Regulatory assessment of nano-enabled health products in public health interest. Position of the scientific advisory board of the French National Agency for the Safety of Medicines and Health Products.

Nanomaterials are present in a wide variety of health products, drugs and medical devices and their use is constantly increasing, varying in terms of diversity and quantity. The topic is vast because it covers nanodrugs, but also excipients (that includes varying proportions of NMs) and medical devices (with intended or not-intended (by-products of wear) nanoparticles). Although researchers in the field of nanomedicines in clinical research and industry push for clearer definitions and relevant regulations, the endeavor is challenging due to the enormous diversity of NMs in use and their specific properties. In addition, regulatory hurdles and discrepancies are often cited as obstacles to the clinical development of these innovative products. The scientific council of the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) undertook a multidisciplinary analysis encompassing fundamental, environmental and societal dimensions with the aim of identifying topics of interest for regulatory assessment and surveillance. This analysis allowed for proposing some recommendations for approximation and harmonization of international regulatory practices for the assessment of the risk/benefit balance of these products, considering as well the public expectations as regards efficacy and safety of nanomaterials used in Health products, in terms of human and environmental health.

Potentially inappropriate medications in nursing homes and the community older adults using the French health insurance databases.

PURPOSE: Potentially inappropriate medications (PIMs) have become a major issue in improving prescribing practices and reducing the risk of adverse drug events in older people. However, very few studies have compared exposition to PIMs controlling for differences in demographic and health between nursing home residents (NHRs) and community-dwelling older adults (CDOAs). This study aimed to assess the prescribing pattern of PIMs between NHRs and CDOAs. METHODS: We conducted a cross-sectional study over three months in 2019 using the French Health Insurance databases. The study population included 274 971 NHRs and 4 893 721 CDOAs aged 75 years or over. The prevalence ratio (PR) between NHRs and CDOAs of 17 PIM indicators, based on the Beers and STOPP criteria lists, was assessed using multivariable robust Poisson regression adjusted for age, sex, diseases, and polypharmacy. RESULTS: During the study period, 54% of NHRs and 29% of CDOAs received at least one PIM. After adjustment, the prevalence of PIMs was 33% higher among NHRs compared to CDOAs (aPR = 1.33; 95% CI [1.33-1.34]). NHRs received PIMs related to benzodiazepines (aPR = 1.43; 95% CI [1.42-1.43]), anticholinergic drugs (aPR = 1.29; 95% CI [1.27-1.31]), and at least three central nervous system-active drugs (aPR = 1.94; 95% CI [1.92-1.96]) more frequently. Prevalence of PIMs related to non-steroidal anti-inflammatory drugs (aPR = 0.50; 95% CI [0.48-0.52]) and long-acting benzodiazepines (aPR = 0.84; 95% CI [0.82-0.85]) was lower among NHRs. CONCLUSION: The NHRs were at greater risk for PIM than CDOAs, although differences exist according to the category of PIMs. As the population is aging, it is essential to promote and evaluate interventions in NHs and the community to enhance medication optimization.

Uses and perceptions of medications among French older adults: results from the 2020 French Health Barometer survey.

BACKGROUND: There are few studies reporting on self-medication, perceptions or difficulties older adults have with their medications. This study aimed to describe the uses and the perceptions of medications among older adults in France and to identify patient groups based on that information. METHODS: We used data from the 2020 'French Health Barometer' - a nationally-representative cross-sectional survey. We assessed polypharmacy (five or more medications), self-medication, and patient perceptions of medications. Robust Poisson regression was used to investigate socio-demographic and health-related factors associated with the outcomes. Latent class analysis was used to identify patient groups classified by the use and the perceptions of medications. Factors associated with group assignment were investigated by multinomial logistic regression. All analyses were weighted. RESULTS: The study sample comprised 1,623 respondents aged 70-85 years. Polypharmacy and self-medication were reported in 23.5 and 48.7% of the older population, respectively. Polypharmacy was associated with increasing age, low education, and impaired health status. Self-medication was associated with female sex and high education. Among individuals taking at least 1 medication, 8.2% reported not to understand all their medications, and 9.7% having difficulty taking medications as prescribed. Among individuals taking at least 2 medications, 23.2% thought that they took too many medications. Three patient groups were identified: 'Non-polypharmacy, positive perceptions' (62.5%), 'Polypharmacy, positive perceptions' (28.0%), and 'Negative perceptions' (9.5%). CONCLUSIONS: Polypharmacy and self-medication are common in French older adults. One segment of people reported negative perceptions of their medications regardless of their polypharmacy status. This underlines the difference between the objective and perceived measures of polypharmacy.

Environmental barriers matter from the early stages of functional decline among older adults in France.

BACKGROUND: The adaptation of living environments can preserve functional independence among older people. A few studies have suggested that this would only benefit the most impaired. But conceptual models theorize that environmental pressure gradually increases with functional decline. OBJECTIVES: We examined (1) how far different environmental barriers increased difficulties and favoured resort to assistance; (2) at what stage in functional decline environmental barriers begin to matter. METHODS: We used the French cross-sectional survey CARE (2015), including 7,451 participants (60+) with at least one severe functional limitation (FL). Multinomial logistic regressions models were used to compare predicted probabilities for outdoor activities of daily living (OADL) difficulties (no OADL difficulties; difficulties but without assistance; use of assistance) among individuals with and without environmental barriers (self-reported or objective), in relation to the number of FLs. RESULTS: Poor-quality pedestrian areas and lack of places to rest were associated with a higher probability of experiencing OADL difficulties, whatever the number of FLs; the association increased with the number of FLs. Up to 6 FLs, individuals with these barriers were more likely to report difficulties without resorting to assistance, with a decreasing association. Living in cities/towns with high diversity of food outlets was associated with a lower probability of reporting assistance, whatever the number of FLs, but with a decreasing association. DISCUSSION: Overall, the results suggest that environmental barriers increasingly contribute to OADL difficulties with the number of FLs. Conclusions differed as to whether they tended to favour resort to assistance, but there was a clear association with food outlets, which decreased with impairment severity. The adaptation of living environments could reduce difficulties in performing activities from the early stages of decline to the most severe impairment. However, the most deteriorated functional impairments seem to generate resort to assistance whatever the quality of the environment.

Treatment for multiple myeloma in hospital at home: clinical characteristics and patient care pathways.

While most patients receive anticancer injection in a conventional hospital, some are treated in hospital at home. Given the lack of data, we seek to determine the clinical characteristics and care pathways of patients benefiting from hospital at home (HAH) for anticancer injection. A longitudinal scheme was conducted about patients with multiple myeloma (MM) starting bortezomib-based regimens in HAH in 2015 with a follow-up to September 2019. 154 patients received bortezomib at home with a mean age of 70.6 years, 72.7% over 65y-old and, a median Karnofsky Performans Status of 70. One-third of the elderly lived alone, 16.1% required domestic help. After a 24-month follow-up, 77.9% of patients were alive. The median overall survival was not reached at 4 years. Between 42.1% and 48.1% of patients returned to HAH for a new line of treatment. Patients were mainly independent and "fit." The involvement of HAH was achieved without safety issues nor compromise long-term outcomes. However, the real-world patterns highlighted that only a small proportion of patients returned to HAH for a new treatment line.

Decreasing trends in potentially inappropriate medications in older people: a nationwide repeated cross-sectional study.

BACKGROUND: Potentially Inappropriate Medications (PIMs) and polypharmacy are widely used indicators of suboptimal prescribing for older people. The aim of this study was to describe the changes in the prevalence of PIMs and polypharmacy among people aged 75 years and over between 2011 and 2019 in France. METHODS: PIMs and polypharmacy were assessed among people aged 75 years and over every two years between 2011 and 2019 using the French health insurance data system. Sixteen PIM criteria from the 2015 Beers and STOPP lists were assessed. Polypharmacy (5 to 9 drugs) and hyper-polypharmacy (≥10 drugs) were defined based on the average number of drugs dispensed per quarter. The Annual Percent Change (APC) and 95%CI were assessed using linear regression models after standardization of the prevalence on age and sex. RESULTS: The study population included 5,777,645 individuals over 75 years old in 2011 and 6,328,155 in 2019. The prevalence of PIMs decreased from 49.6 to 39.6% over the study period (APC: - 1.19% [- 1.35;-1.04]). Of the sixteen indicators assessed, the prevalence of thirteen decreased between 2011 and 2019. Benzodiazepines were the most frequent PIMs (34.7% in 2011 to 26.9% in 2019), followed by anticholinergic drugs (12.1% in 2011 to 8.3% in 2019), oral non-steroidal anti-inflammatory drugs (11.4 to 7.8%), and PIMs related to antihypertensive drugs (7.4 to 6.0%). Overall, women and individuals aged 85 years and older were more likely to receive PIMs. The prevalence of hyper-polypharmacy decreased from 30.5 to 25.9% over the study period. CONCLUSION: This study, which is the first to assess the change in prevalence of PIMs and polypharmacy over time from comprehensive health data in France, highlights that PIMs and hyper-polypharmacy declined between 2011 and 2019. However, PIMs remains frequent for older people and often involves benzodiazepines.

Impacts on health outcomes and on resources utilization for anticancer drugs injection at home, a complex intervention: a systematic review.

BACKGROUND: As hospital-based home care is a complex intervention, we critically appraised the key elements that could ensure the completeness of assessment and explain the heterogeneity of the literature results about the comparison between home and hospital setting for the anticancer drugs injection within the same standards of clinical care. METHODS: Systematic review was conducted. Medline, Embase, Cochrane Library, Web of Sciences, and Cumulative Index of Nursing and Allied Health (Cinahl) searched to February 1, 2019, and combined with grey literature. Methodological quality has been rated using the "Quality Assessment Tool for Quantitative Studies" developed by the Effective Public Health Practice Project (EPHHP) in addition to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement for economic studies and the consolidated criteria for reporting qualitative research (COREQ) checklist for qualitative studies. RESULTS: Of 400 records identified, we identified 13 relevant studies (nine quantitative and four mixed-method studies). The quality of studies was hardly strong. The home-based anticancer injection involved highly heterogeneous home care interventions that generally kept a strong link with the hospital setting. The study schemes limited the comparison of clinical outcomes (OS, PFS, toxicity). Unlike the quality of life remaining similar, patients preferred to be treated at home. Cost savings were in favor of Hospital at Home, but the charge categories used to compare or the home intervention were heterogeneous and rarely integrating relatives' duties and hospital staff's time. Qualitative studies highlighted about benefits and barriers of home. CONCLUSION: The current state of evidence shows as it still remains difficult to appraise the anticancer injection at home when considering the details of this complex intervention, the role of each stakeholder, and the missing data.

COVID-19 outbreak: An experience to reappraise the role of hospital at home in the anti-cancer drug injection.

BACKGROUND: The COVID-19 outbreak has posed considerable challenges to the health care system worldwide, especially for cancer treatment. We described the activity and the care organisation of the Hospitalisation At Home (HAH) structure during the pandemic for treating patients with anti-cancer injections. METHODS: We report the established organisation, the eligibility criteria, the patient characteristics, the treatment schemes and the stakeholders' role during two 5-week periods in 2020, before and during the French population's lockdown. RESULTS: The increase of activity during the lockdown (+32% of treated patients, +156% of new patients and +28% of delivered preparations) concerned solid tumour, mainly breast cancer, even if haematological malignancies remained the most frequent. Thirty different drugs were delivered, including three new drugs administered in HAH versus 19 during the routine period (p < 0.01). For those clinical departments accustomed to using HAH, the usual organisation was kept, but with adjustments. Five clinical departments increased the number of patients treated at home and widened the panel of drugs prescribed. Three oncology departments and one radiotherapy department for the first time solicited HAH for anti-cancer injections, mainly for immunotherapy. We adjusted the HAH organisation with additional human resources and allowed to prescribe drugs with an infusion time of <30 min only for the new prescribers. CONCLUSION: HAH allowed for the continuation of anti-cancer injections without postponement during the pandemic, and for a decrease in unnecessary patient travel to hospital with its concomitant COVID-19 transmission risk. Often left out of guidelines, the place of HAH in treating cancer patients should be reappraised, even more so during a pandemic.

Removal of Drugs for Alzheimer's Disease from the List of Reimbursable Drugs in France: Analysis of Change in Drug Use, Disease Management and Cognition Using the National Alzheimer Data Bank (BNA).

BACKGROUND: Because of insufficient data about their benefit-risk ratio in real life, drugs used for Alzheimer's disease (AD; cholinesterase inhibitors and memantine) were withdrawn from the list of reimbursable drugs in France on 1 August 2018. OBJECTIVES: In this context, this study aimed to investigate the effects of the removal of AD drugs from the list of reimbursed drugs among patients followed in memory centres in France, in terms of prevalence and factors associated with drug discontinuation and evolution of disease management and cognition after drug discontinuation. METHODS: This is an observational study based on data from the National Alzheimer Data Bank ('Banque Nationale Alzheimer' [BNA]), which centralizes information about patients consulting in memory centres. The drug discontinuation rate was estimated among patients receiving AD drugs at the last visit before the end of reimbursement. Factors associated with drug discontinuation were investigated among sociodemographic and disease characteristics, as well as among the use of healthcare resources before the end of reimbursement. We compared the evolution of disease management (psychotropic drugs and non-pharmacological interventions) and Mini-Mental State Examination (MMSE) score during the year following the end of reimbursement among patients with a diagnosis of AD. RESULTS: Among the 19,380 patients of the study sample (62.5% females, mean age 81 years, 86.8% with a diagnosis of AD), 19.5% discontinued their treatment after the end of reimbursement. The main factors associated with drug discontinuation were the type of dementia and lower MMSE level. Compared with patients with a diagnosis of AD, those with vascular dementia were more likely to stop their treatment, whereas those with dementia with Lewy bodies were less likely to discontinue. Among patients with a diagnosis of AD, drug discontinuation was associated with increased use of psychotropic medications, especially antidepressants, and non-pharmacological interventions afterwards, but there was no difference regarding the evolution of MMSE score. CONCLUSION: This study provides real-life information about the use of AD drugs after they were withdrawn from reimbursement in France and shows that drug discontinuation was limited among patients followed in memory centres and accompanied by increased use of other healthcare resources.

Asthma is associated with frailty among community-dwelling adults: the GAZEL cohort.

INTRODUCTION: Early management of chronic respiratory diseases (CRDs) and frailty have been identified as key targets towards healthy ageing, but the association between CRDs and frailty has been poorly investigated. We studied the association between asthma and frailty in adults of the GAZEL cohort using different definitions of asthma over the 26 years of follow-up. METHODS: Current asthma definitions are based on yearly self-reports of symptoms or medication (in 2015, constant reports or at least one report between 1990 and 2015), or on a detailed respiratory symptoms questionnaire in 2002. Frailty definition is based on weakness, fatigue, unintentional weight loss, low physical activity and mobility in 2015. Frail participants had three criteria or more, pre-frail 1 or 2, and robust 0. Multinomial regression models adjusted for age, sex, body mass index, smoking, education, marital status and comorbidities were performed. RESULTS: In 2015, 12 345 adults (73% men, 61 to 77 years old) were included: 3% of them reported current asthma, 1.6% had constant reports during the follow-up and 9% reported current asthma at least once. In 2015, 6% were frail, 34% pre-frail and 13% of current asthmatics and 6% of non-asthmatics were frail (adjusted OR (aOR) 2.19 (1.44 to 3.34)). Significant associations were also found with the 2002 definition (aOR 2.24 (1.73 to 2.90)), constant reports (aOR 3.67 (1.70 to 7.93)) or at least once (aOR 1.50 (1.15 to 1.98)). Current asthma was also associated with pre-frailty with the 2002 definition (aOR 1.46 (1.26 to 1.68)). DISCUSSION: Participants with asthma had increased risk of frailty. A better understanding of their relationship could help to define and evaluate strategies for a better ageing of asthmatics.

Association Between Life-Course Obesity and Frailty in Older Adults: Findings in the GAZEL Cohort.

OBJECTIVE: This study aimed to assess the relationship between weight history during adulthood and frailty in late life in men and women participating in the GAZEL (GAZ and ELectricité) cohort. METHODS: This cohort study included 8,751 men and 3,033 women (aged 61 to 76 years) followed up since 1989. Modified Fried's frailty criteria (weakness, fatigue, unintentional weight loss, low physical activity, and impaired mobility) were assessed in 2015. Reported BMI was determined each year to characterize: obesity status in 2015, obesity duration over the 1990 to 2015 period, and trajectories of BMI. Associations between frailty and weight history were assessed using multinomial regression. RESULTS: In 2015, 12% of men had obesity, 1.8% severe obesity, and 0.4% morbid obesity; for women, these percentages were 11%, 2.2%, and 0.8%, respectively. Individuals with obesity were more likely to be frail than those with normal BMI and the risk of frailty increased with each additional year of obesity (adjusted odds ratio 1.04 [1.00-1.08] for men and 1.07 [1.02-1.13] for women). Trajectories of BMI revealed that both long-term obesity and onset of obesity in late adulthood were associated with frailty. CONCLUSIONS: Current and past obesity appear to be important determinants of frailty. Early weight management may be beneficial in old age.

Factors associated with changes of the frailty status after age 70: Findings in the MAPT study.

PURPOSE: Frailty has become a major issue in the prevention of functional decline and disability in aged populations. Using repeated measurements of frailty over 3 years, this work aimed to describe transitions between frailty states and associated factors. METHODS: This study used the data from the Multidomain Alzheimer Preventive Trial and included the 842 participants aged 70 and over who did not receive the multidomain intervention. Frailty was assessed using the phenotype proposed by Fried et al. at baseline and at 6, 12, 24, and 36 months. Factors influencing the transitions across frailty states were examined using multistate modeling. RESULTS: The study population included 548 women and 294 men, mean age 75.4 ± 4.5 years. At baseline, 430 (53%) participants were nonfrail, 349 (43%) prefrail, and 28 (4%) frail. A total of 2271 pairs of consecutive measurements of frailty status were available over the 3 years of follow-up, with no change in frailty status in 1548 of them (68%), a worsening of frailty status in 426 of them (19%), and an improvement in frailty status in the remaining 297 (13%). Polypharmacy (i.e., ≥6 drugs) and probable depression were associated with incident prefrailty. Female gender was systematically associated with a lower probability of recovering from prefrailty and frailty. Older age, overweight, comorbidity, and abnormal C-reactive protein also reduced the probability of recovery from frailty or prefrailty. CONCLUSIONS: This study sheds light on factors that should be further investigated in future research to help the prevention and management of frailty.

Frailty and Associated Factors among Centenarians in the 5-COOP Countries.

BACKGROUND: The global number of centenarians is still strongly growing and information about the health and healthcare needs of this segment of the population is needed. This study aimed to estimate the prevalence of frailty among centenarians included in a multinational study and to investigate associated factors. METHODS: The 5-COOP study is a cross-sectional survey including 1,253 centenarians in 5 countries (Japan, France, Switzerland, Denmark, and Sweden). Data were collected using a standardized questionnaire during a face-to-face interview (73.3%), telephone interview (14.5%), or by postal questionnaire (12.2%). The 5 dimensions of the frailty phenotype (weight loss, fatigue, weakness, slow walking speed, and low level of physical activity) were assessed by using self-reported data. Factors associated with frailty criteria were investigated by using multivariate regression models. RESULTS: Almost 95% of the participants had at least 1 frailty criterion. The overall prevalence of frailty (3 criteria or more) was 64.7% (from 51.5% in Sweden to 77.6% in Switzerland), and 32.2% of the participants had 4 or 5 criteria. The most frequent criteria were weakness (84.2%), slow walking speed (77.6%), and low level of physical activity (72.5%), followed by fatigue (43.8%) and weight loss (23.8%). Factors associated with frailty included data collection modes, country of residence, gender, living in institution, depression, dementia, disability, falls, and sensory impairments. CONCLUSIONS: This study shows that reaching 100 years of age rarely goes without frailty and sheds light on factors associated with frailty at a very old age.

What is the duration of life expectancy in the state of frailty? Estimates in the SIPAF study.

The screening of frailty can trigger interventions aiming to delay disability in older people. Whereas the prevalence, the consequences, and the factors associated with frailty are well described, little is known about the duration of the state of frailty. This study aimed to estimate the time spent in the state of frailty in men and women using the Sullivan method. Data used were the age- and sex-specific prevalence of frailty found in SIPAF study ("Système d'Information sur la Perte d'Autonomie Fonctionnelle de la personne âgée") and statistics of mortality from the Human Mortality Database. The SIPAF study included 2350 individuals aged 70 and over and living in France. Participants were interviewed at home by trained nurses. Frailty was defined as impairment in three domains or more among nutrition, energy, physical activity, strength, and mobility. People requiring assistance in basic activities of daily living were considered in a separate category. Mean age of the study sample was 83.3 ± 7.5 years, with 59.4% of women. Overall, the prevalence of pre-frailty, frailty, and dependency was 39.1, 17.0, and 15.4%, respectively. Life expectancy at age 70 was 18.3 years for women, of which 7.4 years (95% CI 6.9-7.9) were pre-frail, 3.4 years (95% CI 3.0-3.8) frail, and 2.4 (95% CI 2.1-2.7) with disability. In contrast, LE for men at 70 was 14.8 years, of which pre-frail, frail, and disabled years were 6.0 years (95% CI 5.5-6.5), 1.2 years (95% CI 1.0-1.5), and 1.2 (95% CI 1.0-1.5), respectively. In conclusion, frailty is a transition state that is relatively limited in time compared to pre-frailty that may represent a larger time window for prevention.

Impacts on health outcomes and on resource utilisation of home-based parenteral chemotherapy administration: a systematic review protocol.

INTRODUCTION: Despite the demonstrated feasibility and policies to enable more to receive chemotherapy at home, in a few countries, parenteral chemotherapy administration at home remains currently marginal. Of note, findings of different studies on health outcomes and resources utilisation vary, leading to conflicting results. This protocol outlines a systematic review that seeks to synthesise and critically appraise the current state of evidence on the comparison between home setting and hospital setting for parenteral chemotherapy administration within the same high standards of clinical care. METHODS AND ANALYSIS: This protocol has been prepared following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols approach. Electronic searches will be conducted on bibliographic databases selected from the earliest available data through 15 November 2017 published in French and English languages. Additional potential papers in the selected studies and grey literature will be also included in the review. The review will include all types of studies exploring patients receiving anticancer drugs for injection at home compared with patients receiving the drugs in a hospital setting, and will assess at least one of the following criteria: patients' health outcomes, patients' or caregivers' satisfaction, resource utilisation with cost savings, and incentives and/or barriers of each admission setting according to patients' and relatives' points of view. Two reviewers will independently screen studies and extract relevant data from the included studies. Methodological quality of studies will be assessed using the 'Quality Assessment Tool for Quantitative Studies' developed by the Effective Public Health Practice Project tool, in addition to the Consolidated Health Economic Evaluation Reporting Standards statement for economic studies. ETHICS AND DISSEMINATION: As the review is focused on the analysis of secondary data, it does not require ethics approval. The results of the study will be disseminated through articles in peer-reviewed journals and trade publications, as well as presentations at relevant conferences. PROSPERO REGISTRATION NUMBER: CRD42017068164.

Naturalistic Driving Study Investigating Self-Regulation Behavior in Early Alzheimer's Disease: A Pilot Study.

BACKGROUND: Because cognitive processes decline in the earliest stages of Alzheimer's disease (AD), the driving abilities are often affected. The naturalistic driving approach is relevant to study the driving habits and behaviors in normal or critical situations in a familiar environment of participants. OBJECTIVE: This pilot study analyzed in-car video recordings of naturalistic driving in patients with early-stage AD and in healthy controls, with a special focus on tactical self-regulation behavior. METHODS: Twenty patients with early-stage AD (Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV] criteria), and 21 healthy older adults were included in the study. Data collection equipment was installed in their personal vehicles. Two expert psychologists assessed driving performance using a specially designed Naturalistic Driving Assessment Scale (NaDAS), paying particular attention to tactical self-regulation behavior, and they recorded all critical safety events. RESULTS: Poorer driving performance was observed among AD drivers: their tactical self-regulation behavior was of lower quality. AD patients had also twice as many critical events as healthy drivers and three times more "unaware" critical events. CONCLUSION: This pilot study used a naturalistic approach to accurately show that AD drivers have poorer tactical self-regulation behavior than healthy older drivers. Future deployment of assistance systems in vehicles should specifically target tactical self-regulation components.

Potentially inappropriate prescription of antidepressants in old people: characteristics, associated factors, and impact on mortality.

ABSTRACTBackground:The increasing use of antidepressants (ADs) has raised concerns about their inappropriate use in old people. OBJECTIVE: To examine the prevalence of potentially inappropriate prescribing (PIP) of ADs, their associated factors, and their impact on mortality in a sample of old people in France. METHODS: The analysis used data from the SIPAF study, a cross-sectional study consisting of 2,350 people aged ≥ 70 years. Trained nurses interviewed participants at home between 2008 and 2010. Information was collected concerning socio-demographic and health characteristics, including medication use. The study population consisted of the 318 AD users from the SIPAF study (13.5%). PIP of ADs was defined according to national and international criteria. Factors associated with PIP of ADs were assessed using a multivariate logistic regression model. The influence of PIP of ADs on mortality was assessed using a Cox model (median follow-up 2.8 years). RESULTS: Among the SIPAF study, 71% of AD users were female and the mean age was 84 ± 7 years. Selective serotonin reuptake inhibitors (SSRIs) were the most prescribed ADs (19.8%). We found PIP of ADs in 36.8% of the study population, mainly the co-prescription of diuretics with SSRIs (17.6%) and the prescription of tricyclics (12.9%). PIP of ADs was associated with polypharmacy (aOR5-9 drugs 2. 61, 95% CI 1.11-6.16 and aOR≥10 drugs 2.69, 95% CI 1.06-6.87) and comorbidity (aOR3-4 chronic diseases 2.59, 95%CI 1.04-6.44 and aOR≥5 chronic diseases 2.33, 95%CI 0.94-5.79), and increased the risk of mortality during follow-up (aHR 2.30, 95%CI 1.28-4.12). CONCLUSIONS: This study shows that more than one third of AD prescriptions may be inappropriate in old people. PIP of ADs was related to polypharmacy and comorbidity and increased mortality among AD users.

Evaluation de la culture de sécurité en Etablissement d'Hébergement pour Personnes Agées Dépendantes (EHPAD): adaptation française du questionnaire Nursing Home Survey on Patient Safety Culture.

The objective was to translate into French the American questionnaire "Nursing Home Survey on Patient Safety Culture" and to test the feasibility of its use in a sample of nursing homes. The questionnaire was translated by a multidisciplinary group of six experts and tested on a sample of people working in nursing homes. The questionnaire was then administered in five nursing homes. A first version of the French NHSPSC is proposed in this article. Despite similarities between items and ceiling effect for one item, the choices made were conservative to allow international comparisons. The administration of the questionnaire in five nursing homes confirmed the feasibility of the approach, with a participation of more than 50 per cent. This work made a French version of the NHSPSC available and confirmed that it is a feasible method for evaluating safety culture in nursing homes.

Frailty Related to Anesthesia guided by the Index "bispectraL" (FRAIL) study: study protocol for a randomized controlled trial.

BACKGROUND: Currently, patients older than 60 years of age represent 25% of the population and are at an increased risk during surgery. Therefore, reducing postoperative morbidity and mortality is a major concern in medical research and practice. Dependence on caregivers and cognitive impairment represent two major risk factors in the elderly, especially in frail patients after surgery under general anesthesia. In this context, continuous monitoring of the depth of anesthesia using a bispectral index (BIS) sensor may reduce the occurrence of impairments by gaining better control of the anesthetic depth. The first aim of this study is to compare manual versus automated administration of intravenous anesthetics with regard to 6-month functional decline in persons aged 70 years and older. The secondary objective includes an evaluation of the influence of the frail phenotype on self-sufficiency in elderly patients after general anesthesia. METHODS/DESIGN: After receiving ethical committee approval and written consent, a complete preoperative assessment of physiological reserve and self-sufficiency will be performed on patients more than 70 years old who are scheduled for surgery under general anesthesia. This evaluation will determine the patient's frailty status in three categories: robust, pre-frail, and frail. Then, patients will be randomized into two groups: manual administration of anesthetics guided by BIS sensor (manual group) or automated administration (automated group) with recording of the anesthesia. A second examination will be scheduled after 6 months to assess changes in functional abilities, cognitive functions, and frailty status. A priori calculation of sample size gives a population of 430 patients to be included in this multicenter trial. DISCUSSION: This clinical study is designed to detect any postoperative complications and deaths related to the performance of the general anesthesia guided by the BIS sensor and the preoperative functional status of the elderly: robust, pre-frail, or frail. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02524327 . Registered on 10 August 2015.