Translation and validation of a French version of the Xerostomia Inventory.

OBJECTIVE: This study aimed to assess the transcultural adaptation and psychometric properties of the French-language version of the Xerostomia Inventory (XI-Fr). METHODS: In total, 65 patients aged 65 years or older were recruited from three departments of a single French hospital. Patients had to have a Mini Mental State Examination score of 10 or more and be able to read and write French. The XI-Fr was administered to all patients after transcultural adaptation, at the start of the study, and again at 7 days after inclusion. We assessed reliability, acceptability, validity, internal consistency and reproducibility of the instrument in its French-language version. RESULTS: The XI-Fr showed good internal consistency (Cronbach's alpha 0.79) and good reliability (intra-class correlation 0.83) at 7 days. Convergent validity showed no relation between salivary flow and XI-Fr score, as with the original instrument. Discriminant validity showed a positive correlation between the XI-Fr and the GOHAI, but no difference for the MNA or miniGDS scores. CONCLUSION: The XI-Fr is a valid and reliable measure of xerostomia in French, with psychometric properties comparable to those of the original English-language version.

Fatigue and quality-of-life in the year following SARS-Cov2 infection.

BACKGROUND: The SARS-COV2 pandemic has been ongoing worldwide since at least 2 years. In severe cases, this infection triggers acute respiratory distress syndrome and quasi-systemic damage with a wide range of symptoms. Long-term physical and psychological consequences of this infection are therefore naturally present among these patients. The aim of this study was to describe the state of health of these patients at 6 (M6) and 12 months (M12) after infection onset, and compare quality-of-life (QOL) and fatigue at these time-points. METHODS: A prospective cohort study was set up at Reims University Hospital. Patients were clinically assessed at M6 and M12. Three scores were calculated to describe patient's status: the modified Medical Research Council score (mMRC) used to determine dyspnoea state, the Fatigue Severity Scale (FSS) and the Short Form 12 (SF12) that was carried out to determine the QOL both mentally and physically (MCS12 and PCS12). Descriptive analysis and comparison of scores between M6 and M12 were made. RESULTS: 120 patients completed both follow-up consultations. Overall, about 40% of the patients presented dyspnoea symptoms. The median mMRC score was 1 Interquartile ranges (IQR) = [0-2] at the two assessment. Concerning FSS scores, 35% and 44% of patients experienced fatigue at both follow-ups. The two scores of SF12 were lower than the general population standard scores. The mean PCS12 score was 42.85 (95% confidence interval (95% CI [41.05-44.65])) and mean MCS12 score of 46.70 (95% CI [45.34-48.06]) at 6 months. At 12 months, the mean PCS12 score was 42.18 (95% confidence interval (95% CI [40.46-43.89])) and mean MCS12 score of 47.13 (95% CI [45.98-48.28]). No difference was found between SF12 scores at 6 and 12 months. CONCLUSIONS: This study pinpoints the persistence of fatigue and a low mental and physical QOL compared to population norms even after 1 year following infection. It also supports the claims of mental or psychological alterations due to infection by this new virus, hence a lower overall QOL in patients.

Utility values and its time to deterioration in breast cancer patients after diagnosis and during treatments.

BACKGROUND: The potential effects of breast cancer (BC) on health-related quality of life (HRQoL) should be considered in clinical and policy decision-making, as the economic burden of BC management is currently assessed. In the last decades, time-to-HRQoL score deterioration (TTD) has been proposed as an approach to the analysis of longitudinal HRQoL in oncology. The main objectives of the current study were to investigate the evolution of the utility values in BC patients after diagnosis and during follow-ups and to evaluate the TTD in utility values among women in all stages of BC. METHODS: Health-state utility values (HSUV) were assessed using the EuroQol 5-Dimension 3-Level at diagnosis, at the end of the first hospitalization and 3 and 6 months after the first hospitalization. For a given baseline score, HSUV was considered to have deteriorated if this score decreased by ≥ 0.08 points of the EQ-5D utility index score and ≥ 7 points of the EQ visual analogue scale. TTD curves were calculated using the Kaplan-Meier estimation method. RESULTS: Overall 381 patients were enrolled between February 2006 and February 2008. The highest proportions of respondents at the baseline and all follow-ups reporting some and extreme problems were in pain discomfort and anxiety/depression dimensions; more than 80% of patients experienced a deterioration in EQ-5D utility index score and EQ VAS score with a median TTD of 3.15 months and 6.24 Months, respectively. CONCLUSIONS: BC patients undergoing therapy need psychological support to cope with their discomfort, pain, depression, anxiety, and fear during the process of diagnosis and treatment to improve their QoL.

Optic Nerve and Perioptic Sheath Diameter (ONSD), Eyeball Transverse Diameter (ETD) and ONSD/ETD Ratio on MRI in Large Middle Cerebral Artery Infarcts: A Case-Control Study.

BACKGROUND: Despite recent progress in the multidisciplinary management of large middle cerebral artery infarcts, the neurological prognosis remains worrying in a non-negligible number of cases. The objective of this study is to analyze the contribution of optic nerve and perioptic sheath measurement on MRI to the acute phase of large middle cerebral artery infarcts. METHODS: A retrospective case-control study between January 2008 and December 2019 in a single academic medical center was performed. Cases and controls were selected by interrogation of International Classification of Diseases (ICD), 10th edition, with ischemic stroke as criterion (code I64). Decompressive hemicraniectomy was a criterion for large middle cerebral artery infarcts (cases). Cases were matched with controls (1:3) based on age (± 5 years), sex, and year of hospitalization (± 2 years) The examinations were performed on 3T MRI (Siemens IRM 3T Magnetom).Optic nerve and perioptic sheath diameter was calculated using electronic calipers, 3 mm behind retina and in a perpendicular vector with reference to the orbit in axial 3D TOF sequence. RESULTS: Of 2612 patients, 22 patients met all the criteria of large middle cerebral artery infarcts and they were paired with 44 controls. Patients were mainly women, mean age of 53.6 years. There is a significant difference in the size of the optic nerve and perioptic sheath diameter measured on MRI at patient's admission (right: 5.13 ± 0.2 mm vs. 4.80 mm ± 0.18, p <0. 0001, left: 5.16 ± 0.17 vs 4.78 ± 0.20, p<0.0001). The AUC of optic nerve and perioptic sheath diameter was 0.93 (95%IC [0.85-1.00]), for a threshold at 5.03 mm, the sensitivity was 0.82 (95%IC [0.6-0.93]), specificity 0.94 (95%IC [0.85-0.98]). The Odds Ratio of large middle cerebral artery infarcts was 46.4 for optic nerve and perioptic sheath diameter the (95%IC [6.15-350.1] p=0.0002). CONCLUSION: Optic nerve and perioptic sheath diameter in the first MRI can predict the risk of developing large middle cerebral artery infarcts requiring a decompressive hemicraniectomy.

Assessing abdominal aortic calcifications before performing colocolic or colorectal anastomoses: A case-control study.

BACKGROUND: Preoperative evaluation needs objective measurement of the risk of anastomotic leakage (AL). This study aimed to determine if cardiovascular disease, evaluated by abdominal aortic calcification (AAC), was associated with AL after colorectal anastomoses. We conducted a retrospective case-control study on patients who underwent colorectal anastomosis between 2012 and 2016 at Reims University Hospital (France). Abdominal aortic calcification was the main variable of measurement. MATERIALS AND METHODS: We reviewed all patients who had a left-sided colocolic or a colorectal anastomosis, all patients with AL were cases; 2 controls, or 3 when possible, without AL were randomly selected and matched by operation type, pathology, and age. For multivariate analysis, 2 logistic regression models were tested, the first one used the calcification rate as a continuous variable and the second one used the calcification rate ≥ 5% as a qualitative variable. RESULTS: Forty-five cases and 116 controls were included. In univariate analysis, the calcification rate and the percentage of patients with a calcification rate ≥5% were significantly higher in cases than in control groups (4.4 ± 5.5% vs. 2.5 ± 5.2%, odds ratio [OR] =1.6 95% CI: 1.1-2.5; n = 22, 49% and n = 34.3 3%, OR = 2.8 95% CI: 1.2-6.2). In multivariate models, calcification rate as a continuous variable and calcification rate ≥5% as qualitative variable were independent significant risk factors for AL (respectively, aOR = 1.8; 95% CI: 1.1-3, P = 0.01; aOR = 3.2; 95% CI: 1.4-7.55, P < 0.01). CONCLUSION: AAC ≥5% should alert on a higher risk of AL and should lead to discussion about the decision of performing an anastomosis.

Factors associated with quality of life in patients with Alzheimer's disease.

BACKGROUND: Evaluation of health-related quality of life (HRQoL) in patients with Alzheimer's disease (AD) is necessary to ensure optimal management. Several scales for assessing HRQoL of patients with AD exist, in particular the Quality of Life in Alzheimer's Disease (QoL-AD), which includes an evaluation by the caregiver of the patient's HRQoL. The aim of this study was to identify factors associated with patient, caregiver and overall HRQoL as assessed by the QoL-AD. METHODS: Cross-sectional multicenter study in subjects aged 65 years and older, with mild to moderate AD. HRQoL scores from the QoL-AD were recorded (3 scores, corresponding to patient, caregiver and overall), as well as sociodemographic variables for the patient and the caregiver, and data from the geriatric cognitive assessment (cognitive, psycho-behavioral, functional evaluations). Caregiver burden was evaluated using the Zarit caregiver burden scale. Factors associated with each QoL-AD score were identified by multivariate linear regression using t-tests and ß estimations. Study was registered in Clinical Trial.gov (NCT02814773). RESULTS: In total, 123 patients with AD were included. For the patient QoL-AD evaluation, depression was significantly associated with lower HRQoL (ß = - 2.56 ± 1.28, p = 0.04), while polypharmacy (ß = - 1.80 ± 0.99, p = 0.07) and anxiety (ß = - 1.70 ± 1.01, p = 0.09) tended to be associated with lower HRQoL scores. In terms of caregiver evaluations, depression (ß = - 3.46 ± 1.09, p = 0.002), polypharmacy (ß = - 1.91 ± 0.92, p = 0.04) and the presence of caregiver burden (ß = - 3.50 ± 0.91, p = 0.0002) were associated with lower HRQoL. For the overall evaluation, depression (ß = - 3.26 ± 1.02, p = 0.002) and polypharmacy (ß = - 1.85 ± 0.81, p = 0.03) were significantly related to lower HRQoL. CONCLUSIONS: Depression and polypharmacy were two factors influencing HRQoL in patients with AD, both by patient self-report and on the caregiver report. Thus, despite the discrepancies between HRQoL as assessed by patients with AD and HRQoL as assessed by their caregiver, the caregiver's assessment may be used to guide patient management when the patient can no longer complete QoL evaluations. Moreover, the association between caregiver burden and the caregiver's QoL-AD score underlines the need to take caregivers into consideration in the overall management of the AD patient.

[Clinical research and data collection during the investigation: Influence of a dedicated staff]. / Recherche clinique et recueil de données lors de l'investigation : influence d'un personnel dédié.

OBJECTIVE: In clinical research, the recourse to a staff dedicated as CRA with the investigator is common practice to facilitate the work of collection and limiting the missing data (MD). We, therefore, looked for the interest of the recourse of such personnel to data collection. METHODS: MD were classified according to five categories: clinical, para-clinical, treatment, adverse events (serious) and others. Studies were separated in two designs, one-off studies during a single visit (so-called "no follow") and studies on the duration and including several visits (say "with follow"). Similarly, studies were differentiated according to their type of collection "Without ARC" if the data were collected by an investigator, and studies "With ARC". RESULTS: The presence of a CRA can reduce the number of MD whatever their type (Student test: P<0.0001): With CRA mean of MD is 4.8%±8.4% and Without CRA mean of MD is 22.1%±17.0%. CONCLUSION: The delegation of data collection to a staff dedicated reduces significantly the percentage of missing data.

Incidence of solitary pulmonary nodules in Northeastern France: a population-based study in five regions.

BACKGROUND: The discovery of a solitary pulmonary nodule (SPN) on a chest imaging exam is of major clinical concern. However, the incidence rates of SPNs in a general population have not been estimated. The objective of this study was to provide incidence estimates of SPNs in a general population in 5 northeastern regions of France. METHODS: This population-based study was undertaken in 5 regions of northeastern France in May 2002-March 2003 and May 2004-June 2005. SPNs were identified by chest CT reports collected from all radiology centres in the study area by trained readers using a standardised procedure. All reports for patients at least 18 years old, without a previous history of cancer and showing an SPN between 1 and 3 cm, were included. RESULTS: A total of 11,705 and 20,075 chest CT reports were collected for the 2002-2003 and 2004-2005 periods, respectively. Among them, 154 and 297 reports showing a SPN were included, respectively for each period. The age-standardised incidence rate (IR) was 10.2 per 100,000 person-years (95% confidence interval 8.5-11.9) for 2002-2003 and 12.6 (11.0-14.2) for 2004-2005. From 2002 to 2005, the age-standardised IR evolved for men from 16.4 (13.2-19.6) to 17.7 (15.0-20.4) and for women from 4.9 (3.2-6.6) to 8.2 (6.4-10.0). In multivariate Poisson regression analysis, gender, age, region and period were significantly associated with incidence variation. CONCLUSIONS: This study provides reference incidence rates of SPN in France. Incidence was higher for men than women, increased with age for both gender and with time for women. Trends in smoking prevalence and improvement in radiological equipment may be related to incidence variations.

The quality of life in genetic neuromuscular disease questionnaire: Rasch validation of the French version.

INTRODUCTION: Slowly progressive, genetic neuromuscular diseases (gNMDs) often lead to important motor deficiencies and functional limitations. The Quality of Life in Genetic Neuromuscular Disease Questionnaire (QoL-gNMD) is a new health-related quality-of-life questionnaire developed for these patients. The purpose of the present study was to validate the French version of the QoL-gNMD and to calibrate its measurement system. METHODS: Both the QoL-gNMD and a validated generic questionnaire (WHOQOL-BREF) were administered to patients. Validation was performed using item response theory. The partial credit model (Rasch) was used to calibrate each domain. RESULTS: Three hundred fifteen adult patients were included. All 3 domains showed adequate psychometric properties (internal consistency: person separation index >0.77; repeatability: test-retest intraclass correlation coefficient >0.75, scalability coefficient >0.38) and fitted the partial credit model. The QoL-gNMD also demonstrated adequate concurrent validity with the WHOQOL-BREF. DISCUSSION: The QoL-gNMD showed adequate psychometric properties and can be used in clinical settings. Although not anchor-based, the minimum detectable change tables help in interpreting score change. Muscle Nerve 56: 1085-1091, 2017.

Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit.

OBJECTIVE: To identify risk factors for the occurrence of adverse drug reactions (ADRs) based on geriatric evaluation. DESIGN: Longitudinal prospective study from May 2010 to November 2011. SETTING: Dedicated acute geriatric care unit specializing in the management of patients with dementia syndrome (Alzheimer disease or related syndromes) at the University Hospital of Reims, France. PARTICIPANTS: Older patients with dementia syndrome (Alzheimer disease or related syndromes). MEASUREMENTS: Sociodemographic variables and comprehensive geriatric assessment were recorded. Occurrence of ADRs was noted. Risk factors for ADR were identified by multivariate logistic regression. RESULTS: During the study period, 293 patients were included; average age was 82 ± 8 years; the majority were women (61.4%). Average Mini-Mental State Examination score was 13 ± 8; average activities of daily living (ADL) score was 3.6 ± 2.1. Independent risk factors for occurrence of at least one ADR were polypharmacy (≥5 drugs/day) (OR: 4.0, 95% CI: 1.1-14.1) and dependence on at least 1 ADL (OR: 2.6, 95% CI: 1.1-6.5). CONCLUSIONS: Risk factors for ADRs were polypharmacy and dependence on at least one ADL. Our findings underline the importance of taking into consideration the characteristics of the patients when prescribing drugs in this specific population. Prescriptions should be re-evaluated at each follow-up.

Impact of functional alterations on quality of life in patients with Alzheimer's disease.

AIM: To identify factors associated with health-related quality of life (HRQoL) as assessed by the Dementia Quality of Life (DQoL) in patients with Alzheimer's disease (AD), focusing particularly on functional alterations. METHODS: Cross-sectional multicenter study in subjects aged 65 years or older with mild to moderate AD. HRQoL was measured using the DQoL (five domains: self-esteem, positive affect/humor, negative affect, feeling of belonging, and sense of esthetics). Functional alterations were assessed based on activities of daily living (ADLs) and instrumental activities of daily living (IADLs). We also recorded socio-demographic characteristics of the patient and their carer, and comprehensive geriatric assessment including MMSE and psycho-behavioral data (Neuropsychiatric Inventory, Cornell depression score). Factors associated with each domain of the DQol were identified by multivariate linear regression. RESULTS: In total, 123 subjects were included (mean age 82 ± 6 years, 64% women). Two of the five domains of the DQoL were significantly associated with factors based on functional evaluation. The ability to transfer within the home and the ability to use the telephone were associated with an increase in HRQoL in the 'self-esteem' domain (p = 0.02 and 0.05, respectively). Ability to get dressed without assistance was associated with lower HRQoL in the 'negative affect' domain (p = 0.0007). CONCLUSION: Alterations in functional capacity have a significant effect on HRQoL in several domains of the DQoL.

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.

Mesenteric panniculitis: review of consecutive abdominal MDCT examinations with a matched-pair analysis.

Background The relationship between mesenteric panniculitis (MP), a benign condition involving adipose mesenteric tissue, and malignancy is still being questioned. Purpose To investigate the prevalence of MP and study its relationship with malignancy. To investigate the 5-year outcome of MP patients for the development of malignancy. Material and Methods Retrospective search for MP reviewing 3054 consecutive multidetector row computed tomography (MDCT) scans. Two radiologists in consensus selected the final MP population. For each MP, two subsequent MDCT scans of patients matched by gender and age. Five-year follow-up data regarding cancer occurrence after index MDCT scans were obtained for the MP and control groups. Comparisons between groups were performed using univariate conditional logistic regression. Results A total of 160 patients had at least three of the five MDCT features defining MP. Sixty-four were excluded owing to disease causing mesenteric infiltration or contiguous neoplastic involvement. The final population included 96 MP and 192 control patients. The prevalence of MP was 3.14%. Most cases of MP were discrete (66.7%), 2.1% were marked. In total, 60.4% and 59.4% of MP and control patients, respectively, had cancer ( P = 0.86). There was no significant association between MP score and presence of cancer ( P = 0.06) nor any relationship between the course of associated cancer and MP evolution. In total, 80/96 MP patients and 50/78 control patients without associated cancer had a 5-year follow-up at least. No significant difference between both groups for new tumor occurrence during follow-up was found ( P = 0.15). Conclusion Our results do not suggest that patients with incidentally found MP should be followed up for early detection of a cancer.

Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial.

IMPORTANCE: Therapeutic options for severe emphysema are limited. Lung volume reduction using nitinol coils is a bronchoscopic intervention inducing regional parenchymal volume reduction and restoring lung recoil. OBJECTIVE: To evaluate the efficacy, safety, cost, and cost-effectiveness of nitinol coils in treatment of severe emphysema. DESIGN, SETTING, AND PARTICIPANTS: Multicenter 1:1 randomized superiority trial comparing coils with usual care at 10 university hospitals in France. Enrollment of patients with emphysema occurred from March to October 2013, with 12-month follow-up (last follow-up, December 2014). INTERVENTIONS: Patients randomized to usual care (n = 50) received rehabilitation and bronchodilators with or without inhaled corticosteroids and oxygen; those randomized to bilateral coil treatment (n = 50) received usual care plus additional therapy in which approximately 10 coils per lobe were placed in 2 bilateral lobes in 2 procedures. MAIN OUTCOMES AND MEASURES: The primary outcome was improvement of at least 54 m in the 6-minute walk test at 6 months (1-sided hypothesis test). Secondary outcomes included changes at 6 and 12 months in the 6-minute walk test, lung function, quality of life as assessed by St George's Respiratory Questionnaire (range, 0-100; 0 being the best and 100 being the worst quality of life; minimal clinically important difference, ≥4), morbidity, mortality, total cost, and cost-effectiveness. RESULTS: Among 100 patients, 71 men and 29 women (mean age, 62 years) were included. At 6 months, improvement of at least 54 m was observed in 18 patients (36%) in the coil group and 9 patients (18%) in the usual care group, for a between-group difference of 18% (1-sided 95% CI, 4% to ∞; P = .03). Mean between-group differences at 6 and 12 months in the coil and usual care groups were +0.09 L (95% CI, 0.05 L to ∞) (P = .001) and +0.08 L (95% CI, 0.03 L to ∞) (P = .002) for forced expiratory volume in the first second, +21 m (95% CI, -4 m to ∞) (P = .06) and +21 m (95% CI, -5 m to ∞) (P = .12) for 6-minute walk distance, and -13.4 points (95% CI, -8 points to ∞) and -10.6 points (95% CI, -5.8 points to ∞) for St George's Respiratory Questionnaire (1-sided P < .001 for both). Within 12 months, 4 deaths occurred in the coil group and 3 in the usual care group. The mean total 1-year per-patient cost difference between groups was $47,908 (95% CI, $47,879-$48,073) (P < .001); the incremental cost-effectiveness ratio was $782,598 per additional quality-adjusted life-year. CONCLUSIONS AND RELEVANCE: In this preliminary study of patients with severe emphysema followed up for 6 months, bronchoscopic treatment with nitinol coils compared with usual care resulted in improved exercise capacity with high short-term costs. Further investigation is needed to assess durability of benefit and long-term cost implications. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01822795.

Lung concentrations of ceftazidime administered by continuous versus intermittent infusion in patients with ventilator-associated pneumonia.

Ceftazidime is a beta-lactam compound that exerts a time-dependent bactericidal effect. Numerous arguments are in favor of continuous administration of ceftazidime, both for reasons of clinical efficacy and to preserve bacteriological mutation. We report a prospective, single-center, parallel-group, randomized, controlled trial comparing two modes of administration of ceftazidime, namely, continuous administration (loading dose of 20 mg/kg of body weight followed by 60 mg/kg/day) versus intermittent administration (20 mg/kg over 30 min every 8 h) in 34 patients with ventilator-associated pneumonia due to Gram-negative bacilli. The study was performed over 48 h with 13 and 18 assessments of serum ceftazidime in the continuous-infusion group (group A) and the intermittent-fusion group (group B), respectively. Bronchoalveolar lavage (BAL) was performed at steady state in both groups at 44 h to determine ceftazidime levels in the epithelial lining fluid. We chose a predefined threshold of 20 mg/liter for serum concentrations of ceftazidime because of ecological conditions in our center. The median time above 20 mg/liter (T>20 mg) was 100% in group A versus 46% in group B. In group A, 14/17 patients had 100% T>20 mg, versus only 1/17 patients in group B. In the epithelial lining fluid, the median concentration of ceftazidime was 12 mg/liter in group A versus 6 mg/liter in group B. A threshold of 8 mg/liter in the epithelial lining fluid was achieved twice as often in group A as in group B. This study of ceftazidime concentrations in the epithelial lining fluid indicates that continuous infusion presents advantages in terms of pharmacodynamics and predictable efficacy in patients presenting ventilator-associated pneumonia.

Construction of a Quality of Life Questionnaire for slowly progressive neuromuscular disease.

PURPOSE: To build a questionnaire to assess health-related quality of life (HRQL) in patients suffering from slowly progressive neuromuscular disease (NMD) using item response theory (IRT). METHODS: A pool of 64 items and a validated questionnaire (WHOQOL-BREF) were administered to 159 patients recruited in eight NMD referral centers. Exploratory statistical analysis included methods derived from both IRT and classical test theory. RESULTS: We constructed a questionnaire named QoL-NMD which is composed of two general items and 24 items classified in three domains: (1) "Impact of Physical Symptoms," (2) "Self-perception" and (3) "Activities and Social Participation." Each domain has good psychometric properties (Cronbach's alpha > 0.77, test-retest ICC > 0.81, Loevinger's H > 0.41) and meets IRT assumptions. Comparison with the WHOQOL-BREF enabled assessing similarities and discrepancies with a generic questionnaire. CONCLUSION: This study enabled the development of a new HRQL questionnaire specifically designed for slowly progressive NMD patients. The QoL-NMD is short enough to be used in clinical practice (26 items). The next steps will be to validate QoL-NMD by re-assessing psychometrics in an independent sample of patients and calibrate the IRT scoring system.

Comparison of QoL-AD and DQoL in elderly with Alzheimer's disease.

OBJECTIVE: The Dementia Quality of Life (DQoL) and the Quality of Life in Alzheimer's Disease (QoL-AD) are the two most widely used dementia-specific QoL instruments in the world. We aimed to compare the psychometric properties of these two instruments and identify which is most adapted to use in geriatric consultations. METHODS: To evaluate the psychometric properties of the French language validation of DQoL and QoL-AD, 123 patients aged 65 years and over suffering from AD (Mini Mental State Examination score ≥10) were recruited in seven French hospitals and one Switzerland hospital. The DQoL comprises 29 items, ranked on a five-point Likert scale and measuring five QoL domains: self-esteem, positive affect, negative affect, feeling of belonging and sense of aesthetics. The QoL-AD contains 13 items giving an overall score ranging from 13 to 52 and evaluating the domains of interpersonal relationships, financial difficulties, physical condition, memory, mood and overall health. RESULTS: Both questionnaires showed adequate reproducibility at 2 weeks interval (intra-class correlation coefficient >0.80), good internal consistency (Cronbach's alpha coefficient >0.70) and good convergent validity with the general health dimension of the Duke Health Profile. The time required to complete the QoL-AD was significantly shorter (p < 0.0001). DQoL had better discriminant capacity (with at least one dimension significant for each subgroup of severity of cognitive decline, dependency, presence of depression or behavioural disorders). CONCLUSIONS: For quick evaluation of QoL during consultations in geriatric care, the QoL-AD is preferable, whereas for the purposes of research and more in-depth evaluation, the DQoL is more suitable.

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.

Quality of life after the initial treatments of non-small cell lung cancer: a persistent predictor for patients' survival.

BACKGROUND: Health-related quality of life (HRQoL) before treatment may predict survival of patients with non-small-cell lung cancer (NSCLC). We investigated the predictive role of HRQoL after the initial treatments, on the survival of these patients. METHODS: A prospective multi-center study conducted in northeastern France. The SF-36 and European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (QLQ C-30) were mailed to patients 3 months after the end of the diagnostic process. High scores for functioning dimensions on both questionnaires indicated better QoL, and low scores for symptom dimensions on the QLQ C-30 indicated few symptoms. Cox regression modeling was used to identify predictive factors of survival. RESULTS: In total, 230 (63.5%) patients responded to the SF-36 and QLQ C-30. Before completing the questionnaires, almost 60% of patients had undergone some chemotherapy, about 10% underwent radio/chemotherapy or both and more than 30% underwent surgery or surgery plus chemo/radiotherapy. On SF-36, the highest mean score was for social functioning dimension (55.5 ± 28), and the lowest was for the physical role dimension (17.9 ± 32.2). On QLQ C-30, for the functioning dimensions, the highest mean score was for cognitive functioning (74.6 ± 25.9) and the lowest was for role functioning (47.2 ± 34.1). For symptom dimensions, the lowest score was for diarrhoea (11.5 ± 24.2) and the highest was for fatigue (59.7 ± 27.7). On multivariate analysis, high bodily pain, social functioning and general health scores (SF-36) were associated with a lower risk of death (hazard ratio 0.580; 95% confidence interval [0.400-0.840], p = 0.004; HR 0.652 [0.455-0.935], p < 0.02; HR 0.625 [0.437-0.895] respectively). Better general QoL on QLQ C-30 was related to lower risk of death (HR 0.689 [0.501-0.946], p = 0.02). CONCLUSION: Adding to previous knowledge about factors that may influence patients QoL, this study shows a persisting relationship between better perceived health in HRQoL after the initial treatment of NSCLC and better survival.

Assessment of bullous pemphigoid disease area index during treatment: a prospective study of 30 patients.

BACKGROUND: Recently, a consensus Bullous Pemphigoid Disease Area Index (BPDAI) was proposed to measure therapeutic outcomes in bullous pemphigoid (BP). OBJECTIVE: To compare BPDAI with other clinical parameters of disease activity at baseline and to describe the variations of BPDAI during the initial phase of treatment. METHODS: Thirty BP patients were included and followed for 1 year. BPDAI was assessed at baseline and on days 30, 90 and 360 by the same investigator. Concomitantly, the number of daily new blisters, the skin surface area of erythematous/eczematous/urticarial plaques and blisters/erosions, total lesion area (TLA), pruritus score and mucosal involvement were recorded. RESULTS: At baseline, BPDAI was 46.7 ± 25 (mean ± SD); it was well correlated with erythematous/eczematous/urticarial skin surface (r = 0.63), TLA (r = 0.83), number of daily new blisters (r = 0.7; p ≤ 0.0002) and anti-BP180 autoantibodies (r = 0.49; p = 0.006), but not with anti-BP230 autoantibodies. For the 8 patients with severe BP at baseline, the mean BPDAI was 76.5, versus 35.9 for moderate BP (p = 0.0007). A value of 56 was proposed as a cut-off value for severe BP. BPDAI decreased to 11.9 ± 8.7, 10.7 ± 12.7 and 2.5 ± 4.1 on days 30, 90 and 360, respectively. CONCLUSION: BPDAI rapidly decreased during the early treatment stage of BP with variations almost totally conditioned by the skin activity component.