ReviewCancer medicine2020
Investigating the impact of open label design on patient-reported outcome results in prostate cancer randomized controlled trials.
Review in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 4 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
22 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Comparative safety of B/F/TAF versus other antiretroviral therapy regimens for treatment-experienced people with HIV-1: a systematic literature review and network meta-analysis.Journal of comparative effectiveness research · 2026Pooled it
- Global hotspots and trends in the application of neoadjuvant therapy for gastric cancer: a bibliometric analysis.Frontiers in oncology · 2026Pooled 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
- Impact of open-label versus blinded study design on patient-reported outcomes data in randomized clinical trials of immunotherapy in advanced or metastatic cancer patients: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Pooled it
- 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
- 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
- Patient-reported outcomes from DESTINY-Breast04: trastuzumab deruxtecan versus physician's choice of chemotherapy in patients with HER2-low mBC.The oncologist · 2025Trial
- Trial
- Home-based high tone therapy may alleviate chemotherapy-induced neuropathic symptoms in patients with colorectal cancer: A randomized double-blind placebo-controlled pilot evaluation.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024Trial
- Trial
- Health-Related Quality of Life Following Allogeneic Hematopoietic Cell Transplantation with Omidubicel versus Umbilical Cord Blood.Transplantation and cellular therapy · 2023Trial
- Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Trial
- Patient-reported outcomes with first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma treated in CheckMate 9ER: an open-label, randomised, phase 3 trial.The Lancet. Oncology · 2022Trial
- Pharmacist-led, digitally enabled transitional care after acute myocardial infarction: design and baseline characteristics of the AMI-HOPE nationwide stepped-wedge trial.European heart journal. Digital health · 2026Article
- CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials.BMJ (Clinical research ed.) · 2025Article
- Review
- Assessing the impact of open-label designs in patient-reported outcomes: investigation in oncology clinical trials.JNCI cancer spectrum · 2023Article
- Investigating the trends in patient-reported outcomes pre-treatment and implications to efficacy analyses: A post-hoc analysis of a cancer clinical trial.Contemporary clinical trials communications · 2022Article
- Patient-reported outcomes labeling for oncology drugs: Multidisciplinary perspectives on current status and future directions.Frontiers in pharmacology · 2022Article
- A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020.Frontiers in medicine · 2022Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWhile open-label randomized controlled trials (RCT) are common in oncology, some concerns have been expressed with regard to Patient-Reported Outcomes (PRO)-based claims stemming from these studies. We aimed to investigate the impact of open-label design in the context of prostate cancer (PCa) RCTs with PRO data.
methodsRandomized controlled trials of PCa with a PRO endpoint published between 2004 and 2018 were considered. RCTs were systematically evaluated on the basis of previously defined criteria, including international PRO reporting quality standards and the Cochrane Collaboration's tool for assessing Risk of Bias. The rate of concordance was estimated and compared between traditional clinical outcomes (eg, survival or tumor response) and PRO in open and blinded RCTs.
resultsWe identified 110 RCTs published between 2004 and 2018, of which 62% (n = 68) were open-label. The general characteristics of PCa RCTs were not different according to their design (open-label vs blinded). The proportion of PCa RCTs with high-quality PRO reporting was not different between open-label RCTs and blinded RCTs (41.2% vs 38.1%; P = .75). No statistically significant difference was found between PRO results and concordance with traditional clinical outcomes according to the study design.
conclusionOur findings suggest that there is no evidence of significant bias for PROs due to the absence of blinding in the context of PCa RCTs. Further analyses should be conducted in other cancer disease sites.
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