Hemorrhoid Disease Symptom and Impact Measure Validation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current patient-reported outcome measures for hemorrhoid disease (HD) lack validation using standard psychometric methods, failing to accurately assess the severity and impact of HD on quality of life.
Innovation Solution
The Hemorrhoid Disease Symptom and Impact Measure (HD-SIM) Assessment System, which includes 38 items across six subscales, was developed through a qualitative phase of cognitive interviews and a quantitative phase of a web-based survey. This system provides a validated method for assessing HD symptoms and their impact on patients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If existing patient-reported outcome measures for hemorrhoid disease are used, then assessment of HD symptoms is available, but the measures lack validation using standard psychometric methods and fail to accurately assess severity and impact on quality of life
Solution Approach 1:
The patent applies preliminary action by conducting extensive psychometric validation studies before the measure can be used for clinical assessment. This includes cognitive interviewing with patients to refine item wording, establishing internal consistency reliability through Cronbach's alpha analysis, and demonstrating construct validity through factor analysis. These preliminary validation actions ensure the measure achieves both measurement precision and reliability before clinical deployment.
2Measurement precision
If a comprehensive PROM with multiple questions about symptoms, bowel health, manageability, mental health impact, and life impact is administered, then accurate health assessment is achieved, but the complexity of the assessment increases
Solution Approach 1:
The patent applies segmentation by dividing the comprehensive PROM into six distinct subscales: Symptoms at Worst, Symptoms at Best, Bowel Health Problems, Life Impact, Mental Health Impact, and Manageability. Each subscale targets specific domains of hemorrhoid disease impact. This segmentation allows the assessment to maintain comprehensive measurement precision while organizing complexity into manageable, clinically interpretable components that can be administered and analyzed systematically.
Data Source
AI summary
Disclosed is a method of assessing health of a patient that includes presenting a patient reported outcome measure (PROM) for at least partial completion by the patient about an illness, injury, or condition. The PROM including questions extending beyond a question about a symptom or sign of the illness, injury, or condition. The method further includes performing a calculation as a function of responses to the questions to assess the health of the patient. A particular embodiment includes correlating a result of the calculation with an objective measurement of the symptom or sign to produce patient reported outcome information for assessing the health of the patient.