A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries

Endovascular therapy is a rapidly evolving field for the treatment of patients with peripheral arterial disease, and a magnitude of studies reporting on various modern revascularization concepts have been recently published. Thus, studies assessing the efficacy of endovascular therapy of peripheral arteries do not operate with uniformly defined endpoints, rendering a direct comparison of studies difficult. The purpose of this consensus statement is to highlight differences in the terminology used in the current literature and to propose some standardized criteria that must be considered when reporting results of endovascular revascularization for chronic ischaemia of lower limb arteries.

Community managed rural water supply systems in the Dominican Republic : assessment of sustainability of systems built by the National Institute of Potable Water and Peace Corps, Dominican Republic

In the Dominican Republic economic growth in the past twenty years has not yielded sufficient improvement in access to drinking water services, especially in rural areas where 1.5 million people do not have access to an improved water source (WHO, 2006). Worldwide, strategic development planning in the rural water sector has focused on participatory processes and the use of demand filters to ensure that service levels match community commitment to post-project operation and maintenance. However studies have concluded that an alarmingly high percentage of drinking water systems (20-50%) do not provide service at the design levels and/or fail altogether (up to 90%): BNWP (2009), Annis (2006), and Reents (2003). World Bank, USAID, NGOs, and private consultants have invested significant resources in an effort to determine what components make up an “enabling environment” for sustainable community management of rural water systems (RWS). Research has identified an array of critical factors, internal and external to the community, which affect long term sustainability of water services. Different frameworks have been proposed in order to better understand the linkages between individual factors and sustainability of service. This research proposes a Sustainability Analysis Tool to evaluate the sustainability of RWS, adapted from previous relevant work in the field to reflect the realities in the Dominican Republic. It can be used as a diagnostic tool for government entities and development organizations to characterize the needs of specific communities and identify weaknesses in existing training regimes or support mechanisms. The framework utilizes eight indicators in three categories (Organization/Management, Financial Administration, and Technical Service). Nineteen independent variables are measured resulting in a score of sustainability likely (SL), possible (SP), or unlikely (SU) for each of the eight indicators. Thresholds are based upon benchmarks from the DR and around the world, primary data collected during the research, and the author’s 32 months of field experience. A final sustainability score is calculated using weighting factors for each indicator, derived from Lockwood (2003). The framework was tested using a statistically representative geographically stratified random sample of 61 water systems built in the DR by initiatives of the National Institute of Potable Water (INAPA) and Peace Corps. The results concluded that 23% of sample systems are likely to be sustainable in the long term, 59% are possibly sustainable, and for 18% it is unlikely that the community will be able to overcome any significant challenge. Communities that were scored as unlikely sustainable perform poorly in participation, financial durability, and governance while the highest scores were for system function and repair service. The Sustainability Analysis Tool results are verified by INAPA and PC reports, evaluations, and database information, as well as, field observations and primary data collected during the surveys. Future research will analyze the nature and magnitude of relationships between key factors and the sustainability score defined by the tool. Factors include: gender participation, legal status of water committees, plumber/operator remuneration, demand responsiveness, post construction support methodologies, and project design criteria.

Systemic prokinetic pharmacologic treatment for postoperative adynamic ileus following abdominal surgery in adults

BACKGROUND: Postoperative adynamic bowel atony interferes with recovery following abdominal surgery. Prokinetic pharmacologic drugs are widely used to accelerate postoperative recovery. OBJECTIVES: To evaluate the benefits and harms of systemic acting prokinetic drugs to treat postoperative adynamic ileus in patients undergoing abdominal surgery. SEARCH STRATEGY: Trials were identified by computerised searches of the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and the Cochrane Colorectal Cancer Group specialised register. The reference lists of included trials and review articles were tracked and authors contacted. SELECTION CRITERIA: Randomised controlled parallel-group trials (RCT) comparing the effect of systemically acting prokinetic drugs against placebo or no intervention. DATA COLLECTION AND ANALYSIS: Four reviewers independently extracted the data and assessed trial quality. Trial authors were contacted for additional information if needed. MAIN RESULTS: Thirty-nine RCTs met the inclusion criteria contributing a total of 4615 participants. Most trials enrolled a small number of patients and showed moderate to poor (reporting of) methodological quality, in particular regarding allocation concealment and intention-to-treat analysis. Fifteen systemic acting prokinetic drugs were investigated and ten comparisons could be summarized. Six RCTs support the effect of Alvimopan, a novel peripheral mu receptor antagonist. However, the trials do not meet reporting guidelines and the drug is still in an investigational stage. Erythromycin showed homogenous and consistent absence of effect across all included trials and outcomes. The evidence is insufficient to recommend the use of cholecystokinin-like drugs, cisapride, dopamine-antagonists, propranolol or vasopressin. Effects are either inconsistent across outcomes, or trials are too small and often of poor methodological quality. Cisapride has been withdrawn from the market due to adverse cardiac events in many countries. Intravenous lidocaine and neostigmine might show a potential effect, but more evidence on clinically relevant outcomes is needed. Heterogeneity among included trials was seen in 10 comparisons. No major adverse drug effects were evident. AUTHORS' CONCLUSIONS: Alvimopan may prove to be beneficial but proper judgement needs adherence to reporting standards. Further trials are needed on intravenous lidocaine and neostigmine. The remaining drugs can not be recommended due to lack of evidence or absence of effect.

INVESTIGATION OF STRATEGIES TO PROMOTE EFFECTIVE TEACHER PROFESSIONAL DEVELOPMENT EXPERIENCES IN EARTH SCIENCE

This dissertation serves as a call to geoscientists to share responsibility with K-12 educators for increasing Earth science literacy. When partnerships are created among K-12 educators and geoscientists, the synergy created can promote Earth science literacy in students, teachers, and the broader community. The research described here resulted in development of tools that can support effective professional development for teachers. One tool is used during the planning stages to structure a professional development program, another set of tools supports measurement of the effectiveness of a development program, and the third tool supports sustainability of professional development programs. The Michigan Teacher Excellence Program (MiTEP), a Math/Science Partnership project funded by the National Science Foundation, served as the test bed for developing and testing these tools. The first tool, the planning tool, is the Earth Science Literacy Principles (ESLP). The ESLP served as a planning tool for the two-week summer field courses as part of the MiTEP program. The ESLP, published in 2009, clearly describe what an Earth science literate person should know. The ESLP consists of nine big ideas and their supporting fundamental concepts. Using the ESLP for planning a professional development program assisted both instructors and teacher-participants focus on important concepts throughout the professional development activity. The measurement tools were developed to measure change in teachers’ Earth science content-area knowledge and perceptions related to teaching and learning that result from participating in a professional development program. The first measurement tool, the Earth System Concept Inventory (ESCI), directly measures content-area knowledge through a succession of multiple-choice questions that are aligned with the content of the professional development experience. The second measurement, an exit survey, collects qualitative data from teachers regarding their impression of the professional development. Both the ESCI and the exit survey were tested for validity and reliability. Lesson study is discussed here as a strategy for sustaining professional development in a school or a district after the end of a professional development activity. Lesson study, as described here, was offered as a formal course. Teachers engaged in lesson study worked collaboratively to design and test lessons that improve the teachers’ classroom practices. Data regarding the impact of the lesson study activity were acquired through surveys, written documents, and group interviews. The data are interpreted to indicate that the lesson study process improved teacher quality and classroom practices. In the case described here, the lesson study process was adopted by the teachers’ district and currently serves as part of the district’s work in Professional Learning Communities, resulting in ongoing professional development throughout the district.

The CONSORT statement checklist in allergen-specific immunotherapy: a GA2LEN paper

The methodology of randomized clinical trials is essential for the critical assessment and registration of therapeutic interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement was developed to alleviate the problems arising from the inadequate reporting of randomized controlled trials. The present article reflects on the items that we believe should be included in the CONSORT checklist in the context of conducting and reporting trials in allergen-specific immunotherapy. Only randomized, blinded (in particular blinding of patients, health care providers, and outcome assessors), placebo-controlled Phase III studies in this article. Our analysis focuses on the definition of patients' inclusion and exclusion criteria, allergen standardization, primary, secondary and exploratory outcomes, reporting of adverse events and analysis.

Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores

BACKGROUND: To validate the concept of early implant placement for use in the esthetically sensitive anterior maxilla, clinical trials should ideally include objective esthetic criteria when assessing outcome parameters. METHODS: In this cross-sectional, retrospective 2- to 4-year study involving 45 patients treated with maxillary anterior single-tooth implants according to the concept of early implant placement, a novel comprehensive index, comprising pink esthetic score and white esthetic score (PES/WES; the highest possible combined score is 20), was applied for the objective esthetic outcome assessment of anterior single-tooth implants. RESULTS: All 45 anterior maxillary single-tooth implants fulfilled strict success criteria for dental implants with regard to osseointegration, including the absence of peri-implant radiolucency, implant mobility, suppuration, and pain. The mean total PES/WES was 14.7 +/- 1.18 (range: 11 to 18). The mean total PES of 7.8 +/- 0.88 (range: 6 to 9) documents favorable overall peri-implant soft tissue conditions. The two PES variables facial mucosa curvature (1.9 +/- 0.29) and facial mucosa level (1.8 +/- 0.42) had the highest mean values, whereas the combination variable root convexity/soft tissue color and texture (1.2 +/- 0.53) proved to be the most difficult to fully satisfy. Mean scores were 1.6 +/- 0.5 for the mesial papilla and 1.3 +/- 0.5 for the distal papilla. A mean value of 6.9 +/- 1.47 (range: 4 to 10) was calculated for WES. CONCLUSIONS: This study demonstrated that anterior maxillary single-tooth replacement, according to the concept of early implant placement, is a successful and predictable treatment modality, in general, and from an esthetic point of view, in particular. The suitability of the PES/WES index for the objective outcome assessment of the esthetic dimension of anterior single-tooth implants was confirmed. However, prospective clinical trials are needed to further validate and refine this index.

The role of psychological stress in inflammatory bowel disease: quality assessment of methods of 18 prospective studies and suggestions for future research

BACKGROUND: Enquiries among patients on the one hand and experimental and observational studies on the other suggest an influence of stress on inflammatory bowel diseases (IBD). However, since this influence remains hypothetical, further research is essential. We aimed to devise recommendations for future investigations in IBD by means of scrutinizing previously applied methodology. METHODS: We critically reviewed prospective clinical studies on the effect of psychological stress on IBD. Eligible studies were searched by means of the PubMed electronic library and through checking the bibliographies of located sources. RESULTS: We identified 20 publications resulting from 18 different studies. Sample sizes ranged between 10 and 155 participants. Study designs in terms of patient assessment, control variables, and applied psychometric instruments varied substantially across studies. Methodological strengths and weaknesses were irregularly dispersed. Thirteen studies reported significant relationships between stress and adverse outcomes. CONCLUSIONS: Study designs, including accuracy of outcome assessment and repeated sampling of outcomes (i.e. symptoms, clinical, and endoscopic), depended upon conditions like sample size, participants' compliance, and available resources. Meeting additional criteria of sound methodology, like taking into account covariates of the disease and its course, is strongly recommended to possibly improve study designs in future IBD research.

(Lifelong) learning in your pocket?

Der Beitrag fokussiert die Entwicklung, den Einsatz und die Nutzung von innovativen Technologien zur Unterstützung von Bildungsszenarien in Schule, Hochschule und Weiterbildung. Ausgehend von den verschiedenen Phasen des Corporate Learning, Social Learning, Mobile Learning und Intelligent Learning wird in einem ersten Abschnitt das Nutzungsverhalten von Technologien durch Kinder, Jugendliche und (junge) Erwachsene in Schule, Studium und Lehre betrachtet. Es folgt die Darstellung technologischer Entwicklungen auf Basis des Technology Life Cycle und die Konsequenzen von unterschiedlichen Entwicklungszuständen und Reifegraden von Technologien wie Content Learning Management, sozialen Netzwerken, mobilen Endgeräten, multidimensionalen und -modalen Räumen bis hin zu Anwendungen augmentierter Realität und des Internets der Dinge, Dienste und Daten für den Einsatz und die Nutzung in Bildungsszenarien. Nach der Darstellung von Anforderungen an digitale Technologien hinsichtlich Inhalte, Didaktik und Methodik wie etwa hinsichtlich der Erstellung von Inhalten, deren Wiederverwendung, Digitalisierung und Auffindbarkeit sowie Standards werden methodische Hinweise zur Nutzung digitaler Technologien zur Interaktion von Lernenden, von Lehrenden, sozialer Interaktion, kollaborativem Autorieren, Kommentierung, Evaluation und Begutachtung gegeben. Abschließend werden - differenziert für Schule und Hochschule - Erkenntnisse zu Rahmenbedingungen, Einflussgrößen, hemmenden und fördernden Faktoren sowie Herausförderungen bei der Einführung und nachhaltigen Implementation digitaler Technologien im schulischen Unterricht, in Lehre, Studium und Weiterbildung im Überblick zusammengefasst.

Variability in the prevalence of adult ADHD in treatment seeking substance use disorder patients: results from an international multi-center study exploring DSM-IV and DSM-5 criteria

Background: Available studies vary in their estimated prevalence of attention deficit/hyperactivity disor-der (ADHD) in substance use disorder (SUD) patients, ranging from 2 to 83%. A better understanding ofthe possible reasons for this variability and the effect of the change from DSM-IV to DSM-5 is needed.Methods: A two stage international multi-center, cross-sectional study in 10 countries, among patientsform inpatient and outpatient addiction treatment centers for alcohol and/or drug use disorder patients. Atotal of 3558 treatment seeking SUD patients were screened for adult ADHD. A subsample of 1276 subjects,both screen positive and screen negative patients, participated in a structured diagnostic interview. 5AdultsResults: Prevalence of DSM-IV and DSM-5 adult ADHD varied for DSM-IV from 5.4% (CI 95%: 2.4–8.3) forHungary to 31.3% (CI 95%:25.2–37.5) for Norway and for DSM-5 from 7.6% (CI 95%: 4.1–11.1) for Hungary to32.6% (CI 95%: 26.4–38.8) for Norway. Using the same assessment procedures in all countries and centersresulted in substantial reduction of the variability in the prevalence of adult ADHD reported in previousstudies among SUD patients (2–83% → 5.4–31.3%). The remaining variability was partly explained byprimary substance of abuse and by country (Nordic versus non-Nordic countries). Prevalence estimatesfor DSM-5 were slightly higher than for DSM-IV.Conclusions: Given the generally high prevalence of adult ADHD, all treatment seeking SUD patientsshould be screened and, after a confirmed diagnosis, treated for ADHD since the literature indicates poorprognoses of SUD in treatment seeking SUD patients with ADHD.

Assessment of bone channels other than the nasopalatine canal in the anterior maxilla using limited cone beam computed tomography

PURPOSE The anterior maxilla, sometimes also called premaxilla, is an area frequently requiring surgical interventions. The objective of this observational study was to identify and assess accessory bone channels other than the nasopalatine canal in the anterior maxilla using limited cone beam computed tomography (CBCT). METHODS A total of 176 cases fulfilled the inclusion criteria comprising region of interest, quality of CBCT image, and absence of pathologic lesions or retained teeth. Any bone canal with a minimum diameter of 1.00 mm other than the nasopalatine canal was analyzed regarding size, location, and course, as well as patient gender and age. RESULTS A total of 67 accessory canals ≥1.00 mm were found in 49 patients (27.8%). A higher frequency of accessory canals was observed in males (33.0%) than in females (22.7%) (p = 0.130). Accessory canals occurred more frequently in older rather than younger patients (p = 0.115). The mean diameter of accessory canals was 1.31 ± 0.26 mm (range 1.01-2.13 mm). Gender and age did not significantly influence the diameter. Accessory canals were found palatal to all anterior teeth, but most frequently palatal to the central incisors. In 56.7%, the accessory canals curved superolaterally and communicated with the ipsilateral alveolar extension of the canalis sinuosus. CONCLUSIONS The study confirms the presence of bone channels within the anterior maxilla other than the nasopalatine canal. More than half of these accessory bone canals communicated with the canalis sinuosus. From a clinical perspective, studies are needed to determine the content of these accessory canals.

Anaemia may add information to standardised disease activity assessment to predict radiographic damage in rheumatoid arthritis: a prospective cohort study

OBJECTIVE: Anaemia in rheumatoid arthritis (RA) is prototypical of the chronic disease type and is often neglected in clinical practice. We studied anaemia in relation to disease activity, medications and radiographic progression. METHODS: Data were collected between 1996 and 2007 over a mean follow-up of 2.2 years. Anaemia was defined according to WHO (♀ haemoglobin<12 g/dl, ♂: haemoglobin<13 g/dl), or alternative criteria. Anaemia prevalence was studied in relation to disease parameters and pharmacological therapy. Radiographic progression was analysed in 9731 radiograph sets from 2681 patients in crude longitudinal regression models and after adjusting for potential confounding factors, including the clinical disease activity score with the 28-joint count for tender and swollen joints and erythrocyte sedimentation rate (DAS28ESR) or the clinical disease activity index (cDAI), synthetic antirheumatic drugs and antitumour necrosis factor (TNF) therapy. RESULTS: Anaemia prevalence decreased from more than 24% in years before 2001 to 15% in 2007. Erosions progressed significantly faster in patients with anaemia (p<0.001). Adjusted models showed these effects independently of clinical disease activity and other indicators of disease severity. Radiographic damage progression rates were increasing with severity of anaemia, suggesting a 'dose-response effect'. The effect of anaemia on damage progression was maintained in subgroups of patients treated with TNF blockade or corticosteroids, and without non-selective nonsteroidal anti-inflammatory drugs (NSAIDs). CONCLUSIONS: Anaemia in RA appears to capture disease processes that remain unmeasured by established disease activity measures in patients with or without TNF blockade, and may help to identify patients with more rapid erosive disease.

Noninvasive assessment of diffusion hypoxia following administration of nitrous oxide-oxygen.

The phenomenon of diffusion hypoxia is commonly believed to occur unless nitrous oxide-oxygen inhalation sedation is followed by "washout" with 100% oxygen for 5 minutes upon termination of the flow of nitrous oxide. When systematically studied, however, this phenomenon generally appears to be unfounded. The present study evaluated the effect of breathing room air instead of 100% oxygen in healthy (ASA 1) human volunteers following administration of sedative concentrations of nitrous oxide. The occurrence of hypoxia was determined objectively, using pulse oximetry and a standardized psychomotor skills test (Trieger test). Diffusion hypoxia was not observed using these criteria.

Electrodes for Long-Term Esophageal Electrocardiography

The emerging application of long-term and high-quality ECG recording requires alternative electrodes to improve the signal quality and recording capability of surface skin electrodes. The esophageal ECG has the potential to overcome these limitations but necessitates novel recorder and lead designs. The electrode material is of particular interest, since the material has to ensure conflicting requirements like excellent biopotential recording properties and inertness. To this end, novel electrode materials like PEDOT and silver-PDMS as well as established electrode materials such as stainless steel, platinum, gold, iridium oxide, titanium nitride, and glassy carbon were investigated by long-term electrochemical impedance spectroscopy and model-based signal analysis using the derived in vitro interfacial properties in conjunction with a dedicated ECG amplifier. The results of this novel approach show that titanium nitride and iridium oxide featuring microstructured surfaces did not degrade when exposed to artificial acidic saliva. These materials provide low electrode potential drifts and insignificant signal distortion superior to surface skin electrodes making them compatible with accepted standards for ambulatory ECG. They are superior to the noble and polarizable metals such as platinum, silver, and gold that induced more signal distortions and are superior to esophageal stainless steel electrodes that corrode in artificial saliva. The study provides rigorous criteria for the selection of electrode materials for prolonged ECG recording by combining long-term in vitro electrode material properties with ECG signal quality assessment.

The Development and Implementation of an Anthropomorphic Head Phantom for the Assessment of Proton Therapy Treatment Procedures

Proton therapy has become an increasingly more common method of radiation therapy, with the dose sparing to distal tissue making it an appealing option, particularly for treatment of brain tumors. This study sought to develop a head phantom for the Radiological Physics Center (RPC), the first to be used for credentialing of institutions wishing to participate in clinical trials involving brain tumor treatment of proton therapy. It was hypothesized that a head phantom could be created for the evaluation of proton therapy treatment procedures (treatment simulation, planning, and delivery) to assure agreement between the measured dose and calculated dose within ±5%/3mm with a reproducibility of ±3%. The relative stopping power (RSP) and Hounsfield Units (HU) were measured for potential phantom materials and a human skull was cast in tissue-equivalent Alderson material (RLSP 1.00, HU 16) with anatomical airways and a cylindrical hole for imaging and dosimetry inserts drilled into the phantom material. Two treatment plans, proton passive scattering and proton spot scanning, were created. Thermoluminescent dosimeters (TLDs) and film were loaded into the phantom dosimetry insert. Each treatment plan was delivered three separate times. Each treatment plan passed our 5%/3mm criteria, with a reproducibility of ±3%. The hypothesis was accepted and the phantom was found to be suitable for remote audits of proton therapy treatment facilities.