Validity and Reliability of a Novel Multimodal Questionnaire for the Assessment of Abdominal Symptoms in People with Cystic Fibrosis (CFAbd-Score)

Anke Jaudszus (), Elisa Zeman, Tatjana Jans, Elena Pfeifer, Harold Tabori, Christin Arnold, Ruth K. Michl, Michael Lorenz, Natalie Beiersdorf and Jochen G. Mainz
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Anke Jaudszus: Jena University Hospital
Elisa Zeman: Jena University Hospital
Tatjana Jans: Jena University Hospital
Elena Pfeifer: Jena University Hospital
Harold Tabori: Jena University Hospital
Christin Arnold: Jena University Hospital
Ruth K. Michl: Jena University Hospital
Michael Lorenz: Jena University Hospital
Natalie Beiersdorf: Jena University Hospital
Jochen G. Mainz: Jena University Hospital

The Patient: Patient-Centered Outcomes Research, 2019, vol. 12, issue 4, No 7, 419-428

Abstract: Abstract Background and Objective For people with cystic fibrosis, validated patient-reported outcome measures for the assessment of the complex abdominal involvement are lacking. The objective of this study was to examine whether the CFAbd-Score, a novel questionnaire consisting of 28 items, meets the essential requirements (validity and reliability) for a patient-reported outcome measure according to US Food and Drug Administration recommendations. Methods Content validity was assessed by recording the frequencies and severity of symptoms that occurred during the prior 2 weeks in patients with cystic fibrosis (n = 116; aged ≥ 6 years). Comparing the CFAbd-Score results obtained from patients with cystic fibrosis and healthy controls (n = 88), we determined known-groups validity. To explore the structure of the patient-reported outcome measure, a factor analysis was conducted. Internal consistency of the five extracted score domains was assessed using Cronbach’s alpha. For test–retest reliability, a subgroup of patients (n = 43) was reevaluated and intra-class correlation coefficients were determined. Results The CFAbd-Score differentiated patients with cystic fibrosis from healthy controls with a large effect size (17.3 ± 1.1 vs. 8.0 ± 0.7 points; p

Date: 2019
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DOI: 10.1007/s40271-019-00361-2

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