ArticleJournal of the National Cancer Institute2022
Impact of Blinding on Patient-Reported Outcome Differences Between Treatment Arms in Cancer Randomized Controlled Trials.
Article in Journal of the National Cancer Institute, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Opportunities to improve the adoption of health-related quality of life evidence as part of the French Health Technology Assessment process.Health research policy and systems · 2023Pooled it
- Toxicity profiles of antibody-drug conjugates for anticancer treatment: a systematic review and meta-analysis.JNCI cancer spectrum · 2023Pooled it
- Mistletoe extract in patients with advanced pancreatic cancer: Health-related quality of life in a double-blind, randomized, placebo-controlled trial (MISTRAL).Palliative medicine · 2026Trial
- Prognostic associations between patient-reported outcomes and overall survival among patients with advanced squamous non-small cell lung cancer: results from the RATIONALE-307 trial.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Trial
- Multisite Randomized Trial of Inpatient Palliative Care Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Patient-reported outcomes in patients with paroxysmal nocturnal hemoglobinuria treated with crovalimab and approved C5 inhibitors in the phase III COMMODORE 2 and 1 studies.Annals of hematology · 2025Trial
- Health-Related Quality of Life With Nivolumab Plus Chemotherapy Versus Chemotherapy in Patients With Advanced Gastric/Gastroesophageal Junction Cancer or Esophageal Adenocarcinoma From CheckMate 649.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Comment on "Oxycodone combined with pulsed radiofrequency for refractory cancer pain from spinal metastases: a randomized controlled study".Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Association Between Health-Related Quality of Life Measures and Survival Endpoints in Oncology Clinical Trials and in Clinical Decision Making: A Narrative Review.Pharmaceutical medicine · 2025Review
- Burden of lung cancer and application of patient-reported outcomes in the Western Pacific Region: a systematic analysis.Frontiers in medicine · 2025Article
- Comparison of Methods for Short-Segment Posterior Stabilization of Lumbar Spine Fractures and Thoracolumbar Junction.Journal of clinical medicine · 2024Article
- Breast-cancer specific comprehensive archive of Patient-Reported Outcome Measures (PROMs) for clinical research and clinical practice in oncology: Results from the PRO4All project.Breast (Edinburgh, Scotland) · 2024Article
- Review
- Meta-epidemiologic review: blinding and sham treatment in clinical trial design for osteopathic manipulative treatment research.International journal of osteopathic medicine : IJOM · 2024Article
- A Systematic Literature Review of Psychological Interventions for Adults with Type 1 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024Review
- Analysis of patient-reported outcomes in the approval of novel oncology drugs in the United States, 2017-2022.EClinicalMedicine · 2023Review
- Assessing the impact of open-label designs in patient-reported outcomes: investigation in oncology clinical trials.JNCI cancer spectrum · 2023Article
- Time trends in health-related quality of life assessment and reporting within publications of oncology randomised phase III trials: a meta-research study.BMJ oncology · 2023Article
- Patient-Reported Outcomes in Cancer Patients with HIV.Cancers · 2022Article
- Using Patient-Reported Outcomes in Dose-Finding Oncology Trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum.The oncologist · 2022Article
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
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 blinding 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 (blinded vs open-label) 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.