Psychometric evaluation of novel hyperphagia questionnaires in a real-world setting for patients with a rare MC4R pathway disease

Abstract Background There are no validated measures to assess hyperphagia associated with rare MC4R pathway diseases, such as Bardet-Biedl Syndrome (BBS). Symptoms of Hyperphagia© (SoH) and Impacts of Hyperphagia© (IoH) are novel questionnaires designed to assess signs and symptoms of hyperphagia an...

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Main Authors: Jeremy Pomeroy, Usha G. Mallya, Min Yang, Caroline Huber, Alexandra Greatsinger, Ella Hagopian, Andrea M. Haqq
Format: Article
Language:English
Published: BMC 2025-08-01
Series:Orphanet Journal of Rare Diseases
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Online Access:https://doi.org/10.1186/s13023-025-03948-1
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author Jeremy Pomeroy
Usha G. Mallya
Min Yang
Caroline Huber
Alexandra Greatsinger
Ella Hagopian
Andrea M. Haqq
author_facet Jeremy Pomeroy
Usha G. Mallya
Min Yang
Caroline Huber
Alexandra Greatsinger
Ella Hagopian
Andrea M. Haqq
author_sort Jeremy Pomeroy
collection DOAJ
description Abstract Background There are no validated measures to assess hyperphagia associated with rare MC4R pathway diseases, such as Bardet-Biedl Syndrome (BBS). Symptoms of Hyperphagia© (SoH) and Impacts of Hyperphagia© (IoH) are novel questionnaires designed to assess signs and symptoms of hyperphagia and their impacts on patients and caregivers. We evaluated the psychometric performance of the caregiver-versions of the SoH: Caregiver (Observer-reported) and IoH: Caregiver (Observer-reported and Self-reported subscales). Results Reliability and validity were evaluated using data from a multi-country cross-sectional survey of adult caregivers of patients with BBS experiencing hyperphagia and obesity. Other instruments included were Impact of Weight on Quality of Life (IWQOL)-Kids (Parent Proxy), PROMIS Scale Global Health of Caregiver, Revised Impact on Family Scale (RIOFS), and Work Productivity and Activity Impairment. 242 eligible caregivers completed the survey. Exploratory factor analysis identified 1 factor per subscale. Strong internal consistency was observed for IoH: Caregiver (Observer) (Cronbach’s a = 0.66) and IoH: Caregiver (Self) (a = 0.72) and moderate for SoH: Caregiver (Observer) (a = 0.40). Moderate-to-strong correlations were observed with school days missed and all domains of IWQOL-Kids except Physical Comfort (range = 0.315–0.573, p’s < 0.001). Known-groups indicated significantly worse SoH: Caregiver subscores for patients using appetite suppressants or implementing more weight management approaches (6–10 vs. ≤5 or > 10). Caregivers reporting greater strain on RIOFS items and worse mental health had worse IoH subscores. Conclusions The SoH: Caregiver and IoH: Caregiver demonstrated preliminary validity, reliability, and consistency in a real-world setting. Research is underway to further validate these measures for use in clinical trials for BBS and other MC4R pathway-related diseases associated with obesity.
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spelling doaj-art-2c1c9d2fb5bf4dc793a371ff5749671c2025-08-24T11:49:59ZengBMCOrphanet Journal of Rare Diseases1750-11722025-08-012011910.1186/s13023-025-03948-1Psychometric evaluation of novel hyperphagia questionnaires in a real-world setting for patients with a rare MC4R pathway diseaseJeremy Pomeroy0Usha G. Mallya1Min Yang2Caroline Huber3Alexandra Greatsinger4Ella Hagopian5Andrea M. Haqq6Marshfield Clinic Research InstituteRhythm Pharmaceuticals, Inc.Analysis Group, Inc.Rhythm Pharmaceuticals, Inc.Analysis Group, Inc.Analysis Group, Inc.Division of Pediatric Endocrinology, University of AlbertaAbstract Background There are no validated measures to assess hyperphagia associated with rare MC4R pathway diseases, such as Bardet-Biedl Syndrome (BBS). Symptoms of Hyperphagia© (SoH) and Impacts of Hyperphagia© (IoH) are novel questionnaires designed to assess signs and symptoms of hyperphagia and their impacts on patients and caregivers. We evaluated the psychometric performance of the caregiver-versions of the SoH: Caregiver (Observer-reported) and IoH: Caregiver (Observer-reported and Self-reported subscales). Results Reliability and validity were evaluated using data from a multi-country cross-sectional survey of adult caregivers of patients with BBS experiencing hyperphagia and obesity. Other instruments included were Impact of Weight on Quality of Life (IWQOL)-Kids (Parent Proxy), PROMIS Scale Global Health of Caregiver, Revised Impact on Family Scale (RIOFS), and Work Productivity and Activity Impairment. 242 eligible caregivers completed the survey. Exploratory factor analysis identified 1 factor per subscale. Strong internal consistency was observed for IoH: Caregiver (Observer) (Cronbach’s a = 0.66) and IoH: Caregiver (Self) (a = 0.72) and moderate for SoH: Caregiver (Observer) (a = 0.40). Moderate-to-strong correlations were observed with school days missed and all domains of IWQOL-Kids except Physical Comfort (range = 0.315–0.573, p’s < 0.001). Known-groups indicated significantly worse SoH: Caregiver subscores for patients using appetite suppressants or implementing more weight management approaches (6–10 vs. ≤5 or > 10). Caregivers reporting greater strain on RIOFS items and worse mental health had worse IoH subscores. Conclusions The SoH: Caregiver and IoH: Caregiver demonstrated preliminary validity, reliability, and consistency in a real-world setting. Research is underway to further validate these measures for use in clinical trials for BBS and other MC4R pathway-related diseases associated with obesity.https://doi.org/10.1186/s13023-025-03948-1HyperphagiaMC4R pathway diseasesBardet-Biedl syndromeObesityPsychometric evaluationValidity
spellingShingle Jeremy Pomeroy
Usha G. Mallya
Min Yang
Caroline Huber
Alexandra Greatsinger
Ella Hagopian
Andrea M. Haqq
Psychometric evaluation of novel hyperphagia questionnaires in a real-world setting for patients with a rare MC4R pathway disease
Orphanet Journal of Rare Diseases
Hyperphagia
MC4R pathway diseases
Bardet-Biedl syndrome
Obesity
Psychometric evaluation
Validity
title Psychometric evaluation of novel hyperphagia questionnaires in a real-world setting for patients with a rare MC4R pathway disease
title_full Psychometric evaluation of novel hyperphagia questionnaires in a real-world setting for patients with a rare MC4R pathway disease
title_fullStr Psychometric evaluation of novel hyperphagia questionnaires in a real-world setting for patients with a rare MC4R pathway disease
title_full_unstemmed Psychometric evaluation of novel hyperphagia questionnaires in a real-world setting for patients with a rare MC4R pathway disease
title_short Psychometric evaluation of novel hyperphagia questionnaires in a real-world setting for patients with a rare MC4R pathway disease
title_sort psychometric evaluation of novel hyperphagia questionnaires in a real world setting for patients with a rare mc4r pathway disease
topic Hyperphagia
MC4R pathway diseases
Bardet-Biedl syndrome
Obesity
Psychometric evaluation
Validity
url https://doi.org/10.1186/s13023-025-03948-1
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