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19-03-2024

Development and validation of the HDSIM™ assessment system: a measure of hemorrhoid disease symptom impact

Auteurs: Carolyn E. Schwartz, Katrina Borowiec

Gepubliceerd in: Quality of Life Research

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Abstract

Background

Hemorrhoid disease (HD) affects 10 million people in the US at any given time, and 50% of the US population will develop symptomatic hemorrhoids during their lifetime. Approximately 60% of people with hemorrhoids experience symptoms. Despite its prevalence and impact on quality of life, the existing patient-reported outcome measures of HD have not been validated using standard psychometric methods. The present study thus aimed to develop the Hemorrhoid Disease Symptom Impact Measure™ (HDSIM™) assessment system, a patient-reported measure of HD symptoms and impact for use in HD clinical research.

Methods

On the basis of results from qualitative cognitive interviews, we generated the conceptual model and item pool. A cross-sectional web-based survey (n = 1066) was done, including a randomly selected retest subsample (n = 100) 1–2 weeks later. The survey sample was selected to be evenly distributed across mild, moderate, and severe levels of disease and to be nationally representative of the general United States population in terms of race, gender, and region. Existing disease-specific measures of symptoms and generic measures of quality of life and well-being were compared to the new tool for construct validation.

Results

The HDSIM system includes 38 items representing six conceptual-model-driven subscales, aligning with the conceptual model: Symptoms at Worst, Symptoms at Best, Bowel Health Impact, Life Impact, Mental Health Impact, and Manageability. Psychometric analyses documented that the subscales had excellent internal consistency reliability, cross-sectional construct validity (i.e., convergent and divergent validity, known groups validity), test–retest stability, and longitudinal construct validity (i.e., responsiveness).

Conclusion

The HDSIM system is fit for purpose in hemorrhoid disease clinical trials research. Since measures are validated in an iterative manner over many studies and over time, the present study results should be considered preliminary.
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Voetnoten
1
HDSIM™ is a trademark of Cristcot LLC.
 
2
See Supplementary Text for additional information.
 
3
Due to manuscript-length constraints and to copyright-protection consideration, it is not possible to publish the full details of the many analyses done. A full detailed report is available from the corresponding author on reasonable request and was provided during the review process.
 
4
The “problematic” item removed from the Bowel Health Impact scale was removed in this series of analyses.
 
5
6 life impact, 8 mental health impact, and 5 bowel health/problems.
 
6
In our SPSS data set, a response of “Not at all” was coded as “1” and “Very much” was coded as “5,” whereas these same responses were coded as “0” and “4,” respectively in IRTPRO.
 
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Metagegevens
Titel
Development and validation of the HDSIM™ assessment system: a measure of hemorrhoid disease symptom impact
Auteurs
Carolyn E. Schwartz
Katrina Borowiec
Publicatiedatum
19-03-2024
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-024-03619-x