Appropriateness of colonoscopy in Europe (EPAGE II): presentation of methodology, general results, and analysis of complications.

BACKGROUND AND STUDY AIMS: Appropriate use of colonoscopy is a key component of quality management in gastrointestinal endoscopy. In an update of a 1998 publication, the 2008 European Panel on the Appropriateness of Gastrointestinal Endoscopy (EPAGE II) defined appropriateness criteria for various colonoscopy indications. This introductory paper therefore deals with methodology, general appropriateness, and a review of colonoscopy complications. METHODS:The RAND/UCLA Appropriateness Method was used to evaluate the appropriateness of various diagnostic colonoscopy indications, with 14 multidisciplinary experts using a scale from 1 (extremely inappropriate) to 9 (extremely appropriate). Evidence reported in a comprehensive updated literature review was used for these decisions. Consolidation of the ratings into three appropriateness categories (appropriate, uncertain, inappropriate) was based on the median and the heterogeneity of the votes. The experts then met to discuss areas of disagreement in the light of existing evidence, followed by a second rating round, with a subsequent third voting round on necessity criteria, using much more stringent criteria (i. e. colonoscopy is deemed mandatory). RESULTS: Overall, 463 indications were rated, with 55 %, 16 % and 29 % of them being judged appropriate, uncertain and inappropriate, respectively. Perforation and hemorrhage rates, as reported in 39 studies, were in general < 0.1 % and < 0.3 %, respectively CONCLUSIONS: The updated EPAGE II criteria constitute an aid to clinical decision-making but should in no way replace individual judgment. Detailed panel results are freely available on the internet (www.epage.ch) and will thus constitute a reference source of information for clinicians.

Do orthopaedic shoes improve local dynamic stability of gait? An observational study in patients with chronic foot and ankle injuries.

BACKGROUND: Complex foot and ankle fractures, such as calcaneum fractures or Lisfranc dislocations, are often associated with a poor outcome, especially in terms of gait capacity. Indeed, degenerative changes often lead to chronic pain and chronic functional limitations. Prescription footwear represents an important therapeutic tool during the rehabilitation process. Local Dynamic Stability (LDS) is the ability of locomotor system to maintain continuous walking by accommodating small perturbations that occur naturally during walking. Because it reflects the degree of control over the gait, LDS has been advocated as a relevant indicator for evaluating different conditions and pathologies. The aim of this study was to analyze changes in LDS induced by orthopaedic shoes in patients with persistent foot and ankle injuries. We hypothesised that footwear adaptation might help patients to improve gait control, which could lead to higher LDS: METHODS: Twenty-five middle-aged inpatients (5 females, 20 males) participated in the study. They were treated for chronic post-traumatic disabilities following ankle and/or foot fractures in a Swiss rehabilitation clinic. During their stay, included inpatients received orthopaedic shoes with custom-made orthoses (insoles). They performed two 30s walking trials with standard shoes and two 30s trials with orthopaedic shoes. A triaxial motion sensor recorded 3D accelerations at the lower back level. LDS was assessed by computing divergence exponents in the acceleration signals (maximal Lyapunov exponents). Pain was evaluated with Visual Analogue Scale (VAS). LDS and pain differences between the trials with standard shoes and the trials with orthopaedic shoes were assessed. RESULTS: Orthopaedic shoes significantly improved LDS in the three axes (medio-lateral: 10% relative change, paired t-test p < 0.001; vertical: 9%, p = 0.03; antero-posterior: 7%, p = 0.04). A significant decrease in pain level (VAS score -29%) was observed. CONCLUSIONS: Footwear adaptation led to pain relief and to improved foot & ankle proprioception. It is likely that that enhancement allows patients to better control foot placement. As a result, higher dynamic stability has been observed. LDS seems therefore a valuable index that could be used in early evaluation of footwear outcome in clinical settings.

Implementation methodology of practices based on scientific evidence for assistance in natural delivery: a pilot study

AbstractOBJECTIVEPresenting methodology for transferring knowledge to improve maternal outcomes in natural delivery based on scientific evidence.METHOD: An intervention study conducted in the maternity hospital of Itapecerica da Serra, SP, with 50 puerperal women and 102 medical records from July to November 2014. The PACES tool from Joanna Briggs Institute, consisting of pre-clinical audit (phase 1), implementation of best practice (phase 2) and Follow-up Clinical Audit (phase 3) was used. Data were analyzed by comparing results of phases 1 and 3 with Fisher's exact test and a significance level of 5%.RESULTSThe vertical position was adopted by the majority of puerperal women with statistical difference between phases 1 and 3. A significant increase in bathing/showering, walking and massages for pain relief was found from the medical records. No statistical difference was found in other practices and outcomes. Barriers and difficulties in the implementation of evidence-based practices have been identified. Variables were refined, techniques and data collection instruments were verified, and an intervention proposal was made.CONCLUSIONThe study found possibilities for implementing a methodology of practices based on scientific evidence for assistance in natural delivery.

Time standards of nursing in Primary Health Care: an observational study

Abstract OBJECTIVE To determine time standards for interventions and activities conducted by nursing professionals in Family Health Units (FHU) in Brazil to substantiate the calculation of work force. METHOD This was an observational study carried out in 27 FHU, in 12 municipalities in 10 states, in 2013. In each unit, nursing professionals were observed every 10 minutes, for eight work hours, on five consecutive days via the work sampling technique. RESULTS A total of 32,613 observations were made, involving 47 nurses and 93 nursing technicians/assistants. Appointments were the main intervention carried out by nurses, with a mean time of 25.3 minutes, followed by record-keeping, which corresponded to 9.7%. On average, nursing technicians/assistants spent 6.3% of their time keeping records and 30.6 intervention minutes on immunization/vaccination control. CONCLUSION The study resulted in standard times of interventions carried out by the FHU nursing team, which can underpin the determination of nursing staff size and human resource policies. Furthermore, the study showed the panorama of interventions currently employed, allowing for the work process to be reviewed and optimized.

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration.

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research.

Validation of rotational thromboelastometry during cardiopulmonary bypass : a prospective, observational in-vivo study

Le ROTEM est un test de coagulation réalisable au près du malade qui permet d'objectiver la coagulopathie, de distinguer la contribution des différents éléments du système de coagulation et de cibler les produits procoagulants comme le plasma frais congelé (PFC), les plaquettes, le fibrinogène et les facteurs de coagulation purifiés ou les antifibrinolytiques. 3 des tests disponibles pour le ROTEM sont: EXTEM, INTEM, HEPTEM. Le premier test est stable sous hautes doses d'héparine alors que le deuxième est très sensible à sa présence. Dans le dernier test on rajoute de l'héparinase pour mettre en évidence l'éventuel effet résiduel de l'héparine en le comparant à l'INTEM. Idéalement, le ROTEM devrait être effectué avant la fin du bypass cardiopulmonaire (CEC), donc sous anticoagulation maximale pas héparine, afin de pouvoir administrer des produits pro¬coagulants dans les délais les plus brefs et ainsi limiter au maximum les pertes sanguines. En effet la commande et la préparation de certains produits procoagulants peut prendre plus d'une heure. Le but de cette étude est de valider l'utilisation du ROTEM en présence de hautes concentrations d'héparine. Il s'agit d'une étude observationnelle prospective sur 20 patients opérés électivement de pontages aorto-coronariens sous CEC. Méthode : l'analyse ROTEM a été réalisée avant l'administration d'héparine (TO), 10 minutes après l'administration d'héparine (Tl), à la fin de la CEC (T2) et 10 minutes après la neutralisation de l'anticoagulation avec la protamine (T3). L'état.d'héparinisation a été évalué par l'activité anti-Xa à T1,T2,T3. Résultats : Comparé à TO, la phase de polymérisation de la cascade de coagulation et l'interaction fibrine-plaquettes sont significativement détériorées par rapport à Tl pour les canaux EXTEM et HEPTEM. A T2 l'analyse EXTEM et INTEM sont comparables à celles de EXTEM et HEPTEM à T3. Conclusion: les hautes doses d'héparine utilisées induisent une coagulopathie qui reste stable durant toute la durée de la CEC et qui persiste même après la neutralisation de l'anticoagulation. Les mesures EXTEM et HEPTEM sont donc valides en présence de hautes concentrations d'héparine et peuvent être réalisés pendant la CEC avant l'administration de protamine.

Phase-based manganese enhanced MRI, a new methodology to enhance brain cytoarchitectural contrast and study manganese uptake.

PURPOSE: As the magnetic susceptibility induced frequency shift increases linearly with magnetic field strength, the present work evaluates manganese as a phase imaging contrast agent and investigates the dose dependence of brain enhancement in comparison to T1 -weighted imaging after intravenous administration of MnCl2 . METHODS: Experiments were carried out on 12 Sprague-Dawley rats. MnCl2 was infused intravenously with the following doses: 25, 75, 125 mg/kg (n=4). Phase, T1 -weighted images and T1 maps were acquired before and 24h post MnCl2 administration at 14.1 Tesla. RESULTS: Manganese enhancement was manifested in phase imaging by an increase in frequency shift differences between regions rich in calcium gated channels and other tissues, together with local increase in signal to noise ratio (from the T1 reduction). Such contrast improvement allowed a better visualization of brain cytoarchitecture. The measured T1 decrease observed across different manganese doses and in different brain regions were consistent with the increase in the contrast to noise ratio (CNR) measured by both T1 -weighted and phase imaging, with the strongest variations being observed in the dentate gyrus and olfactory bulb. CONCLUSION: Overall from its high sensitivity to manganese combined with excellent CNR, phase imaging is a promising alternative imaging protocol to assess manganese enhanced MRI at ultra high field. Magn Reson Med 72:1246-1256, 2014. © 2013 Wiley Periodicals, Inc.

Persistence of ultrasound synovitis in patients with rheumatoid arthritis fulfilling the DAS28 and/or the new ACR/EULAR RA remission definitions: results of an observational cohort study.

OBJECTIVE: The primary aim of the study was to evaluate whether rheumatoid arthritis (RA) patients considered to be in remission according to clinical criteria sets still had persisting ultrasound (US) synovitis. We further intended to evaluate the capacity of our US score to discriminate between the patients with a clinically active disease versus those in remission. METHODS: This is an observational study nested within the Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) rheumatoid arthritis cohort. A validated US score (SONAR score) based on a semi-quantitative B-mode and Doppler (PwD) score as part of the regular clinical workup by rheumatologists in different clinical settings was used. To define clinically relevant synovitis, the same score was applied to 38 healthy controls and the 90st percentile was used as cut-off for 'relevant' synovitis. RESULTS: Three hundred and seven patients had at least one US examination and concomitant clinical information on disease activity. More than a third of patients in both DAS28 and ACR/EULAR remission showed significant gray scale synovitis (P=0.01 and 0.0002, respectively) and PwD activity (P=0.005 and 0.0005, respectively) when compared to controls. The capacity of US to discriminate between the two clinical remission groups and patients with active disease was only moderate. CONCLUSION: This observational study confirms that many patients considered to be in clinical remission according the DAS and the ACR/EULAR definitions still have residual synovitis on US. The prognostic significance of US synovitis and the exact place of US in patients reaching clinical remission need to be further evaluated.

Use of NIR spectroscopy and multivariate process spectra calibration methodology for pharmaceutical solid samples analysis

Accomplish high quality of final products in pharmaceutical industry is a challenge that requires the control and supervision of all the manufacturing steps. This request created the necessity of developing fast and accurate analytical methods. Near infrared spectroscopy together with chemometrics, fulfill this growing demand. The high speed providing relevant information and the versatility of its application to different types of samples lead these combined techniques as one of the most appropriated. This study is focused on the development of a calibration model able to determine amounts of API from industrial granulates using NIR, chemometrics and process spectra methodology.

The Prenatal Lausanne Trilogue Play: A New Observational Assessment Tool of the Prenatal Co-Parenting Alliance

The goal of this study is to present a new observational assessment tool, the prenatal Lausanne Trilogue Play situation (LTP). Expectant parents were asked to role play their first meeting with their baby using a doll, and the videotaped interaction was subsequently coded. Scores were correlated with measures of the couples' marital satisfaction as well as the postnatal family alliance 3 months after the baby's birth. Results showed that the prenatal co-parenting alliance was positively linked to both fathers' marital satisfaction as well as to the postnatal family alliance at 3 months. Thus, the prenatal LTP allows for assessment of the prenatal co-parenting alliance at the interactional level. It predicts the place the parents will afford their baby after birth and can contribute to methods of clinical assessment and prevention.

Observational study on the consumption of recreational drugs and alcohol by Swiss travelers.

BACKGROUND: Studies carried out on specific travelers' groups such as students describe an increase in the consumption of alcohol and drugs during travel and vacation time. The present study investigates the risk behaviors (alcohol and drugs) in a general adult population in Switzerland travelling abroad who visited a travel clinic before departure. METHODS: This retrospective study was conducted in a travel clinic between January 2006 and December 2008. 14,496 patients came to the clinic for a pre-travel consultation. 3,537 of them answered a questionnaire about their life habits in Switzerland and during their last trip. The only exclusion criterion was an age inferior to 18 years old.The consumption habits of drugs and at-risk alcohol intake (8 standard drinks (SD) per week for women and 15 SD for men) was analyzed according to gender, sex, destination and profession. Predictors of adopting a risky behavior between habits in Switzerland and during their previous trip were also analyzed. RESULTS: 7% (229/3477) of participants declared having at-risk alcohol consumption in Switzerland and 14% (473/3275 [95% CI 13-16]) during their trip. 9% (332/3527) of the participants used drugs in Switzerland and 5% (178/3481) during their trip. Risk factors for at-risk alcohol consumption during a trip were: at-risk alcohol consumption in Switzerland (OR 31[95% CI 21-45]), smoking (1.7 [95% CI 1-2]), use of drugs in Switzerland (OR 2.2 [95% CI 2-3]), leisure travel (OR 1.6 [95% CI 1-2]) and managerial professions (OR 1.8 [95% CI 1-3]). Risk factors for the use of drugs during a trip were: alcohol consumption in Switzerland (OR 2.1 [95% CI 1-4]), smoking (OR 1.9 [95% CI 1-3]), and use of drugs in Switzerland (OR 29.7 [95% CI 19-45]). CONCLUSIONS: At-risk alcohol consumption and, to a lesser extent, use of drugs, affect a large number of travelers which expose them to health problems during a trip. Exploring the alcohol and drugs consumption patterns of people visiting a travel clinic should be part of the pre-travel routine consultation and would allow to identifying people who would benefit most from a specific prevention.

Estudi sobre el perfil de persones grans amb dependència del servei d'ajuda a domicili del Consell Comarcal d'Osona i el tipus de suport formal i informal

The aim of this study is to determine the profile of dependent elderly people users of the home care services (SAD) of the regional council in Osona (Consell Comarcal d´Osona) , and the characteristics of formal and informal types of support they use. Methodology. An observational study of a transversal format has been carried out, with retrospective and descriptive purposes. The target population is 63 people (26 men and 37 women) included in the program of the regional SAD They have a recognized dependence grade approved by the law 39 /2006, December 14th , promoting the individual autonomy and care of elderly people in a dependent situation. The data were collected by social workers of basic social services, first with a home visit and followed by handed out questionnaires, specifically designed for this study, in order to obtain information on socio-demographic characteristics, and the type of support formal and informal. The obtained results on the SAD users are women in a 58.7% and a 41.3 % are men. The 84% of the total sampling are 80 years old and more, being the average age of 85.2 years old. 45% of them are married, 41% are widows and widowers and 14% are single. 54% are rated with severe dependence (grade II), 42.8% with high dependence (grade III). 86% live accompanied. 100% have an informal caregiver and a 95% of the times, the caregiver is a relative who in 73% of the cases the dedication time is permanent. The coverage of the SAD has an average of 4.27 hours per week and per user. The formal services most used are the technical (62%), also the assessment of an occupational therapist at home (57%) and the telecare service in a (56%). Conclusions. The SAD is used primarily for women in an advanced age and severe dependence. The informal assistance structures have an informal caregiver, being a member of the family mostly, living with the dependent, and mainly in a permanent dedication basis. The SAD has a varied intensity in each case. The formal support services complementary to the SAD, are largely used in all cases.