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.

Epidemiology of Pertussis and Pertussis-Related Complications in Adults: A German Claims Data Analysis.

INTRODUCTION: Pertussis is a highly contagious respiratory infection. It affects people of all ages, yet evidence of the impact of pertussis in adults with underlying conditions (UCs) is scarce. This study investigated the incidence and complication rate of pertussis in adult patients with and without UC. METHODS: A retrospective analysis was conducted using routinely collected German claims data between 2015 and 2019. Patients with and without different pneumological, cardiovascular, endocrinological, musculoskeletal, and psychological UCs were matched for incidence estimation. Logistic regression models were used to estimate the risk of pertussis depending on the presence of UCs. Negative binomial models were used to assess complication rates in patients with pertussis and with and without UC. RESULTS: In total, 4383 patients were diagnosed with pertussis during the study period. Patients with any UC had an increased risk for pertussis compared to matched patients without UC (odds ratio [OR] 1.72; 95% confidence interval [CI]1.60-1.84, p < 0.0001). Underlying asthma had the highest risk of pertussis (OR 2.70; 95% CI 2.50-2.91, p < 0.0001), followed by chronic obstructive pulmonary disease (OR 2.35; 95% CI 2.10-2.60, p < 0.0001) and depression (OR 2.08; 95% CI 1.95-2.22, p < 0.0001). Severe complications occurred in 10.8% of the pertussis cohort (13.4% with UC vs. 9.5% without UC). The UC-attributable effect on the risk of severe pertussis-related complications was significantly increased for any UC (incidence rate ratio [IRR] 1.29, 95% CI 1.19-1.39). The severe complication risk was also increased for patients aged 60+ (IRR 1.59, 95% CI 1.46-1.72). CONCLUSION: This study shows that adults with certain UCs have an increased risk for pertussis and are more likely to have complications. These results provide further evidence that pertussis is a relevant and impactful infectious disease in adults with and without certain UC, indicating that these patients need to be considered when developing vaccination recommendations to avoid pertussis and its associated complications. A graphical abstract is available with this article.

Markov-modulated marked Poisson processes for modeling disease dynamics based on medical claims data.

We explore Markov-modulated marked Poisson processes (MMMPPs) as a natural framework for modeling patients' disease dynamics over time based on medical claims data. In claims data, observations do not only occur at random points in time but are also informative, that is, driven by unobserved disease levels, as poor health conditions usually lead to more frequent interactions with the health care system. Therefore, we model the observation process as a Markov-modulated Poisson process, where the rate of health care interactions is governed by a continuous-time Markov chain. Its states serve as proxies for the patients' latent disease levels and further determine the distribution of additional data collected at each observation time, the so-called marks. Overall, MMMPPs jointly model observations and their informative time points by comprising two state-dependent processes: the observation process (corresponding to the event times) and the mark process (corresponding to event-specific information), which both depend on the underlying states. The approach is illustrated using claims data from patients diagnosed with chronic obstructive pulmonary disease by modeling their drug use and the interval lengths between consecutive physician consultations. The results indicate that MMMPPs are able to detect distinct patterns of health care utilization related to disease processes and reveal interindividual differences in the state-switching dynamics.

[Level of Use and User Groups of Online Video Consultations in Outpatient Medical Care: Analysis of Claims Data]. / Nutzungsgrad und Nutzergruppen der Online-Videosprechstunde in der ambulanten ärztlichen Versorgung ­ Eine Routinedatenanalyse.

OBJECTIVE: Despite perceived potentials, billability as a standard service to the statutory health insurance (SHI) and various promotional measures, online video consultation has not yet established itself as a fixed component of everyday outpatient care. Longer-term quantitative studies on the degree of utilisation have been lacking so far. However, these are essential for a better understanding of diffusion processes and the effects of promotional measures. The present study represents a first step towards a continuous examination. METHODS: The utilisation of video consultations in outpatient care was examined from the beginning of their reimbursability in April 2017 until the end of 2018. In order to get an overview of the user groups, relevant physician and patient characteristics (specialist group, age, region) that can be depicted in the billing data were also investigated. RESULTS: During the 21 months of the observation period, a total of 320 video consultations were conducted, with monthly usage figures in 2018 already twice as high as in 2017. Overall, 105 insurants used at least one video consultation (average age 74.6 years; 59.8 from urban regions). Among the 30 doctors who used video consultation, 36.7% were general practitioners, representing the largest group of physicians. CONCLUSION: The study underlines the low significance of online video consultations in outpatient care in the first 21 months after their introduction. The results are in line with previous findings from short-term analyses and demoscopic studies. They also point to initial usage trends that need to be further investigated with extended observation periods and broader data bases across several more statutory insurance companies.

Developing and testing a cognitive bolt-on for the EQ-5D-Y (Youth).

PURPOSE: The aim of this study was to develop and test a cognitive dimension as a bolt-on for the German version of the EQ-5D-Y (Youth). METHODS: A literature review and six focus groups with children and adolescents were used to develop the cognitive dimension for the EQ-5D-Y. In a two-phase pretest, the acceptability, feasibility and performance of this dimension were assessed (phase 1: qualitative face-to-face interviews, phase 2: standard pretest in a clinical setting). In total, 280 children and adolescents participated in this study. RESULTS: School performance, concentration, memory and learning ability represent the most important components of cognitive functioning in children and adolescents. Hence, those components were incorporated into the cognitive dimension of the EQ-5D-Y by adding four items. For children and adolescents living with a rheumatic disorder or type 1 diabetes mellitus, the EQ-5D-Y plus a cognitive bolt-on demonstrated good acceptability, feasibility and performance. The cognitive items improved the explanatory power for the EQ visual analogue scale (EQ-VAS). Factor analysis has shown that a reduction of the cognitive bolt-on into one or two item(s) is justifiable. CONCLUSION: By enhancing the EQ-5D-Y with a cognitive bolt-on, we developed an instrument that incorporates current findings on Health-Related Quality of Life (HRQoL) and is suitable for the target population. Empirical results of this study show that cognitive functioning is an important part of HRQoL assessment in children and adolescents. The inclusion of a cognitive dimension in the EQ-5D-Y improves the HRQoL measurement.

[Individual megaspacers in two-stage revision of infected total hip arthroplasty-clinical and functional results after 2 years : Individual metal-endoskeleton cement spacer (iMECS)]. / Individuelle Megaspacer für den zweizeitigen Wechsel infizierter Hüftendoprothesen ­ klinisches und funktionelles Outcome nach 2 Jahren : Individuelle Metallendoskelett-Zementspacer (iMECS).

BACKGROUND: Large femoral defects in late periprosthetic infection (PPI) after total hip arthroplasty (THA) often require the use of large, individual metal endoskeleton-reinforced cement spacers (iMECS). OBJECTIVES: The aim was to record the clinical, radiological and functional results (Harris Hip Score HHS) up to the 2 years after treatment of a PPI using an iMECS. Major patient-specific parameters were to be evaluated with regard to the treatment outcome. MATERIALS AND METHODS: The collective of this single-center retrospective cohort study comprised 29 patients. The mean follow-up was 24.4 months (range: 23.0 to 27.6 months). The absence of infection after endoprosthetic hip joint reconstruction was rated as successful treatment. The two patient groups (successful (S)/not successful (nS)) were compared with regard to gender distribution, the Charlson comorbidity index (CCI), the number of previous septic changes, and the rate of polymicrobial and difficult-to-treat infections. RESULTS: The average CCI in the total collective was 6.4 points. Joint reconstruction was possible in 23 of 29 patients (79%); 2 years after PPI treatment 4 patients were not available for a follow-up examination (2 deceased, 2 unable to participate). At the time of the follow-up, 17 of the 29 patients had received a joint reconstruction and were free of infection, with an average HHS of 75 points. There were no iMECS-associated complications requiring revision. Only the initial CCI (S: 4.1 points; nS: 9.7 points) differed significantly between the patient groups (p < 0.05). CONCLUSIONS: In the case of large femoral defects, iMECS provide secure temporary stabilization. The chance of a successful joint reconstruction is closely related to the individual comorbidities profile.

Patient-Reported Financial Distress in Cancer: A Systematic Review of Risk Factors in Universal Healthcare Systems.

Financial toxicity is a side effect of cancer that results from the perceived financial distress an individual may experience in the course of the disease. The purpose of this paper is to analyse underlying factors related to subjective financial distress in high-income countries with universal healthcare coverage. A systematic literature review was conducted to identify qualitative and quantitative studies of cancer patient-reported subjective financial distress by performing a search in the databases of PubMed, PsycINFO and CINAHL up to December 2020. A qualitative synthesis was performed linking the time-dependent occurrence of risk factors to derived categories of risk factors. Out of 4321 identified records, 30 quantitative and 16 qualitative studies were eligible. Classification of risk factors resulted in eight categories with a total of 34 subcategories. Subjective financial distress is primarily determined by pre-diagnosis sociodemographic- factors as well as financial and work factors that might change during the course of the disease. The design of healthcare and social security systems shapes the country-specific degree of subjective financial distress. Further research should focus on evolving multidisciplinary intervention schemes and multidimensional instruments for subjective financial distress to account for identified risk factors in universal healthcare systems more precisely.

Effectiveness of the application of an electronic medication management support system in patients with polypharmacy in general practice: a study protocol of cluster-randomised controlled trial (AdAM).

INTRODUCTION: Clinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy. METHODS AND ANALYSIS: Planned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter. SCOPE: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients. POPULATION: patients (≥18 years) with polypharmacy (≥5 prescriptions). SAMPLE SIZE: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved. INTERVENTION: complex intervention eMMa. FOLLOW-UP: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa. OUTCOMES: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse. STATISTICAL ANALYSIS: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints. ETHICS AND DISSEMINATION: Trial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences. TRIAL REGISTRATION: NCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336).

Development and Evaluation of a Decision Aid to Support Patients' Participatory Decision-Making for Tumor-Specific and Palliative Therapy for Advanced Cancer: Protocol for a Pre-Post Study.

BACKGROUND: To support advanced cancer patients and their oncologists in therapeutic decisions, we aim to develop a decision aid (DA) in a multiphased, bicentric study. The DA aims to help patients to better understand risks and benefits of the available treatment options including the options of standard palliative care or cancer-specific treatment (ie, off-label drug use within an individual treatment plan). OBJECTIVE: This study protocol outlines the development and testing of the DA in a pre-post study targeting a heterogeneous population of advanced cancer patients. METHODS: In the first step, we will assess patients' information and decisional needs as well as the views of the health care providers regarding the content and implementation of the DA. Through a scoping review, we aim to analyze specific characteristics of the decision-making process and to specify the treatment options, outcomes, and probabilities. An interdisciplinary research group of experts will develop and review the DA. In the second step, testing of the DA (design and field testing) with patients and oncologists will be conducted. As a last step, we will run a pre-post design study with 70 doctor-patient encounters to assess improvements on the primary study outcome: patients' level of decisional conflict. In addition, the user acceptance of all involved parties will be tested. RESULTS: Interviews with cancer patients, oncologists, and health care providers (ie, nurses, nutritionists) as well as a literature review from phase I have been completed. The field testing is scheduled for April 2021 to August 2021, with the final revision scheduled for September 2021. The pre-post study of the DA and acceptance testing are scheduled to start in October 2021 and shall be finished in September 2022. CONCLUSIONS: A unique feature of this study is the development of a DA for patients with different types of advanced cancer, which covers a wide range of topics relevant for patients near the end of life such as forgoing cancer-specific therapy and switching to best supportive care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04606238; https://clinicaltrials.gov/ct2/show/NCT04606238. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24954.

[Individual financial burden following a cancer diagnosis from the perspective of social services in Germany]. / Individuelle finanzielle Belastungen infolge einer Krebserkrankung aus der Perspektive von Sozialdiensten in Deutschland.

BACKGROUND: In addition to physical, psychological and social effects, economic effects and the associated financial burden of a cancer diagnosis may also gain in importance during prolonged disease progression. Counselling by social services is an important factor in coping with this burden. METHODS: People employed in social work in oncology were invited to participate in a survey. The survey comprises 16 items on the perception of financial burdens, changes in the relevance of the topic, risk factors and current counselling practice. RESULTS: 81% of the respondents reported that the financial burden arising from a cancer diagnosis is a relevant topic of consultation for at least half of the patients. For 55%, this topic has become more important in recent years, which is due to higher survival rates, an increased number of younger patients, and poorer social security and working conditions. DISCUSSION AND CONCLUSION: Despite comprehensive insurance coverage, the financial burden of cancer patients has also gained in importance in Germany and must be increasingly taken into account in everyday social service counselling. Due to numerous risk factors and complex reasons, further measures are required to enable the early identification of risk constellations and to improve the situation of those affected.

The patient-level effect of the cost of Cancer care - financial burden in German Cancer patients.

BACKGROUND: Financial toxicity of cancer has so far been discussed primarily in the US health care system and is associated with higher morbidity and mortality. In European health care systems, the socio-economic impact of cancer is poorly understood. This study investigates the financial burden and patient-reported outcomes of neuroendocrine (NET) or colorectal (CRC) cancer patients at a German Comprehensive Cancer Center. METHODS: This prospective cross-sectional study surveyed 247 advanced stage patients (n = 122 NET/n = 125 CRC) at the National Center for Tumor Diseases, in Germany about cancer-related out-of-pocket costs, income loss, distress, and quality of life. Multiple linear regression analysis was performed to demonstrate the effects of economic deterioration on patients' quality of life and distress. RESULTS: 81% (n = 199) of the patients reported out-of-pocket costs, and 37% (n = 92) income loss as a consequence of their disease. While monthly out-of-pocket costs did not exceed 200€ in 77% of affected patients, 24% of those with income losses reported losing more than 1.200€ per month. High financial loss relative to income was significantly associated with patients' reporting a worse quality of life (p < .05) and more distress (p < .05). CONCLUSIONS: Financial toxicity in third-party payer health care systems like Germany is caused rather by income loss than by co-payments. Distress and reduced quality of life due to financial problems seem to amplify the burden that already results from a cancer diagnosis and treatment. If confirmed at a broader scale, there is a need for targeted support measures at the individual and system level.

[Efficacy of decision support systems to improve medication safety - results of the evaluation of the "Arzneimittelkonto NRW"]. / Wirksamkeit technischer Unterstützungssysteme zur Verbesserung der Arzneimitteltherapiesicherheit ­ Evaluationsergebnisse des Arzneimittelkontos NRW.

Polypharmacy increases the risk of adverse drug reactions, especially in the elderly. Therefore, the reduction of potentially inadequate medication (PIM), an improvement in drug therapy safety and, in general, a more rational use of drugs is an objective of various interventions. The aim of this prospective single-arm interventional study is to investigate the potential of a decision support system (DSS; "Arzneimittelkonto NRW") to improve medication safety in outpatient care. 15 primary care physicians participating in the study recruited 874 patients. Prescription data and results of medication safety tests were available for 654 patients. Data of at least 12 months were available for 86% of these patients. PIM prevalence declined within 12 months (-11.3%), but not at a statistically significant level. The number of prescriptions after the introduction of the DSS is significantly below the prescription volume before the introduction of the DSS (-14.1%). Constantly high alteration rates of up to 85% were observed, for example, on drug interaction system warnings made by the DSS. Technical decision support systems have the potential to support a safer and cost-saving drug use. For the first time, this pilot study provides evidence for this in the context of standard outpatient care in Germany. However, further investigations are necessary to establish a robust body of evidence. A particular focus should be on the qualitative monitoring of the studies and the involvement of other actors in the care process.