Individual versus standard quality of life assessment in a phase II clinical trial in mesothelioma patients: feasibility and responsiveness to clinical changes.

BACKGROUND: In patients with malignant pleural mesothelioma undergoing a multimodality therapy, treatment toxicity may outweigh the benefit of progression-free survival. The subjective experience across different treatment phases is an important clinical outcome. This study compares a standard with an individual quality of life (QoL) measure used in a multi-center phase II trial. PATIENTS AND METHODS: Sixty-one patients with stage I-III technically operable pleural mesothelioma were treated with preoperative chemotherapy, followed by pleuropneumonectomy and subsequent radiotherapy. QoL was assessed at baseline, at day 1 of cycle 3, and 1, 3 and 6 months post-surgery by using the Rotterdam Symptom Checklist (RSCL) and the Schedule for the Evaluation of Quality of Life-Direct Weighting (SEIQoL-DW), a measure that is based on five individually nominated and weighted QoL-domains. RESULTS: Completion rates were 98% (RSCL) and 92% (SEIQoL) at baseline and 98%/89% at cycle 3, respectively. Of the operated patients (N=45) RSCL and SEIQoL were available from 86%/72%, 93%/74%, and 94%/76% at months 1, 3, and 6 post-surgery. Average assessment time for the SEIQoL was 24min compared to 8min needed for the RSCL. Median changes from baseline indicate that both RSCL QoL overall score and SEIQoL index remained stable during chemotherapy with a clinically significant deterioration (change>or=8 points) 1 month after surgery (median change of -66 and -14 for RSCL and SEIQoL, respectively). RSCL QoL overall scores improved thereafter, but remained beneath baseline level until 6 months after surgery. SEIQoL scores improved to baseline-level at month 3 after surgery, but worsened again at month 6. RSCL QoL overall score and SEIQoL index were moderately correlated at baseline (r=.30; p<or=.05) and at 6-month follow-up (r=.42; p<or=.05) but not at the other time points. CONCLUSION: The SEIQoL assessment seems to be feasible within a phase II clinical trial, but may require more effort from staff. More distinctive QoL changes in accordance with clinical changes were measured with the RSCL. Our findings suggest that the two measures are not interchangeable: the RSCL is to favor when mainly information related to the course of disease- and treatment is of interest.

Quality assurance in the EORTC 22033-26033/CE5 phase III randomized trial for low grade glioma: the digital individual case review.

INTRODUCTION: The phase III EORTC 22033-26033/NCIC CE5 intergroup trial compares 50.4 Gy radiotherapy with up-front temozolomide in previously untreated low-grade glioma. We describe the digital EORTC individual case review (ICR) performed to evaluate protocol radiotherapy (RT) compliance. METHODS: Fifty-eight institutions were asked to submit 1-2 randomly selected cases. Digital ICR datasets were uploaded to the EORTC server and accessed by three central reviewers. Twenty-seven parameters were analysed including volume delineation, treatment planning, organ at risk (OAR) dosimetry and verification. Consensus reviews were collated and summary statistics calculated. RESULTS: Fifty-seven of seventy-two requested datasets from forty-eight institutions were technically usable. 31/57 received a major deviation for at least one section. Relocation accuracy was according to protocol in 45. Just over 30% had acceptable target volumes. OAR contours were missing in an average of 25% of cases. Up to one-third of those present were incorrectly drawn while dosimetry was largely protocol compliant. Beam energy was acceptable in 97% and 48 patients had per protocol beam arrangements. CONCLUSIONS: Digital RT plan submission and review within the EORTC 22033-26033 ICR provide a solid foundation for future quality assurance procedures. Strict evaluation resulted in overall grades of minor and major deviation for 37% and 32%, respectively.

Development and growth of the early juveniles of the spider crab Maja squinado (Brachyura: Majoidea) in an individual culture system

The spider crab Maja squinado is an endangered Mediterranean species; therefore, culturing it successfully is essential for developing restocking programs. The survival, growth and development of post-larval stages (juvenile crabs, C1-C8) were studied using larvae obtained from adult individuals collected in the Catalan Sea. The juvenile crab stages were cultured individually from a megalopal stage using a semi-open recirculation system to obtain the precise growth data of each juvenile crab stage until C8. Development up to C8 at 20ºC lasted 154±10 days. Survival from C1 to C8 was 5.8 %. Moult increment values in cephothoracic length were similar in all the crab stages (21-35 %). Intermoult duration (9±1 in C1-C2 to 51±8 days in C7-C8) increased sharply from juvenile stage 5. Males and females can be distinguished from C4 based on sexual dimorphism in the pleopods and the presence of gonopores. The allometric growth of the pleon is sex-dependent from C4, with females showing positive allometry and males isometric growth. The juvenile growth rate was lower compared with that of the previously studied Atlantic species Maja brachydactyla.

Nasopharyngeal carriage of individual Streptococcus pneumoniae serotypes during pediatric radiologically confirmed community acquired pneumonia following PCV7 introduction in Switzerland.

BACKGROUND: Community-acquired pneumonia (CAP) is a serious cause of morbidity among children in developed countries. The real impact of 7-valent pneumococcal conjugate vaccine (PCV7) on pneumococcal pneumonia is difficult to assess accurately. METHODS: Children aged ≤16 years with clinical and radiological pneumonia were enrolled in a multicenter prospective study. Children aged ≤16 years admitted for a minor elective surgery was recruited as controls. Nasopharyngeal samples for PCR serotyping of S. pneumoniae were obtained in both groups. Informations on age, gender, PCV7 vaccination status, day care/school attendance, siblings, tobacco exposure were collected. RESULTS: In children with CAP (n=236), 54% of the nasopharyngeal swabs were PCR-positive for S. pneumoniae compared to 32% in controls (n=105) (p=0.003). Serotype 19A was the most common pneumococcal serotype carried in children with CAP (13%) and in controls (15%). Most common serotypes were non-vaccine types (39.4% for CAP and 47.1% for controls) and serotypes included only in PCV13 (32.3% for CAP and 23.5% for controls). There was no significant difference in vaccine serotype distribution between the two groups. In fully vaccinated children with CAP, the proportion of serotypes carried only in PCV13 was higher (51.4%) than in partially vaccinated or non vaccinated children (27.6% and 28.6% respectively, p=0.037). CONCLUSIONS: Two to 4 years following introduction of PCV7, predominant S. pneumoniae serotypes carried in children with CAP were non PCV7 serotypes, and the 6 new serotypes included in PCV13 accounted for 51.4% of carried serotypes in fully vaccinated children.

Validación de la escala modificada de MASCC y papel de los marcadores biológicos en la estratificación del riesgo individual del paciente con fiebre neutropénica inducida por quimioterapia y neoplasia sódia

Estudi prospectiu d’incidència de NF degut a la QT a pacients amb neoplàsia solida. S’estudia la validació de l’escala modificada de MASCC i utilitat de marcadors d’inflamació en l’estratificació del risc individual. Hem inclòs 54 episodis de NF. El 50% (27/54) va ser de baix risc. Predomini de BGN (73,3%). 13% van ser bacterièmics. La sensibilitat i especificitat de l’escala modificada de MASCC van ser del 56% i 54%, respectivament. El recompte baix de granulòcits prediuen bacterièmia; i els nivells baixos de IL-12, alts de PCR i de proADM, i el temps curt de neutropènia al desenvolupament de complicacions i/o de mort. L’escala modificada de MASCC va obtenir una baixa sensibilitat i especificitat. El recompte de granulòcits, nivells de PCR i proADM s’haurien d’incloure a l’escala clàssica de MASCC per incrementar la seva sensibilitat i especificitat.

Influence of Individual Characteristics on Work Engagement and Job Stress in a Sample of National and Foreign Workers in Switzerland

In most Western postindustrial societies today, the population is aging, businesses are faced with global integration, and important migration flows are taking place. Increasingly work organizations are hiring crossnational and multicultural workteams. In this situation it is important to understand the influence of certain individual and cultural characteristics on the process of professional integration. The present study explores the links between personality traits, demographic characteristics (age, sex, education, income, and nationality), work engagement, and job stress. The sample consisted of 618 participants, including 394 Swiss workers (200 women, 194 men) and 224 foreigners living and working in Switzerland (117 women, 107 men). Each participant completed the NEO-FFI, the UWES, and the GWSS questionnaires. Our results show an interaction between age and nationality with respect to work engagement and general job stress. The levels of work engagement and job stress appear to increase with age among national wotkers, whereas they decrease among foreign workers. In addition, work engagement was negatively associated with Neuroticism and positively with the other four personality dimensions. Finally, job stress was positively associated with Neuroticism and Conscientiousness, and negatively associated with Extraversion. However, the strength of these relationships appeared to vary according to the worker's nationality, age, sex, education, and income.

Variability of North Atlantic hurricanes: seasonal versus individual-event features

Tropical cyclones are affected by a large number of climatic factors, which translates into complex patterns of occurrence. The variability of annual metrics of tropical-cyclone activity has been intensively studied, in particular since the sudden activation of the North Atlantic in the mid 1990’s. We provide first a swift overview on previous work by diverse authors about these annual metrics for the North-Atlantic basin, where the natural variability of the phenomenon, the existence of trends, the drawbacks of the records, and the influence of global warming have been the subject of interesting debates. Next, we present an alternative approach that does not focus on seasonal features but on the characteristics of single events [Corral et al., Nature Phys. 6, 693 (2010)]. It is argued that the individual-storm power dissipation index (PDI) constitutes a natural way to describe each event, and further, that the PDI statistics yields a robust law for the occurrence of tropical cyclones in terms of a power law. In this context, methods of fitting these distributions are discussed. As an important extension to this work we introduce a distribution function that models the whole range of the PDI density (excluding incompleteness effects at the smallest values), the gamma distribution, consisting in a powerlaw with an exponential decay at the tail. The characteristic scale of this decay, represented by the cutoff parameter, provides very valuable information on the finiteness size of the basin, via the largest values of the PDIs that the basin can sustain. We use the gamma fit to evaluate the influence of sea surface temperature (SST) on the occurrence of extreme PDI values, for which we find an increase around 50 % in the values of these basin-wide events for a 0.49 C SST average difference. Similar findings are observed for the effects of the positive phase of the Atlantic multidecadal oscillation and the number of hurricanes in a season on the PDI distribution. In the case of the El Niño Southern oscillation (ENSO), positive and negative values of the multivariate ENSO index do not have a significant effect on the PDI distribution; however, when only extreme values of the index are used, it is found that the presence of El Niño decreases the PDI of the most extreme hurricanes.

Copeptin, a stable peptide derived from the vasopressin precursor, correlates with the individual stress level.

BACKGROUND: During stress, vasopressin is a potent synergistic factor of CRH as a hypothalamic stimulator of the HPA axis. The measurements of CRH and vasopressin levels are cumbersome because of their instability and short half-life. Copeptin is a more stable peptide stoichiometrically released from the same precursor molecule. The aim of our study was to compare copeptin and cortisol levels in different stress situations. METHODS: Three groups of patients with increasing stress levels were investigated: a) healthy controls without apparent stress (n=20), b) hospitalized medical patients with moderate stress (n=25) and c) surgical patients 30 minutes after extubation, with maximal stress (n=29). In all patients we assessed cortisol and copeptin levels. Copeptin levels were measured with a new sandwich immunoassay. RESULTS: Cortisol levels in controls were (median, IQ range, 486 [397-588] nmol/L), not significantly different as compared to medical patients (438 [371-612] nmol/L, p=0.69). Cortisol levels in surgical patients after extubation were higher (744 [645-1062] nmol/L p<0.01 vs controls and medical patients). Copeptin levels in controls were 4.3 [3.2-5.5] pmol/L, which was lower as compared to medical patients (17.5 [6.4-24.1], p<0.001) and surgical patients after extubation (67.5 [37.8-110.0] pmol/L, p<0.001). The correlation between copeptin levels and cortisol was r=0.46, p<0.001. CONCLUSION: Copeptin is a novel marker of the individual stress level. It more subtly mirrors moderate stress as compared to cortisol values.

Behaviour change at population, community and individual levels: NICE Public Health Guidance 6

This guidance is aimed at those responsible for helping people to change their behaviour to improve their health. This includes policy makers and those working in local authorities and the community and voluntary sectors. It gives advice on how to plan and run relevant initiatives. The recommendations include the following advice: base interventions on a proper assessment of the target group, where they are located and the behaviour which is to be changed: careful planning is the cornerstone of success  work with other organisations and the community itself to decide on and develop initiatives build on the skills and knowledge that already exists in the community, for example, by encouraging networks of people who can support each other take account of and resolve problems that prevent people changing their behaviour (for example, the costs involved in taking part in exercise programmes or buying fresh fruit and vegetables, or lack of knowledge about how to make changes) base all interventions on evidence of what works train staff to help people change their behaviour evaluate all interventions.This resource was contributed by The National Documentation Centre on Drug Use.

Individual monitoring of medical staff working in interventional radiology in Switzerland using double dosimetry

Physicians who frequently perform fluoroscopic examinations are exposed to high intensity radiation fields. The exposure monitoring is performed with a regular personal dosimeter under the apron in order to estimate the effective dose. However, large parts of the body are not protected by the apron (e.g. arms, head). Therefore, it is recommended to wear a supplemental dosimeter over the apron to obtain a better representative estimate of the effective dose. The over-apron dosimeter can also be used to estimate the eye lens dose. The goal of this study was to investigate the relevance of double dosimetry in interventional radiology. First the calibration procedure of the dosimeters placed over the apron was tested. Then, results of double dosimetry during the last five years were analyzed. We found that the personal dose equivalent measured over a lead apron was underestimated by ∼20% to ∼40% for X-ray beam qualities used in radiology. Measurements made over five-year period confirm that the use of a single under-apron dosimeter is inadequate for personnel monitoring. Relatively high skin dose (>10 mSv/month) would have remained undetected without a second dosimeter placed on the apron.

Effective exposure to solar UV in building workers: influence of local and individual factors.

Excessive exposure to solar UV light is the main cause of skin cancers in humans. UV exposure depends on environmental as well as individual factors related to activity. Although outdoor occupational activities contribute significantly to the individual dose received, data on effective exposure are scarce and limited to a few occupations. A study was undertaken in order to assess effective short-term exposure among building workers and characterize the influence of individual and local factors on exposure. The effective exposure of construction workers in a mountainous area in the southern part of Switzerland was investigated through short-term dosimetry (97 dosimeters). Three altitudes, of about 500, 1500 and 2500 m were considered. Individual measurements over 20 working periods were performed using Spore film dosimeters on five body locations. The postural activity of workers was concomitantly recorded and static UV measurements were also performed. Effective exposure among building workers was high and exceeded occupational recommendations, for all individuals for at least one body location. The mean daily UV dose in plain was 11.9 SED (0.0-31.3 SED), in middle mountain 21.4 SED (6.6-46.8 SED) and in high mountain 28.6 SED (0.0-91.1 SED). Measured doses between workers and anatomical locations exhibited a high variability, stressing the role of local exposure conditions and individual factors. Short-term effective exposure ranged between 0 and 200% of ambient irradiation, indicating the occurrence of intense, subacute exposures. A predictive irradiation model was developed to investigate the role of individual factors. Posture and orientation were found to account for at least 38% of the total variance of relative individual exposure, and were also found to account more than altitude on the total variance of effective daily exposures. Targeted sensitization actions through professional information channels and specific prevention messages are recommended. Altitude outdoor workers should also benefit from preventive medical examination.

Heterogeneous secretion of individual B cells in response to D-glucose and to nonglucidic nutrient secretagogues.

We used a hemolytic plaque assay for insulin to determine whether the same pancreatic B cells respond to D-glucose, 2-amino-bicyclo[2,2,1]heptane-2-carboxylic acid (BCH) and the association of this nonmetabolized analogue of L-leucine with either the monomethyl ester of succinic acid (SME) or the dimethyl ester of L-glutamic acid (GME). During a 30-min incubation in the absence of D-glucose, BCH alone (5 mM) had no effect on insulin release. In contrast, the combination of BCH with either SME (10 mM) or GME (3 mM) stimulated insulin release to the same extent observed in the sole presence of 16.7 mM D-glucose. The effects of BCH plus SME and BCH plus GME on both percentage of secreting B cells and total insulin output were little affected in the presence of D-glucose concentrations ranging from 0 to 16.7 mM. Varying the concentration of SME from 2 to 10 mM also did not influence these effects. In other experiments, the very same B cells were first exposed 45 min to 16.7 mM D-glucose, then incubated 45 min in the presence of only BCH and SME. Under these conditions, most (80.3 +/- 2.5%) of the cells contributing to insulin release did so during both incubation periods. Furthermore, virtually all cells responding to BCH and SME during the second incubation corresponded to cells also responsive to D-glucose during the first incubation. Similar observations were made when the sequence of the two incubations was reversed.(ABSTRACT TRUNCATED AT 250 WORDS)

Individual serological follow-up of patients with suspected or confirmed abdominal angiostrongyliasis

Abdominal angiostrongyliasis (AA) is a zoonotic nematode infection caused by Angiostrongylus costaricensis, with widespread occurrence in the Americas. Although the human infection may be highly prevalent, morbidity is low in Southern Brazil. Confirmed diagnosis is based on finding parasitic structures in pathological examination of biopsies or surgical resections. Serology stands as an important diagnostic tool in the less severe courses of the infection. Our objective is to describe the follow up of humoral reactivity every 2-4 weeks up to one year, in six individuals with confirmed (C) and ten suspected (S) AA. Antibody (IgG) detection was performed by ELISA and resulted in gradually declining curves of reactivity in nine subjects (56%) (4C + 5S), that were consistently negative in only three of them (2C + 1S) after 221, 121 and 298 days. Three individuals (2C + 1S) presented with low persistent reacitivity, other two (1C + 1S) were serologically negative from the beginning, but also presenting a declining tendency. The study shows indications that abdominal angiostrongyliasis is usually not a persistent infection: although serological negativation may take many months, IgG reactivity is usually declining along time and serum samples pairing may add valuable information to the diagnostic workout.