How to protect long-term care facilities from pandemic-like events? - A systematic review on the effectiveness of non-pharmacological measures to prevent viral respiratory infections.

BACKGROUND: The SARS-CoV-2 pandemic underscored the need for pandemic preparedness, with respiratory-transmitted viruses considered as a substantial risk. In pandemics, long-term care facilities (LTCFs) are a high-risk setting with severe outbreaks and burden of disease. Non-pharmacological interventions (NPIs) constitute the primary defence mechanism when pharmacological interventions are not available. However, evidence on the effectiveness of NPIs implemented in LTCFs remains unclear. METHODS: We conducted a systematic review assessing the effectiveness of NPIs implemented in LTCFs to protect residents and staff from viral respiratory pathogens with pandemic potential. We searched Medline, Embase, CINAHL, and two COVID-19 registries in 09/2022. Screening and data extraction was conducted independently by two experienced researchers. We included randomized controlled trials and non-randomized observational studies of intervention effects. Quality appraisal was conducted using ROBINS-I and RoB2. Primary outcomes encompassed number of outbreaks, infections, hospitalizations, and deaths. We synthesized findings narratively, focusing on the direction of effect. Certainty of evidence (CoE) was assessed using GRADE. RESULTS: We analysed 13 observational studies and three (cluster) randomized controlled trials. All studies were conducted in high-income countries, all but three focused on SARS-CoV-2 with the rest focusing on influenza or upper-respiratory tract infections. The evidence indicates that a combination of different measures and hand hygiene interventions can be effective in protecting residents and staff from infection-related outcomes (moderate CoE). Self-confinement of staff with residents, compartmentalization of staff in the LTCF, and the routine testing of residents and/or staff in LTCFs, among others, may be effective (low CoE). Other measures, such as restricting shared spaces, serving meals in room, cohorting infected and non-infected residents may be effective (very low CoE). An evidence gap map highlights the lack of evidence on important interventions, encompassing visiting restrictions, pre-entry testing, and air filtration systems. CONCLUSIONS: Although CoE of interventions was low or very low for most outcomes, the implementation of NPIs identified as potentially effective in this review often constitutes the sole viable option, particularly prior to the availability of vaccinations. Our evidence-gap map underscores the imperative for further research on several interventions. These gaps need to be addressed to prepare LTCFs for future pandemics. TRIAL REGISTRATION: CRD42022344149.

Listening to the Voices of Health Care Workers During the COVID-19 Pandemic: A Qualitative Study Providing In-Depth Insights Into Ethical and Individual Challenges.

In their daily practice, health care workers (HCWs) experience the effects of tensions between professional ethos and work realities, which can lead to ethical dilemmas. We aim to explore the ethical dilemmas that affected HCWs in Germany during the COVID-19 pandemic and to understand these in the context of the German health system. Between April and December 2022, we interviewed HCWs from various levels of care and key informants responsible for decisions related to HCWs in Germany. Three themes were identified in the data analyzed from 78 participants. The first highlighted the potency of pre-existing health system problems during the COVID-19 pandemic. The second captured the ethical dilemmas that were described as having arisen due to the tension between professional ethos and structural constraints. The third included factors related to increasing or diminishing the implications of ethical dilemmas. A lack of opportunities for HCWs to participate in political and managerial decisions was suggested to result in policies that do not meet the needs of HCWs and patients. Positive interpersonal interactions were described as helpful when coping with dilemmatic decision-making situations. In order to avoid negative consequences caused by unresolved ethical dilemmas, including moral distress, among HCWs, staff shortages and decision-making in the German health system urgently need to be addressed. HCWs' working conditions regularly evoke ethical dilemmas, particularly during public health emergencies. Together with HCWs, decision-makers must develop new models for working in health care settings that are in line with HCWs' professional ethos.

[What is a public health intervention? Results of a Delphi process in German-speaking countries]. / Was wird unter einer Public-Health-Intervention verstanden? Ergebnisse eines Delphi-Prozesses im deutschsprachigen Raum.

BACKGROUND: Internationally, a variety of definitions for public health interventions (PHI) exist. In the German-speaking countries, however, a definition is still outstanding. Therefore, the aim of this study was to derive consensus criteria for the definition of PHI from the expert perspective of science and practice. METHODS: A Delphi survey with two online rounds was conducted from December 2022 to February 2023. Six criteria were formulated by a working group and posed for consensus: 1) the intention of the intervention, 2) potential conflicts of interest of the initiators of the intervention, 3) primary vs. secondary/tertiary prevention, 4) costs, 5) targeting, and 6) the reach of the intervention. In both Delphi rounds, experts from academia and practice were recruited through relevant networks and associations throughout the German-speaking world. The judgments were asked about standardized rating scales with the possibility of open justification. RESULTS: In the first Delphi round, n = 52 and in the second round n = 43 experts from research, care and administration/management in health care participated. Consensus was reached on four of the six criteria after the second Delphi round: the intention of the intervention, possible conflicts of interest of the initiators of the intervention, primary vs. secondary/tertiary prevention, and the scope of the intervention. From the perspective of the experts interviewed, these are the criteria that distinguish PHI. DISCUSSION AND CONCLUSION: Based on the consensus criteria, PHI can be defined more concretely. Thus, the results contribute to a better inter- and transdisciplinary understanding. Ideally, the criteria will make it easier to assign interventions to the public health sector in the future, even if a precise examination will be necessary in individual cases, among other things because the experts disagreed on the criteria of costs and how to address the target group.

Prioritisation processes for programme implementation and evaluation in public health: A scoping review.

Background: Programme evaluation is an essential and systematic activity for improving public health programmes through useful, feasible, ethical, and accurate methods. Finite budgets require prioritisation of which programmes can be funded, first, for implementation, and second, evaluation. While criteria for programme funding have been discussed in the literature, a similar discussion around criteria for which programmes are to be evaluated is limited. We reviewed the criteria and frameworks used for prioritisation in public health more broadly, and those used in the prioritisation of programmes for evaluation. We also report on stakeholder involvement in prioritisation processes, and evidence on the use and utility of the frameworks or sets of criteria identified. Our review aims to inform discussion around which criteria and domains are best suited for the prioritisation of public health programmes for evaluation. Methods: We reviewed the peer-reviewed literature through OVID MEDLINE (PubMed) on 11 March 2022. We also searched the grey literature through Google and across key websites including World Health Organization (WHO), US Centers for Disease Control and Prevention (CDC), European Centre for Disease Prevention and Control (ECDC), and the International Association of National Public Health Institutes (IANPHI) (14 March 2022). Articles were limited to those published between 2002 and March 2022, in English, French or German. Results: We extracted over 300 unique criteria from 40 studies included in the analysis. These criteria were categorised into 16 high-level conceptual domains to allow synthesis of the findings. The domains most frequently considered in the studies were "burden of disease" (33 studies), "social considerations" (30 studies) and "health impacts of the intervention" (28 studies). We only identified one paper which proposed criteria for use in the prioritisation of public health programmes for evaluation. Few prioritisation frameworks had evidence of use outside of the setting in which they were developed, and there was limited assessment of their utility. The existing evidence suggested that prioritisation frameworks can be used successfully in budget allocation, and have been reported to make prioritisation more robust, systematic, transparent, and collaborative. Conclusion: Our findings reflect the complexity of prioritisation in public health. Development of a framework for the prioritisation of programmes to be evaluated would fill an evidence gap, as would formal assessment of its utility. The process itself should be formal and transparent, with the aim of engaging a diverse group of stakeholders including patient/public representatives.

Radiation exposure by medical X-ray applications.

Background: Radioactive material and ionising radiation play a central role in medical diagnostics and therapy. The benefit of ionising radiation is opposed by the risk of irreparable damage of the human organism. This risk, especially for developing malign neoplasms, has particularly been investigated in the population surviving the atomic bombing of Hiroshima and Nagasaki, but also increasingly in persons with occupational or medical exposure to ionising radiation. Methods: We conducted a systematic search for publications in English and German in relevant databases in March 2016. Retrievals were screened by two independent reviewers. We included examinations using imaging procedures with ionising radiation. The assessment of methodological quality was done concerning representativeness, risk of bias, and further limitations, and reporting quality was assessed using the RECORD checklist. Results: The systematic searches identified seven cross-sectional, one register, and four cohort studies. An increase in collective effective doses analogue to the increase of computed tomography (CT) examinations could be observed. An increased risk of brain tumours in children after exposition to head CT and by an increase of the number of examinations was shown. For children with predisposing factors, an increased risk of tumours of the central nerve system, leukemia, and lymphoma was found. Furthermore, a general risk for malign neoplasms or haemoblastoma, and a specific risk for lymphoma after CT examinations of different parts of the body could be observed. Discussion: Taking into consideration a mostly unclear representativeness of studies and an unclear or high risk of bias as well as lack of comparability due to different research questions, the validity of results is limited. Conclusion: The risk of bias due to a large number of reference sources must be reduced in studies leading to realistic estimates of collective radiation doses. The risk of CT-induced radiation exposure for children should be investigated by further studies with a follow-up of at least ten years.

Development and Pilot Test of the Registry Evaluation and Quality Standards Tool: An Information Technology-Based Tool to Support and Review Registries.

OBJECTIVES: Health technology assessment (HTA) bodies are increasingly making use of real-world evidence and data. High-quality registries could be an asset for this; nevertheless, there is a lack of specified standards to assess the quality of data in the registry, or the registry itself. The European Network for Health Technology Assessment Joint Action 3 led the work to develop a tool for the evaluation of clinical registries: the "Registry Evaluation and Quality Standards Tool" (REQueST). METHODS: REQueST was developed in 4 steps: (1) A partnership between HTA bodies across Europe drafted the assessment criteria. (2) Multiple rounds of consultation across HTA bodies and the public domain developed an Excel version of REQueST. (3) This version was transformed into a web-based application. (4) An external pilot tested this REQueST tool with SMArtCARE and NeuroTransData registries. RESULTS: Haute Autorité de Santé, the National Institute for Health and Care Excellence, and the Croatian Institute of Public Health led the development of REQueST. Another 4 HTA bodies contributed regularly to development meetings, and all European Network for Health Technology Assessment partners were invited to contribute. Eight methodological, 12 essential, and 3 supplementary criteria were identified. Both pilot registries scored well, fulfilling the requirements for >70% of criteria, with none failed. Feedback by registry holders led to streamlining of the process and clarification of the criteria. CONCLUSIONS: The REQueST tool uses an iterative and collaborative methodology with registry holders. It has the potential to maximize the utility of registry data for decision making by regulatory and HTA bodies and provides a foundation for future research.

Methodological guidance for rapid reviews in healthcare: A scoping review.

The aim of the present work was to identify published methodological guidance for rapid reviews (RRs) and to analyze the recommendations with regard to time-saving measures. A literature search was performed in PubMed and EMBASE in November 2020. In addition, a search based on Google Scholar and websites of governmental and non-governmental organizations was conducted. Literature screening was carried out by two researchers independently. A total of 34 publications were included. These describe 38 distinct RR types. The timeframe to complete the identified RR types ranges from 24 h to 6 months (mean time 2.2 months). For most RR types a specific research question (n = 21) and a prioritizing search (n = 25; preference for e.g., systematic reviews and meta-analyses) is employed. Different approaches such as reduced personnel in literature screening (n = 21) and data extraction (n = 21) are recommended. The majority of RR types include a bias assessment (n = 28) and suggest a narrative report focusing on safety and efficacy. The included RR types are heterogeneous in terms of completion time, considered domains and strategies to alter the standard systematic review methods. A rationale for the recommended shortcuts is rarely presented.

[Post-corona fatigue-a familiar picture in a new guise?] / Post-Corona-Fatigue ­ das bekannte Bild in neuem Gewand?

BACKGROUND: Myalgic encephalitis or chronic fatigue syndrome (ME/CFS) has again come into focus as a result of coronavirus disease 2019 (COVID-19). Fundamentally problematic is the fact that ME/CFS is considered a separate entity; however, extreme fatigue is also a common symptom of an underlying disease. Our article aims to increase the acceptance of ME/CFS and extreme fatigue facing a symptomatology that is not fully understood, and to highlight the need for research, orientation for physicians, and counselling services for patients. MATERIALS AND METHODS: Orientative research by focused information gathering. RESULTS: In various research projects, the hypothesis of post-infectious ME/CFS as an autoimmune disease could be confirmed. In general, the heterogeneity of diagnostic criteria as well as the variety of formulations to describe the symptomatology and different coding options make it difficult to clearly assign symptoms to a clinical picture. Exertion intolerance has been identified as a severe symptom of post-COVID-19 disorder. For this reason, recommendations in international guidelines are currently being revised, especially with regard to pacing. The implications for recommendations in tumor-related fatigue or due to multiple sclerosis are unclear. CONCLUSION: Against the background of a decreasing burden of disease due to increasing vaccination rates, research on fatigue should not only include viral diseases.

Using INTEGRATE-HTA for the assessment of videorasterstereography in idiopathic scoliosis.

OBJECTIVE: For the assessment of videorasterstereography compared with radiography for monitoring idiopathic scoliosis, new tools given by the INTEGRATE-HTA methodology were included within the frame set by the authority. In contrast to the usual linear approach by covering the single domains' safety and efficacy, costs, and ethical, legal, socio-cultural and organizational issues (ELSOI) separately, the methodology is based on the assumption of interactions of different aspects of the domains. From the very beginning, these interactions are captured systematically using various tools and are repeatedly discussed with stakeholders. METHODS: Relevant databases were systematically searched for studies and question catalogues were processed in order to be able to search for specific aspects in orienting bibliographic research. An initial logic model was developed and successively expanded. A synoptic table showing multiple mapping of aspects to domains, a complexity checklist, and a semantic complex highlighting the socio-cultural impact of the disease were newly developed. RESULTS: Four diagnostic studies with high risk of bias were included. For the clinical outcome, Cobb angle standard deviations up to 8.2 degrees and average measurement differences up to 8.8 degrees were determined. These differences in measurement accuracy correspond to those observed for purely radiographic measurements in other studies. In addition to freedom from radiation as the greatest advantage, there were clear arguments in favor of videorasterstereography when considering ELSOI, for example less harm. CONCLUSIONS: Using INTEGRATE-HTA contributes to identify interactions between domains and to significantly expand the perspective on a technology. It improves patient-centered understanding and facilitates discussions.

Discrete choice experiment to determine preferences of decision-makers in healthcare for different formats of rapid reviews.

BACKGROUND: Time-saving formats of evidence syntheses have been developed to fulfill healthcare policymakers' demands for timely evidence-based information. A discrete choice experiment (DCE) with decision-makers and people involved in the preparation of evidence syntheses was undertaken to elicit preferences for methodological shortcuts in the conduct of abbreviated reviews. METHODS: D-efficient scenarios, each containing 14 pairwise comparisons, were designed for the DCE: the development of an evidence synthesis in 20 working days (scenario 1) and 12 months (scenario 2), respectively. Six attributes (number of databases, number of reviewers during screening, publication period, number of reviewers during data extraction, full-text analysis, types of HTA domains) with 2 to 3 levels each were defined. These were presented to the target population in an online survey. The relative importance of the individual attributes was determined using logistic regression models. RESULTS: Scenario 1 was completed by 36 participants and scenario 2 by 26 participants. The linearity assumption was confirmed by the full model. In both scenarios, the linear difference model showed a preference for higher levels for "number of reviewers during data extraction", followed by "number of reviewers during screening" and "full-text analysis". Subgroup analyses showed that preferences were influenced by participation in the preparation of evidence syntheses. CONCLUSION: The surveyed persons expressed preferences for quality standards in the process of literature screening and data extraction.

Hot days and Covid-19: Online survey of nurses and nursing assistants to assess occupational heat stress in Germany during summer 2020.

Objectives: Our aim was to identify if working during hot days while wearing Covid-19 related personal protective equipment causes occupational heat stress for nurses and nursing assistants in Germany. Design: Using an online survey, we assessed the impact of hot weather on nurses and nursing assistants working with personal protective equipment. Respondents were recruited by distributing the link to the survey via personal communication, email and various social media channels to nursing staff from hospitals, nursing homes and outpatient care. Results: There were in total 428 participants (18.2% male, 82.5% female), mostly (30.5%) aged between 45 and 55 years. Half of respondents (48.3%) had more than 20 years of experience in nursing. Cardiac, pulmonary, or other pre-existing conditions were reported by 46.2%.Nurses and nursing assistants working in personal protective equipment during hot days were exposed to occupational heat stress. Work was found exhaustive by 96.5% of the participants during those days. 93.0% reported breathing problems and 85.8% reported difficulties with focusing on their work. Many workplaces did not provide adequate heat protection, with distinct differences concerning the amount of prophylactic and heat mitigating measures across institutions. There were significant differences across institutions when it comes to the number of drinks served (p < 0.001), the availability of room thermometers (p < 0.001), the use of mobile cooling devices (p < 0.001) and fans (p < 0.05). Conclusions: Results suggest employers must make more of an effort to provide adequate heat protection for their nursing staff. In order to ensure patient care, there is a need for action; in particular, attention must be paid to the pre-existing health conditions of the nursing staff.

[Horizon Scanning in Health Care: A German Perspective]. / Horizon-Scanning im Gesundheitswesen ­ wo steht Deutschland?

BACKGROUND: Decision makers in health care act in an area in which expectations increase to make beneficial new technologies available as soon as possible, to protect patients from unsafe or ineffective technologies, and to expedite or decelerate technology diffusion. Horizon Scanning (HS) is a process to identify early new and emerging technologies and to inform about their potential consequences concerning the health care system. OBJECTIVES: Methods of HS, worldwide existing activities and the status quo in Germany are described. METHODS: In April 2015, a systematic electronic search was conducted which was supplemented by hand searching. Additionally, a qualitative acquisition of German expert knowledge in health care was realized. RESULTS: 27 formal HS systems (HSS) worldwide were identified of which 18 are current members of the "International Information Network on New and Emerging Health Technologies". Essentially, the same process steps are applied but there may be differences in methods due to different structures and interests of the health care systems. There is no official HSS in Germany. The survey of experts revealed a lack of knowledge and a varying understanding of HS, but basically there seems to be a need for this. CONCLUSIONS: The systematic process of HS can be adapted to current circumstances and objectives of a specific health care system and has international acceptance. In Germany, it could enable decision makers and other stakeholders to have information early and thus support them in their decisions.

[Horizon Scanning in Health Care: A German Perspective]. / Horizon Scanning im Gesundheitswesen ­ wo steht Deutschland?

BACKGROUND: Decision makers in health care act in an area in which expectations increase to make beneficial new technologies available as soon as possible, to protect patients from unsafe or ineffective technologies, and to expedite or decelerate technology diffusion. Horizon Scanning (HS) is a process to identify early new and emerging technologies and to inform about their potential consequences concerning the health care system. OBJECTIVES: Methods of HS, worldwide existing activities and the status quo in Germany are described. METHODS: In April 2015, a systematic electronic search was conducted which was supplemented by hand searching. Additionally, a qualitative acquisition of German expert knowledge in health care was realized. RESULTS: 27 formal HS systems (HSS) worldwide were identified of which 18 are current members of the "International Information Network on New and Emerging Health Technologies". Essentially, the same process steps are applied but there may be differences in methods due to different structures and interests of the health care systems. There is no official HSS in Germany. The survey of experts revealed a lack of knowledge and a varying understanding of HS, but basically there seems to be a need for this. CONCLUSIONS: The systematic process of HS can be adapted to current circumstances and objectives of a specific health care system and has international acceptance. In Germany, it could enable decision makers and other stakeholders to have information early and thus support them in their decisions.

Efficacy of bevacizumab in first-line treatment of metastatic colorectal cancer: A systematic review and meta-analysis.

BACKGROUND: This systematic review and meta-analysis aims to evaluate the additive effect of bevacizumab when combined with first-line chemotherapy in metastatic colorectal cancer (mCRC). METHODS: We searched EMBASE, MEDLINE, the Cochrane Library in April 2018. When possible, data were pooled to estimate summary effects. The present analysis evaluated treatment related efficacy based on progression-free survival (PFS) and overall survival (OS). The analysis was performed to define the overall effect and the effect observed in currently used chemotherapy regimens. RESULTS: Seven randomised studies were included. In the analysis of the overall effect, PFS (hazard ratio [HR] 0.71, p < 0.00001) and OS (HR 0.85, p = 0.0008) clearly favoured bevacizumab plus chemotherapy versus chemotherapy alone. When the analysis was focused on currently used chemotherapy excluding 5-FU bolus regimens and including only infusional 5-FU plus irinotecan or oxaliplatin, the addition of bevacizumab prolonged PFS (HR 0.79, p < 0.0001) but not OS (HR 0.92, p = 0.18). However, addition of bevacizumab to fluoropyrimidine monotherapy lead to a significant prolongation of PFS (HR 0.57, p < 0.00001) and OS (HR 0.83, p = 0.03). CONCLUSION: The present meta-analysis demonstrates that the effect of bevacizumab on survival is not consistent throughout the included regimens. Considering only presently used regimens, a significant effect on PFS and OS was only observed when bevacizumab was added to fluoropyrimidine monotherapy.

Time and cost associated with utilization of services at mobile health clinics among pregnant women.

BACKGROUND: Antenatal care (ANC) is provided for free in Tanzania in all public health facilities. Yet surveys suggested that long distances to the facilities limit women from accessing these services. Mobile health clinics (MHC) were introduced to address this problem; however, little is known about the client cost and time associated with utilizing ANC at MHC and whether these costs deter women from using the provided services. METHODS: Client-exit interviews were conducted by interviewing 293 pregnant women who visited the MHC in rural Tanzania. Two subgroups were created, one with women who travelled more than 1.5 h to the MHC, and the other with women who travelled within 1.5 h. For each subgroup we estimated the direct cost in US$ and time in hours for utilizing services and they hinder service utilization. The Wilcoxon-Mann-Whitney rank sum test was performed to compare the differences between the estimated mean values in the two groups. RESULT: Total direct cost per visit was: US$2.27 (SD = 0.90) for overall, US$2.29 (SD = 1.03) for those women who travelled less than 1.5 h and US$2.53 (SD = 0.63) for those who travelled more than 1.5 h (p = 0.08). Laboratory and medicine cost accounted for 70 and 16% of the total direct cost and were similar across the groups. Total time cost per visit (in hours) was: 3.75 (SD = 1.83), 2.88 (SD = 1.27) for those women who travelled less than 1.5 h and 5.02 (SD = 1.81) for those who travelled more than 1.5 h (p < 0.01). The major contributor of time cost was waiting time; 1.89 (SD = 1.29) for overall, 1.68 (SD = 1.02) for those women who travelled less than 1.5 h and 2.17 (SD = 1.57) for those who travelled more than 1.5 h (p = 0.07). Participants reported having missed their scheduled visit due to lack of money (15%) and time (9%). CONCLUSION: Women receiving nominally free ANC incur considerable time and direct cost, which may result in an unsteady use of maternal care. Improving availability of essential medicine and supplies at health facilities, as well as focusing on efficient utilization of community health workers may reduce these costs.

Evaluation of outpatient acupuncture for relief of pregnancy-related conditions.

BACKGROUND: Acupuncture is a non-pharmacological option to relieve pregnancy-related complaints. OBJECTIVES: To critically appraise the best available evidence for the use of acupuncture in outpatient care. SEARCH STRATEGY: The MEDLINE, Cochrane Library, and Centre for Reviews and Dissemination databases were searched for English-language and German-language papers published from January 1980 to March 2017 using search terms related to pregnancy combined with 'acupuncture'. SELECTION CRITERIA: Systematic reviews and randomized controlled trials (RCTs) comparing non-pharmacological treatments in unselected or low-risk pregnant women. DATA COLLECTION AND ANALYSIS: Quality was assessed using a checklist (A Measurement Tool to Assess Systematic Reviews) and the Cochrane risk of bias tool. Meta-analyses were also performed. MAIN RESULTS: High-quality systematic reviews (n=5) and RCTs with low risk of bias (n=3) were identified. The systematic reviews were based on single studies, with small sample sizes, that showed a benefit of acupuncture for evening pelvic pain; pelvic and low-back pain; nausea; functional disability; and sleep quality. Contradictory results were found in the RCTs regarding cesarean delivery; time to delivery; spontaneous labor; fetal distress; and Apgar score. Data pooling emphasized the heterogeneity of results. CONCLUSIONS: Evidence to support the use of acupuncture for relief of pregnancy-related conditions was limited.