Patient- And Observer-Reported Outcomes with Therapeutic Medical Devices for the Management of Adults with Obesity: A Systematic Literature Review
Author(s)
Jhanavi Shenoy B, MPharm1, Vamshi K. Krishna, PHD1, Mohd Kashif Siddiqui, MBA, MPH, PharmD2, Preety Rajora, MPharm2, Chunduri Preethi, MS2, 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: Therapeutic medical devices (TMDs) offer promising intervention for managing obesity, a global health concern linked with impaired health related quality of life (HRQoL). Despite their increasing use, a comprehensive evaluation of impact of TMDs on HRQoL is sparse. This systematic literature review aims to identify various instruments utilized for assessing patient-reported outcomes (PROs) and observer-reported outcomes (ObsROs) with TMDs in adults with obesity.
METHODS: A comprehensive search was conducted across Embase® and MEDLINE® to identify English language studies published in last 10 years. The eligibility criteria included adults with obesity reporting PROs and ObsROs with TMDs for the management of obesity. A single reviewer performed screening and data extractions using predefined criterion. A 100% quality check was performed for data accuracy.
RESULTS: Of 1,687 studies screened, 57 studies met the inclusion criteria. Included studies assessed 14,074 adults predominantly females (45% to 100%) with mean age ranging from 18.2 to 51 years. Most studies were real-world studies (n=37) and randomized controlled trials (n=20). The TMDs evaluated in the studies included adjustable gastric banding (n=26), endoscopic sleeve gastroplasty (n=15), intragastric balloon (n=9), duodenal jejunal bypass liner (n=3), aspiration therapy (n=2), gastric electrical stimulation device (n=2). The identified instruments were mostly disease-specific (n=20) and generic (n=17). Two symptom-specific instruments identified were Beck Depression Inventory-II and Hospital Anxiety and Depression Scale. The most used generic instruments were SF-36 (n=15) and EQ-5D (n=8) whereas, the disease-specific instruments were Impact of Weight on QoL (IWQOL; n=12) and Moorehead-Ardelt QoL Questionnaire II (n=8). All instruments assessed the PROs and none assessed ObsROs.
CONCLUSIONS: Commonly used instruments assessing PROs were SF-36, EQ-5D, and IWQOL. There were no studies assessing ObsROs. Future research is warranted to explore the psychometric properties of the instruments and impact of TMDs in the management of obesity in adults.
METHODS: A comprehensive search was conducted across Embase® and MEDLINE® to identify English language studies published in last 10 years. The eligibility criteria included adults with obesity reporting PROs and ObsROs with TMDs for the management of obesity. A single reviewer performed screening and data extractions using predefined criterion. A 100% quality check was performed for data accuracy.
RESULTS: Of 1,687 studies screened, 57 studies met the inclusion criteria. Included studies assessed 14,074 adults predominantly females (45% to 100%) with mean age ranging from 18.2 to 51 years. Most studies were real-world studies (n=37) and randomized controlled trials (n=20). The TMDs evaluated in the studies included adjustable gastric banding (n=26), endoscopic sleeve gastroplasty (n=15), intragastric balloon (n=9), duodenal jejunal bypass liner (n=3), aspiration therapy (n=2), gastric electrical stimulation device (n=2). The identified instruments were mostly disease-specific (n=20) and generic (n=17). Two symptom-specific instruments identified were Beck Depression Inventory-II and Hospital Anxiety and Depression Scale. The most used generic instruments were SF-36 (n=15) and EQ-5D (n=8) whereas, the disease-specific instruments were Impact of Weight on QoL (IWQOL; n=12) and Moorehead-Ardelt QoL Questionnaire II (n=8). All instruments assessed the PROs and none assessed ObsROs.
CONCLUSIONS: Commonly used instruments assessing PROs were SF-36, EQ-5D, and IWQOL. There were no studies assessing ObsROs. Future research is warranted to explore the psychometric properties of the instruments and impact of TMDs in the management of obesity in adults.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO188
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)