Terms Of Study Design Research Articles

Ginger on Human Health: A Comprehensive Systematic Review of 109 Randomized Controlled Trials.

Clinical applications of ginger with an expectation of clinical benefits are receiving significant attention. This systematic review aims to provide a comprehensive discussion in terms of the clinical effects of ginger in all reported areas. Following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guideline, randomized controlled trials on the effects of ginger were investigated. Accordingly, 109 eligible papers were fully extracted in terms of study design, population characteristics, evaluation systems, adverse effects, and main outcomes. The reporting quality of the included studies was assessed based on the Cochrane Collaboration’s tool for assessing the risk of bias in randomized trials and integrated together with studies that investigated the same subjects. The included studies that examined the improvement of nausea and vomiting in pregnancy, inflammation, metabolic syndromes, digestive function, and colorectal cancer’s markers were consistently supported, whereas other expected functions were relatively controversial. Nevertheless, only 43 clinical trials (39.4%) met the criterion of having a ‘high quality of evidence.’ In addition to the quality assessment result, small populations and unstandardized evaluation systems were the observed shortcomings in ginger clinical trials. Further studies with adequate designs are warranted to validate the reported clinical functions of ginger.

Prevalence of traumatic dental injuries in India: A systematic review and meta-analysis

The aim of this systematic review and meta-analysis was to estimate the prevalence of traumatic dental injuries (TDI) in India. The secondary objective was to evaluate the prevalence rate according to the differences in gender, age, regions, type of TDI and risk factors associated with TDI. The PubMed, LILACS, Web of Science, Cochrane, CINHAL, and Scopus databases, along with the Public Health Electronic Library, TRoPHI and DoPHER were searched from 1st March to 15thApril 2019 without any restriction of language and year of publication. The qualitative synthesis was done regarding the demographics, study methods, cause of trauma, geographic location, increased overjet and inadequate lip coverage. The meta-analysis was undertaken with STATA-14 software (USA). The pooled prevalence of TDI was calculated using data extracted from 48 studies included in qualitative synthesis and meta-analysis. A sub-group meta-analysis was done by extraction of the data for age groups of 6 years and >6 years. The pooled prevalence of TDI in Indian population was 13 cases in 100 individuals. The prevalence of TDI for age groups of ≤6 was 15% (males, 15%; females, 16%) and for >6 years was 12% (males, 13%; females, 8%). The most common cause of TDI was falls, and most frequent location was home. The odds ratio for occurrence of TDI and inadequate lip-coverage was 3.35 and overjet greater than 3 mm was 3.53. The pooled prevalence of TDI was 13% and slightly higher in children less than 6 years of age. Inadequate lip coverage and increased overjet are the risk factors associated with TDI. Heterogeneity was observed among the studies in terms of design, variables recorded, sampling, study methods and statistical methods. Majority of them also suffered from moderate to high risk of bias.

Therapeutic potential of pyruvate therapy for patients with mitochondrial diseases: a systematic review.

Background:Mitochondrial disease is a term used to describe a set of heterogeneous genetic diseases caused by impaired structure or function of mitochondria. Pyruvate therapy for mitochondrial disease is promising from a clinical point of view.Methods:According to PRISMA guidelines, the following databases were searched to identify studies regarding pyruvate therapy for mitochondrial disease: PubMed, EMBASE, Cochrane Library, and Clinicaltrials. The search was up to April 2019. The endpoints were specific biomarkers (plasma level of lactate, plasma level of pyruvate, L/P ratio) and clinical rating scales [Japanese mitochondrial disease-rating scale (JMDRS), Newcastle Mitochondrial Disease Adult Scale (NMDAS), and others]. Two researchers independently screened articles, extracted data, and assessed the quality of the studies.Results:A total of six studies were included. Considerable differences were noted between studies in terms of study design, patient information, and outcome measures. The collected evidence may indicate an effective potential of pyruvate therapy on the improvement of mitochondrial disease. The majority of the common adverse events of pyruvate therapy were diarrhea and short irritation of the stomach.Conclusion:Pyruvate therapy with no serious adverse events may be a potential therapeutic candidate for patients with incurable mitochondrial diseases, such as Leigh syndrome. However, recent evidence taken from case series and case reports, and theoretical supports of basic research are not sufficient. The use of global registries to collect patient data and more adaptive trial designs with larger numbers of participants are necessary to clarify the efficacy of pyruvate therapy.

Photobiomodulation in Periodontology and Implant Dentistry: Part 1.

(Part 2 of this article can be located at www.liebertpub.com/doi/10.1089/photob.2019.4731.) Objective: Finding evidence-based treatment strategies for low-level light therapy (LLLT) and the correct incorporation of these treatment methods in the clinical practice of periodontics. Background: Photobiomodulation has been shown to have biostimulatory, anti-inflammatory and analgesic effects that can be beneficial in periodontal and dental implant treatment procedures. Methods: In this review we have addressed some clinical questions regarding the potential clinical application of low-level light irradiation and its photobiomodulatory effects in periodontology and implantology. The literature was searched for in vivo (animal or clinical) articles written in English in four electronic databases of PubMed, Scopus, Google Scholar, and Cochrane Library until April 2019. Only studies with low irradiation doses without any thermal effects used only for their photobiomodulatory purposes were included. Results: We were able to find relevant studies for all of our questions, and positive effects for the application of light therapy were reported in most of the studies. However, there is still great deal of heterogeneity in terms of study designs and most importantly in light irradiation devices and the parameters used. Owing to this issue it was not possible to reach specific evidence-based irradiation protocols for the questions addressed in this review. Conclusions: Based on our search results, an obvious positive effect of LLLT on stimulation of healing of periodontal soft and hard tissues and reduction of inflammation can be seen. Future well-designed randomized control studies with the same irradiation settings and systematic reviews evaluating the studies found on the questions mentioned are necessary to reach evidence-based recommendations.

Long-Term Sequelae and Health-Related Quality of Life Associated With Lyme Disease: A Systematic Review.

Lyme disease (LD) is the most commonly reported vector-borne disease, but its clinical consequences remain uncertain. We conducted a systematic review of the long-term sequelae and health-related quality of life (HRQoL) associated with LD in North America and Europe. We performed searches in 6 electronic databases up to December 2018 following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, including observational studies reporting long-term sequelae, HRQoL, and prognostic factors. We included 46 studies, published between 1994 and 2019. Based on 21 studies reporting attributable outcomes, higher proportions of sequelae reported from exposed patients were: neck pain, myalgia, arthralgia, paresthesia, sleep disorder, poor appetite, and concentration difficulties. Patients with PTLDS reported impaired HRQoL compared to the general US population. Included studies were highly heterogeneous in terms of study design, settings, patient characteristics, and quality. Patients with LD are more likely to report nonspecific long-term sequelae, especially those experiencing persistent symptoms posttreatment. Opportunities exist for prospective longitudinal studies to better understand LD outcomes.

Photobiomodulation in Periodontology and Implant Dentistry: Part 2.

(Part 1 of this article can be located at www.liebertpub.com/doi/10.1089/photob.2019.4710.) Objective: Finding evidence-based treatment strategies for low-level light therapy and the correct incorporation of these treatment methods in the clinical practice of periodontics. Background: Photobiomodulation has been shown to have biostimulatory, anti-inflammatory, and analgesic effects that can be beneficial in periodontal and dental implant treatment procedures. Methods: In this review, we have addressed some clinical questions regarding the potential clinical application of low-level light irradiation and its photobobiomodulatory effects in periodontology and implantology. The literature was searched for in vivo (animal or clinical) articles written in English in four electronic databases of PubMed, Scopus, Google Scholar, and Cochrane Library until April 2019. Only studies with low irradiation doses without any thermal effects used only for their photobiomodulatory purposes were included. Results: We were able to find relevant studies for all of our questions, and positive effects for the application of light therapy were reported in most of the studies. However, there is still a great deal of heterogeneity in terms of study designs and most importantly in light irradiation devices and the parameters used. Due to this issue, it was not possible to reach specific evidence-based irradiation protocols for the questions addressed in this review. Conclusions: Based on our search results, an obvious positive effect of low-level light therapy on stimulation of healing of periodontal soft and hard tissues and reduction of inflammation can be seen. Future well-designed randomized control studies with the same irradiation settings and systematic reviews evaluating the studies found on the questions mentioned are necessary to reach evidence-based recommendations.

Mindfulness-based interventions in the early phase of affective and non-affective psychoses: Special Section on “Translational and Neuroscience Studies in Affective Disorders” Section Editor, Maria Nobile MD, PhD

BackgroundIn the last 10 years, psychological approaches based on mindfulness techniques have been proposed for the management of psychotic experiences. MethodIn this brief review we summarized, to our knowledge for the first time, published studies on mindfulness-based interventions (MBIs) applied to the early phase of major psychoses (affective and non-affective). ResultsDespite the great variability in terms of MBIs protocols, available studies on young people at risk to develop or with a first episode of psychosis suggest MBIs as a feasible, well-tolerated and effective approach in ameliorating symptoms, functioning, emotion regulation, and finally reducing the psychological distress associated with the onset of mania and/or psychotic experience. LimitationsThe small sample size and inconsistencies between studies in terms of design, MBIs protocols and outcome measures suggest being cautious in interpreting and generalizing results. Moreover, specific guidelines are missing for the adaptation of MBIs to youth at risk of developing affective psychoses. ConclusionsPreliminary findings show that MBIs may be considered a promising adjunctive therapy for the treatment of major psychoses in the early phases of the illness. However, the conduct of further studies in larger samples and with a more rigorous methodology is warranted to confirm the beneficial effect of MBIs in the early stages of major psychoses.

Determining the Impact of a Cancer Diagnosis on Diabetes Management: A Systematic Literature Review.

Cancer patients with comorbid diabetes have a 50% increased risk of all-cause mortality compared with cancer patients without diabetes. Less attention to diabetes management (glucose control, medication adherence, and diabetes self-management behaviors) during active cancer treatment is hypothesized as an explanation for worse outcomes among diabetic cancer patients. The objective of this systematic review is to determine and quantify how a cancer diagnosis impacts diabetes management. Quantitative and qualitative studies evaluating diabetes management among patients were identified by searching 4 databases: MEDLINE, EMBASE, The Cochrane Library, and Web of Science. Two independent reviewers extracted data and summarized results from eligible studies. Study quality was formally assessed. Thirty-six studies met all inclusion criteria. We observed heterogeneity across studies in terms of study design, sample size, cancer site, type of diabetes management evaluated, and quality. Numerous articles discussed that overall, glucose control, medication adherence, and diabetes self-management behaviors declined following a cancer diagnosis. However, findings were inconsistent across studies. Although the effects of a cancer diagnosis on diabetes management are mixed, when results across studies were synthesized together, diabetes management appeared to generally decline after a cancer diagnosis. Declines in diabetes management seem to be primarily due to shifts in the priority of care from diabetes management to cancer. A next critical step in this line of work is to identify patient and provider level predictors of better or worse diabetes management to design and test interventions aimed at improving effective diabetes management for cancer patients.

P6138Quality of clinical trial evidence on devices and drugs approved to treat coronary artery disease

Abstract Background Regulatory approval of drugs and devices follow two different pathways. Whether different approval pathways underlie meaningful differences in quality of clinical trial evidence is unknown. We aimed to compare the quality of evidence of clinical trials that served as a basis for approval by the U.S. Food and Drug Administration (FDA) of drugs and devices used for the treatment of coronary artery disease. Methods FDA databases were searched for devices (i.e., coronary artery drug-eluting stents) and drugs (i.e., agents targeting atherothrombosis) approved between January 1st, 2001 and December 31st, 2017. FDA medical reviews were screened to identify trials that served for approval purposes. The pre-specified primary outcome was the prevalence of randomized trials used for approval (i.e. number of randomized trials/overall number of trials). Results A total of 97 trials were identified, 39 serving for approval of 13 devices and 58 serving for approval of 8 drugs. Devices were evaluated by fewer trials per item as compared with drugs (3.0±1.4 vs. 7.3±5.3, P=0.012) with similar study size (501 [100–1314] vs. 379 [183–904] patients per trial, P=0.55). Trials evaluating devices were less frequently randomized (56.4% vs. 94.8%, P<0.001) and more frequently designed powered for clinical endpoints (53.8% vs. 17.2%, P<0.001) as compared to those evaluating drugs. Use of randomization declined over time among trials supporting FDA approval of devices. In addition, significant differences were present between trials evaluating devices and those evaluating drugs in terms of study design, comparator used, blinding to treatment allocation, primary hypothesis, primary endpoint, and type of patients included. Use of randomized trials for approval Conclusions There are substantial differences in clinical trial evidence serving for FDA approval of devices and drugs used for treatment of coronary artery disease. The lower degree of randomized evidence used for approval of devices as compared to drugs raises some concerns, particularly in view of its decline over time.

Economic Impact of Pharmacist-Participated Medication Management for Elderly Patients in Nursing Homes: A Systematic Review.

This systematic review examined the varied studies that have assessed the economic impact of pharmacist-participated medication management for nursing home residents older than 65 years of age. The articles published during 1990–2017 were found through PubMed, EMBASE and Ovid Medline. After the selection process by independent reviewers, a total of 12 studies were included. The quality of the selected articles was assessed using the Effective Public Health Practice Project checklist for economic studies. The articles were highly heterogeneous in terms of study design, pharmacist participation type, and measures of economic outcome. Therefore, the results are presented narratively according to the type of pharmacist involvement featured in the articles: interprofessional networks, interprofessional coordination, or interprofessional teamwork. Of the eight studies performing statistical comparison analyses, one study of interprofessional coordination and three of interprofessional teamwork showed statistically significant positive economic outcomes. The remaining four studies showed non-significant tendencies towards favorable economic outcomes. This review provides insights into the essential features of successful pharmacist-participated medication management for elderly patients in nursing homes.

Should Platelet-Rich Plasma or Stem Cell Therapy Be Used to Treat Osteoarthritis?

Osteoarthritis is the most common form of arthritis and unfortunately lacks disease-modifying treatments. This has led to a growing demand for more effective nonoperative treatment options. Platelet-rich plasma and mesenchymal stem cell therapy offer the potential to modify the natural course of knee osteoarthritis using cell-based technology. Because of the lack of high-quality evidence and the large degree of heterogeneity, in terms of study designs and measured outcomes, the use of platelet-rich plasma or mesenchymal stem cell therapy to treat knee osteoarthritis cannot be recommended at this time.

Pregnancy-associated stroke \u2013a systematic review of subsequent pregnancies and maternal health

BackgroundPregnancy-associated stroke is a rare but life-threatening event, with an estimated incidence of 30/100000 deliveries. Data on the risk of stroke recurrence and the risk of other adverse pregnancy outcomes are essential for adequate counselling and surveillance in subsequent pregnancies. The aim of this systematic review is to describe the implications of a pregnancy-associated stroke for the future health of these women.MethodsWe searched Ovid Medline, PubMed, Cochrane Library and CINAHL for articles published in 1980–2018. Articles including women with pregnancy-associated stroke and information on at least one of the following outcomes were included: 1) recurrence of stroke during subsequent pregnancy, 2) number and course of subsequent pregnancies and their outcomes and 3) subsequent cardiovascular health.ResultsTwelve articles were included in the review, with six providing information on subsequent pregnancies, four on subsequent maternal health and two on both. The included articles varied greatly in terms of study design, length of follow up and reported outcomes. We found 252 women with pregnancy-associated stroke for whom the outcomes of interest were reported: 135 women with information on subsequent pregnancies and 123 women with information on future health. In total, 55 pregnancies after stroke were found. In the majority of studies, the incidence of pregnancy complications was comparable to that of the general population. The risk of stroke recurrence during pregnancy was 2%. Data on subsequent health of these women were limited, and the quality of the data varied between the studies.ConclusionsData on subsequent pregnancies and health of women with a history of pregnancy-associated stroke are limited. Further research on this topic is essential for adequate counselling and secondary prevention.

Systematic review of exposure to albendazole or mebendazole during pregnancy and effects on maternal and child outcomes, with particular reference to exposure in the first trimester

Soil-transmitted helminth infections cause an important burden of morbidity worldwide, primarily from blood loss and malabsorption of nutrients. Where STH endemicity ≥20%, the World Health Organization (WHO) recommends preventive chemotherapy with single dose anthelminthic drugs: albendazole or mebendazole. Although WHO recommends that women of reproductive age, including pregnant women after the first trimester, be included in large-scale deworming programs, there are concerns related to the use of anthelminthic drugs during pregnancy, especially inadvertent use in the first few weeks when the pregnancy may not yet be confirmed. We therefore conducted a systematic review using the MEDLINE database with the aim of appraising all peer-reviewed evidence, published up to July 1, 2018, on the association between exposure to albendazole or mebendazole and outcomes in pregnant women, including those in the first trimester of pregnancy, and their children. From a yield of 205 papers based on titles alone, 58 papers, reporting results from 46 originator studies conducted in pregnant populations, constituted the initial evidence base. Among the nine originator observational studies which had included women in the first trimester of pregnancy within their study population, five compared birth outcomes between women exposed in the first trimester with women who were not exposed, and none reported higher rates of adverse birth outcomes in the exposed group. Due to heterogeneity in terms of study design, sample size, deworming drug, dosage and outcomes measured, data from these studies could not be pooled. Based on this cumulative evidence, it is unlikely that inadvertent exposure to albendazole or mebendazole in the first trimester carries an additional risk of adverse birth outcomes. To optimize relevance for policy making, future research in pregnant populations should aim to provide data disaggregated by trimester and to report on maternal and child adverse events, whenever possible.

Analysis of study trends with a focus on arts therapy for offenders of school violence

본 연구의 목적은 학교폭력 가해자 대상 예술치료 중심의 국내 연구 동향을 분석하는 것이다. 2009년부터 2018년까지 지난 10년 동안 학교폭력 가해학생을 대상으로 연구된 학술지 121편과 학위논문 98편의 총 219편 중에서, 예술치료 연구 총 26편을 추출하여 본 연구대상으로 선정하였다. 예술치료의 세부영역은 음악치료, 미술치료, 무용/동작치료, 영화치료, 연극치료, 문학치료의 6개로 분류하여 연구영역(교과)비교, 연도, 연구대상, 예술치료 내 영역, 연구 설계 및 방법, 프로그램 실행 관련 분석, 예술치료 활용매체 및 연구결과 분석에 의한 전체 7개 유형으로 나누어 분석되었다. 내용분석의 결과 예술치료 연구는 2013년에서 2015년에 걸쳐 활발히 연구되었으며, 중학생 대상 연구가 가장 많았다. 연구 세부영역에서는 미술치료가 가장 많이 연구되었다. 연구 설계 및 방법은 실험집단과 통제집단을 대상으로 한 혼합연구방법을 주로 사용되었다. 예술치료 프로그램 실행 관련 분석에서는 주 2회 10회기 이상 30~90분 이상의 프로그램이 가장 많았다. 예술치료 매체에서는 만다라, 꼴라주, 노래 부르기, 악기연주, 즉흥연주가 가장 많이 활용되었으며, 그 결과 대상군의 특성을 파악하는 보조 자료로써 활용가능성과 주요증상 감소에 영향이 있는 것으로 나타났다. 본 연구에서 최종결과는 첫째, 학교폭력 가해자 대상 연구에서 예술치료 내 미술치료 외 다른 영역의 치료가 보다 더 활발히 진행될 필요가 있으며, 둘째, 다양한 연구 설계 및 방법과 매체의 적용이 필요하며, 셋째, 학교폭력 대상군의 연구에서 아동을 대상으로 한 연구가 많아질 필요가 있으며, 마지막으로 예술치료 세부 영역 내에서는 각 분야의 치료 매체 활용이 더 다양화되어져야 한다.The objective of this study is to analyze the trends in Korea concerning studies on arts therapy for offenders of school violence. Of a total of 219 studies of which 121 were academic papers and 98 were theses studying offenders of school violence over the past decade from 2009 to 2018, 26 studies on arts therapy were selected to be analyzed. The detailed categories of arts therapy were divided into the six categories of music therapy, visual arts therapy, dance/movement therapy, film therapy, theater therapy and literature therapy. The studies were analyzed into a total of seven types based on study fields (subjects), year, study participants, areas within arts therapy, the design and methodology of the study, analysis realted to implementation of programs, use of media in arts therapy and study results. The analysis showed that arts therapy studies were actively conducted from 2013 to 2015, with middle school students being the most frequent subjects. In terms of detailed study fields, visual arts therapy was the most frequent. in terms of study design and methodology, a mixed study method with an experiment group and a control group, was most often used. In terms of programs, those lasting 30-90 minutes for more than 10 sessions, with two sessions per week, were the most common. In terms of media used in arts therapy, mandala, collage, singing, musical instrument playing and spontaneous music playing were the most frequently used. The results of this study will be meaningful as a supplement material in understanding the characteristics of the study subjects to reduce major symptoms. The findings of this study were as follows: First, in the study on offenders of school violence, there needs to be more varied therapies used in addition to visual arts therapy. Second, a wide variety of designs, methodology and media need to be applied. Third, there should be more studies conducted on children. Lastly, in terms of the detailed field of arts therapy, therapy media in each field should become more varied.

Study of the Status of Medical Students and Residents' Thesis in Kerman University of Medical Sciences in Terms of Contribution to Scientific Development

Background Dissertations or theses are valuable sources of information, which play an important role in scientific development because of their specific nature and characteristics. Objectives The aim of this study was to investigate the status of medical students and residents' dissertations in terms of contribution to scientific development in Kerman University of Medical Sciences. Methods This cross-sectional, analytical study examined the status of medical students and residents' dissertations, submitted to the Medical Faculty of Kerman University of Medical Sciences during 2012 - 2015. First, the research deputy of Kerman University of Medical Sciences provided the dissertation information. Then, the information was analyzed in terms of study design, study type, extraction of Persian and English articles, publication in domestic and international journals, and indexing in reputable scientific databases in two groups of medical students and residents' dissertations. SPSS was used for all statistical analyses. Results In total, 643 dissertations were studied, including 342 (53%) residents and 301 (47%) medical students' thesis. Overall, 267 (41.5%) dissertations were published as articles in domestic and international journals. The findings showed that 13.4% of articles were indexed in the Scopus database. The mean scores of medical students and residents' dissertations were 19.22 ± 0.70 and 19.15 ± 0.85, respectively. Conclusions Despite the large number of medical students and residents' dissertations submitted to Kerman University of Medical Sciences, a limited number of dissertations were published as scientific and research papers, and the number of articles indexed in international journals was insignificant. Thesis writing is generally a unique opportunity for students to learn research skills and methods. In addition, publication of thesis findings in domestic and international databases can lead to scientific development.

Effects of smoking on outcomes of hematopoietic cell transplantation: a systemic review and future directions.

Hematopoietic cell transplantation (HCT) survivors are at risk of increased mortality compared to the general population. Smoking by HCT survivors has been reported to impact a variety of health outcomes, resulting in an increased risk for infections, cardio-pulmonary diseases, and cancer. The purpose of our study was to conduct a systematic literature search to determine the relationship between tobacco smoking pre-HCT and post-HCT outcomes. We conducted an electronic literature search from all languages from multiple peer-reviewed databases of studies that evaluated the effects of tobacco smoking prior to HCT on clinical outcomes. Data were extracted from the studies according to a strict selection criterion. Due to differences in primary endpoint and different populations evaluated in different studies, a meta-analysis was not possible, and a descriptive quantitative analysis is provided. Out of the 447 publications fulfilling the selection criteria for the electronic search, 17 articles were included in the final sample. The studies varied in terms of study design, patient characteristics, and HCT type. Considerable variability in definition of smoking was observed. We found that smoking pre-HCT was associated with a higher incidence of cardiovascular diseases, new infections, pulmonary complications, and cancers in comparison to non-smokers. Moreover, smoking pre-HCT was significantly associated with increased risks of both relapse and non-relapse mortality, and inversely related to median overall survival. Smoking adversely affects mortality in all HCT survivors by increasing the risks of both malignant and non-malignant complications. Thus, guidelines are urgently needed to formulate lifestyle factor modifications for HCT survivors focusing on smoking cessation strategies and abstinence maintenance in former smokers. Given the strength of these findings, guidelines should include systematic definitions of smoking for use in clinical trials as well as in standardized data reporting.

Review and ranking of crash risk factors related to the road infrastructure

The objective of this paper is the review and comparative assessment of infrastructure related crash risk factors, with the explicit purpose of ranking them based on how detrimental they are towards road safety (i.e. crash risk, frequency and severity). This analysis was carried out within the SafetyCube project, which aimed to identify and quantify the effects of risk factors and measures related to behaviour, infrastructure or vehicles, and integrate the results in an innovative road safety Decision Support System (DSS). The evaluation was conducted by examining studies from the existing literature. These were selected and analysed using a specifically designed common methodology. Infrastructure risk factors were structured in a hierarchical taxonomy of 10 areas with several risk factors in each area (59 specific risk factors in total), examples include: alignment features (e.g. horizontal-vertical alignment deficiencies), cross-section characteristics (e.g. superelevation, lanes, median and shoulder deficiencies), road surface deficiencies, workzones, junction deficiencies (interchange and at-grade) etc. Consultation with infrastructure stakeholders (international organisations, road authorities, etc.) took place in dedicated workshops to identify user needs for the DSS, as well as “hot topics” of particular importance. The following analysis methodology was applied to each infrastructure risk factor: (i) A search for relevant international literature, (ii) Selection of studies on the basis of rigorous criteria, (iii) Analysis of studies in terms of design, methods and limitations, (iv) Synthesis of findings - and meta-analysis, when feasible. In total 243 recent and high quality studies were selected and analysed. Synthesis of results was made through 39 ‘Synopses’ (including 4 original meta-analyses) on individual risk factors or groups of risk factors. This allowed the ranking of infrastructure risk factors into three groups: risky (11 risk factors), probably risky (18 risk factors), and unclear (7 risk factors).

Interventions to reduce the prescription of inappropriate medicines in older patients.

ABSTRACTOBJECTIVE:Identify and critically evaluate systematic reviews addressing the effectiveness of interventions to reduce the number of prescriptions of potentially inappropriate medication to older patients.METHODS:This is an overview of systematic reviews. The studies were searched and selected from Medline, Cochrane Library, Embase, CINAHL, Virtual Health Library, and Web of Science databases, combining the terms aged, prescriptions, inappropriate prescribing and potentially inappropriate medication list with their entry terms and other related descriptors, published by June 2017. This study included systematic reviews with or without meta-analysis that addressed the effectiveness of any intervention or combined interventions to reduce the number of prescriptions of potentially inappropriate medications to older patients, without restriction in terms of design, language or date of publication of primary studies. AMSTAR – A MeaSurement Tool to Assess systematic Reviews – was used to evaluate the methodological quality of selected systematic reviews. Study selection and the methodological quality evaluation were performed by two independent evaluators, who resolved any divergence by consensus. The main findings were grouped into thematic categories, defined after a content analysis and discussed qualitatively as narrative synthesis.RESULTS:This study analyzed 24 systematic reviews. In terms of study design and methodological quality evaluation, most were systematic reviews of randomized controlled clinical trials and studies of moderate quality, respectively. The interventions were analyzed in five thematic categories: medication review services, pharmaceutical interventions, computerized systems, educational interventions, and others. The interventions analyzed showed good results and most of them helped reduce the number of prescriptions of potentially inappropriate medication to older patients.CONCLUSIONS:The systematic reviews included in this overview showed potential benefits of different interventions. However, it was not possible to determine the most effective intervention. Combined interventions are likely to provide better results than isolated interventions.

Quality Governance in Biomedical Research.

Quality research data are essential for quality decision-making and thus for unlocking true innovation potential to ultimately help address unmet medical needs.The factors influencing quality are diverse. They depend on institution type and experiment type and can be of both technical and cultural nature. A well-thought-out governance mechanism will help understand, monitor, and control research data quality in a research institution.In this chapter we provide practical guidance for simple, effective, and sustainable quality governance, tailored to the needs of an organization performing nonregulated preclinical research and owned by all stakeholders.GLP regulations have been developed as a managerial framework under which nonclinical safety testing of pharmaceutical and other products should be conducted. One could argue whether these regulations should be applied to all nonclinical biomedical studies. However, the extensive technical requirements of GLP may not always be fit to the wide variety of studies outside the safety arena and may be seen as overly prescriptive and bureaucratic. In addition, GLP regulations do not take into account scientific excellence in terms of study design or adequacy of analytical methods. For these reasons and in order to allow a lean and fit for purpose approach, the content of this chapter is independent from GLP. Nevertheless, certain topics covered by GLP can be seen as valuable across biomedical research. Examples are focus on transparency and the importance of clear roles and responsibilities for different functions participating in a study.

An evaluation of mainstream type 2 diabetes educational programmes in relation to the needs of people with intellectual disabilities: A systematic review of the literature

Risk reduction and self-management programs for type 2 diabetes (T2D) are commonplace. However, little is known about their appropriateness for people with intellectual disabilities (ID). This review evaluates successful components and theoretical basis of interventions and preventions in relation to the needs of people with ID with or at risk of T2D. Characteristics of 23 randomised controlled trialled T2D educational programs were systematically assessed alongside the needs of people with ID, and evaluated in terms of study design and theoretical application. Successful components of programs align to the needs of people with ID. Further adaptations are required to ensure accessibility of materials and social support to enable reflection on illness perceptions and self-efficacy, as underpinned by Self-regulation and Social-cognitive theories. Support is provided for further trials of self-management and preventative adaptations under development. Impact may be enhanced through preventions aimed at younger groups in educational settings.