Effects of task shifting from primary care physicians to nurses: a protocol for an overview of systematic reviews.

INTRODUCTION: Task-shifting from primary care physicians (PCPs) to nurses is one option to better and more efficiently meet the needs of the population in primary care and to overcome PCP shortages. This protocol outlines an overview of systematic reviews to assess the effects of delegation or substitution by nurses of PCPs' activities regarding clinical, patient-relevant, professional and health services-related outcomes. METHODS AND ANALYSIS: We will conduct a systematic literature search for secondary literature in PubMed/MEDLINE, EMBASE, CINAHL and Cochrane databases. Systematic reviews, meta-analyses and Health Technology Assessments in German and English comprising randomised controlled trials and prospective controlled trials will be considered for inclusion. Search terms will include Medical Subject Headings combined with free text words. At least one-third of abstracts and full-text articles are reviewed by two independent reviewers. Methodological quality will be assessed using the Overview Quality Assessment Questionnaire. We will only consider reviews if they include controlled trials, if the profession that substituted or delegated tasks was a nurse, if the profession of the control was a PCP, if the assessed intervention was the same in the intervention and control group and if the Overview Quality Assessment Questionnaire score is ≥5. The corrected covered area will be calculated to describe the degree of overlap of studies in the reviews included in the study. We will report the overview according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. ETHICS AND DISSEMINATION: The overview of secondary literature does not require the approval of an Ethics Committee and will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42020183327.

Customization options in consumer health information materials on type-2 diabetes mellitus-an analysis of modifiable features in different types of media.

Introduction: The understanding of health-related information is essential for making informed decisions. However, providing health information in an understandable format for everyone is challenging due to differences in consumers' health status, disease knowledge, skills, and preferences. Tailoring health information to individual needs can improve comprehension and increase health literacy. Objective: The aim of our research was to analyze the extent to which consumers can customize consumer health information materials (CHIMs) for type-2 diabetes mellitus through various media types. Methods: We conducted a comprehensive search for various CHIMs across various media types, such as websites, apps, videos, and printed or printable forms. A representative sample of CHIMs was obtained for analysis through blocked randomization across the various media types. We conducted a quantitative content analysis to determine the frequency of user-centered customization options. Cross-comparisons were made to identify trends and variations in modifiable features among the media. Results: In our representative sample of 114 CHIMs, we identified a total of 24 modifiable features, which we grouped into five main categories: (i) language, (ii) text, (iii) audiovisual, (iv) presentation, and (v) medical content. Videos offered the most customization opportunities (95%), while 47% of websites and 26% of apps did not allow users to tailor health information. None of the printed or printable materials provided the option to customize the information. Overall, 65% of analyzed CHIMs did not allow users to tailor health information according to their needs. Conclusion: Our results show that CHIMs for type-2 diabetes mellitus could be significantly improved by providing more customization options for users. Further research is needed to investigate the effectiveness and usability of these options to enhance the development and appropriate provision of modifiable features in health information.

[Factors promoting and hindering the use of an evidence-based clinical pathway for the management of overweight or obese children and adolescents]. / Förderliche und hinderliche Faktoren für den Einsatz eines evidenzbasierten Behandlungspfades zur Versorgung von übergewichtigen oder adipösen Kindern und Jugendlichen.

BACKGROUND/OBJECTIVE: Evidence-based clinical pathways can be a useful tool for guideline implementation. However, there seem to be barriers to the use of clinical pathways. The aim of the present questionnaire survey was to assess the perceived usability of the clinical pathway "Overweight/obesity in children and adolescents at primary care level" and to identify factors promoting and hindering the use of the clinical pathway. METHODS: In January 2020, an online questionnaire survey was sent out to 3,916 general practitioners and 470 pediatricians in Austria. The data collected were analysed descriptively. RESULTS: A total of 148 people took part in the questionnaire survey (response rate 3.7 %). The majority of respondents indicated that they, in general, perceive evidence-based clinical pathways as helpful (90 %) and also make use of them (57 %). Few respondents (9 %) felt well-informed about new clinical pathways developed in Austria. Most of the respondents considered the clinical pathway "Overweight/obesity in children and adolescents at primary care level" as a useful support (60 %), as a reference work (72 %) or as a facilitator for justifying their approach to their patients (68 %). However, a large proportion of the respondents stated that the clinical pathway is not easily applicable in everyday practice. The three most frequently cited barriers to using the clinical pathway were lack of time resources, lack of structures and lack of financial incentives. Other display and access options (e. g., individualisation, integration into practice software) were most frequently cited as factors that might promote the use of the pathway. CONCLUSION: Although the majority of the respondents had positive expectations regarding the use of the clinical pathway "Overweight/obesity in children and adolescents at primary care level", many of them still perceived its usability in everyday clinical practice as difficult. The necessary next steps to improve the use of evidence-based clinical pathways seem to be: an economic and practicable design, easy accessibility of clinical pathways and the creation of framework conditions that facilitate their use in everyday practice.

Comprehensive catalogue of international measures aimed at preventing general practitioner shortages.

BACKGROUND: Many countries are facing a shortage and misallocation of general practitioners (GPs). The development of a policy response may benefit from the knowledge of worldwide policies that have been adopted and recommended to counteract such a development. AIM: To identify measures proposed or taken internationally to prevent GP shortages. DESIGN AND SETTING: A literature review followed by an expert assessment focussed on sources from OECD countries. METHOD: The literature search identified international policy documents and literature reviews in bibliographical databases, and examined institutional websites and references of included publications. The internet search engine Google was also used. The resulting measures were then assessed for completeness by three experts. RESULTS: Ten policy documents and 32 literature reviews provided information on 102 distinct measures aimed at preventing GP shortages. The measures attempt to influence GPs at all stages of their careers. CONCLUSIONS: This catalogue of measures to prevent GP shortages is significantly more comprehensive than any of the policy documents it is based on. It may serve as a blueprint for effective reforms aimed at preventing GP shortages internationally.

This review identified 102 distinct measures to prevent a GP shortage. These measures influence GPs at all stages of their careers. These measures may serve as a blueprint for reforms to prevent GP shortages.

Long-term effects of weight-reducing diets in people with hypertension.

BACKGROUND: All major guidelines for antihypertensive therapy recommend weight loss. Dietary interventions that aim to reduce body weight might therefore be a useful intervention to reduce blood pressure and adverse cardiovascular events associated with hypertension. OBJECTIVES: Primary objectives To assess the long-term effects of weight-reducing diets in people with hypertension on all-cause mortality, cardiovascular morbidity, and adverse events (including total serious adverse events, withdrawal due to adverse events, and total non-serious adverse events). Secondary objectives To assess the long-term effects of weight-reducing diets in people with hypertension on change from baseline in systolic blood pressure, change from baseline in diastolic blood pressure, and body weight reduction. SEARCH METHODS: For this updated review, the Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to April 2020: the Cochrane Hypertension Specialised Register, CENTRAL (2020, Issue 3), Ovid MEDLINE, Ovid Embase, and ClinicalTrials.gov. We also contacted authors of relevant papers about further published and unpublished work. The searches had no language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of at least 24 weeks' duration that compared weight-reducing dietary interventions to no dietary intervention in adults with primary hypertension. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risks of bias and extracted data. Where appropriate and in the absence of significant heterogeneity between studies (P > 0.1), we pooled studies using a fixed-effect meta-analysis. In case of moderate or larger heterogeneity as measured by Higgins I2, we used a random-effects model. MAIN RESULTS: This second review update did not reveal any new trials, so the number of included trials remains the same: eight RCTs involving a total of 2100 participants with high blood pressure and a mean age of 45 to 66 years. Mean treatment duration was 6 to 36 months. We judged the risks of bias as unclear or high for all but two trials. No study included mortality as a predefined outcome. One RCT evaluated the effects of dietary weight loss on a combined endpoint consisting of the necessity of reinstating antihypertensive therapy and severe cardiovascular complications. In this RCT, weight-reducing diet lowered the endpoint compared to no diet: hazard ratio 0.70 (95% confidence interval (CI) 0.57 to 0.87). None of the trials evaluated adverse events as designated in our protocol. The certainty of the evidence was low for a blood pressure reduction in participants assigned to weight-loss diets as compared to controls: systolic blood pressure: mean difference (MD) -4.5 mm Hg (95% CI -7.2 to -1.8 mm Hg) (3 studies, 731 participants), and diastolic blood pressure: MD -3.2 mm Hg (95% CI -4.8 to -1.5 mm Hg) (3 studies, 731 participants). We judged the certainty of the evidence to be high for weight reduction in dietary weight loss groups as compared to controls: MD -4.0 kg (95% CI -4.8 to -3.2) (5 trials, 880 participants). Two trials used withdrawal of antihypertensive medication as their primary outcome. Even though we did not consider this a relevant outcome for our review, the results of these RCTs strengthen the finding of a reduction of blood pressure by dietary weight-loss interventions. AUTHORS' CONCLUSIONS: In this second update, the conclusions remain unchanged, as we found no new trials. In people with primary hypertension, weight-loss diets reduced body weight and blood pressure, but the magnitude of the effects are uncertain due to the small number of participants and studies included in the analyses. Whether weight loss reduces mortality and morbidity is unknown. No useful information on adverse effects was reported in the relevant trials.

Long-term effects of weight-reducing drugs in people with hypertension.

BACKGROUND: This is the third update of this review, first published in July 2009. All major guidelines on treatment of hypertension recommend weight loss; anti-obesity drugs may be able to help in this respect. OBJECTIVES: Primary objectives: To assess the long-term effects of pharmacologically-induced reduction in body weight in adults with essential hypertension on all-cause mortality, cardiovascular morbidity, and adverse events (including total serious adverse events, withdrawal due to adverse events, and total non-serious adverse events).. Secondary objectives: To assess the long-term effects of pharmacologically-induced reduction in body weight in adults with essential hypertension on change from baseline in systolic and diastolic blood pressure, and on body weight reduction. SEARCH METHODS: For this updated review, the Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to March 2020: the Cochrane Hypertension Specialised Register, CENTRAL, MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. The searches had no language restrictions. We contacted authors of relevant papers about further published and unpublished work. SELECTION CRITERIA: Randomised controlled trials of at least 24 weeks' duration in adults with hypertension that compared approved long-term weight-loss medications to placebo.  DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risks of bias, and extracted data. Where appropriate and in the absence of significant heterogeneity between studies (P > 0.1), we pooled studies using a fixed-effect meta-analysis. When heterogeneity was present, we used the random-effects method and investigated the cause of the heterogeneity. MAIN RESULTS: This third update of the review added one new trial, investigating the combination of naltrexone/bupropion versus placebo. Two medications, which were included in the previous versions of this review (rimonabant and sibutramine) are no longer considered relevant for this update, since their marketing approval was withdrawn in 2010 and 2009, respectively. The number of included studies in this review update is therefore six (12,724 participants in total): four RCTs comparing orlistat to placebo, involving a total of 3132 participants with high blood pressure and a mean age of 46 to 55 years; one trial comparing phentermine/topiramate to placebo, involving 1305 participants with high blood pressure and a mean age of 53 years; and one trial comparing naltrexone/bupropion to placebo, involving 8283 participants with hypertension and a mean age of 62 years. We judged the risks of bias to be unclear for the trials investigating orlistat or naltrexone/bupropion. and low for the trial investigating phentermine/topiramate. Only the study of naltrexone/bupropion included cardiovascular mortality and morbidity as predefined outcomes. There were no differences in the rates of all-cause or cardiovascular mortality, major cardiovascular events, or serious adverse events between naltrexone/bupropion and placebo. The incidence of overall adverse events was significantly higher in participants treated with naltrexone/bupropion. For orlistat, the incidence of gastrointestinal side effects was consistently higher compared to placebo. The most frequent side effects with phentermine/topiramate were dry mouth and paraesthesia. After six to 12 months, orlistat reduced systolic blood pressure compared to placebo by mean difference (MD) -2.6 mm Hg (95% confidence interval (CI) -3.8 to -1.4 mm Hg; 4 trials, 2058 participants) and diastolic blood pressure by MD -2.0 mm Hg (95% CI -2.7 to -1.2 mm Hg; 4 trials, 2058 participants). After 13 months of follow-up, phentermine/topiramate decreased systolic blood pressure compared to placebo by -2.0 to -4.2 mm Hg (1 trial, 1030 participants) (depending on drug dosage), and diastolic blood pressure by -1.3 to -1.9 mm Hg (1 trial, 1030 participants) (depending on drug dosage). There was no difference in the change in systolic or diastolic blood pressure between naltrexone/bupropion and placebo (1 trial, 8283 participants). We identified no relevant studies investigating liraglutide or lorcaserin in people with hypertension. AUTHORS' CONCLUSIONS: In people with elevated blood pressure, orlistat, phentermine/topiramate and naltrexone/bupropion reduced body weight; the magnitude of the effect was greatest with phentermine/topiramate. In the same trials, orlistat and phentermine/topiramate, but not naltrexone/bupropion, reduced blood pressure. One RCT of naltrexone/bupropion versus placebo showed no differences in all-cause mortality or cardiovascular mortality or morbidity after two years. The European Medicines Agency refused marketing authorisation for phentermine/topiramate due to safety concerns, while for lorcaserin the application for European marketing authorisation was withdrawn due to a negative overall benefit/risk balance. In 2020 lorcaserin was also withdrawn from the US market. Two other medications (rimonabant and sibutramine) had already been withdrawn from the market in 2009 and 2010, respectively.

Management of non-specific low back pain in primary care - A systematic overview of recommendations from international evidence-based guidelines.

AIM: Systematic identification, characterization and analysis of recommendations concerning the diagnosis and treatment of non-specific low back pain (LBP) in primary care provided in international evidence-based guidelines from high-income countries. BACKGROUND: LBP is one of the most common reasons for consulting a primary care physician and its prevalence is higher in high-income than in middle- or low-income countries. The majority of LBP is non-specific and treatment recommendations are not often based on high-quality and patient-oriented evidence. METHODS: We systematically searched PubMed and major guideline databases from 2013 to 2020. Two independent reviewers performed literature selection and the quality assessment of included guidelines using the AGREE II tool. We extracted all relevant recommendations including the corresponding Grade of Recommendation. We grouped all included recommendations by topic and compared them to each other. FINDINGS: This overview includes 10 current guidelines and overall 549 relevant recommendations. Recommendations covered aspects of assessment and diagnosis (15%), non-pharmacological interventions (46%), pharmacological interventions (26%), invasive treatments (8%) and multimodal pain management (5%). In total, 30% of all recommendations were strong and 57% weak or very weak. The proportion of recommendations for and against an intervention was 45% and 38%, respectively. The recommendations from the different guidelines were largely in good agreement. We identify only a small number of contradictory recommendations, mostly dealing with very specific interventions. CONCLUSION: In conclusion, current evidence-based guidelines published in high-income countries provide recommendations for all major aspects of the management of people with LBP in primary care. Recommendations from different guidelines were largely consistent. More than 50% of these recommendations were weak or very weak and a high proportion of recommendation advised against an intervention.

(Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus.

BACKGROUND: Evidence that antihyperglycaemic therapy is beneficial for people with type 2 diabetes mellitus is conflicting. While the United Kingdom Prospective Diabetes Study (UKPDS) found tighter glycaemic control to be positive, other studies, such as the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, found the effects of an intensive therapy to lower blood glucose to near normal levels to be more harmful than beneficial. Study results also showed different effects for different antihyperglycaemic drugs, regardless of the achieved blood glucose levels. In consequence, firm conclusions on the effect of interventions on patient-relevant outcomes cannot be drawn from the effect of these interventions on blood glucose concentration alone. In theory, the use of newer insulin analogues may result in fewer macrovascular and microvascular events. OBJECTIVES: To compare the effects of long-term treatment with (ultra-)long-acting insulin analogues (insulin glargine U100 and U300, insulin detemir and insulin degludec) with NPH (neutral protamine Hagedorn) insulin (human isophane insulin) in adults with type 2 diabetes mellitus. SEARCH METHODS: For this Cochrane Review update, we searched CENTRAL, MEDLINE, Embase, ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was 5 November 2019, except Embase which was last searched 26 January 2017. We applied no language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing the effects of treatment with (ultra-)long-acting insulin analogues to NPH in adults with type 2 diabetes mellitus. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias, extracted data and evaluated the overall certainty of the evidence using GRADE. Trials were pooled using random-effects meta-analyses. MAIN RESULTS: We identified 24 RCTs. Of these, 16 trials compared insulin glargine to NPH insulin and eight trials compared insulin detemir to NPH insulin. In these trials, 3419 people with type 2 diabetes mellitus were randomised to insulin glargine and 1321 people to insulin detemir. The duration of the included trials ranged from 24 weeks to five years. For studies, comparing insulin glargine to NPH insulin, target values ranged from 4.0 mmol/L to 7.8 mmol/L (72 mg/dL to 140 mg/dL) for fasting blood glucose (FBG), from 4.4 mmol/L to 6.6 mmol/L (80 mg/dL to 120 mg/dL) for nocturnal blood glucose and less than 10 mmol/L (180 mg/dL) for postprandial blood glucose, when applicable. Blood glucose and glycosylated haemoglobin A1c (HbA1c) target values for studies comparing insulin detemir to NPH insulin ranged from 4.0 mmol/L to 7.0 mmol/L (72 mg/dL to 126 mg/dL) for FBG, less than 6.7 mmol/L (120 mg/dL) to less than 10 mmol/L (180 mg/dL) for postprandial blood glucose, 4.0 mmol/L to 7.0 mmol/L (72 mg/dL to 126 mg/dL) for nocturnal blood glucose and 5.8% to less than 6.4% HbA1c, when applicable. All trials had an unclear or high risk of bias for several risk of bias domains. Overall, insulin glargine and insulin detemir resulted in fewer participants experiencing hypoglycaemia when compared with NPH insulin. Changes in HbA1c were comparable for long-acting insulin analogues and NPH insulin. Insulin glargine compared to NPH insulin had a risk ratio (RR) for severe hypoglycaemia of 0.68 (95% confidence interval (CI) 0.46 to 1.01; P = 0.06; absolute risk reduction (ARR) -1.2%, 95% CI -2.0 to 0; 14 trials, 6164 participants; very low-certainty evidence). The RR for serious hypoglycaemia was 0.75 (95% CI 0.52 to 1.09; P = 0.13; ARR -0.7%, 95% CI -1.3 to 0.2; 10 trials, 4685 participants; low-certainty evidence). Treatment with insulin glargine reduced the incidence of confirmed hypoglycaemia and confirmed nocturnal hypoglycaemia. Treatment with insulin detemir compared to NPH insulin found an RR for severe hypoglycaemia of 0.45 (95% CI 0.17 to 1.20; P = 0.11; ARR -0.9%, 95% CI -1.4 to 0.4; 5 trials, 1804 participants; very low-certainty evidence). The Peto odds ratio for serious hypoglycaemia was 0.16, 95% CI 0.04 to 0.61; P = 0.007; ARR -0.9%, 95% CI -1.1 to -0.4; 5 trials, 1777 participants; low-certainty evidence). Treatment with detemir also reduced the incidence of confirmed hypoglycaemia and confirmed nocturnal hypoglycaemia. Information on patient-relevant outcomes such as death from any cause, diabetes-related complications, health-related quality of life and socioeconomic effects was insufficient or lacking in almost all included trials. For those outcomes for which some data were available, there were no meaningful differences between treatment with glargine or detemir and treatment with NPH. There was no clear difference between insulin-analogues and NPH insulin in terms of weight gain. The incidence of adverse events was comparable for people treated with glargine or detemir, and people treated with NPH. We found no trials comparing ultra-long-acting insulin glargine U300 or insulin degludec with NPH insulin. AUTHORS' CONCLUSIONS: While the effects on HbA1c were comparable, treatment with insulin glargine and insulin detemir resulted in fewer participants experiencing hypoglycaemia when compared with NPH insulin. Treatment with insulin detemir also reduced the incidence of serious hypoglycaemia. However, serious hypoglycaemic events were rare and the absolute risk reducing effect was low. Approximately one in 100 people treated with insulin detemir instead of NPH insulin benefited. In the studies, low blood glucose and HbA1c targets, corresponding to near normal or even non-diabetic blood glucose levels, were set. Therefore, results from the studies are only applicable to people in whom such low blood glucose concentrations are targeted. However, current guidelines recommend less-intensive blood glucose lowering for most people with type 2 diabetes in daily practice (e.g. people with cardiovascular diseases, a long history of type 2 diabetes, who are susceptible to hypoglycaemia or older people). Additionally, low-certainty evidence and trial designs that did not conform with current clinical practice meant it remains unclear if the same effects will be observed in daily clinical practice. Most trials did not report patient-relevant outcomes.

Healthcare experiences of patients with chronic heart failure in Germany: a scoping review.

OBJECTIVES: To review systematically the past 10 years of research activity into the healthcare experiences (HCX) of patients with chronic heart failure (CHF) in Germany, in order to identify research foci and gaps and make recommendations for future research. DESIGN: In this scoping review, six databases and grey literature sources were systematically searched for articles reporting HCX of patients with CHF in Germany that were published between 2008 and 2018. Extracted results were summarised using quantitative and qualitative descriptive analysis. RESULTS: Of the 18 studies (100%) that met the inclusion criteria, most were observational studies (60%) that evaluated findings quantitatively (60%). HCX were often concerned with patient information, global satisfaction as well as relationships and communication between patients and providers and generally covered ambulatory care, hospital care and rehabilitation services. Overall, the considerable heterogeneity of the included studies' outcomes only permitted relatively trivial levels of synthesis. CONCLUSION: In Germany, research on HCX of patients with CHF is characterised by missing, inadequate and insufficient information. Future research would benefit from qualitative analyses, evidence syntheses, longitudinal analyses that investigate HCX throughout the disease trajectory, and better reporting of sociodemographic data. Furthermore, research should include studies that are based on digital data, reports of experiences gained in under-investigated yet patient-relevant healthcare settings and include more female subjects.

[Antibody tests for COVID-19: What the results tell us]. / Antikörpertests bei COVID-19 - Was uns die Ergebnisse sagen.

INTRODUCTION: In the context of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, the detection of virus-specific antibodies (AB) will play an increasing role. The presence or absence of such antibodies can potentially lead to considerations regarding immunity and infection. ISSUE: How reliable are inferences from positive or negative test results regarding the actual presence of SARS-CoV-2 specific antibodies? METHODS: Calculation of the probability that, depending on the pretest probability (prevalence of SARS-CoV-2 infection) and test properties, antibodies are present or absent in the case of positive or negative test results. RESULTS: Sensitivity and specificity of different SARS-CoV-2 AB test systems vary between 53 % and 94 % and between 91 % and 99.5 %, respectively. When using a test with high test quality, the positive predictive value (PPV) is 42 % and 7 9%, respectively, with a pre-test probability of 1 % to 5 %, as can currently be assumed for the general population in Austria or Germany. For persons with an increased pre-test probability of 20 %, e. g. persons from high-risk professions, the PPW is 95 %, with a pre-test probability of 80 % the PPW is almost 100 %. The negative predictive value (NPV) is at least 99.7 % for persons with a low pre-test probability of up to 5 % and 79.1 % for persons with a pre-test probability of 80 %. When using test systems with lower sensitivity and specificity, the reliability of the results decreases considerably. The PPV is 5.9 % with a pre-test probability of 1 %. CONCLUSIONS: A sufficiently high sensitivity and specificity are prerequisites for the application of antibody test systems. Positive test results are often false if the pre-test probability is low. Depending on the assumed prevalence of a SARS-CoV-2 infection, there are substantial differences in the significance of a concrete test result for the respective affected persons.

Management of overweight and obesity in primary care-A systematic overview of international evidence-based guidelines.

Overweight and obesity are increasing worldwide. In general practice, different approaches exist to treat people with weight problems. To provide the foundation for the development of a structured clinical pathway for overweight and obesity management in primary care, we performed a systematic overview of international evidence-based guidelines. We searched in PubMed and major guideline databases for all guidelines published in World Health Organization (WHO) "Stratum A" nations that dealt with adults with overweight or obesity. Nineteen guidelines including 711 relevant recommendations were identified. Most of them concluded that a multidisciplinary team should treat overweight and obesity as a chronic disease. Body mass index (BMI) should be used as a routine measure for diagnosis, and weight-related complications should be taken into account. A multifactorial, comprehensive lifestyle programme that includes reduced calorie intake, increased physical activity, and measures to support behavioural change for at least 6 to 12 months is recommended. After weight reduction, long-term measures for weight maintenance are necessary. Bariatric surgery can be offered to people with a BMI greater than or equal to 35 kg/m2 when all non-surgical interventions have failed. In conclusion, there was considerable agreement in international, evidence-based guidelines on how multidisciplinary management of overweight and obesity in primary care should be performed.

How many women take oral supplementation in pregnancy in Austria? : Who recommended it? A cross-sectional study.

BACKGROUND: Iron deficiency anemia is common in pregnancy with a prevalence of approximately 16% in Austria; however, international guideline recommendations on screening and subsequent treatment with iron preparations are inconsistent. The aim of this study was to find out how often pregnant women take iron-containing supplements, and who recommended them. As hemoglobin data were available for a sub-group of women, hemoglobin status during pregnancy and associated consumption of iron-containing medications were also recorded. METHODS: This cross-sectional study was conducted at the Mother-Child-Booklet service center of the Styrian Health Insurance Fund in Graz, Austria. A questionnaire containing seven questions was developed. Absolute and relative numbers were determined, and corresponding 95% confidence intervals calculated using bootstrapping techniques. RESULTS: A total of 325 women completed the questionnaire, 11% had been diagnosed with anemia before becoming pregnant, 67% reported taking iron-containing compounds. The women reported taking 45 different products but 61% took 1 of 3 different supplements. Overall, 185 (57%) women had not been diagnosed with anemia before becoming pregnant but reported taking an iron-containing supplement and 89% of the women took supplements on the recommendation of their physician. Of the 202 women whose hemoglobin status was assessed, 92% were found not to be anemic. CONCLUSION: Overall, 67% of pregnant women took iron-containing compounds, irrespective of whether they were deficient in iron. Physicians were generally responsible for advising them to take them. No standardized procedure is available on which to base the decision whether to take iron during pregnancy, even in guidelines. As most guidelines only recommend taking iron supplements in cases of anemia, the high percentage of women taking them in Austria is incomprehensible.

Chronic heart failure patients' experiences of German healthcare services: a protocol for a scoping review.

INTRODUCTION: Chronic heart failure (CHF) is a heterogeneous condition requiring complex treatment from diverse healthcare services. An increasingly holistic understanding of healthcare has resulted in contextual factors such as perceived quality of care, as well as patients' acceptance, preferences and subjective expectations of health services, all gaining in importance. How patients with CHF experience the use of healthcare services has not been studied within the scope of a systematic review in a German healthcare context. The aim of this scoping review is therefore to review systematically the experiences of patients affected by CHF with healthcare services in Germany in the literature and to map the research foci. Further objectives are to identify gaps in evidence, develop further research questions and to inform decision makers concerned with improving healthcare of patients living with CHF. METHODS AND ANALYSIS: This scoping review will be based on a broad search strategy involving systematic and comprehensive electronic database searches in MEDLINE, EMBASE, PsycINFO, PSYNDEX, CINAHL and Cochrane's Database of Systematic Reviews, grey literature searches, as well as hand searches through reference lists and non-indexed key journals. The methodological procedure will be based on an established six-stage framework for conducting scoping reviews that includes two independent reviewers. Data will be systematically extracted, qualitatively and quantitatively analysed and summarised both narratively and visually. To ensure the research questions and extracted information are meaningful, a patient representative will be involved. ETHICS AND DISSEMINATION: Ethical approval will not be required to conduct this review. Results will be disseminated through a clearly illustrated report that will be part of a wider research project. Furthermore, it is intended that the review's findings should be made available to relevant stakeholders through conference presentations and publication in peer-reviewed journals (knowledge transfer). Protocol registration in PROSPERO is not applicable for scoping reviews.

[Quality Indicators of Primary Health Care Facilities in Austria]. / Qualitätsindikatoren für Primary-Health-Care-Einrichtungen in Österreich.

BACKGROUND: The strengthening of primary health care is one major goal of the current national health reform in Austria. In this context, a new interdisciplinary concept was developed in 2014 that defines structures and requirements for future primary health care facilities. OBJECTIVE: The aim of this project was the development of quality indicators for the evaluation of the scheduled primary health care facilities in Austria, which are in accordance with the new Austrian concept. METHODS: We used the RAND/NPCRDC method for the development and selection of the quality indicators. We conducted systematic literature searches for existing measures in international databases for quality indicators as well as in bibliographic databases. All retrieved measures were evaluated and rated by an expert panel in a 2-step process regarding relevance and feasibility. RESULTS: Overall, the literature searches yielded 281 potentially relevant quality indicators, which were summarized to 65 different quality measures for primary health care. Out of these, the panel rated and accepted 30 measures as relevant and feasible for use in Austria. Five of these indicators were structure measures, 14 were process measures and the remaining 11 were outcome measures. Based on the Austrian primary health care concept, the final set of quality indicators was grouped in the 5 following domains: Access to primary health care (5), quality of care (15), continuity of care (5), coordination of care (4), and safety (1). CONCLUSION: This set of quality measures largely covers the four defined functions of primary health care. It enables standardized evaluation of primary health care facilities in Austria regarding the implementation of the Austrian primary health care concept as well as improvement in healthcare of the population.

Short-acting insulin analogues versus regular human insulin for adult, non-pregnant persons with type 2 diabetes mellitus.

BACKGROUND: The use of short-acting insulin analogues (insulin lispro, insulin aspart, insulin glulisine) for adult, non-pregnant people with type 2 diabetes is still controversial, as reflected in many scientific debates. OBJECTIVES: To assess the effects of short-acting insulin analogues compared to regular human insulin in adult, non-pregnant people with type 2 diabetes mellitus. SEARCH METHODS: For this update we searched CENTRAL, MEDLINE, Embase, the WHO ICTRP Search Portal, and ClinicalTrials.gov to 31 October 2018. We placed no restrictions on the language of publication. SELECTION CRITERIA: We included all randomised controlled trials with an intervention duration of at least 24 weeks that compared short-acting insulin analogues to regular human insulin in the treatment of people with type 2 diabetes, who were not pregnant. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. We assessed dichotomous outcomes by risk ratios (RR), and Peto odds ratios (POR), with 95% confidence intervals (CI). We assessed continuous outcomes by mean differences (MD) with 95% CI. We assessed trials for certainty of the evidence using the GRADE approach. MAIN RESULTS: We identified 10 trials that fulfilled the inclusion criteria, randomising 2751 participants; 1388 participants were randomised to receive insulin analogues and 1363 participants to receive regular human insulin. The duration of the intervention ranged from 24 to 104 weeks, with a mean of about 41 weeks. The trial populations showed diversity in disease duration, and inclusion and exclusion criteria. None of the trials were blinded, so the risk of performance bias and detection bias, especially for subjective outcomes, such as hypoglycaemia, was high in nine of 10 trials from which we extracted data. Several trials showed inconsistencies in the reporting of methods and results.None of the included trials defined all-cause mortality as a primary outcome. Six trials provided Information on the number of participants who died during the trial, with five deaths out of 1272 participants (0.4%) in the insulin analogue groups and three deaths out of 1247 participants (0.2%) in the regular human insulin groups (Peto OR 1.66, 95% CI 0.41 to 6.64; P = 0.48; moderate-certainty evidence). Six trials, with 2509 participants, assessed severe hypoglycaemia differently, therefore, we could not summarise the results with a meta-analysis. Overall, the incidence of severe hypoglycaemic events was low, and none of the trials showed a clear difference between the two intervention arms (low-certainty evidence).The MD in glycosylated haemoglobin A1c (HbA1c) change was -0.03% (95% CI -0.16 to 0.09; P = 0.60; 9 trials, 2608 participants; low-certainty evidence). The 95% prediction ranged between -0.31% and 0.25%. The MD in the overall number of non-severe hypoglycaemic episodes per participant per month was 0.08 events (95% CI 0.00 to 0.16; P = 0.05; 7 trials, 2667 participants; very low-certainty evidence). The 95% prediction interval ranged between -0.03 and 0.19 events per participant per month. The results provided for nocturnal hypoglycaemic episodes were of questionable validity. Overall, there was no clear difference between the two short-acting insulin analogues and regular human insulin. Two trials assessed health-related quality of life and treatment satisfaction, but we considered the results for both outcomes to be unreliable (very low-certainty evidence).No trial was designed to investigate possible long term effects (all-cause mortality, microvascular or macrovascular complications of diabetes), especially in participants with diabetes-related complications. No trial reported on socioeconomic effects. AUTHORS' CONCLUSIONS: Our analysis found no clear benefits of short-acting insulin analogues over regular human insulin in people with type 2 diabetes. Overall, the certainty of the evidence was poor and results on patient-relevant outcomes, like all-cause mortality, microvascular or macrovascular complications and severe hypoglycaemic episodes were sparse. Long-term efficacy and safety data are needed to draw conclusions about the effects of short-acting insulin analogues on patient-relevant outcomes.

[Development of methods to evaluate nephrological screening and support measures, and lessons learned from the Styrian nephrological screening program "niere.schützen"]. / Entwicklung von Evaluationsmöglichkeiten für nephrologische Screening- und Betreuungsmaßnahmen und lessons learned aus dem nephrologischen Früherkennungs-Programm "niere.schützen" des Landes Steiermark.

Throughout the world, the incidence and prevalence of patients with chronic kidney disease have been steadily rising. In 2016, the Styrian nephrology awareness program "niere.schützen" ("Kidney Protection") was launched to early identify patients with renal insufficiency. The aim of this study was to search for existing international nephrological screening and support programs in order to identify possible evaluation parameters and concepts for niere.schützen. A search in MEDLINE® revealed five relevant international programs from four countries. These differed from one another with respect to the population to be screened, the screening method and the support measures. All the programs involved the transparent documentation of patient data, and allowed for disease monitoring, as well as the impact of specific measures on assessed parameters and variables (laboratory data, participation rates) to be determined. Depending on the data sources employed and the availability and comprehensiveness of additional documentation, three evaluation methods of different informative value were developed. The first method requires no participant labelling, while the second and third methods require the participants to be assigned to a particular program. With the third method, the documentation also needs to be conducted in line with a disease management program. Considering that the speedy implementation of the niere.schützen program is desired for political reasons, the only practical method is the first one as it does not entail patient documentation and only involves the evaluation of process parameters.

Choosing Wisely: assessment of current US top five list recommendations' trustworthiness using a pragmatic approach.

OBJECTIVES: Identification of sufficiently trustworthy top 5 list recommendations from the US Choosing Wisely campaign. SETTING: Not applicable. PARTICIPANTS: All top 5 list recommendations available from the American Board of Internal Medicine Foundation website. MAIN OUTCOME MEASURES/INTERVENTIONS: Compilation of US top 5 lists and search for current German highly trustworthy (S3) guidelines. Extraction of guideline recommendations, including grade of recommendation (GoR), for suggestions comparable to top 5 list recommendations. For recommendations without guideline equivalents, the methodological quality of the top 5 list development process was assessed using criteria similar to that used to judge guidelines, and relevant meta-literature was identified in cited references. Judgement of sufficient trustworthiness of top 5 list recommendations was based either on an 'A' GoR of guideline equivalents or on high methodological quality and citation of relevant meta-literature. RESULTS: 412 top 5 list recommendations were identified. For 75 (18%), equivalents were found in current German S3 guidelines. 44 of these recommendations were associated with an 'A' GoR, or a strong recommendation based on strong evidence, and 26 had a 'B' or a 'C' GoR. No GoR was provided for 5 recommendations. 337 recommendations had no equivalent in the German S3 guidelines. The methodological quality of the development process was high and relevant meta-literature was cited for 87 top 5 list recommendations. For a further 36, either the methodological quality was high without any meta-literature citations or meta-literature citations existed but the methodological quality was lacking. For the remaining 214 recommendations, either the methodological quality was lacking and no literature was cited or the methodological quality was generally unsatisfactory. CONCLUSIONS: 131 of current US top 5 list recommendations were found to be sufficiently trustworthy. For a substantial number of current US top 5 list recommendations, their trustworthiness remains unclear. Methodological requirements for developing top 5 lists are recommended.

Short-acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus.

BACKGROUND: Short-acting insulin analogue use for people with diabetes is still controversial, as reflected in many scientific debates. OBJECTIVES: To assess the effects of short-acting insulin analogues versus regular human insulin in adults with type 1 diabetes. SEARCH METHODS: We carried out the electronic searches through Ovid simultaneously searching the following databases: Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R) (1946 to 14 April 2015), EMBASE (1988 to 2015, week 15), the Cochrane Central Register of Controlled Trials (CENTRAL; March 2015), ClinicalTrials.gov and the European (EU) Clinical Trials register (both March 2015). SELECTION CRITERIA: We included all randomised controlled trials with an intervention duration of at least 24 weeks that compared short-acting insulin analogues with regular human insulins in the treatment of adults with type 1 diabetes who were not pregnant. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed trials for risk of bias, and resolved differences by consensus. We graded overall study quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) instrument. We used random-effects models for the main analyses and presented the results as odds ratios (OR) with 95% confidence intervals (CI) for dichotomous outcomes. MAIN RESULTS: We identified nine trials that fulfilled the inclusion criteria including 2693 participants. The duration of interventions ranged from 24 to 52 weeks with a mean of about 37 weeks. The participants showed some diversity, mainly with regard to diabetes duration and inclusion/exclusion criteria. The majority of the trials were carried out in the 1990s and participants were recruited from Europe, North America, Africa and Asia. None of the trials was carried out in a blinded manner so that the risk of performance bias, especially for subjective outcomes such as hypoglycaemia, was present in all of the trials. Furthermore, several trials showed inconsistencies in the reporting of methods and results.The mean difference (MD) in glycosylated haemoglobin A1c (HbA1c) was -0.15% (95% CI -0.2% to -0.1%; P value < 0.00001; 2608 participants; 9 trials; low quality evidence) in favour of insulin analogues. The comparison of the risk of severe hypoglycaemia between the two treatment groups showed an OR of 0.89 (95% CI 0.71 to 1.12; P value = 0.31; 2459 participants; 7 trials; very low quality evidence). For overall hypoglycaemia, also taking into account mild forms of hypoglycaemia, the data were generally of low quality, but also did not indicate substantial group differences. Regarding nocturnal severe hypoglycaemic episodes, two trials reported statistically significant effects in favour of the insulin analogue, insulin aspart. However, due to inconsistent reporting in publications and trial reports, the validity of the result remains questionable.We also found no clear evidence for a substantial effect of insulin analogues on health-related quality of life. However, there were few results only based on subgroups of the trial populations. None of the trials reported substantial effects regarding weight gain or any other adverse events. No trial was designed to investigate possible long-term effects (such as all-cause mortality, diabetic complications), in particular in people with diabetes related complications. AUTHORS' CONCLUSIONS: Our analysis suggests only a minor benefit of short-acting insulin analogues on blood glucose control in people with type 1 diabetes. To make conclusions about the effect of short acting insulin analogues on long-term patient-relevant outcomes, long-term efficacy and safety data are needed.

Validation and reliability of a guideline appraisal mini-checklist for daily practice use.

BACKGROUND: The use of comprehensive instruments for guideline appraisal is time-consuming and requires highly qualified personnel. Since practicing physicians are generally busy, the rapid-assessment Mini-Checklist (MiChe) tool was developed to help them evaluate the quality and utility of guidelines quickly. The aim of this study was to validate the MiChe in comparison to the AGREE II instrument and to determine its reliability as a tool for guideline appraisal. METHODS: Ten guidelines that are relevant to general practice and had been evaluated by 2 independent reviewers using AGREE II were assessed by 12 GPs using the MiChe. The strength of the correlation between average MiChe ratings and AGREE II total scores was estimated using Pearson's correlation coefficient. Inter-rater reliability for MiChe overall quality ratings and endorsements was determined using intra-class correlations (ICC) and Kendall's W for ordinal recommendations. To determine the GPs' satisfaction with the MiChe, mean scores for the ratings on five questions were computed using a six-point Likert scale. RESULTS: The study showed a high level of agreement between MiChe and AGREE II in the quality rating of guidelines (Pearson's r = 0.872; P < 0.001). Inter-rater-reliability for overall MiChe ratings (ICC = 0.755; P < 0.001) and endorsements (Kendall's W = 0.73; P < 0.001) were high. The mean time required for guideline assessment was less than 15 min und user satisfaction was generally high. CONCLUSIONS: The MiChe performed well in comparison to AGREE II and is suitable for the rapid evaluation of guideline quality and utility in practice. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00007480.

Long-term effects of weight-reducing diets in people with hypertension.

BACKGROUND: All major guidelines for antihypertensive therapy recommend weight loss. Thus dietary interventions that aim to reduce body weight might be a useful intervention to reduce blood pressure and adverse cardiovascular events associated with hypertension. OBJECTIVES: Primary objectivesTo assess the long-term effects of weight-reducing diets in people with hypertension on all-cause mortality, cardiovascular morbidity, and adverse events (including total serious adverse events, withdrawal due to adverse events, and total non-serious adverse events). Secondary objectivesTo assess the long-term effects of weight-reducing diets in people with hypertension on change from baseline in systolic blood pressure, change from baseline in diastolic blood pressure, and body weight reduction. SEARCH METHODS: We obtained studies from computerised searches of the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Hypertension Specialised Register, Ovid MEDLINE, and Ovid EMBASE, and from searches in reference lists, systematic reviews, and the clinical trials registry ClinicalTrials.gov (status as of 2 February 2015). SELECTION CRITERIA: We included randomised controlled trials (RCTs) of at least 24 weeks' duration that compared weight-reducing dietary interventions to no dietary intervention in adults with primary hypertension. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and extracted data. We pooled studies using fixed-effect meta-analysis. In case of moderate or larger heterogeneity as measured by Higgins I(2), we used a random-effects model. MAIN RESULTS: This review update did not reveal any new studies, so the number of included studies remained the same: 8 studies involving a total of 2100 participants with high blood pressure and a mean age of 45 to 66 years. Mean treatment duration was 6 to 36 months. We judged the risk of bias as unclear or high for all but two trials. No study included mortality as a predefined outcome. One RCT evaluated the effects of dietary weight loss on a combined endpoint consisting of the necessity of reinstating antihypertensive therapy and severe cardiovascular complications. In this RCT, weight-reducing diet lowered the endpoint compared to no diet: hazard ratio 0.70 (95% confidence interval (CI), 0.57 to 0.87). None of the studies evaluated adverse events as designated in our protocol. There was low-quality evidence for a blood pressure reduction in participants assigned to weight loss diets as compared to controls: systolic blood pressure: mean difference (MD) -4.5 mm Hg (95% CI -7.2 to -1.8 mm Hg) (3 of 8 studies included in analysis), and diastolic blood pressure: MD -3.2 mm Hg (95% CI -4.8 to -1.5 mm Hg) (3 of  8  studies included in analysis). There was moderate-quality evidence for weight reduction in dietary weight loss groups as compared to controls: MD -4.0 kg (95% CI -4.8 to -3.2) (5 of 8 studies included in analysis). Two studies used withdrawal of antihypertensive medication as their primary outcome. Even though we did not consider this a relevant outcome for our review, the results of these studies strengthen the finding of reduction of blood pressure by dietary weight loss interventions. AUTHORS' CONCLUSIONS: In this update, the conclusions remain the same, as we found no new trials. In people with primary hypertension, weight loss diets reduced body weight and blood pressure, however the magnitude of the effects are uncertain due to the small number of participants and studies included in the analyses. Whether weight loss reduces mortality and morbidity is unknown. No useful information on adverse effects was reported in the relevant trials.