Evidence map›Paper›PMID 30825026›Full record

ArticleSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2019

Validity and performance of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) among advanced urothelial cancer patients.

Arnold Degboe, Cristina Ivanescu, Jeffrey M Rohay, Ralph R Turner, David Cella

Open access · hybridAbstract readEvaluation StudyMulticenter StudyValidation Study
In one paragraph

Article in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 4% of its field
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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

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  15. Bladder cancer.Nature reviews. Disease primers · 2023
    Review
  16. 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 · 2023
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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

5 authors at 3 institutions in 1 country.

Arnold DegboeAstraZeneca, One MedImmune Way, Gaithersburg, MD, 20878, USA.
Cristina IvanescuIQVIA, Diane Bldg., Office 314, Herikerbergweg 181, 1101 CN, Amsterdam-Zuidoost, The Netherlands.
Jeffrey M RohayIQVIA, 26th Floor, 485 Lexington Ave., New York, NY, 10017, USA.
Ralph R TurnerScotch Mountain Associates, LLC, 13248 Fieldstone Way, Gainesvillle, VA, 20155, USA.
David CellaFeinberg School of Medicine, Northwestern University, 633 N. Saint Clair St., 19th Floor, Chicago, IL, 60611, USA. d-cella@northwestern.edu.
AstraZeneca (United States) · USIQVIA (United States) · USNorthwestern University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe recent increase in emerging novel therapies in the bladder cancer therapeutic area has increased the need for fit-for-purpose patient-reported outcome (PRO) measures for these patients. This study evaluates the psychometric properties of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) in 182 patients with advanced urothelial cancer (UC) and fills an important gap by demonstrating its validity for use in clinical trials.

methodsData were collected as part of a multicentre, open-label study of durvalumab in patients with inoperable or metastatic solid tumours. Psychometric properties evaluated include item and subscale characteristics (including correlation analysis), reliability (estimated using Cronbach's α), validity (by independent sample t test), responsiveness (using mixed models with repeated measures), and clinically meaningful changes using both anchor-based and distribution-based methods.

resultsOne hundred and seventy-two patients completed the FACT-Bl questionnaire at baseline. Many individual items had floor or ceiling effects indicative of minimal symptoms and high functioning. The psychometric properties of the existing established scales were assessed and found to range from acceptable to very good. Internal consistency (most Cronbach's α coefficients range 0.66-0.85) and stability (test-retest reliability) generally exceeded standards for good reliability (most estimated intraclass correlations [ICCs] exceeded 0.70, although ICCs for some items [e.g. emotional well-being, ICC 0.58; social well-being, ICC 0.66] were lower than 0.70). Evidence for known-group validity of relevant FACT-Bl subscales and total score was demonstrated by significant differences between groups defined by baseline tumour burden and quality of life scores (difference of FACT-Bl total between low/high tumour burden groups 11.72 (p = 0.001); difference between low/high QoL scores groups 30.51 (p < 0.0001)). The FACT-Bl subscale and total scores were responsive to changes in bladder cancer symptom severity. Clinically meaningful changes in FACT-Bl scores were estimated.

conclusionsResults support the use of the FACT-Bl within this patient population in future clinical research.

Indexed as

Patient Reported Outcome MeasuresSurveys and QuestionnairesAdultAgedAged, 80 and overAntibodies, MonoclonalFemaleHumansMaleMiddle AgedPsychometricsQuality of LifeReproducibility of ResultsUrinary Bladder NeoplasmsUrotheliumAntibodies, MonoclonaldurvalumabHealth-related quality of lifePatient-reported outcome measuresPsychometricsUrinary bladder neoplasmsValidation studies as topic

Identifiers

PMID30825026
PMCPMC6803583
OpenAlexW2919903985

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.