Evidence map›Paper›PMID 34982354›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2022

Minimal important differences of EORTC QLQ-C30 for metastatic breast cancer patients: Results from a randomized clinical trial.

Takuya Kawahara, Naruto Taira, Takeru Shiroiwa, Yasuhiro Hagiwara, Takashi Fukuda, Yukari Uemura, Hirofumi Mukai

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Takuya KawaharaClinical Research Promotion Center, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. takuyakawahara@g.ecc.u-tokyo.ac.jp.ORCID http://orcid.org/0000-0002-3859-2756
Naruto TairaBreast and Endocrine Surgery Department, Okayama University Hospital, Okayama, Japan.
Takeru ShiroiwaCenter for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, Wako, Japan.
Yasuhiro HagiwaraDepartment of Biostatistics, Division of Health Sciences and Nursing, The University of Tokyo, Tokyo, Japan.
Takashi FukudaCenter for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, Wako, Japan.
Yukari UemuraDepartment of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.
Hirofumi MukaiDepartment of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo establish minimal important differences (MIDs) for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30) in patients with metastatic breast cancer.

methodsThe dataset was obtained from the SELECT BC-CONFIRM randomized clinical trial. Anchors obtained from patients (transition items) and clinicians (performance status) were used for anchor-based methods. Anchors obtained through 6 months after starting treatment were used for this analysis. Correlation coefficients of anchor and change in QLQ-C30 and effect size were used to qualify for estimating MIDs. Mean change method and generalized estimating equation were applied to estimate MIDs. Distribution-based methods were used for comparison.

resultsWe analyzed a dataset of 154 metastatic breast cancer patients. MIDs were estimated in 8 of 15 scales of QLQ-C30. Estimated MIDs for within-group improvement varied from 7 to 15 and those for deterioration varied from - 7 to - 17. Estimated MIDs for between-group improvement varied from 5 to 11 and those for deterioration varied from - 5 to - 8 across QLQ-C30 scales. Patient-reported anchors were more susceptible to early changes in health status than clinician-reported anchors.

conclusionWe provided the MIDs of the QLQ-C30 using both patient- and clinicians-reported anchors measured in a randomized trial of Japanese patients with metastatic breast cancer. We recommend patient-reported anchors for anchor-based estimation of MID. Our results can aid patients and clinicians, as well as researchers, in the interpretation of QLQ-C30.

Indexed as

Breast NeoplasmsQuality of LifeFemaleHumansResearch DesignSurveys and QuestionnairesAnchoringEORTC QLQ-C30Health-related quality of lifeMinimal important differencePatient-reported outcomes

Identifiers

PMID34982354
PMCPMC9098551

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Registered trials

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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.