TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) Project: Protocol for an International Longitudinal Multicenter Study.

BACKGROUND: Nursing-sensitive events (NSEs) are common, accounting for up to 77% of adverse events in hospitalized patients (eg, fall-related harm, pressure ulcers, and health care-associated infections). NSEs lead to adverse patient outcomes and impose an economic burden on hospitals due to increased medical costs through a prolonged hospital stay and additional medical procedures. To reduce NSEs and ensure high-quality nursing care, appropriate nurse staffing levels are needed. Although the link between nurse staffing and NSEs has been described in many studies, appropriate nurse staffing levels are lacking. Existing studies describe constant staffing exposure at the unit or hospital level without assessing patient-level exposure to nurse staffing during the hospital stay. Few studies have assessed nurse staffing and patient outcomes using a single-center longitudinal design, with limited generalizability. There is a need for multicenter longitudinal studies with improved potential for generalizing the association between individual nurse staffing levels and NSEs. OBJECTIVE: This study aimed (1) to determine the prevalence, preventability, type, and severity of NSEs; (2) to describe individual patient-level nurse staffing exposure across hospitals; (3) to assess the effect of nurse staffing on NSEs in patients; and (4) to identify thresholds of safe nurse staffing levels and test them against NSEs in hospitalized patients. METHODS: This international multicenter study uses a longitudinal and observational research design; it involves 4 countries (Switzerland, Sweden, Germany, and Iran), with participation from 14 hospitals and 61 medical, surgery, and mixed units. The 16-week observation period will collect NSEs using systematic retrospective record reviews. A total of 3680 patient admissions will be reviewed, with 60 randomly selected admissions per unit. To be included, patients must have been hospitalized for at least 48 hours. Nurse staffing data (ie, the number of nurses and their education level) will be collected daily for each shift to assess the association between NSEs and individual nurse staffing levels. Additionally, hospital data (ie, type, teaching status, and ownership) and unit data (ie, service line and number of beds) will be collected. RESULTS: As of January 2024, the verification process for the plausibility and comprehensibility of patients' and nurse staffing data is underway across all 4 countries. Data analyses are planned to be completed by spring 2024, with the first results expected to be published in late 2024. CONCLUSIONS: This study will provide comprehensive information on NSEs, including their prevalence, preventability, type, and severity, across countries. Moreover, it seeks to enhance understanding of NSE mechanisms and the potential impact of nurse staffing on these events. We will evaluate within- and between-hospital variability to identify productive strategies to ensure safe nurse staffing levels, thereby reducing NSEs in hospitalized patients. The TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) study will focus on the optimization of scarce staffing resources. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56262.

Integrating home treatment into the Austrian child and adolescent mental health care system: an implementation science perspective.

BACKGROUND: In Austria, similar to other countries, health care planners have considered implementing home treatment (HT) programs for children and adolescents with mental health problems. However, introducing any new service innovation into the complex environment of the child and adolescent mental health care system requires context and implementation issues to be taken into account in advance. METHODS: We identified implementation themes from international HT models and developed a questionnaire with open-ended implementation-related questions for Austrian professionals. We analysed the qualitative results alongside the domains in the Context and Implementation of Complex Interventions (CICI) framework to detect key implementation challenges for HT in Austria. RESULTS: We found six implementation themes in international HT models, which formed the basis for development of the questionnaire. Within the qualitative data from ten Austrian professionals who responded to the questionnaire, we identified implementation challenges in all eight context and all four implementation domains of the CICI framework. CONCLUSIONS: Key implementation challenges detected highlight the need to address the fit of HT within existing sociocultural norms and limited available human resources. Regional context-specific solutions need to be found on how to embed this new element best into the existing provider and financing structures. This calls for monitoring and evaluation alongside implementation to support decision-making.

[Effectiveness and Safety of Home Treatment in Child and Adolescent Mental Health Care: A Systematic Literature Review]. / Wirksamkeit und Sicherheit von Home-Treatment in der Kinder- und Jugendpsychiatrie: Eine systematische Literaturübersicht.

OBJECTIVE: In child and adolescent psychiatry, home treatment is becoming increasingly important due to limited inpatient care capacities and changing treatment philosophies. This paper examines its effectiveness and safety. METHODS: We did a systematic literature search and summarized the home treatment model characteristics as well as the evidence on its benefits and harms narratively. RESULTS: In the six identified studies, improvements in symptoms were found in both, home and institutionalized treatment. In the long-term, home treatment seems to be slightly superior and involves fewer hospital days. However, a best-practice model cannot be derived from the data available. CONCLUSION: Home treatment can be considered as an alternative to inpatient treatment, but requires coordination with other mental health care elements and further evaluation.

Cancer care near the end-of-life in Austria: A retrospective data analysis.

OBJECTIVE: Since end-of-life care (EOL) is an internationally accepted indicator for the quality of oncological care we aimed to investigate the current EOL care situation for Austrian cancer patients especially concerning the place of death cancer treatment hospitalisation near death and palliative care. METHODS: A retrospective data analysis was carried out based on Austrian routine inpatient data of the years 2012 to 2016. Data including the date of death of adult patients with a main hospital discharge diagnosis of a neoplasm were included. All analyses were source-related and based on the place of residence. RESULTS: In total 80818 cancer patients have died between 2012 and 2016 of whom 53.4% died in the inpatient setting. Palliative care at the EOL (last hospitalisation) was present in 12.9% of patients whereby more than 50% were admitted two to 14 days before death. Considering cancer treatment at the EOL (30 days before death) 6.9% of cancer patients have received chemotherapy 1.7% radiation therapy and 0.75% were treated with a monoclonal antibody. CONCLUSION: In international comparison Austria appears to do well on quality indicators concerning ICU-admission and chemotherapy treatment average on hospital death and poorly on hospital admissions and timely referral for palliative care.

Automated Fall Detection Algorithm With Global Trigger Tool, Incident Reports, Manual Chart Review, and Patient-Reported Falls: Algorithm Development and Validation With a Retrospective Diagnostic Accuracy Study.

BACKGROUND: Falls are common adverse events in hospitals, frequently leading to additional health costs due to prolonged stays and extra care. Therefore, reliable fall detection is vital to develop and test fall prevention strategies. However, conventional methods-voluntary incident reports and manual chart reviews-are error-prone and time consuming, respectively. Using a search algorithm to examine patients' electronic health record data and flag fall indicators offers an inexpensive, sensitive, cost-effective alternative. OBJECTIVE: This study's purpose was to develop a fall detection algorithm for use with electronic health record data, then to evaluate it alongside the Global Trigger Tool, incident reports, a manual chart review, and patient-reported falls. METHODS: Conducted on 2 campuses of a large hospital system in Switzerland, this retrospective diagnostic accuracy study consisted of 2 substudies: the first, targeting 240 patients, for algorithm development and the second, targeting 298 patients, for validation. In the development study, we compared the new algorithm's in-hospital fall rates with those indicated by the Global Trigger Tool and incident reports; in the validation study, we compared the algorithm's in-hospital fall rates with those from patient-reported falls and manual chart review. We compared the various methods by calculating sensitivity, specificity, and predictive values. RESULTS: Twenty in-hospital falls were discovered in the development study sample. Of these, the algorithm detected 19 (sensitivity 95%), the Global Trigger Tool detected 18 (90%), and incident reports detected 14 (67%). Of the 15 falls found in the validation sample, the algorithm identified all 15 (100%), the manual chart review identified 14 (93%), and the patient-reported fall measure identified 5 (33%). Owing to relatively high numbers of false positives based on falls present on admission, the algorithm's positive predictive values were 50% (development sample) and 47% (validation sample). Instead of requiring 10 minutes per case for a full manual review or 20 minutes to apply the Global Trigger Tool, the algorithm requires only a few seconds, after which only the positive results (roughly 11% of the full case number) require review. CONCLUSIONS: The newly developed electronic health record algorithm demonstrated very high sensitivity for fall detection. Applied in near real time, the algorithm can record in-hospital falls events effectively and help to develop and test fall prevention measures.

Evaluating options for decision making on costly hospital drugs in Austria.

OBJECTIVES: The aim of this study was to suggest options for a national and standardized process for the reimbursement of costly drugs provided in Austrian hospitals. METHODS: For answering the research questions, reimbursement processes of ten countries were investigated and the strengths and weaknesses of elaborated options of actions were analyzed, resulting in suggestions for solutions in the Austrian reimbursement processes for hospital drugs. RESULTS: Based on the information derived from the international analysis and the deliberation of the strengths and weaknesses on optional approaches, as well as, on the consideration of the existing reimbursement processes in Austria, three options to reorganize the current decentralized inpatient reimbursement process in Austria were suggested. The first option presents a process following the established processes of the decision making for outpatient drugs. The second option suggests stronger coordination of and cooperation across the existing processes of the nine regional "Pharmaceutical and Therapeutics Committees". The third option proposes to expand the already established reimbursement process for non-drug interventions. CONCLUSIONS: Evidence-based, transparent, fair and efficient resource allocations are needed for priority setting decisions. However, a decision process can be based on the best available evidence, can be fair and transparent, although it might be substantially more time-consuming. Thus, a pragmatic balance between quality, transparency and timeliness is crucial.

Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015.

OBJECTIVE: Health-related quality of life (HRQoL) is one of the most important patient-relevant study end-points for the direct measurement of the benefit of cancer drugs. Therefore, our aim is to detect cancer indications with no published information on HRQoL at the time of European Medicines Agency (EMA) approval and monitor any reported HRQoL evidence updates after at least three years of follow-up. METHODS: We included all cancer indications that were approved by the EMA between January 2009 and October 2015. Our main sources of information were the EMA website, clinicaltrials.gov and a systematic literature search in PubMed. Information on HRQoL outcomes was extracted alongside evidence on median overall survival. RESULTS: In total, we identified 110 indications, of which more than half (n = 58, 53%) were lacking available information on HRQoL assessments at the time of EMA approval. After a monitoring period of at least three years, 24 updates were identified, resulting in 34 (31%) therapies where information on HRQoL was still not available. For the 76 therapies with reported information on HRQoL, cancer-specific instruments were mostly used (n = 49/76). Regarding cumulative evidence on median overall survival and HRQoL, 33 (n = 33/110, 30%) as well as 15 (n = 15/110, 14%) cancer drugs were lacking information on both study end-points at the time of approval and after monitoring, respectively. CONCLUSION: Our results demonstrate that there is an urgent need of routine re-evaluation of reimbursed cancer drugs with initially missing information on major outcomes. Standardisation of the typology and quality of HRQoL assessments need to be improved to allow better comparability of results.

Pioneer interneurons instruct bilaterality in the Drosophila olfactory sensory map.

Interhemispheric synaptic connections, a prominent feature in animal nervous systems for the rapid exchange and integration of neuronal information, can appear quite suddenly during brain evolution, raising the question about the underlying developmental mechanism. Here, we show in the Drosophila olfactory system that the induction of a bilateral sensory map, an evolutionary novelty in dipteran flies, is mediated by a unique type of commissural pioneer interneurons (cPINs) via the localized activity of the cell adhesion molecule Neuroglian. Differential Neuroglian signaling in cPINs not only prepatterns the olfactory contralateral tracts but also prevents the targeting of ingrowing sensory axons to their ipsilateral synaptic partners. These results identified a sensitive cellular interaction to switch the sequential assembly of diverse neuron types from a unilateral to a bilateral brain circuit organization.

Describing adverse events in medical inpatients using the Global Trigger Tool.

AIMS: The purpose of the study was to describe the type, prevalence, severity and preventability of adverse events (AEs) that affected hospitalised medical patients. We used the previously developed and validated Global Trigger Tool from the Institute for Healthcare Improvement. METHODS: Using an adapted version of the Global Trigger Tool, we conducted a retrospective chart review of adult patients hospitalised in five medical wards at a university hospital in Switzerland. We reviewed a random sample of 20 patients’ charts for a total study period of 12 months (September 2016 to August 2017). Two trained nurses searched independently for triggers and possible AEs. All AEs were further validated by a senior physician. The number of triggers and AEs detected, as well as the severity and preventability of each, was assessed and analysed using descriptive statistics. RESULTS: From a sample of 240 patient charts, we identified 1371 triggers and 336 AEs in 144 (60%) inpatients. This translates to an AE rate of 95.7 AEs per 1000 patient days. Most AEs (86.1%) caused temporary harm to the patient and required an intervention and/or prolonged hospitalisation. The estimated preventability of the in-hospital AEs was 29%. Healthcare-associated infections (25.8%) and neurological reactions (22.9%) were the most frequent AE types. CONCLUSION: We found that about two thirds of patients suffered from AEs with harm during hospitalisation. It is common knowledge that AEs occur in hospitals and that they have potentially harmful consequences for patients, as well as a strong economic impact. However, to adequately prioritise patient safety interventions, it is essential to explore the nature, prevalence, severity and preventability of AEs. This is not only beneficial for the patients, but also cost effective in terms of shorter hospital stays.

Pre-reimbursement: early assessment for coverage decisions.

BACKGROUND: In the past decade, the Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) has introduced two programs: "Horizon Scanning in Oncology" (HSO) and extra medical services ("MELs"), which are to facilitate coverage decisions based on early assessments. This article aims to outline the general process and methods within these two programs. METHODS: A narrative-descriptive synthesis of the literature was performed to outline the general and LBI-HTA-specific processes and methods of early assessments. RESULTS: In total, 79 HSO assessments (2009-2018) and 95 MELs (2008-2018) have been conducted by the LBI-HTA. Recently, additional methods that contribute to European applicability have been introduced into these programs. CONCLUSIONS: Overall, pre-coverage decisions based on early assessment reports are dependent on the existing evidence. However, the organisation of the health care system and the cross-linking between decision-makers and HTA institutions can have an impact.

Between January 2009 and April 2016, 134 novel anticancer therapies were approved: what is the level of knowledge concerning the clinical benefit at the time of approval?

OBJECTIVE: In the last decade an increasing number of high-priced, new cancer treatments received marketing authorisation in Europe. What is actually known about the clinical benefit of those therapies at the time of approval needs to be elucidated in order to inform decisions about the use and reimbursement of these novel treatment options. Thus, the aim of the current analysis was to systematically investigate oncological therapies approved between January 2009 and April 2016 and extract as well as quantify the level of knowledge of the clinical benefit at the time of marketing authorisation. METHODS: To assess the benefit of new interventions as well as expanded indications, we extracted the median gain of the two study end points: progression-free survival (PFS) and overall survival (OS). Information is based on approval documents provided by the European Medicines Agency and assessments from the Austrian Horizon Scanning programme. We included all cancer therapies approved in Europe between 2009 (January 1) and 2016 (April 15). RESULTS: Cancer drugs for 134 new indications approved since 2009 were identified. In the case of 37 indications (27%), no data were available for PFS or for OS. A positive difference in median OS was reached by 76 licensed indications (55.5%); 22 (16%) of them showed a difference of more than 3 months. Regarding the study end point PFS, an improvement was shown in 90 indications (65.2%). CONCLUSION: Scarce knowledge regarding the clinical benefit of anticancer therapies is available at the time of approval. In addition, the survival benefit of the approved indications is less than 3 months in the majority of approved therapies.