[WHO Guidelines on Mental Health at Work]. / WHO-Leitlinie zur psychischen Gesundheit am Arbeitsplatz.

The World Health Organization (WHO) published the "Guidelines on mental health at work" in September 2022. WHO developed the guidelines in accordance with WHO standards. The summary of this guideline was translated into German by the team of the WHO Collaborating Center for Evidence-based Medicine at the University for Continuing Education Krems (Austria) for use in German-speaking countries. An estimated 15+% of working-age adults have had some mental disorder at some point of time in their lives. This can lead to impaired capacity to work, resulting in reduction in productivity and performance, and ability to work safely, or in difficulties in retaining their jobs or obtaining gainful employment. The guidelines contain 12 recommendations. These provide evidence-based global public health guidance on organizational interventions, manager and worker training, and individual interventions for the promotion of positive mental health and prevention of mental health conditions, as well as recommendations on returning to work following absence associated with mental health conditions and gaining employment for people living with mental health conditions. Through the provision of these WHO recommendations, it is anticipated that the guidelines will facilitate national and workplace-level actions in the areas of policy development, service planning and delivery in the domains of mental and occupational health.

Medication Apps - A Systematic Search and Classification.

The landscape of mobile health applications is evolving rapidly. This includes a growing set of medication-related health apps. Keeping track of the functional diversity in medication apps is a challenge for both practitioners and regulators, limiting the scope of innovative use of digital technologies in healthcare service delivery. In this paper, we present the results of a systematic search and functional classification of medication apps. We combine this with a discussion of the current and future landscape of regulation and reimbursement decision-making. We show that a majority of apps offers a cluster of functions including medication information, interaction checks and/or medication plans. The number of apps in the functional categories most affected by the Medical Device Regulation (identification, dosage, monitoring) is still low. This suggests that there is a window of opportunity for public sector decision-making on quality criteria.

Efficacy Assessment of Radiofrequency Ablation as a Palliative Pain Treatment in Patients with Painful Metastatic Spinal Lesions: A Systematic Review.

BACKGROUND: Metastatic spinal lesions are difficult-to-treat entities that are most commonly associated with pain and severely reduced health-related quality of life (HRQoL). Within the last 5 to 10 years, radiofrequency ablation (RFA) has emerged as an option in the palliative treatment of vertebral metastases. OBJECTIVES: Our review aims to evaluate the clinical effectiveness and safety of RFA, mostly in combination with vertebroplasty, in patients with painful vertebral metastases. STUDY DESIGN: The design of this study is a systematic review. METHODS: We conducted a systematic literature search and a manual search of 5 databases in December 2016. The review applied a methodological framework based on the HTA Core Model®. Data on each selected outcome category were synthesized according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) scheme. Risk of bias was assessed using the Institute of Health Economics (IHE) Risk of Bias checklist for case series. RESULTS: We identified 299 citations. After applying the inclusion criteria, a total of 9 studies (4 prospective and 5 retrospective studies) were determined to be eligible. These studies included a total of 583 patients with vertebral metastases who were treated with RFA and, in most cases, received an additional vertebroplasty treatment (n = 437). The studies were categorized as having a moderate to high risk of bias. The strength of evidence was found to be "very low" for safety outcomes and could not be assessed for efficacy outcomes. Current evidence suggests that RFA leads to significant pain reduction. Furthermore, no major complications occurred when using RFA. LIMITATIONS: A major concern is the low number of included patients and heterogeneity of study characteristics in most of the studies. The low number of patients also impeded comparison of the effectiveness of RFA alone to RFA in combination with vertebroplasty. CONCLUSION: According to the available evidence, RFA may be safe and effective, especially for patients with painful vertebral metastases who show contraindications or unresponsiveness to conventional therapies (e.g., radiation) or for those who are at risk of tumor progression. KEY WORDS: Radiofrequency ablation, vertebral metastases, metastatic spinal lesions, pain, clinical effectiveness, safety, palliative pain treatment.

Thrombectomy for ischemic stroke: meta-analyses of recurrent strokes, vasospasms, and subarachnoid hemorrhages.

Mechanical thrombectomy with stent retrievers is an effective treatment for patients with ischemic stroke. Results of recent meta-analyses report that the treatment is safe. However, the endpoints recurrent stroke, vasospasms, and subarachnoid hemorrhage have not been evaluated sufficiently. Hence, we extracted data on these outcomes from the five recent thrombectomy trials (MR CLEAN, ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND IA published in 2015). Subsequently, we conducted meta-analyses for each outcome. We report the results of the fixed, as well as the random effects model. Three studies reported data on recurrent strokes. While the results did not reach statistical significance in the random effects model (despite a three times elevated risk), the fixed effects model revealed a significantly higher rate of recurrent strokes after thrombectomy. Four studies reported data on subarachnoid hemorrhage. The higher pooled rates in the intervention groups were statistically significant in both, the fixed and the random effects model. One study reported on vasospasms. We recorded 14 events in the intervention group and none in the control group. The efficacy of mechanical thrombectomy is not questioned, yet our results indicate an increased risk for recurrent strokes, subarachnoid hemorrhage, and vasospasms post-treatment. Therefore, we strongly recommend a thoroughly surveillance, concerning these adverse events in future clinical trials and routine registries.

[Practical experience with overviews of reviews--valuable decision aid or academic exercise?]. / Praxiserfahrungen mit Overviews of Reviews--wertvolle Entscheidungsunterstützung oder wissenschaftliche Fingerübung?

The "overview of reviews" has evolved as a method to aggregate information from systematic reviews. Based on research projects conducted by two Austrian institutions, this article aims to point out methods and perceived strengths and limitations of overviews of reviews and to discuss their application and constraints for different healthcare settings. The six analysed projects differed in their objectives as well as in the corresponding methodology. We identified the following strengths of the overviews of reviews performed: the overview of the evidence base on an issue, the rapid detection of the results of numerous reviews, the demonstration of evidence gaps and potential savings in time and resources. At the same time, the methodology could lead to a loss of information, limited relevance and to uncertainties regarding the robustness of the overall results. However, the heterogeneity of the methods used shows that the development of methods for overviews of reviews is still ongoing. Whether overviews of reviews provide valuable decision support depends on the research question and realistic expectations towards the method.

[Outcome quality in the mental health rehabilitation of children and adolescents ]. / Ergebnisqualität in der Mental Health Rehabilitation für Kinder und Jugendliche.

The range of mental health rehabilitation (MHR) available to children and adolescents with mental health disorders differs internationally. While MHR programs have been already implemented for this target group in Germany, in Austria such services are still in the planning phase. With regard to the quality assurance of potential MHR programs, however, ongoing evaluation approaches are needed already in the course of program design. This review focuses on indicators and measurement methods used in MHR program evaluations. Through a systematic literature search, we identified six studies providing information on five evaluation indicators (clinical symptoms, quality of life, functionality, rehabilitation progress, and rehabilitation satisfaction). By measuring these endpoints, the studies included mainly reported on instruments that had been used throughout different indication groups ("generic tools"). In addition to children and adolescents with mental-health disorders, the parents were usually also included in the evaluations. Thus, the self-assessments of the children and adolescents (e.g., regarding the development of behavioral problems and strengths) were complemented by external assessments. Most evaluation studies included several subsequent time-points of measurement ("longitudinal studies"). The indicators may play a central role in future evaluation projects, since their range of topics provides comprehensive insights into rehabilitation results. However, with regard to the measurement methods, the psychometric quality criteria require proper reviews and consideration.

Antenatal interventions to reduce preterm birth: an overview of Cochrane Systematic Reviews.

BACKGROUND: Several factors are associated with an increased risk of preterm birth (PTB); therefore, various interventions might have the potential to influence it. Due to the large number of interventions that address PTB, the objective of this overview is to summarise evidence from Cochrane reviews regarding the effects and safety of these different interventions. METHODS: We conducted a systematic literature search in the Cochrane Database of Systematic Reviews. Included reviews should be based on randomised controlled trials comparing antenatal non-pharmacological and pharmacological interventions that directly or indirectly address PTB with placebo/no treatment or routine care in pregnant women at less than 37 completed weeks of gestation without signs of threatened preterm labour. We considered PTB at less than 37 completed weeks of gestation as the primary outcome. RESULTS: We included 56 Cochrane systematic reviews. Three interventions increased PTB risk significantly. Twelve interventions led to a statistically significant lower incidence of PTBs. However, this reduction was mostly observed in defined at-risk subgroups of pregnant women. The remaining antenatal interventions failed to prove a significant effect on PTB < 37 weeks, but some of them at least showed a positive effect in secondary outcomes (e.g., reduction in early PTBs). As an unintended result of this review, we identified 28 additional Cochrane reviews which intended to report on PTB < 37 weeks, but were not able to find any RCTs reporting appropriate data. CONCLUSIONS: The possible effects of a diverse range of interventions on PTB have been evaluated in Cochrane systematic reviews. Few interventions have been demonstrated to be effective and a small number have been found to be harmful. For around half of the interventions evaluated, the Cochrane review concluded that there was insufficient evidence to provide sound recommendations for clinical practice. No RCT evidence is available for a number of potentially relevant interventions.

Recommendations from international clinical guidelines for routine antenatal infection screening: does evidence matter?

AIM: Maternal infections in pregnancy may cause severe child morbidity. In this article, we aim to summarise recommendations from international evidence-based clinical guidelines for infection screening in pregnancy. METHODS: We conducted a systematic search for evidence-based guidelines in two databases (Guidelines International Network and National Guideline Clearinghouse) and a hand search on websites of international institutions and societies that develop evidence-based guidelines. We considered guidelines published from the 1 of January 2007 onwards and developed in Western, industrialised countries. The guidelines in our analysis had to be based on a systematic literature search in at least two databases and needed to provide recommendations explicitly linked to the evidence. We included five general antenatal clinical practice guidelines from Australia, UK and the United States and 20 disease-specific guidelines published by Canadian, German, UK and US guideline development groups. RESULTS: The comparison of evidence-based guidelines from nine different guideline development groups for 17 antenatal infection screenings showed variations in directions (pro-screening or contra-screening) as well as in grades of recommendations. Uniformly, all-pro-universal or all-contra-universal screening recommendations were identified for 10 of 17 diseases. Contradictions were primarily observed for group B streptococcus, chlamydia trachomatis, genital herpes and gonorrhoea infection screening. Whereas certainty of recommendations was high for all-pro-screening recommendations, it decreased in all-contra-screening recommendations and even displayed conflicting results for contradictory recommendations. CONCLUSION: The variety of grades of recommendations hamper across-guideline comparison. Nevertheless, the article highlights agreed screening areas based on the best available evidence as well as areas of still existing uncertainty. Local health policy decisions on whether to include or refrain from including screening measures in preventive care programmes can be facilitated by the comparison of recommendations from international evidence-based guidelines. Beyond the availability of evidence each country's health policy makers will have to make a judgement on the value of the test for a population-wide screening.

Affordability of programmes to prevent spontaneous preterm birth in Austria: a budget impact analysis.

BACKGROUND: Preterm birth is a rising health problem in Europe generally, and in Austria specifically. Decision makers require objective information on the effects and costs of measures to prevent preterm birth. METHODS: We undertook a budget impact analysis from a public payer perspective and for a 1-year and 5-year time horizon for five prevention approaches to reduce preterm birth. These were cervix screening + progesterone application, progesterone injection, smoking cessation, fish oil supplementation and infection screening. We analysed affordability in terms of programme costs and potential cost savings. RESULTS: Programme costs range from below €50 000 (cervix screening in high-risk pregnancy) to €500 000 (universal infection screening). The lowest health effects have been shown for smoking cessation programmes (-10 preterm births per year), whereas infection screening demonstrated the largest effect (-230 preterm births per year). In the base-case analysis, all programmes are potentially cost saving (-€500 000 to -€13 million per year). In the sensitivity analyses, preterm birth costs, target group size and (partly) unit costs of programme components have an influence on potential cost savings. However, except for two programmes, the results are robust concerning an overall economic net benefit of the programmes analysed compared with no programme. The study is mainly limited by the quality of some cost data and choice of the reference scenario. CONCLUSION: When considering potential cost savings, the five prevention programmes analysed seem affordable, with cervix screening and infection screening likely being the most promising in Austria.

[Outpatient cardiac phase III rehabilitation at a Viennese institution - retrospective cohort study]. / Ambulante kardiologische Phase-III-Rehabilitation - retrospektive Kohortenstudie zu einer Wiener Einrichtung.

BACKGROUND: This retrospective cohort study analyses effectiveness and sustainability of the current cardiac Phase III (Ph-III) rehabilitation program, provided by the Centre for Outpatient Rehabilitation (ZAR). METHODS: We analysed routine data of 451 intervention group patients (IG, with Ph-III) and 781 control group patients (KG, without Ph-III). RESULTS: In a median observation period of 2.73 years we found 30% less cases of death in the IG based on the mortality risk observed in the KG (rr = 0.70; p = 0.108). However, we registered more re-events, mainly stent implantations in the IG (rr = 1.34; p = 0.095). Groups differed in some baseline characteristics. CONCLUSIONS: The lower mortality risk by trend might be explained by the close-meshed care, the IG patients' more health conscious behaviour or a selection bias of the KG (e.g. more severe underlying disease). The causality of potential positive effects cannot be confirmed by this study because of the study design.

[Types of medical registries - definitions, methodological aspects and quality of the scientific work with registries]. / Formen medizinischer Register - Definitionen, ausgewählte methodische Aspekte und Qualität der Forschung mit Registern.

This work presents a comprehensive list of registry definitions including broader and narrower definitions. Compared to each other different methodological issues can be identified. Some of these issues are common for all registry types; some can be assigned more easily to a specific registry type. Instruments for evaluating the quality of registers reflect many of the mentioned aspects. Generally, and especially at registers with a descriptive or exploratory research dimension it is important to consider their intended purpose and in about it was achieved. This includes, for instance, whether the purpose and the methodology are coordinated. From the start of registration an initiator should be - based on the purpose - aware of the methodological dimension of the registry. This helps to apply the correct type of the registry, the appropriate guidance and, ultimately, the arguments for the effort (cost-benefit ratio).

Self-management of oral anticoagulation reduces major outcomes in the elderly. A randomized controlled trial.

Although many patients with long-term oral anticoagulation (OAC) can manage their medication safely and reliably themselves, no study on elderly patients has as yet assessed the safety and efficacy of OAC self-management with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre trial, patients aged 60 years or more were randomised into a self-management (SMG) (N = 99) or routine care group (RCG) (N = 96). The primary outcome was the combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications. Mean follow-up was 2.9 +/- 1.2 and 3.0 +/- 1.1 years in the SMG and RCG, respectively. In intention-to-treat analysis, 12 patients in the SMG versus 22 patients in the RCG reached a primary endpoint (hazard ratio [HR]: 0.50; 95% confidence interval [CI]: 0.25 to 1.00; p = 0.049). The post-hoc analysis on OAC treatment sensitivity supported the benefit of self-management (HR 0.27; 95% CI: 0.13 to 0.71; p = 0.006). Fifteen patients in the SMG died during the study, but none of the deaths was directly associated with anticoagulation therapy. In the RCG, 11 patients died; of those, three deaths were directly associated with anticoagulation therapy and there was one death of unknown cause. During follow-up, the quality of OAC control was significantly better in the SMG than in the RCG. In elderly patients, long-term self-management of oral anticoagulation is superior for the prevention of major thromboembolic and bleeding complications and for the quality of oral anticoagulation control compared to routine care for a mean follow-up period of three years.

Self-management of oral anticoagulation in the elderly: rationale, design, baselines and oral anticoagulation control after one year of follow-up. A randomized controlled trial.

Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre, open, randomised controlled trial, patients aged 60 years or more were randomised into the self-management group (SMG) (N = 99) or routine care group (RCG) (N = 96). We describe the rationale, design, baseline characteristics and interim analyses of oral anticoagulation control quality within the first year of follow-up. The medians of the squared international normalised ratio (INR) value deviations after six and 12 months were significantly lower in the SMG with medians of 0.16 and 0.16 compared to the RCG with medians of 0.25 and 0.25. The percentage of time within target range and the percentage of INR measurements within target range were significantly higher in the SMG versus the RCG within the first six months (medians 71% vs. 58% and 69% vs. 57%), and during the second six months of the study (75% vs. 67% and 72% vs. 57%). The numbers of all thromboembolic events requiring hospitalisation, major bleeding events, and deaths were similar in both groups. These preliminary results suggest that self-management of oral anticoagulation is safe and feasible for elderly patients willing to participate in a structured training programme.