How intervention studies measure the effectiveness of medication safety-related clinical decision support systems in primary and long-term care: a systematic review.

BACKGROUND: Medication errors and associated adverse drug events (ADE) are a major cause of morbidity and mortality worldwide. In recent years, the prevention of medication errors has become a high priority in healthcare systems. In order to improve medication safety, computerized Clinical Decision Support Systems (CDSS) are increasingly being integrated into the medication process. Accordingly, a growing number of studies have investigated the medication safety-related effectiveness of CDSS. However, the outcome measures used are heterogeneous, leading to unclear evidence. The primary aim of this study is to summarize and categorize the outcomes used in interventional studies evaluating the effects of CDSS on medication safety in primary and long-term care. METHODS: We systematically searched PubMed, Embase, CINAHL, and Cochrane Library for interventional studies evaluating the effects of CDSS targeting medication safety and patient-related outcomes. We extracted methodological characteristics, outcomes and empirical findings from the included studies. Outcomes were assigned to three main categories: process-related, harm-related, and cost-related. Risk of bias was assessed using the Evidence Project risk of bias tool. RESULTS: Thirty-two studies met the inclusion criteria. Almost all studies (n = 31) used process-related outcomes, followed by harm-related outcomes (n = 11). Only three studies used cost-related outcomes. Most studies used outcomes from only one category and no study used outcomes from all three categories. The definition and operationalization of outcomes varied widely between the included studies, even within outcome categories. Overall, evidence on CDSS effectiveness was mixed. A significant intervention effect was demonstrated by nine of fifteen studies with process-related primary outcomes (60%) but only one out of five studies with harm-related primary outcomes (20%). The included studies faced a number of methodological problems that limit the comparability and generalizability of their results. CONCLUSIONS: Evidence on the effectiveness of CDSS is currently inconclusive due in part to inconsistent outcome definitions and methodological problems in the literature. Additional high-quality studies are therefore needed to provide a comprehensive account of CDSS effectiveness. These studies should follow established methodological guidelines and recommendations and use a comprehensive set of harm-, process- and cost-related outcomes with agreed-upon and consistent definitions. PROSPERO REGISTRATION: CRD42023464746.

Health economic evaluation of an electronic mindfulness-based intervention (eMBI) to improve maternal mental health during pregnancy - a randomized controlled trial (RCT).

BACKGROUND: Anxiety and depression are the most prevalent psychiatric diseases in the peripartum period. They can lead to relevant health consequences for mother and child as well as increased health care resource utilization (HCRU) and related costs. Due to the promising results of mindfulness-based interventions (MBI) and digital health applications in mental health, an electronic MBI on maternal mental health during pregnancy was implemented and assessed in terms of transferability to standard care in Germany. The present study focused the health economic outcomes of the randomized controlled trial (RCT). METHODS: The analysis, adopting a payer's and a societal perspective, included women of increased emotional distress at < 29 weeks of gestation. We applied inferential statistics (α = 0.05 significance level) to compare the intervention group (IG) and control group (CG) in terms of HCRU and costs. The analysis was primarily based on statutory health insurance claims data which covered the individual observational period of 40 weeks. RESULTS: Overall, 258 women (IG: 117, CG: 141) were included in the health economic analysis. The results on total health care costs from a payer's perspective indicated higher costs for the IGi compared to the CG (Exp(ß) = 1.096, 95% CI: 1.006-1.194, p = 0.037). However, the estimation was not significant after Bonferroni correction (p < 0.006). Even the analysis from a societal perspective as well as sensitivity analyses did not show significant results. CONCLUSIONS: In the present study, the eMBI did neither reduced nor significantly increased health care costs. Further research is needed to generate robust evidence on eMBIs for women suffering from peripartum depression and anxiety. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00017210. Registered on 13 January 2020. Retrospectively registered.

[INTEGRATE-ADHD: Comparison and Integration of Administrative and Epidemiological ADHD Diagnosis Data through Clinical Assessment - Presentation of the Project]. / INTEGRATE-ADHD: Vergleich und Integration administrativer und epidemiologischer ADHS-Diagnosedaten durch klinisches Assessment ­ Vorstellung des Projekts.

As one of the most frequently diagnosed mental disorders in children and adolescents with sometimes serious individual, family and social consequences, attention deficit/hyperactivity disorder (ADHD) is highly relevant to society and health policy. In Germany, data from statutory health insurance companies has reported increasing ADHD diagnosis prevalence rates over years, while epidemiological data has shown constant and recently even decreasing prevalence rates. The clinical validity of diagnoses from either data sources is unknown. In the framework of the consortium project INTEGRATE-ADHD, 5461 parents of children aged 0 to 17 years with a confirmed administrative ADHD diagnosis insured with the third-largest German statutory health insurance provider (DAK-Gesundheit) in at least one quarter of 2020 were surveyed with the questionnaires from the epidemiological German Health Interview and Examination Survey (KiGGS study) and its in-depth module on child mental health (BELLA study) on their child's ADHD diagnosis and symptoms and on other topics, including comorbidity, utilisation of healthcare services, quality of care and satisfaction, psychosocial risk and protective factors and health-related quality of life. In addition, a subsample of 202 children and adolescents with a clinical diagnosis based on the AMWF S3 guideline on ADHD was analysed. An important aim of the project is to use data linkage on person-level to identify possible causes for the often divergent prevalence estimates from epidemiological and administrative data and to integrate and validate the data sources using a guideline-based clinical diagnosis, thereby contributing to a more accurate population-based prevalence estimate of ADHD in children and adolescents and clarifying actual or supposed contradictions between the data sources. The INTEGRATE-ADHD data linkage project combines administrative, epidemiological and clinical ADHD diagnosis data to create a "three-dimensional view" of the ADHD diagnosis. The results will be used to identify fields of action for healthcare policy and self-administration in the German healthcare system and to derive recommendations for the actors and stakeholders in the field of ADHD. The first results will be published in 2024.

Comparing the EQ-5D-5L and stroke impact scale 2.0 in stroke patients: an analysis of measurement properties.

BACKGROUND: Stroke has evolved to become a chronic disease and a major public health challenge. To adequately capture the full disease burden of stroke patients, the assessment of health-related quality of life (HRQoL) and thus the performance of respective measures is increasingly relevant. The aim of this analysis was to compare the measurement properties of two self-report instruments, the EQ-5D-5L and the Stroke Impact Scale 2.0. METHODS: The data used for the analysis was derived from a quasi-experimental case management study for mildly to moderately affected incident stroke and transient ischemic attack (TIA) patients aged ≥ 18 in Germany. Data was collected patient-individually at 3, 6 and 12 months after initial stroke. The EQ-5D-5L and SIS 2.0 were compared in terms of feasibility, ceiling and floor effects, responsiveness and known-groups validity (Kruskal-Wallis H and Wilcoxon rank-sum test). RESULTS: A response for all three follow-ups is available for n = 855 patients. The feasibility of the EQ-5D-5L is determined as good (completion rate: 96.4-96.6%, ≥ one item missing: 3.2 - 3.3%), whereas the SIS 2.0 is moderately feasible (overall completion rate: 44.9-46.1%, ≥ one item missing in domains: 4.7 - 28.7%). The SIS 2.0 shows substantial ceiling effects in comparable domains (physical function: 10.4 - 13%, others: 3.5-31.3%) which are mainly larger than ceiling effects in the EQ-5D-5L index (17.1-21.5%). In terms of responsiveness, the EQ-5D-5L shows small to moderate change while the SIS 2.0 presents with moderate to large responsiveness. The EQ-5D-5L index, mobility, usual activities and Visual Analogue Scale show known-groups validity (p < 0.05). Content-related domains of the SIS 2.0 show known-groups validity as well (p < 0.05). However, it is compromised in the emotion domain in both measures (p > 0.05). CONCLUSIONS: The EQ-5D-5L seems to be slightly more suitable for this cohort. Nonetheless, the results of both measures indicate limited suitability for TIA patients. Large-scale studies concerning responsiveness and known-groups validity are encouraged. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register, retrospective registration on 21.09.2022. REGISTRATION ID: DRKS00030297.

Secondary Prevention via Case Managers in Stroke Patients: A Cost-Effectiveness Analysis of Claims Data from German Statutory Health Insurance Providers.

Strokes remain a leading cause of death and disability worldwide. The STROKE OWL study evaluated a novel case management approach for patients with stroke (modified Rankin Scale 0-4) or transient ischemic attack (TIA) who received support across healthcare settings and secondary prevention training from case managers for one year. The primary aim of this quasi-experimental study was a reduction in stroke recurrence. Here, we report the results of a health economic analysis of the STROKE OWL study, conducted in accordance with CHEERS guidelines. The calculations were based on claims data of cooperating statutory health insurance companies. In addition to a regression analysis for cost comparison, the incremental cost-effectiveness ratio was determined, and a probabilistic sensitivity analysis was carried out. In total, 1167 patients per group were included in the analysis. The intervention group incurred 32.3% higher direct costs (p < 0.001) than the control group. With a difference of EUR 1384.78 (95% CI: [1.2384-1.4143], p < 0.0001) and a 5.32% increase in hazards for the intervention group (HR = 1.0532, 95% CI: [0.7869-1.4096], p = 0.7274) resulting in an ICER of EUR 260.30, we found that the case management intervention dominated in the total stroke population, even for an arbitrarily high willingness to pay. In the TIA subgroup, however, the intervention was cost-effective even for a low willingness to pay. Our results are limited by small samples for both TIA and severe stroke patients and by claims data heterogeneity for some cost components, which had to be excluded from the analysis. Future research should investigate the cost-effectiveness of case management interventions for both severe stroke and TIA populations using appropriate data.

A case management intervention in stroke care: Evaluation of a quasi-experimental study.

BACKGROUND: Patients with initial stroke or transient ischemic attack (TIA) are at high risk for further strokes, death or cardiovascular events. Even the first-ever stroke is associated with a high chance of disability and need for assistance. The risk of long-term health care demands increases with each subsequent event. Although the inpatient sector already provides a high standard of care in Germany, it can be difficult to obtain cross-sectoral aftercare. Thus, the study investigated whether a structured case management program can avoid stroke recurrences. METHODS: The study was conducted with a quasi-experimental study design in three regions in North Rhine-Westphalia. Patients with first-ever stroke or TIA were eligible to participate. The intervention group was prospectively recruited and supported by a case manager during a one-year follow-up. Optimal Full Matching was used to generate a control group based on statutory claims data. The primary outcome was the stroke recurrence. Recurrence and mortality were analysed by using Cox regression; other secondary outcomes were examined with test-based procedures and with logistic regressions. Additionally, subgroup analyses were performed. RESULTS: From June 2018 to March 2020, 1,512 patients were enrolled in the intervention group. Claims data from 19,104 patients have been transmitted for establishing the control group. After the matching process, 1,167 patients of each group were included in the analysis. 70 recurrences (6.0%) occurred in the intervention group and 67 recurrences (5.7%) in the control group. With a hazard ratio of 1.06 (95% CI: [1.42-0.69]; p=0.69), no significant effect was found for the primary outcome. With regard to the secondary outcome mortality, 36 patients in the intervention group and 46 in the control group died (3.1% vs. 3.9%). Again, there was no significant effect (HR: 0.86; 95% CI: [0.58-1.28], p=0.46). DISCUSSION: Based on the present findings, the case management approach for stroke patients evaluated here was unable to demonstrate an improvement in health care. Potential effects of case management might not be adequately depicted in short observation periods. Thus, future studies should consider longer observation periods. CONCLUSION: A panel of experts should discuss whether the core approach of case management to support cost-intensive individual cases is contrary to a broad implementation with a one-size-fits-all intervention for stroke patients. In this case, further research should focus on more specific study populations.

Modelling the Public Health Impact of MenACWY and MenC Adolescent Vaccination Strategies in Germany.

INTRODUCTION: Invasive meningococcal disease (IMD) causes significant mortality and long-term sequelae. This study assesses the potential public health impact of adolescent vaccination strategies employing MenACWY and MenC vaccines in Germany, where the existing meningococcal immunisation programme predominantly involves MenC administration in toddlers. METHODS: A dynamic transmission model was developed to simulate the carriage of five meningococcal serogroup compartments (AY/B/C/W/Other) from 2019 until 2060 within 1-year age groups from 0 to 99 years of age. IMD cases were estimated based on case-carrier ratios. The model considered vaccine effectiveness against carriage acquisition and IMD. RESULTS: The model predicts that introducing MenACWY adolescent vaccination could lead to a considerable reduction in IMD incidence, with the potential to prevent up to 65 cases per year and a cumulative total of 1467 cases by 2060. This decrease, mainly driven by herd effects, would result in a reduction of IMD incidence across all age groups, regardless of vaccination age. Furthermore, implementing MenACWY vaccination in adolescents is projected to decrease annual MenACWY-related IMD mortality by up to 64%, equating to an overall prevention of 156 IMD deaths by 2060. These protective outcomes are expected to culminate in approximately 2250 life years gained (LYG) throughout the model's projected time horizon. In contrast, the adoption of MenC vaccination in adolescents is predicted to have minimal influence on both IMD incidence and mortality, as well as on LYG. CONCLUSION: The results of this study demonstrate that implementing MenACWY vaccination for adolescents in Germany is likely to notably reduce IMD incidence and mortality across age groups. However, the introduction of MenC adolescent vaccination shows only limited impact. Considering the extensive healthcare resources typically required for IMD management, these findings suggest the potential for economic benefits associated with the adoption of MenACWY adolescent vaccination, warranting further cost-effectiveness analysis.

Digital Medication Management in Polypharmacy.

BACKGROUND: Inappropriate drug prescriptions for patients with polypharmacy can have avoidable adverse consequences. We studied the effects of a clinical decision-support system (CDSS) for medication management on hospitalizations and mortality. METHODS: This stepped-wedge, cluster-randomized, controlled trial involved an open cohort of adult patients with polypharmacy in primary care practices (=clusters) in Westphalia-Lippe, Germany. During the period of the intervention, their medication lists were checked annually using the CDSS. The CDSS warns against inappropriate prescriptions on the basis of patient-related health insurance data. The combined primary endpoint consisted of overall mortality and hospitalization for any reason. The secondary endpoints were mortality, hospitalizations, and high-risk prescription. We analyzed the quarterly health insurance data of the intention- to-treat population with a mixed logistic model taking account of clustering and repeated measurements. Sensitivity analyses addressed effects of the COVID-19 pandemic and other effects. RESULTS: 688 primary care practices were randomized, and data were obtained on 42 700 patients over 391 994 quarter years. No significant reduction was found in either the primary endpoint (odds ratio [OR] 1.00; 95% confidence interval [0.95; 1.04]; p = 0.8716) or the secondary endpoints (hospitalizations: OR 1.00 [0.95; 1.05]; mortality: OR 1.04 [0.92; 1.17]; high-risk prescription: OR 0.98 [0.92; 1.04]). CONCLUSION: The planned analyses did not reveal any significant effect of the intervention. Pandemicadjusted analyses yielded evidence that the mortality of adult patients with polypharmacy might potentially be lowered by the CDSS. Controlled trials with appropriate follow-up are needed to prove that a CDSS has significant effects on mortality in patients with polypharmacy.

Risk factors for herpes zoster infections: a systematic review and meta-analysis unveiling common trends and heterogeneity patterns.

PURPOSE: The burden of herpes zoster (HZ) is substantial and numerous chronic underlying conditions are known as predisposing risk factors for HZ onset. Thus, a comprehensive study is needed to synthesize existing evidence. This study aims to comprehensively identify these risk factors. METHODS: A systematic literature search was done using MEDLINE via PubMed, EMBASE and Web of Science for studies published from January 1, 2003 to January 1, 2023. A random-effects model was used to estimate pooled Odds Ratios (OR). Heterogeneity was assessed using the I2 statistic. For sensitivity analyses basic outlier removal, leave-one-out validation and Graphic Display of Heterogeneity (GOSH) plots with different algorithms were employed to further analyze heterogeneity patterns. Finally, a multiple meta-regression was conducted. RESULTS: Of 6392 considered records, 80 were included in the meta-analysis. 21 different conditions were identified as potential risk factors for HZ: asthma, autoimmune disorders, cancer, cardiovascular disorders, chronic heart failure (CHF), chronic obstructive pulmonary disorder (COPD), depression, diabetes, digestive disorders, endocrine and metabolic disorders, hematological disorders, HIV, inflammatory bowel disease (IBD), mental health conditions, musculoskeletal disorders, neurological disorders, psoriasis, renal disorders, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and transplantation. Transplantation was associated with the highest risk of HZ (OR = 4.51 (95% CI [1.9-10.7])). Other risk factors ranged from OR = 1.17-2.87, indicating an increased risk for all underlying conditions. Heterogeneity was substantial in all provided analyses. Sensitivity analyses showed comparable results regarding the pooled effects and heterogeneity. CONCLUSIONS: This study showed an increased risk of HZ infections for all identified factors.