Patient- and Observer-Reported Outcomes with Therapeutic Medical Devices in Children and Adolescents with Obesity: A Systematic Literature Review
Author(s)
Jhanavi Shenoy B, MPharm1, Vamshi Krishna, PHD1, Preety Rajora, MPharm2, Chunduri Preethi, MS2, Mohd Kashif Siddiqui, MBA, MPH, PharmD2, Jatin Gupta, MPharm2;
1Manipal College of Pharmaceutical Science, Pharamaceutics, Manipal, India, 2EBM Health Consultants, New Delhi, India
1Manipal College of Pharmaceutical Science, Pharamaceutics, Manipal, India, 2EBM Health Consultants, New Delhi, India
OBJECTIVES: Obesity (BMI≥30 Kg/m2) affects one-fifth of children and adolescents globally, significantly impairing their health-related quality of life (HRQoL). While surgery, medicine, and lifestyle modifications are common treatment options, therapeutic medical devices (TMDs) present an effective alternative. This systematic literature review evaluates the instruments used for assessing patient-reported outcomes (PROs) and observer-reported outcomes (ObsROs) with TMDs in children and adolescent with obesity.
METHODS: Comprehensive searches were conducted in EMBASE® and MEDLINE® for English language studies published in last 10 years. Eligibility criteria included studies on children and adolescents with obesity that reported PROs and ObsROs with TMDs for obesity management. A single reviewer screened studies and extracted data using a predefined criterion, with a 100% quality check performed for data accuracy.
RESULTS: Of the 1,687 studies screened, six studies met the inclusion criteria. These studies predominantly enrolled females (50% to 86%), with mean age ranging from 15 to 17.23 years. Five were real-world studies and one was non-randomised controlled trial. Evaluated TMDs included laparoscopic adjustable gastric band (n=4), duodenal-jejunal bypass liner (n=1), and intragastric balloon (n=1). Nine instruments were identified, including four generic, two domain-specific, and three disease-specific. The generic instruments included the SF-36 (n=2), Youth Self Report (n=1), Pediatric QoL Inventory 4.0 (Peds-QoLI; n=1), and Multidimensional Body-Self Relations Questionnaire-Appearance Scales (n=1). Domain-specific instruments were Children and Youth Physical Self-Perception Profile (n=1) and Physical Activity Questionnaire (n=1). Disease-specific instruments included the Impact of Weight on QoL (IWQoL; n=2), Bariatric Analysis and Reporting Outcome System Questionnaire (n=1) and Eating Disorder Examination Questionnaire (n=1). All instruments assessed PROs, while Peds-QoLI assessed both PROs and ObsROs.
CONCLUSIONS: This review underscores the limited evidence on HRQoL instruments for PROs and ObsROs with TMDs in children and adolescent with obesity. Further research is needed to understand the impact of TMDs in the management of obesity in children and adolescents.
METHODS: Comprehensive searches were conducted in EMBASE® and MEDLINE® for English language studies published in last 10 years. Eligibility criteria included studies on children and adolescents with obesity that reported PROs and ObsROs with TMDs for obesity management. A single reviewer screened studies and extracted data using a predefined criterion, with a 100% quality check performed for data accuracy.
RESULTS: Of the 1,687 studies screened, six studies met the inclusion criteria. These studies predominantly enrolled females (50% to 86%), with mean age ranging from 15 to 17.23 years. Five were real-world studies and one was non-randomised controlled trial. Evaluated TMDs included laparoscopic adjustable gastric band (n=4), duodenal-jejunal bypass liner (n=1), and intragastric balloon (n=1). Nine instruments were identified, including four generic, two domain-specific, and three disease-specific. The generic instruments included the SF-36 (n=2), Youth Self Report (n=1), Pediatric QoL Inventory 4.0 (Peds-QoLI; n=1), and Multidimensional Body-Self Relations Questionnaire-Appearance Scales (n=1). Domain-specific instruments were Children and Youth Physical Self-Perception Profile (n=1) and Physical Activity Questionnaire (n=1). Disease-specific instruments included the Impact of Weight on QoL (IWQoL; n=2), Bariatric Analysis and Reporting Outcome System Questionnaire (n=1) and Eating Disorder Examination Questionnaire (n=1). All instruments assessed PROs, while Peds-QoLI assessed both PROs and ObsROs.
CONCLUSIONS: This review underscores the limited evidence on HRQoL instruments for PROs and ObsROs with TMDs in children and adolescent with obesity. Further research is needed to understand the impact of TMDs in the management of obesity in children and adolescents.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO189
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)