[Long-term occupational situation after cancer: A French registry-based study]. / Situation professionnelle à long terme après un cancer : étude réalisée à partir de registres de population.

INTRODUCTION: Few studies have explored the long-term occupational situation after cancer. The aim of our study were to study the employment status among long-term cancer survivors and to compare it to cancer-free controls from the general population at 5, 10 or 15 years after cancer diagnosis. METHODS: From data of a registry-based study, long-term survivors from breast,cervical and colorectal cancer, randomly selected from three tumor registries in France, were compared to cancer-free controls randomly selected from electoral lists. We selected active cancer survivors and cancer-free controls aged less than 60 at the time of the survey. We have studied the employment status of cases vs. controls and the factors associated with employment status. RESULTS: At 5, 10 or 15 years after diagnosis, we did not observe any significant difference in employment status between cases and controls. Among cases, 17% had lost their jobs. Older age, lower incomes, lower education, a short-term employment contract, the presence of co-morbidities, fatigue and a worse quality of life were associated with job loss. DISCUSSION: Although the employment status of the cases was comparable to that of the controls, efforts should be intensified to make it easier for patients diagnosed with cancer to return to work.

Cancer-related fatigue among long-term survivors of breast, cervical, and colorectal cancer: a French registry-based controlled study.

BACKGROUND: While several studies have documented fatigue during and after cancer treatment, long-term cancer survivor fatigue is underreported. In this study, we compare fatigue, quality of life (QoL), and anxiety between relapse-free cancer survivors 15 years after diagnosis and healthy controls. METHODS: Cancer survivors (CS) were randomly selected from three large population-based cancer registries (Bas-Rhin, Calvados, and Doubs, France). Cancer-free controls were randomly selected from electoral lists with stratification on age group, residence area, and gender. All participants completed self-reported fatigue (MFI), QoL (EORTC QLQ-C30), and anxiety (STAI) questionnaires. Univariable and multivariable logistic regression were used to study the association between fatigue and cancer status, in three cancer subgroups: breast cancer (BC), cervical cancer (CC), and colorectal cancer (CRC). RESULTS: Two hundred sixty-three CS and 688 controls (125/275, 45/153, 93/260 CS/controls for BC, CC, and CRC respectively) were included. The mean age was 66 years. In multivariable analyses, CS had higher general and mental fatigue than controls p = 0.04 and p = 0.02, respectively. No difference in QoL was observed between CS and controls. CS were more anxious than controls (p < 0.01). Anxiety was associated with general fatigue (p < 0.0001) and mental fatigue (p < 0.0001). CONCLUSION: Fifteen years after diagnosis, cancer survivors reported more general and mental fatigue compared with controls. Our results reinforce guidelines, identifying fatigue as a persistent symptom.

Cross-cultural adaptation and validation of the French version of the Expanded Prostate cancer Index Composite questionnaire for health-related quality of life in prostate cancer patients.

BACKGROUND: Health-related quality of life (HRQoL) has been positioned as one of the major endpoints in oncology. Thus, there is a need to validate cancer-site specific survey instruments. This study aimed to perform a transcultural adaptation of the 50-item Expanded Prostate cancer Index Composite (EPIC) questionnaire for HRQoL in prostate cancer patients and to validate the psychometric properties of the French-language version. METHODS: The EPIC questionnaire measures urinary, bowel, sexual and hormonal domains. The first step, corresponding to transcultural adaptation of the original English version of the EPIC was performed according to the back translation technique. The second step, comprising the validation of the psychometric properties of the EPIC questionnaire, was performed in patients under treatment for localized prostate cancer (treatment group) and in patients cured of prostate cancer (cured group). The EORTC QLQ-C30 and QLQ-PR25 prostate cancer module were also completed by patients to assess criterion validity. Two assessments were performed, i.e., before and at the end of treatment for the Treatment group, to assess sensitivity to change; and at 2 weeks' interval in the Cured group to assess test-retest reliability. Psychometric properties were explored according to classical test theory. RESULTS: The first step showed overall good acceptability and understanding of the questionnaire. In the second step, 215 patients were included from January 2012 to June 2014: 125 in the Treatment group, and 90 in the Cured group. All domains exhibited good internal consistency, except the bowel domain (Cronbach's α = 0.61). No floor effect was observed. Test-retest reliability assessed in the cured group was acceptable, expect for bowel function (intraclass coefficient = 0.68). Criterion validity was good for each domain and subscale. Construct validity was not demonstrated for the hormonal and bowel domains. Sensitivity to change was exhibited for 5/8 subscales and 2/4 summary scores for patients who experienced toxicities during treatment. CONCLUSIONS: The French EPIC questionnaire seems to have adequate psychometric properties, comparable to those exhibited by the original English-language version, except for the construct validity, which was not available in original version.

Impact of the occurrence of a response shift on the determination of the minimal important difference in a health-related quality of life score over time.

BACKGROUND: An important challenge of the longitudinal analysis of health-related quality of life (HRQOL) is the potential occurrence of a Response Shift (RS) effect. While the impact of RS effect on the longitudinal analysis of HRQOL has already been studied, few studies have been conducted on its impact on the determination of the Minimal Important Difference (MID). This study aims to investigate the impact of the RS effect on the determination of the MID over time for each scale of both EORTC QLQ-C30 and QLQ-BR23 questionnaires in breast cancer patients. METHODS: Patients with breast cancer completed the EORTC QLQ-C30 and the EORTC QLQ-BR23 questionnaires at baseline (time of diagnosis; T0), three months (T1) and six months after surgery (T2). Four hospitals and care centers participated in this study: cancer centers of Dijon and Nancy, the university hospitals of Reims and Strasbourg At T1 and T2, patients were asked to evaluate their HRQOL change during the last 3 months using the Jaeschke transition question. They were also asked to assess retrospectively their HRQOL level of three months ago. The occurrence of the RS effect was explored using the then-test method and its impact on the determination of the MID by using the Anchor-based method. RESULTS: Between February 2006 and February 2008, 381 patients were included of mean age 58 years old (SD = 11). For patients who reported a deterioration of their HRQOL level at each follow-up, an increase of RS effect has been detected between T1 and T2 in 13/15 dimensions of QLQ-C30 questionnaire, and 4/7 dimensions of QLQ-BR23 questionnaire. In contrast, a decrease of the RS effect was observed in 8/15 dimensions of QLQ-C30 questionnaire and in 5/7 dimensions of QLQ-BR23 questionnaire in case of improvement. At T2, the MID became ≥ 5 points when taking into account the RS effect in 10/15 dimensions of QLQ-C30 questionnaire and in 5/7 dimensions of QLQ-BR23 questionnaire. CONCLUSIONS: This study highlights that the RS effect increases over time in case of deterioration and decreases in case of improvement. Moreover, taking the RS into account produces a reliable and significant MID.

Long-term quality of life among localised prostate cancer survivors: QALIPRO population-based study.

BACKGROUND: To evaluate quality of life (QoL) 10 years after treatments for localised prostate cancer (LPCa) patients in comparison with aged-matched healthy controls. METHODS: LPCa patients diagnosed in 2001 were obtained from 11 French cancer registries. Controls were recruited among the general population and were matched to patients on age and geographic area. EORTC Quality of Life Questionnaire - Core 30 items, Expanded Prostate Cancer Index Composite, Hospital Anxiety and Depression Scale and Multidimensional Fatigue Inventory self-reported questionnaires were used to measure QoL, anxiety and fatigue. Patients were classified in three groups according to previous treatments: radical prostatectomy (RP), radiotherapy (RT) and radical prostatectomy and radiotherapy (RP+RT). The differences in QoL between patients and controls and according to treatment groups were evaluated. RESULTS: There were 287 patients and 287 controls. There was no socio-demographic difference between patients and controls. Treatments were: RP (143), RT (78), PR+RT (33), baseline hormone therapy (49) and hormone therapy at the time of the study (34). Patients had similar levels of global QoL, anxiety, depression and fatigue as controls. They reported more urinary troubles (urinary function and incontinence) (p < 0.0001) and more sexual dysfunctions (p < 0.0001) than controls, whatever the treatment group. Worse bowel dysfunction was reported in patients treated by RT and RP+RT (p < 0.002). According to the treatments, RP groups had the worst urinary function and incontinence (p < 0.01), and reported more bowel bother when the treatment was combined with RT. CONCLUSIONS: Even though patients reported similar global QoL as control 10 years after treatment, patients reported numerous urinary and sexual dysfunctions. Patients treated with RP+RT reported cumulative sequelae of both treatments.

Health-related quality of life is a prognostic factor for survival in older patients after colorectal cancer diagnosis: A population-based study.

BACKGROUND: Studies carried out in the context of clinical trials have shown a relationship between survival and health-related quality of life in colorectal cancer patients. AIMS: We assessed the prognostic value of health-related quality of life at diagnosis and of its longitudinal evolution on survival in older colorectal cancer patients. METHODS: All patients aged ≥65 years, diagnosed with new colorectal cancer between 2003 and 2005 and registered in the Digestive Cancer Registry of Burgundy were eligible. Patients were asked to complete the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at inclusion, three, six and twelve months after. Multivariate regression models were used to evaluate the prognostic value of health-related quality of life scores at diagnosis and their deterioration on relative survival. RESULTS: In multivariate analysis, a role functioning dimension lower than median was predictive of lower survival (hazard ratio=3.1, p=0.015). After three and six months of follow-up, patients with greater appetite loss were more likely to die, with hazard ratios of 4.7 (p=0.013) and 3.7 (p=0.002), respectively. CONCLUSIONS: Health-related quality of life assessments at diagnosis are independently associated with older colorectal cancer patients' survival. Its preservation should be a major management goal for older cancer patients.

Human papillomavirus genotypes among women with or without HIV infection: an epidemiological study of Moroccan women from the Souss area.

BACKGROUND: Data on Human PapillomaVirus (HPV) infection are scarce in Morocco. The objective of the study was to determine the prevalence of HPV and cervical cytology abnormalities in women from the Souss area, Morocco. METHODS: Two hundred and thirty two women who attended the Hassan II hospital (Agadir, Morocco) were recruited in this study. Socio-economic data, sexual activity, reproductive life, history of Pap smear, smoking and HIV status were recorded. Cervical samples were taken using an Ayre spatula. Cytology was reported using the Bethesda system. HPVs were first detected by MY09/11 consensus PCR and then genotyped with INNO-LiPA(®) assay. Data were analyzed using the logistic regression model. RESULTS: The median age of women was 42 years (18-76 years). HIV prevalence was 36.2 %. Any HPV type prevalence was 23.7 % in the study population, lower in HIV-negative women (13.3 %) than in HIV-positive women (39.3 %). HPV16 was the most prevalent type (6.5 %), followed by HPV53 and HPV74 (3.4 % each). Most women had normal cervical smears (82 %), the remaining were diagnosed with LGSIL (13 %) and HGSIL (5 %). HPV was detected in 17.4 % of normal smears, 43.4 % of LGSIL and 75 % of HGSIL. HIV status was the most powerful predictor of high risk (hr) and probable hr (phr) HPV infection (odds ratio 4.16, 95 % confidence interval 1.87-9.24, p = 0.0005) followed by abnormal cytology (OR 3.98, 95 % CI 1.39-11.40, p = 0.01), independently of socio-demographic and behavioral risk factors. CONCLUSIONS: In a Moroccan hospital based-population of the Souss area, HPV infections are frequently detected. In addition, high prevalence of hr and phrHPVs and precancerous lesions among HIV-positive women is likely associated with an increased risk of cervical cancer. This highlights the need for HPV and cervical cancer prevention campaigns in Morocco.

Impact of TG4010 Vaccine on Health-Related Quality of Life in Advanced Non-Small-Cell Lung Cancer: Results of a Phase IIB Clinical Trial.

BACKGROUND: This study describes the effect of TG4010 vaccine on Health related Quality of Life (HRQOL) in patients with stage IIIb and IV non-small-cell lung cancer (NSCLC). METHODS: 148 patients with advanced NSCLC expressing MUC1 were randomly assigned to receive TG4010 plus chemotherapy or chemotherapy alone. HRQOL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline and every 6 weeks until disease progression. Time until definitive deterioration (TUDD) of the four well-being dimensions of the FACT-L physical (PWB), functional (FWB), emotional (EWB) and social well-being (SWB) and the Lung Cancer Subscale (LCS) domains were analyzed for a 5-point minimal clinically important difference. RESULTS: No difference of TUDD of HRQOL has been found between treatment arms. No prognostic factors have been found to have a significant impact on the TUDD of PWB, SWB and LCS domains. The gender, the performance status and the smoking habits seemed to be associated with a shorter TUDD of EWB domain. The smokers and the former smokers seemed to present a shorter TUDD of FWB domain. CONCLUSION: This study suggests that adding therapeutic vaccination with TG4010 to standard chemotherapy in patients with advanced NSCLC is associated with a similar evolution in HRQOL compared to chemotherapy alone.

Outcomes associated with routine systemic antifungal therapy in critically ill patients with Candida colonization.

PURPOSE: To assess the evolution of patient deep colonization by Candida spp. in a surgical ICU over an 8-year period. METHODS: This retrospective, observational study included all patients hospitalized for more than 2 days in a surgical and trauma ICU of a university hospital, from 2005 to 2012. Mycological samples were monitored weekly from five sites (oropharyngeal, rectal, gastric, tracheal and urinary). Preemptive fluconazole therapy was started in patients highly colonized with Candida albicans. The evolution in Candida spp. involved in the deep colonization sites distribution over the study period (main outcome measure, trend chi-square and time-series analysis), antifungal consumption, ICU-acquired candidemia and mortality were determined. RESULTS: Among the 3029 patients with ICU stay >48 h, 2651 had at least one set of mycological sampling. Thirty percent of the 31,171 samples were positive to Candida spp. Caspofungin consumption increased over the years, whereas fluconazole consumption decreased. No trend in C. albicans colonization was observed, after adjusting on colonization risk-factors. A significant increase of acquired C. glabrata colonization was observed, whereas the clearing of C. parapsilosis colonization significantly decreased. No significant shift of colonization to other Candida spp. and mortality was observed. CONCLUSIONS: Preemptive strategy of antifungal drug prescriptions in highly colonized ICU patients induced an increase in C. glabrata colonization without significant shift of colonization to other Candida spp. in surgical ICU patients. However, the potential detrimental impact of fluconazole on Candida ecology in ICU and/or on Candida susceptibility to antifungal drugs should be considered, and deserves further studies.

Stroke impact scale version 2: validation of the French version.

BACKGROUND: Almost 1 person in 1,000 experiences a stroke annually in France. Health-related quality-of-life (HRQoL) measurement with specific questionnaires is useful to study the consequences of stroke on patients' daily lives. OBJECTIVE: The purpose of this study was to validate the French version of the Stroke Impact Scale (SIS) questionnaire, as no disease-specific questionnaire was validated in French heretofore. METHODS: Two hundred eighty-eight patients with stroke were classified into 2 groups (158 acute, 130 chronic). Rate of item completion, test-retest reliability, sensitivity to change, and construct validity, convergent validity, and discriminant validity of the questionnaire were assessed. Acute group patients were recruited during the first month poststroke and followed for 3 months. Chronic group patients (stroke dating from 1 year) were recruited from outpatient consultations. The first 100 patients in the chronic group were called back 15 days after inclusion for test-retest measurements. The Barthel Index, Hospital Anxiety and Depression Scale (HADS), and Duke Health Profile questionnaires were administered. RESULTS: The French version of the SIS was well accepted by all participants. It had good reproducibility. Cronbach alpha was 89% for all scales. A ceiling effect was noted in the majority of scales. Physical domains were significantly correlated to other measures of physical capacity (Barthel Index and Duke Health Profile; Spearman coefficients were between .5 and .73), and the emotional and social domains were significantly correlated to almost all domains of the Duke Health Profile. Psychometric properties were similar to those of the US version. Responsiveness was good for physical and emotional domains. LIMITATIONS: Validation was conducted only on people who were able to answer the questionnaire. CONCLUSIONS: The French SIS version presents good psychometric properties, except for ceiling effect. This is the first stroke-specific questionnaire evaluating perceived health after stroke to be validated in France and could be useful for further investigations of HRQoL after stroke.

Parenteral nutrition at the palliative phase of advanced cancer: the ALIM-K study protocol for a randomized controlled trial.

BACKGROUND: Malnutrition is a common complication in patients at the palliative stage of cancer. During the curative phase of cancer, optimal enteral or parenteral nutrition intake can reduce morbidity and mortality, and improve quality of life. When the main goal of treatment becomes palliative, introduction of artificial nutrition is controversial. Although scientific societies do not recommend the introduction of artificial nutrition in all cases of malnutrition, especially in hypophagic patients if their life expectancy is shorter than 2 months, considerable differences in the use of parenteral nutrition in nonsurgical oncology practice are noted around the world. One explanation is a paucity of well-conducted randomized controlled trials in these situations, and consequently, the risk/benefit ratio of parenteral nutrition and its impact on quality of life in palliative care remains uncertain. METHODS/DESIGN: The ALIM-K study is a French national multicenter randomized controlled trial designed to evaluate the effectiveness of parenteral nutrition, versus an exclusive oral-feeding supply, on the quality of life of malnourished patients who have a functional digestive tube and who are at the palliative phase of advanced cancer with a life expectancy of more than 2 months. DISCUSSION: This article presents the methodologic options chosen for our study, and in particular, the choice of the Zelen method of randomization, the definition of the main end point (quality of life), the choice of comparator (oral feeding), and the inclusion criteria (life expectancy of more than 2 months), which are all critical points in building a randomized controlled trial in the setting of palliative care. TRIAL REGISTRATION: This study was registered with the clinical trials database ClinicalTrials.gov on May 27, 2014, under the number NCT02151214.

Impact of response shift on time to deterioration in quality of life scores in breast cancer patients.

BACKGROUND: This prospective multicenter study aimed to study the impact of the recalibration component of response-shift (RS) on time to deterioration (TTD) in health related quality of life (QoL) scores in breast cancer (BC) patients and the influence of baseline QoL expectations on TTD. METHODS: The EORTC-QLQ-C30 and BR-23 questionnaires were used to assess the QoL in a prospective multicenter study at inclusion (T0), at the end of the first hospitalization (T1) and, three (T2) and 6 months after the first hospitalization (T3). Recalibration was investigated by the then-test method. QoL expectancy was assessed at diagnosis. Deterioration was defined as a 5-point decrease in QoL scores, considered a minimal clinically important difference (MCID). TTD was estimated using the Kaplan-Meier method. Cox regression analyses were used to identify factors influencing TTD. RESULTS: From February 2006 to February 2008, 381 women were included. Recalibration of breast cancer patients' internal standards in the assessment of their QoL had an impact on TTD. Median TTD were significantly shorter when recalibration was not taken into account than when recalibration was taken into account for global health, role-functioning, social-functioning, body-image and side effects of systemic therapy. Cox multivariate analyses showed that for body image, when recalibration was taken into account, radiotherapy was associated with a shorter TTD (HR: 0.60[0.38-0.94], whereas, no significant impact of surgery type on TTD was observed. For global health, cognitive and social functioning dimensions, patients expecting a deterioration in their QoL at baseline had a significantly shorter TTD. CONCLUSIONS: Our results showed that RS and baseline QoL expectations were associated with time to deterioration in breast cancer patients.

Item response theory and factor analysis as a mean to characterize occurrence of response shift in a longitudinal quality of life study in breast cancer patients.

BACKGROUND: The occurrence of response shift (RS) in longitudinal health-related quality of life (HRQoL) studies, reflecting patient adaptation to disease, has already been demonstrated. Several methods have been developed to detect the three different types of response shift (RS), i.e. recalibration RS, 2) reprioritization RS, and 3) reconceptualization RS. We investigated two complementary methods that characterize the occurrence of RS: factor analysis, comprising Principal Component Analysis (PCA) and Multiple Correspondence Analysis (MCA), and a method of Item Response Theory (IRT). METHODS: Breast cancer patients (n = 381) completed the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires at baseline, immediately following surgery, and three and six months after surgery, according to the "then-test/post-test" design. Recalibration was explored using MCA and a model of IRT, called the Linear Logistic Model with Relaxed Assumptions (LLRA) using the then-test method. Principal Component Analysis (PCA) was used to explore reconceptualization and reprioritization. RESULTS: MCA highlighted the main profiles of recalibration: patients with high HRQoL level report a slightly worse HRQoL level retrospectively and vice versa. The LLRA model indicated a downward or upward recalibration for each dimension. At six months, the recalibration effect was statistically significant for 11/22 dimensions of the QLQ-C30 and BR23 according to the LLRA model (p ≤ 0.001). Regarding the QLQ-C30, PCA indicated a reprioritization of symptom scales and reconceptualization via an increased correlation between functional scales. CONCLUSIONS: Our findings demonstrate the usefulness of these analyses in characterizing the occurrence of RS. MCA and IRT model had convergent results with then-test method to characterize recalibration component of RS. PCA is an indirect method in investigating the reprioritization and reconceptualization components of RS.

Prevalence and risk factors of human papillomavirus infection types 16/18/45 in a cohort of French females aged 15-23 years.

Investigation of the prevalence and risk factors of human papillomavirus (HPV) infection is the basis for developing prophylactic strategies against cervical cancer, especially for young women. This study aimed to assess the prevalence and risk factors of HPV infection among a cohort of sexually active young French women eligible for catch-up vaccination. Between 1997 and 2007, 2163 women aged 15-23 years attending consultations at the department of gynecology in the Hospital of Besançon (France) were screened for high risk HPV (HR HPV) infection. Risk factors were investigated through a questionnaire sent to all participants in 2010. HPV DNA was detected by HC2 and Probe Set assays. The overall prevalence for HR HPV and HPV16, 18 and/or HPV45 was 44.6% (95% CI, 42.5-46.7%) and 19% (95% CI, 17.3-20.7%), respectively. The response rate to the questionnaire was 22.6%. The prevalence of independent risk factors (age older than 19, smoking, and oral contraception) for HPV 16/18/45 infection in this population was less than 20%. Based on this study, HPV vaccination should be offered not only to teenage girls, but also to young women, regardless of their sexual activity.

Statistical challenges of quality of life and cancer: new avenues for future research.

Statistical modeling conference on the quality of life measurements of the French National Platform of Quality of Life and Cancer Faculty of Science in Luminy, Marseille, France, 12-13 September 2013 The French National Platform of Quality of Life and Cancer and the statistical team of the Mathematical Institute of Luminy undertook a successful first conference addressing the statistical challenges of measuring the quality of life in the field of oncology. More than 15 presentations were made over a 2-day period by the Faculty of Sciences in Luminy. The conference managed to assemble participants from different disciplines, such as mathematics and statistics, public health, epidemiology and psychology, to debate the key statistical and methodological issues of quality of life measurement and analysis. Three main topics were covered in this conference: the treatment of missing data, the development of item banking and computerised adaptive testing and the detection/understanding of response shift.

A longitudinal analysis of patient satisfaction with care and quality of life in ambulatory oncology based on the OUT-PATSAT35 questionnaire.

BACKGROUND: In the oncology setting, there has been increasing interest in evaluating treatment outcomes in terms of quality of life and patient satisfaction. The aim of our study was to investigate the determinants of patient satisfaction, especially the relationship between quality of life and satisfaction with care and their changes over time, in curative treatment of cancer outpatients. METHODS: Patients undergoing ambulatory chemotherapy or radiotherapy in two centers in France were invited to complete the OUT-PATSAT35, at the beginning of treatment, at the end of treatment, and three months after treatment. This questionnaire evaluates patients' perception of doctors and nurses, as well as other aspects of care organization and services. Additionally, for each patient, socio-demographic and clinical characteristics, and self-reported quality of life data (EORTC QLQ-C30) were collected. RESULTS: Of the 691 patients initially included, 561 answered the assessment at all three time points. By cross-sectional analysis, at the end of the treatment, patients who experienced a deterioration of their global health reported less satisfaction on most scales (p ≤ 0.001). Three months after treatment, the same patients had lower satisfaction scores only in the evaluation of doctors (p ≤ 0.002). Furthermore, longitudinal analysis showed a significant relationship between a deterioration in global health and a decrease in satisfaction with their doctor and, conversely, between an improvement in global health and an increase in satisfaction on the overall satisfaction scale. Global health at baseline was largely and significantly associated with all satisfaction scores measured at the following assessment time points (p < 0.0001). Younger age (<55 years), radiotherapy (versus chemotherapy) and head and neck cancer (versus other localizations) were clinical factors significantly associated with less satisfaction on most scales evaluating doctors. CONCLUSIONS: Pre-treatment self-evaluated global health was found to be the major determinant of patient satisfaction with care. The subsequent deterioration of global health, during and after treatment, emphasized the decrease in satisfaction scores, mainly in the evaluation of doctors. Early initiatives aimed at improving the delivery of care in patients with poor health status should lead to improved perception of the quality of care received.

The relationship between traits optimism and anxiety and health-related quality of life in patients hospitalized for chronic diseases: data from the SATISQOL study.

BACKGROUND: The impact of psychological factors is often taken into account in the evaluation of quality of life. However, the effect of optimism and trait anxiety remains controversial and they are rarely studied simultaneously. We aimed to study the effect of this factor on health-related quality of life (HRQOL) of patients after a hospitalization in relation with their chronic disease. METHODS: Using cross-sectional data from the SATISQOL cohort, we conducted a multicentric study, including patients hospitalized for an intervention in connection with their chronic disease. Six months after hospitalization, patients completed a generic HRQOL questionnaire (SF-36), and the STAI and LOT-R questionnaires to evaluate optimism and trait anxiety. We studied the effect of each trait on HRQOL separately, and simultaneously, taking account of their interaction in 3 models, using an ANOVA. RESULTS: In this study, 1529 patients were included in three participating hospitals and there existed wide diversity in the chronic diseases in our population. The HRQOL score increased for all dimensions of SF36 between 15,8 and 44,5 when the level of anxiety decreased (p < 0.0001) for the model 1, assessing the effect of anxiety on HRQOL and increased for all dimensions of SF36 between 3.1 and 12.7 with increasing level of optimism (< 0.0001) in the model 2 assessing the effect of optimism on HRQOL. In the model 3, assessing the effect of both anxiety and optimism on HRQOL, and their interaction, the HRQOL score for all dimensions of the SF36 increased when the level of anxiety decreased (p < 0.0001). It increased with increasing level of optimism (p < 0.006) in the model for all dimensions of SF36 except the Role Physical dimension. In this model, interaction between anxiety and optimism was significant for the Social Functioning dimension (p = 0.0021). CONCLUSIONS: Optimism and trait anxiety appeared to be significantly correlated with HRQOL. Furthermore, an interaction existed between the trait anxiety and optimism for some dimensions of SF36. Contrary to optimism, it seems essential to evaluate trait anxiety in future studies about HRQOL, since it could represent a confounding factor.

Quality of life in long-term cervical cancer survivors: a population-based study.

OBJECTIVES: To assess long-term quality of life (QOL) in cervical cancer survivors (CCSs), 5, 10, and 15 years after diagnosis. METHODS: In a cross-sectional population-based study, CCSs diagnosed in 1990, 1995, or 2000 were randomly selected from 3 tumor registries in France. Healthy controls were randomly selected from electoral rolls, stratifying on age group and residence area. Five QOL questionnaires (SF-36, EORTC QLQ-C30, the cervical cancer-specific module (EORTC QLQ-CX24), the MFI fatigue questionnaire, the STAI for anxiety) and a life condition questionnaire were used. Analysis of variance was used to compare QOL scores of survivors by period of diagnosis (5, 10, and 15 years) with those of controls and according to treatment modality, adjusted for socio-demographic data. RESULTS: A total of 173 localized CCSs (42% treated with surgery alone and 58% with a combination of treatments) and 594 controls participated in the study. Compared with controls, CCSs expressed globally similar good QOL, except for impaired psychoemotional domains in 15-year survivors (p<0.01). Worsening of some symptoms was observed over time, 15-year survivors in particular reported significantly more lymphedema than 5-year (p=0.0009) and 10-year CCSs (p=0.002). Compared with CCSs treated by surgery alone, QOL of CCSs who received radiotherapy was significantly more affected in terms of cervical cancer specific problems, such as sexual dysfunction (p=0.002), voiding and abdominal symptoms (p=0.01), and lymphedema (p=0.01). CONCLUSIONS: Even after 15 years, QOL of CCSs is impacted in psychological domains, compared with healthy controls. Among CCSs, women treated by adjuvant radiotherapy expressed more physical sequelae.

Early-onset ventilator-associated pneumonia in adults randomized clinical trial: comparison of 8 versus 15 days of antibiotic treatment.

PURPOSE: The optimal treatment duration for ventilator-associated pneumonia is based on one study dealing with late-onset of the condition. Shortening the length of antibiotic treatment remains a major prevention factor for the emergence of multiresistant bacteria. OBJECTIVE: To demonstrate that 2 different antibiotic treatment durations (8 versus 15 days) are equivalent in terms of clinical cure for early-onset ventilator-associated pneumonia. METHODS: Randomized, prospective, open, multicenter trial carried out from 1998 to 2002. MEASUREMENTS: The primary endpoint was the clinical cure rate at day 21. The mortality rate was evaluated on days 21 and 90. RESULTS: 225 patients were included in 13 centers. 191 (84.9%) patients were cured: 92 out of 109 (84.4%) in the 15 day cohort and 99 out of 116 (85.3%) in the 8 day cohort (difference = 0.9%, odds ratio = 0.929). 95% two-sided confidence intervals for difference and odds ratio were [-8.4% to 10.3%] and [0.448 to 1.928] respectively. Taking into account the limits of equivalence (10% for difference and 2.25 for odds ratio), the objective of demonstrative equivalence between the 2 treatment durations was fulfilled. Although the rate of secondary infection was greater in the 8 day than the 15 day cohort, the number of days of antibiotic treatment remained lower in the 8 day cohort. There was no difference in mortality rate between the 2 groups on days 21 and 90. CONCLUSION: Our results suggest that an 8-day course of antibiotic therapy is safe for early-onset ventilator-associated pneumonia in intubated patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT01559753.