Risk of cervical high-grade squamous intraepithelial neoplasia in cytologic negative and persistently high-risk human papillomavirus positive patients according to genotypes: a retrospective single center analysis.

In January 2020, a different cervical cancer screening program started in Germany. Women above the age of 35 are recommended to have a combined HPV and cytology swab every three years. Showing persistent high-risk human papillomavirus (hrHPV), cytologic negative cervical samples at baseline and after 12 months, patients are referred to colposcopy. Entailing considerable additional workload due to the required colposcopies, we analyzed the risk of high-grade cervical intraepithelial neoplasia (CIN 3) in cytologic negative and persistent hrHPV women according to their hrHPV genotypes.Methods In this single center retrospective study, patients with persistent hrHPV, cytology negative cervical samples from our certified Colposcopy Unit in 2020 and 2021 were analyzed. Patient demographics, hrHPV types, biopsy rates and histological reports were collected.Results During the study, 69 patients were enrolled. Most frequent hrHPV genotypes were: hrHPV other 72.5%; HPV 16, 20.3% and HPV 18, 7.2%. Colposcopy showed no or minor changes in 92.7% and major changes in 7.2%. CIN 3 was found in 7 patients (10.1%). Prevalence of CIN 3 by hrHPV genotypes was 27.3% for HPV16, 20.0% for HPV18 and 7.1% for HPVO. A statistically significant dependency between hrHPV and cervical intraepithelial neoplasia was demonstrated (p = 0.048).Conclusion Within this single center study of persistent hrHPV, cytologic negative samples, patients with HPV 16 were more likely to have high-grade disease compared to other hrHPV subtypes. Larger prospective randomized trials are needed to substantiate our results and obtain adjusted cervical cancer screening time intervals according to the hrHPV genotypes.

Therapeutic patterns and migraine disease burden in switchers of CGRP-targeted monoclonal antibodies - insights from the German NeuroTransData registry.

BACKGROUND: Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have shown good efficacy in migraine prophylaxis. However, a subset of patients does not respond to the first mAb treatment and switches among the available mAbs. The goal of this study is to characterize the switching pattern of migraine patients treated with anti-CGRP(-receptor, -R) mAbs, and to describe the headache burden of those who did not switch, switched once, and switched twice. METHODS: This study used real world data from the NeuroTransData Cohort, a registry of migraine patients treated at outpatient neurology clinics across Germany. Patients who had received at least one anti-CGRP(-R) mAb were included. Headache diaries were collected at baseline and during treatment, along with quality of life measures every three months. Results were summarized for the subgroups of patients who did not switch and those with one and two switches. RESULTS: Of the 655 eligible patients, 479 did not switch, 135 switched once, 35 twice, and 6 three or more times. The ≥ 50% response rates for monthly migraine days were 64.7%, 50.7%, and 25.0% for the no switch, one switch, and two switches groups in their last treatment cycles, respectively. Quality of life measures improved for the no switch and one switch groups, but not for the two switches group. CONCLUSION: Patients who switched among anti-CGRP(-R) mAbs during the course of their treatment still benefited overall but to a lesser extent than those who did not switch. Treatment response in patients who switched twice was markedly lower compared to the no switch and one switch subgroup.

COVID-19 Vaccine Effectiveness and Digital Pandemic Surveillance in Germany (eCOV Study): Web Application-Based Prospective Observational Cohort Study.

BACKGROUND: The COVID-19 pandemic posed significant challenges to global health systems. Efficient public health responses required a rapid and secure collection of health data to improve the understanding of SARS-CoV-2 and examine the vaccine effectiveness (VE) and drug safety of the novel COVID-19 vaccines. OBJECTIVE: This study (COVID-19 study on vaccinated and unvaccinated subjects over 16 years; eCOV study) aims to (1) evaluate the real-world effectiveness of COVID-19 vaccines through a digital participatory surveillance tool and (2) assess the potential of self-reported data for monitoring key parameters of the COVID-19 pandemic in Germany. METHODS: Using a digital study web application, we collected self-reported data between May 1, 2021, and August 1, 2022, to assess VE, test positivity rates, COVID-19 incidence rates, and adverse events after COVID-19 vaccination. Our primary outcome measure was the VE of SARS-CoV-2 vaccines against laboratory-confirmed SARS-CoV-2 infection. The secondary outcome measures included VE against hospitalization and across different SARS-CoV-2 variants, adverse events after vaccination, and symptoms during infection. Logistic regression models adjusted for confounders were used to estimate VE 4 to 48 weeks after the primary vaccination series and after third-dose vaccination. Unvaccinated participants were compared with age- and gender-matched participants who had received 2 doses of BNT162b2 (Pfizer-BioNTech) and those who had received 3 doses of BNT162b2 and were not infected before the last vaccination. To assess the potential of self-reported digital data, the data were compared with official data from public health authorities. RESULTS: We enrolled 10,077 participants (aged ≥16 y) who contributed 44,786 tests and 5530 symptoms. In this young, primarily female, and digital-literate cohort, VE against infections of any severity waned from 91.2% (95% CI 70.4%-97.4%) at week 4 to 37.2% (95% CI 23.5%-48.5%) at week 48 after the second dose of BNT162b2. A third dose of BNT162b2 increased VE to 67.6% (95% CI 50.3%-78.8%) after 4 weeks. The low number of reported hospitalizations limited our ability to calculate VE against hospitalization. Adverse events after vaccination were consistent with previously published research. Seven-day incidences and test positivity rates reflected the course of the pandemic in Germany when compared with official numbers from the national infectious disease surveillance system. CONCLUSIONS: Our data indicate that COVID-19 vaccinations are safe and effective, and third-dose vaccinations partially restore protection against SARS-CoV-2 infection. The study showcased the successful use of a digital study web application for COVID-19 surveillance and continuous monitoring of VE in Germany, highlighting its potential to accelerate public health decision-making. Addressing biases in digital data collection is vital to ensure the accuracy and reliability of digital solutions as public health tools.

Nonfinancial Conflict of Interest in Medical Research: Is Regulation the Right Answer.

Medical research plays a vital role in advancing human knowledge, developing new therapies and procedures, and reducing human suffering. Following the atrocities committed in the name of medical research by German physicians during the Nazi era, the Nuremberg trials were held, and an ethical code was created to establish the limits within which medical research can operate. Consequently, legal regimes built upon this ethical foundation to develop laws that ensure the integrity of medical research and the safety of human subjects. These laws sought to protect human subjects by minimizing conflicts of interest that may arise during the process. Furthermore, conflicts of interest may be financial such as monetary gain, or nonfinancial such as promotion and career advancement. However, with a $1.1 billion median cost of developing a new drug, the focus of these laws was directed towards financial conflicts of interest. But should we expand these laws to include nonfinancial conflicts of interest? This Article highlights prominent arguments in favor of and against the regulation of nonfinancial conflicts of interest in medical research. It further concludes that adequate institutional policies--not additional regulations--strike the right balance between the need to safeguard against the harmful effects of nonfinancial conflicts of interest on the one hand and avoiding the drawbacks of overregulation on the other.

Climate protection, health and other motives for active transport - results of a cross-sectional survey in Germany.

BACKGROUND: Active transport- for example walking and bicycling to travel from place to place- may improve physical fitness and health and mitigate climate change if it replaces motorised transport. The aim of this study is to analyse the active transport behaviour of adults living in Germany, to investigate differences among population groups and to determine whether climate protection is a frequent motive for this behaviour. METHODS: This study uses self-reported data of 4,971 adults who participated in a national health survey (German Health Update 2021), which was conducted as a telephone survey from July to December 2021. Associations between active transport behaviour and corresponding motives with sociodemographic and health-related variables were analysed using logistic regression models. RESULTS: Of the adult population, 83% use active transport at least once a week. The frequency and duration of walking per week are significantly higher than those for bicycling (walking 214 min/week; bicycling 57 min/week). Those with a lower education level are less likely to practise active transport than those with a higher education level. Furthermore, women are less likely to use a bicycle for transport than men. Among those practising active transport, the most frequently mentioned motive is "is good for health" (84%) followed by "to be physically active" (74%) and "is good for the climate/environment" (68%). Women and frequent bicyclists (at least 4 days/week) mention climate protection as a motive more often than men and those bicycling occasionally. CONCLUSIONS: The improvement of active transport, especially among people with lower education and women (for bicycling), may benefit from better insights into motives and barriers. Climate protection is an important motivator for practising active transport within the adult population living in Germany and should therefore have greater emphasis in behavioural change programmes.

Implementation of health-related quality of life in the German TraumaRegister DGU® - first results of a pilot study.

BACKGROUND: Approximately 30,000 people are affected by severe injuries in Germany each year. Continuous progress in prehospital and hospital care has significantly reduced the mortality of polytrauma patients. With increasing survival rates, the functional outcome, health-related quality (hrQoL) of life and ability to work are now gaining importance. Aim of the study is, the presentation of the response behavior of seriously injured patients on the one hand and the examination of the factors influencing the quality of life and ability to work 12 months after major trauma on the other hand. Building on these initial results, a standard outcome tool shall be integrated in the established TraumaRegister DGU® in the future. METHODS: In 2018, patients [Injury Severity Score (ISS) ≥ 16; age:18-75 years] underwent multicenter one-year posttraumatic follow-up in six study hospitals. In addition to assessing hrQoL by using the Short-Form Health Survey (SF-12), five additional questions (treatment satisfaction; ability to work; trauma-related medical treatment; relevant physical disability, hrQoL as compared with the prior to injury status) were applied. RESULTS: Of the 1,162 patients contacted, 594 responded and were included in the analysis. The post-injury hrQoL does not show statistically significant differences between the sexes. Regarding age, however, the younger the patient at injury, the better the SF-12 physical sum score. Furthermore, the physically perceived quality of life decreases statistically significantly in relation to the severity of the trauma as measured by the ISS, whereas the mentally perceived quality of life shows no differences in terms of injury severity. A large proportion of severely injured patients were very satisfied (42.2%) or satisfied (39.9%) with the treatment outcome. It should be emphasized that patients with a high injury severity (ISS > 50) were on average more often very satisfied with the treatment outcome (46.7%). A total of 429 patients provided information on their ability to work 12 months post-injury. Here, 194 (45.2%) patients had a full employment, and 58 (13.5%) patients were had a restricted employment. CONCLUSION: The present results show the importance of a structured assessment of the postinjury hrQoL and the ability to work after polytrauma. Further studies on the detection of influenceable risk factors on hrQoL and ability to work in the intersectoral course of treatment should follow to enable the best possible outcome of polytrauma survivors.

Addition of quantitative MRI to the routine clinical care of patients with multiple sclerosis-Results from the MAGNON project.

BACKGROUND: The revised Lublin classification offers a framework for categorizing multiple sclerosis (MS) according to the clinical course and imaging results. Diagnosis of secondary progressive MS (SPMS) is often delayed by a period of uncertainty. Several quantitative magnetic resonance imaging (qMRI) markers are associated with progressive disease states, but they are not usually available in clinical practice. METHODS: The MAGNON project enrolled 629 patients (early relapsing-remitting MS (RRMS), n = 51; RRMS with suspected SPMS, n = 386; SPMS, n = 192) at 55 centers in Germany. Routine magnetic resonance imaging (MRI) scans at baseline and after 12 months were analyzed using a centralized automatic processing pipeline to quantify lesions and normalized brain and thalamic volume. Clinical measures included relapse activity, disability, and MS phenotyping. Neurologists completed questionnaires before and after receiving the qMRI reports. RESULTS: According to the physicians' reports, qMRI results changed their assessment of the patient in 31.8% (baseline scan) and 27.6% (follow-up scan). For ∼50% of patients with RRMS with suspected SPMS, reports provided additional information that the patient was transitioning to SPMS. In >25% of all patients, this information influenced the physicians' assessment of the patient's current phenotype. However, actual changes of treatment were reported only in a minority of these patients. CONCLUSIONS: The MAGNON results suggest that standardized qMRI reports may be integrated into the routine clinical care of MS patients and support the application of the Lublin classification as well as treatment decisions. The highest impact was reported in patients with suspected SPMS, indicating a potential to reduce diagnostic uncertainty.

Long-Term Adoption of Televisits in Nursing Homes During the COVID-19 Crisis and Following Up Into the Postpandemic Setting: Mixed Methods Study.

BACKGROUND: There is growing evidence that telemedicine can improve the access to and quality of health care for nursing home residents. However, it is still unclear how to best manage and guide the implementation process to ensure long-term adoption, especially in the context of a decline in telemedicine use after the COVID-19 crisis. OBJECTIVE: This study aims to identify and address major challenges for the implementation of televisits among residents in a nursing home, their caring nurses, and their treating general practitioners (GPs). It also evaluated the impact of televisits on the nurses' workload and their nursing practice. METHODS: A telemedical system with integrated medical devices was introduced in 2 nursing homes and their cooperating GP offices in rural Germany. The implementation process was closely monitored from the initial decision to introduce telemedicine in November 2019 to its long-term routine use until March 2023. Regular evaluation was based on a mixed methods approach combining rigorous qualitative approaches with quantitative measurements. RESULTS: In the first phase during the COVID-19 pandemic, both nursing homes achieved short-term adoption. In the postpandemic phase, an action-oriented approach made it possible to identify barriers and take control actions for long-term adoption. The implementation of asynchronous visits, strong leadership, and sustained training of the nurses were critical elements in achieving long-term implementation in 1 nursing home. The implementation led to enhanced clinical skills, higher professional recognition, and less psychological distress among the nursing staff. Televisits resulted in a modest increase in time demands for the nursing staff compared to organizing in-person home visits with the GPs. CONCLUSIONS: Focusing on health care workflow and change management aspects depending on the individual setting is of utmost importance to achieve successful long-term implementation of telemedicine.

Political party affiliation, social identity cues, and attitudes about protective mask-wearing during the COVID-19 pandemic in Germany.

This cross-sectional study aimed to determine 1) whether German citizens' adherence to health professionals' recommendations and mandates regarding protective masks during the COVID-19 pandemic varied according to their political party affiliations, and 2) how behavioral cues provided by members of shared social groups, such as family and friends, influenced individual mask-wearing behavior. A quota-based sample of German voters (n = 330) consisting of 55 citizens whose voting intentions aligned with each of the country's six main political parties responded to an online questionnaire consisting of multiple-choice and open-ended questions. Univariate descriptive statistical analyses of quantitative data were conducted, and multiple regressions were performed to determine log odds and significant variations among group-based responses. A pragmatic inductive coding process was used to conduct a thematic analysis of qualitative data. Results indicated that those participants who expressed an intention to vote for the populist radical right party were the least likely to follow health experts' recommendations and the most likely to express anger and dissatisfaction over mask mandates. Prospective Left Party voters were the most likely to adhere to the advice of their doctors, while those associated with the Green Party were the most likely to adhere to the advice of public health experts. Most survey participants reported aligning their mask-wearing behavior with that of family and friends, with prospective CDU/CSU voters particularly likely to consider the mask-wearing behavior of family members. The results indicate that public health officials should consider how group-related factors influence public health compliance in order to encourage protective mask-wearing in the future.