Impact of Blinding on Patient-Reported Outcome Differences between Treatment Arms in Cancer Randomized Controlled Trials.

Efficace, Fabio, Cella, David, Aaronson, Neil K, Calvert, Melanie J, Cottone, Francesco, Di Maio, Massimo, Perrone, Francesco, Sparano, Francesco, Gamper, Eva-Maria, Vignetti, Marco and Giesinger, Johannes M (2021) Impact of Blinding on Patient-Reported Outcome Differences between Treatment Arms in Cancer Randomized Controlled Trials. Journal of the National Cancer Institute. ISSN 1460-2105. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs

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Official URL: http://jnci.oxfordjournals.org/

Abstract

Some concerns have been raised about potential bias in patient-reported outcome (PRO) results from open-label cancer randomized controlled trials (RCTs). We investigated if open-label trials favor the experimental treatment over the standard treatment more frequently than blinded trials. We also examined if the effect of treatment concealment differs for distal vs more proximal PROs. We assessed 538 RCTs with a PRO endpoint conducted in the most prevalent cancers, of which 366 (68.0%) were open-label, 148 (27.5%) were blinded, and 24 (4.5%) were categorized as unclear. In our multivariable logistic regression model, we did not observe a statistically significant association of the independent variable treatment concealment (open-label vs blinded) on the dependent variable measuring the proportion of trials favoring the experimental treatment (adjusted odds ratio = 1.19, 95% confidence interval = 0.79 to 1.79, 2-sided P = .40. This was also the case when comparing distal and proximal PROs. Our findings provide novel evidence-based data that support the validity of PRO results from open label cancer RCTs.

Item Type: Article
Additional Information: This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Subjects: QZ Pathology. Oncology
W Public health. Health statistics. Occupational health. Health education
WC Communicabable diseases
WH Haemic and lymphatic systems. Haematology
WM Psychiatry. Mental health
Divisions: Planned IP Care > Oncology and Clinical Haematology
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Depositing User: Jamie Edgar
Date Deposited: 20 Sep 2021 11:38
Last Modified: 20 Sep 2021 11:38
URI: http://www.repository.uhblibrary.co.uk/id/eprint/4656

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