Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study

Moustgaard, Helene; Clayton, Gemma L; Jones, Hayley E; Boutron, Isabelle; Jørgensen, Lars; Laursen, David R T; Olsen, Mette F; Paludan-Müller, Asger; Ravaud, Philippe; Savović, Jelena; Sterne, Jonathan A C; Higgins, Julian P T; Hróbjartsson, Asbjørn

doi:10.1136/bmj.l6802

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

Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study

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Moustgaard, Helene, Clayton, Gemma L, Jones, Hayley E, Boutron, Isabelle, Jørgensen, Lars, Laursen, David R T, Olsen, Mette F, Paludan-Müller, Asger +5 more·2020·BMJ

DOI 10.1136/bmj.l6802PMC PMC7190062

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Abstract

Objectives: To study the impact of blinding on estimated treatment effects, and their variation between trials; differentiating between blinding of patients, healthcare providers, and observers; detection bias and performance bias; and types of outcome (the MetaBLIND study). Design: Meta-epidemiological study. Data source: Cochrane Database of Systematic Reviews (2013-14). Eligibility criteria for selecting studies: Meta-analyses with both blinded and non-blinded trials on any topic. Review methods: Blinding status was retrieved from trial publications and authors, and results retrieved automatically from the Cochrane Database of Systematic Reviews. Bayesian hierarchical models estimated the average ratio of odds ratios (ROR), and estimated the increases in heterogeneity between trials, for non-blinded trials (or of unclear status) versus blinded trials. Secondary analyses adjusted for adequacy of concealment of allocation, attrition, and trial size, and explored the association between outcome subjectivity (high, moderate, low) and average bias. An ROR lower than 1 indicated exaggerated effect estimates in trials without blinding. Results: The study included 142 meta-analyses (1153 trials). The ROR for lack of blinding of patients was 0.91 (95% credible interval 0.61 to 1.34) in 18 meta-analyses with patient reported outcomes, and 0.98 (0.69 to 1.39) in 14 meta-analyses with outcomes reported by blinded observers. The ROR for lack of blinding of healthcare providers was 1.01 (0.84 to 1.19) in 29 meta-analyses with healthcare provider decision outcomes (eg, readmissions), and 0.97 (0.64 to 1.45) in 13 meta-analyses with outcomes reported by blinded patients or observers. The ROR for lack of blinding of observers was 1.01 (0.86 to 1.18) in 46 meta-analyses with subjective observer reported outcomes, with no clear impact of degree of subjectivity. Information was insufficient to determine whether lack of blinding was associated with increased heterogeneity between trials. The ROR for trials not reported as double blind versus those that were double blind was 1.02 (0.90 to 1.13) in 74 meta-analyses. Conclusion: No evidence was found for an average difference in estimated treatment effect between trials with and without blinded patients, healthcare providers, or outcome assessors. These results could reflect that blinding is less important than often believed or meta-epidemiological study limitations, such as residual confounding or imprecision. At this stage, replication of this study is suggested and blinding should remain a methodological safeguard in trials.

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This overemphasizes the assumed effect of blinding in trials, which is not reflected in clinical data.
“However, this overemphasizes the assumed effect of blinding in trials, which is not reflected in clinical data [59].”
From Efficacy and Acceptance of Cognitive Behavioral Therapy in Adults with Chronic Fatigue Syndrome: A Meta-analysis. (2024) · cites this paper as [59]
The Discussion (Mechanisms and implications; page not provided) reports no evidence of an average difference in estimated treatment effects between trials with and without blinding. But it does not establish that blinding's effect is generally overemphasized: the authors say the finding could reflect study limitations, note evidence of bias in specific settings, and recommend retaining blinding as a safeguard. (LLM, conf=0.85)
Experimental — accuracy not yet measured
Meta-epidemiological studies found little to no effect of blinding on treatment results among randomised trials, including a review of oral health trials.
“based on meta-epidemiological studies [22][23][24][25] that found little to no effect of blinding on treatment results among randomised trials (including a review of oral health trials 26 )”
From Management of chronic pain secondary to temporomandibular disorders: a systematic review and network meta-analysis of randomised trials (2023) · cites this paper as [22]
The Discussion reports no evidence of an average difference in estimated treatment effects between blinded and non-blinded randomised trials. Its “Other studies” section says an oral-health trial study found no evidence of an effect from blinding outcome assessors, but some evidence of a moderate effect from blinding patients. Thus the unqualified “little to no effect” summary misses an important exception for oral-health trials. (LLM, conf=0.84)
Experimental — accuracy not yet measured
A recent meta-epidemiological study found no evidence that lack of patients' blinding had an impact on estimate effects.
“However, a recent meta-epidemiological study found no evidence that lack of patients’ blinding had an impact on estimate effects.39”
From Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews (2022) · cites this paper as [39]

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The Cochrane Collaboration's tool for assessing risk of bias in randomised trials
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Self-citation
RoB 2: a revised tool for assessing risk of bias in randomised trials
Sterne, J. A. C., Savović, J., Page, M. J., Elbers, R. G., Blencowe, N. S., Boutron, I., Cates, C. J., Cheng, H.-Y., Corbett, M. S., Eldridge, S. M., et al. (2019) · BMJ · doi:10.1136/bmj.l4898 · Cited by 33,583 · see citing works
Self-citation
The “Golden Age” of Probiotics: A Systematic Review and Meta-Analysis of Randomized and Observational Studies in Preterm Infants
Dermyshi, E., Wang, Y., Yan, C., Hong, W., Qiu, G., Gong, X., & Zhang, T. (2017) · Neonatology · doi:10.1159/000454668 · Cited by 24,577 · see citing works
Confirmation Bias: A Ubiquitous Phenomenon in Many Guises
Nickerson, R. S. (1998) · Review of General Psychology · doi:10.1037/1089-2680.2.2.175 · Cited by 7,267 · see citing works
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Schulz (1995) · doi:10.1001/jama.1995.03520290060030 · Cited by 5,634 · see citing works
Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials
Savović, J., Jones, H. E., Altman, D. G., Harris, R. J., Jüni, P., Pildal, J., Als-Nielsen, B., Balk, E. M., Gluud, C., Gluud, L. L., et al. (2012) · Annals of Internal Medicine · doi:10.7326/0003-4819-157-6-201209180-00537 · Cited by 1,049 · see citing works
Self-citation
Observer bias in randomized clinical trials with measurement scale outcomes: a systematic review of trials with both blinded and nonblinded assessors
Hróbjartsson, A., Thomsen, A. S. S., Emanuelsson, F., Tendal, B., Hilden, J., Boutron, I., Ravaud, P., & Brorson, S. (2013) · Canadian Medical Association Journal · doi:10.1503/cmaj.120744 · Cited by 527 · see citing works
Self-citation
Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors
Hróbjartsson, A., Thomsen, A. S. S., Emanuelsson, F., Tendal, B., Hilden, J., Boutron, I., Ravaud, P., & Brorson, S. (2012) · BMJ · doi:10.1136/bmj.e1119 · Cited by 487 · see citing works
Self-citation
Epidemiology and reporting of randomised trials published in PubMed journals
Chan, A.-W., & Altman, D. G. (2005) · The Lancet · doi:10.1016/s0140-6736(05)71879-1 · Cited by 474 · see citing works
Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies
Hróbjartsson, A., Emanuelsson, F., Skou Thomsen, A. S., Hilden, J., & Brorson, S. (2014) · International Journal of Epidemiology · doi:10.1093/ije/dyu115 · Cited by 462 · see citing works
Self-citation
Statistical methods for assessing the influence of study characteristics on treatment effects in 'meta-epidemiological' research
Sterne, J. A. C., Jüni, P., Schulz, K. F., Altman, D. G., Bartlett, C., & Egger, M. (2002) · Statistics in Medicine · doi:10.1002/sim.1184 · Cited by 382 · see citing works
Self-citation
Association between risk-of-bias assessments and results of randomized trials in Cochrane reviews: The ROBES meta-epidemiologic study
Savović, J., Turner, R. M., Mawdsley, D., Jones, H. E., Beynon, R., Higgins, J. P. T., & Sterne, J. A. C. (2018) · American Journal of Epidemiology · doi:10.1093/aje/kwx344 · Cited by 382 · see citing works
Self-citation
On the social psychology of the psychological experiment: the experimenter's hypothesis as unintended determinant of experimental results.
Rosenthal, R. (1963) · PubMed · Cited by 366 · see citing works
Intentional Ignorance: A History of Blind Assessment and Placebo Controls in Medicine
Kaptchuk, T. J. (1998) · Bulletin of the history of medicine · doi:10.1353/bhm.1998.0159 · Cited by 315 · see citing works
Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies
Page, M. J., Higgins, J. P. T., Clayton, G., Sterne, J. A. C., Hróbjartsson, A., & Savović, J. (2016) · PLOS ONE · doi:10.1371/journal.pone.0159267 · Cited by 284 · see citing works
Self-citation
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Ware, J. H., & Hamel, M. B. (2011) · New England Journal of Medicine · doi:10.1056/nejmp1103502 · Cited by 268 · see citing works
Physician Interpretations and Textbook Definitions of Blinding Terminology in Randomized Controlled Trials
Devereaux, P. J. (2001) · JAMA · doi:10.1001/jama.285.15.2000 · Cited by 258 · see citing works
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Higgins, J. P., Ramsay, C., Reeves, B. C., Deeks, J. J., Shea, B., Valentine, J. C., Tugwell, P., & Wells, G. (2013) · Research Synthesis Methods · doi:10.1002/jrsm.1056 · Cited by 183 · see citing works
Self-citation
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Akl, E. A., Sun, X., Busse, J. W., Johnston, B. C., Briel, M., Mulla, S., You, J. J., Bassler, D., Lamontagne, F., Vera, C., et al. (2012) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2011.04.015 · Cited by 179 · cited 1× · see citing works
“We assessed the blinding status of patients, healthcare providers, and outcome assessors using a modified algorithm derived from that of Akl and colleagues 11 (full details are given in the appendix).”
Blinding in Physical Therapy Trials and Its Association with Treatment Effects
Armijo-Olivo, S. L., Fuentes, J., da Costa, B. R., Saltaji, H., Ha, C., & Cummings, G. G. (2016) · American Journal of Physical Medicine & Rehabilitation · doi:10.1097/phm.0000000000000521 · Cited by 165 · see citing works
Meta-analysis as Evidence
Berlin, J. A., & Golub, R. M. (2014) · JAMA · doi:10.1001/jama.2014.8167 · Cited by 161 · see citing works
Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors
Haahr, M. T., & Hróbjartsson, A. (2006) · Clinical Trials · doi:10.1177/1740774506069153 · Cited by 152 · see citing works
Self-citation
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Nüesch, E., Reichenbach, S., Trelle, S., Rutjes, A. W., Liewald, K., Sterchi, R., Altman, D. G., & Jüni, P. (2009) · Arthritis Care & Research · doi:10.1002/art.24894 · Cited by 150 · see citing works
Models for Potentially Biased Evidence in Meta-Analysis using Empirically Based Priors
Welton, N. J., Ades, A. E., Carlin, J. B., Altman, D. G., & Sterne, J. A. C. (2008) · Journal of the Royal Statistical Society Series A (Statistics in Society) · doi:10.1111/j.1467-985x.2008.00548.x · Cited by 147 · see citing works
Self-citation
Observer bias in randomized clinical trials with time-to-event outcomes: systematic review of trials with both blinded and non-blinded outcome assessors
Hróbjartsson, A., Thomsen, A. S. S., Emanuelsson, F., Tendal, B., Rasmussen, J. V., Hilden, J., Boutron, I., Ravaud, P., & Brorson, S. (2014) · International Journal of Epidemiology · doi:10.1093/ije/dyt270 · Cited by 142 · see citing works
Self-citation
Influence of blinding on treatment effect size estimate in randomized controlled trials of oral health interventions
Saltaji, H., Armijo-Olivo, S. L., Cummings, G. G., Amin, M. S., da Costa, B. R., & Flores‐Mir, C. (2018) · BMC Medical Research Methodology · doi:10.1186/s12874-018-0491-0 · Cited by 87 · see citing works
Empirical evaluation of which trial characteristics are associated with treatment effect estimates
Dechartres, A., Trinquart, L., Faber, T., & Ravaud, P. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2016.04.005 · Cited by 85 · see citing works
Self-citation
Subjective and objective outcomes in randomized clinical trials: definitions differed in methods publications and were often absent from trial reports
Moustgaard, H., Bello, S., Miller, F. G., & Hróbjartsson, A. (2014) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2014.06.020 · Cited by 69 · see citing works
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Giraudeau, B., Higgins, J. P. T., Tavernier, E., & Trinquart, L. (2015) · Statistics in Medicine · doi:10.1002/sim.6627 · Cited by 40 · see citing works
Self-citation
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Bello, S., Moustgaard, H., & Hróbjartsson, A. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2016.08.002 · Cited by 33 · see citing works
Self-citation
Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial.
Claessen, F., Mellema, J. J., Stoop, N., Lubberts, B., Ring, D., & Poolman, R. (2016) · Psychosomatics · doi:10.1016/j.psym.2015.09.005 · Cited by 26 · see citing works
Label‐invariant models for the analysis of meta‐epidemiological data
Rhodes, K. M., Mawdsley, D., Turner, R., Jones, H. E., Savović, J., & Higgins, J. P. T. (2017) · Statistics in Medicine · doi:10.1002/sim.7491 · Cited by 13 · see citing works
Self-citation
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Chinn, S. (2000) · Statistics in Medicine · doi:10.1002/1097-0258(20001130)19:22

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Bennell, K. L., Schwartz, S., Teo, P. L., Hawkins, S., Mackenzie, D., McManus, F. J., Lamb, K. E., Kimp, A. J., Metcalf, B., Hunter, D. J., et al. (2022) · Annals of Internal Medicine · doi:10.7326/m22-1761 · Cited by 49 · see citing works
Efficacy of hypnosis in adults undergoing surgical procedures: a meta-analytic update
Holler, M., Koranyi, S., Strauss, B., & Rosendahl, J. (2021) · Clinical Psychology Review · doi:10.1016/j.cpr.2021.102001 · Cited by 53 · see citing works
Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods
Hohenschurz‐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 47 · see citing works
Ten questions to consider when interpreting results of a meta‐epidemiological study—the MetaBLIND study as a case
Moustgaard, H., Jones, H. E., Savović, J., Clayton, G., Sterne, J. A. C., Higgins, J. P. T., & Hróbjartsson, A. (2019) · Research Synthesis Methods · doi:10.1002/jrsm.1392 · Cited by 45 · see citing works
Self-citation
Goal Attainment Scaling Rehabilitation Improves Satisfaction with Work Activities for Younger Working Patients After Knee Arthroplasty
Hoorntje, A., Witjes, S., Koenraadt, K. L. M., Kuijer, P., Blankevoort, L., Kerkhoffs, G. M. M. J., & van Geenen, R. C. I. (2020) · Journal of Bone and Joint Surgery · doi:10.2106/jbjs.19.01471 · Cited by 45 · see citing works
Impact of Blinding on Patient-Reported Outcome Differences Between Treatment Arms in Cancer Randomized Controlled Trials
Efficace, F., Cella, D. F., Aaronson, N. K., Calvert, M., Cottone, F., Maïo, M. D., Perrone, F., Sparano, F., Gamper, E., Vignetti, M., et al. (2021) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djab177 · Cited by 43 · see citing works
Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial
Fehm, T. N., Cottone, F., Dunton, K., André, F., Krop, I. E., Park, Y. H., Laurentiis, M. D., Miyoshi, Y., Armstrong, A. C., Borrego, M. R., et al. (2024) · The Lancet Oncology · doi:10.1016/s1470-2045(24)00128-1 · Cited by 45 · see citing works
Alcoholic chlorhexidine skin preparation or triclosan-coated sutures to reduce surgical site infection: a systematic review and meta-analysis of high-quality randomised controlled trials
Ademuyiwa, A. O., Adisa, A., Bach, S. P., Bhangu, A. A., Harrison, E. M., Ingabire, J. A., Haque, P. D., Lawani, I., Glasbey, J. C., Ghosh, D., et al. (2022) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(22)00133-5 · Cited by 42 · see citing works
Sample size, study length, and inadequate controls were the most common self-acknowledged limitations in manual therapy trials: A methodological review
Álvarez, G., Núñez‐Cortés, R., Solà, I., Sitjà‐Rabert, M., Vanmeerhaeghe, A. F., Fernández, C., Bonfill, X., & Urrútia, G. (2020) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2020.10.018 · Cited by 41 · see citing works
The effect of self-practicing systematic clinical observations in a multiplayer, immersive, interactive virtual reality application versus physical equipment: a randomized controlled trial
Berg, H., & Steinsbekk, A. (2021) · Advances in Health Sciences Education · doi:10.1007/s10459-020-10019-6 · Cited by 40 · see citing works
Effects of Endurance Training on Motor Signs of Parkinson’s Disease: A Systematic Review and Meta-Analysis
de Almeida, F. O., Santana, V. P., Corcos, D. M., Ugrinowitsch, C., & Silva‐Batista, C. (2022) · Sports Medicine · doi:10.1007/s40279-022-01650-x · Cited by 38 · see citing works
Blinding, sham, and treatment effects in randomized controlled trials for back pain in 2000–2019: A review and meta-analytic approach
Freed, B., Williams, B., Situ, X., Landsman, V., Kim, J., Moroz, A., Bang, H., & Park, J. J. (2021) · Clinical Trials · doi:10.1177/1740774520984870 · Cited by 38 · see citing works
Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units
Iflaifel, M., Partlett, C., Bell, J., Cook, A., Gamble, C. L., Julious, S. A., Juszczak, E., Linsell, L., Montgomery, A. A., & Sprange, K. (2022) · Trials · doi:10.1186/s13063-022-06481-9 · Cited by 36 · see citing works
Self-reports vs clinician ratings of efficacies of psychotherapies for depression: a meta-analysis of randomized trials
Miguel, C., Harrer, M., Karyotaki, E., Plessen, C. Y., Čihařová, M., Furukawa, T. A., Cristea, I. A., & Cuijpers, P. J. (2025) · Epidemiology and Psychiatric Sciences · doi:10.1017/s2045796025000095 · Cited by 38 · see citing works
The impact of blinding on trial results: A systematic review and meta‐analysis
(2023) · doi:10.1002/cesm.12015 · Cited by 35 · see citing works
Menstrual hygiene management interventions and their effects on schoolgirls’ menstrual hygiene experiences in low and middle countries: A systematic review
Betsu, B. D., Medhanyie, A. A., Gebrehiwet, T. G., & Wall, L. L. (2024) · PLoS ONE · doi:10.1371/journal.pone.0302523 · Cited by 47 · see citing works
Endovascular thrombectomy with or without intravenous alteplase for acute ischemic stroke due to large vessel occlusion: a systematic review and meta-analysis of randomized trials
Wang, X., Ye, Z., Busse, J. W., Hill, M. D., Smith, E. E., Guyatt, G. H., Prasad, K., Lindsay, M. P., Yang, H., Zhang, Y., et al. (2022) · Stroke and Vascular Neurology · doi:10.1136/svn-2022-001547 · Cited by 34 · see citing works
Association Between Lack of Blinding and Mortality Results in Critical Care Randomized Controlled Trials: A Meta-Epidemiological Study*
Martin, G. L., Trioux, T., Gaudry, S., Tubach, F., Hajage, D., & Dechartres, A. (2021) · Critical Care Medicine · doi:10.1097/ccm.0000000000005065 · Cited by 22 · see citing works
Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis
White, P. D., Abbey, S. E., Angus, B., Ball, H. A., Buchwald, D., Burness, C. E., Carson, A. J., Chalder, T., Clauw, D. J., Coebergh, J. A., et al. (2023) · Journal of Neurology Neurosurgery & Psychiatry · doi:10.1136/jnnp-2022-330463 · Cited by 35 · see citing works
Surgery for the treatment of obesity in children and adolescents
Torbahn, G., Brauchmann, J., Axon, E., Clare, K., Metzendorf, M., Wiegand, S., Pratt, J. S. A., & Ells, L. J. (2022) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011740.pub2 · Cited by 34 · see citing works
Infraclavicular nerve block reduces postoperative pain after distal radial fracture fixation: a randomized controlled trial
Wong, S. S. C., Chan, W. S., Fang, C. X., Chan, C. W., Lau, T.-W., Leung, F. K. L., & Cheung, C. W. (2020) · BMC Anesthesiology · doi:10.1186/s12871-020-01044-4 · Cited by 31 · see citing works
Cancer-related fatigue in patients treated with mistletoe extracts: a systematic review and meta-analysis
Pelzer, F., Loef, M., Martin, D. D., & Baumgartner, S. (2022) · Supportive Care in Cancer · doi:10.1007/s00520-022-06921-x · Cited by 31 · see citing works
Ivermectin for COVID-19 in adults in the community (PRINCIPLE): An open, randomised, controlled, adaptive platform trial of short- and longer-term outcomes
Hayward, G., Yu, L.-M., Little, P., Gbinigie, O., Shanyinde, M., Harris, V., Dorward, J., Saville, B. R., Berry, N., Evans, P. H., et al. (2024) · Journal of Infection · doi:10.1016/j.jinf.2024.106130 · Cited by 31 · see citing works
Acupuncture-related interventions improve chemotherapy-induced peripheral neuropathy: A systematic review and network meta-analysis
Yeh, M., Liao, R., Yeh, P.-H., Lin, C.-J., & Wang, Y.-J. (2024) · BMC Complementary Medicine and Therapies · doi:10.1186/s12906-024-04603-1 · Cited by 30 · see citing works
A systematic review highlights the need to improve the quality and applicability of trials of physical therapy interventions for low back pain
Cashin, A. G., Lee, H., Bagg, M. K., O’Hagan, E. T., Traeger, A. C., Kamper, S. J., Folly, T., Jones, M. D., Booth, J., & McAuley, J. H. (2020) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2020.06.025 · Cited by 30 · see citing works
No Benefit of Wearing Compression Stockings after Endovenous Thermal Ablation of Varicose Veins: A Systematic Review and Meta-Analysis
Hu, H., Wang, J., Wu, Z., Liu, Y., Ma, Y., & Zhao, J. (2021) · European Journal of Vascular and Endovascular Surgery · doi:10.1016/j.ejvs.2021.09.034 · Cited by 30 · see citing works
Placebo analgesia in physical and psychological interventions: Systematic review and meta‐analysis of three‐armed trials
Hohenschurz‐Schmidt, D., Phalip, J., Chan, J., Gauhe, G., Soliman, N., Vollert, J., Lunde, S. J., & Vase, L. (2023) · European Journal of Pain · doi:10.1002/ejp.2205 · Cited by 32 · see citing works
Effects of Psychoactive Massage in Outpatients with Depressive Disorders: A Randomized Controlled Mixed-Methods Study
Arnold, M. M., Müller-Oerlinghausen, B., Hemrich, N., & Bönsch, D. (2020) · Brain Sciences · doi:10.3390/brainsci10100676 · Cited by 32 · see citing works
Use of Placebo and Nonoperative Control Groups in Surgical Trials
Karjalainen, T., Heikkinen, J., Busija, L., Jokihaara, J., Lewin, A. M., Naylor, J., Harris, L., Harris, I. A., Buchbinder, R., & Adie, S. (2022) · JAMA Network Open · doi:10.1001/jamanetworkopen.2022.23903 · Cited by 29 · see citing works
Multimodal Physical Exercise and Functional Rehabilitation Program in Oncological Patients with Cancer-Related Fatigue—A Randomized Clinical Trial
Rodríguez, E. J. F., Gómez, C. S., Sánchez, R. M., Recio-Rodriguez, J. I., Puente-González, A. S., González‐Sánchez, J., Cruz, J. J., & Rihuete-Galve, M. I. (2023) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph20064938 · Cited by 31 · see citing works
Efficacy and Acceptance of Cognitive Behavioral Therapy in Adults with Chronic Fatigue Syndrome: A Meta-analysis.
Maas genannt Bermpohl, F., Kucharczyk-Bodenburg, A.-C., & Martin, A. (2024) · International Journal of Behavioral Medicine · doi:10.1007/s12529-023-10254-2 · Cited by 29 · see citing works
“However, this overempha-sizes the assumed effect of blinding in trials, which is not reflected in clinical data [59].”
Effectiveness of placebo interventions for patients with nonspecific low back pain: a systematic review and meta-analysis
Strijkers, R., Schreijenberg, M., Gerger, H., Koes, B. W., & Chiarotto, A. (2021) · Pain · doi:10.1097/j.pain.0000000000002272 · Cited by 27 · see citing works
Platform Randomised trial of INterventions against COVID-19 In older peoPLE (PRINCIPLE): protocol for a randomised, controlled, open-label, adaptive platform, trial of community treatment of COVID-19 syndromic illness in people at higher risk
Hayward, G., Butler, C., Yu, L., Saville, B. R., Berry, N., Dorward, J., Gbinigie, O. A., van Hecke, O., Ogburn, E., Swayze, H., et al. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-046799 · Cited by 28 · see citing works
Methodology and design of platform trials: a meta-epidemiological study
Pitre, T., Cheng, S., Cusano, E., Khan, N., Mikhail, D., Leung, G., Vernooij, R. W. M., Yarnell, C. J., Goligher, E. C., Murthy, S., et al. (2023) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2023.02.010 · Cited by 27 · see citing works
A systematic literature review of randomized controlled trials evaluating prognosis following treatment for adults with chronic fatigue syndrome
Ingman, T., Smakowski, A., Goldsmith, K., & Chalder, T. (2022) · Psychological Medicine · doi:10.1017/s0033291722002471 · Cited by 27 · see citing works
Platform adaptive trial of novel antivirals for early treatment of COVID-19 In the community (PANORAMIC): protocol for a randomised, controlled, open-label, adaptive platform trial of community novel antiviral treatment of COVID-19 in people at increased risk of more severe disease
Gbinigie, O. A., Ogburn, E., Allen, J., Dorward, J., Dobson, M., Madden, T., Yu, L., Lowe, D. M., Rahman, N. M., Petrou, S., et al. (2023) · BMJ Open · doi:10.1136/bmjopen-2022-069176 · Cited by 26 · see citing works
Adverse outcomes in trials of graded exercise therapy for adult patients with chronic fatigue syndrome
White, P. D., & Etherington, J. (2021) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2021.110533 · Cited by 25 · see citing works
Evidence-Based Care for People with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis
Sharpe, M., Chalder, T., & White, P. D. (2021) · Journal of General Internal Medicine · doi:10.1007/s11606-021-07188-4 · Cited by 25 · see citing works
Oedema on STIR modified the effect of amoxicillin as treatment for chronic low back pain with Modic changes—subgroup analysis of a randomized trial
Kristoffersen, P. M., Bråten, L. C. H., Vetti, N., Grøvle, L., Hellum, C., Storheim, K., Zwart, J., Aßmus, J., & Espeland, A. (2020) · European Radiology · doi:10.1007/s00330-020-07542-w · Cited by 24 · see citing works
Measuring the success of blinding in placebo-controlled trials: Should we be so quick to dismiss it?
Webster, R., Bishop, F. L., Collins, P. G. S., Evers, A. W. M., Hoffmann, T., Knottnerus, J. A., Lamb, S. E., Macdonald, H., Madigan, C. D., Napadow, V., et al. (2021) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2021.02.022 · Cited by 24 · see citing works
Efficacy and safety of chloroquine and hydroxychloroquine for treatment of COVID-19 patients-a systematic review and meta-analysis of randomized controlled trials.
Eze, P., Mezue, K. N., Nduka, C. U., Obianyo, I., & Egbuche, O. (2021) · PubMed Central · Cited by 24 · see citing works
Effectiveness of osteopathic manipulative treatment for pediatric conditions: A systematic review
Franke, H., Franke, J.-D., & Fryer, G. (2022) · Journal of Bodywork and Movement Therapies · doi:10.1016/j.jbmt.2022.03.013 · Cited by 23 · see citing works
Chronic temporomandibular disorders are associated with higher propensity to develop central sensitization: a case–control study
Cayrol, T., van den Broeke, E. N., Gerard, E., Meeus, M., Mouraux, A., Roussel, N. A., & Pitance, L. (2022) · Pain · doi:10.1097/j.pain.0000000000002803 · Cited by 23 · see citing works
The blinding status and characteristics in acupuncture clinical trials: a systematic reviews and meta-analysis
Liu, T., Jiang, L., Li, S., Cheng, S., Zhuang, R., Xiong, Z., Sun, C., Liu, B., Zhang, H., & Yan, S. (2024) · Systematic Reviews · doi:10.1186/s13643-024-02692-0 · Cited by 22 · see citing works
Empirical evidence of observer bias in randomized clinical trials: updated and expanded analysis of trials with both blinded and non-blinded outcome assessors
Salazar, J., Moustgaard, H., Bracchiglione, J., & Hróbjartsson, A. (2025) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2025.111787 · Cited by 22 · see citing works
Self-citation
Setting and techniques for monitoring blood pressure during pregnancy
Ashworth, D., Maule, S. P., Stewart, F. A., Nathan, H. L., Shennan, A. H., & Chappell, L. C. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012739.pub2 · Cited by 22 · see citing works
Headache and musculoskeletal pain in school children are associated with uncorrected vision problems and need for glasses: a case–control study
Thorud, H.-M. S., Aurjord, R., & Falkenberg, H. K. (2021) · Scientific Reports · doi:10.1038/s41598-021-81497-w · Cited by 21 · see citing works
The Effect of Nature-Based Adventure Interventions on Depression: A Systematic Review
Rosa, C. D., Chaves, T. S., Collado, S., Larson, L. R., & Profice, C. C. (2023) · Environment and Behavior · doi:10.1177/00139165231174615 · Cited by 20 · see citing works
Health outcomes 3 months and 6 months after molnupiravir treatment for COVID-19 for people at higher risk in the community (PANORAMIC): a randomised controlled trial
Harris, V. C., Holmes, J., Gbinigie, O. A., Rahman, N. M., Richards, D. B., Hayward, G., Dorward, J., Lowe, D. M., Standing, J. F., Breuer, J., et al. (2024) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(24)00431-6 · Cited by 21 · see citing works
Clinical and methodological considerations for psychological treatment of cognitive impairment in major depressive disorder
Douglas, K. M., Milanovic, M., Porter, R., & Bowie, C. R. (2020) · BJPsych Open · doi:10.1192/bjo.2020.53 · Cited by 20 · see citing works
The MIPAM trial – motivational interviewing and physical activity monitoring to enhance the daily level of physical activity among older adults – a randomized controlled trial
Larsen, R. T., Korfitsen, C. B., Keller, C., Christensen, J., Andersen, H. B., Juhl, C. B., & Langberg, H. (2021) · European Review of Aging and Physical Activity · doi:10.1186/s11556-021-00269-7 · Cited by 21 · see citing works
Performance, Detection, Contamination, Compliance, and Cointervention Biases in Rehabilitation Research
Armijo-Olivo, S. L., Mohamad, N., de Oliveira‐Souza, A. I. S., de Castro‐Carletti, E. M., Ballenberger, N., & Fuentes, J. (2021) · American Journal of Physical Medicine & Rehabilitation · doi:10.1097/phm.0000000000001893 · Cited by 22 · see citing works
Large randomized controlled trials in infertility
Wang, R., Chen, Z., Vuong, L. N., Legro, R. S., Mol, B. W., & Wilkinson, J. (2020) · Fertility and Sterility · doi:10.1016/j.fertnstert.2020.04.037 · Cited by 19 · see citing works
The effect of oil pulling in comparison with chlorhexidine and other mouthwash interventions in promoting oral health: A systematic review and meta‐analysis
Jong, F. J. X., Ooi, D. J., & Teoh, S. L. (2023) · International Journal of Dental Hygiene · doi:10.1111/idh.12725 · Cited by 21 · see citing works
Expanding revascularization trials to women and underserved minorities and shifting to patient-centered outcomes: RECHARGE trials program
Redfors, B., Spertus, J. A., Yancy, C. W., Creber, R. M., Stone, G. W., & Gaudino, M. F. L. (2024) · Current Opinion in Cardiology · doi:10.1097/hco.0000000000001177 · Cited by 18 · see citing works
Specific Probiotics for the Treatment of Pediatric Acute Gastroenteritis in India
McFarland, L. V., Srinivasan, R., Setty, R., Ganapathy, S., Bavdekar, A., Mitra, M., Raju, B. B., & Mohan, N. (2021) · JPGN Reports · doi:10.1097/pg9.0000000000000079 · Cited by 17 · see citing works
Better Short‐Term Outcomes After Rotator Cuff Repair in Studies With Poorer Mean Shoulder Scores and Predominantly Small to Medium‐Sized Tears at Baseline: A Systematic Review and Meta‐analysis
Holtedahl, R., Bøe, B., & Brox, J. I. (2021) · Arthroscopy The Journal of Arthroscopic and Related Surgery · doi:10.1016/j.arthro.2021.08.019 · Cited by 17 · see citing works
Empirical evidence of study design biases in nutrition randomised controlled trials: a meta-epidemiological study
Stadelmaier, J., Roux, I., Πετροπούλου, Μ., & Schwingshackl, L. (2022) · BMC Medicine · doi:10.1186/s12916-022-02540-9 · Cited by 18 · see citing works
Effects of a brief intervention based on Acceptance and Commitment Therapy versus usual care for cardiac rehabilitation patients with coronary heart disease (ACTonHEART): a randomised controlled trial
Spatola, C. A. M., Rapelli, G., Giusti, E. M., Cattivelli, R., Goodwin, C. L., Pietrabissa, G., Malfatto, G., Facchini, M., Cappella, E. A. M., Varallo, G., et al. (2024) · BMJ Open · doi:10.1136/bmjopen-2024-084070 · Cited by 17 · see citing works
The effect of osteopathic medicine on pain in musicians with nonspecific chronic neck pain: a randomized controlled trial
Rotter, G., Fernholz, I., Binting, S., Keller, T., Roll, S., Kass, B., Reinhold, T., Willich, S. N., Schmidt, A., & Brinkhaus, B. (2020) · Therapeutic Advances in Musculoskeletal Disease · doi:10.1177/1759720x20979853 · Cited by 17 · see citing works
Efficacy and Tolerability of Seven Antipsychotic Drugs in Acutely Ill Patients With Schizophrenia: A Randomized, Multicenter, Assessor-Blinded Trial
Zhao, G., Sun, Y., Zhang, Y., Lu, T., Lu, Z., Kang, Z., Schneider‐Thoma, J., Xie, W., Yang, Y., Guo, J., et al. (2025) · American Journal of Psychiatry · doi:10.1176/appi.ajp.20250111 · Cited by 16 · see citing works
Oseltamivir for coronavirus illness: post-hoc exploratory analysis of an open-label, pragmatic, randomised controlled trial in European primary care from 2016 to 2018
Coenen, S., van der Velden, A. W., Cianci, D., Goossens, H., Bongard, E., Saville, B. R., Gobat, N., de Paor, M., Ieven, M. M., Verheij, T. J., et al. (2020) · British Journal of General Practice · doi:10.3399/bjgp20x711941 · Cited by 16 · see citing works
Effect of Mobile-Based Lifestyle Intervention on Weight Loss among the Overweight and Obese Elderly Population in China: A Randomized Controlled Trial
Zhou, M., Zhang, N., Zhang, Y., Yan, X., Li, M., Guo, W., Guo, X., He, H., Guo, K., & Ma, G. (2021) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph18168825 · Cited by 16 · see citing works
The importance of methodology to palliative care research: A new article type for Palliative Medicine
van der Steen, J. T., Bloomer, M. J., & Pereira, S. M. (2021) · Palliative Medicine · doi:10.1177/02692163211069566 · Cited by 16 · see citing works
(Cost-)effectiveness of a personalized multidisciplinary eHealth intervention for knee arthroplasty patients to enhance return to activities of daily life, work and sports – rationale and protocol of the multicentre ACTIVE randomized controlled trial
Straat, A. C., Maarleveld, J. M., Smit, D. J. M., Visch, L., Hulsegge, G., Huirne, J. A. F., van Dongen, J. M., van Geenen, R. C. I., Kerkhoffs, G. M. M. J., Anema, J. R., et al. (2023) · BMC Musculoskeletal Disorders · doi:10.1186/s12891-023-06236-w · Cited by 16 · see citing works
The effect of using desktop VR to practice preoperative handovers with the ISBAR approach: a randomized controlled trial
Andreasen, E. M., Berg, H., Steinsbekk, A., Høigaard, R., & Haraldstad, K. (2023) · BMC Medical Education · doi:10.1186/s12909-023-04966-y · Cited by 16 · see citing works
Patient-reported outcomes from DESTINY-Breast04: trastuzumab deruxtecan versus physician’s choice of chemotherapy in patients with HER2-low mBC
Ueno, N. T., Cottone, F., Dunton, K., Jacot, W., Yamashita, T., Sohn, J., Tokunaga, E., Prat, A., Tsurutani, J., Park, Y. H., et al. (2025) · The Oncologist · doi:10.1093/oncolo/oyaf048 · Cited by 16 · see citing works
Induction of labor at term with vaginal misoprostol or a prostaglandin E2 pessary: a noninferiority randomized controlled trial
Gaudineau, A., Sénat, M.-V., Ehlinger, V., Gallini, A., Morin, M., Olivier, P., Roth, E., Orusco, E., Javoise, S., Fort, J., et al. (2021) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2021.04.226 · Cited by 16 · see citing works
A digital therapeutic (CT-152) as adjunct to antidepressant medication: A phase 3 randomized controlled trial (the Mirai study)
Rothman, B., Slomkowski, M., Speier, A., Rush, A. J., Trivedi, M. H., Lakhan, S. E., Lawson, E., Fahmy, M., Carpenter, D., Chen, D., et al. (2025) · Journal of Affective Disorders · doi:10.1016/j.jad.2025.119409 · Cited by 15 · see citing works
Overall Reporting Descriptions of Acupuncture for Chronic Pain in Randomized Controlled Trials in English Journals
Zhang, N., Tu, J., Lin, Y., Li, J., Zou, X., Wang, Y., Li, H., Wei, X., Wang, Y., Shi, G., et al. (2021) · Journal of Pain Research · doi:10.2147/jpr.s319195 · Cited by 15 · see citing works
Antibiotics for hospital-acquired pneumonia in neonates and children
Korang, S. K., Nava, C., Mohana, S. P., Nygaard, U., & Jakobsen, J. C. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013864.pub2 · Cited by 15 · see citing works
Influence of lack of blinding on the estimation of medication-related harms: a retrospective cohort study of randomized controlled trials
Xu, C., Zhang, F., Doi, S. A. R., Furuya‐Kanamori, L., Lin, L., Chu, H., Yang, X., Li, S., Zorzela, L., Golder, S., et al. (2024) · BMC Medicine · doi:10.1186/s12916-024-03300-7 · Cited by 14 · see citing works
The Effectiveness of Intraosseous Basivertebral Nerve Ablation in the Treatment of Nonradiating Vertebrogenic Pain: A Systematic Review
Nwosu, M., Agyeman, W. Y., Bisht, A., Gopinath, A., Cheema, A. H., Chaludiya, K., Khalid, M., & Yu, A. K. (2023) · Cureus · doi:10.7759/cureus.37114 · Cited by 14 · see citing works

Empirical evidence of observer bias in randomized clinical trials: updated and expanded analysis of trials with both blinded and non-blinded outcome assessors
Salazar, J., Moustgaard, H., Bracchiglione, J., & Hróbjartsson, A. (2025) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2025.111787 · Cited by 22 · see citing works
Self-citation
Empirical Evidence of Observer Bias in Randomised Clinical Trials: Updated and Expanded Analysis of Trials with Blinded and Non-Blinded Outcome AssessorsPreprint
Salazar, J., Moustgaard, H., Bracchiglione, J., & Hróbjartsson, A. (2025) · SSRN Electronic Journal · doi:10.2139/ssrn.5141572
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The impact of blinding on trial results: A systematic review and meta‐analysis
(2023) · doi:10.1002/cesm.12015 · Cited by 35 · see citing works
Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study
Jüni, P., Schulz, K. F., Martin, R., Wood, A. J. G., Egger, M., Wood, L., Gluud, L. L., Sterne, J. A. C., Gluud, C. N., & Altman, D. G. (2020) · Carolina Digital Repository (University of North Carolina at Chapel Hill) · doi:10.17615/z4kh-xh14
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Compelling evidence from meta-epidemiological studies demonstrates overestimation of effects in randomized trials that fail to optimize randomization and blind patients and outcome assessors
Schulz, K. F., Wang, Q., Gluud, L. L., Armijo-Olivo, S., Ravaud, P., Guyatt, G. H., Brignardello‐Petersen, R., Zeraatkar, D., Briel, M., Couban, R., et al. (2026) · Carolina Digital Repository (University of North Carolina at Chapel Hill) · doi:10.17615/w77n-wj97
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Authors: Moustgaard, H., Clayton, G. L., Jones, H. E., Boutron, I., Jørgensen, L., Laursen, D. R. T., Olsen, M. F., Paludan-Müller, A., Ravaud, P., Savović, J., Sterne, J. A. C., Higgins, J. P. T., & Hróbjartsson, A.
Affiliations: Odense University Hospital (DK)
University of Bristol (GB)
Hôtel-Dieu de Paris (FR)
Cochrane (DK)
University Hospitals Bristol NHS Foundation Trust (GB)
University of Southern Denmark (DK)
Corresponding author: Moustgaard, Helene
ORCID: Moustgaard, Helene
Clayton, Gemma L
Jones, Hayley E
Boutron, Isabelle
Jørgensen, Lars
Laursen, David R T
Olsen, Mette F
Ravaud, Philippe
Savović, Jelena
Sterne, Jonathan A C
Higgins, Julian P T
Hróbjartsson, Asbjørn
Venue: BMJ
Publisher: BMJ
Published: 2020-01-21
Volume: 368
Issue: 2
Pages: l6802
ISSN: 1756-1833 (ISSN-L)
DOI: 10.1136/bmj.l6802
PMC: PMC7190062
OpenAlex: W3001993019
Cited by: 300
References: 36
Citations by year: 2026: 21 · 2025: 45 · 2024: 55 · 2023: 50 · 2022: 49 · 2021: 50 · 2020: 27 · 2019: 1
FWCI: 9.08
Type: journal article
Language: en
Update notices: correction (2020-02-05)
Open access: hybrid
doi.org
Licence: cc-by-nc
creativecommons.org/licenses/by-nc/4.0/ (unspecified)
Locations: BMJ (publishedVersion, cc-by-nc)
PubMed Central (publishedVersion, cc-by-nc)
PubMed (publishedVersion)
Bristol Research (University of Bristol) (publishedVersion, cc-by)
University of Southern Denmark Research Portal (University of Southern Denmark) (acceptedVersion, cc-by-nc)
HAL (submittedVersion)
HighWire Press Open Archive (submittedVersion)
Funders: University Hospitals Bristol NHS Foundation Trust
NIHR Bristol Biomedical Research Centre (NF-SI-0617-10145)
National Institute for Health and Care Research (NF-SI-0611-10168, NF-SI-0616-10111, NIHR200268, NF-SI-0617-10145)
Department of Health and Social Care
University of Bristol
Medical Research Council (MR/K025643/1, MR/M014533/1, MR/L004933/1, MR/L004933/2)
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, randomized controlled trials, treatment effect estimation, detection bias, performance bias, trial heterogeneity, meta-analysis bias, double blinding, allocation concealment, attrition, meta-epidemiology, patient-reported outcomes
MeSH terms: Clinical Trials as Topic, Humans, Research Design, Epidemiologic Research Design, Observer Variation, Outcome Assessment, Health Care

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Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study

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