R. S., Levack, W., & Hay‐Smith, J. (2025) · Trials · doi:10.1186/s13063-025-09223-9 · Cited by 11
The effectiveness of exercise with behavior change techniques in people with knee osteoarthritis: A systematic review with meta‐analysis
Ariie, T., Takasaki, H., Okoba, R., Chiba, H., Handa, Y., Miki, T., Taito, S., Tsutsumi, Y., & MORITA, M. (2022) · PM&R · doi:10.1002/pmrj.12898 · Cited by 8
Effectiveness of physical rehabilitation for physical functioning and quality of life in long-term care residents with dementia: a systematic review and meta-analysis
McArthur, C., Alizadehsaravi, N., Affoo, R. H., Cooke, K., Douglas, N., Earl, M., Flynn, T., Ghanouni, P., Hunter, S. W., Kalu, M. E., et al. (2024) · JBI Evidence Synthesis · doi:10.11124/jbies-23-00431 · Cited by 10
“What I wanted to do was build myself back up and prepare”: qualitative findings from the PERCEPT trial of prehabilitation during autologous stem cell transplantation in myeloma
McCourt, O., Fisher, A., Land, J., Ramdharry, G. M., Roberts, A., Bekris, G., & Yong, K. (2023) · BMC Cancer · doi:10.1186/s12885-023-10799-1 · Cited by 10
“Testing complex interventions, such as rehabilitation and behavioural interventions, through traditional RCT designs is inherently undermined by an inability, in most cases, to blind participants to their allocation [32].”
Background
Primer: assessing the efficacy and safety of nonpharmacologic treatments for chronic rheumatic diseases
Ravaud, P., & Boutron, I. (2006) · Nature Clinical Practice Rheumatology · doi:10.1038/ncprheum0194 · Cited by 10
“The planning of such trials should take into account issues such as difficulties in blinding, duration of the study, main outcome, difficulties in standardizing the treatment and the influence of health-care providers”
BackgroundSelf-citation
ALGINATE versus NPWT in the Preparation of Surgical Excisions for an STSG: ATEC Trial
Casanova, D., Guerreschi, P., Sinna, R., Bertheuil, N., Philandrianos, C., Chignon‐Sicard, B., Duteille, F., Atlan, M., Rousseau, P., Châtellier, G., et al. (2020) · Plastic & Reconstructive Surgery Global Open · doi:10.1097/gox.0000000000002691 · Cited by 10
Conservative Treatments of Carpal Tunnel Syndrome: A Systematic Review and Network Meta-analysis
Chen, Y., Han, B., Zhang, X., Guo, C., Han, Q., Zhang, Z., & Hou, S. (2025) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2025.04.002 · Cited by 12
Good Scientific Practice and Ethics in Sports and Exercise Science: A Brief and Comprehensive Hands-on Appraisal for Sports Research
Arora, N. K., Röhrken, G., Crumbach, S., Phatak, A. A., Labott, B. K., Nicklas, A., Wicker, P. V., & Donath, L. (2023) · Sports · doi:10.3390/sports11020047 · Cited by 9
“Blinding of participants is difficult to achieve and maintain [34,39,40,49] in exercise trials as the participants would usually be aware of whether they are in the exercise group or the control (inactive) group [31,39,50].”
Background
The quality of surgical versus non-surgical randomized controlled trials
Adie, S., Harris, I. A., Naylor, J., & Mittal, R. (2016) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2016.12.001 · Cited by 9
“Where surgical interventions are tested, blinding is difficult [2], patients and/or surgeons usually prefer one treatment, and surgical interventions are difficult to standardize [3].”
Background
Vigabatrin versus carbamazepine monotherapy for epilepsy
Xiao, Y., Gan, L., Wang, J., Luo, M., & Luo, H. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008781.pub2 · Cited by 9
Bias in the measurement of the outcome is associated with effect sizes in randomized clinical trials on exercise therapy for chronic low back pain: a meta-epidemiological study
Innocenti, T., Hayden, J. A., Salvioli, S., Giagio, S., Piano, L., Cosentino, C., Brindisino, F., Feller, D., Ogilvie, R., Gianola, S., et al. (2023) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2023.09.001 · Cited by 8
Telephone follow-up by nurse following total knee arthroplasty – protocol for a randomized clinical trial (NCT 01771315)
Szöts, K., Konradsen, H., Solgaard, S., & Østergaard, B. (2014) · BMC Nursing · doi:10.1186/1472-6955-13-14 · Cited by 8
“In non-pharmacological trials the care providers and the patients are frequently un-blinded [46].”
Background
The risk of bias in randomized controlled trials in otorhinolaryngology: hardly any improvement since 1950
Peters, J. P. M., Stegeman, I., Grolman, W., & Hooft, L. (2017) · BMC Ear Nose and Throat Disorders · doi:10.1186/s12901-017-0036-x · Cited by 8
“We acknowledge that blinding may be difficult to perform in otorhinolaryngology, as investigated treatments are often surgical interventions [19].”
Background
Efficacy of custom-fitted footwear to increase physical activity in children and adolescents with Down syndrome (ShoeFIT): randomised pilot study
Hassan, N. M., Shields, N., Landorf, K. B., Buldt, A. K., Taylor, N. F., Evans, A., Williams, C., Menz, H. B., & Munteanu, S. E. (2019) · Disability and Rehabilitation · doi:10.1080/09638288.2019.1692380 · Cited by 8
“This is an inherent problem faced when conducting trials using physical interventions [43].”
Background
Effects of exercise training on muscle wasting, muscle strength and quality of life in adults with acute burn injury
Schieffelers, D. R., Dombrecht, D., Lafaire, C., Cuyper, L. D., Rose, T., Vandewal, M., Meirte, J., Gebruers, N., van Breda, E., & Daele, U. V. (2023) · Burns · doi:10.1016/j.burns.2023.04.003 · Cited by 8
Medicinal clays improve the endurance of loaded inspiratory muscles in COPD: a randomized clinical trial of nonpharmacological treatment
Baldi, S., Pinna, G. D., Bruschi, C., Caldara, F., Dacosto, E., Crotti, P., Popovich, E., Bellinzona, E., Montemartini, S., Fracchia, C., et al. (2015) · International Journal of COPD · doi:10.2147/copd.s87999 · Cited by 8
Reprint of “The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016: Explanation and Elaboration”
Tate, R. L., Perdices, M., Rosenkoetter, U., McDonald, S., Togher, L., Shadish, W. R., Horner, R. H., Kratochwill, T. R., Barlow, D. H., Kazdin, A. E., et al. (2019) · Pratiques Psychologiques · doi:10.1016/j.prps.2019.03.001 · Cited by 10
Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation
van Cooten, V. J., Gielissen, M. F. M., van Mastrigt, G. A. P. G., den Hollander, W., Evers, S., Smeets, O., Smit, F., & Boon, B. J. F. (2022) · JMIR Research Protocols · doi:10.2196/42555 · Cited by 7
“Open-label trials are common among trials that investigate devices and other nonpharmaceutical interventions [32].”
Background
'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy
Laguna, J. M., Kurmann, A., Hofstetter, L., Nyantakyi, E., Braun, J., Clack, L., Bang, H., Farshad, M., Foster, N. E., Puhan, M. A., et al. (2025) · Chiropractic & Manual Therapies · doi:10.1186/s12998-024-00561-0 · Cited by 7
“Yet, blinding can be challenging to achieve and maintain in RCTs of physical interventions for low back pain (LBP) [2].”
A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical Trial
Arroyo-Fernández, R., Avendaño‐Coy, J., Velasco-Velasco, R., Palomo‐Carrión, R., Bravo-Esteban, E., & Ferri‐Morales, A. (2021) · Brain Sciences · doi:10.3390/brainsci11101335 · Cited by 7
Implications for blinding in clinical trials with THC-containing cannabinoids based on the CANNA-TICS trial
Müller‐Vahl, K., Jakubovski, E., Fremer, C., Lenz-Ziegenbein, M., Großhennig, A., Klages, C. S., Koch, A., Haas, M., & Pisarenko, A. (2022) · Frontiers in Neuroscience · doi:10.3389/fnins.2022.793703 · Cited by 7
“In general, it is easier to maintain blinding in pharmacological than non-pharmacological studies (Boutron et al., 2004).”
Background
Vigabatrin versus carbamazepine monotherapy for epilepsy
Xiao, Y., Gan, L., Wang, J., Luo, M., & Luo, H. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008781.pub3 · Cited by 7
Randomized controlled trials: Fundamental concepts
Morrow, B. M. (2008) · International Journal of Therapy and Rehabilitation · doi:10.12968/ijtr.2008.15.7.30408 · Cited by 7
Improving General Flexibility with a Mind-Body Approach
Jensen, A. M., Ramasamy, A., & Hall, M. W. (2012) · The Journal of Strength and Conditioning Research · doi:10.1519/jsc.0b013e31823a408f · Cited by 7
“, both participants and practitioners blinded) because of the unfeasibility of blinding practitioners during hand-on therapies (6).”
Background
A pilot randomized controlled trial of a yoga program for alleviating cancer-related fatigue and psychological distress in women with gynecological cancer
Ma, X., Shang, M., Wong, C. L., Qi, Y., & Chan, D. N. S. (2024) · European Journal of Oncology Nursing · doi:10.1016/j.ejon.2024.102731 · Cited by 6
The Effectiveness of Acupressure on Sleep Quality in Cancer Patients: A Systematic Review and Meta‐Analysis of Randomised Controlled Trials
Yang, C., Huang, Y., Ling, W., Cheung, D. S. T., & Lee, J. J. (2025) · Journal of Clinical Nursing · doi:10.1111/jocn.17707 · Cited by 6
“An important source of risk of bias was deviation from the intended intervention, primarily because true blinding is often challenging in non-pharmacological interventions (Boutron et al. 2004).”
Effectiveness of Psychological Interventions in Improving Relationship Functioning Among Couples Coping With Prostate Cancer: A Systematic Review and Meta‐Analysis
Ma, H., Yang, Y., Li, Y., Cariola, L. A., & Gillanders, D. T. (2025) · Psycho-Oncology · doi:10.1002/pon.70080 · Cited by 7
“Blinding can be a challenge in these trials because participants and interventionists are usually aware of the intervention, unlike in pharmacological trials [65].”
Foot orthoses for first metatarsophalangeal joint osteoarthritis: study protocol for the FORT randomised controlled trial
Paterson, K. L., Hinman, R. S., Metcalf, B. R., Jones, S. E., Menz, H. B., Munteanu, S. E., Kasza, J., & Bennell, K. L. (2020) · BMC Musculoskeletal Disorders · doi:10.1186/s12891-020-03809-x · Cited by 6
Patient Education for Renal Transplant Recipients
Urstad, K. H. (2013) · NORA - Norwegian Open Research Archives · Cited by 6

Authors: Boutron, I., Tubach, F., Giraudeau, B., & Ravaud, P.
Affiliations: Inserm (FR)
Corresponding author: Boutron, Isabelle
ORCID: Boutron, Isabelle
Tubach, Florence
Giraudeau, Bruno
Ravaud, Philippe
Venue: Journal of Clinical Epidemiology
Publisher: Elsevier BV
Published: 2004-06
Volume: 57
Issue: 6
Pages: 543-550
ISSN: 0895-4356 (ISSN-L)
DOI: 10.1016/j.jclinepi.2003.12.010
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
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
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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Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials

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