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"Borel, Christian"
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Building a home ventilation programme: population, equipment, delivery and cost
by
Winck, Joao Carlos
,
Toussaint, Michel
,
McKim, Doug
in
Assisted Ventilation
,
Developing countries
,
Hypoventilation
2022
Home mechanical ventilation (HMV) improves quality of life and survival in patients with neuromuscular disorders (NMD). Developing countries may benefit from published evidence regarding the prevalence, cost of equipment, technical issues and organisation of HMV in NMD, facilitating the development of local turn-key HMV programmes. Unfortunately, such evidence is scattered in the existing literature. We searched Medline for publications in English and French from 2005 to 2020. This narrative review analyses 24 international programmes of HMV. The estimated prevalence (min–max) of HMV is ±7.3/100 000 population (1.2–47), all disorders combined. The prevalence of HMV is associated with the gross domestic product per capita in these 24 countries. The prevalence of NMD is about 30/100 000 population, of which ±10% would use HMV. Nocturnal (8/24 hour), discontinuous (8–16/24 hours) and continuous (>16/24 hours) ventilation is likely to concern about 60%, 20% and 20% of NMD patients using HMV. A minimal budget of about 168€/patient/year (504€/100 000 population), including the cost of equipment solely, should address the cost of HMV equipment in low-income countries. When services and maintenance are included, the budget can drastically increase up to between 3232 and 5760€/patient/year. Emerging programmes of HMV in developing countries reveal the positive impact of international cooperation. Today, at least 12 new middle, and low-income countries are developing HMV programmes. This review with updated data on prevalence, technical issues, cost of equipment and services for HMV should trigger objective dialogues between the stakeholders (patient associations, healthcare professionals and politicians); potentially leading to the production of workable strategies for the development of HMV in patients with NMD living in developing countries.
Journal Article
Immunotherapy Breakthroughs in the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
by
Burgy, Mickaël
,
Borel, Christian
,
Jung, Alain C.
in
Drug therapy
,
Head and neck cancer
,
Immunotherapy
2020
Head and neck squamous cell carcinoma (HNSCC) in the recurrent or metastatic (R/M) setting is a devastating disease with a poor prognosis. Until recently, the reference first line treatment was the EXTREME protocol, which yields a 10.1 months median survival, and almost no effective treatment are available in second line. Immune checkpoint inhibitors (ICIs) have changed the prognosis of several metastatic solid tumors. Given their inflammatory profile and high mutational burden, HNSCC is a good candidate for ICIs treatments. First, a strong pembrolizumab efficacy signal was shown in the Keynote-012 Phase Ib study. Then, the phase III Checkmate-141 study validated the efficacy of nivolumab in platinum-resistant patients. Finally, the first line conquest is acquired since the final results of the keynote-048 phase III study that demonstrated the superiority of pembrolizumab versus EXTREME in CPS ≥ 1 patients, and with the addition of platinum and 5FU in all patients. However, the first line treatment landscape is not frozen. Two studies (Checkmate-651 and Kestrel) are investigating the efficacy of the combination of antibodies raised against CTLA-4 and PD-(L)1. Results are impatiently awaited. Further progress needs the use of new immunotherapeutic agents such as monalizumab or ICOS agonist rather in combination with an anti-PD(L)1. New associations of ICIs and chemotherapeutic or targeted therapeutic agents are also actively investigated. Finally, ICIs has to be studied in the locally advanced setting where there is a chance of cure. Several trials are testing the potential synergistic combination of ICIs with radiotherapy and platinum or cetuximab, or ICIs used in a neoadjuvant setting.
Journal Article
Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study
by
Bourdin, Arnaud
,
Martinez, Christian
,
Rotty, Marie-Caroline
in
Aged
,
Airway management
,
Apnea
2021
Background
For some patients, Continuous Positive Airway Pressure (CPAP) remains an uncomfortable therapy despite the constant development of technological innovations. To date, no real life study has investigated the relationship between mask related side-effects (MRSEs) and CPAP-non-adherence (defined as < 4 h/day) or residual-excessive-sleepiness (RES, Epworth-Sleepiness-Scale (ESS) score ≥ 11) in the long-term.
Methods
The InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks). MRSEs were evaluated using visual-analogue-scales, CPAP-data using CPAP-software, sleepiness using ESS.
Results
1484 patients were included in the analysis (72.2% male, median age 67 years (IQ
25–75
: 60–74), initial Apnea–Hypopnea-Index (AHI) of 39 (31–56)/h, residual AHI
flow
was 1.9 (0.9–4) events/h), CPAP-treatment lasted 4.4 (2.0–9.7) years, CPAP-usage was 6.8 (5.5–7.8) h/day, the prevalence of CPAP-non-adherence was 8.6%, and the prevalence of RES was 16.17%. Leak-related side-effects were the most prevalent side-effects (patient-reported leaks concerned 75.4% of responders and had no correlation with CPAP-reported-leaks). Multivariable logistic regression analyses evaluating explanatory-variable (demographic data, device/mask data and MRSEs) effects on variables-of-interest (CPAP-non-adherence and RES), indicated for patient-MRSEs significant associations between: (i) CPAP-non-adherence and dry-mouth (p = 0.004); (ii) RES and patient-reported leaks (p = 0.007), noisy mask (p < 0.001), dry nose (p < 0.001) and harness pain (p = 0.043).
Conclusion
In long-term CPAP-treated patients, leak-related side-effects remain the most prevalent side-effects, but patient-reported leaks cannot be predicted by CPAP-reported-leaks. Patient-MRSEs can be independently associated with CPAP-non-adherence and RES, thus implying a complementary role for MRSE questionnaires alongside CPAP-device-reported-data for patient monitoring.
Trial registration
InterfaceVent is registered with ClinicalTrials.gov (NCT03013283).
Journal Article
Defining a need for rapid response and practical guidance for recurrent and metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) management in France: A Delphi consensus
by
Clatot, Florian
,
Saada, Esma
,
Daste, Amaury
in
Analgesics
,
Biology and Life Sciences
,
Cancer therapies
2025
Recurrent and metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) presents substantial treatment challenges due to its aggressive and heterogeneous nature. While evidence-based guidelines provide useful recommendations, they may not offer sufficient support for real-time clinical decision-making.
This Delphi consensus aimed to establish expert agreement on clinical parameters guiding first- and second-line treatment decisions and the management of specific clinical scenarios in R/M SCCHN in France.
A two-round Delphi consensus was conducted between December 2023 and June 2024. A scientific committee of six national experts developed consensus statements based on a literature review and supervised the process. An expert panel of 25 oncologists from across France participated in both rounds.
All respondents agreed that the need for a rapid therapeutic response and the presence of comorbidities were critical factors influencing first-line treatment choice. Seven major indicators of rapid response were identified: rapidly progressive relapse, partial airway obstruction, respiratory compromise, tumour-related bleeding, uncontrolled symptoms, carotid axis lesions, and pain resistant to third-step analgesics. For patients requiring rapid response, 76% supported using cetuximab with chemotherapy as a first-line option in cases with a combined positive score (CPS) between 1 and 19. Furthermore, 84% recommended immunotherapy (alone or combined with chemotherapy) as first-line treatment for CPS ≥ 20 tumours, while 41% would consider it for CPS 1-19 cases. A strong consensus (80%) held that first-line treatment should not restrict second-line options. Notably, 100% of respondents agreed that all patients should receive immunotherapy, cetuximab, taxanes, and platinum salts within the first two treatment lines.
This Delphi consensus offers valuable, expert-based perspectives on the management of R/M SCCHN in France. It highlights a progressive shift from standardized European guideline frameworks toward a more personalized approach that accounts for individual patient profiles and tumour characteristics. The insights generated provide practical guidance for clinical decision-making and lay the groundwork for future research and optimisation of treatment strategies in real-world settings.
Journal Article
Mask side-effects are related to gender in long-term CPAP: results from the InterfaceVent real-life study
2024
Background
Over the past three decades, our understanding of sleep apnea in women has advanced, revealing disparities in pathophysiology, diagnosis, and treatment compared to men. However, no real-life study to date has explored the relationship between mask-related side effects (MRSEs) and gender in the context of long-term CPAP.
Methods
The InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks, no gender specific mask series). MRSE were assessed by the patient using visual analog scales (VAS). CPAP-non-adherence was defined as a mean CPAP-usage of less than 4 h per day. The primary objective of this ancillary study was to investigate the impact of gender on the prevalence of MRSEs reported by the patient. Secondary analyses assessed the impact of MRSEs on CPAP-usage and CPAP-non-adherence depending on the gender.
Results
A total of 1484 patients treated for a median duration of 4.4 years (IQ
25–75
: 2.0–9.7) were included in the cohort, with women accounting for 27.8%. The prevalence of patient-reported mask injury, defined as a VAS score ≥ 5 (p = 0.021), was higher in women than in men (9.6% versus 5.3%). For nasal pillow masks, the median MRSE VAS score for dry mouth was higher in women (p = 0.039). For oronasal masks, the median MRSE VAS score for runny nose was higher in men (p = 0.039). Multivariable regression analyses revealed that, for both women and men, dry mouth was independently and negatively associated with CPAP-usage, and positively associated with CPAP-non-adherence.
Conclusion
In real-life patients treated with long-term CPAP, there are gender differences in patient reported MRSEs. In the context of personalized medicine, these results suggest that the design of future masks should consider these gender differences if masks specifically for women are developed. However, only dry mouth, a side effect not related to mask design, impacts CPAP-usage and non-adherence.
Trial Registration
: InterfaceVent is registered with ClinicalTrials.gov (NCT03013283).First registration date is 2016–12-23.
Journal Article
Contribution of obstructive sleep apnoea to arterial stiffness: a meta-analysis using individual patient data
by
Tamisier, Renaud
,
Destors, Marie
,
Joyeux-Faure, Marie
in
Blood pressure
,
Body mass index
,
Cardiology and cardiovascular system
2018
BackgroundArterial stiffness, measured by pulse wave velocity (PWV), is a strong independent predictor of late cardiovascular events and mortality. It is recognised that obstructive sleep apnoea (OSA) is associated with cardiovascular comorbidities and mortality. Although previous meta-analyses concluded that PWV is elevated in OSA, we feel that an individual patient data analysis from nine relatively homogeneous studies could help answer: to what extent does OSA drive arterial stiffness?MethodsIndividual data from well-characterised patients referred for suspicion of OSA, included in nine studies in which carotid–femoral PWV was measured using a Complior device, were merged for an individual patient data meta-analysis.Results893 subjects were included (age: 56±11 (mean±SD), 72% men, 84% with confirmed OSA). Body Mass Index varied from 15 to 81 kg/m2 (30±7 kg/m2). PWV ranged from 5.3 to 20.5 m/s (10.4±2.3 m/s). In univariate analysis, log(PWV) was strongly related to age, gender, systolic blood pressure, presence of type 2 diabetes (all p<0.01) as well as to dyslipidaemia (p=0.03) and an Epworth Sleepiness Scale score ≥9 (p=0.04), whereas it was not related to obesity (p=0.54), a severe Apnoea–Hypopnoea Index (p=0.14), mean nocturnal saturation (p=0.33) or sleep time with oxygen saturation below 90% (p=0.47). In multivariable analysis, PWV was independently associated with age, systolic blood pressure and diabetes (all p<0.01), whereas severe OSA was not significantly associated with PWV.ConclusionOur individual patient meta-analysis showed that elevated arterial stiffness in patients with OSA is driven by conventional cardiovascular risk factors rather than apnoea parameters.
Journal Article
Nasal versus oronasal masks for home non-invasive ventilation in patients with chronic hypercapnia: a systematic review and individual participant data meta-analysis
by
Pallero, Mercedes
,
Sánchez-Quiroga, M-Ángeles
,
Funk, Georg Chistian
in
Chronic obstructive pulmonary disease
,
Collaboration
,
COPD pathology
2021
BackgroundThe optimal interface for the delivery of home non-invasive ventilation (NIV) to treat chronic respiratory failure has not yet been determined. The aim of this individual participant data (IPD) meta-analysis was to compare the effect of nasal and oronasal masks on treatment efficacy and adherence in patients with COPD and obesity hypoventilation syndrome (OHS).MethodsWe searched Medline and Cochrane Central Register of Controlled Trials for prospective randomised controlled trials (RCTs) of at least 1 month’s duration, published between January 1994 and April 2019, that assessed NIV efficacy in patients with OHS and COPD. The main outcomes were diurnal PaCO2, PaO2 and NIV adherence (PROSPERO CRD42019132398).FindingsOf 1576 articles identified, 34 RCTs met the inclusion criteria and IPD were obtained for 18. Ten RCTs were excluded because only one type of mask was used, or mask data were missing. Data from 8 RCTs, including 290 IPD, underwent meta-analysis. Oronasal masks were used in 86% of cases. There were no differences between oronasal and nasal masks for PaCO2 (0.61 mm Hg (95% CI −2.15 to 3.38); p=0.68), PaO2 (−0.00 mm Hg (95% CI −4.59 to 4.58); p=1) or NIV adherence (0·29 hour/day (95% CI −0.74 to 1.32); p=0.58). There was no interaction between the underlying pathology and the effect of mask type on any outcome.InterpretationOronasal masks are the most used interface for the delivery of home NIV in patients with OHS and COPD; however, there is no difference in the efficacy or tolerance of oronasal or nasal masks.
Journal Article
Ventilatory support or respiratory muscle training as adjuncts to exercise in obese CPAP-treated patients with obstructive sleep apnoea: a randomised controlled trial
by
Tamisier, Renaud
,
Sériès, Frédéric
,
Vivodtzev, Isabelle
in
Cardiovascular health
,
Chronic illnesses
,
Continuous positive airway pressure
2018
BackgroundObstructive sleep apnoea (OSA) and obesity are interdependent chronic diseases sharing reduced exercise tolerance and high cardiovascular risk.InterventionA 3-month intervention with innovative training modalities would further improve functional capacity and cardiovascular health than usual cycle exercise training in already continuous positive airway pressure (CPAP)-treated obese patients with OSA.MethodsFifty three patients (35
Journal Article
Energy conservation technique improves dyspnoea when patients with severe COPD climb stairs: a randomised crossover study
by
Quieffin, Jean
,
Reychler, Gregory
,
Lamia, Bouchra
in
Asthma
,
Brief communication
,
Chronic obstructive pulmonary disease
2020
In this randomised, crossover trial, 22 patients with severe chronic obstructive pulmonary disease climbed six flights of stairs (108 steps) twice, under two test conditions: (1) energy conservation technique (ECT): participants were asked to rest for at least 5 seconds every three steps and (2) control condition: participants climbed the stairs at their own pace. Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time.Clinical trial registration NCT03564028
Journal Article
Home and outpatient versus in-hospital initiation of non-invasive ventilation in people with neuromuscular and restrictive thoracic disorders: a network meta-analysis
by
Khouri, Charles
,
Borel, Jean Christian
,
Saulnier, Lucas
in
Ambulatory Care - methods
,
Blood pressure
,
Carbon dioxide
2025
IntroductionThere is a growing trend towards outpatient or home initiation of long-term non-invasive ventilation (NIV) instead of in-hospital initiation. However, evidence supporting the non-inferiority of this strategy is limited in people with neuromuscular diseases (NMDs) or restrictive thoracic disorders (RTDs).MethodsSystematic review and network meta-analysis (NMA) to compare the effect of three NIV initiation settings (home, outpatient and in-hospital) on long-term NIV efficacy in people with NMD or RTD. We used MEDLINE, Web of Science and the CENTRAL (Cochrane Central Register of Controlled Trials) to identify randomised controlled trials (RCTs), controlled and uncontrolled prospective studies comparing NIV efficacy between home and outpatient, and in-hospital initiation. Studies published between January 2000 and February 2023 with endpoints ≥1 month were included. The main outcomes were diurnal arterial carbon dioxide pressure (PaCO2) (primary), oxygen partial blood pressure (PaO2), bicarbonate (HCO3−), quality-of-life and NIV adherence.ResultsEight studies (five RCTs), comprising 350 individuals with PaCO2 measurements (144, 119 and 87 individuals for in-hospital, home and outpatient NIV initiation, respectively) were included. Home and outpatient initiation were not inferior to in-hospital initiation in terms of mean PaCO2 change (Δ) based on the adjusted Bayesian NMA model. No significant difference was found for any secondary outcomes: PaO2, HCO3−, adherence and quality of life.ConclusionDespite the limited number of studies included in this NMA, we found no evidence suggesting that home or outpatient NIV initiation is less effective than in-hospital initiation for individuals with NMD or RTD who are deemed suitable for home or outpatient care. Home NIV initiation may therefore be a particularly valuable strategy, especially when hospital resources are limited or when patient autonomy is compromised.PROSPERO registration numberCRD42023403339.
Journal Article
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