ArticleSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2022
Validity of a single-item indicator of treatment side effect bother in a diverse sample of cancer patients.
Article in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Patient-Reported Outcome Instruments in Non-Muscle-Invasive Bladder Cancer (NMIBC): A Systematic Review.Oncology and therapy · 2026Pooled it
- Patient-Reported Outcomes for Patients with Previously Treated Small Cell Lung Cancer Receiving Tarlatamab: Results from the DeLLphi-301 Phase 2 Trial.Advances in therapy · 2025Trial
- Trial
- Assessing tolerability with the Functional Assessment of Cancer Therapy item GP5: psychometric evidence from LIBRETTO-531, a phase 3 trial of selpercatinib in medullary thyroid cancer.Journal of patient-reported outcomes · 2024Trial
- The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024Trial
- Validity, reliability, responsiveness, and clinically meaningful change threshold estimates of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16).Journal of patient-reported outcomes · 2024Trial
- Patient-Reported Adverse Events and Early Treatment Discontinuation Among Patients With Multiple Myeloma.JAMA network open · 2024Trial
- Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III-IV melanoma in phase III trial E1609.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Trial
- A single item for overall side effect impact: Association with clinician-reported adverse events and global health.Clinical trials (London, England) · 2026Article
- Patient-Reported Side Effect Bother: Understanding the Value of the Baseline Report.The patient · 2026Article
- Review
- Defining and measuring tolerability in pediatric, adolescent, and young adult oncology: The essential voices.Cancer · 2025Review
- Article
- Incorporation of patient-reported outcomes in pediatric cancer clinical trials: design, implementation, and dissemination.Journal of the National Cancer Institute · 2025Article
- Patterns of self-reported diarrhea in patients with cancer receiving chemotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Article
- Symptom experience of patients undergoing treatment for multiple myeloma: a longitudinal real-world electronic patient-reported outcomes study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024Article
- Validity of a single-item indicator of treatment side effect bother in patients with head and neck cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024Article
- Article
- Administering selected subscales of patient-reported outcome questionnaires to reduce patient burden and increase relevance: a position statement on a modular approach.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024Article
- Importance of Low- and Moderate-Grade Adverse Events in Patients' Treatment Experience and Treatment Discontinuation: An Analysis of the E1912 Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWith higher efficacy of cancer therapies, the numbers and types of side effects experienced by patients have also increased, evidencing a need for brief assessments of side effect bother. The Functional Assessment of Cancer Therapy-General (FACT-G) includes the item "I am bothered by side effects of treatment" (GP5). This study aimed to confirm GP5's validity in a large, diverse, real-world patient sample.
methodsReal-world data were drawn from 10 Adelphi Disease Specific Programmes (DSP™) conducted between 2015 and 2019 in France, Germany, Italy, Spain, the UK and the USA, covering 10 cancer sites. We examined correlations between GP5 responses and varied measures of patient-reported global health and the number of side effects experienced. We explored whether more advanced patients and those with worse Eastern Cooperative Oncology Group Performance Status Rating (ECOG PSR) reported greater side effect bother. Finally, we conducted differential item functioning (DIF) assessment using the Mantel-Haenszel approach.
resultsThe sample included 6755 advanced cancer patients. GP5 responses were distributed similarly across most cancer sites. A moderate, negative correlation (r
conclusionGP5 exhibited evidence of validity across cancer sites and countries and appeared to measure the same construct across these countries. GP5 has significant promise as a summary indicator of side effect bother.
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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.