Medico-economics and QoL of Obese Patients Followed by Medical Analysis Laboratories (BIOSAOS ) (BIOSAOS)

Medico-economic and Quality of Life Evaluations in Obese Patients Followed by Medical Analysis Laboratories

University Hospital, Angers, Poitiers University Hospital, Union hospital, Toulouse, Hospital Alpes Leman, Annemasse, Hospital La Louvière, Lille, Oriade Laboratory, Vizille, Cerballiance laboratories, Lille, Oriade laboratory, Annemasse

Obesity is a major risk factor for obstructive sleep apnea (OSA). However, OSA is still largely under diagnosed in patients with a high cardiovascular risk. In this population the STOP-BANG questionnaire facilitates OSA screening. Moreover, blood bicarbonate concentration is a simple tool to screen for chronic respiratory disease and if elevated, is a marker of cardiometabolic comorbidities in obese patients. A combination of blood bicarbonate concentration and STOP BANG score could provide a cost-effective method of screening for OSA in obese patients. Such screening could enable earlier management and might significantly reduce the costs of treatment and improve the quality of life of patients at 2 years.

OSA is a frequent condition in the general population (3% of women and 10% of men), but remains largely undiagnosed. Obesity is a risk factor for OSA. Sleep apnea is associated with diurnal and nocturnal symptoms (snoring, somnolence, fatigue), and with increased cardiometabolic morbidity and mortality. Currently, continuous positive airway pressure (CPAP) is the gold-standard treatment for OSA and the cost-effectiveness of this treatment has already been demonstrated. Easy-to-use procedures to identify OSA patients earlier and thus to initiate treatment earlier, need to be developed and validated. The STOP-BANG questionnaire has been designed to facilitate the screening of OSA patients. Moreover, a measure of blood bicarbonate concentration is a simple method for screening for chronic respiratory diseases and a marker of cardiometabolic comorbidities. A combination of blood bicarbonate measurement and STOP-BANG score could permit earlier screening and less expensive care of obese patients. The hypothesize is that such OSA screening in the obese population (bicarbonates + STOPBANG) associated with earlier care (with treatment if necessary) could lead to improvement in quality of life of obese patients at 2 years.

Patients in the usual care group will be referred to their general practitioner (GP) / primary care practitioner as usual.

A different care pathway will be followed by the patients randomized to this group. They will be referred to a specialist (pneumologist) for OSA diagnosis and treatment if necessary

Screening for OSA using a combination of bicarbonate assay and STOP-BANG questionnaire and further management by a pneumologist as necessary

incremental cost-effectiveness ratio at 24 months calculated from the difference in healthcare costs between the 2 groups (early care vs usual care) adjusted to the difference in the number of quality adjusted life years

Economic impact of the implementation of early care in obese patients with OSA over 3 years on the healthcare costs

The economic impact on healthcare costs from the Health Insurer's perspective will be calculated from the difference in healthcare costs between the two groups (early care vs usual care)

The EQ-5D-5L health status questionnaire, This scale is numbered from 0 to 100. 100 means the best health status. 0 means the worst health status.

The EQ-5D-5L health status questionnaire, This scale is numbered from 0 to 100. 100 means the best health status. 0 means the worst health status.

Stroke and Aphasia Quality of Life Scale (SAQOL), This questionnaire is intended to study the relationship between sleep and the quality of life. This scale is numbered from 0 to 4. higher values represent a worse outcome

Stroke and Aphasia Quality of Life Scale (SAQOL), This questionnaire is intended to study the relationship between sleep and the quality of life. This scale is numbered from 0 to 4. higher values represent a worse outcome

Inclusion Criteria: Patients aged from 18 to 80 years Obese (BMI ≥ 30kg/m²) Referred by GPs to the medical analysis laboratory for usual biological assessment Patients with no respiratory follow-up already in place Patient affiliated with a social protection plan Bicarbonate - Concentration ≥ 27 mmol/L STOP-BANG score ≥ 3 Informed written consent signed by the patient Exclusion Criteria: Acute disease or recently diagnosed chronic disease (< 2 months) Hospitalization for respiratory, metabolic or cardiovascular event (< 2 months) Renal insufficiency stage 4 or 5, or autoimmune disease, or viral hepatitis, or cirrhosis Cited persons in Sections L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, a person who is the subject of a judicial or administrative legal protection) Patients already included in an interventional study (end of the study < 1 month)