Blinding in Clinical Trials: Seeing the Big Picture

Monaghan, Thomas F.; Agudelo, Christina W.; Rahman, Syed N.; Wein, Alan J.; Lazar, Jason; Everaert, Karel; Dmochowski, Roger R.

doi:10.3390/medicina57070647

Cited by 35 publications

(23 citation statements)

References 87 publications

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“…It is acknowledged there may be negative impacts of undertaking a blinding strategy on trial recruitment. 2 In the OPTIMIST-A trial, a separate study team carried out the intervention. This team took time to mobilise, and in some instances added to the trial costs.…”

Section: Discussionmentioning

confidence: 99%

“…Blinding is a key strength of randomised clinical trial (RCT) methodology, preventing ascertainment bias and preserving the integrity of estimates of treatment effect. 1,2 However, there is a widespread lack of information provided in trial reports detailing how and whether blinding was achieved. 3,4 This may limit critical appraisal of RCTs, undermine confidence in the results and recommendations, and may ultimately impede their translation to clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support

et al. 2023

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Background: Blinding of treatment allocation from treating clinicians in neonatal randomised controlled trials can minimise performance bias, but its effectiveness is rarely assessed. Methods: To examine the effectiveness of blinding a procedural intervention from treating clinicians in a multicentre randomised controlled trial of minimally invasive surfactant therapy versus sham treatment in preterm infants of gestation 25–28 weeks with respiratory distress syndrome. The intervention (minimally invasive surfactant therapy or sham) was performed behind a screen within the first 6 h of life by a ‘study team’ uninvolved in clinical care including decision-making. Procedure duration and the study team’s words and actions during the sham treatment mimicked those of the minimally invasive surfactant therapy procedure. Post-intervention, three clinicians completed a questionnaire regarding perceived group allocation, with the responses matched against actual intervention and categorised as correct, incorrect, or unsure. Success of blinding was calculated using validated blinding indices applied to the data overall (James index, successful blinding defined as > 0.50), or to the two treatment allocation groups (Bang index, successful blinding: −0.30 to 0.30). Blinding success was measured within staff role, and the associations between blinding success and procedural duration and oxygenation improvement post-procedure were estimated. Results: From 1345 questionnaires in relation to a procedural intervention in 485 participants, responses were categorised as correct in 441 (33%), incorrect in 142 (11%), and unsure in 762 (57%), with similar proportions for each of the response categories in the two treatment arms. The James index indicated successful blinding overall 0.67 (95% confidence interval (CI) 0.65–0.70). The Bang index was 0.28 (95% CI 0.23–0.32) in the minimally invasive surfactant therapy group and 0.17 (95% CI 0.12–0.21) in the sham arm. Neonatologists more frequently guessed the correct intervention (47%) than bedside nurses (36%), neonatal trainees (31%), and other nurses (24%). For the minimally invasive surfactant therapy intervention, the Bang index was linearly related to procedural duration and oxygenation improvement post-procedure. No evidence of such relationships was seen in the sham arm. Conclusion: Blinding of a procedural intervention from clinicians is both achievable and measurable in neonatal randomised controlled trials.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support

et al. 2023

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“…Thus, we suspect that there are several reasons. First, during the implementation of the intervention, patients were not and could not be blinded to the way they were going to be treated, which may have led to bias ( 25 , 26 ). Second, patients in the AI-assisted group did not know exactly how to use Smart-doctor .…”

Section: Discussionmentioning

confidence: 99%

Using artificial intelligence to reduce queuing time and improve satisfaction in pediatric outpatient service: A randomized clinical trial

Tian

et al. 2022

Front. Pediatr.

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IntroductionComplicated outpatient procedures are associated with excessive paperwork and long waiting times. We aimed to shorten queuing times and improve visiting satisfaction.MethodsWe developed an artificial intelligence (AI)-assisted program named Smart-doctor. A randomized controlled trial was conducted at Shanghai Children’s Medical Center. Participants were randomly divided into an AI-assisted and conventional group. Smart-doctor was used as a medical assistant in the AI-assisted group. At the end of the visit, an e-medical satisfaction questionnaire was asked to be done. The primary outcome was the queuing time, while secondary outcomes included the consulting time, test time, total time, and satisfaction score. Wilcoxon rank sum test, multiple linear regression and ordinal regression were also used.ResultsWe enrolled 740 eligible patients (114 withdrew, response rate: 84.59%). The median queuing time was 8.78 (interquartile range [IQR] 3.97,33.88) minutes for the AI-assisted group versus 21.81 (IQR 6.66,73.10) minutes for the conventional group (p < 0.01), and the AI-assisted group had a shorter consulting time (0.35 [IQR 0.18, 0.99] vs. 2.68 [IQR 1.82, 3.80] minutes, p < 0.01), and total time (40.20 [IQR 26.40, 73.80] vs. 110.40 [IQR 68.40, 164.40] minutes, p < 0.01). The overall satisfaction score was increased by 17.53% (p < 0.01) in the AI-assisted group. In addition, multiple linear regression and ordinal regression showed that the queuing time and satisfaction were mainly affected by group (p < 0.01), and missing the turn (p < 0.01).ConclusionsUsing AI to simplify the outpatient service procedure can shorten the queuing time of patients and improve visit satisfaction.

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“…The most effective trial design is a double-blinded randomized controlled trial. These trials involve blinding potential information which could influence study results, alongside aiding in alleviating several potential sources of bias that if unchecked, could affect the outcomes of the study in a negative light [8] . Typically, in a clinical trial, alongside testing the novel drug treatment, researchers also often use a placebo treatment on a control group, to give researchers something to compare the results from their novel drug treatment with.…”

Section: A Practical Clinical Protocol and The Accompanying Methods F...mentioning

confidence: 99%

The importance of the clinical trialing process in the development of modern-day drugs

Ying

2023

Second International Conference on Biological Engineering and Medical Science (ICBioMed 2022)

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The drug development process for a single drug can be extremely costly, extensive, and arduous. Furthermore, approximately only 14% of drugs as of recent during the clinical trial process make it through the process and obtain FDA approval, making the clinical trial process very daunting for pharmaceutical researchers. The clinical trial process is very important in confirming that a novel drug's safety and efficacy when administered is mirrored in both human clinical studies and animal preclinical studies. Furthermore, understanding the current frameworks, techniques, and study designs that allow for a better assessment of a novel drug's safety and efficacy can help make the clinical trial process smoother and a better basis for the future optimization of current clinical procedures. Finally, collecting and analyzing important data while interpreting it correctly is crucial in making sure that a novel drug treatment is as safe and effective as it can be at a specific dosage. This paper is important, for it focuses on mitigating any shortcomings or problems in the clinical trial process that might prevent the drug from ever reaching FDA approval. The paper does this by highlighting the important and successful aspects of the clinical trial process that can help solidify and optimize a novel drug treatment as safe and effective for FDA approval.

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Blinding in Clinical Trials: Seeing the Big Picture

Cited by 35 publications

References 87 publications

Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support

Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support

Using artificial intelligence to reduce queuing time and improve satisfaction in pediatric outpatient service: A randomized clinical trial

The importance of the clinical trialing process in the development of modern-day drugs

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