Evidence map›Paper›PMID 24379136›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2014

Measurement properties of the flu-like symptom index from the hepatitis physical symptom severity diary.

Susan Mathias, Ross D Crosby, Martha S Bayliss, Gilbert L'Italien, Sandhya Sapra

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 90% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

5 authors at 3 institutions in 1 country.

Susan MathiasHealth Outcomes Solutions, Winter Park, FL, USA, smathias@healthoutcomessolutions.com.
Ross D Crosby
Martha S Bayliss
Gilbert L'Italien
Sandhya Sapra
Bristol-Myers Squibb (United States) · USHealth Outcomes Solutions (United States) · USNeuropsychiatric Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeChronic Hepatitis C (CHC) Virus infection is a serious health issue in the US. Standard treatment involves peginterferon alpha and ribavirin, often associated with adverse side effects including flu-like symptoms. These adverse effects are common reasons for the discontinuation of treatment and therefore represent a major obstacle in the effective treatment of CHC.

methodsThe Hepatitis Physical Symptom Severity Diary, a newly developed patient-reported outcome measure for assessing physical symptoms in CHC patients, was recently developed. It contains four questions addressing flu-like symptoms [the Flu-Like Symptom Index (FLSI)]. Measurement properties of the FLSI in CHC patients were assessed using data from two randomized clinical trials.

resultsExploratory factor analysis using data from baseline and the last visit while on treatment supported a single-factor solution for the FLSI. Internal reliability and test-retest reliability are acceptable (Cronbach's alpha range 0.73-0.81; intraclass correlation coefficient range 0.85-0.97), and correspondence to several similar constructs was acceptable. The FLSI score was higher among those with investigator-reported flu-like symptoms (mean = 4.1) versus those without (1.4), although not statistically significant (p = 0.12). Responsiveness of the FLSI was moderate, as measured by standardized effect sizes and response means, and the minimum important difference (MID) was estimated at 2.5-3.0 points.

conclusionsWhile additional research should be conducted to evaluate validity with more closely related constructs and to utilize anchor-based methods for estimating the MID, data suggest that the FLSI has acceptable measurement properties and can be an effective tool in assessing flu-like symptoms in CHC patients.

Indexed as

Severity of Illness IndexSickness Impact ProfileAdolescentAdultAgedAntiviral AgentsCohort StudiesDepressionDrug Therapy, CombinationFactor Analysis, StatisticalFatigueFemaleHepacivirusHepatitis C, ChronicHumansInterferon-alphaAntiviral AgentsInterferon-alphaRibavirin

Identifiers

PMID24379136
PMCPMC4031396
OpenAlexW2062296597

What OpenQuestion holds

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LicenceCC BY
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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.