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.

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.

Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial.

BACKGROUND: Recent studies in North American contexts have suggested that the Housing First model is a promising strategy for providing effective services to homeless people with mental illness. In the context of the highly generous French national health and social care system, which is easily accessible and does not require out-of-pocket payment, the French Health Ministry insists on rigorous techniques, including randomized protocols, to evaluate the impact of Housing First approaches in France. METHOD AND DESIGN: A prospective randomized trial was designed to assess the impact of a Housing First intervention on health outcomes and costs over a period of 24 months on homeless people with severe mental illness, compared to Treatment-As-Usual. The study is being conducted in four cities in France: Lille, Marseille, Paris and Toulouse. The inclusion criteria are as follows: over 18 years of age, absolutely homeless or in precarious housing, and possessing a 'high' level of need: diagnosis of schizophrenia or bipolar disorder and moderate to severe disability according to the Multnomah Community Ability Scale (score ≤ 62) and at least one of the following three criteria: 1) having been hospitalized for mental illness two or more times in any one year during the preceding five years; 2) co-morbid alcohol or substance use; and 3) having been recently arrested or incarcerated. Participants will be randomized to receiving the Housing First intervention or Treatment-As-Usual. The Housing First intervention provides immediate access to independent housing and community care. The primary outcome criterion is the use of high-cost health services (that is,, number of hospital admissions and number of emergency department visits) during the 24-month follow-up period. Secondary outcome measures include health outcomes, social functioning, housing stability and contact with police services. An evaluation of the cost-effectiveness and cost-utility of Housing First will also be conducted. A total of 300 individuals per group will be included. DISCUSSION: This is the first study to examine the impact of a Housing First intervention compared to Treatment-As-Usual in France. It should provide key information to policymakers concerning the cost-effectiveness and health outcomes of the Housing First model in the French context. TRIAL REGISTRATION: The current clinical trial number is NCT01570712.

Heath-related quality of life in thyroid cancer patients following radioiodine ablation.

BACKGROUND: There is limited information about the medium to long-term health-related quality of life (QOL) in thyroid cancer patients after initial therapy and the existing studies suffer from limitations. The aim of the study was to assess the determinants of medium-term QOL after the initial therapy. METHODS: Following a total thyroidectomy, 88 thyroid cancer patients received either rhTSH or hypothyroid-assisted radioiodine ablation (RRA) using 3.7 GBq (100 mCi) of radioiodine. QOL evaluation of the patients using the validated Functional Assessment of Chronic Illness & Therapy (FACIT) was performed at the time of inclusion (t0) and later at the 9-month post-RRA (t1). RESULTS: 83 patients were eligible for the final evaluation. Medium-term FACIT scores were not statistically different between t0 and t1 patients. All but one domain of the QOL score was similar between t0 and t1. Using a multivariate analysis, only age and immediate postoperative QOL scores were found to be determinants of the overall medium term 9-month QOL scores. Analysis showed that 'high QOL levels' (baseline and 9-month) and 'no depression', 'low anxiety levels', were associated with '<45 yrs', 'men', 'partner', and 'rhTSH stimulation'. CONCLUSIONS: The use of radioiodine ablation does not seem to affect the medium term QOL scores of patients. Medium-term QOL is mainly determined by pre-ablation QOL. The assessment of baseline QOL might be interesting to evaluate in order to adapt the treatment protocols, the preventive strategies, and medical information to patients for potentially improving their outcomes.

Harmonic scalpel in multinodular goiter surgery: impact on surgery and cost analysis.

INTRODUCTION: The aim of this study was to evaluate the potential advantages and the general operative cost of the Harmonic Scalpel (HS) in surgery for multinodular goiter (MNG). METHODS: Patients undergoing total thyroidectomy (TT) for MNG were prospectively allocated in a conventional tie-and-clip (TC) group (n = 50) and an HS group (n = 50). All pre- and postoperative data were recorded. The economic evaluation was based on a microcost measurement and aimed to consider all the resources consumed for each patient during the surgical procedure. To compare the results, we used the nonparametric unpaired two-tailed Mann-Whitney test. RESULTS: There were 81 women and 19 men (mean age, 55 +/- 15 years). Mean preoperative TSH level was 1.2 (SD, 1.1) (TC) and 1.3 (SD, 2) (HS) (P = NS). Mean body mass index was 24.72 (SD, 8) (TC) and 25.6 (SD, 8) (HS) (P = NS). Four patients experienced a transient hypocalcemia (2 in each group). One patient had a postoperative hematoma requiring surgical evacuation (HS). One patient experienced a transient recurrent nerve palsy (TC). Mean length of surgery was 104 (SD, 32) (TC) and 84 minutes (SD, 17) (HS) (P = .0001). Mean length of hospitalization was 2 days in both groups (SD, 1) (P = NS). Mean operative cost per patient was 990 euro (SD, 191) in the TC group and 1,024 euro (SD, 143) in the HS group (P = NS). CONCLUSION: Safety and efficiency of the HS is comparable to the tie-and-clip technique in thyroid surgery. The use of the HS in MNG surgery allows for a significant reduction in the length of the procedure with a comparable cost.