Institute for Quality and Efficiency in Health Care: Germany

Provides an overview of evidence-based policy making in the German healthcare system. Focuses on the Institute for Quality and Efficiency in Health Care, which evaluates comparative effectiveness of drugs and medical services for decisions on coverage

Setting priorities for conducting and updating systematic reviews

Abstract Systematic reviews - appraisal and synthesis of all primary research - are increasingly being used to inform policy and practice in health care. Therefore, it is important to understand how the key questions in systematic reviews are identified and prioritised and whether they are relevant to policy makers, practitioners and members of the public. Research priority setting (RPS) is usually defined as any interpersonal activity that leads to the selection of topics and/or choices of key questions to investigate . Diverse approaches to setting research priorities are used in different countries, regions and organisations. There is no consensus in the literature on the most effective processes with which to set these priorities. However, these decisions define the quality and implications of the evidence, and syntheses of it, available to patients, public and policy makers to help them make informed decisions. My initial scoping work, was to design and conduct a survey across an influential international systematic review organisation (Cochrane Collaboration ) on how they set priorities for their reviews. We identified 13 structured approaches to setting priorities. As part of the project, we developed an evaluation framework that demonstrated whether the priority setting processes meet the values and principles of the Cochrane Collaboration. Subsequently, we developed an equity lens for research priority setting exercises to inform the design of research priority setting processes to ensure that they consider the priorities of disadvantaged groups along with advantaged groups. We used the equity lens to do a second evaluation on the priority setting processes in the Cochrane Collaboration. Both evaluation frameworks demonstrated that the Cochrane Collaboration requires better designed priority setting approaches and must be more transparent in reporting those processes. The evaluation of research priority setting exercises in the Cochrane Collaboration, along with the wider literature, demonstrates that research priority setting exercises cannot be evaluated in isolation from organisational cultures, values and context. Therefore, the next step of the project focused on a specific stakeholder group (major research funders) with significant influence on research, including support for systematic reviews. We selected 11 national research agencies in the UK, Netherlands, France, Norway, Denmark, Germany, Australia, Canada, and the USA. We devised and used a checklist based on Chalmers and Glasziou’s “avoidable research waste” framework (and evaluated the processes and policies of these agencies using this checklist). As previous evaluations had demonstrated, this second evaluation found a lack of transparency in the process of setting priorities for research and other related organisational and policy issues. Increased funding is needed for methodological research to evaluate research practices and to monitor how funding research projects is done and reported. My evaluation of funding agencies and the Cochrane Collaboration found a similar lack of transparency and accountability in the context of conflicting values among stakeholders that decreases accountability and scrutiny of researchers and their institutions. However, the projects have led to organisational and policy changes in the two key stakeholder groups (the Cochrane Collaboration and selected funding agencies). Officials of national health research funding agencies have approached me to collaborate with them to address the issues raised by my work on reducing research waste. This led to the establishment of Funders Forum - the Ensuring Value in Research (EViR) Funders’ Collaboration and Development Forum - to enable agencies in various countries to exchange their experience in addressing issues and creating work groups to address them. The Forum is chaired by individuals from three major research funders: NIHR (UK), ZonMW (Netherlands) and Patient-Centered Outcomes Research Institute (PCORI; USA). The Forum organises several meetings to establish common principles, standards and work plans to achieve the common objective around reducing research waste and adding value for research for a national research funder

EFFECT OF METHYL-Î’-CYCLODEXTRIN COMPLEXATION ON THE HYPOGLYCEMIC AND HYPOLIPIDEMIC EFFECTS OF KHELLIN: EXPERIMENTAL STUDY

Objective: The present work tackled the development and evaluation of inclusion complex of khellin (KH) and methyl-β-cyclodextrin (MβCD). In addition, it tested its possible hypoglycemic and hypolipidemic effects.Methods: Inclusion complexes of KH-MβCD in the presence of water-soluble polymer were prepared by freeze drying (FD), co-evaporation (EV) and kneading methods (KN). The selected ternary complex was characterized by Fourier transform infrared spectrophotometry (FTIR), x-ray diffractometry (XRD), differential scanning calorimetry (DSC) and scanning electron microscopy [1]. Assessment of the hypoglycemic effect of the selected ternary complex versus the standard drug metformin was studied. Two different doses of the ternary complex were administered orally to streptozotocin (STZ)-induced type 2diabetic rats. Their hypoglycemic and hypolipidemic effects were evaluated by measuring the fasting blood glucose level (BGL), total cholesterol (TC) and triglycerides levels (TG) along the study period.Results: The FD complex showed the highest drug dissolution rate. All the performed characterization analysis confirmed the formation of a KH-MβCD inclusion complex. The in vivo study declared that both doses showed a marked hypoglycemic and hypolipidemic effects compared to metformin.Conclusion: In conclusion, this study points for the first time that the complexation of KH with MβCD could notably improve the dissolution rate and hence the bioavailability of KH. Moreover, this study demonstrated that this compound has a hypoglycemic and hypolipidemic effect. Thus, it can be a promising natural supportive treatment in type 2 diabetes mellitus (T2DM).Â

Distinct cytokine patterns in Occult Hepatitis C and Chronic Hepatitis C Virus Infection

Background & Aim: 
The immunopathogenesis of chronic hepatitis C virus (HCV) infection is a matter of great controversy. The imbalance of T-helper lymphocyte cell cytokine production was believed to play an important pathogenic role in chronic viral hepatitis. Occult hepatitis C infection is regarded as a new entity that should be considered when diagnosing patients with a liver disease of unknown origin. The aim of this study was to determine serum T-helper 1 and T-helper 2 cytokine production in patients with occult HCV infection and its role in pathogenesis versus chronic viral hepatitis C infection.

Methods: 
Serum levels of cytokines of T-helper 1 (IL-2, IFN-[gamma]) and T-helper 2 (IL-4) were measured in 27 patients with occult HCV infection and 50 patients with chronic hepatitis C infection.

Results: 
The levels of the T-helper 1 cytokines, IL-2 and IFN-[gamma], were highly and significantly increased in patients with chronic HCV infection as compared with occult HCV infection (p<0.001). The T-helper 2 cytokine IL-4 was highly and significantly increased in occult HCV infection as compared with chronic HCV infection (p<0.001). Necroinflammation (P<0.001) fibrosis (P<0.001) and cirrhosis (P =0.03) were significantly increased in chronic HCV than occult HCV. 

Conclusion: 
Patients with occult HCV infection exhibited distinct immunoregulatory cytokine patterns, favoring viral persistence in the liver in spite of its absence from peripheral blood and explaining the less aggressive course of this disease entity than chronic hepatitis C virus infection

Can we deliver effective alcohol-related brief advice in general dental practice?

Design Two-arm cluster randomised controlled feasibility trial. Intervention Twelve NHS dental practices were randomised to the intervention and control arms. Patients consuming alcohol above the recommended levels were eligible to participate in the trial. The intervention was delivered by the dentists in the participating practices and entailed the delivery of a short tailored alcohol-related advice tool and a leaflet, which included information about the effects of alcohol on oral health and the benefits of reducing alcohol intake to both oral and general health. Patients in the control arm were given a mouth cancer prevention leaflet only. The level of alcohol consumption was measured by validated tools (AUDIT: Alcohol Use Disorders Identification Test and AUTID-C: Alcohol Use Disorders Identification Test for Consumption). The patients were followed-up after six months by a telephone interview. Outcome Measures The feasibility trial outcomes were the recruitment, retention, eligibility and delivery rate. The primary outcome of the trial was the impact of the intervention in lowering the level of alcohol consumption as captured by the AUDIT tool. Secondary outcomes included health related quality of life and alcohol consumption and abstinence in the last 90 days. The acceptability of the intervention was also assessed.Results The recruitment and retention rate were high (95.4% and 76.9% respectively). At the follow-up, participants in the intervention arm were significantly more likely to report a longer abstinence period (3.2 vs. 2.3 weeks respectively, P = 0.04). Non-significant differences in AUDIT (44.9% vs. 59.8% AUDIT positive respectively, P = 0.053) and AUDIT-C between baseline and follow-up (-0.67 units vs. -0.29 units respectively, P = 0.058) were observed. Results from the process evaluation indicated that the intervention and study procedures were acceptable to dentists and patients.Conclusion According to this study, dentists offering screening for alcohol misuse and brief advice in a primary dental care setting is not only feasible but also well-welcomed by both the dental team and patients

Comparative study between fisher anatomical subunit approximation technique and millard rotation- advancement technique in unilateral cleft lip repair

Introduction: The ideal lip repair is characterized by; the symmetrical shape of nasolabial folds and both alae of the nose with a natural-looking philtrum and Cupid’s bow in both static and dynamic states, in addition to a hidden scar.Objective: to compare between Fisher anatomical subunit approximation technique and Millard rotational advancement technique in unilateral cleft lip repair.Methods: Prospective study for 40 patients presented to Alexandria Main University hospital with unilateral cleft lip deformity between March 2019 and October 2020. Twenty patients with unilateral cleft lip deformity were repaired by Fisher anatomical subunit approximation technique, while the other twenty were repaired by Millard rotational-advancement technique. The postoperative photographs of the patients were captured and processed in computer photogrammetry software through which anthropometric parameters including (lip height, lip width, vermilion height, and alar base width) were compared between the normal side and the repaired side. In this software, each anthropometric parameter length on the normal side is taken as a control with a fixed value of (1) then the same parameter on the repaired side was measured as a ratio of this value to avoid bias. Comparison between both groups for assessment of the quality of cleft lip repair was also done based on Steffensen grading criteria.Results: Comparison between both techniques in unilateral cleft lip repair showed that there was no significant difference between them in the anthropometric measurements. While the comparison between the two groups using Steffensen grading criteria showed that Fisher’s technique surpassed Millard’s technique.Conclusion: We recommend the use of the Fisher anatomical subunit approximation technique in unilateral cleft lip repair for its superior results over the Millard rotational advancement technique

Beta2-adrenoceptor agonists for dysmenorrhoea

Background:Dysmenorrhoea is a common gynaecological complaint that can affect as many as 50% of premenopausal women, 10% of whom suffer severely enough to be rendered incapacitated for one to three days during each menstrual cycle. Primary dysmenorrhoea is where women suffer from menstrual pain but lack any pathology in their pelvic anatomy. Beta2-adrenoceptor agonists have been used in the treatment of women with primary dysmenorrhoea but their effects are unclear.Objectives:To determine the effectiveness and safety of beta2-adrenoceptor agonists in the treatment of primary dysmenorrhoea. Search methods: We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register, CENTRAL (The Cochrane Library 2011, Issue 8), MEDLINE, EMBASE, PsycINFO and the EBM Reviews databases. The last search was on 22 August 2011.Selection criteriaRandomised controlled trials comparing beta2-adrenoceptor agonists with placebo or no treatment, each other or any other conventional treatment in women of reproductive age with primary dysmenorrhoea. Data collection and analysisTwo review authors independently assessed trial quality and extracted the data.Main results:Five trials involving 187 women with an age range of 15 to 40 years were included. Oral isoxsuprine was compared with placebo in two trials, terbutaline oral spray, ritodrine chloride and oral hydroxyphenyl-orciprenalin were compared with placebo in a further three trials. Clinical diversity in the studies in terms of the interventions being evaluated, assessments at different time points and the use of different assessment tools mitigated against pooling of outcome data across studies in order to provide a summary estimate of effect for any of the comparisons. Only one study, with unclear risk of bias, reported pain relief with a combination of isoxsuprine, acetaminophen and caffeine. None of the other studies reported any significant clinical difference in effectiveness between the intervention and placebo. Adverse effects were reported with all of these medications in up to a quarter of the total number of participants. They included nausea, vomiting, dizziness, quivering, tremor and palpitations.Authors\u27 conclusions:The evidence presented in this review was based on a few relatively small-sized studies that were categorised to have unclear to high risk of bias, which does not allow confident decision-making at present about the use of beta2-adrenoceptor agonists for dysmenorrhoea. The benefits as reported in one study should be balanced against the wide array of unacceptable side effects documented with this class of medication. We have emphasised the lack of precision and limitations in the reported data where appropriate

Nutraceutical and pharmaceutical behavior of bioactive compounds of miracle oilseeds: an overview

India plays an important role in the production of oilseeds, which are mainly cultivated for future extraction of their oil. In addition to the energic and nutritional contribution of these seeds, oilseeds are rich sources of bioactive compounds (e.g., phenolic compounds, proteins, minerals). A regular and moderate dietary supplementation of oilseeds promotes health, prevents the appearance of certain diseases (e.g., cardiovascular diseases (CVDs), cancers) and delays the aging process. Due to their relevant content in nutraceutical molecules, oilseeds and some of their associated processing wastes have raised interest in food and pharmaceutical industries searching for innovative products whose application provides health benefits to consumers. Furthermore, a circular economy approach could be considered regarding the re-use of oilseeds’ processing waste. The present article highlights the different oilseed types, the oilseeds-derived bioactive compounds as well as the health benefits associated with their consumption. In addition, the different types of extractive techniques that can be used to obtain vegetable oils rich from oilseeds, such as microwave-assisted extraction (MAE), ultrasonic-assisted extraction (UAE) and supercritical fluid extraction (SFE), are reported. We conclude that the development and improvement of oilseed markets and their byproducts could offer even more health benefits in the future, when added to other foods.King Khalid University (Saudi Arabia) | Ref. #RGP2/3/4

Notre Dame Law School Religious Liberty Initiative

I want Notre Dame to be a light for the people who are suffering darkness. I want this to be a place that people all around the world can see as a source of hope, where they can find people who are willing to fight for them, for their religious freedom and for their human flourishing. — Dean G. Marcus Cole, Notre Dame Law School Learn more about Notre Dame Law School\u27s Religious Liberty Initiative at https://law.nd.edu/RLI