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

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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.

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Notes

  1. HDSIM™ is a trademark of Cristcot LLC.

  2. The “problematic” item removed from the Bowel Health Impact scale was removed in this series of analyses.

  3. 6 life impact, 8 mental health impact, and 5 bowel health/problems.

  4. 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.

Abbreviations

CFA:

Confirmatory factor analysis

CORECTS:

COloRectal Evaluation of Clinical Therapeutics Scale

CTT:

Classical Test Theory

EFA:

Exploratory factor analysis

ES:

Effect size

HD:

Hemorrhoid Disease

HDSIM:

Hemorrhoid Disease Symptom Impact Measure

HIPAA:

Health Insurance Portability and Accountability Act

IRT:

Item Response Theory

PRO:

Patient-reported outcome

PROMIS:

Patient-Reported Outcome Measurement Information System

QOL:

Quality of life

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Acknowledgements

We are grateful to Drs. Bruce D. Rapkin and Maria Orlando Edelen for helpful input during data analysis; to Jennifer Davagian and Dr. Mukul Agrawal for input on an earlier draft of the manuscript; to Rare Patient Voice, LLC, and IPSOS-Insight, LLC, for facilitating access to participants for the cognitive interviews and online survey, respectively; and to the participants themselves who provided data for this project.

Funding

This work was funded by Cristcot, LLC.

Author information

Authors and Affiliations

  1. DeltaQuest Foundation, Inc., 31 Mitchell Road, Concord, MA, 01742 , USA

    Carolyn E. Schwartz & Katrina Borowiec

  2. Departments of Medicine and Orthopaedic Surgery, Tufts University Medical School, Boston, MA, USA

    Carolyn E. Schwartz

  3. Department of Measurement, Evaluation, Statistics, & Assessment, Boston College Lynch School of Education and Human Development, Chestnut Hill, MA, USA

    Katrina Borowiec

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Contributions

CES: designed the research study. CES and KB: analyzed the data. CES: wrote the paper, and KB edited the manuscript. Both authors read and approved the final manuscript.

Corresponding author

Correspondence to Carolyn E. Schwartz.

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Data availability

The study data are confidential and thus not able to be shared.

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Both authors declare that they have no potential conflicts of interest and report no disclosures.

Ethical approval

The protocol was reviewed and approved by the WCG Independent Review Board (WCGIRB #20225513).

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All participants provided informed consent prior to beginning the survey.

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All participants agreed to their data being published in a journal article.

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Schwartz, C.E., Borowiec, K. Development and validation of the HDSIM™ assessment system: a measure of hemorrhoid disease symptom impact. Qual Life Res (2024). https://doi.org/10.1007/s11136-024-03619-x

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