New care pathway to enable ambulances transfer patients to a model 2 hospital medical assessment unit.

BACKGROUND: Reconfiguration of the Irish acute hospital sector resulted in the establishment of a Medical Assessment Unit (MAU) in Mallow General Hospital (MGH). We developed a protocol whereby certain patients deemed to be low risk for clinical deterioration could be brought by the National Ambulance Service (NAS) to the MAU following a 999 or 112 call. AIMS: The aim of this paper is to report on the initial experience of this quality improvement initiative. METHODS: The Plan-Do-Study-Act (PDSA) Cycle for quality improvement was implemented when undertaking this project. A pathway was established whereby, following discussion between paramedic and physician, patients for whom a 999 or 112 call had been made could be brought directly to the MAU in MGH. Strict inclusion and exclusion criteria were agreed. The protocol was implemented from the 1st of September 2022 for a 3-month pilot period. RESULTS: Of 39 patients discussed, 29 were accepted for review in the MAU. One of the 29 accepted patients declined transfer to MAU. Of 28 patients reviewed in the MAU, 7 were discharged home. One patient required same day transfer to a model 4 centre. Twenty patients were admitted to MGH with an average length of stay of 8 days. Frailty and falls accounted for 7 of the admissions and the mean length of stay for these patients was 12 days. CONCLUSIONS: Our results have demonstrated the safety, feasibility and effectiveness of this pathway. With increased resourcing, upscaling of this initiative is possible and should be considered.

Optimization of HIV testing services in Germany using HIV indicator diseases: study protocol of the HeLP study.

BACKGROUND: Despite the potentially accompanying negative clinical, epidemiologic, and health economic effects, a large proportion of persons living with the human immunodeficiency virus (HIV) are diagnosed late. Internationally, numerous diseases are known to be HIV indicator diseases. Adequate HIV testing in the presence of HIV indicator diseases could help to diagnose unknown HIV infections earlier. The objective of the HeLP study is to validate published HIV indicator diseases for the German setting and to identify guidelines in terms of these indicator diseases in order to reduce knowledge gaps and increase HIV testing when HIV indicator diseases are diagnosed. METHODS: A mixed methods approach is used. In a first step, published HIV indicator diseases will be identified in a systematic literature review and subsequently discussed with clinical experts regarding their relevance for the German setting. For the validation of selected indicator diseases different data sets (two cohort studies, namely HIV-1 seroconverter study & ClinSurv-HIV, and statutory health insurance routine data) will be analyzed. Sensitivity analyses using different time periods will be performed. Guidelines of HIV indicator diseases validated in the HeLP study will be reviewed for mentioning HIV and for HIV testing recommendations. In addition, semi-standardized interviews (followed by a free discussion) with guideline creators will identify reasons why HIV testing recommendations were (not) included. Subsequently, a random sample of physicians in medical practices will be surveyed to identify how familiar physicians are with HIV testing recommendations in guidelines and, if so, which barriers are seen to perform the recommended tests in everyday care. DISCUSSION: The HeLP-study adopts the challenge to validate published HIV indicator diseases for the German setting and has the potential to close a knowledge gap regarding this objective. This has the potential to improve targeted HIV testing for patients with HIV indicator diseases and consequently lead to earlier HIV diagnosis. TRIAL REGISTRATION: DRKS00028743.

[Evaluating the introduction of HIV pre-exposure prophylaxis as a benefit of statutory health insurance (EvE-PrEP) : Highly effective protection against HIV without an increase in sexually transmitted infections]. / Evaluation der Einführung der HIV-Präexpositionsprophylaxe als Leistung der gesetzlichen Krankenversicherung (EvE­PrEP) : Hocheffektiver Schutz vor HIV und keine Zunahme von sexuell übertragbaren Infektionen.

BACKGROUND: We investigated the impact of HIV pre-exposure prophylaxis (PrEP) as a new service of the statutory health insurance (SHI) on the incidence of HIV and other sexually transmitted infections (STIs) in Germany. In addition, PrEP needs and access barriers were analyzed. METHODS: The following data were evaluated as part of the evaluation project: HIV and syphilis notification data and extended surveillance by the Robert Koch Institute (RKI), pharmacy prescription data, SHI routine data, PrEP use in HIV-specialty care centers, Checkpoint, the BRAHMS and PrApp studies, as well as a community board. RESULTS: The majority of PrEP users were male (98-99%), primarily aged between 25-45 years, and predominantly of German nationality or origin (67-82%). The majority were men who have sex with men (99%). With regard to HIV infections, PrEP proved to be highly effective. There were only isolated cases of HIV infections (HIV incidence rate 0.08/100 person years); in most cases the suspected reason was low adherence. The incidences of chlamydia, gonorrhea, and syphilis did not increase but remained almost the same or even decreased. A need for information on PrEP for people in trans*/non-binary communities, sex workers, migrants, and drug users emerged. Needs-based services for target groups at increased risk of HIV are necessary. DISCUSSION: PrEP proved to be a very effective HIV prevention method. The partly feared indirect negative influences on STI rates were not confirmed in this study. Due to the temporal overlap with the containment measures during the COVID-19 pandemic, a longer observation period would be desirable for a conclusive assessment.

Retrospective benefit estimation of motorcycle ABSs based on Swiss insurance data.

OBJECTIVE: With the growing use of motorcycle antilock braking systems (ABSs) in the European market in recent years, we would expect to see a noticeable reduction in the number of motorcycle crashes. Several studies have proved a crash-reducing effect of motorcycle ABSs. The objective of this survey is to expand former studies by analyzing Swiss insurance data to derive estimates about the effect of motorcycle ABSs in Europe. METHODS: Swiss insurance data are analyzed descriptively, and based on these data, regression models are estimated to determine the effect of motorcycle ABSs retrospectively. RESULTS: Motorcycles equipped with standard ABSs were associated with an 18% reduction in claim frequency compared to motorcycles without ABSs, based on Swiss liability insurance data. CONCLUSIONS: These numbers are in line with the results of other studies estimating the benefit of motorcycle ABSs. This study updates and adds to previous European studies by using insurance data.

Cost-savings and potential cost-savings through the distribution of generic antiretroviral drugs within the statutory health insurance market of Germany between January 2017 and June 2019.

BACKGROUND: Recent patent losses for antiretroviral drugs (ARV) have led to the debate of cost-saving through the replacement of patented drugs with generic drugs. The split of recommended single-tablet regimens (STR) into their single substance partners is one of the considerations mentioned in said debate. Particularly, generic tenofovir disoproxil/emtricitabine (TDF/FTC) is expected to hold untapped cost-saving potential, which may curb increasing overall expenditures for combined antiretroviral therapy (cART) within the statutory health insurance (SHI) of Germany. METHODS: Data of ARV reimbursed by the SHI were used to describe the trends of defined daily doses (DDD) as well as the revenue within the German ARV market. They were also used to determine the cost-savings of moving to generic drugs. The time period observed was between January 2017 and June 2019. The potential cost-savings were determined with following assumption in mind: the maximum possible use of generic ARV, including 1) the split of STR and replacing all substance partners with generic ones, and 2) replacing patented tenofovir alafenamide/emtricitabine (TAF/FTC) with generic TDF/FTC. RESULTS: Throughout the observation period, the DDD of generic ARV increased nearly five-fold while their revenue increased more than four-fold. Total cost-saving showed a sharp increase over the same period, with generic TDF/FTC accounting for a share of around 70%. The largest potential cost-saving could have been achieved through replacing patented TAF/FTC with generic TDF/FTC, peaking at nearly 10% of total revenue, but showing decreasing trends in general. CONCLUSION: The progressive distribution of generic ARV ensured increasing cost-savings, but consequently curbed the potential cost-savings. Unique price reductions of generic TDF/FTC have played a pivotal role for these effects. In any case, substituting with generic ARV should not fail to adhere to the treatment guidelines and continue to consider the medical requirements for the treatment.

[How do generic quotas work? An analysis using HIV infection as an example]. / Wie wirken Generikaquoten? Eine Analyse am Beispiel der HIV-Infektion.

BACKGROUND: Instruments controlling statutory healthcare medical supply have long been a topic of debate in health policy reform discussions. Over the years, a variety of tools have been developed, most of which are aimed at controlling drug expenditure. The instruments controlling regional prescriptions primarily focus on controlling behavioural patterns of the prescribing physicians. Important to note is the increased use of indication-directed quotas, primarily of drug leads and/or generics/biosimilars. These are now also available in the area of the human immunodeficiency virus (HIV), such as the generic quotas for HIV medications introduced in Bavaria and Berlin in 2020. OBJECTIVE: The aim of this article is to analyse the benefits and limitations of generic quota solutions in HIV care using statutory health insurance drug prescription data and to outline recommendations for action. RESULTS: It was observed that the quota potential for generics in the area of patent-free drugs in HIV care has already been largely exhausted. This can be explained by HIV prescribers supporting product exchange on the prescription. DISCUSSION: The best-case scenario in terms of regulation has almost been reached. This is due to a suitable set of instruments, including the framework agreement for medical supply as well as prescribing according to guidelines - in conjunction with the Pharmaceuticals Market Reorganisation Act (AMNOG) and reference prices for drugs. Conforming with guidelines and (existing) single-tablet regimens play an integral role in maintaining good quality of care.

Smoking and blood DNA methylation: an epigenome-wide association study and assessment of reversibility.

We conducted a genome-wide association study of blood DNA methylation and smoking, attempted replication of previously discovered associations, and assessed the reversibility of smoking-associated methylation changes. DNA methylation was measured in baseline peripheral blood samples for 5,044 participants in the Melbourne Collaborative Cohort Study. For 1,032 participants, these measures were repeated using blood samples collected at follow-up, a median of 11 years later. A cross-sectional analysis of the association between smoking and DNA methylation and a longitudinal analysis of changes in smoking status and changes in DNA methylation were conducted. We used our cross-sectional analysis to replicate previously reported associations for current (N = 3,327) and former (N = 172) smoking. A comprehensive smoking index accounting for the biological half-life of smoking compounds and several aspects of smoking history was constructed to assess the reversibility of smoking-induced methylation changes. This measure of lifetime exposure to smoking allowed us to detect more associations than comparing current with never smokers. We identified 4,496 cross-sectional associations at P < 10-7, including 3,296 annotated to 1,326 genes that were not previously implicated in smoking-associated DNA methylation changes at this significance threshold. We replicated the majority of previously reported associations (P < 10-7) for current and former smokers. In our data, we observed for former smokers a substantial degree of return to the methylation levels of never smokers, compared with current smokers (median: 74%, IQR = 63-86%), corresponding to small values (median: 2.75, IQR = 1.5-5.25) for the half-life parameter of the comprehensive smoking index. Longitudinal analyses identified 368 sites at which methylation changed upon smoking cessation. Our study demonstrates the usefulness of the comprehensive smoking index to detect associations between smoking and DNA methylation at CpGs across the genome, replicates the vast majority of previously reported associations, and quantifies the reversibility of smoking-induced methylation changes.

Real-world treatment for chronic hepatitis C infection in Germany: Analyses from drug prescription data, 2010-2015.

BACKGROUND & AIMS: Direct-acting antivirals (DAAs) for hepatitis C virus (HCV) have strongly improved treatment options since 2014, but it is unclear if treatment numbers have increased. We aimed to estimate the number of treatment regimens per month from 2010-2015 and the number of patients treated and cured with DAAs since 2014, as well as the associated costs. METHODS: Drug prescription data of hepatitis C virus (HCV) antivirals for patients with statutory health insurance in Germany (∼85% of population) from January 2010-December 2015 were evaluated. Standard 28-day prescriptions of pegylated interferon (PegIFN) and 1st/2nd generation DAAs were combined according to treatment guidelines and analysed. Drug costs were calculated from pharmacy sales prices. Mean treatment durations/regimen from real-world data were used to calculate drug costs/regimen and numbers of DAA-treated persons in 2014/15. RESULTS: From January 2010-December 2015 PegIFN/ribavirin-treatments/month decreased from ∼6500 to ∼650. Monthly HCV-prescriptions rose with the approval of 1st generation DAAs (2011), and decreased at the end of 2013. With the approval of 2nd generation DAAs, prescriptions/month increased (peak: ∼6600; March 2015), and subsequently decreased (∼4000; December 2015). In 2014, ∼7000 patients were treated with DAAs, and ∼20,100 in 2015. Treatment costs/month were stable at 12 million EUR (2010-2011), increased to ∼38 million EUR (March 2012), and peaked to 150 million EUR (March 2015). DAA-drug costs/year added up to ∼664million EUR (2014) and ∼1.3billion EUR (2015). CONCLUSIONS: Despite an increase in DAA prescriptions, in December 2015 less persons/month were under treatment compared to January 2010, even though access to DAAs is not limited. However, yearly treatment numbers increased from 2014-2015. Under observed conditions, ∼18,000 patients/year can be cured, making substantial reduction of the estimated 160,000 diagnosed patients realizable. Political commitment to achieve further reduce DAA-prices and increase treatment numbers is recommended. LAY SUMMARY: New treatment options with all-oral second generation direct-acting antivirals (DAAs) have resulted in the potential to cure chronic hepatitis C infection, but at high costs. Analyses from HCV drug prescription data of patients with statutory health insurance in Germany from 2010-2015, showed that DAAs replaced treatments with pegylated interferon and ribavirin, but accompanied by a disproportionate rise in costs. Although the monthly number of patients under treatment did not increase over time, the total number of patients yearly treated with DAAs increased from ∼7000 patients in 2014 to ∼20,100 in 2015, with a trend to shorter treatment regimens. Under observed conditions ∼18,000 patients can be cured yearly, making a substantial reduction of the estimated 160,000 diagnosed patients in Germany achievable.

A systematic characterization of the low-energy photon response of plastic scintillation detectors.

To characterize the low energy behavior of scintillating materials used in plastic scintillation detectors (PSDs), 3 PSDs were developed using polystyrene-based scintillating materials emitting in different wavelengths. These detectors were exposed to National Institute of Standards and Technology (NIST)-matched low-energy beams ranging from 20 kVp to 250 kVp, and to (137)Cs and (60)Co beams. The dose in polystyrene was compared to the dose in air measured by NIST-calibrated ionization chambers at the same location. Analysis of every beam quality spectrum was used to extract the beam parameters and the effective mass energy-absorption coefficient. Monte Carlo simulations were also performed to calculate the energy absorbed in the scintillators' volume. The scintillators' expected response was then compared to the experimental measurements and an energy-dependent correction factor was identified to account for low-energy quenching in the scintillators. The empirical Birks model was then compared to these values to verify its validity for low-energy electrons. The clear optical fiber response was below 0.2% of the scintillator's light for x-ray beams, indicating that a negligible amount of fluorescence contamination was produced. However, for higher-energy beams ((137)Cs and (60)Co), the scintillators' response was corrected for the Cerenkov stem effect. The scintillators' response increased by a factor of approximately 4 from a 20 kVp to a (60)Co beam. The decrease in sensitivity from ionization quenching reached a local minimum of about [Formula: see text] between 40 keV and 60 keV x-ray beam mean energy, but dropped by 20% for very low-energy (13 keV) beams. The Birks model may be used to fit the experimental data, but it must take into account the energy dependence of the kB quenching parameter. A detailed comprehension of intrinsic scintillator response is essential for proper calibration of PSD dosimeters for radiology.

Supercomputing enabling exhaustive statistical analysis of genome wide association study data: Preliminary results.

Most published GWAS do not examine SNP interactions due to the high computational complexity of computing p-values for the interaction terms. Our aim is to utilize supercomputing resources to apply complex statistical techniques to the world's accumulating GWAS, epidemiology, survival and pathology data to uncover more information about genetic and environmental risk, biology and aetiology. We performed the Bayesian Posterior Probability test on a pseudo data set with 500,000 single nucleotide polymorphism and 100 samples as proof of principle. We carried out strong scaling simulations on 2 to 4,096 processing cores with factor 2 increments in partition size. On two processing cores, the run time is 317h, i.e. almost two weeks, compared to less than 10 minutes on 4,096 processing cores. The speedup factor is 2,020 that is very close to the theoretical value of 2,048. This work demonstrates the feasibility of performing exhaustive higher order analysis of GWAS studies using independence testing for contingency tables. We are now in a position to employ supercomputers with hundreds of thousands of threads for higher order analysis of GWAS data using complex statistics.

The 'wise list'- a comprehensive concept to select, communicate and achieve adherence to recommendations of essential drugs in ambulatory care in Stockholm.

The aim was to present and evaluate the impact of a comprehensive strategy over 10 years to select, communicate and achieve adherence to essential drug recommendations (EDR) in ambulatory care in a metropolitan healthcare region. EDRs were issued and launched as a 'Wise List' by the regional Drug and Therapeutics Committee in Stockholm. This study presents the concept by: (i) documenting the process for selecting, communicating and monitoring the impact of the 'Wise List'; (ii) analysing the variation in the number of drug substances recommended between 2000 and 2010; (iii) assessing the attitudes to the 'Wise List' among prescribers and the public; (iv) evaluating the adherence to recommendations between 2003 and 2009. The 'Wise List' consistently contained 200 drug substances for treating common diseases. The drugs were selected based on their efficacy, safety, suitability and cost-effectiveness. The 'Wise List' was known among one-third of a surveyed sample of the public in 2002 after initial marketing campaigns. All surveyed prescribers knew about the concept and 81% found the recommendations trustworthy in 2005. Adherence to recommendations increased from 69% in 1999 to 77% in 2009. In primary care, adherence increased from 83% to 87% from 2003 to 2009. The coefficient of variation (CV%) decreased from 6.1% to 3.8% for 156 healthcare centres between these years. The acceptance of the 'Wise List' in terms of trust among physicians and among the public and increased adherence may be explained by clear criteria for drug recommendations, a comprehensive communication strategy, electronic access to recommendations, continuous medical education and involvement of professional networks and patients.

Straight talk: new approaches in healthcare. Physician practice turnaround in an integrated delivery system.

This is the second installment in a series of group discussions by top executives on key issues in healthcare today. Straight Talk is present by Modern Healthcare and PricewaterhouseCoopers. This session tackles the subject of physician practice turnaround in an Integrated Delivery System. The discussion was held on March 5, 2002 at Modern Healthcare's Chicago headquarters, moderated by Charles S. Lauer.