ArticleJournal of patient-reported outcomes2020
Patient-reported outcome instruments used in immune-checkpoint inhibitor clinical trials in oncology: a systematic review.
Article in Journal of patient-reported outcomes, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
15 citing papers in PubMed, 1 synthesis or guideline pooled 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
- Trial
- Adverse events self-reported by patients with extensive-stage small-cell lung cancer in the phase III CASPIAN study.Future oncology (London, England) · 2025Trial
- Trial
- Development of an eHealth-enhanced model of care for the monitoring and management of immune-related adverse events in patients treated with immune checkpoint inhibitors.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Trial
- Study Protocol to Characterize Symptom Experience During Immune Checkpoint Inhibitor Therapy for Cutaneous Melanoma.Nursing research · 2026Article
- Article
- Composite patient-reported outcomes and risk prediction for overall survival in advanced non-small cell lung cancer with first-line cemiplimab.Frontiers in oncology · 2026Article
- A SITC vision: adapting clinical trials to accelerate drug development in cancer immunotherapy.Journal for immunotherapy of cancer · 2025Article
- Development and validation of the self-report symptom inventory of immune-related adverse events in patients with lung cancer.Asia-Pacific journal of oncology nursing · 2024Article
- Patient-reported outcomes in CD30-directed CAR-T cells against relapsed/refractory CD30+ lymphomas.Journal for immunotherapy of cancer · 2023Article
- Reliability and validity of the simplified Chinese version of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
- Health-related quality of life in cancer immunotherapy: a systematic perspective, using causal loop diagrams.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Article
- A Narrative Review on the Collection and Use of Electronic Patient-Reported Outcomes in Cancer Survivorship Care with Emphasis on Symptom Monitoring.Current oncology (Toronto, Ont.) · 2022Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
contextImmune-checkpoint inhibitors (ICI) have shown significant benefits for overall survival across various cancer types. Patient-reported outcomes (PROs) are assessed in clinical trials as a measure of efficacy. However, it remains unclear to what extent current PRO instruments capture symptoms specific to ICI toxicities. We conducted a systematic review to identify the use and content validity of PRO instruments in ICI clinical trials in oncology.
methodsLiterature was retrieved from PubMed, Embase, PsycINFO, Medline and CINAHL databases. Articles presenting ICI clinical trials' PRO results, clinical trial study protocols, and conference abstracts stating the use of PRO measures were assessed. We evaluated the validity of identified instruments by comparing their symptom-related content with the adverse events reported in each ICI clinical trial.
resultsFrom database inception until January 2020, we identified 191 ICI clinical trials stating the use of PRO measures of which 26 published PRO results. The cancer-specific EORTC QLQ-C30 and the generic EQ-5D questionnaires were the most widely used instruments, often in combination with disease-specific PROs. Instruments used to report PRO symptom-related toxicities covered 45% of the most frequently reported AEs, whereas 23% of AEs were partially covered and 29% were not covered at all. Of non-covered AEs, 59% referred to the dermatologic system. Partially covered AEs related to endocrine and specific types of pain.
conclusionDespite the high frequency of symptom-related toxicities related to ICI, these events are only partially covered (or not addressed) by current PRO instruments, even when combined. Further research is needed to develop new strategies to tailor PRO instruments to specific ICI toxicities.
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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.