Assessment of health literacy in a French emergency department.

BACKGROUND: Health literacy (HL) has become a subject of major interest in public health worldwide. It is known to be linked to self-efficacy in care use and to global health status, and a non-negligible frequency of problematic or inadequate levels of HL in populations worldwide is reported. As this has yet to be evaluated in France, the present study aimed to evaluate the HL level of patients in a French emergency department (ED). METHODS: We conducted a descriptive, cross-sectional observational, single center study in the ED of the Lyon Sud hospital (Hospices civils de Lyon, Lyon, France). The primary endpoint was the HL level of the patients determined according to the score obtained using the 16-item European Health Literacy Survey Questionnaire. The secondary endpoint was the identification of sociodemographic factors associated with the HL level. RESULTS: A total of 189 patients were included for analysis. 10% (95% CI [3%; 17%]) of the patients had an inadequate HL, 38% (95% CI [31%; 45%]) had a problematic HL, and 53% (95% CI [46%; 61%] had an adequate HL. In multivariate analysis, age and perceived health status were independent predictors of the HL level; OR =0.82 (95% CI [0.69; 0.97]; p=0.026) for a 10-year increase in age, and OR =1.84 (95% CI [1.22; 2.82]; p=0.004]). CONCLUSIONS: The HL level of the patients in the ED studied herein was similar to that found in the population of France and other European countries and was influenced by age and perceived health status, which are both associated with care needs. It may be therefore interesting to explore in future studies how taking into consideration HL in the general population may lead to a better self-efficacy in care and optimize the use of the healthcare system.

Comparison of healthcare costs before and after a STEMI: A French national health data system-based cohort study.

BACKGROUND: Few studies have investigated real-world healthcare costs following a myocardial infarction (MI) and, to our knowledge, none after an ST-elevation MI (STEMI) specifically. Producing such data is important in order to help evaluate the economic burden of STEMI, but also to feed economic evaluation models and eventually show the economic interest of reducing STEMI incidence. The aim of this study was to estimate the healthcare cost in the year preceding and the year following a STEMI in France, in order to estimate the surplus in healthcare resource consumption after a STEMI. METHODS: This study was conducted from the healthcare system perspective. The individual data from the HIBISCUS-STEMI cohort, which included patients with acute STEMI undergoing primary percutaneous coronary intervention, were matched with the French national health data system (Système National des Données de Santé, SNDS) using a probabilistic method. All expenses (in- and out-hospital) presented for reimbursement were taken into account to estimate a mean annual healthcare cost. RESULTS: A total 258 patients from the HIBISCUS-STEMI cohort were included in this economic study. The total mean healthcare cost was estimated at €3516 before the STEMI, and at €9980 after the STEMI. Hospitalizations constituted the largest cost item, 27 % of the total cost before the STEMI and 41.8 % after the STEMI (Δ + 338.8 %). Follow-up and rehabilitative care represented the second largest cost item (25.9 % before and 18 % after the STEMI, Δ + 96.7 %). Treatments represented 19.4 % of the total cost before the STEMI and 17.2 % after (Δ + 150.8 %). CONCLUSIONS: This study shows a significant surplus (threefold) of healthcare resource consumption in the year following a STEMI compared to the year preceding the STEMI.

Toward an Interdisciplinary Approach to Constructing Care Delivery Pathways From Electronic Health Care Databases to Support Integrated Care in Chronic Conditions: Systematic Review of Quantification and Visualization Methods.

BACKGROUND: Electronic health care databases are increasingly used for informing clinical decision-making. In long-term care, linking and accessing information on health care delivered by different providers could improve coordination and health outcomes. Several methods for quantifying and visualizing this information into data-driven care delivery pathways (CDPs) have been proposed. To be integrated effectively and sustainably into routine care, these methods need to meet a range of prerequisites covering 3 broad domains: clinical, technological, and behavioral. Although advances have been made, development to date lacks a comprehensive interdisciplinary approach. As the field expands, it would benefit from developing common standards of development and reporting that integrate clinical, technological, and behavioral aspects. OBJECTIVE: We aimed to describe the content and development of long-term CDP quantification and visualization methods and to propose recommendations for future work. METHODS: We conducted a systematic review following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) recommendations. We searched peer-reviewed publications in English and reported the CDP methods by using the following data in the included studies: long-term care data and extracted data on clinical information and aims, technological development and characteristics, and user behaviors. The data are summarized in tables and presented narratively. RESULTS: Of the 2921 records identified, 14 studies were included, of which 13 (93%) were descriptive reports and 1 (7%) was a validation study. Clinical aims focused primarily on treatment decision-making (n=6, 43%) and care coordination (n=7, 50%). Technological development followed a similar process from scope definition to tool validation, with various levels of detail in reporting. User behaviors (n=3, 21%) referred to accessing CDPs, planning care, adjusting treatment, or supporting adherence. CONCLUSIONS: The use of electronic health care databases for quantifying and visualizing CDPs in long-term care is an emerging field. Detailed and standardized reporting of clinical and technological aspects is needed. Early consideration of how CDPs would be used, validated, and implemented in clinical practice would likely facilitate further development and adoption. TRIAL REGISTRATION: PROSPERO CRD42019140494; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=140494. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-033573.

Adherence with brand versus generic bisphosphonates among osteoporosis patients: a new-user cohort study in the French National Healthcare Insurance database.

Several studies documented declines in treatment adherence with generic forms of oral bisphosphonates in osteoporosis compared to branded forms, while others did not support this relation. Our aim was to compare medication adherence with brand versus generic forms of oral bisphosphonates. A new-user cohort study was conducted using routinely collected administrative and healthcare data linked at the individual level extracted from a nationwide representative sample of the French National Healthcare Insurance database. We included all patients aged 50 and older, new users of oral bisphosphonates for primary osteoporosis between 01/01/2009 and 31/12/2015. Two components of adherence were measured: implementation (continuous multiple-interval measure of medication availability version 7; CMA7) and persistence (time to discontinuation). The sample was composed of 1,834 in the "brand bisphosphonate" group and 1,495 patients in the "generic bisphosphonate" group. Initiating oral bisphosphonate treatment with brand was associated with a higher risk of discontinuation within 12 months (Hazard Ratio = 1.08; 95%CI = [1.02;1.14]). The risk of good implementation (CMA7 ≥ 0.90) was significantly lower in "brand bisphosphonate" group (Risk Ratio = 0.90; 95%CI = [0.85; 0.95]). We did not find any evidence to support the hypothesis of a lower adherence to generic bisphosphonates. In fact, prescribing of generic bisphosphonates led to a higher persistence rate and to better implementation at 1 year.

Myocardial infarction: Economic, health, and social impacts on informal caregivers.

OBJECTIVES: The aim of the study was to measure the economic impact of informal care (IC) on caregivers assisting myocardial infarction (MI) survivors in France. Health and social impacts were also described. METHODS: Data from the prospective 2008 Health and Disabilities Households Survey (Enquête Handicap-Santé), carried out among the French general population, were used to obtain information about patients with MI and their informal caregivers. To estimate the approximate monetary value of IC, three methods were used: the proxy good method, opportunity cost method (OCM), and contingent valuation method (CVM). A multivariate analysis was performed to determine the associations of the IC duration and the existence of professional care with the health indicators stated by caregivers. RESULTS: The analysis included data from 147 caregivers. The mean value of IC ranged from €9,679 per year using the CVM to €11,288 per year using the OCM (p > .05). The mean willingness to pay for an additional hour of IC was €10.9 (SD = 8.3). A total of 46.2 percent of caregivers reported that IC negatively affected theirs physical condition, and 46.3 percent reported that it negatively affected their psychological health. In addition, 40.1 percent declared that caregiving activity made them anxious and 38.8 percent stated they felt alone. Associations were identified between the duration of IC and feeling the need to be replaced, feeling alone and making sacrifices (p < .05). CONCLUSIONS: Informal caregiver burden may be recognized in health technology assessment in order not to underestimate the cost of strategies and to facilitate the comparability of cost-effectiveness outcomes between studies.

Cost-effectiveness analyses of interventions to improve osteoporosis care in France.

Osteoporosis (OP) is responsible for an important economic burden, but OP care is far from meeting therapeutic guidelines. Some interventions were effective to improve OP management. Our objective was to evaluate the cost-effectiveness of these interventions. Structural interventions and interventions consisting in sending educational material were dominant strategies. PURPOSE: Osteoporosis (OP) causes many osteoporotic fractures worldwide and an important economic burden as a result. OP care is far from meeting treatment guidelines, but in a recent meta-analysis, we showed that some interventions were effective to improve appropriate bone mineral density (BMD) and treatment prescriptions. In the context of limited resources, it is of major importance to measure these interventions' efficiency. Our objective was to evaluate the cost-effectiveness of existing effective intervention types. METHODS: We used a decision tree incorporating Markov models to compare costs and benefits (quality-adjusted life-years or QALYs) between usual care and three intervention types: structural (I), direct educational through conversation (II), and indirect educational by sending material (III). We adopted the collectivity perspective and chose a 30-year time horizon. The model included efficacy of interventions and risk of further fracture or death, depending on BMD T-score results and OP management, obtained from published literature. The model was populated to reflect a French setting. Deterministic and probabilistic sensitivity analyses were conducted. Costs were presented in 2018 euros (€). RESULTS: Interventions type I and III were dominant strategies compared with usual care (cost-saving with a QALY gain). Our results were consistent through sensitivity analyses. CONCLUSION: Our results suggest that structural interventions and indirect interventions to improve OP care (BMD and OP treatment prescription), in women 50 years old with a first fragility fracture, were dominant strategies.

Economic valuation of informal care provided to people after a myocardial infarction in France.

BACKGROUND: The aim of this study was to estimate the mean cost per caregiver of informal care during the first year after myocardial infarction event in France. METHODS: We used the Handicap-Santé French survey carried out in 2008 to obtain data about MI survivors and their caregivers. After obtaining the total number of informal care hours provided by caregiver during the first year after MI event, we estimated the value of informal care using the proxy good method and the contingent valuation method. RESULTS: For MI people receiving informal care, an annual mean cost was estimated at €12,404 (SD = 13,012) with the proxy good method and €12,798 (SD = 13,425) with the contingent valuation method per caregiver during the first year after myocardial infarction event. CONCLUSIONS: The present study suggests that informal care should be included more widely in economic evaluations in order not to underestimate the cost of diseases which induce disability.

Behavior Change Content, Understandability, and Actionability of Chronic Condition Self-Management Apps Available in France: Systematic Search and Evaluation.

BACKGROUND: The quality of life of people living with chronic conditions is highly dependent on self-management behaviors. Mobile health (mHealth) apps could facilitate self-management and thus help improve population health. To achieve their potential, apps need to target specific behaviors with appropriate techniques that support change and do so in a way that allows users to understand and act upon the content with which they interact. OBJECTIVE: Our objective was to identify apps targeted toward the self-management of chronic conditions and that are available in France. We aimed to examine what target behaviors and behavior change techniques (BCTs) they include, their level of understandability and actionability, and the associations between these characteristics. METHODS: We extracted data from the Google Play store on apps labelled as Top in the Medicine category. We also extracted data on apps that were found through 12 popular terms (ie, keywords) for the four most common chronic condition groups-cardiovascular diseases, cancers, respiratory diseases, and diabetes-along with apps identified through a literature search. We selected and downloaded native Android apps available in French for the self-management of any chronic condition in one of the four groups and extracted background characteristics (eg, stars and number of ratings), coded the presence of target behaviors and BCTs using the BCT taxonomy, and coded the understandability and actionability of apps using the Patient Education Material Assessment Tool for audiovisual materials (PEMAT-A/V). We performed descriptive statistics and bivariate statistical tests. RESULTS: A total of 44 distinct native apps were available for download in France and in French: 39 (89%) were found via the Google Play store and 5 (11%) were found via literature search. A total of 19 (43%) apps were for diabetes, 10 for cardiovascular diseases (23%), 8 for more than one condition in the four groups (18%), 6 for respiratory diseases (14%), and 1 for cancer (2%). The median number of target behaviors per app was 2 (range 0-7) and of BCTs per app was 3 (range 0-12). The most common BCT was self-monitoring of outcome(s) of behavior (31 apps), while the most common target behavior was tracking symptoms (30 apps). The median level of understandability was 42% and of actionability was 0%. Apps with more target behaviors and more BCTs were also more understandable (ρ=.31, P=.04 and ρ=.35, P=.02, respectively), but were not significantly more actionable (ρ=.24, P=.12 and ρ=.29, P=.054, respectively). CONCLUSIONS: These apps target few behaviors and include few BCTs, limiting their potential for behavior change. While content is moderately understandable, clear instructions on when and how to act are uncommon. Developers need to work closely with health professionals, users, and behavior change experts to improve content and format so apps can better support patients in coping with chronic conditions. Developers may use these criteria for assessing content and format to guide app development and evaluation of app performance. TRIAL REGISTRATION: PROSPERO CRD42018094012; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=94012.

The French Pregnancy Cohort: Medication use during pregnancy in the French population.

PURPOSE: We described the medication use during pregnancy in the French population using the French Pregnancy Cohort (FPC). METHODS: The FPC was built with the sampling of all pregnant women included in the French Echantillon généraliste des bénéficiaires (EGB), which is a 1/97th representative sample of the population covered by the French health insurance. The EGB includes anonymized information on the socio-demographic and medical characteristics of beneficiaries, and the health care services they have received such as diagnoses and procedure codes as well as data on filled reimbursed medication; EGB also includes data on hospital stays in all public and private French health facilities. Each filled prescription record contains information on drug brand and generic names, date of prescription and date of dispensing, quantity dispensed, mode of administration, duration of prescription, dosage, and prescribing physician specialty. FPC includes data on all pregnancies of women in the EGB (2010-2013). Date of entry in the FPC is the first day of pregnancy regardless of pregnancy outcome (spontaneous abortions or planned abortions (with or without medical reasons), deliveries), and data on women are collected retrospectively for a period of one year before pregnancy, and prospectively during pregnancy, and up to one year after delivery. The prevalence of prescribed medications before, during and after pregnancy was compared; comparison was also done between trimesters. Pregnancy outcomes are described and include spontaneous and planned abortions, livebirths, and stillbirths. RESULTS: FPC includes data on 36,065 pregnancies. Among them, 27,253 (75.6%) resulted in a delivery including 201 stillbirths (0.7%). The total number of spontaneous abortions was 6,718 (18.6%), and planned abortions 2,094 (5.8%). The prevalence of filled medication use was 91.1%, 89.9%, and 95.6% before, during and after pregnancy, respectively. Although there was a statistically significant decrease in the proportion of use once the pregnancy was diagnosed (first trimester exposure, 76.4% vs. exposure in the year prior to pregnancy, 91.1% (p < .01)), post-pregnancy medication use was above the pre-pregnancy level (95.6%). Maternal depression was the most prevalent comorbidity during pregnancy (20%), and post-partum depression was higher in those who delivered a stillborn infant (38.8%) as well as in those with a spontaneous (19.5%) or planned abortion (22.4%) compared to those with a liveborn (12.0%). CONCLUSION: FPC is an excellent tool for the study of the risk and benefit of drug use during the perinatal period. FPC has the advantage of including a representative sample of French pregnant women, and study medications only available in France in addition to others available worldwide.

Inequalities in Financial Distress, Symptoms, and Quality of Life Among Patients with Advanced Cancer in France and the U.S.

BACKGROUND: Financial distress (FD) is common among patients with advanced cancer. Our purpose was to compare the frequency and intensity of FD and its associations with symptom distress and quality of life (QOL) in these patients in France and the U.S. MATERIALS AND METHODS: In this secondary analysis of two cross-sectional studies, we assessed data on 292 patients who received cancer care at a public hospital or a comprehensive cancer center in France (143 patients) or the U.S. (149 patients). Outpatients and hospitalized patients over 18 years of age with advanced lung or breast or colorectal or prostate cancer were included. Diagnosed cognitive disorder was considered a noninclusion criterion. Advanced cancer included relapse or metastasis or locally advanced cancer or at least a second-line chemotherapy regimen. Patients self-rated FD and assessed symptoms, psychosocial distress, and QOL on validated questionnaires. RESULTS: The average patient age was 59 years, and 144 (49%) were female. FD and high intensity were reported more frequently in U.S. patients than in French (respectively 129 [88%] vs. 74 [52%], p < .001; 100 [98%] vs. 48 [34%], p < .001,). QOL was rated higher by the U.S. patients than by the French (69 [SD, 18] vs. 63 [SD, 18], p = .003). French patients had more psychological symptoms such as anxiety (8 [SD, 4] vs. 6 [SD, 5], p = .008). Associations were found between FD and U.S. residence, FD and single status (0.907, p = .023), and FD and metastasis (1.538, p = .036). In contrast, negative associations were found between FD and older age (-0.052, p = .003) and FD and France residence (-3.376, p = .001). CONCLUSION: Regardless of health care system, FD is frequent in patients with advanced cancer. U.S. patients were more likely to have FD than French patients but reported better QOL. Further research should focus on factors contributing to FD and opportunities for remediation. IMPLICATIONS FOR PRACTICE: Suffering is experienced in any component of the lives of patients with a life-threatening illness. Financial distress (FD) is one of the least explored cancer-related symptoms, and there are limited studies describing its impact on this frail population. This study highlights the high frequency and severity of FD in patients with advanced cancer in the U.S. and France as well as its impact on their physical and emotional symptoms and their quality of life in these different health care systems. It is necessary for all health care providers to explore and evaluate the presence of FD in patients living with life-threatening illnesses.

Health policy for telestroke in France: A retrospective description from 2003 to 2016.

INTRODUCTION: Stroke is a public health priority in France. The use of telemedicine for stroke known as telestroke, is a safe and effective practice improving access to acute stroke care including thrombolysis. Telestroke is currently being implemented in France. The objective was to describe the public health policy supporting telestroke implementation in France. METHODS: An external ex-post evaluation of telestroke policy in France was conducted through a retrospective descriptive study from 2003 to 31st December 2016. Process, content, and actors of the health policy were described at a national level. The logical framework of the telestroke policy was described. The stages model of public policy from the 'Institut National de Santé Publique du Quebec' was used. RESULTS: Agenda setting was produced from 2003 to 2007. Policy formulation lasted from 2008 to 2009 with official reports on telemedicine, telehealth and stroke. The decision-making stage included the national stroke plan, the national telemedicine implementation strategy and an administrative document in 2012 that described the organization of telestroke implementation. Implementation in 2011 was initiated with dedicated funding and methodological resources. No dedicated evaluation of policy for telestroke was defined. CONCLUSIONS: Using a health policy model allowed to describe the policies supporting telestroke implementation in France and to highlight the need for better evaluation.

A systematic review of economic evaluations on stent-retriever thrombectomy for acute ischemic stroke.

BACKGROUND: Our objective was to review economic evaluations on stent-retriever thrombectomy (SRT) added/not added to intravenous (IV) tissue plasminogen activator (t-PA) in acute ischemic stroke (AIS) due to large-vessel occlusion (LVO). METHODS: We conducted a systematic review using several electronic databases and searching for studies published from January 2009 to September 2017. INCLUSION CRITERIA: any publication type reporting the incremental cost-effectiveness ratio of SRT in people with AIS secondary to LVO. Quality assessment was undertaken with the CHEERS and the Philips' checklists. RESULTS: Eight original articles (four from North America/four from Europe) were included; of these, seven were model-based cost-effectiveness studies and one was a study conducted alongside a clinical trial. The perspective was the healthcare system in seven studies, and societal in one. The time horizon was lifetime (minimum 20 years) in all but two studies where it was 1 and 5 years. Overall, studies were rated of good quality (mean score 79%; range 70-90). Data sources, effectiveness outcomes and other input parameters were heterogeneous across studies. In three studies, SRT was dominant (less expensive and more effective). In five studies, SRT was more expensive and generated more quality-adjusted life years but had a high probability (79-100%) to be cost-effective at conventional thresholds. CONCLUSION: This review shows that SRT added/not added to IV t-PA is likely to be cost-effective or even dominant, which is consistent with the opinion from several Health Technology Assessment bodies recommending SRT. However, our findings are supported by primary studies with substantial methodological heterogeneity.

Financial distress in patients with advanced cancer.

PURPOSE: We examined the frequency and severity of financial distress (FD) and its association with quality of life (QOL) and symptoms among patients with advanced cancer in France. DESIGN: In this cross-sectional study, 143 patients with advanced cancer were enrolled. QOL was assessed using the Functional Assessment of Cancer General (FACT-G) and symptoms assessed using Edmonton Assessment System (ESAS) and Hospital Anxiety and Depression Scale (HADS). FD was assessed using a self-rated numeric scale from 0 to 10. RESULTS: Seventy-three (51%) patients reported having FD. Patients reported having FD were most likely to be younger (53.8 (16,7SD) versus 62 (10.5SD), p<0.001), single (33 (62%) versus 40(44%), p = 0.03) and had a breast cancer (26 (36%), p = 0.024). Patients with FD had a lower FACT-G score (59 versus 70, p = 0.005). FD decreased physical (14 versus 18, p = 0.008), emotional (14 versus 16, p = 0.008), social wellbeing (17 versus 19, p = 0.04). Patients with FD had higher HADS-D (8 versus 6 p = 0.007) and HADS-A (9 versus 7, p = 0.009) scores. FD was linked to increased ESAS score (59 (18SD) versus 67 (18SD), p = 0.005) and spiritual suffering (22(29SD) versus 13(23SD), p = 0.045). CONCLUSION: The high rate of patient-reported FD was unexpected in our studied population, as the French National Health Insurance covers specific cancer treatments. The FD was associated with a poorer quality of life. Having a systematic assessment, with a simple tool, should lead to future research on interventions that will increase patients' QOL.

Comparison of French training and non-training general practices: a cross-sectional study.

BACKGROUND: As the medicine practiced in hospital settings has become more specialized, training in primary care is becoming increasingly essential for medical students, especially for future general practitioners (GPs). Only a few limited studies have investigated the representativeness of medical practices delivering this training. The aim of this study was to assess the representativeness of French GP trainers in terms of socio-demographics, patients and activities. METHODS: We conducted a cross-sectional study covering all private GPs practicing in the Rhône-Alpes region of France in 2011. This population consisted of 4992 GPs, including 623 trainers and 4369 non-trainers, managing 8,198,684 individual patients. Data from 2011 to 2012 were provided by the Regional Health Care Insurance (RHCI). We compared GP trainers with non-trainers using the Pearson chi-square test for qualitative variables and the Student t-test for quantitative variables RESULTS: GP trainers do not differ from non-trainers for gender, but they tend to be younger, more frequently in mid-career, and more likely to practice in a rural area. Their patients are broadly representative of patients attending general practice for age (with the exception of a higher consultation rate for infants), but patients with medical fee exemption status relating to low income are underrepresented. GP trainers have a heavier workload in terms of office visits and on-call duties. They prescribe a higher proportion of generic drugs, perform more electrocardiograms and cervical smears, and fewer plaster casts. GP trainers show better performance in diabetes follow-up, and to a lesser extent for seasonal flu vaccination and mammograms. CONCLUSIONS: GPs and patients of training practices are globally representative, which is particularly critical in countries such as France, where the length of specialty training in a general practice setting is still limited to a few months. In addition, GP trainers tend to have better clinical performance, which conforms to their teaching modelling role and may encourage other GPs to become trainers.

Patient Mortality Is Associated With Staff Resources and Workload in the ICU: A Multicenter Observational Study.

OBJECTIVE: Matching healthcare staff resources to patient needs in the ICU is a key factor for quality of care. We aimed to assess the impact of the staffing-to-patient ratio and workload on ICU mortality. DESIGN: We performed a multicenter longitudinal study using routinely collected hospital data. SETTING: Information pertaining to every patient in eight ICUs from four university hospitals from January to December 2013 was analyzed. PATIENTS: A total of 5,718 inpatient stays were included. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We used a shift-by-shift varying measure of the patient-to-caregiver ratio in combination with workload to establish their relationships with ICU mortality over time, excluding patients with decision to forego life-sustaining therapy. Using a multilevel Poisson regression, we quantified ICU mortality-relative risk, adjusted for patient turnover, severity, and staffing levels. The risk of death was increased by 3.5 (95% CI, 1.3-9.1) when the patient-to-nurse ratio was greater than 2.5, and it was increased by 2.0 (95% CI, 1.3-3.2) when the patient-to-physician ratio exceeded 14. The highest ratios occurred more frequently during the weekend for nurse staffing and during the night for physicians (p < 0.001). High patient turnover (adjusted relative risk, 5.6 [2.0-15.0]) and the volume of life-sustaining procedures performed by staff (adjusted relative risk, 5.9 [4.3-7.9]) were also associated with increased mortality. CONCLUSIONS: This study proposes evidence-based thresholds for patient-to-caregiver ratios, above which patient safety may be endangered in the ICU. Real-time monitoring of staffing levels and workload is feasible for adjusting caregivers' resources to patients' needs.

Impact of vitamin D supplementation on health-care use in a 25-hydroxyvitamin D-tested population in France: a population-based descriptive cohort study.

OBJECTIVE: Chronic vitamin D deficiency has been associated in some patients with diffuse musculoskeletal pain. These unspecific symptoms may partly explain why vitamin D deficiency is often diagnosed late. Our aim was to analyse health-care claims after vitamin D supplementation in patients likely to have vitamin D deficiency. DESIGN: Ambulatory health-care claims were compared before and after a vitamin D supplementation prescribed following a 25-hydroxyvitamin D assay. SETTING: Health Insurance Fund (FHIF) database of the Rhône-Alpes area, France. SUBJECTS: Among patients reimbursed for a 25-hydroxyvitamin D assay between 1 December 2008 and 31 January 2009, those supplemented with vitamin D after the assay were matched on the date of assay to patients who did not receive vitamin D. RESULTS: Among the 3023 patients who had a 25-hydroxyvitamin D assay, 935 were consequently supplemented and matched to 935 patients not supplemented. Their median age was 50·0 and 49·5 years, respectively. Patients supplemented decreased their muscle relaxant consumption whereas no change was observed in the reference group, the difference between the two groups was significant (P=0·03). Second and third Pain Relief Ladder prescriptions decreased in both groups but not significantly differently between groups (P=0·58). There was a decrease in prescriptions of biological examination in both groups with no significant difference. CONCLUSIONS: Besides a decrease in muscle relaxant prescriptions in the supplemented group, it was difficult to assess the impact of vitamin D supplementation in patients likely to have vitamin D deficiency. Prospective cohort studies and randomized trials are needed to assess the efficiency of screening and supplementing vitamin D deficiency.

Persistence at 1 year of oral antiosteoporotic drugs: a prospective study in a comprehensive health insurance database.

OBJECTIVE: Treatments against osteoporosis have demonstrated fracture risk reduction but persistence to therapy remains a major issue. Intermittent regimens have been developed to improve persistence. The aim of this 1-year prospective study was to compare, in the general population, the persistence of various oral regimens of antiosteoporotic treatment. METHODS: We conducted this prospective study in the French comprehensive public health insurance database of the Rhône-Alpes region. Women aged 45 years or older who had a first reimbursement of an oral antiosteoporotic treatment during February 2007 composed the study cohort. Persistence was defined by the proportion of patients refilling a prescription in the pharmacist delivery register (ERASME). Using statistical analyses like Kaplan-Meier survival curves and log-rank tests, we compared the treatment persistence of strontium ranelate, raloxifene, and daily-, weekly-, and monthly bisphosphonates. RESULTS: Two thousand four hundred and nineteen patients were included over a period of 1 month and followed up for 12 months. Two hundred and eighty-nine (11.9%) patients were treated with monthly bisphosphonates, 1298 (53.7%) with weekly bisphosphonates, and 832 (34.4%) with daily treatments (526 strontium ranelate (21.7%), 296 raloxifene (12.2%), and 10 bisphosphonates (0.4%)). At 1 year, overall persistence was 34%. Fifty percent of patients on monthly bisphosphonates were still persistent while only 37% of patients on weekly bisphosphonates, 34% on raloxifene, and 16% on strontium ranelate were persistent. Therapy monitoring with biochemical markers or bone mineral density was associated with improved persistence. CONCLUSION: Overall persistence at 1 year was low, but intermittent regimens were associated with higher persistence rates, along with women who had therapy monitoring.

Crude versus case-mix-adjusted control charts for safety monitoring in thyroid surgery.

INTRODUCTION: Patient-safety monitoring based on health-outcome indicators can lead to misinterpretation of changes in case mix. This study aimed to compare the detection of indicator variations between crude and case-mix-adjusted control charts using data from thyroid surgeries. METHODS: The study population included each patient who underwent thyroid surgery in a teaching hospital from January 2006 to May 2008. Patient safety was monitored according to two indicators, which are immediately recognisable postoperative complications: recurrent laryngeal nerve palsy and hypocalcaemia. Each indicator was plotted monthly on a p-control chart using exact limits. The weighted κ statistic was calculated to measure the agreement between crude and case-mix-adjusted control charts. RESULTS: We evaluated the outcomes of 1405 thyroidectomies. The overall proportions of immediate recurrent laryngeal nerve palsy and hypocalcaemia were 7.4% and 20.5%, respectively. The proportion of agreement in the detection of indicator variations between the crude and case-mix-adjusted p-charts was 95% (95% CI 85% to 99%). The strength of the agreement was κ = 0.76 (95% CI 0.54 to 0.98). The single special cause of variation that occurred was only detected by the case-mix-adjusted p-chart. CONCLUSIONS: There was good agreement in the detection of indicator variations between crude and case-mix-adjusted p-charts. The joint use of crude and adjusted charts seems to be a reasonable approach to increase the accuracy of interpretation of variations in outcome indicators.

Breast cancer incidence using administrative data: correction with sensitivity and specificity.

OBJECTIVE: To estimate breast cancer incidence in the general population using a method that corrects for lack of sensitivity and specificity in the identification of incident breast cancer in inpatient claims data. STUDY DESIGN AND SETTINGS: Two-phase study: phase 1 to identify incident cases in claims data, and phase 2 to estimate sensitivity and specificity in a subset of the population. Two algorithms (1: principal diagnosis; 2: principal diagnosis+specific surgery procedures) were used to identify incident cases in claims of women aged 20 years or older, living in a French district covered by a cancer registry. Sensitivity and specificity were estimated in one district and used to correct incident cases identified. RESULTS: The sensitivity and specificity for algorithms 1 and 2 were 69.0% and 99.89%, and 64.4% and 99.93%, respectively. In contrast to specificity, the sensitivity for both algorithms was lower for women younger than 40 years and older than 65 years. Cases reported by cancer registries were closer to cases identified with algorithm 2 (-3.2% to +20.1%) and to corrected numbers with algorithm 1 (-1% to +15%). CONCLUSION: To obtain reliable estimates of breast cancer incidence in the general population, sensitivity and specificity, which reflect medical and coding practice variations, are necessary.

French claims data as a source of information to describe cancer incidence: predictive values of two identification methods of incident prostate cancers.

Claims data from the "Programme de Médicalisation du Système d'Information" (PMSI) have been commonly used for several years to complement cancer registries and describe cancer incidence in France. It is less clear whether or not it is possible to use these data as an independent source of information to assess cancer incidence, in the absence of a regional cancer registry. Following a similar study on breast cancer, we present a study which aimed to evaluate two methods of identifying incident prostate cancer using claims data. These methods were developed using claims data from the Hospices Civils de Lyon (HCL) and their validity was tested against medical records. The first method (M1) identified incident patients as those who had at least one stay with a principal diagnosis of prostate cancer. The second method (M2) had a prostate cancer treatment code in addition to the criteria for the first method. Both methods of identification had similar results, indicating a low rate of false negatives (negative predictive values: M1 = 100 [CI95: 93.8-100], M2 = 98.6 [CI95: 90.1-99.6]) and a high rate of false positives (positive predictive values: M1 = 33.3 [CI95: 23.2-42.1], M2 = 33.7 [CI95: 24.2-43.2]). The sample size did not allow us to produce consistent estimates of sensitivity and specificity. Our results showed that an estimation of the number of incident cases of prostate cancer using both methods of identification would be biased because of the high rate of false positives. Statistical methods that correct identification errors should be used.