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Respir Res. 2019 Mar 1;20(1):47. doi: 10.1186/s12931-019-1010-5.

Psychometric properties and minimal important differences of SF-36 in Idiopathic Pulmonary Fibrosis.

Author information

1
Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Member of the German Center for Lung Research (DZL), Comprehensive Pneumology Center Munich (CPC-M), Neuherberg, Germany. sabine.witt@helmholtz-muenchen.de.
2
European IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
3
Universities of Giessen and Marburg Lung Center (UGMLC), Member of the German Center for Lung Research (DZL), Giessen, Marburg, Germany.
4
Hospital Clinico San Carlos, Madrid, Spain.
5
Department of Pulmonology, Semmelweis University, Budapest, Hungary.
6
Reference Center for Rare Pulmonary Diseases, Centre Hospitalier Universitaire Dijon-Bourgogne, INSERMU1231, Université Bourgogne/Franche-Comté, Dijon, France.
7
Department of Clinical and Molecular Biomedicine, Università degli Studi di Catania, Catania, Italy.
8
Interstitial Lung Disease Unit, Royal Brompton Hospital, London, UK.
9
First Faculty of Medicine, Thomayer University Hospital Prague, Prague, Czech Republic.
10
Ospedale San Gerardo, Monza, Italy.
11
Department of Thoracic Surgery, Vienna University Hospital, Vienna, Austria.
12
Cardio-Pulmonary Institute (CPI), EXC 2026, Project ID: 390649896, Justus-Liebig University Giessen , Giessen, Germany.
13
Institut National de la Santé et de la Recherche Médicale (INSERM 700), Hôpital Bichat, Service de Pneumologie, Paris, France.
14
Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Member of the German Center for Lung Research (DZL), Comprehensive Pneumology Center Munich (CPC-M), Neuherberg, Germany.
15
Ludwig-Maximilians-University, Munich Center of Health Sciences, Munich, Germany.
16
AGAPLESION Lung Clinic Waldhof-Elgershausen, Greifenstein, Germany.

Abstract

BACKGROUND:

Idiopathic pulmonary fibrosis (IPF) is a rare disease with a median survival of 3-5 years after diagnosis with limited treatment options. The aim of this study is to assess the psychometric characteristics of the Short Form 36 Health Status Questionnaire (SF-36) in IPF and to provide disease specific minimally important differences (MID).

METHODS:

Data source was the European IPF Registry (eurIPFreg). The psychometric properties of the SF-36 version 2 were evaluated based on objective clinical measures as well as subjective perception. We analysed acceptance, feasibility, discrimination ability, construct and criterion validity, responsiveness and test-retest-reliability. MIDs were estimated via distribution and anchor-based approaches.

RESULTS:

The study population included 258 individuals (73.3% male; mean age 67.3 years, SD 10.7). Of them 75.2% (194 individuals) had no missing item. The distribution of several items was skewed, although floor effect was acceptable. Physical component score (PCS) correlated significantly and moderately with several anchors, whereas the correlations of mental component score (MCS) and anchors were only small. The tests showed mainly significant lower HRQL in individuals with long-term oxygen therapy. Analyses in stable individuals did not show significant changes of HRQL except for one dimension and anchor. Individuals with relevant changes of the health status based on the anchors had significant changes in all SF-36 dimensions and summary scales except for the dimension PAIN. PCS and MCS had mean MIDs of five and six, respectively. Mean MIDs of the dimensions ranged from seven to 21.

CONCLUSION:

It seems that the SF-36 is a valid instrument to measure HRQL in IPF and so can be used in RCTs or individual monitoring of disease. Nevertheless, the additional evaluation of longitudinal aspects and MIDs can be recommended to further analyse these factors. Our findings have a great potential impact on the evaluation of IPF patients.

TRIAL REGISTRATION:

The eurIPFreg and eurIPFbank are listed in https://clinicaltrials.gov ( NCT02951416 ).

KEYWORDS:

Idiopathic pulmonary fibrosis; Patient-reported outcome; Quality of life; Rare diseases

PMID:
30823880
DOI:
10.1186/s12931-019-1010-5
Free PMC Article

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