Development of a Sensitive Resource Use Questionnaire

Alcoholism is a chronic disease and the evaluation of its burden usually focuses on long-term co-morbidity and mortality. Clinical Trials evaluating new interventions for alcohol-dependent patients rarely last more than 12 to 24 months. OBJECTIVES: Develop a questionnaire capable of capturing principal resource use yet sensitive enough to show short-term economic benefit of drugs developed to reduce consump¬tion in alcohol-dependent patients. METHODS: Comprehensive Medline literature search using keywords: Alcohol-related-disorders, economics, cost of illness. Further, experts panel discussions provided additional data. RESULTS: Two key cost drivers, hospitalisation and sick leaves were identified by the literature review. Expert findings related to costs of social consequences were incorporated. These three important resources were included in the questionnaire in addition to standard medical resource use consumption input. Finally, the following items were included: consultation visits, hospitalisations, sick leaves and working situation, living situation, social environ¬ment, accidents, arrests and domestic violence. The recall period is 3 months. DISCUSSION: A great deal of information is collected in this questionnaire in order to capture all relevant resources. Tests to validate the questionnaire in a real-life setting will be conducted (face validity, concurrent validity, and test-retest) in a cohort of dependent patients initiated at Lausanne University hospital ( Switzerland). Items not sensitive enough to capture short-term costs and consequences will be removed. Translation into other major languages and adaptation to different settings after cultural validation is planned. CONCLUSIONS: Publication of this tool should facilitate additional knowledge about resource utilisation at the patient level and enable evaluation of short-term economic impact of pharmacological and non-pharmacological interventions.

Mise en place d'un protocole d'insulinothérapie intraveineuse sûr et efficace hors des soins intensifs. [Establishing a protocol for safe intravenous insulin therapy and effective outside intensive care.]

Introductionþ: L'insulinothérapie intraveineuse est la mieux adaptée pour obtenirun contrôle glycémique rapidement efficace ou lors de besoins en insulinechangeants de façon peu prévisible, mais son emploi hors des soins intensifs seheurte souvent aux manque de formation et réticences des soignants. L'inclusionL'inclusiondu contrôle glycémique rapide dans nos standards institutionnels de priseen charge de l'AVC aigu a suscité une demande de protocole thérapeutiqueadapté aux besoins de l'Unité cérébrovasculaire.Patients et méthodesþ: Le protocole d'insulinothérapie a été dérivé d'algorithmespubliés intégrant glycémie actuelle, cinétique glycémique et sensibilité àl'insuline du patient. Aux repas, une augmentation du débit d'insuline iv. pendant1 h a été ajoutée. Les objectifs glycémiques étaient 4-6þmmol/l en préprandialetþ< 8þmmol/l en postprandial. L'implémentation s'est faite à travers unprocessus de co-construction (outils de gestion, documents et activités de formation)avec les responsables médico-infirmiers du service.Résultatsþ: Les données des 90 premiers patients ont été analysées (diabète connuþ:38, hyperglycémie nouvelleþ: 52, 2715h de traitement cumulées). Les duréesd'insulinothérapie iv. étaient de 34,5 h [interquartile 24-39] et 26,5 h [21-36,3] respectivement(pþ=þ0,03), les délais d'atteinte de l'objectif de 5 h [4.0-8.25] et 7 h[4.0-9.75] (pþ=þns.). Pendant les 24 h suivantes, les taux de glycémies dans la cibleétaient de 70,4þ%/81,3þ% (90,3þ%/94,6þ% entre 4-8þmmol/l), avec un faible tauxd'hypoglycémies (3,9þ%/3,1þ%þ< 4,0þmmol/l, 0,4þ%/0,2þ%þ<þ3,3þmmol/l) et un contrôleglycémique postprandial comparable (excursions +2,6þmmol/l [0,7-3,9] et+1,7þmmol/l [0,6-3,7]þ; Nþ=þ75þ; pþ=þns.).Conclusionþ: L'insulinothérapie intraveineuse hors des soins intensifs est faisable,hautement sûre et efficace, même avec des objectifs glycémiques particulièrementstricts. Outre la fiabilité perçue de l'outil de gestion, la démarche departenariat adoptée avec les soignants, permettant la prise en compte de leurspréoccupations à chaque étape du processus, a été un facteur de succès importantpour son implémentation.

Inexperienced sonographers can successfully visualize and assess a three-dimensional image of the fetal face using a standardized ultrasound protocol.

Introduction: A standardized three-dimensional ultrasonographic (3DUS) protocol is described that allows fetal face reconstruction. Ability to identify cleft lip with 3DUS using this protocol was assessed by operators with minimal 3DUS experience. Material and Methods: 260 stored volumes of fetal face were analyzed using a standardized protocol by operators with different levels of competence in 3DUS. The outcomes studied were: (1) the performance of post-processing 3D face volumes for the detection of facial clefts; (2) the ability of a resident with minimal 3DUS experience to reconstruct the acquired facial volumes, and (3) the time needed to reconstruct each plane to allow proper diagnosis of a cleft. Results: The three orthogonal planes of the fetal face (axial, sagittal and coronal) were adequately reconstructed with similar performance when acquired by a maternal-fetal medicine specialist or by residents with minimal experience (72 vs. 76%, p = 0.629). The learning curve for manipulation of 3DUS volumes of the fetal face corresponds to 30 cases and is independent of the operator's level of experience. Discussion: The learning curve for the standardized protocol we describe is short, even for inexperienced sonographers. This technique might decrease the length of anatomy ultrasounds and improve the ability to visualize fetal face anomalies.

Efficacy of an adjunctive brief psychodynamic psychotherapy to usual inpatient treatment of depression: rationale and design of a randomized controlled trial.

BACKGROUND: A few recent studies have found indications of the effectiveness of inpatient psychotherapy for depression, usually of an extended duration. However, there is a lack of controlled studies in this area and to date no study of adequate quality on brief psychodynamic psychotherapy for depression during short inpatient stay exists. The present article describes the protocol of a study that will examine the relative efficacy, the cost-effectiveness and the cost-utility of adding an Inpatient Brief Psychodynamic Psychotherapy to pharmacotherapy and treatment-as-usual for inpatients with unipolar depression. METHODS/DESIGN: The study is a one-month randomized controlled trial with a two parallel group design and a 12-month naturalistic follow-up. A sample of 130 consecutive adult inpatients with unipolar depression and Montgomery-Asberg Depression Rating Scale score over 18 will be recruited. The study is carried out in the university hospital section for mood disorders in Lausanne, Switzerland. Patients are assessed upon admission, and at 1-, 3- and 12- month follow-ups. Inpatient therapy is a manualized brief intervention, combining the virtues of inpatient setting and of time-limited dynamic therapies (focal orientation, fixed duration, resource-oriented interventions). Treatment-as-usual represents the best level of practice for a minimal treatment condition usually proposed to inpatients. Final analyses will follow an intention-to-treat strategy. Depressive symptomatology is the primary outcome and secondary outcome includes measures of psychiatric symptomatology, psychosocial role functioning, and psychodynamic-emotional functioning. The mediating role of the therapeutic alliance is also examined. Allocation to treatment groups uses a stratified block randomization method with permuted block. To guarantee allocation concealment, randomization is done by an independent researcher. DISCUSSION: Despite the large number of studies on treatment of depression, there is a clear lack of controlled research in inpatient psychotherapy during the acute phase of a major depressive episode. Research on brief therapy is important to take into account current short lengths of stay in psychiatry. The current study has the potential to scientifically inform appropriate inpatient treatment. This study is the first to address the issue of the economic evaluation of inpatient psychotherapy. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry (ACTRN12612000909820).

The GENCODE pseudogene resource.

BACKGROUND: Pseudogenes have long been considered as nonfunctional genomic sequences. However, recent evidence suggests that many of them might have some form of biological activity, and the possibility of functionality has increased interest in their accurate annotation and integration with functional genomics data. RESULTS: As part of the GENCODE annotation of the human genome, we present the first genome-wide pseudogene assignment for protein-coding genes, based on both large-scale manual annotation and in silico pipelines. A key aspect of this coupled approach is that it allows us to identify pseudogenes in an unbiased fashion as well as untangle complex events through manual evaluation. We integrate the pseudogene annotations with the extensive ENCODE functional genomics information. In particular, we determine the expression level, transcription-factor and RNA polymerase II binding, and chromatin marks associated with each pseudogene. Based on their distribution, we develop simple statistical models for each type of activity, which we validate with large-scale RT-PCR-Seq experiments. Finally, we compare our pseudogenes with conservation and variation data from primate alignments and the 1000 Genomes project, producing lists of pseudogenes potentially under selection. CONCLUSIONS: At one extreme, some pseudogenes possess conventional characteristics of functionality; these may represent genes that have recently died. On the other hand, we find interesting patterns of partial activity, which may suggest that dead genes are being resurrected as functioning non-coding RNAs. The activity data of each pseudogene are stored in an associated resource, psiDR, which will be useful for the initial identification of potentially functional pseudogenes.

Computed tomography of the cervical spine: comparison of image quality between a standard-dose and a low-dose protocol using filtered back-projection and iterative reconstruction.

OBJECTIVE: To compare image quality of a standard-dose (SD) and a low-dose (LD) cervical spine CT protocol using filtered back-projection (FBP) and iterative reconstruction (IR). MATERIALS AND METHODS: Forty patients investigated by cervical spine CT were prospectively randomised into two groups: SD (120 kVp, 275 mAs) and LD (120 kVp, 150 mAs), both applying automatic tube current modulation. Data were reconstructed using both FBP and sinogram-affirmed IR. Image noise, signal-to-noise (SNR) and contrast-to-noise (CNR) ratios were measured. Two radiologists independently and blindly assessed the following anatomical structures at C3-C4 and C6-C7 levels, using a four-point scale: intervertebral disc, content of neural foramina and dural sac, ligaments, soft tissues and vertebrae. They subsequently rated overall image quality using a ten-point scale. RESULTS: For both protocols and at each disc level, IR significantly decreased image noise and increased SNR and CNR, compared with FBP. SNR and CNR were statistically equivalent in LD-IR and SD-FBP protocols. Regardless of the dose and disc level, the qualitative scores with IR compared with FBP, and with LD-IR compared with SD-FBP, were significantly higher or not statistically different for intervertebral discs, neural foramina and ligaments, while significantly lower or not statistically different for soft tissues and vertebrae. The overall image quality scores were significantly higher with IR compared with FBP, and with LD-IR compared with SD-FBP. CONCLUSION: LD-IR cervical spine CT provides better image quality for intervertebral discs, neural foramina and ligaments, and worse image quality for soft tissues and vertebrae, compared with SD-FBP, while reducing radiation dose by approximately 40 %.

Protocol per a la implantació de noves eines didàctiques: competències i habilitats adquirides pels estudiants

L'adaptació al nou espai europeu d'educació superior (EEES) ha plantejat alguns canvis en l'enfocament de la formació universitària al nostre país. On abans era el docent el protagonista, ara és l'estudiant el que pren el rol d'actor principal de la seva formació, i l'aprenentatge s¿orienta cap a una autonomia i reflexió més grans. En aquest escenari, les noves tecnologies ofereixen un ampli ventall d'opcions per millorar els processos formatius. En aquests sentit, el Grup d'Innovació Docent G¿IDEA ha participat activament en aquest procés d'adaptació des de ja fa uns quants anys, i ha creat una sèrie de recursos docents digitals que han estat àmpliament provats en diversos ensenyaments de la Facultat d'Economia i Empresa de la Universitat de Barcelona. L'objectiu d¿aquest article és presentar el protocol dissenyat per l'equip d'investigadors del G¿IDEA per implantar aquestes eines didàctiques (webquestes i exercicis tutoritzats), i també els resultats d'una enquesta de satisfacció sobre les competències i habilitats adquirides pels nostres estudiants en la utilització dels recursos. Els resultats mostren, d'una banda, que no ha estat possible crear un mateix protocol aplicable a tots els recursos, a causa de les diferències en els objectius didàctics de les distintes eines docents implantades. D'altra banda, la valoració que els estudiants fan de la utilització de les eines és molt positiva, tot i que hi ha algunes diferències entre els recursos analitzats. Conèixer la valoració que l'alumnat fa d'aquests recursos permet al grup d'investigadors poder-los millorar i adequar al perfil dels estudiants perquè aquests en puguin treure el màxim profit possible.

Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol.

Background: Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and costeffectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression. Methods/design: A randomized controlled trial, with 6-month follow-up, comparing patients receiving a pharmaceutical care support programme in primary care with patients receiving usual care. The total sample comprises 194 patients (aged between 18 and 75) diagnosed with depressive disorder in a primary care health centre in the province of Barcelona (Spain). Subjects will be asked for written informed consent in order to participate in the study. Diagnosis will be confirmed using the SCID-I. The intervention consists of an educational programme focused on improving knowledge about medication, making patients aware of the importance of compliance, reducing stigma, reassuring patients about side-effects and stressing the importance of carrying out general practitioners' advice. Measurements will take place at baseline, and after 3 and 6 months. Main outcome measure is compliance with antidepressants. Secondary outcomes include; clinical severity of depression (PHQ-9), anxiety (STAI-S), health-related quality of life (EuroQol-5D), satisfaction with the treatment received, side-effects, chronic physical conditions and sociodemographics. The use of healthcare and social care services will be assessed with an adapted version of the Client Service Receipt Inventory (CSRI). Discussion: This trial will provide valuable information for health professionals and policy makers on the effectiveness and cost-effectiveness of a pharmaceutical intervention programme in the context of primary care. Trial registration: NCT00794196

Lapatax: Safety profile of neoadjuvant lapatinib combined with docetaxel in Her 2/neu overexpressing breast cancer - EORTC protocol 10054

Objective: To assess the safety/tolerability of the combination lapatinib (L) and docetaxel (D) in patients with Her 2/neu overexpressing breast cancer (BC). This study is important as it will define how to deliver lapatinib with taxotere, a highly active drug in breast cancer. Patients and Methods: Female patients (pts) with locally advanced, inflammatory or large operable BC were treated with escalating doses of L from 1000 to 1250 mg/day, in combination with D given IV every 21 days at doses ranging from 75 to 100 mg/m2 for 4 cycles. At least 3 pts were treated at each dose level. The definition of dose limiting toxicity (DLT) is based on the toxicity assessed at cycle 1 as follows: any grade 3−4 non hematological toxicity, ANC < 0.5 G/L lasting for 7 days or more, febrile neutropenia or thrombocytopenia <25 G/L. GCSF was not permitted as primary prophylaxis. Core biopsies were mandatory at baseline and after cycle 4. Pharmcokinetic (PK) samples were collected on day 1 of cycles 1 and 2. Results: To date, 18 pts with a median age of 53 years (range 36−65) have been enrolled at 5 Dose Levels (DLs). The toxicity profile for 18 patients (68 documented cycles) is summarized below. At DL5 (1000/100), 2 pts had DLTs (neutropenia grade 4 _7 days and febrile neutropenia), and 3 additional pts were enrolled with primary prophylactic G-CSF. As expected, the safety profile improved and the dose escalation will continue with prophylactic G-CSF to investigate DL6 (1250/100). These findings are consistent with published Phase I data for this combination [1]. N= 18 patients n (%) Grade 1 Grade 2 Grade 3 Grade 4 neutropenia 1 (6) 3 (17) 13 (72) febrile neutropenia 2 (11) fatigue 8 (44) 7 (39) diarrhoea 9 (50) 3 (17) pain: joint/muscle/other 5 (28)/4 (22)/3 (17) 4 (22)/4 (22)/3 (17) 0/0/1 (6) constipation 2 (11) 3 (17) 1 (6) elevated transaminases SGPT/SGOT 7 (39)/5 (28) Conclusions: The main toxicity of the L + D combination is haematological and was reached at DL5 (1000/100), without primary GCSF. An additional DL6 with primary prophylactic GCSF is being investigated (1250/100). PK data will be presented at the meeting plus the recommended dose for phase II studies.

Iowa Department of Naturals Resource Performance Report, FY 2013-2014, January 2014

This report provides insight on accomplishments we have achieved in Fiscal Year 2015 as well as some challenges we face in the not so distant future. The DNR, in partnership with the Iowa Department of Agriculture and Land Stewardship and Iowa State University,

Protocol de viabilitat socioecològica del llop : àrea d'estudi de la Vall d'Alinyà

Aquest estudi analitza diferents variables ecològiques i socials amb l’objectiu de determinar la viabilitat de l’espècie Canis lupus en el territori que compren la Vall d’Alinyà, i definir unes pautes per extrapolar aquest tipus d’anàlisis a altres àrees d’estudi. El llop va desaparèixer de Catalunya a causa de la forta pressió antròpica exercida sobre l’espècie en el passat. En l’última dècada, s’han donat indicis d’una possible reaparició del súper depredador en el territori català. Com a mètode per a la cerca del llop s’ha experimentat amb l’ús de gossos de rastreig per a la cerca i diferenciació de rastres de llop, aquesta és una tècnica innovadora no utilitzada anteriorment per a aquest tipus d’objectiu. L’exploració de les inquietuds dels ramaders i caçadors de la zona, mostra una bona predisposició a la reaparició de l’animal. Malgrat no s’ha detectat llop amb els mètodes emprats, es demostra que li és viable d’establir-se a la zona.