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Background: Programmes based on the World Health Organization's Health Promoting Schools framework (HPS) have been implemented in several countries but for evidence-based policy-making more research is required to determine the effectiveness of the HPS approach.Methods: We conducted a cluster randomised controlled trial. The units of randomisation were primary school classes recruited in May 2010. Eligible participants were Year 3 primary school classes in Lower Austria that had not participated in a similar programme during the last two years. After baseline assessment in September 2010, 53 classes from 45 primary schools in Lower Austria were randomly assigned to an intervention (n = 26 classes, 432 children) or waiting control arm (n = 27 classes, 493 children aged 8.7 years +/- 4 months). Over the course of 1.5 academic years, participating teachers received on-the-job training (20 h) and two workshops (8 h) to promote health related behaviour in students such as physical activity during the school day and to improve the quality of regular physical education classes. We assessed 15 outcomes grouped into five categories: Emotional and Social Experience in School, Physical Activity, Well-being, and Attention Performance measured by validated and standardised questionnaire and Motor Skills measured by validated and standardised motoric and coordination tests in the school gym. The primary outcome was Classroom Climate and part of the outcomecategory Emotional and Social Experience in School. The final assessment took place in April 2012. All assessors were blinded to the allocation of classes. Multilevel growth modelling was used to investigate programme effectiveness.Results: We could not detect any statistically significant differences between groups for the outcomecategories Emotional and Social Experience in school (p = 0.22 to 0.78), Physical Activity, Well-being, and Attention Performance. Significant differences between groups were limited to the outcomecategory Motor Skills (Complex Reaction Ability, Spatial Orientation Skills, Coordination with Precision) which were higher in the intervention group (P < .05).Conclusions: Despite small statistically significant differences in Motor Skills, our study could not detect any clinically relevant improvements in the Emotional and Social Experience at School (including the primary outcome ClassroomClimate), Physical Activity, Well-being, Motor Skills and Attention Performance of students.Trial Registration: German register of clinical studies: DRKS00000622 . Retrospectively registered: 03.12.2010. Approved by the Ethics Committee of Lower Austria (GS4-EK-4/107-2010). [ABSTRACT FROM AUTHOR]

Background: Early childhood is a time during which a child's habits are formed and family lifestyle habits are open to changes and adaptations., Objective: This guideline provides recommendations on the amount of time during the 24 hours of a day that young children, under 5 years of age, should spend being physically active or sleeping for their health and wellbeing., Method: The guideline was developed by the World Health Organization (WHO) in accordance with WHO standards. The summary was translated into German by employees of the WHO Collaborating Center at Danube University Krems (Austria)., Results and Conclusion: A day consists of sleep time, sedentary time and physical activity of light, moderate or vigorous intensity. Young children should have opportunities to participate in a range of developmentally appropriate, safe, enjoyable play-based physical activities., Competing Interests: Gerald Gartlehner und Barbara Nußbaumer-Streit haben in den letzten 3 Jahren von der Weltgesundheitsorganisation (WHO) Honorare für das Abhalten von GRADE Workshops erhalten., (Thieme. All rights reserved.)

Background: Despite considerable progress in the fight against tuberculosis, it is still the most deadly bacterial infectious disease worldwide. Every year, up to 10 million people worldwide still die of tuberculosis. The World Health Assembly has set itself the goal of reducing the number of tuberculosis deaths by 90% and the number of new infections by 80% by 2030. Prevention and infection control measures in public health facilities and wherever the risk of transmission of the tuberculosis bacterium "Mycobacterium tuberculosis" is high are especially important., Objective: The aim of the guideline is to provide updated and evidence-based recommendations for public health measures to prevent the spread of the tuberculosis bacterium in clinical settings and in tuberculosis management., Methodology: The World Health Organization (WHO) developed these recommendations according to the methods outlined in the WHO handbook for guideline development. This publication is a summary of the most important aspects of this guideline translated into German by members of the WHO Collaborating Centre at the Danube University Krems (Austria)., Results: This guideline takes into account the current evidence base and provides recommendations and comments on the implementation of tuberculosis prevention and control measures at the level of health care institutions and at the national level., Competing Interests: Gerald Gartlehner und Barbara Nußbaumer-Streit haben in den letzten drei Jahren von der Weltgesundheitsorganisation (WHO) Honorare für das Abhalten von GRADE Workshops erhalten., (Thieme. All rights reserved.)

Background: Many clinical trials have assessed treatments for depressive disorders and bipolar depression. However, whether, and which, assessed outcome domains really matter to patients, informal caregivers, and health-care professionals remains unclear., Methods: We did an international online survey in French, German, and English. Participants were adult patients with a history of depression, informal caregivers, and health-care professionals, recruited by purposeful sampling. To identify outcome domains, participants answered four open-ended questions about their expectations for depression treatment. We disseminated the survey without restriction via social media, patient and professional associations, and a media campaign. Four researchers independently did qualitative content analyses. We assessed data saturation using mathematical models to ensure the comprehensive identification of outcome domains., Findings: Between April 5, 2018, and Dec 10, 2018, 1912 patients, 464 informal caregivers, and 627 health-care professionals from 52 countries provided 8183 open-ended answers. We identified 80 outcome domains related to symptoms (64 domains), such as mental pain (or psychological or psychic pain, 523 [17%] of 3003 participants) and motivation (384 [13%]), and functioning (16 domains), such as social isolation (541 [18%]). We identified 57 other outcome domains regarding safety of treatment, health care organisation, and social representation, such as stigmatisation (408 [14%])., Interpretation: This study provides a list of outcome domains important to patients, informal caregivers, and health-care professionals. Unfortunately, many of these domains are rarely measured in clinical trials. Results from this study should set the foundation for a core outcome set for depression., Funding: Fondation pour la Recherche Medicale and NIHR Oxford Health Biomedical Research Centre., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: COVID-19 (coronavirus disease 2019) is a new, rapidly emerging zoonotic infectious disease, that was reported to the World Health Organization for the first time on 31 December 2019. Currently, no effective pharmacological interventions or vaccines are available to treat or prevent COVID-19, therefore nonpharmacological public health measures are more in focus., Objectives: The aim was to assess the effects of quarantine - alone or in combination with other measures - during coronavirus outbreaks., Methods: Because of the current COVID-19 pandemic, WHO commissioned a rapid review. To save time, the method of systematic reviews was slightly and with caution modified. This publication is a summary of the most important aspects of the rapid review, translated into German by members of the WHO Collaborating Centre at the Danube University Krems (Austria)., Results: Overall, 29 studies were included. Ten modeling studies focused on COVID-19, 4 observational studies and 15 modeling studies focused on SARS and MERS. The modeling studies consistently reported a benefit of the simulated quarantine measures. For example, the models estimated that quarantine of people exposed to confirmed or suspected cases of COVID-19 prevented between 44 and 81% of the cases that would otherwise have happened and 31 to 63% of the deaths, when compared to no such measures. In regard to costs, the earlier the quarantine measures are implemented, the greater the cost savings will be., Conclusion: Our confidence in the evidence is very limited. This is mainly because the COVID-19 studies based their models on the limited data that have been available in the early weeks of the pandemic and made different assumptions about the virus. The studies of SARS and MERS are not completely generalizable to COVID-19. Despite only having limited evidence, all the studies found quarantine to be important for controlling the spread of severe coronavirus diseases. Looking to the coming months, in order to maintain the best possible balance of measures, decision makers must continue to constantly monitor the outbreak situation and the impact of the measures they implement., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Breastfeeding is one of the foundations of child health, development, and survival. Despite extensive evidence that lack of breastfeeding is associated with higher mortality rates and other long-term negative health outcomes, less than half of all babies under the age of 6 months are breastfed worldwide. Breastfeeding counselling is one of the key interventions, to improve breastfeeding rates., Aim: The objective of this guideline is to give recommendations on how to implement breastfeeding counselling to improve breastfeeding practices., Methods: This guideline was developed by the World Health Organization (WHO) according to the methods outlined in the WHO handbook for guideline development. This publication is a summary of the most important aspects of this guideline translated into German by members of the WHO Collaborating Centre at the Danube University Krems (Austria)., Results/conclusions: This guideline is based on current evidence and gives recommendations and makes comments on the implementation of breastfeeding counselling, such as frequency, timing, or mode and provider of breastfeeding counselling to improve breastfeeding practices. The scope of the guideline is limited to this intervention., Competing Interests: Gerald Gartlehner und Barbara Nußbaumer-Streit haben in den letzten drei Jahren von der Weltgesundheitsorganisation (WHO) Honorare für das Abhalten von GRADE-Workshops erhalten., (© Georg Thieme Verlag KG Stuttgart · New York.)

The Austrian periodic health examination (PHE) was introduced in 1974 as a health insurance benefit and was redesigned for the last time in 2005. Therefore, the aim of this work was to revise the scientific basis of the PHE using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. We updated the scientific evidence of examinations and consultations that are currently part of the PHE and searched and integrated new examinations. We assessed the expectations of the population towards the PHE in three focus groups. A panel of experts developed evidence-based recommendations for the revised PHE. They formulated 26 recommendations on 20 target diseases or risk factors. In comparison to the previous PHE, the panel added screening for abdominal aortic aneurysm, osteoporotic fracture risk, and chronic kidney disease to the recommendations, while screening for asymptomatic bacteriuria, screening for iron deficiency/pernicious anaemia, and risk identification of glaucoma should no longer be included.

Background: The engagement of citizens in the development of evidence-based screening programs is internationally supported. The aim of our research was to explore the motivations and reasons of adult citizens in Austria for attending periodic health examinations (PHE) as well as their satisfaction with the way PHE are organized., Methods: We conducted three focus groups with a random sample of previous attenders of PHE. Participants were stratified by age, gender, and education. The discussions were recorded, transcribed, and analyzed using a thematic analysis approach., Results: Main motivations of attenders (n = 30) were to detect diseases early, to prevent suffering, and to live a long, healthy life. They believed that PHE work as an incentive of health behavior change. As possible reasons not to attend PHE, participants mentioned lack of awareness, time constraints, unpleasant prior experiences, and fear of harm or negative consequences. They wanted the range of examinations to be selected based on individual risks and to be more comprehensive. Some participants expressed frustration with the lack of time doctors dedicated to the examination or discussion of the results. Throughout the discussion, participants realized there is a great diversity among doctors in the quality of health examinations and how content is delivered., Conclusion: The study showed that attenders of PHE have high expectations concerning the beneficial outcomes of PHE. They requested a comprehensive and individualized program that does not reflect the scientific evidence from effectiveness studies of PHE. These findings indicate serious shortcomings in the communication of benefits and harms of screening interventions and highlight the need for a more proactive communication about aims and content of the program.

The development of evidence-based guidelines is an interdisciplinary process in which methodologists play an important role. In addition to creating new or assessing existing systematic reviews as a basis for evidence-based decision making, methodologists can support the entire development process. Due to the increasing complexity of methods and the information overload of available publications, cooperation between the involved experts (especially clinicians and methodologists, but also patient representatives) is essential in order to develop reliable, acceptable and practical guidelines. This article looks at eight key points of the guideline development process (transparency, conflicts of interest, composition of guideline development group, establishing evidence foundation, development and formulation of recommendations, external review and updating) from the perspective of methodologists, and highlights problems, challenges and solution approaches. The earliest possible involvement of methodologists, a clear and a--for non-methodologists--understandable presentation of the best available evidence, the integration of methodologists in the creation and formulation of recommendations (systematic, evidence-based decision-making process) and cooperation between the participating experts are essential to improve the development process of evidence-based guidelines., (Copyright © 2015. Published by Elsevier GmbH.)

We rated the body of evidence for 219 health-related questions that had been covered by 990 media articles in Austrian print and online media. In 59.5 % of these articles, the evidence for medical facts is reported in a highly distorted (exaggerated or understated) manner; only 10.8 % adequately reflect the actual strength of evidence. While 61.3% of the articles imply that the reported effects are based on the highest level of evidence, it really only applies to 2.6% of the articles. Compared to quality media, tabloid media report in a more distorted way. However, this is mainly due to a different subject coverage, since the degree of distorted reporting does not significantly differ for subjects covered by both tabloid and quality media. Online media do not report in a more distorted way than print media, with the exception of the newspaper "Der Standard". A clear difference can be seen in the reporting on different subjects. Articles on medications regulated by governmental authorities or interventions which only physicians are allowed to perform were significantly less distorted than articles on nutritional supplements or interventions that may be provided by non-physician staff. Reports on cosmetic or weight loss interventions were most distorted., (Copyright © 2015. Published by Elsevier GmbH.)

Background: Evidence-based information materials about the pros and cons of cancer screening are important sources for men and women to decide for or against cancer screening. The aim of this paper was to compare recommendations from different cancer institutions in German-speaking countries (Austria, Germany, and Switzerland) regarding screening for breast, cervix, colon, and prostate cancer and to assess the quality and development process of patient information materials., Methods: Relevant information material was identified through web searches and personal contact with cancer institutions. To achieve our objective, we employed a qualitative approach. The quality of 22 patient information materials was analysed based on established guidance by Bunge et al. In addition, we conducted guided interviews about the process of developing information materials with decision-makers of cancer institutes., Results: Overall, major discrepancies in cancer screening recommendations exist among the Austrian, German, and Swiss cancer institutes. Process evaluation revealed that crucial steps of quality assurance, such as assembling a multi-disciplinary panel, assessing conflicts of interest, or transparency regarding funding sources, have frequently not been undertaken. All information materials had substantial quality deficits in multiple areas. Three out of four institutes issued information materials that met fewer than half of the quality criteria., Conclusion: Most patient information materials of cancer institutes in German-speaking countries are fraught with substantial deficits and do not provide an objective source for patients to be able to make an informed decision for or against cancer screening., (Copyright © 2015. Published by Elsevier GmbH.)

The most common reason for rating up the quality of evidence is a large effect. GRADE suggests considering rating up quality of evidence one level when methodologically rigorous observational studies show at least a two-fold reduction or increase in risk, and rating up two levels for at least a five-fold reduction or increase in risk. Systematic review authors and guideline developers may also consider rating up quality of evidence when a dose-response gradient is present, and when all plausible confounders or biases would decrease an apparent treatment effect, or would create a spurious effect when results suggest no effect. Other considerations include the rapidity of the response, the underlying trajectory of the condition and indirect evidence., (Copyright © 2013. Published by Elsevier GmbH.)

Aim: To investigate lifestyle intervention effects and cost-effectiveness of a structured 6-month exercise and nutrition program for individuals at high risk for cardiovascular disease., Methods: Uncontrolled before and after study with assessments at baseline and six months. Adults without existing cardiovascular disease (CVD) but at increased CVD risk were eligible. The analysis was done by intention-to-treat (last-observation-carried-forward). Incremental cost-effectiveness analysis was performed. Main outcome measures were changes in cardiovascular risk-factors (blood pressure, weight, body-mass index, serum lipids, blood glucose, smoking cessation, and exercise) and health-related quality of life., Results: A total of 356 adults (70.5% female; mean age 48.9 years; mean body mass index 32.4; drop-out 10.4%) participated. At 6 months significant favorable effects were observed in several cardiovascular risk outcomes, exercise behaviour and health related quality of life. At an average incremental cost per life year saved for the ITT-population of 22.474 the program can be considered cost-effective.

The debate surrounding whether the findings of efficacy studies are applicable to real-world treatment situations is ongoing. The issue of lack of applicability due to a lack of clinical heterogeneity could be addressed by employing less restrictive inclusion criteria. Given that health economic assessments based on cost-effectiveness measures are required by many governments and insurance providers, the impact of this choice may be far reaching. The objective of this article was to explore the use of a pilot study to examine the impact of inclusion criteria on cost-effectiveness results and clinical heterogeneity. A health economic assessment was conducted using QRISK®2 and simulation modelling of different population groups within the pilot study in Lower Austria. Patients were referred by their family physicians to 'Active Prevention' (Vorsorge Aktiv), a community-based lifestyle intervention focused on exercise and nutritional programmes. Cardiovascular risk factors were recorded before and after the intervention and translated to cardiovascular events. As expected, enforcing restrictive inclusion criteria produced stronger and more irrefutable computations - in the expected number of events, the number of deaths, the incremental cost per life-year saved and in the 95% confidence interval. These findings provide insight into the issues surrounding clinical heterogeneity and the need for restrictive inclusion criteria. This is not a full health economic assessment of the intervention. While inclusion criteria provide stronger results by limiting populations to those who would benefit the most, they must be enforced, both within and outside the clinical trial setting. Enforcement has costs, both monetary and arising from unintended negative consequences of enforcement mechanisms. All these considerations will affect the results realized by the payer organization. A pilot study can reveal whether an intervention may be cost effective 'enough' without restrictive inclusion criteria and can enable researchers to search for population subgroups in which the intervention remains cost effective. When the pilot study does not indicate sufficiently strong cost-effectiveness results, the broader trade-offs between clinical heterogeneity and the strength of the submission package to the reimbursement agency can be discussed by all parties. Payer concerns about the ability to generalize the results beyond the clinical trial can also be discussed at this time. Applicability then depends on the ability to enforce inclusion criteria similar to those used in the trials in the real world.

Background: Currently, the available evidence regarding the net benefits of prostate cancer screening with PSA (prostate-specific antigen) tests is unclear. Therefore, international guidelines do not recommend PSA-screening on a regular basis for men. Because of the unclear evidence, guidelines emphasize the importance of shared decision-making. Shared decision-making, however, requires that balanced and evidence-based information is available for those who take PSA-screening into consideration. The aim of this paper was to evaluate all in Austria available patient information materials on PSA-screening with regard to their evidence-based content and their potential to facilitate informed decision-making., Methods: To get information materials, we contacted a wide variety of public, industry, and academic institutions, professional organisations, patient advocacy groups, and other organisations that are concerned with prostate cancer screening in Austria. Two persons independently evaluated the quality of each information product based on adapted criteria of the UK (United Kingdom) General Medical Council., Results: We evaluated a total of 17 information leaflets. Not a single brochure fulfilled all of the criteria necessary for informed decision-making. More than half fulfilled less than 50% of the recommended criteria. All of the analysed leaflets provided information about the benefits of screening, while only 35% mentioned the possibility of harms caused by screening., Conclusions: To date, Austrian patient information materials on PSA-screening do not meet international standards. Therefore, they cannot serve as a balanced and objective information base for informed decision-making.

The assessment of the balance between benefits and harms of population-based interventions faces both methodological and practical difficulties. This paper uses the example of cancer screening to outline existing challenges such as the consideration of outcomes that occur at substantially different times, or the lack of direct evidence which can lead to false conclusions and adverse health effects for healthy individuals undergoing screening. Sometimes not even sound evidence provides clear answers about the benefits and harms of preventive interventions. This is why informed decision-making is a particularly important step for individuals taking preventive interventions into consideration. Due to the lack of a clear answer to the question of benefits and harms from scientific evidence, individuals' attitudes and values may become a decisive factor. Studies, however, indicate that the prerequisite for informed decision making, namely objective and balanced information about benefits and harms, is often missing., (Copyright © 2011. Published by Elsevier GmbH.)

Despite the large availability of diagnostic tests and procedures and their importance to medicine, evidence for their appropriate use is often limited. Unfortunately, the evaluation of tests is difficult and susceptible to several forms of bias. This paper describes the standard methods for characterizing and comparing the accuracy of diagnostic tests and addresses initiatives such as STARD and QUADAS to improve the quality of diagnostic studies. We inform the reader how to critically appraise the study results and when to rely on the results of diagnostic accuracy studies or randomised clinical trials.

The evaluation of health interventions has become internationally known as Health Technology Assessment (HTA) and has received increased attention as an instrument for supporting policy decisions in health care in recent years. HTA is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of new, and established health interventions in a systematic, transparent, unbiased, robust manner. HTA strives to provide pertinent information to help formulate safe and effective health policies that focus on the patient while aiming to achieve the best use of assets available.

Over the past years, systematic reviews and meta-analyses have led to significant changes in clinical medicine and health policy. To date, they can be viewed as the most objective instruments to answer clinical as well health policy questions. In addition, systematic reviews are an important tool to synthesize the enormous amount of new medical knowledge into a manageable format. Nevertheless, the methodological quality of published systematic reviews and meta-analyses varies and biased results can be misleading. Therefore, it is important for readers of systematic reviews to critically evaluate the underlying methods, to be able to assess the validity of their findings. This manuscript is part of a methods series of the Wiener Medizinische Wochenschrift. It summarizes the methodological hallmarks of systematic reviews and meta-analyses to provide readers with the methodological background necessary to critically evaluate systematic reviews and meta-analyses.