Evidence map›Paper›PMID 26892541›Full record

ReviewBMC cancer2016

Methodology of health-related quality of life analysis in phase III advanced non-small-cell lung cancer clinical trials: a critical review.

Frédéric Fiteni, Amélie Anota, Virginie Westeel, Franck Bonnetain

Abstract readReview
In one paragraph

Review in BMC cancer, 2016. 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.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 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

22 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Methodology of analysis of cognitive impairment in longitudinal randomized clinical trials in oncology: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Time to deterioration of patient-reported outcomes in non-small cell lung cancer: exploring different definitions.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022
    Article
  13. Article
  14. Functional status in older patients with lung cancer: an observational cohort study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Observational
  15. Crucial Roles of miR-625 in Human Cancer.Frontiers in medicine · 2022
    Review
  16. Article
  17. Review
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  19. Article
  20. Determining clinically important differences in health-related quality of life in older patients with cancer undergoing chemotherapy or surgery.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2019
    Article
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

4 authors.

Frédéric FiteniMethodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France. fredericfiteni@gmail.com.
Amélie AnotaMethodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France. aanota@chu-besancon.fr.
Virginie WesteelChest disease Department, University Hospital of Besançon, Besançon, France. virginie.westeel@univ-fcomte.fr.
Franck BonnetainMethodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France. franck.bonnetain@univ-fcomte.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHealth-related quality of life (HRQoL) is recognized as a component endpoint for cancer therapy approvals. The aim of this review was to evaluate the methodology of HRQoL analysis and reporting in phase III clinical trials of first-line chemotherapy in advanced non-small cell lung cancers (NSCLC).

methodsA search in MEDLINE databases identified phase III clinical trials in first-line chemotherapy for advanced NSCLC, published between January 2008 to December 2014. Two authors independently extracted information using predefined data abstraction forms.

resultsA total of 55 phase III advanced NSCLC trials were identified. HRQoL was declared as an endpoint in 27 studies (49%). Among these 27 studies, The EORTC questionnaire Quality of Life Questionnaire C30 was used in 13 (48%) of the studies and The Functional Assessment of Cancer Therapy-General was used in 12 (44%) trials. The targeted dimensions of HRQoL, the minimal clinically important difference and the statistical approaches for dealing with missing data were clearly specified in 13 (48.1%), 9 (33.3%) and 5 (18.5%) studies, respectively. The most frequent statistical methods for HRQoL analysis were: the mean change from baseline (33.3%), the linear mixed model for repeated measures (22.2%) and time to HRQoL score deterioration (18.5%). For each targeted dimension, the results for each group, the estimated effect size and its precision were clearly reported in 4 studies (14.8%), not clearly reported in 11 studies (40.7%) and not reported at all in 12 studies (44.4%).

conclusionsThis review demonstrated the weakness and the heterogeneity of the measurement, analysis, and reporting of HRQoL in phase III advanced NSCLC trials. Precise and uniform recommendations are needed to compare HRQoL results across publications and to provide understandable messages for patients and clinicians.

Indexed as

Quality of LifeCarcinoma, Non-Small-Cell LungClinical Trials, Phase III as TopicHumansLinear ModelsLung NeoplasmsSurveys and Questionnaires

Identifiers

PMID26892541
PMCPMC4758022

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.