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BACKGROUND AND AIMS: The recurrence of obstructive sleep apnoea (OSA) after positive airway pressure (PAP) therapy termination has physiological consequences that may increase cardiovascular (CV) risk. We aimed to determine whether PAP termination is associated with an increased incidence of major adverse CV events (MACE) compared with adherent PAP continuation. METHODS: Data from the Pays de la Loire Sleep Cohort were linked to the French national health insurance database to identify incident MACE (composite outcome of mortality, stroke and cardiac diseases), and CV active drug (lipid-lowering, antihypertensive and antiplatelet drugs, beta-blockers) adherence (medication possession ratio ≥80%). The association of PAP termination with MACE was evaluated using a time-dependent survival Cox model, with adjustment for confounders including CV active drug status. RESULTS: After a median follow-up of 8 years, 969 of 4188 included patients (median age 58 years, 69.6% men) experienced MACE, 1485 had terminated PAP while 2703 continued PAP with at least 4 hours/night use. 38% of patients were adherent to all CV drugs in the PAP continuation group versus 28% in the PAP termination group (p<0.0001). After adjustment for confounders, PAP termination was associated with an increased risk of MACE (HR (95% CI): 1.39 (1.20 to 1.62); p<0.0001). PAP termination was not associated with incident heart failure and coronary artery disease. CONCLUSIONS: In this multicentre clinical-based cohort involving 4188 patients with OSA, PAP termination compared with adherent PAP continuation was associated with an increased risk of MACE. More research is needed to determine whether support programmes on PAP adherence could improve CV outcomes.
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RATIONALE: Three-year continuous positive airway pressure (CPAP) therapy termination rates are up to 50%, and therapy termination is associated with higher all-cause mortality and incident cardiovascular event risk. OBJECTIVE(S): This study investigated the impact of CPAP therapy termination in the first year on long sick leave leading to permanent work disability in patients with obstructive sleep apnea (OSA) based on data from the nAtionwide cLAimS data laKe for sleep Apnoea (ALASKA). METHODS: French national health insurance reimbursement system (SNDS) data were analyzed for all adults with OSA aged ≤62 years who started CPAP therapy in France in 2015/2016. CPAP therapy termination was defined as the cessation of CPAP reimbursements triggered by the respiratory physician/sleep specialist in charge of follow-up. Individuals who terminated therapy were compared with those who continued to use CPAP. The primary outcome was sick leave ultimately leading to permanent work disability. A multivariable Finn and Gray model, adjusted for age, sex, cardiovascular/metabolic comorbidities, depression, and CPAP prescriber clinical specialty was used to assess the risk of long-term sick leave leading to permanent work disability over 3 years' follow-up. RESULTS: The analysis included 174,270 individuals (median age 52.0 years [interquartile range 44.0-57.0], 67.5% male). The 1-year CPAP therapy termination rate was 22.3%. The proportion of individuals with long-term sick leave leading to permanent work disability was significantly higher in the CPAP termination versus continuation group (0.60% vs. 0.52%; p=0.042). In an adjusted multivariable Cox model, CPAP termination was associated with an increased risk of permanent work disability (hazard ratio [HR] 1.21, 95% confidence interval [CI] 1.04-1.41; p=0.01), primarily in the subgroup aged >55 years (HR 1.41, 95% CI 1.06-1.87; p=0.02). CONCLUSIONS: These real-world data from a comprehensive, unbiased database highlight the potential occupational impact of CPAP therapy termination.
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Tafasitamab plus lenalidomide (TAFA-LEN) treatment relevance pre- or post-anti-CD19 CAR T-cell is currently debated. We analyzed large B-cell lymphoma patients in the DESCAR-T registry treated with axi-cel or tisa-cel in ≥3rd line (L3+) and TAFA-LEN before (n=15, 'TL-pre-CAR-T' set) or directly after (n=52, 'TL-post-CAR-T' set) CAR T-cell. We compared TAFA-LEN v. other treatments using inverse probability weighting in the TL-post-CAR-T set. In the TL-post-CAR-T' set, the median follow-up duration (mFUD) was 7 months, and the median progression-free survival, overall survival and duration of response since the 1st treatment for progression (mPFS2/mOS2/mDOR2) were 3, 4.7 and 8.1 months, respectively. The best overall response rate (bORR) and best complete response rate (bCRR) after TAFA-LEN were 13.5% and 7.7%, respectively. Outcomes were better for patients who relapsed >6 months after CAR T-cell (mPFS2: 5.6 vs. 2 months, p=0.0138; mOS2: not reached vs. 3.8 months, p=0.0034). bORR and bCRR between TAFA-LEN and other treatments were 20.6% vs. 24.9% and 11.6% vs. 15.6%, respectively. Outcomes were similar between TAFA-LEN and other treatments (mPFS2: 2.9 [2-2.6] vs. 2.4 [1.5-4.2] months, p=0.91; mOS2: 3.3 [1.8-6.4] vs. 5.5 [4.4-6.3] months, p=0.06). In an exploratory analysis of the TL-pre-CAR-T set (mFUD since CAR T-cell: 2.8 months), the median TAFA-LEN treatment duration prior to CAR-T was 3.7 months and no patients were reported to become CD19 negative. The bORR, bCRR, 6-month PFS and OS rates after CAR T-cell infusion were 45.5%, 36.4%, 20.1% and 58.2%, respectively. Neither TAFA-LEN nor comparative salvage treatments improved outcomes of patients who relapsed after CAR T-cell.
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INTRODUCTION: Long-term adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnoea remains suboptimal and low adherence increases healthcare costs. This study investigated relationships between CPAP adherence and the intensity of support provided by homecare providers after implementation of telemonitoring and pay-for-performance reimbursement for CPAP in France. METHODS: Adults who started CPAP in 2018/2019, used telemonitoring, and had ≥1 year of homecare provider data were eligible. The main objective was to determine associations between CPAP adherence at 1 month (low [<2h/night], intermediate [2 to <4h/night], high [≥4h/night]) and the number/type of homecare provider interactions (home visits, phone calls, mask change) during the first year. RESULTS: Eleven thousand, one hundred sixty-six individuals were included (mean age 59.8±12.7 years, 67% male). The number of homecare provider interactions per person increased significantly as 1-month CPAP usage decreased (7.65±4.3, 6.5±4.0, 5.4±3.4 in low, intermediate and high adherence groups; p<0.01). There was marked improvement in device usage over the first 5-6 months of therapy in the low and intermediate adherence subgroups (p<0.05 after adjustment for age, sex, initial CPAP adherence, and number of interactions). After adjustment for age, sex and 1-month adherence, having 3-4 interactions was significantly associated with better 1-year adherence (odds ratio 1.24, 95% confidence interval 1.05-1.46), while having >7 interactions was significantly associated with worse 1-year adherence. CONCLUSIONS: The telemonitoring/reimbursement scheme in France had a positive impact on CPAP adherence and facilitated a more personalised approach to therapy management, focusing resources on patients with low and intermediate adherence.
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In a prospective cohort of OSA patients without comorbidities at inclusion, age, mean blood pressure, mean oxygen saturation and minimum oxygen saturation were associated with long-term incidence of severe health events https://bit.ly/3VyYEzC.
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INTRODUCTION: Behavioural weight loss programmes are generally accepted as being beneficial in reducing cardiometabolic risk and improving patient-reported outcomes. However, prospective data from large real-world cohorts are scarce concerning the mid-term and long-term impact of such interventions. The objective of this large prospective cohort study (n>10 000 participants) is to demonstrate the effectiveness of the standardised Nutritional and Psycho-Behavioural Rehabilitation programme (RNPC Programme) in reducing the percentage of subjects requiring insulin and/or other diabetes drug therapy, antihypertensive drugs, lipid-lowering therapies and continuous positive airway pressure therapy for obstructive sleep apnoea after the end of the intervention. The rate of remission of hypertension, type 2 diabetes and sleep apnoea will also be prospectively assessed. METHODS: This is a prospective multicentre observational study carried out in 92 RNPC centres in France. Participants will follow the standardised RNPC Programme. The prospective dataset will include clinical, anthropometric and biochemical data, comorbidities, medications, body composition, patient-reported outcome questionnaire responses, sleep study data with objective measurements of sleep apnoea severity and surrogate markers of cardiovascular risk (ie, blood pressure and arterial stiffness). About 10 000 overweight or obese participants will be included over 2 years with a follow-up duration of up to 5 years. ETHICS AND DISSEMINATION: Ethical approval for this study has been granted by the Ethics Committee (Comité de protection des personnes Sud-Est I) of Saint-Etienne University Hospital, France (SI number: 23.00174.000237). Results will be submitted for publication in peer-review journals, presented at conferences and inform the design of a future randomised controlled trial in the specific population identified as good responders to the RNPC Programme. TRIAL REGISTRATION NUMBER: NCT05857319.
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Obésité , Perte de poids , Humains , Études prospectives , Obésité/complications , Obésité/thérapie , France , Diabète de type 2/complications , Diabète de type 2/thérapie , Hypertension artérielle/thérapie , Programmes de perte de poids/méthodes , Syndrome d'apnées obstructives du sommeil/thérapie , Plan de recherche , Femelle , Études observationnelles comme sujet , Mâle , Études multicentriques comme sujet , Maladies cardiovasculaires/prévention et contrôleRÉSUMÉ
BACKGROUND: The healthy adherer effect has gained increasing attention as potential source of bias in observational studies examining the association of positive airway pressure (PAP) adherence with health outcomes in OSA. RESEARCH QUESTION: Is adherence to PAP associated with healthy behaviors and health care resource use prior to device prescription? STUDY DESIGN AND METHODS: Data from the IRSR Pays de la Loire Sleep Cohort were linked to health administrative data to identify proxies of heathy behaviors, including adherence to cardiovascular (CV) drugs (medical possession ratio), cancer screening tests, influenza vaccination, alcohol and smoking consumption, and drowsiness-related road accidents during the 2 years preceding PAP onset in patients with OSA. Multivariable regression analyses were conducted to evaluate the association of heathy behaviors with subsequent PAP adherence. Health care resource use was evaluated according to subsequent PAP adherence. RESULTS: We included 2,836 patients who had started PAP therapy between 2012 and 2018 (65% of whom were PAP adherent with mean daily use ≥ 4 h/night). Being adherent to CV active drugs (medical possession ratio ≥ 80%) and a person who does not smoke were associated with a higher likelihood of PAP adherence (OR, 1.43; 95% CI, 1.15-1.77 and OR, 1.37; 95% CI, 1.10-1.71, respectively). Patients with no history of drowsiness-related road accidents were more likely to continue PAP (OR, 1.39; 95% CI, 1.04-1.87). Patients who were PAP adherent used less health care resources 2 years before PAP initiation than patients who were nonadherent (mean number of outpatient consultations: 19.0 vs 17.2, P = .003; hospitalization days: 5.7 vs 5.0; P = .04; ED visits: 30.7% vs 24.0%, P = .0002, respectively). INTERPRETATION: Patients who adhere to PAP therapy for OSA were more health-seeking and used less health care resources prior to device initiation than patients who were nonadherent. Until the healthy adherer effect associated with PAP adherence is better understood, caution is warranted when interpreting the association of PAP adherence with CV health outcomes and health care resource use in nonrandomized cohorts.
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INTRODUCTION: Monitoring changes in symptoms over time during long-term nocturnal home non-invasive ventilation (NIV) using patient-reported outcome measures is crucial. This study aimed to identify factors associated with changes in the S3-NIV total score, its two domains ("respiratory symptoms" and "sleep and NIV-related side effects") and individual item responses. METHODS: We conducted a retrospective, longitudinal data analysis of a cohort of adults with chronic respiratory failure treated with NIV. Data were obtained from a French homecare provider. Multivariate linear and multinomial ordinal mixed effect models were used to identify factors associated with changes in S3-NIV scores over time. RESULTS: Median follow-up was 2 years for 2135 participants. Each participant completed a median of five S3-NIV questionnaires; totaling 11,359 analyzed questionnaires. Type of respiratory condition, sex, age and time since NIV initiation were associated with change in S3-NIV score over time. NIV adherence was not associated with total S3-NIV score but high adherence was associated with more severe respiratory symptoms and an improvement in sleep and NIV-related side effects during the follow-up. Intensity of pressure support was associated with a lower total S3-NIV score and more side effects. Face masks and supplemental oxygen were associated with a lower S3-NIV total score. CONCLUSION: Changes in S3-NIV scores over time are associated with the individual's characteristics and NIV settings. Analysis of the two domains and individual items of the S3-NIV could increase understanding of the difficulties experienced by people on NIV.
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Services de soins à domicile , Ventilation non effractive , Insuffisance respiratoire , Humains , Mâle , Femelle , Insuffisance respiratoire/thérapie , Études rétrospectives , Sujet âgé , Adulte d'âge moyen , Maladie chronique , Études longitudinales , Mesures des résultats rapportés par les patients , Observance par le patient , Facteurs temps , Sujet âgé de 80 ans ou plus , Adulte , FranceRÉSUMÉ
Obstructive sleep apnea is a common type of sleep-disordered breathing associated with multiple comorbidities. Nearly a billion people are estimated to have obstructive sleep apnea, which carries a substantial economic burden, but under-diagnosis is still a problem. Continuous positive airway pressure (CPAP) is the first-line treatment for OSAS. Telemedicine-based interventions (TM) have been evaluated to improve access to diagnosis, increase CPAP adherence, and contribute to easing the follow-up process, allowing healthcare facilities to provide patient-centered care. This narrative review summarizes the evidence available regarding the potential future of telemedicine in the management pathway of OSA. The potential of home sleep studies to improve OSA diagnosis and the importance of remote monitoring for tracking treatment adherence and failure and to contribute to developing patient engagement tools will be presented. Further studies are needed to explore the impact of shifting from teleconsultations to collaborative care models where patients are placed at the center of their care.
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OBJECTIVE/BACKGROUND: Chronic obstructive pulmonary disease (COPD), obstructive sleep apnea (OSA) and their comorbid association called Overlap Syndrome (OS) are frequent chronic diseases with high individual and societal burdens. Precise descriptions of the respective symptoms, comorbidities, and medications associated with these three conditions are lacking. We used a multidimensional phenotyping approach to identify relevant phenotypes characterizing these 3 disorders. PATIENTS/METHODS: 308 patients with OSA, COPD and OS were prospectively assessed using a combination of body shape measurements and multidimensional questionnaires evaluating sleep, fatigue, depression and respiratory symptoms. Comorbidities and medications were confirmed by physicians. Patients made home blood pressure self-measurements using a connected wearable device to identify undiagnosed or uncontrolled hypertension. RESULTS: Three distinct relevant phenotypes were identified. OSA patients were round in shape with a balanced waist-to-hip ratio, frequent witnessed apneas, nocturia, daytime sleepiness, depression, and high diastolic blood pressure. COPD patients had a thinner body shape with a high waist-to-hip ratio, complained mainly of fatigue, and exhibited a higher resting heart rate. OS patients were round in shape with a balanced waist-to-hip ratio, reported little sleepiness and depression, but had impaired sleep and the highest rate of cardio-metabolic comorbidities. Diminished fitness-to-drive was most apparent in patients with OSA and OS. Home blood pressure measurements identified undiagnosed hypertension in 80 % of patients and in nearly 80 % of those with hypertension it was uncontrolled by their current medications. CONCLUSIONS: Our systematic multidimensional phenotyping approach identified distinct body shapes, symptoms, and comorbidity profiles among patients with OSA, COPD, and OS.
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Comorbidité , Phénotype , Broncho-pneumopathie chronique obstructive , Syndrome d'apnées obstructives du sommeil , Humains , Mâle , Femelle , Syndrome d'apnées obstructives du sommeil/diagnostic , Broncho-pneumopathie chronique obstructive/complications , Broncho-pneumopathie chronique obstructive/physiopathologie , Adulte d'âge moyen , Sujet âgé , Enquêtes et questionnaires , Études prospectives , Hypertension artérielle/complications , Hypertension artérielle/diagnostic , Dépression , Rapport taille-hanches , FatigueRÉSUMÉ
OBJECTIVES: Causal inference methods for observational data represent an alternative to randomised controlled trials when they are not feasible or when real-world evidence is sought. Inverse-probability-of-treatment weighting (IPTW) is one of the most popular approaches to account for confounding in observational studies. In medical research, IPTW is mainly applied to estimate the causal effect of a binary treatment, even when the treatment has in fact multiple categories, despite the availability of IPTW estimators for multiple treatment categories. This raises questions about the appropriateness of the use of IPTW in this context. Therefore, we conducted a systematic review of medical publications reporting the use of IPTW in the presence of a multi-category treatment. Our objectives were to investigate the frequency of use and the implementation of these methods in practice, and to assess the quality of their reporting. STUDY DESIGN AND SETTING: Using Pubmed, Embase and Web of Science, we screened 5660 articles and retained 106 articles in the final analysis that were from 17 different medical areas. This systematic review is registered on PROSPERO (CRD42022352669). RESULTS: The number of treatment groups varied between 3 and 9, with a large majority of articles (90 [84.9%]) including 3 or 4 groups. The most commonly used method for estimating the weights was multinomial regression (51 [48.1%]) and generalized boosted models (48 [45.3%]). The covariates of the weight model were reported in 91 articles (85.9 %). Twenty-six articles (24.5 %) did not discuss the balance of covariates after weighting, and only 16 articles (15.1 %) referred to the assumptions needed to obtain correct inferences. CONCLUSION: The results of this systematic review illustrate that medical publications scarcely use IPTW methods for more than two treatment categories. Among the publications that did, the quality of reporting was suboptimal, in particular in regard to the assumptions and model building. IPTW for multi-category treatments could be applied more broadly in medical research, and the application of the proposed guidelines in this context will help researchers to report their results and to ensure reproducibility of their research.
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Recherche biomédicale , Humains , Recherche biomédicale/normes , Recherche biomédicale/statistiques et données numériques , Études observationnelles comme sujet , Probabilité , Plan de recherche/normes , Causalité ,RÉSUMÉ
OBJECTIVE: In many countries, the first line response to an emergency call is decided by the emergency dispatch center EMS clinician. Our main objective was to compare the pre-hospital response to calls received from cancer and non-cancer patients. We also compared the reasons for calling, for each group. METHODS: We conducted a retrospective cohort study of data collected between January 1, 2016 and December 31, 2020, from emergency dispatch center records of the Isère county, France. Statistical tests were conducted after matching one cancer patient with two non-cancer patients, resulting in a cohort of 44,022 patients. We used multivariate logistic regression to determine the impact of patient cancer status on the medical decision taken in response to the emergency call. RESULTS: Overall, data on 849,110 patients were extracted, including 16,451 patients with a diagnosis of cancer and 29,348 non-cancer patients. In the matched cohort, cancer was associated with a higher odd of having a mobile intensive care unit (MICU) [odds ratio (OR)=2.02 (1.81-2.26), p<0.001] or an ambulance being dispatched to the patient's home or other location [OR=2.36 (2.24-2.48), p<0.001]. The two most frequent medical responses were to send an ambulance (58.6%) and giving advice only (36.8%). The five main reasons for the emergency call for the cancer group were cardiovascular disease symptoms (13.5%), respiratory problems (10.6%), digestive disorders (10.4%), infections (8.9%) and neurological disorders (6.0%). CONCLUSION: An MICU or an ambulance was more often dispatched for cancer patients than for others. Considering that cancer is a very frequent comorbidity in Western countries, knowledge of the patient's cancer status should be sought and taken into consideration when a patient seeks emergency help.
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Tumeurs , Humains , Tumeurs/thérapie , Tumeurs/complications , Tumeurs/épidémiologie , France/épidémiologie , Études rétrospectives , Femelle , Mâle , Adulte d'âge moyen , Sujet âgé , Unités de soins intensifs/statistiques et données numériques , Ambulances/statistiques et données numériques , Bases de données factuelles , Services des urgences médicales/statistiques et données numériques , Adulte , Répartition des urgences médicales/statistiques et données numériques , Unités sanitaires mobiles/statistiques et données numériques , Modèles logistiques , Sujet âgé de 80 ans ou plus , Répartiteur aux urgences médicales/statistiques et données numériquesRÉSUMÉ
BACKGROUND: The incidence, causes and impact of diaphragm thickness evolution in veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for cardiogenic shock are unknown. Our study investigates its evolution during the first week of VA-ECMO and its relationship with sweep gas flow settings. METHODS: We conducted a prospective monocentric observational study in a 12-bed ICU in France, enrolling patients on the day of the VA-ECMO implantation. The diaphragm thickness and the diaphragm thickening fraction (as index of contractile activity, dTF; dTF < 20% defined a low contractile activity) were daily measured for one week using ultrasound. Factors associated with diaphragm thickness evolution (categorized as increased, stable, or atrophic based on > 10% modification from baseline to the last measurement), early extubation role (< day4), and patients outcome at 60 days were investigated. Changes in diaphragm thickness, the primary endpoint, was analysed using a mixed-effect linear model (MLM). RESULTS: Of the 29 included patients, seven (23%) presented diaphragm atrophy, 18 remained stable (60%) and 4 exhibited an increase (17%). None of the 13 early-extubated patients experienced diaphragm atrophy, while 7 (46%) presented a decrease when extubated later (p-value = 0.008). Diaphragm thickness changes were not associated with the dTF (p-value = 0.13) but with sweep gas flow (Beta = - 3; Confidence Interval at 95% (CI) [- 4.8; - 1.2]. p-value = 0.001) and pH (Beta = - 2; CI [- 2.9; - 1]. p-value < 0.001) in MLM. The dTF remained low (< 20%) in 20 patients (69%) at the study's end and was associated with sweep gas flow evolution in MLM (Beta = - 2.8; 95% CI [- 5.2; - 0.5], p-value = 0.017). Odds ratio of death at 60 days in case of diaphragm atrophy by day 7 was 8.50 ([1.4-74], p = 0.029). CONCLUSION: In our study, diaphragm thickness evolution was frequent and not associated with the diaphragm thickening fraction. Diaphragm was preserved from atrophy in case of early extubation with ongoing VA-ECMO assistance. Metabolic disorders resulting from organ failures and sweep gas flow were linked with diaphragm thickness evolution. Preserved diaphragm thickness in VA-ECMO survivors emphasizes the importance of diaphragm-protective strategies, including meticulous sweep gas flow titration.
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INTRODUCTION: Obstructive sleep apnoea syndrome (OSAS) is a chronic multiorgan pathology that has a negative impact on quality of life. Continuous positive airway pressure (CPAP) is the first-line treatment for OSAS. However, CPAP termination rates remain very high, and adherence to therapy is a major issue. To date, studies targeting predictive factors of CPAP adherence by OSAS patients mainly include clinical data. The social, socioeconomic, psychological, and home environment aspects have been far less studied and largely underestimated. This study aims to obtain solid quantitative results examining the relationship between the determinants of refusal, non-adherence, or termination of CPAP treatment, and in particular the pivotal role played by health literacy. METHODS AND ANALYSIS: This is a prospective, multicentre, observational study recruiting patients attending the sleep clinic of the Grenoble Alpes University Hospital, France. Consecutive adults (>18 years) recently diagnosed with OSAS and prescribed CPAP treatment with telemonitoring will be enrolled in the present study. They will benefit from home visits by a CPAP technician or nurse at CPAP initiation. Patients will then be followed up for 6 months through the telemonitoring platform of a home-care provider. The primary objective is to evaluate the impact of health literacy (health literacy, measured by the European Health Literacy Survey questionnaire (HLS-EU-16) on the refusal, non-adherence or termination of CPAP treatment in newly diagnosed OSAS patients, during the first 6 months after diagnosis. The target sample size is 250 participants. ETHICS AND DISSEMINATION: The study protocol, patient information, and the non-opposition form were approved by the French national ethics committee (CPP 2021-92, January 2022). All patients are required to have signed a written informed consent form permitting their anonymised personal and medical data to be used for clinical research purposes. We will publish the results in a peer-reviewed medical journal and on our institutional websites. TRIAL REGISTRATION NUMBER: NCT05385302.
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Syndromes d'apnées du sommeil , Syndrome d'apnées obstructives du sommeil , Adulte , Humains , Ventilation en pression positive continue , Études prospectives , Qualité de vie , Syndrome d'apnées obstructives du sommeil/thérapie , Établissements de soins ambulatoires , Études observationnelles comme sujet , Études multicentriques comme sujetRÉSUMÉ
New sleep technologies are being developed, refined and delivered at a fast pace. However, there are serious concerns about the validation and accuracy of new sleep-related technologies being made available, as many of them, especially consumer-sleep technologies, have not been tested in comparison with gold-standard methods or have been approved by health regulatory agencies. The importance of proper validation and performance evaluation of new sleep technologies has already been discussed in previous studies and some recommendations have already been published, but most of them do not employ standardized methodology and are not able to cover all aspects of new sleep technologies. The current protocol describes the methods of a Delphi consensus study to create guidelines for the development, performance evaluation and validation of new sleep devices and technologies. The resulting recommendations are not intended to be used as a quality assessment tool to evaluate individual articles, but rather to evaluate the overall procedures, studies and experiments performed to develop, evaluate performance and validate new technologies. We hope these guidelines can be helpful for researchers who work with new sleep technologies on the appraisal of their reliability and validation, for companies who are working on the development and refinement of new sleep technologies, and by regulatory agencies to evaluate new technologies that are looking for registration, approval or inclusion on health systems.
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Rationale: Oral appliances are second-line treatments after continuous positive airway pressure for obstructive sleep apnea (OSA) management. However, the need for oral appliance titration limits their use as a result of monitoring challenges to assess the treatment effect on OSA. Objectives: To assess the validity of mandibular jaw movement (MJM) automated analysis compared with polysomnography (PSG) and polygraphy (PG) in evaluating the effect of oral appliance treatment and the effectiveness of MJM monitoring for oral appliance titration at home in patients with OSA. Methods: This observational, prospective study included 135 patients with OSA eligible for oral appliance therapy. The primary outcome was the apnea-hypopnea index (AHI), measured through in-laboratory PSG/PG and MJM-based technology. Additionally, MJM monitoring at home was conducted at regular intervals during the titration process. The agreement between PSG/PG and MJM automated analysis was revaluated using Bland-Altman analysis. Changes in AHI during the home-based oral appliance titration process were evaluated using a generalized linear mixed model and a generalized estimating equation model. Results: The automated MJM analysis demonstrated strong agreement with PG in assessing AHI at the end of titration, with a median bias of 0.24/h (limits of agreement, -11.2 to 12.8/h). The improvement of AHI from baseline in response to oral appliance treatment was consistent across three evaluation conditions: in-laboratory PG (-59.6%; 95% confidence interval, -59.8% to -59.5%), in-laboratory automated MJM analysis (-59.2%; -65.2% to -52.2%), and at-home automated MJM analysis (-59.7%; -67.4% to -50.2%). Conclusions: Incorporating MJM automated analysis into the oral appliance titration process has the potential to optimize oral appliance therapy outcomes for OSA.
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Polysomnographie , Syndrome d'apnées obstructives du sommeil , Humains , Syndrome d'apnées obstructives du sommeil/thérapie , Syndrome d'apnées obstructives du sommeil/diagnostic , Études prospectives , Mâle , Femelle , Adulte d'âge moyen , Adulte , Mandibule , Sujet âgé , Ventilation en pression positive continue/instrumentation , Ventilation en pression positive continue/méthodes , Mouvement , Monitorage physiologique/méthodes , Monitorage physiologique/instrumentationRÉSUMÉ
INTRODUCTION: Severe sleep apnea (SA) affects one-third of stroke patients. Sleepiness, one of the cardinal symptoms of SA, negatively impacts functional stroke outcomes. The impact of continuous positive airway pressure (CPAP) on post-stroke sleepiness is poorly described. We aimed to compare through a propensity score matching the trajectories of self-reported sleepiness post-stroke with matched individuals including SA patients adherent or not to CPAP. PATIENTS AND METHODS: Sixty five (80.2%) ischemic stroke and 16 (19.8%) TIA patients (median [Q1;Q3] age = 67.0 [58.0;74.0] years, 70.4% male, body mass index [BMI] = 26.1 [24.5;29.8] kg·m-2, admission NIHSS = 3.0 [1.0;5.0]), with polysomnography and an Epworth Sleepiness Scale (ESS) performed within 1 year following stroke and with a follow-up ESS (delay = 236 [147;399] days) were included in the analysis. A 2:1 propensity score matching based on age, gender, BMI, and the apnea-hypopnea index was performed to identify 162 matched individuals referred for SA suspicion, free of stroke or TIA. Multivariable negative binomial regression models were performed to identify the determinants of sleepiness trajectories post-stroke. RESULTS: Baseline ESS was comparable between stroke/TIA and matched individuals (median [Q1; Q3] ESS = 7 [4;10] versus 6 [4;10], p = 0.86). The range of improvement in ESS was higher in stroke patients compared to controls (∆ESS = -2 [-4;1] vs -1 [-3;2], p = 0.03). In multivariable analysis, comorbid SA and CPAP treatment did not influence trajectories of sleepiness post-stroke. DISCUSSION AND CONCLUSION: Sleepiness improvement was unexpectedly higher in stroke patients compared to matched individuals, with no significant influence of comorbid SA and CPAP on its trajectory. Sleepiness may not be primarily indicative of SA in stroke or TIA patients.
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Accident ischémique transitoire , Accident vasculaire cérébral ischémique , Score de propension , Autorapport , Humains , Mâle , Femelle , Accident ischémique transitoire/complications , Accident ischémique transitoire/épidémiologie , Sujet âgé , Adulte d'âge moyen , Accident vasculaire cérébral ischémique/complications , Accident vasculaire cérébral ischémique/thérapie , Ventilation en pression positive continue , Syndromes d'apnées du sommeil/épidémiologie , Syndromes d'apnées du sommeil/complications , Syndromes d'apnées du sommeil/thérapie , Envie de dormir , Polysomnographie/méthodes , Accident vasculaire cérébral/complicationsRÉSUMÉ
BACKGROUND: Experimental infection with Plasmodium falciparum results in malaria attack within a few days of exposure. However, we have regularly observed malaria attack within a short time after return, regardless of the time spent in an endemic area. We therefore aimed to assess whether the time before return and malaria attack varies according to length of stay. METHODS: We used anonymized data from the French National Reference Centre for Malaria between 2006 and 2016. We analyzed 11,823 cases aged at least 1 year and diagnosed with P. falciparum malaria 1 day to 1 year after returning to France, after a stay of 1 day to 1 year in an at-risk area. RESULTS: Trips had a median duration of 31 days [IQR: 19-56]. Median time between return from the endemic area and onset of malaria symptoms was 5 days [IQR: 0-10], and the median between return and malaria diagnosis was 9 days [IQR: 5-14]. Times to symptom onset or diagnosis were longer for stays of fewer than 15 days vs 15 days or more (for symptoms: 7 vs 4 days for longer stays, for diagnosis: 11 vs 9 days). For stays longer than 15 days, no variation was observed according to length of stay. CONCLUSIONS: Aside from at-risk stays of fewer than 15 days, the time between return and malaria attack is constant and rather short, even after long stays. The 2 weeks following return should be considered as a risk period whatever the length of stay in an at-risk area.