Health care management adequacy among French persons with severe profound intellectual and multiple disabilities: a longitudinal study.

BACKGROUND: The care organization of persons with profound intellectual and multiple disabilities (PIMD) varies by country according to the health care system. This study used a large sample of French individuals with severe PIMD/polyhandicap to assess: 1) the adequacy of care setting over a 5-year period and 2) health care consumption. METHODS: The longitudinal study used data from the French EVALuation PoLyHandicap (EVAL-PLH) cohort of persons with severe PIMD/polyhandicap who were receiving managed in specialized care centres and residential facilities. Two assessments were performed: wave 1 (T1) in 2015-2016 and wave 2 (T2) in 2020-2021. The inclusion criteria were as follows: age > 3 years at the time of inclusion; age at onset of cerebral lesion younger than 3 years old; and severe PIMD. The adequacy of the care setting was based on the following: i) objective indicators, i.e., adequacy for age and adequacy for health status severity; ii) subjective indicators, i.e., self-perception of the referring physician about medical care adequacy and educational care adequacy. Health care consumption was assessed based on medical and paramedical care. RESULTS: Among the 492 persons assessed at the 2 times, 50% of individuals at T1 and 46% of individuals at T2 were in an inadequate care setting based on age and severity. Regarding global subjective inadequacy, the combination of medical adequacy and educational adequacy, 7% of individuals at T1 and 13% of individuals at T2 were in an inadequate care setting. At T2, a majority of individuals were undermonitored by medical care providers (general practitioners, physical medicine rehabilitation physicians, neurologists, orthopaedists, etc.). Important gaps were found between performed and prescribed sessions of various paramedical care (physiotherapy, occupational therapy, psychomotor therapy, etc.). CONCLUSIONS: This study revealed key elements of inadequate care management for persons with severe PIMD/polyhandicap in France. Based on these important findings, healthcare workers, familial caregivers, patients experts, and health decision-makers should develop appropriate care organizations to optimize the global care management of these individuals. TRIAL REGISTRATION: NCT02400528, registered 27/03/2015.

Pregnancy, delivery and neonatal complications in women with schizophrenia: a national population-based cohort study.

BACKGROUND: Existing studies evaluating the association between schizophrenia and complications associated with pregnancy, delivery and neonatal outcomes are based on data prior to 2014 and have reported heterogeneous results. The objective of our study was to determine whether pregnant women with schizophrenia were at increased risk of pregnancy, delivery and neonatal complications compared with women without severe mental disorders. METHODS: We performed a population-based cohort study of all singleton deliveries in France between Jan. 1, 2015, and Dec. 31, 2019. We divided this population into cases (i.e., women with schizophrenia) and controls (i.e., women without a diagnosis of severe mental disorder). Cases and controls were matched (1:4) inside the same hospital and the same year by age, social deprivation, parity, smoking, alcohol and substance addictions, malnutrition, obesity, and comorbidities. Univariate and multivariate models with odds ratios and 95% confidence intervals (ORs [95% CIs]) were used to estimate the association between schizophrenia and 24 pregnancy, delivery and neonatal outcomes. FINDINGS: Over 5 years, 3,667,461 singleton deliveries were identified, of which 3,108 occurred in women with schizophrenia. Compared to controls, women with schizophrenia were found to be older; have more frequent smoking, alcohol and substance addictions; suffer from obesity, diabetes and chronic obstructive pulmonary disease; and often be hospitalized in tertiary maternity hospitals. Compared to matched controls, women with schizophrenia had more pregnancy complications (adjusted OR=1.41[95%CI 1.31-1.51]) (i.e., gestational diabetes, gestational hypertension, genito-urinary infection, intrauterine growth retardation and threatened preterm labour). They had more delivery complications (aOR=1.18[95%CI 1.09 1.29]) with more still births/medical abortions (aOR=2.17[95%CI 1.62-2.90]) and caesarean sections (aOR=1.15[95%CI 1.05-1.25]). Newborns of women with schizophrenia had more neonatal complications (aOR=1.38[95%CI 1.27-1.50]) with more born preterm (aOR=1.64[95%CI1.42 -1.90]), small for gestational age (aOR=1.34[95%CI 1.19-1.50]) and low birth weight (aOR=1.75[95%CI 1.53-2.00]). INTERPRETATION: Our results highlight the importance of health disparities between pregnant women with and without schizophrenia, as well as in their newborns. Our study calls for health policy interventions during and before pregnancy, including proportionate intensified care to the level of needs, effective case management and preventive and social determinant approaches. FUNDING: No funding.

Comparative study of lung ultrasound and chest computed tomography scan in the assessment of severity of confirmed COVID-19 pneumonia.

PURPOSE: The relationship between lung ultrasound (LUS) and chest computed tomography (CT) scans in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia is not clearly defined. The primary objective of our study was to assess the performance of LUS in determining severity of SARS-CoV-2 pneumonia compared with chest CT scan. Secondary objectives were to test the association between LUS score and location of the patient, use of mechanical ventilation, and the pulse oximetry (SpO2)/fractional inspired oxygen (FiO2) ratio. METHODS: A multicentre observational study was performed between 15 March and 20 April 2020. Patients in the Emergency Department (ED) or Intensive Care Unit (ICU) with acute dyspnoea who were PCR positive for SARS-CoV-2, and who had LUS and chest CT performed within a 24-h period, were included. RESULTS: One hundred patients were included. LUS score was significantly associated with pneumonia severity assessed by chest CT and clinical features. The AUC of the ROC curve of the relationship of LUS versus chest CT for the assessment of severe SARS-CoV-2 pneumonia was 0.78 (CI 95% 0.68-0.87; p < 0.0001). A high LUS score was associated with the use of mechanical ventilation, and with a SpO2/FiO2 ratio below 357. CONCLUSION: In known SARS-CoV-2 pneumonia patients, the LUS score was predictive of pneumonia severity as assessed by a chest CT scan and clinical features. Within the limitations inherent to our study design, LUS can be used to assess SARS-CoV-2 pneumonia severity.

Impact of severe polyhandicap cared for at home on French informal caregivers' burden: a cross-sectional study.

OBJECTIVES: Polyhandicap (PLH), defined by a combination of profound intellectual impairment and serious motor deficits, is a severe condition with complex disabilities. In France, care of the large majority of PLH individuals is managed in specialised rehabilitation centres or residential facilities, but some of PLH individuals are cared for at home. The aims of this study were to assess the self-perceived burden among informal caregivers of PLH individuals and to identify potential determinants of this burden. DESIGN: Cross-sectional study (Neuropaediatric Department, Trousseau Hospital, Paris, France). SETTINGS: PLH children were recruited from a specialised paediatric/neurological department. PARTICIPANTS: The selection criteria of caregivers were age above 18 years and being the PLH individual's next of kin. OUTCOMES MEASURES: From March 2015 to December 2016, data were collected from the caregivers, including sociodemographical data, health status, psycho-behavioural data (quality of life, mood disorders and coping) and self-perceived burden. In addition, the health status of the PLH individual was collected. Relationships between the burden scores and potential determinants were tested (correlations coefficients, Mann-Whitney tests, generalised estimating equations models). RESULTS: Eighty-four children were eligible; 77 families returned their questionnaire. The informal caregivers of PLH children experienced a high level of perceived burden (scores ranged from 55±20 to 81±12). Eighty per cent of them had more than 5 hours of daily caregiving and 51% of them had to get up more than twice during the night. The main factors associated with caregiver burden were age, financial issues, health status, daily care and coping strategies. The patients' health status was not associated with caregiver burden. CONCLUSIONS: Some of the caregiver burden determinants might be modifiable. These findings should help healthcare workers and health-decision makers implement specific and appropriate interventions. TRIAL REGISTRATION NUMBER: NCT02400528.

Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch-anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271).

BACKGROUND: There is no quality evidence of the benefit of defunctioning ileostomy (DI) in ileal pouch-anal anastomoses (IPAAs) performed for inflammatory bowel disease (IBD), but most surgical teams currently resort to DI. In the case of a staged procedure with subtotal colectomy first, completion proctectomy with IPAA is performed for healthy patients, namely, after nutritional support, inflammation reduction and immunosuppressive agent weaning. Therefore, the aim of this trial is to assess the need for systematic DI after completion proctectomy and IPAA for IBD. METHODS/DESIGN: This is a multicenter randomized open trial comparing completion proctectomy and IPAA without (experimental) or with (control) DI in patients presenting with ulcerative colitis or indeterminate colitis. Crohn's disease patients will not be included. The design is a superiority trial. The main objective is to compare the 6-month global postoperative morbidity, encompassing both surgical and medical complications, between the two groups. The morbidity of DI closure will be included, as appropriate. The sample size calculation is based on the hypothesis that the overall 6-month morbidity rate is 30% in the case of no stoma creation (i.e., experimental group) vs. 55% otherwise (control group). With the alpha risk and power are fixed to 0.05 and 0.80, respectively, and considering a dropout rate of 10%, the objective is set to 194 patients. The secondary objectives are to compare both strategies in terms of morbi-mortality at 6 months and functional results as well as quality of life at 12 months, namely, the 6-month major morbidity and unplanned reoperation rates, 6-month anastomotic leakage rate, 6-month mortality, length of hospital stay, 6-month unplanned readmission rate, quality of life assessed 3 and 12 months from continuity restoration (i.e., either IPAA or stoma closure), functional results assessed 3 and 12 months from continuity restoration, 12-month pouch results, 12-month cost-utility analysis, and 12-month global morbidity. DISCUSSION: The IDEAL trial is a nationwide multicenter study that will help choose the optimal strategy between DI and no ileostomy in completion proctectomy with IPAA for IBD. TRIAL REGISTRATION: ClinicalTrial.gov: NCT03872271, date of registration March 13th, 2019.

End-of-life care among patients with schizophrenia and cancer: a population-based cohort study from the French national hospital database.

BACKGROUND: Patients with schizophrenia represent a vulnerable, underserved, and undertreated population who have been neglected in health disparities work. Understanding of end-of-life care in patients with schizophrenia and cancer is poor. We aimed to establish whether end-of-life care delivered to patients with schizophrenia and cancer differed from that delivered to patients with cancer who do not have diagnosed mental illness. METHODS: We did a population-based cohort study of all patients older than 15 years who had a diagnosis of advanced cancer and who died in hospital in France between Jan 1, 2013, and Dec 31, 2016. We divided this population into cases (ie, patients with schizophrenia) and controls (ie, patients without a diagnosis of mental illness) and compared access to palliative care and indicators of high-intensity end-of-life care between groups. In addition to unmatched analyses, we also did matched analyses (matched in terms of age at death, sex, and site of primary cancer) between patients with schizophrenia and matched controls (1:4). Multivariable generalised linear models were done with adjustment for social deprivation, year of death, time from cancer diagnosis to death, metastases, comorbidity, and hospital type (ie, specialist cancer centre vs non-specialist centre). FINDINGS: The main analysis included 2481 patients with schizophrenia and 222 477 controls. The matched analyses included 2477 patients with schizophrenia and 9896 controls. Patients with schizophrenia were more likely to receive palliative care in the last 31 days of life (adjusted odds ratio 1·61 [95% CI 1·45-1·80]; p<0·0001) and less likely to receive high-intensity end-of-life care-such as chemotherapy and surgery-than were matched controls without a diagnosis of mental illness. Patients with schizophrenia were also more likely to die younger, had a shorter duration between cancer diagnosis and death, and were more likely to have thoracic cancers and comorbidities than were controls. INTERPRETATION: Our findings suggest the existence of disparities in health and health care between patients with schizophrenia and patients without a diagnosis of mental illness. These findings underscore the need for better understanding of health inequalities so that effective interventions can be developed for this vulnerable population. FUNDING: Assistance Publique des Hôpitaux de Marseille and Aix-Marseille University.

Assessment of patients' self-perceived intensive care unit discomforts: Validation of the 18-item version of the IPREA.

BACKGROUND AND AIMS: We reported the validation of the 18-item version of the 'Inconforts des Patients de REAnimation (IPREA)' questionnaire that includes 2 new items exploring feeling depressed and shortness of breath during an intensive care unit (ICU) stay. METHODS: The validation process was integrated in a multicenter, cluster-randomized, controlled, two-parallel group study built to assess the effectiveness of a tailored multicomponent program for reducing self-perceived discomfort in the ICU. All patients aged 18 years or older who survived an ICU stay of 3 calendar days or more were eligible for inclusion. Data collection included demographics (sex, age), type of admission (medical and surgical), health status scores at admission (Knaus score and McCabe index, Simplified Acute Physiology Score (SAPS) II), specific ICU therapeutics such as mechanical ventilation (MV), noninvasive ventilation (NIV), use of vasopressors, or renal replacement therapy (RRT), and ICU stay duration. RESULTS: A total of 994 patients were included. The initial structure of IPREA was confirmed using confirmatory factor analysis showing satisfactory fit (RMSEA at 0.042, CFI at 0.912). No multidimensional structure was identified, allowing the calculation of an overall discomfort score. The three highest discomforts were sleep deprivation, thirst, and perfusion lines and other devices, and the 3 lowest discomforts were limited visiting hours, hunger, and isolation. The overall discomfort score of the 18-item version of IPREA did not differ between men and women. Higher age was significantly correlated with a lower overall discomfort score. While MV was not linked to self-reported discomfort, patients treated by NIV reported higher overall discomfort scores than patients not treated by NIV. CONCLUSION: The 18-item version of IPREA is easy to use and possesses satisfactory psychometric properties. The availability of a reliable and valid French questionnaire asking about patients' self-perceived ICU discomforts enables feedback from the health care team to be incorporated in a continuous quality health care improvement strategy. TRIAL REGISTRATION: clinicaltrial.gov NCT02442934 (registration date: May 18, 2015, retrospectively registered).

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial.

BACKGROUND: Social isolation potentiates the risk of death by cancer in the older cancer patient population. The PREDOMOS study investigates the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance on the improvement of quality of life of older isolated patients, treated for locally advanced or metastatic cancer. This paper updates the pilot trial protocol. METHODS/DESIGN: The original protocol was published in Trials, accessible at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1894-7 . This update reports on the eligibility criteria expansion and on the adjunction of a cost-utility analysis. We widened the eligible population to patients with locally advanced or metastatic cancer including malignant hemopathies (except acute myeloid leukemia) and to patients in the first and second lines of oncologic treatment. We restricted the inclusion to patients with a Mini Mental State Examination score strictly over 24. In addition to the secondary outcomes outlined in the protocol, a medico-economic analysis has been added to evaluate both the health benefits and costs of the two strategies and calculate the incremental cost-utility ratio of the innovative program assessed, compared to the standard practice. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02829762 . Registered on 29 June 2016.

Modernizing quality of life assessment: development of a multidimensional computerized adaptive questionnaire for patients with schizophrenia.

OBJECTIVE: Quality of life (QoL) is still assessed using paper-based and fixed-length questionnaires, which is one reason why QoL measurements have not been routinely implemented in clinical practice. Providing new QoL measures that combine computer technology with modern measurement theory may enhance their clinical use. The aim of this study was to develop a QoL multidimensional computerized adaptive test (MCAT), the SQoL-MCAT, from the fixed-length SQoL questionnaire for patients with schizophrenia. METHODS: In this multicentre cross-sectional study, we collected sociodemographic information, clinical characteristics (i.e., duration of illness, the PANSS, and the Calgary Depression Scale), and quality of life (i.e., SQoL). The development of the SQoL-CAT was divided into three stages: (1) multidimensional item response theory (MIRT) analysis, (2) multidimensional computerized adaptive test (MCAT) simulations with analyses of accuracy and precision, and (3) external validity. RESULTS: Five hundred and seventeen patients participated in this study. The MIRT analysis found that all items displayed good fit with the multidimensional graded response model, with satisfactory reliability for each dimension. The SQoL-MCAT was 39% shorter than the fixed-length SQoL questionnaire and had satisfactory accuracy (levels of correlation >0.9) and precision (standard error of measurement <0.55 and root mean square error <0.3). External validity was confirmed via correlations between the SQoL-MCAT dimension scores and symptomatology scores. CONCLUSION: The SQoL-MCAT is the first computerized adaptive QoL questionnaire for patients with schizophrenia. Tailored for patient characteristics and significantly shorter than the paper-based version, the SQoL-MCAT may improve the feasibility of assessing QoL in clinical practice.

Impact of caring for patients with severe and complex disabilities on health care workers' quality of life: determinants and specificities.

AIM: Individuals with severe and complex disabilities, defined by a combination of profound intellectual impairment and serious motor deficit resulting in extreme dependence, often remain in hospital or at residential facilities. The aim of this study was to identify the determinants of quality of life (QoL) of 238 health care workers (HCWs) caring for individuals with severe and complex disabilities. METHOD: We conducted a cross-sectional study. The recruitment of the HCWs was performed in five French centres specializing in patients with severe and complex disabilities. The selection criteria were age above 18 years, being an institutional referent HCW (a resource person coordinating various issues for or about the patient), and agreeing to participate. Sociodemographic, health, professional variables, and psycho-behavioural (QoL, burn-out, and coping strategies) data were collected. RESULTS: Of the 362 eligible HCWs, 65.7% returned the questionnaires. The scores of the physical and social dimensions of QoL were significantly lower, and the score of the psychological dimension significantly higher, than those of a comparison group. The main factors modulating QoL were age, financial difficulties, nature of coping strategy, and burn-out. INTERPRETATION: This research provides preliminary evidence that caring for patients with severe and complex disabilities affects the QoL of HCWs. These results support the need for optimization of the work environments for HCWs.

Impact of a pharmacist-led medication review on hospital readmission in a pediatric and elderly population: study protocol for a randomized open-label controlled trial.

BACKGROUND: Early hospital readmission of patients after discharge is a public health problem. One major cause of hospital readmission is dysfunctions in integrated pathways between community and hospital care that can cause adverse drug events. Furthermore, the French ENEIS 2 study showed that 1.3% of hospital stays originated from serious adverse drug events in 2009. Pharmacy-led medication reviews at hospital transitions are an effective means of decreasing medication discrepancies when conducted at admission or discharge. However, it is difficult to assess the true impact of pharmacist-led medication reviews in specific high-risk populations, such as pediatric and geriatric populations. In such a context, it is important to demonstrate the effectiveness of medication reconciliation as part of a standardized medication review process-in pediatric and elderly populations-on all-cause readmissions in a large randomized controlled clinical trial. The aim of this study is to assess the impact of the pharmacist-led medication review on the rate of readmissions and/or death after hospital discharge and patient treatment satisfaction. METHODS/DESIGN: The study is a randomized controlled clinical trial. A total of 1400 hospitalized patients will be randomized in two groups: (1) the experimental group (group receiving a pharmacist-led medication review) and (2) the control group (group receiving usual care). The pharmacist-led medication review process includes medication reconciliation, treatment review and medication liaison service. The primary endpoint will be the rate of readmissions and/or death at 30 days following initial hospitalization discharge. The secondary endpoints will be the rate of hospital readmission, the rate of emergency department visits, the rate of mortality, the number of consultations and patient treatment satisfaction at 30 days following initial hospitalization discharge. DISCUSSION: A randomized controlled trial provides the most extensive evidence on the impact of pharmacist-led medication reviews on early hospital readmission for extreme age populations. TRIAL REGISTRATION: Current Controlled Trials, NCT02734017 . Registered on 4 May 2016.

Assessment of coping: a new french four-factor structure of the brief COPE inventory.

BACKGROUND: The Brief Coping Orientation to Problems Experienced (Brief COPE) inventory is the most usual measure to identify the nature of coping strategies implemented by individuals and explore 14 coping strategies. The availability of a structure with fewer factors rather than the initial 14-factor structure may be of interest for both healthcare professionals and researchers. We report the validation process of a 4-factor structure of the French version of the Brief COPE in a French sample of individuals facing a singular life event, such as cancer, including patients and their caregivers. METHODS: The cross-sectional study included cancer patients and their caregivers. Self-administered data were collected including: socio-demographic (age, gender, marital status, employment status, and education level), coping strategies using the French version of the Brief COPE, quality of life (QoL) using the French version of the short form health survey questionnaire (SF36). Construct validity, internal consistency, reliability, and external validity were tested. RESULTS: The sample included 398 individuals. The principal component factor analysis identified a 4-factor structure. The dimensions were labeled according to their constitutive items: social support (8 items), problem solving (4), avoidance (10), and positive thinking (6). The 4-factor structure was supported by different theoretical models of coping and showed satisfactory psychometric properties. CONCLUSION: The 4-factor structure of the French version of the Brief COPE, validated in a sample of individuals facing a singular stressful event, including cancer patients and their caregivers, makes the instrument easier to use both in clinical practice and clinical research.

Psychosocial risks assessment at hospital: development of a French questionnaire.

BACKGROUND: In order to improve the well-being, health, and performance of hospital workers, it should be important to focus on the psychosocial risk (PSR) factors in the work environment and on job satisfaction. Although many epidemiological questionnaires are used to measure PSR among healthcare workers, no specific existing model can be applied to all categories of hospital workers. OBJECTIVE: To develop a short French self-administered instrument for measuring the PSR for hospital workers: the PSRH questionnaire. METHODS: The content of the PSRH questionnaire was partly derived from the well-known and standardized questionnaires (Karasek Job Content and Siegriest effort-reward imbalance questionnaires). The validation process was carried out in all the departments of a large public university hospital (Marseille, France). Eligible workers were adult employees present on the day of the assessment: healthcare, administrative, and technical workers. A total of 2203 subjects were included from September 2012 to October 2013. RESULTS: The PSRH contains 24 items describing 6 dimensions (Management, cooperation and hierarchical support; Requirements, constraints and autonomy related to work; Support and relationship with the team; Complexity of the work and unforeseen factors; Meaning of work and recognition; and Conciliation work - work out). The six-factor structure presented satisfactory internal consistency and scalability. All the scores showed significant correlations with a well-being score. Acceptability was high. CONCLUSION: The PSRH is a self-administered instrument assessing PSR at hospital that presents satisfactory psychometric properties. Future studies should identify factors that determine low- and high-risk workers in order to implement appropriate preventing strategies.

Esophageal and anorectal involvement in systemic sclerosis: a systematic assessment with high resolution manometry.

OBJECTIVES: In systemic sclerosis (SSc), esophageal and anorectal involvements are frequent and often associated with each other. In clinical practice, esophageal explorations are often prescribed, while anorectal explorations are rarely proposed and therefore, under-recognised. However, it is well documented in the literature that early detection of anorectal dysfunction could delay and/or prevent the onset of symptoms such as fecal incontinence (FI). The main objective was the systematic evaluation and detection of esophageal and anorectal involvements in SSc patients. METHODS: In this monocentric retrospective study, all patients with SSc addressed in the Department of Functional Digestive Explorations, North Hospital, Marseille for esophageal and anorectal explorations were included. Self-Questionnaires, evaluating the symptoms and quality of life, were filled by patients during their visit. Explorations were performed on the same day: high resolution esophageal manometry (EHRM), 3 Dimensional high resolution anorectal manometry (3DHRARM) and endo anal sonography (EUS). RESULTS: 44 patients (41 women), mean age 59.8±12 years, were included. With regard to the symptoms, 45.5% of patients had gastro-esophageal reflux disease (GERD), 66.9% dysphagia, 65.9% constipation and 77.3% FI. The incidence of esophageal dismotility was 65.9%, anorectal and both upper and lower dysfunction were 43.2%. More than 89% patients with abnormal explorations (EHRM, 3DHRARM or both) were symptomatic. Duration of SSc and altered quality of life was correlated with the severity of digestive involvement. CONCLUSIONS: Anorectal dysfunction appears to be closely linked to esophageal involvement in SSc. Their routine screening is undoubtedly essential to limit the occurrence of severe symptoms such as FI.

Screen-and-treat program by point-of-care of Atopobium vaginae and Gardnerella vaginalis in preventing preterm birth (AuTop trial): study protocol for a randomized controlled trial.

BACKGROUND: International recommendations in favor of screening for vaginal infection in pregnancy are based on heterogeneous criteria. In most developed countries, the diagnosis of bacterial vaginosis is only recommended for women with high-risk of preterm birth. The Nugent score is currently used, but molecular quantification tools have recently been reported with a high sensitivity and specificity. Their value for reducing preterm birth rates and related complications remains unexplored. This trial was designed to assess the cost-effectiveness of a systematic screen-and-treat program based on a point-of-care technique for rapid molecular diagnosis, immediately followed by an appropriate antibiotic treatment, to detect the presence of abnormal vaginal flora (specifically, Atopobium vaginae and Gardnerella vaginalis) before 20 weeks of gestation in pregnant women in France. We hypothesized that this program would translate into significant reductions in both the rate of preterm births and the medical costs associated with preterm birth. METHODS/DESIGN: A multicenter, open-label randomized controlled trial (RCT) will be conducted in which 20 French obstetrics and gynecology centers will recruit eligible pregnant women at less than 20 weeks gestation with singleton pregnancy and with a low-risk factor for preterm birth. Interventions will include a) an experimental group that will receive a systematic rapid screen-and-treat program from a point-of-care analysis using a molecular quantification method and b) a control group that will receive usual care management. Randomization will be in a 1:1 allocation ratio. The primary endpoint that will be assessed over a period of 12 months will be the incremental cost-effectiveness ratio (ICER) expressed as cost per avoided preterm birth before 37 weeks. Secondary endpoints will include ICER per avoided preterm birth before 24, 28 and 32 weeks, obstetrical outcomes, neonatal outcomes, rates of treatment failure and recurrence episodes for positive women. Uncertainty surrounding these estimates will be addressed using nonparametric bootstrapping and represented using cost-effectiveness acceptability curves. A total of 6,800 pregnant women will be included. DISCUSSION: This appropriate randomized controlled design will provide insight into the cost-effectiveness and therefore the potential cost savings of a rapid screen-and-treat strategy for molecular abnormal vaginal flora in pregnant women. National and international recommendations could be updated based on the findings of this study. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02288832 (registration date: 30 October 2014); Eudract: 2014-001559-22.

The role of stable housing as a determinant of poverty-related quality of life in vulnerable individuals.

OBJECTIVE: The aim of this study was to identify potential socio-demographic and socio-economic determinants associated with quality of life (QoL) in impoverished individuals admitted in emergency departments (EDs) using a self-administered multidimensional poverty-related QoL questionnaire (PQoL) and a generic QoL questionnaire (Duke). DESIGN: cross-sectional study. SETTING: Ten EDs in France. PARTICIPANTS: All participants included in this study lived in impoverished conditions. INTERVENTION AND OUTCOME MEASURES: We collected socio-demographic information, economic data, and data related to the ED visit. Multiple linear regressions were performed to determine which variables were linked to QoL scores. RESULTS: Three-hundred and eighty-seven individuals were enrolled, and 378 (98%) responded to the QoL questionnaires. PQoL was significantly lower for single individuals (ß from -0.15 to -0.23), without a stable home (ß from -0.17 to -0.34) and individuals without general health coverage (ß = 0.20). Compared with men, women reported lower scores in the psychological well-being dimension (ß = -0.19) and higher scores in the relationships with friends dimension (ß = 0.17). CONCLUSIONS: Not having stable housing was the most important factor associated with low QoL in impoverished people. This finding demonstrates the need for support from policymakers at the national and local levels for these vulnerable populations.

Quality of life in patients with locked-in syndrome: Evolution over a 6-year period.

BACKGROUND: Improved knowledge of the quality of life (QoL) of locked-in syndrome (LIS) patients have implications for managing their care, and assists clinicians in choosing the most appropriate interventions. We performed a survey of a population of LIS patients to describe the course of the QoL of LIS patients over a 6-year period and to determine the potential predictive factors of QoL changes over time. METHOD: This is a study performed over a 6-year period in patients with a LIS diagnosis. Questionnaires were sent in 2007 and 2013. The following data were recorded: i) sociodemographic data; ii) clinical data related to LIS, physical/handicap status, psychological status; iii) self-reported QoL: Anamnestic Comparative Self-Assessment (ACSA); iv) Integration in life: French Reintegration to Normal Living Index (RNLI). RESULTS: Among the 67 patients included in 2007, 39 (58 %) patients returned their questionnaire in 2013. The LIS etiology was stroke in 51 individuals. The QoL of the patients was relatively satisfactory compared to populations in other severe conditions. Twenty-one (70 %) individuals reported a stable/improved QoL between 2007 and 2013. The physical/handicap statuses in 2007 and 2013 were not related to the QoL 6 years later, with the exception of one communication parameter: the individuals who used yes-no code reported significantly lower QoL levels than those who did not in 2013. DISCUSSION: In opposition to a widespread opinion, LIS persons report a relatively satisfactory QoL level that stays stable over time, suggesting that life with LIS is worth living. Preservation of autonomy and communication may help them to live as normal life as possible.

Quantification of relevance of quality of life assessment for patients with cognitive impairment: the suitability indices.

BACKGROUND: The extent to which MS patients with cognitive dysfunction can accurately self-report outcomes has been a crucial issue. The aim of this study was to quantify and compare the relevance of the quality of life (QoL) assessment between two populations with a high occurrence of cognitive dysfunction, specifically in individuals with multiple sclerosis (MS) and in individuals suffering from schizophrenia (SCZ). DESIGN: A cross-sectional study was performed using the following inclusion criteria: MS and SCZ patients were diagnosed according to the McDonald criteria and DSM-IV criteria, respectively. Data on sociodemographic (age, gender, education level) and clinical (disease severity, disease duration) factors, QoL (disease-specific questionnaires, MusiQoL and SQoL) and cognitive performance (executive, memory, and attention functions) were collected. Non-impaired and impaired populations were defined according to the French norms. Psychometric properties were compared to those reported in reference populations, which were assessed in the respective validation studies. Suitability indices were provided used to quantitatively compare how the structures in the different populations matched with the initial structure of the questionnaires (reference populations). RESULTS: One hundred and twenty-four MS patients and 113 SCZ patients were enrolled. Factor analysis was performed on the impaired populations and revealed that the questionnaire structure adequately matched the initial structure of the disease-specific QoL questionnaires. All of the suitability indices of construct and external validity in the non-impaired populations ranged from 70 to 100%. CONCLUSIONS: Our study suggested that cognitive dysfunction did not compromise the reliability or validity of the self-reported QoL questionnaires among subjects with cognitive dysfunction, such as MS and SCZ. Thus, this report may clarify the relevance of using self-reported QoL assessments in clinical practice.

A poverty-related quality of life questionnaire can help to detect health inequalities in emergency departments.

OBJECTIVES: This study aimed to develop a self-administered, multidimensional, poverty-related quality of life (PQoL) questionnaire for individuals seeking care in emergency departments (EDs): the PQoL-17. STUDY DESIGN AND SETTING: The development of the PQoL was undertaken in three steps: item generation, item reduction, and validation. The content of the PQoL was derived from 80 interviews with patients seeking care in EDs. Using item response and classical test theories, item reduction was performed in 3 EDs on 300 patients and validation was completed in 10 EDs on 619 patients. RESULTS: The PQoL contains 17 items describing seven dimensions (self-esteem/vitality, psychological well-being, relationships with family, relationships with friends, autonomy, physical well-being/access to care, and future perception). The seven-factor structure accounted for 75.1% of the total variance. This model showed a good fit (indices from the LISREL model: root mean square error of approximation, 0.055; comparative fit index, 0.97; general fit index, 0.96; standardized root mean square residual, 0.058). Each item achieved the 0.40 standard for item internal consistency, and Cronbach α coefficients were >0.70. Significant associations with socioeconomic and clinical indicators showed good discriminant and external validity. Infit statistics ranged from 0.82 to 1.16. CONCLUSION: The PQoL-17 presents satisfactory psychometric properties and can be completed quickly, thereby fulfilling the goal of brevity sought in EDs.

Toward meeting the needs of homeless people with schizophrenia: the validity of quality of life measurement.

OBJECTIVE: To provide new evidence regarding the suitability of using quality of life (QoL) measurements in homeless people with schizophrenia, we assess the acceptability and psychometric properties of a specific QoL instrument (S-QoL 18) in a population of homeless people with schizophrenia, and we compare their QoL levels with those observed in non-homeless people with schizophrenia. METHODS: This multi-centre prospective study was conducted in the following 4 French cities: Lille, Marseille, Paris and Toulouse. Two hundred and thirty-six homeless patients with schizophrenia were recruited over a 12 month-period. The S-QoL 18 was tested for construct validity, reliability, external validity and sensitivity to change. The QoL of the 236 homeless patients was compared with 236 French age- and sex-matched non-homeless patients with schizophrenia. RESULTS: The eight-factor structure of the S-QoL 18 was confirmed by confirmatory factor analysis (RMSEA = 0.035, CFI = 0.95, GFI = 0.99 and SRMR = 0.015). Internal consistency, reliability and sensitivity to change were satisfactory. External validity was confirmed via correlations between S-QoL 18 dimension scores and SF-36, symptomatology and recovery scores. The percentage of missing data did not exceed 5%. Finally, homeless patients had significantly lower QoL levels than non-homeless patients with schizophrenia. CONCLUSIONS: These results demonstrate the satisfactory acceptability and psychometric properties of the S-QoL 18, suggesting the validity of QoL measurement among homeless patients with schizophrenia. Our study also reported that QoL levels in homeless patients with schizophrenia were dramatically low, highlighting the need for new policies to eradicate homelessness and tackle poverty.