Original Title: Valoración de la composición corporal mediante bioimpedancia eléctrica para la evaluación del sobrepeso y la obesidad en atención primaria

Authors' objectives: The main objective of this Health Technology Assessment (HTA) report is to evaluate the safety, clinical effectiveness, and cost-effectiveness, as well as the ethical, legal, organizational, and social aspects of using BIA to assess overweight and obesity, with the aim of informing the decision to include this technology in the common services portfolio of the National Health System (SNS) for use in primary care.

Authors' results and conclusions: RESULTS EFFECTIVENESS AND SAFEY A total of 3,757 unique references were retrieved from the database searches. The evaluation of effectiveness and safety was based on data from 19 longitudinal studies (sample size: 891,836 patients) published between 1996 and 2024 that analyzed the association between BIA and anthropometric measures with the risk of future health events (mortality, ischemic heart disease, and other cardiovascular events, prostate cancer, kidney disease, asthma, and cataracts). The overall quality of the evidence was considered low. No studies were identified evaluating key outcomes such as quality of life and diabetes mellitus. Regarding BIA results, no significant associations were observed between body fat percentage (BFP, increase of 1 standard deviation [SD], 5%), lean mass (LM, increase of 1 SD, 5 kg), or fat mass (FM, increase of 1 SD, 5 kg) and key outcomes. Regarding anthropometric measurement results, several significant associations were observed: - BMI increase (1 SD, 5 kg/m²) was associated with a 14% increase in the risk of cardiovascular events (HR=1.14; 95% CI: 1.02–1.28; p=0.02; I²=89%; k=3 studies, 5 cohorts). Specifically, it was associated with an 18% increase in ischemic heart disease risk (HR=1.18; 95% CI: 1.06–1.32; p=0.003; I²=71%; k=1 study, 3 cohorts) and a 22% increase in cardiovascular events (HR=1.22; 95% CI: 1.08–1.39; p=0.002; k=1 study). - Waist circumference (WC) increase (1 SD, 5 cm) was associated with a 0.5% increase in all-cause mortality risk (HR=1.05; 95% CI: 1.02–1.07; p=0.0006; I²=0%; k=2 studies, 3 cohorts), a 16% increase in ischemic heart disease risk (HR=1.16; 95% CI: 1.07–1.26; p=0.003; I²=0%; k=1 study, 2 cohorts), and a 21% increase in cardiovascular events risk (HR=1.21; 95% CI: 1.09–1.35; p=0.0006; k=1 study). - Waist-hip ratio (WHR) increase (1 SD, 0.05) was associated with a 10% increase in all-cause mortality risk (HR=1.10; 95% CI: 1.05–1.17; p=0.0003; I²=16%; k=1 study, 2 cohorts) and a 16% increase in ischemic heart disease risk (HR=1.16; 95% CI: 1.07–1.25; p=0.0003; I²=0%; k=1 study, 2 cohorts). - Waist to Height Ratio (WHtR) increase (1 SD, 0.05) was associated with an 8% increase in all-cause mortality risk (HR=1.08; 95% CI: 1.04–1.12; p<0.0001; I²=0%; k=2 studies, 3 cohorts) and a 26% increase in diabetes-related mortality (HR=1.26; 95% CI: 1.07–1.48; p=0.006; k=1 study). It was also associated with a 23% increase in cardiovascular event risk (HR=1.23; 95% CI: 1.21–1.25; p<0.0001; I²=0%; k=2 studies, 5 cohorts), a 23% increase in ischemic heart disease risk (HR=1.23; 95% CI: 1.20–1.26; p<0.0001; I²=0%; k=2 studies, 3 cohorts), a 22% increase in stroke risk (HR=1.22; 95% CI: 1.18–1.26; p<0.0001; k=1 study), and a 24% increase in acute myocardial infarction risk (HR=1.24; 95% CI: 1.21–1.27; p<0.0001; k=1 study). - Skinfold thickness (ST) increase (1 SD, 5 mm) was associated with a 3% reduction in all-cause mortality risk (HR=0.97; 95% CI: 0.94–0.99; p=0.01; I²=0%; k=3 studies). COST ANALYSIS The SR did not identify any economic evaluations that met the established requirements. The cost analysis showed that the annual cost for a primary care center acquiring a BIA device with the specified features would be €1,600. The cost per patient would vary depending on the number of people treated; for example, with seven weekly patients, the cost would be €4.40 per patient. In a scenario including all primary care centers, the gross budget impact for the SNS over five years would be €218,814,851. If the equipment were installed only in health centers, excluding local clinics, the impact would be reduced to €51,045,612 over the same period. ETHICAL, LEGAL, ORGANIZATIONAL AND SOCIAL ASPECTS The systematic review of ethical, legal, organizational, and social aspects did not identify studies meeting the established inclusion criteria. CONCLUSIONS Based on the SR on effectiveness, safety, and cost-effectiveness, as well as the economic evaluation and analysis of ethical, legal, organizational, and social aspects, the following conclusions can be drawn regarding the inclusion of BIA for the assessment of overweight and obesity in primary care: • The best available evidence on clinical effectiveness and safety comes from 19 longitudinal observational studies involving 891,836 participants. These studies assess the association between methods for evaluating overweight/obesity (BIA and anthropometric measures) and future health outcomes. • No statistically significant associations were identified between BIA measurements (BFP, LM, or FM increase) and future health outcomes such as all-cause mortality, cardiovascular mortality, diabetes-related mortality, or cardiovascular events (ischemic heart disease, acute myocardial infarction, stroke). Evidence quality: Low ⊕⊕⊖⊖ to Moderate ⊕⊕⊕⊖. • Significant associations were observed for anthropometric measurements: - BMI increase by 5 kg/m² was associated with a 14% increase in cardiovascular events risk, 18% increase in ischemic heart disease risk, and 22% increase in cardiovascular morbidity and mortality risk. - WHR increase by 0.05 was associated with a 10% increase in all-cause mortality risk, 16% increase in cardiovascular events risk, and 16% increase in ischemic heart disease risk. - WHtR increase by 0.05 was associated with a 9% increase in all-cause mortality risk, 26% increase in diabetes-related mortality, 23% increase in cardiovascular events risk, 23% increase in ischemic heart disease risk, 22% increase in stroke risk, and 24% increase in acute myocardial infarction risk. - WC increase by 5 cm was associated with a 5% increase in all-cause mortality risk, 16% increase in ischemic heart disease risk, and 21% increase in cardiovascular events risk. - ST increase by 5 mm was associated with a 3% reduction in all-cause mortality risk. • No prior economic evaluations on the use of BIA in overweight or obese individuals were identified. • The estimated annual cost for acquiring, using, and maintaining a BIA device in a primary care center is €1,600, including acquisition, installation, maintenance, and software over 15 years. • The estimated budget impact is €219 million over five years if each primary care center is equipped with a BIA device. Excluding local clinics, the impact would be €51 million over five years. • No studies analyzing the ethical, legal, organizational, and social aspects of the evaluated technology were identified, highlighting the need for future research to address these dimensions.

Authors' methods: EFFECTIVENESS AND SAFETY A systematic review (SR) of the published scientific literature was conducted. Searches were performed in the following electronic databases without restrictions on date or language: MEDLINE (OVID), Embase (Elsevier), CENTRAL (Cochrane Library-Wiley), CINAHL (EBSCOhost), and Web of Science Core Collection (Clarivate Analytics) up to October 8, 2024. Randomized clinical trials were selected, followed by non-randomized trials, and then longitudinal observational studies (case-control and cohort studies). Key outcomes considered were mortality, quality of life, ischemic heart disease, acute myocardial infarction, stroke, and diabetes mellitus. The risk of bias was assessed using the ROBINS-E tool from the Cochrane Collaboration. Where possible, quantitative synthesis of results was performed through meta-analysis using Review Manager version 5.4 and R (Comprehensive R Archive Network version 4.2.2). The quality of the evidence and the strength of the recommendations were graded using the methodology of the international Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group. ECONOMIC ANALYSIS / COST-EFFECTIVENESS The SR included searches for economic evaluations (alongside primary studies or models) reporting any of the following outcomes: incremental cost-effectiveness ratio (ICER), costs expressed in monetary units, and benefits expressed in quality-adjusted life years (QALYs), life years gained (LYG), monetary units, or any of the effectiveness outcomes mentioned. The methodological quality was assessed using Drummond et al.'s checklist and/or OSTEBA’s Critical Reading Sheet FLC 3.0, along with data extraction and a narrative synthesis of results. Additionally, a partial economic evaluation was conducted estimating the direct costs related to BIA from a primary care center perspective, including acquisition, installation, maintenance, and specific software costs. Finally, the gross budget impact of including this technology in the SNS was estimated over a five-year period, assuming one BIA device per center (health center or local clinic). ORGANIZATIONAL, ETHICAL, LEGAL AND SOCIAL ASPECTS The evaluation of these aspects was based on the same population, intervention, and comparison described for the effectiveness and cost-effectiveness assessment. Searches were conducted in MEDLINE (Ovid), Embase (Elsevier), and CINAHL (EBSCOhost) until September 2024. A narrative synthesis of the results was planned, considering criteria of relevance and consistency of the results.

Project Status: Completed

Year Published: 2024

URL for published report: https://sescs.es/en/bioimpedance-for-evaluation-overweight-obesity-primary-care/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es