Cognition, mood and fatigue in patients in the early stage of multiple sclerosis.

QUESTION UNDER STUDY: Cognitive impairment occurs during multiple sclerosis (MS) and contributes to the burden of the disease, but its effect in the initial phase of MS still needs to be better understood. METHODS: We prospectively studied 127 early MS patients presenting with a clinically isolated syndrome (CIS) or definite MS, a mean disease duration of 2.6 years, and with minor disability (mean Expanded Disability Status Scale score 1.8). Patients were tested for long-term memory, executive functions, attention, fatigue, mood disorders, functional handicap and quality of life (QoL). Twenty-one CIS patients were excluded from study as the diagnosis of MS could not be confirmed. RESULTS: Over the 106 MS patients analysed, 31 (29.3%) were cognitively impaired (23.6% for memory, 10.4% for attention and 5.7% for executive functions). Cognitive deficits were already present in CIS patients in whom the diagnosis was not yet confirmed (20%). Impaired cognition was associated with anxiety (p = 0.05), depression(p = 0.004), fatigue (p = 0.03), handicap (p <0.001) and a lower QoL (p <0.001). After adjustment for QoL, handicap, depression, anxiety and fatigue were no longer associated with the presence of cognitive deficits. CONCLUSIONS: In this well-defined early MS group one third of the patients already exhibited cognitive deficits, which were usually apparent in an effortful learning situation and were generally mild. Mood disorders, fatigue, handicap and decreased QoL were all associated with the occurrence of cognitive deficits. QoL itself appeared to take all the other factors into account. Our results confirm the existence of an interplay between cognitive, affective and functional changes and fatigue in early MS.

Diabetic patients who report receiving processes of diabetic care do not express a better quality of life

Background: Chronic disease management initiatives emphasize patient-centered care, and quality of life (QoL) is increasingly considered a representative outcome in that context. In this study we evaluated the association between receipt of processes of diabetic care and QoL. Methods: This cross-sectional population-based study (2011) used self-reported data from non-institutionalized, adult diabetics, recruited from randomly selected community pharmacies in Vaud. Outcomes included the physical and mental composites of the SF-36 (PCS, MCS) and the disease-specific Audit of Diabetes-Dependent QoL (ADDQoL). Main exposure variables were receipt of six diabetes processes-of care in the past 12 months. We also evaluated whether the association between care received and QoL was congruent with the chronic care model, when assessed by the Patient Assessment of Chronic Illness Care (PACIC). We used linear regressions to examine the association between process measures and the three composites of health-related QoL. Analyses were adjusted for age, gender, socioeconomic status, living companion, BMI, alcohol, smoking, physical activity, co-morbidities and diabetes mellitus (DM) characteristics (type, insulin use, complications, duration). Results: Mean age of the 519 diabetic patients was 64.4 years (SD 11.3), 60% were male and 73% had a living companion; 87% reported type 2 DM, half of respondents required insulin treatment, 48% had at least one DM complication, and 48% had DM over 10 years. Crude overall mean QoL scores were PCS: 43.4 (SD 10.5), MCS: 47.0 (SD 11.2) and ADDQoL: -1.56 (SD 1.6). In bivariate analyses, patients who received the influenza vaccine versus those who did not, had lower ADDQoL and PCS scores; there were no other indicator differences. In adjusted models including all processes, receipt of influenza vaccine was associated with lower ADDQoL (β= - 0.41, p=.01); there were no other associations between process indicators and QoL composites. There was no process association even when these were reported as combined measures of processes of care. PACIC score was associated only with the MCS (β= 1.57, p=.004). Conclusions: Process indicators for diabetes care did not show an association with QoL. This may represent an effect lag time between time of process received and quality of life; or that treatment may be related with inconvenience and patient worry. Further research is needed to explore these unexpected findings.

Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001.

PURPOSE: To compare clinical benefit response (CBR) and quality of life (QOL) in patients receiving gemcitabine (Gem) plus capecitabine (Cap) versus single-agent Gem for advanced/metastatic pancreatic cancer. PATIENTS AND METHODS: Patients were randomly assigned to receive GemCap (oral Cap 650 mg/m(2) twice daily on days 1 through 14 plus Gem 1,000 mg/m(2) in a 30-minute infusion on days 1 and 8 every 3 weeks) or Gem (1,000 mg/m(2) in a 30-minute infusion weekly for 7 weeks, followed by a 1-week break, and then weekly for 3 weeks every 4 weeks) for 24 weeks or until progression. CBR criteria and QOL indicators were assessed over this period. CBR was defined as improvement from baseline for >or= 4 consecutive weeks in pain (pain intensity or analgesic consumption) and Karnofsky performance status, stability in one but improvement in the other, or stability in pain and performance status but improvement in weight. RESULTS: Of 319 patients, 19% treated with GemCap and 20% treated with Gem experienced a CBR, with a median duration of 9.5 and 6.5 weeks, respectively (P < .02); 54% of patients treated with GemCap and 60% treated with Gem had no CBR (remaining patients were not assessable). There was no treatment difference in QOL (n = 311). QOL indicators were improving under chemotherapy (P < .05). These changes differed by the time to failure, with a worsening 1 to 2 months before treatment failure (all P < .05). CONCLUSION: There is no indication of a difference in CBR or QOL between GemCap and Gem. Regardless of their initial condition, some patients experience an improvement in QOL on chemotherapy, followed by a worsening before treatment failure.

Quality of life depends on the drinking pattern in alcohol-dependent patients.

AIMS: In patients with alcohol dependence, health-related quality of life (QOL) is reduced compared with that of a normal healthy population. The objective of the current analysis was to describe the evolution of health-related QOL in adults with alcohol dependence during a 24-month period after initial assessment for alcohol-related treatment in a routine practice setting, and its relation to drinking pattern which was evaluated across clusters based on the predominant pattern of alcohol use, set against the influence of baseline variables METHODS: The Medical Outcomes Study 36-Item Short-Form Survey (MOS-SF-36) was used to measure QOL at baseline and quarterly for 2 years among participants in CONTROL, a prospective observational study of patients initiating treatment for alcohol dependence. The sample consisted of 160 adults with alcohol dependence (65.6% males) with a mean (SD) age of 45.6 (12.0) years. Alcohol use data were collected using TimeLine Follow-Back. Based on the participant's reported alcohol use, three clusters were identified: 52 (32.5%) mostly abstainers, 64 (40.0%) mostly moderate drinkers and 44 (27.5%) mostly heavy drinkers. Mixed-effect linear regression analysis was used to identify factors that were potentially associated with the mental and physical summary MOS-SF-36 scores at each time point. RESULTS: The mean (SD) MOS-SF-36 mental component summary score (range 0-100, norm 50) was 35.7 (13.6) at baseline [mostly abstainers: 40.4 (14.6); mostly moderate drinkers 35.6 (12.4); mostly heavy drinkers 30.1 (12.1)]. The score improved to 43.1 (13.4) at 3 months [mostly abstainers: 47.4 (12.3); mostly moderate drinkers 44.2 (12.7); mostly heavy drinkers 35.1 (12.9)], to 47.3 (11.4) at 12 months [mostly abstainers: 51.7 (9.7); mostly moderate drinkers 44.8 (11.9); mostly heavy drinkers 44.1 (11.3)], and to 46.6 (11.1) at 24 months [mostly abstainers: 49.2 (11.6); mostly moderate drinkers 45.7 (11.9); mostly heavy drinkers 43.7 (8.8)]. Mixed-effect linear regression multivariate analyses indicated that there was a significant association between a lower 2-year follow-up MOS-SF-36 mental score and being a mostly heavy drinker (-6.97, P < 0.001) or mostly moderate drinker (-3.34 points, P = 0.018) [compared to mostly abstainers], being female (-3.73, P = 0.004), and having a Beck Inventory scale score ≥8 (-6.54, P < 0.001), at baseline. The mean (SD) MOS-SF-36 physical component summary score was 48.8 (10.6) at baseline, remained stable over the follow-up and did not differ across the three clusters. Mixed-effect linear regression univariate analyses found that the average 2-year follow-up MOS-SF-36 physical score was increased (compared with mostly abstainers) in mostly heavy drinkers (+4.44, P = 0.007); no other variables tested influenced the MOS-SF-36 physical score. CONCLUSION: Among individuals with alcohol dependence, a rapid improvement was seen in the mental dimension of QOL following treatment initiation, which was maintained during 24 months. Improvement was associated with the pattern of alcohol use, becoming close to the general population norm in patients classified as mostly abstainers, improving substantially in mostly moderate drinkers and improving only slightly in mostly heavy drinkers. The physical dimension of QOL was generally in the normal range but was not associated with drinking patterns.

Poesia epica e letteratura femminile nell'Italia del XVII secolo: "L'Enrico, ovvero Bisanzio acquistato" (1635) di Lucrezia Marinelli

Nella mia tesi di dottorato mi concentro sul poema di Lucrezia Marinelli, L'Enrico, ovvero Bisanzio acquistato, pubblicato a Venezia nel 1635, indagando le strategie messe in atto dall'autrice per rivisitare il genere epico in un'ottica di riscatto femminile. Rispetto al canone epico e, in particolare, al modello di riferimento - la Gerusalemme liberata del Tasso - le vicende nodali sono, infatti, riscritte da un punto di vista chiaramente femminile. Pur occupandomi principalmente dell'opera di Marinelli, in alcuni casi nel corso del mio lavoro propongo dei confronti con altri poemi epici e cavallereschi prodotti da donne - in particolare I tredici canti del Floridoro di Moderata Fonte (1581) - volti a mostrare come le scrittrici avessero degli intenti comuni, dialogando in maniera critica con i modelli maschili da cui, tuttavia, traggono ispirazione. Nei primi capitoli del mio lavoro prendo in esame alcuni personaggi tradizionali dell'epica (le guerriere, la maga, ...) presenti ne L'Enrico e ne ripercorro gli episodi topici (le sortite notturne, l'eroe sull'isola, ...) dimostrando come, pur inserendosi coerentemente nel genere epico, siano caratterizzati in modo sostanzialmente diverso rispetto alla precedente tradizione maschile. Il primo capitolo si concentra sulle figure di guerriere, le quali presentano - rispetto ai precedenti modelli - differenze notevoli: non si lasciano coinvolgere in vicende amorose e non finiscono per essere sottomesse o uccise da un uomo, mantenendo così coerentemente intatti i valori di forza e indipendenza. Neppure la maga sull'isola - presa in esame nel capitolo dedicato alle Altre figure di donne idealizzate - è coinvolta in vicende sentimentali o caratterizzata sensualmente. L'autrice la rappresenta, non alla stregua di una tentatrice al servizio delle forze del male, ma come una donna colta, casta e disposta ad aiutare il cavaliere naufragato sulla sua isola. Nello stesso capitolo sono indagate anche altre figure femminili idealizzate, per taluni aspetti meno innovative, ma ugualmente interessanti: la Vergine, la personificazione di Venezia e la Musa. Queste rappresentazioni dal carattere iconico, presentano, infatti, diverse caratteristiche in comune con i personaggi più attivi del poema, le guerriere e la maga. Il capitolo Delle pene e delle tragedie amorose è dedicato all'amore e ai suoi esiti tragici. Le figure di donna coinvolte sono le madri, le mogli e Idillia, in cui è riconoscibile il personaggio topico della "damigella in difficoltà". Queste protagoniste, destinate a soffrire perché abbandonate dall'uomo che amano - il quale sente più forte il richiamo della guerra rispetto a quello dell'amore - servono da exempla, dimostrando che attaccamento affettivo e dipendenza conducono inesorabilmente all'infelicità. Rispetto al canone epico Marinelli riscatta alcune figure femminili, permettendo alle sue guerriere di prendersi la rivincita, vendicando la morte di eroine quali Camilla e Clorinda. Conseguentemente, alcuni guerrieri sono destinati a morire per mano di una donna. Nel quarto capitolo, mi concentro proprio su La sconfitta degli eroi, mettendo in luce come l'autrice proponga una sua personale regola del contrappasso, volta a cambiare (e addirittura invertire) le sorti dei personaggi che animano il suo poema. Questi aspetti risultano essere ancora più significativi se confrontati con l'opera - data alle stampe per la prima volta nel 1600 - intitolata Nobiltà et eccellenza delle donne. In questo trattato Marinelli sosteneva la superiorità del genere femminile su quello maschile. Alcune delle posizioni assunte nello scritto giovanile sono confermate dai personaggi e dalle vicende che animano l'Enrico. Confronti puntuali fra trattato e poema epico sono effettuati nell'ultimo capitolo del mio lavoro, sottolineando come fra le due opere vi siano delle affinità volte a confermare l'eccellenza delle donne.

Impact of etanercept-methotrexate therapy on patient-reported outcomes in rheumatoid arthritis patients with up to 12 months of symptoms.

Background/Purpose: Patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) are critical in evaluating RA treatment effects on function and health-related quality of life (HR-QoL). Significant improvement in PROs has been reported in RA studies of biologic agents, including etanercept (ETN), but most studies have been conducted in patients with established disease. In addition to assessing treatment effects in early RA, there is interest in therapeutic strategies that allow dose reduction or withdrawal of biologic therapy (biologic-free) after induction of response. The PRIZE trial is an ongoing, 3-period study to evaluate the efficacy of combined ETN and methotrexate (MTX) therapy in patients with early, moderate-to-severe RA and to assess whether efficacy (remission) can be maintained with ETN dose reduction or biologic-free (Period 2) or drug-free (Period 3). Herein we report PROs associated with ETN 50 mg QW plus MTX (ETN50/MTX) therapy administered for 52 wks in Period 1 (induction) of the PRIZE trial. Methods: In Period 1, MTX- and biologic-naı‥ve patients with early, active RA (symptom onset 12 mo from enrollment; DAS28 _3.2) received open-label ETN50/MTX for 52 wks. The starting dose of MTX was 10 mg QW; at the discretion of the investigator, titration was permitted up to a maximum of 25 mg QW to achieve remission. Corticosteroid boosts were administered to patients not achieving low disease state at wks 13 and 26, unless contraindicated or not tolerated. PROs were assessed using the Health Assessment Questionnaire (HAQ) total score; Patient Acceptable Symptom State (PASS); EuroQol-5 Dimensions (EQ-5D) total index; Short Form Health Survey (SF-36); Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue; Work Instability Scale for Rheumatoid Arthritis (RAWIS); and Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI:RA). Results: A total of 306 patients received treatment in Period 1 (mITT population); 222 (73%) patients completed the period. The majority of patients were female (70%), with a mean age of 50 y, mean DAS28 of 6.0 (median, 6.0), and duration of disease symptoms from onset of 6.5 months (median, 6.3 mo). Significant and clinically meaningful improvements in PROs, including in HAQ, EQ-5D, SF-36, and FACIT-Fatigue, were demonstrated with ETN50/MTX therapy from baseline to the final on therapy visit (Table; P_0.0001). Similar improvements were observed in all dimensions of RA-WIS and WPAI:RA (Table; P_0.0001). Conclusion: Combination therapy with ETN50/MTX for 52 wks in patients with _12 mo of symptomatic, active RA resulted in significant, clinically important improvements in measures of physical function, including normal HAQ (66.6% of patients), HR-QoL, fatigue, and work productivity. These outcomes are consistent with those reported in prior studies in patients with more established disease.

Effects of a school-based physical activity program on physical and psychosocial quality of life in elementary school children: a cluster-randomized trial.

The present study tested the effect of a school-based physical activity (PA) program on quality of life (QoL) in 540 elementary school children. First and fifth graders were randomly assigned to a PA program or a no-PA control condition during one academic year. QoL was assessed by the Child Health Questionnaire at baseline and postintervention. Based on mixed linear model analyses, physical QoL in first graders and physical and psychosocial QoL in fifth graders were not affected by the intervention. In first graders, the PA intervention had a positive impact on psychosocial QoL (effect size [d], 0.32; p < .05). Subpopulation analyses revealed that this effect was caused by an effect in urban (effect size [d], 0.38; p < .05) and overweight first graders (effect size [d], 0.45; p < .05). In conclusion, a school-based PA intervention had little effect on QoL in elementary school children.

Qualité de vie après traitement de l'insuffisance veineuse superficielle primaire. [Quality of life in patients traited for primary superficial venous insufficiency].

Venous symptoms and quality of life (QOL) of 78 patients (54 women, mean age 49,5±13,3 years) with primary superficial venous insufficiency (PSVI) were compared at one year after treatment with crossectomy and stripping (C/S, 56 patients) or endovenous laser ablation (EVLA, 22 patients) using the VEINES-QOL questionnaire. Both treatments significantly (p<0,001) improved the scores for venous symptoms (difference 10,6±9,9 and 9,9±8,2 score points for C/S and EVLA, respectively) and QOL (difference 10,3±8,7 and 8,4±6,6 score points for C/S and EVLA, respectively). No difference was found between treatments regarding symptoms or QOL improvement (p=0,30). We conclude that C/S and EVLA are equally effective in improving symptoms and QOL in PSVI.

Qui utilise les crèches en Suisse ? : logiques sociales du recours aux structures d'accueil collectif pour la petite enfance

Depuis quelque temps, de plus en plus de spécialistes de la politique sociale préconisent une stratégie d'investissement social dans laquelle les crèches joueraient un rôle majeur. Cette stratégie vise à prévenir les exclusions sociales par la promotion de l'égalité des chances et de l'accès à l'emploi en vue d'un allègement des dépenses de protection sociale passive. Outre qu'elles permettent aux familles d'avoir deux revenus, les crèches ont en effet l'avantage de réduire les écarts au niveau des compétences cognitives et linguistiques entre les enfants venant de différents milieux sociaux. Mais le succès d'une telle stratégie présuppose que certains publics cibles recourent effectivement aux crèches, à savoir les ménages disposant d'un faible revenu ou/et de niveau de formation, ainsi que les familles issues de l'immigration. Or, des analyses statistiques sur la base de l'Enquête suisse sur la population active (ESPA) de 2008 montrent que, pour les familles en Suisse, les chances d'utiliser une crèche augmentent avec le niveau de formation des parents. Concernant plus particulièrement le niveau de formation des mères, ce phénomène n'est d'ailleurs que partiellement conditionné par le taux d'activité supérieur de celles ayant accompli une formation de degré tertiaire. En outre, certaines populations d'immigrés dont l'intégration dans la société suisse est réputée difficile sont peu disposées à recourir aux crèches. Les immigrés de première génération de quasiment toutes les origines fortement représentées en Suisse ont en revanche plus de chances que les parents d'origine suisse de faire appel au service d'une crèche à raison d'au moins 4 jours/semaine, ce qui peut influer négativement sur le comportement de l'enfant. Ce dernier résultat semble paradoxal mais montre qu'une migration rend plus difficile l'organisation d'une garde informelle comme solution complémentaire à la crèche. En synthèse, la présente étude attire l'attention sur le fait que les atouts pédagogiques et socialisants des crèches reviennent avant tout aux enfants de parents d'origine suisse ou venant de pays culturellement proches et ayant un niveau de formation supérieur. Telle que conçue actuellement, l'offre de crèches en Suisse ne semble guère opérer comme un instrument efficace de l'investissement social. Immer mehr Experten der Sozialpolitik empfehlen eine ,,Strategie der sozialen Investitionen", die den Kindertagesstätten (bzw. Kinderkrippen) eine wichtige Rolle zuschreibt. Ziel dieser Strategie ist es, durch Förderung von Chancengleichheit und Arbeitsmarktpartizipation sozialen Ausgrenzungen vorzubeugen, um Einsparungen im Bereich der passiven Sozialleistungen zu ermöglichen. Krippen haben einerseits den Vorteil, dass sie es den Familien ermöglichen, zwei Einkommen zu erzielen. Andererseits tragen sie zur Minderung von kognitiven und sprachlichen Fähigkeitsunterschieden zwischen Vorschulkindern aus verschiedenen sozialen Milieus bei. Der Erfolg dieser Strategie setzt jedoch voraus, dass gewisse Zielgruppen tatsächlich Krippen nutzen, nämlich bezüglich Einkommen und/oder Bildung benachteiligte Haushalte sowie Familien mit Migrationshintergrund. Die vorliegenden statistischen Analysen aufgrund der SAKE-Daten von 2008 (Schweizerische Arbeitskräfteerhebung) ergeben jedoch für die Schweiz, dass die Wahrscheinlichkeit, eine Krippe zu nutzen, mit dem Bildungsniveau der Eltern steigt. Was das Bildungsniveau der Mütter im Besonderen anbelangt, ist dieses Phänomen nur teilweise bedingt durch den tendenziell höheren Beschäftigungsgrad der besser Ausgebildeten. Zudem haben einige Migrantengruppen, deren Integration in die Schweizer Gesellschaft als besonders schwierig betrachtet wird, eine bedeutend tiefere Benützungswahrscheinlichkeit als Eltern Schweizer Herkunft. Für fast alle in der Schweiz stark vertretenen Migranten erster Generation ist dennoch das statistische Risiko grösser, die Krippe während mindestens 4 Tagen/Woche zu nutzen, was einen negativen Einfluss auf das Verhalten des Kindes haben kann. Dieses scheinbar paradoxe Ergebnis ist darauf zurückzuführen, dass ein Migrationshintergrund das Organisieren von krippenergänzenden Betreuungslösungen informeller Art meist erschwert. Gesamthaft zeigt die vorliegende Studie auf, dass die positiven pädagogischen und sozialisierenden Effekte der Krippen in erster Linie Kindern zugutekommen, deren Eltern eine höhere Ausbildung haben, Schweizer Herkunft sind oder aus einem kulturell nahestehenden Land kommen. So wie es gegenwärtig eingerichtet ist, scheint das Krippenangebot in der Schweiz kaum als effizientes Instrument sozialer Investitionen zu wirken.

Réduction de la consommation de sel: une mesure importante de santé publique en Suisse. [Reducing dietary salt intake: an important public health strategy in Switzerland]

La consommation actuelle de sel (chlorure de sodium) est très supérieure aux besoins physiologiques (1,5 g par jour, soit environ 550 mg par jour de sodium) dans la plupart des pays (> 8 g par jour). Les principales sources de sel sont les pains, les fromages, les produits dérivés de la viande et les plats précuisinés. En moyenne, une consommation élevée de sel est associée à une pression artérielle plus élevée. En Suisse, un adulte sur trois souffre d'hypertension artérielle. La moitié des accidents vasculaires cérébraux et des maladies cardiaques ischémiques sont attribuables à une pression artérielle trop élevée. L'Office fédéral de la santé publique conduit actuellement une stratégie visant à diminuer la consommation de sel dans la population suisse à moins de 5 g par jour sur le long terme (Salz Strategie 2008-2012). [Abstract] Current dietary salt (sodium chloride) intake largely exceeds physiological needs (about 1.5 g salt per day, or 550 mg sodium per day) in most countries (> 8 g salt per day). The main sources of dietar salt intake are breads, cheeses, products derived from meat and ready-to-eat meals. On average, a high-salt diet is associated with higher blood pressure levels. In Switzerland, one out of three adults suffers from arterial hypertension. Half of cerebrovascular events and ischaemic cardiac events are attributable to elevated blood pressure. The Swiss Federal Office of Public Health is currently running a strategy aiming at reducing dietary salt intake in the Swiss population to less than 5 g per day on the long run (Salz Strategie 2008-2012).

Subgroup And Quality Of Life Analyses Of The Phase Iii Clinical Trial Of Novottf-100a Versus Best Standard Chemotherapy For Recurrent Glioblastoma

BACKGROUND: NovoTTF is a portable device delivering low-intensity, intermediate-frequency, electric fields using noninvasive, disposable scalp electrodes. These fields physically interfere with cell division. Preliminary studies in recurrent and newly diagnosed glioblastoma (GBM) have shown promising results. A phase III study in recurrent GBM has recently been concluded. METHODS: Adults (KPS ≥ 70%) with recurrent GBM (any recurrence) were randomized (stratified by surgery and center) to either NovoTTF administered continuously (20-24 hours/day, 7 days/week) or the best available chemotherapy (best physician choice [BPC]). Primary endpoint was overall survival (OS); 6-month progression-free survival (PFS6), 1-year survival, and QOL were secondary endpoints. RESULTS: Two hundred thirty-seven patients were randomized (28 centers in the United States and Europe) to either NovoTTF alone (120 patients) or BPC (117 patients). Patient characteristics were balanced, median age was 54 years (range, 23-80 years), median KPS was 80% (range, 50-100). One quarter had surgery for recurrence, and over half were at their second or more recurrence. A survival advantage for the device group was seen in patients treated according to protocol (median OS, 7.8 months vs. 6.1 months; n = 185; p = 0.01). Moreover, subgroup analysis in patients with better prognostic baseline characteristics (KPS ≥ 80%; age ≤ 60; 1st-3rd recurrence) demonstrated a robust survival benefit for NovoTTF patients compared to matched BPC patients (median OS, 8.8 months vs. 6.6 months; n = 110; p < 0.01). In this group, 1-year survival was 35% vs. 20% and PFS6 was 25.6% vs. 7.7%. Interestingly, in patients who failed bevacizumab prior to the trial, OS was also significantly extended by NovoTTF (4.4 months vs. 3.1 months; n = 23 vs. n = 21; p < 0.02). Quality of life was equivalent or superior in NovoTTF patients. CONCLUSIONS: NovoTTF, a noninvasive, novel cancer treatment modality shows significant therapeutic efficacy with improved quality of life. The impact of NovoTTF was more pronounced when patients with better baseline prognostic factors were treated. A large scale phase III clinical trial in newly diagnosed GBM is currently being conducted.

5

Le management stratégique est devenu un outil de gestion presque incontournable dans les organisations publiques, notamment du fait de la généralisation de la contractualisation et de gouvernance à distance. Bien sûr, gérer sur la base d'une stratégie afin d'atteindre des objectifs précis paraît fort raisonnable. Cependant, l'étude du fonctionnement contemporain des organisations publiques démontre que le management stratégique se limite bien souvent à des stratégies de contrôle, conduisant à une bureaucratisation accrue des organisations publiques en lieu et place d'une plus grande liberté managériale. Nous expliquons ce mécanisme en prenant pour exemple le secteur hospitalier suisse en pleine restructuration.

Specialized home palliative care for adults and children: differences and similarities.

OBJECTIVE: To compare the provision of specialized home palliative care (SHPC) by the adult and pediatric SHPC teams at the Munich University Hospital. METHODS: All patients treated by one of the SHPC teams and their primary caregivers were eligible for the prospective nonrandomized survey. We analyzed the demographics, the underlying diseases, duration and impact of SHPC on symptom control and quality of life (QOL) as well as the caregivers' burden and QOL. RESULTS: Between April 2011 and June 2012, 100 adult and 43 pediatric patients were treated consecutively; 60 adults (median age, 67.5 years; 55% male) and 40 children (median age, 6 years, 57% male) were included in the study. Oncologic diseases were dominant only in the adult cohort (87 versus 25%, p<0.001). The median period of care was higher in the pediatric sample (11.8 versus 4.3 weeks; NS). Ninety-five percent of adult and 45% of pediatric patients died by the end of the study (p<0.001), 75% and 90% of them at home, respectively. The numbers of significant others directly affected by the patient's disease was higher in children (mean 3.4 versus 1.2; p<0.001). The QOL of adult patients and children (p<0.05 for both), as well as of their primary caregivers (p<0.001 for both) improved during SHPC, while the caregivers' burden was lowered (p<0.001 for both). CONCLUSIONS: Our results show important differences in several clinically relevant parameters between adults and children receiving SHPC. This should assist in the development of age-group specific SHPC concepts that effectively address the specific needs of each patient population.

Glioblastoma in elderly patients: health-related quality of life (hrqol) in a randomized trial comparing 6-weeks of tadiotherapy (rt) vs hypofractionated rt over 2 weeks vs temozolomide chemotherapy (tmz)

BACKGROUND: Despite advances in treatment, survival of patients with GBM over 60 years is still often less than 1 year. In the perspective of a short expected survival, the quality of the remaining life and the effects of therapy on health-related quality of life (HRQoL) should be given special emphasis when recommending treatment for the individual patients. Several studies have focused on survival of the elderly, but few data are available on HRQoL for different treatments. In a randomized trial, we compared survival and HRQoL for 3 treatment options, 6 weeks of RT, vs hypofractionated RT, or chemotherapy with TMZ. MATERIALS AND METHODS: Newly diagnosed GBM patients, age ≥60 years with PS 0-2, were randomized to either standard RT (60 Gy in 2-Gy fractions over 6 weeks), hypofractionated RT (34 Gy in 3.4-Gy fractions over 2 weeks), or 6 cycles of chemotherapy with TMZ (200 mg/m2 day 1-5 every 28 days). QoL was determined by the EORTC QLQ 30 questionnaire and the Brain Cancer Module at inclusion, before start of therapy, at 6 weeks, 3 months, and 6 months after start of treatment. Patients were followed until death. The primary study endpoint was overall survival (OS) and secondary objectives were HRQoL, neurologic symptom control, and safety. RESULTS: A total of 342 patients were included and 292 patients were randomized between the 3 treatment options and 50 patients between hypofractionated RT and TMZ. Median age was 70 years (range 60-92) with 58% being male. Performance status was 0-1 for 75% of patients and 73% had undergone surgical resection. CONCLUSION: The results from the HRQoL analysis of this trial will be presented together with survival data at the upcoming EANO meeting.

From dialysis to transplantation, illness experience and patients' concerns about future: A longitudinal qualitative study

Background: Transplantation is the treatment of choice when compared to dialysis. Long-term evolution of patients is rarely comprehensively described. Thirty end-stage renal disease patient's experience of illness was explored from registration for transplantation until twenty-four months after transplantation. Methods: Longitudinal semi-structured interviews were conducted, and qualitative discourse analysis performed. Findings: Before transplantation loss of quality of life (QOL), emotional fragility related to dialysis constraints were reported, and increased with waiting-time. Six months after transplantation, recovered freedom was described but acute rejection, and life-dependency to immunosuppressants generated concerns. After twelve months, long-term survival of the graft, and possible return-to-dialysis were mentioned. After twenty months graft's dysfunction, co-morbidities, immunosuppressants side effects rose concerns even though QOL persisted. Most patients report positive transformations after transplantation, which are related to graft survival and limited co-morbidities. Discussion: As time passes, patients deal with changing illness constraints, and contemplate with anxiety possible new return to dialysis and/or transplantation.