Evidence map›Paper›PMID 31111255›Full record

ArticleJournal of patient-reported outcomes2019

Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis.

David Cella, Hilary Wilson, Huda Shalhoub, Dennis A Revicki, Joseph C Cappelleri, Andrew G Bushmakin, Elizabeth Kudlacz, Ming-Ann Hsu

2 registry-linked trialsAbstract readCorrected and Republished Article
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of patient-reported outcomes, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing 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.

NCT01877668 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorPfizerRan2014 to 2015Enrolled422ConditionsPsoriatic ArthritisArmsTofacitinib 5 mg BID, Tofacitinib 10 mg BID, Adalimumab, Placebo
NCT01882439 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor

TypeinterventionalSponsorPfizerRan2013 to 2016Enrolled395ConditionsPsoriatic ArthritisArmsTofacitinib, Placebo
3 · Its place in the literature

Who cites it

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

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

David CellaDepartment of Medical Social Sciences, Northwestern University, Chicago, IL, USA. d-cella@northwestern.edu.
Hilary WilsonEvidera, Bethesda, MD, USA.
Huda ShalhoubEvidera, Waltham, MA, USA.
Dennis A RevickiEvidera, Bethesda, MD, USA.
Joseph C CappelleriPfizer Inc, Groton, CT, USA.
Andrew G BushmakinPfizer Inc, Groton, CT, USA.
Elizabeth KudlaczPfizer Inc, Groton, CT, USA.
Ming-Ann HsuPfizer Inc, Groton, CT, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the measurement properties (e.g., content validity, reliability, and ability to detect change) of the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale in patients with active psoriatic arthritis (PsA).

methodsOne-on-one semi-structured qualitative interviews with adult patients with active PsA evaluated the content validity of FACIT-Fatigue. Quantitative measurement properties were evaluated using data from phase III tofacitinib randomized controlled trials (RCTs) in PsA: OPAL Broaden (NCT01877668) and OPAL Beyond (NCT01882439).

resultsOf 12 patients included in the qualitative study, 2 (17%) had mild, 8 (67%) had moderate, and 2 (17%) had severe PsA disease activity; 7 (58%) attributed fatigue to PsA, and 7 (58%) rated fatigue as important or extremely important. Most patients considered the FACIT-Fatigue items relevant to their PsA experience, and understood item content and response options as intended. In the psychometric analysis of RCT data, a second-order confirmatory factor model fit the data well (Bentler's Comparative Fit Index ≥0.92). FACIT-Fatigue demonstrated good internal consistency (Cronbach's coefficient α ≥ 0.90), test-retest reliability (Intraclass Correlation Coefficient ≥ 0.80) and a strong correlation with SF-36 Vitality (r > 0.80). A robust relationship between disease activity (based on Patient's Global Assessment of Psoriasis and Arthritis) and FACIT-Fatigue was observed (effect sizes > 1.4), with clinically important difference for the FACIT-Fatigue total score estimated as 3.1 points, and the responder definition estimated as a 4-point improvement for FACIT-Fatigue total score.

conclusionFatigue was confirmed to be an important symptom to patients with PsA, and FACIT-Fatigue was found to be a reliable and valid measure in this population.

Indexed as

Content validityFACIT-FatiguePsoriatic arthritisPsychometric propertiesTofacitinib

Identifiers

PMID31111255
PMCPMC6527714

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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.