Evidence map›Paper›PMID 39046616›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2024

The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments.

Cara Arizmendi, Yanyan Zhu, Maryam Khan, Jonathon Gable, Bryce B Reeve, Bellinda King-Kallimanis, Jill Bell

Registry-linked trialAbstract 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, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00065325 (A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT00065325 phase3completednot on this map

A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy

TypeinterventionalSponsorAstraZenecaRan2003 to 2014Enrolled694ConditionsLocally Advanced Breast Cancer, Metastatic Breast CancerArmsFulvestrant, Exemestane
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Article
  4. Review
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.

Cara ArizmendiAstraZeneca, Oncology Digital Health R&D, Gaithersburg, MD, USA. cara.arizmendi@astrazeneca.com.ORCID http://orcid.org/0000-0001-5608-7385
Yanyan ZhuAstraZeneca, Oncology Digital Health R&D, Gaithersburg, MD, USA.
Maryam KhanAstraZeneca, Oncology Digital Health R&D, Gaithersburg, MD, USA.
Jonathon GableAstraZeneca, Oncology Digital Health R&D, Gaithersburg, MD, USA.
Bryce B ReeveCenter for Health Measurement, Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.
Bellinda King-KallimanisLungevity Foundation, Chicago, IL, USA.
Jill BellAstraZeneca, Oncology Digital Health R&D, Gaithersburg, MD, USA.

Funding

AstraZeneca United States AstraZeneca United States
6 · The paper itself

Abstract

purposeThe Functional Assessment of Cancer Therapy item (FACT-GP5) has the potential to provide an understanding of global treatment tolerability from the patient perspective. Longitudinal evaluations of the FACT-GP5 and challenges posed by data missing-not-at-random (MNAR) have not been explored. Robustness of the FACT-GP5 to missing data assumptions and the responsiveness of the FACT-GP5 to key side-effects are evaluated.

methodsIn a randomized, double-blind study (NCT00065325), postmenopausal women (n = 618) with hormone receptor-positive (HR+), advanced breast cancer received either fulvestrant or exemestane and completed FACT measures monthly for seven months. Cumulative link mixed models (CLMM) were fit to evaluate: (1) the trajectory of the FACT-GP5 and (2) the responsiveness of the FACT-GP5 to CTCAE grade, Eastern Cooperative Oncology Group (ECOG) Performance Status scale, and key side-effects from the FACT. Sensitivity analyses of the missing-at-random (MAR) assumption were conducted.

resultsOdds of reporting worse side-effect bother increased over time. There were positive within-person relationships between level of side-effect bother (FACT-GP5) and severity of other FACT items, as well as ECOG performance status and Common Terminology Criteria for Adverse Events (CTCAE) grade. The number of missing FACT-GP5 assessments impacted the trajectory of the FACT-GP5 but did not impact the relationships between the FACT-GP5 and other items (except for nausea [FACT-GP2]).

conclusionsResults support the responsiveness of the FACT-GP5. Generally speaking, the responsiveness of the FACT-GP5 is robust to missing assessments. Missingness should be considered, however, when evaluating change over time of the FACT-GP5.

trial registrationNCT00065325. TRIAL REGISTRATION YEAR: 2003.

Indexed as

Breast NeoplasmsAgedAndrostadienesDouble-Blind MethodFemaleFulvestrantHumansMiddle AgedPostmenopauseQuality of LifeSurveys and QuestionnairesAndrostadienesexemestaneFulvestrantFACT-GP5Missing dataOncologyPatient-reported outcomesTolerabilityTrajectories

Identifiers

PMID39046616
PMCPMC11452438

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.