Karine Baumstarck

Effect of Statin Therapy on Mortality in Patients With Ventilator-AssociatedPneumonia: A Randomized Clinical Trial

IMPORTANCE Observational studies have reported that statin use may be associated with improved outcomes of various infections. Ventilator-associated pneumonia (VAP) is the most common infection in the intensive care unit (ICU) and is associated with substantial mortality. OBJECTIVE To determine whether statin therapy can decrease day-28 mortality in patients with VAP. DESIGN, SETTING, AND PARTICIPANTS Randomized, placebo-controlled, double-blind, parallel-group, multicenter trial performed in 26 intensive care units in France from January 2010 to March 2013. For power to detect an 8% absolute reduction in the day-28 mortality rate, we planned to enroll 1002 patients requiring invasive mechanical ventilation for more than 2 days and having suspected VAP, defined as a modified Clinical Pulmonary Infection Score of 5 or greater. The futility stopping rules were an absolute increase in day-28 mortality of at least 2.7% with simvastatin compared with placebo after enrollment of the first 251 patients. INTERVENTIONS Participants were randomized to receive simvastatin (60 mg) or placebo, started on the same day as antibiotic therapy and given until ICU discharge, death, or day 28, whichever occurred first. MAIN OUTCOMES AND MEASURES Primary outcome was day-28 mortality. Day-14, ICU, and hospital mortality rates were determined, as well as duration of mechanical ventilation and Sequential Organ Failure Assessment (SOFA) scores on days 3, 7, and 14. RESULTS The study was stopped for futility at the first scheduled interim analysis after enrollment of 300 patients, of whom all but 7% in the simvastatin group and 11% in the placebo group were naive to statin therapy at ICU admission. Day-28 mortality was not lower in the simvastatin group (21.2% [95% CI, 15.4% to 28.6%) than in the placebo group (15.2% [95% CI, 10.2% to 22.1%]; P = .10; hazard ratio, 1.45 [95% CI, 0.83 to 2.51]); the between-group difference was 6.0% (95% CI, -3.0% to 14.9%). In statin-naive patients, day-28 mortality was 21.5% (95% CI, 15.4% to 29.1%) with simvastatin and 13.8% (95% CI, 8.8% to 21.0%) with placebo (P = .054) (between-group difference, 7.7% [95%CI, -1.8% to 16.8%). There were no significant differences regarding day-14, ICU, or hospital mortality rates; duration of mechanical ventilation; or changes in SOFA score. CONCLUSIONS AND RELEVANCE In adults with suspected VAP, adjunctive simvastatin therapy compared with placebo did not improve day-28 survival. These findings do not support the use of statins with the goal of improving VAP outcomes. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01057758.

Measuring quality of life in patients with schizophrenia:an overview

Quality of life (QoL) is of great importance to patients with schizophrenia and their families. Although the use of QoL measures may contribute to better adherence to therapeutic interventions, more satisfaction with care, improved health outcomes and reduction of health costs, QoL assessment remains underutilized in clinical practice. In this review, the authors propose a reflection on the limitations and lack of impact of QoL measures in clinical care. Our argument is based on three challenges regarding conceptual aspects and metrics, use and limits and the usefulness of measuring QoL. For each challenge, the authors have suggested pragmatic proposals and new research directions to promote the use of QoL measures in the future. These avenues of research involve a shared responsibility between QoL researchers, the medical community and decision makers. Close collaboration between all parties is necessary to promote the use of QoL measures in schizophrenia.

Hormonal therapy is associated with better self-esteem, mood, and quality of life in transsexuals.

Abstract Few studies have assessed the role of cross-sex hormones on psychological outcomes during the period of hormonal therapy preceding sex reassignment surgery in transsexuals. The objective of this study was to assess the relationship between hormonal therapy, self-esteem, depression, quality of life (QoL), and global functioning. This study incorporated a cross-sectional design. The inclusion criteria were diagnosis of gender identity disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) and inclusion in a standardized sex reassignment procedure. The outcome measures were self-esteem (Social Self-Esteem Inventory), mood (Beck Depression Inventory), QoL (Subjective Quality of Life Analysis), and global functioning (Global Assessment of Functioning). Sixty-seven consecutive individuals agreed to participate. Seventy-three percent received hormonal therapy. Hormonal therapy was an independent factor in greater self-esteem, less severe depression symptoms, and greater “psychological-like” dimensions of QoL. These findings should provide pertinent information for health care providers who consider this period as a crucial part of the global sex reassignment procedure.

Evaluating the impact of a quality of life assessment with feedback to clinicians in patients with schizophrenia: randomised controlled trial

BACKGROUND Quality of life (QoL) measurements are increasingly considered to be an important evaluation of the treatment and care provided to patients with schizophrenia. However, there is little evidence that assessing QoL improves patient outcomes in clinical practice. AIMS To investigate the impact of a QoL assessment with feedback for clinicians regarding satisfaction and other health outcomes in patients with schizophrenia. METHOD We conducted a 6-month, prospective, randomised and controlled open-label study. Patients with schizophrenia were assigned to one of three groups: standard psychiatric assessment; QoL assessment with standard psychiatric assessment; and QoL feedback with standard psychiatric assessment. The primary outcome was patient satisfaction at 6 months. The local ethics committee (Comité de Protection des Personnes Sud-Méditerranéee V, France, trial number 07 067) and the French drug and device regulation agency (Agence Française de Sécurité Sanitaire des Produits de Santé, France, trial number A01033-50) approved this study. RESULTS We randomly assigned 124 patients into groups. Quality of life feedback significantly affected patient satisfaction. Global satisfaction was significantly higher in the QoL feedback group (72.5% of patients had a high level of satisfaction) compared with the standard psychiatric assessment (67.5%) and QoL assessment groups (45.2%). Despite trends towards decreased severity for all clinical outcomes and increased changes to medication in the QoL feedback group at 6-month follow-up, these effects were not significant. CONCLUSIONS Quality of life feedback positively influences patient satisfaction, which confirms the relevance of measuring QoL in clinical practice. The absence of a significant effect of QoL feedback on clinical outcomes also suggests that clinicians did not use these data optimally. Our findings suggest a nocebo effect of QoL assessment without feedback that should be considered by researchers and clinicians.

Measuring the quality of life in patients with multiple sclerosis in clinical practice: a necessary challenge.

While the physical disability aspect of multiple sclerosis (MS) is of great importance, quality of life (QoL) measurements are being considered increasingly important with regard to evaluating disease progression, treatment, and the management of care provided to MS patients. Despite the acknowledged need to consider QoL issues, QoL assessment remains underutilized in clinical practice. These issues should be explored and understood to promote the use of measuring QoL in MS clinical practice. We explore the difficulties for clinicians: choosing and determining the most appropriate QoL measure and how to best integrate QoL measurements into clinical practice. This paper discusses several avenues to provide to clinicians arguments of the clinical relevance and accuracy of QoL instruments and ultimately to enhance the use of QoL measures in clinical practice for MS patients.

Self-reported quality of life measure is reliable and valid in adult patients suffering from schizophrenia with executive impairment

BACKGROUND Impaired executive functions are among the most widely observed in patients suffering from schizophrenia. The use of self-reported outcomes for evaluating treatment and managing care of these patients has been questioned. The aim of this study was to provide new evidence about the suitability of self-reported outcome for use in this specific population by exploring the internal structure, reliability and external validity of a specific quality of life (QoL) instrument, the Schizophrenia Quality of Life questionnaire (SQoL18). METHODS DESIGN cross-sectional study. INCLUSION CRITERIA age over 18 years, diagnosis of schizophrenia according to the DSM-IV criteria. DATA COLLECTION sociodemographic (age, gender, and education level) and clinical data (duration of illness, Positive and Negative Syndrome Scale, Calgary Depression Scale for Schizophrenia); QoL (SQoL18); and executive performance (Stroop test, lexical and verbal fluency, and trail-making test). Non-impaired and impaired populations were defined for each of the three tests. For the six groups, psychometric properties were compared to those reported from the reference population assessed in the validation study. RESULTS One hundred and thirteen consecutive patients were enrolled. The factor analysis performed in the impaired groups showed that the questionnaire structure adequately matched the initial structure of the SQoL18. The unidimensionality of the dimensions was preserved, and the internal/external validity indices were close to those of the non-impaired groups and the reference population. CONCLUSIONS Our study suggests that executive dysfunction did not compromise the reliability or validity of self-reported disease-specific QoL questionnaire.

A French Cohort of Childhood Leukemia Survivors: Impact of Hematopoietic Stem Cell Transplantation on Health Status and Quality of Life

The late effects and quality of life (QoL) in childhood acute leukemia survivors were compared between hematopoietic stem cell transplantation (HSCT) recipients and patients who underwent conventional therapy. The study included 943 patients, 256 of whom underwent HSCT (27.1%). Medical visits were conducted to detect the occurrence of physical late effects. Based on patient age, different questionnaires were used to assess QoL. To evaluate the association between HSCT and each type of late effect or QoL dimension, the appropriate multivariate regressions were performed. QoL mean scores were compared with those obtained for age- and sex-matched French control subjects. Of all the survivors, 674 (71.5%) had at least 1 late effect, with the risk being 5.0 CI95 (3.0-8.6) times higher for transplantation survivors. For child survivors, scoring of QoL showed no significant differences between the treatment groups. The adult HSCT survivors reported lower physical dimension QoL scores than chemotherapy survivors. Compared with French norms, the survivor group reported a significantly lower mental composite score; however, the physical composite score showed no significant difference. Thus, transplanted survivors have a high risk of developing late effects, resulting in a decreased physical well-being in adulthood. However, long after treatment completion, childhood leukemia survivors report that effects on psychological well-being are more important than they are in physical QoL dimensions.

Using the random forest method to detect a response shift in the quality of life of multiple sclerosis patients: a cohort study

BackgroundMultiple sclerosis (MS), a common neurodegenerative disease, has well-described associations with quality of life (QoL) impairment. QoL changes found in longitudinal studies are difficult to interpret due to the potential response shift (RS) corresponding to respondents’ changing standards, values, and conceptualization of QoL. This study proposes to test the capacity of Random Forest (RF) for detecting RS reprioritization as the relative importance of QoL domains’ changes over time.MethodsThis was a longitudinal observational study. The main inclusion criteria were patients 18 years old or more with relapsing-remitting multiple sclerosis. Every 6 months up to month 24, QoL was recorded using generic and MS-specific questionnaires (MusiQoL and SF-36). At 24 months, individuals were divided into two ‘disability change’ groups: worsened and not-worsened patients. The RF method was performed based on Breiman’s description. Analyses were performed to determine which QoL scores of SF-36 predicted the MusiQoL index. The average variable importance (AVI) was estimated.ResultsA total of 417 (79.6%) patients were defined as not-worsened and 107 (20.4%) as worsened. A clear RS was identified in worsened patients. While the mental score AVI was almost one third higher than the physical score AVI at 12 months, it was 1.5 times lower at 24 months.ConclusionThis work confirms that the RF method offers a useful statistical approach for RS detection. How to integrate the RS in the interpretation of QoL scores remains a challenge for future research.Trial registrationClinicalTrials.gov identifier: NCT00702065

Is there any benefit to adding intravenous ketamine to patient-controlled epidural analgesia after thoracic surgery? A randomized double-blind study

OBJECTIVES Thoracic surgery is associated with severe acute postoperative pain, leading to pulmonary complications and hyperalgesia-induced chronic pain. Thoracic patient-controlled epidural analgesia is also considered as the gold-standard postoperative analgesia. As previously described in major digestive surgery, combination with low-dose intravenous (i.v.) ketamine could potentiate epidural analgesia and facilitate pulmonary function recovery following thoracotomy. METHODS In a randomized, double-blind trial, 60 patients scheduled to undergo thoracotomy were included. All patients received a thoracic epidural catheter placed before surgery, and standardized general anaesthesia. They were allocated to two groups to receive either an i.v. bolus of ketamine at induction, followed by a continuous infusion during surgery and the first 48 h postoperatively, or an i.v. placebo (a saline solution under the same infusion modalities). Cumulative epidural ropivacaine consumption, postoperative pain scores (patient self-rated numeric pain intensity scale), analgesic rescue consumption, residual pain, haemodynamics and respiratory recovery function were recorded from 12 h to 3 months. Data were expressed as mean ± standard deviation or median ± interquartile range (25-75%). The comparisons between ketamine and placebo groups were performed using χ(2) or Fishers exact tests for frequencies, and Mann-Whitney tests for quantitative variables. RESULTS Epidural ropivacaine consumption was similar between groups during the first 48 postoperative hours. Postoperative pain scores and spirometric parameters were not significantly different between groups. But the incidence of postoperative nausea was significantly increased in patients owning to the ketamine group. Finally, the incidence of residual pain was similar between groups at 1 and 3 months following thoracotomy. CONCLUSIONS Adding i.v. ketamine did not potentiate epidural analgesia neither to reduce acute and chronic postoperative pain nor to improve pulmonary dysfunction following thoracic surgery. Pain scores were low in both groups, mainly because of an optimized analgesia provided by the patient-controlled epidural mode, and might explain this lack of benefit in adding i.v. ketamine.

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.