Use of the FallAkte Plus System as an IT Infrastructure for the North Rhine-Westphalian General Practice Research Network: Mixed Methods Usability Study.

BACKGROUND: Primary care research networks can generate important information in the setting where most patients are seen and treated. However, this requires a suitable IT infrastructure (ITI), which the North Rhine-Westphalian general practice research network is looking to implement. OBJECTIVE: This mixed methods research study aims to evaluate (study 1) requirements for an ITI and (study 2) the usability of an IT solution already available on the market, the FallAkte Plus (FA+) system for the North Rhine-Westphalian general practice research network, which comprises 8 primary care university institutes in Germany's largest state. METHODS: In study 1, a survey was conducted among researchers from the institutes to identify the requirements for a suitable ITI. The questionnaire consisted of standardized questions with open-ended responses. In study 2, a mixed method approach combining a think-aloud approach and a quantitative survey was used to evaluate the usability and acceptance of the FA+ system among 3 user groups: researchers, general practitioners, and practice assistants. Respondents were asked to assess the usability with the validated system usability scale and to test a short questionnaire on vaccination management through FA+. RESULTS: In study 1, five of 8 institutes participated in the requirements survey. A total of 32 user requirements related primarily to study management were identified, including data entry, data storage, and user access management. In study 2, a total of 36 participants (24 researchers and 12 general practitioners or practice assistants) were surveyed in the mixed methods study of an already existing IT solution. The tutorial video and handouts explaining how to use the FA+ system were well received. Researchers, unlike practice personnel, were concerned about data security and data protection regarding the system's emergency feature, which enables access to all patient data. The median overall system usability scale rating was 60 (IQR 33.0-85.0), whereby practice personnel (median 82, IQR 58.0-94.0) assigned higher ratings than researchers (median 44, IQR 14.0-61.5). Users appreciated the option to integrate data from practices and other health care facilities. However, they voted against the use of the FA+ system due to a lack of support for various study formats. CONCLUSIONS: Usability assessments vary markedly by professional group and role. In its current stage of development, the FA+ system does not fully meet the requirements for a suitable ITI. Improvements in the user interface, performance, interoperability, security, and advanced features are necessary to make it more effective and user-friendly. Collaborating with end users and incorporating their feedback are crucial for the successful development of any practice network research ITI.

Tiza-Titre increase and enhanced immunity through an adjuvanted, recombinant herpes zoster subunit vaccine in patients with liver cirrhosis and post-liver transplantation: a study protocol for a prospective cohort study.

INTRODUCTION: Shingrix, an effective adjuvanted, recombinant herpes zoster vaccine (RZV), has been available since 2018. Immunocompromised patients are known to be predisposed to vaccine failure. In-vitro testing of immunological surrogates of vaccine protection could be instrumental for monitoring vaccination success. So far, no test procedure is available for vaccine responses to RZV that could be used on a routine basis. METHODS AND ANALYSIS: This is a single-centre, three-arm, parallel, longitudinal cohort study aspiring to recruit a total of 308 patients (103 with a liver cirrhosis Child A/B, 103 after liver transplantation (both ≥50 years), 102 immunocompetent patients (60-70 years)). Blood samples will be taken at seven data collection points to determine varicella zoster virus (VZV) and glycoprotein E (gE)-specific IgG and T cell responses. The primary study outcome is to measure and compare responses after vaccination with RZV depending on the type and degree of immunosuppression using gE-specific antibody detection assays. As a secondary outcome, first, the gE-specific CD4+ T cell response of the three cohorts will be compared and, second, the gE-VZV antibody levels will be compared with the severity of possible vaccination reactions. The tertiary outcome is a potential association between VZV immune responses and clinical protection against shingles. ETHICS AND DISSEMINATION: Ethical approval was issued on 07/11/2022 by the Ethics Committee Essen, Germany (number 22-10805-BO). Findings will be published in peer-reviewed open-access journals and presented at local, national and international conferences. TRIAL REGISTRATION NUMBER: German Clinical Trials Registry (number DRKS00030683).

[Physician assistants as a future model in primary care: Experiences, needs, potentials and barriers]. / Physician Assistants als Zukunftsmodell in der hausärztlichen Versorgung ­ Erfahrungen, Bedarfe, Potenziale und Hürden.

INTRODUCTION: In the coming decades, demographic change will dramatically increase health care needs, especially for general practitioners (GPs). However, there is a shortage of young primary care physicians, with signs of (impending) underuse already becoming apparent in rural and structurally weak areas. Innovative care concepts are needed to counteract this development and ensure the future of primary care. In addition to medical assistants (MFA), academically trained physician assistants (PAs) could be considered for more demanding delegation tasks and be involved in direct patient care under the responsibility of a physician in the practice team. In England, the Netherlands and the USA, PAs have been a part of the health care systems for many years. RESEARCH QUESTIONS: 1) What are the potentials for delegation/possibilities for PAs working in primary care practices in contrast to medical assistants? 2) What structural requirements are necessary to regularly integrate PAs in primary care practices? METHODS: After preliminary interviews with PA experts and primary care researchers and practitioners (n=29), four expert interviews (n=4) with GPs and PAs were performed in a case analysis in order to elicit experiences with PAs in family practice. Based on this, three focus groups were conducted with GPs and practice staff (n=15) to discuss the extent, the need and the willingness to delegate physician services to PAs, as well as existing barriers. After transcription, analyses were performed using qualitative content analysis according to Mayring. RESULTS: The participants acknowledged the potential to reduce physician workloads and showed a high willingness to delegate tasks. Practical examples suggest that a clearly defined delegation of medical tasks to PAs, e.g. participation in infection consultations, is possible after only a few weeks working in family practices. Thus, the cooperation between GPs, PAs and medical assistants can be successful. Uncertainties exist regarding the legal possibilities and limits of delegation as well as the current and future financial reimbursement of PAs. DISCUSSION: The legal and financial framework for the utilization of PAs in ambulatory care should be reliably clarified as well as transparently communicated so that the considerable potentials of delegating tasks to academically trained staff, e.g. PAs, especially in the GP sector, can be exploited in the future. CONCLUSION: Participation of PAs in the GP team could be key to overcoming the often threatening or already existing under-provision of medical care in structurally weak regions.

cfDNA as a surrogate marker for COVID-19 severity in patients with influenza-like symptoms with and without SARS-CoV-2 infections in general practice: a study protocol for a prospective cohort study.

INTRODUCTION: The clinical course of patients with a SARS-CoV-2 (COVID-19) infection varies widely, from symptom-free to severe courses that can lead to death. Laboratory values of SARS-CoV-2 patients such as lymphocyte counts or C-reactive protein (CRP) do not allow a prediction of the actual course of the disease. To identify a possible predictive marker for the differentiation and prognosis of illness with influenza-like symptoms with and without SARS-CoV-2 infections in general practice, we will analyse the concentrations of cell-free DNA (cfDNA) levels, laboratory and clinical parameters, temperature, oxygen saturation, breathing rate and concomitant symptoms in patients with flu-like symptoms with and without a SARS-CoV-2 infection. METHODS AND ANALYSIS: This is a single-centre, two-arm, parallel longitudinal cohort study with a total of 44 patients. 22 patients with flu-like symptoms without a SARS-CoV-2 infection and 22 patients with flu-like symptoms with a SARS-CoV-2 infection will be recruited. The primary objective is to compare cfDNA levels in ambulatory patients in general practice with flu-like symptoms with SARS-CoV-2 infection with those with influenza like symptoms without a SARS-CoV-2 infection during the disease (day 7 and day 14). The secondary objective is to determine whether there is a correlation between cfDNA concentrations on the one hand, and laboratory and clinical parameters on the other hand. cfDNA, differential blood count, high-sensitive CRP and erythrocyte sedimentation rate will be measured in blood samples, concomitant symptoms will be surveyed via a self-assessment questionnaire, and oxygen saturation, breathing rate and examination of the lungs will be reported by treating physicians. ETHICS AND DISSEMINATION: Ethical approval was issued on 1 March 2021 by the Ethics Committee Essen under the number 21-9916-BO. Findings will be published in peer-reviewed open-access journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: DRKS00024722.

Discrepancy between frequent occurrence of COVID-19-like symptoms and low seroconversion rates among healthcare workers.

During the first wave of the pandemic, we compared the occurrence of subjectively experienced COVID-19-like symptoms and true severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroconversion rates among medical personnel in general practices. This cross-sectional study determined the SARS-CoV-2-specific immunoglobulin G (IgG) antibody status of medical staff from 100 outpatient practices in Germany. Study cohort characteristics and COVID-19-like symptoms were obtained by questionnaires. The initial screening for SARS-CoV-2-recognizing antibodies was performed using a commercial chemiluminescence microparticle immunoassay. Positive results were controlled with another approved test. Samples with discrepant results were subjected to a third IgG-binding assay and a neutralization test. A total of 861 participants were included, 1.7% (n = 15) of whom tested positive for SARS-CoV-specific IgG in the initial screening test. In 46.6% (n = 7) of positive cases, test results were confirmed by an independent test. In the eight samples with discrepant results, neither spike-specific antibodies nor in vitro neutralizing capacity were detectable, resulting in a genuine seroprevalence rate of 0.8%. 794 participants completed the questionnaire. Intriguingly, a total of 53.7% (n = 426) of them stated episodes of COVID-19-like symptoms. Except for smell and taste dysfunction, there were no significant differences between the groups with and without laboratory-confirmed SARS-CoV-2 seroconversion. Our results demonstrated that only 0.8% of participants acquired SARS-CoV-2 even though 53.7% of participants reportedly experienced COVID-19-like symptoms. Thus, even among medical staff, self-diagnosis based on subjectively experienced symptoms does not have a relevant predictive value.

Improving the vaccination status of liver transplant patients: Effectiveness of personally addressing patients and written recommendations to family physicians after 3 years.

BACKGROUND: After documenting insufficient vaccinations in 444 liver transplant (LT) patients, we investigated the effects of a combined strategy (addressing both patients and primary care physicians) on immunization prevalences after a 3-year follow-up. METHODS: The primary care physicians of all adult LT patients from a university center received a written recommendation addressing immunization needs. Patients were asked for their vaccination documents by phone. Changes in immunization rates for vaccine-preventable diseases after the intervention were calculated based on patients' immunization documents from 2014-2016. RESULTS: The study cohort consisted of 401 patients. Prevalence rates for all vaccinations improved during the intervention period compared to the baseline study: tetanus from 88.3% to 92.8%, diphtheria from 80.0% to 89.0%, hepatitis A from 50.1% to 60.8%, hepatitis B from 66.3% to 77.1%, and pneumococci from 62.8% to 76.3%. The influenza vaccination rate improved, but remained at a low level before (2010:13%, 2011:11.5%, 2012:19%) and during the intervention (2014:27.4%, 2015:24.4%, 2016:23.2%). Despite these vaccinations, the prevalence rates of the quality indicators standard vaccinations completed (2013:17.2%; 2016:21.2%), indicated vaccinations completed (2013:2.7%, 2016:4.5%), and all vaccinations completed (2013:1%; 2016 1.5%) improved only slightly. CONCLUSIONS: Our results demonstrated that intensified communication by written information to the primary care physician and phone calls to the patients improved the number of vaccinations. Nonetheless, a potential for further improvement persists, especially with regard to annual influenza vaccinations.

Patient factors driving overuse of cardiac catheterisation: a qualitative study with 25 participants from two German teaching practices.

OBJECTIVES: Percutaneous coronary interventions do not provide a benefit over medical therapy for stable patients. However, an overuse of cardiac catheterisation (CC) for stable coronary artery disease (CAD) is documented in Germany and other countries. In this study, we aim to understand patient factors that foster this overuse. DESIGN: Our study is an exploratory qualitative interview study with narrative, structured interviews. The interviews were analysed using qualitative content analysis by Mayring. SETTING: The interviews were conducted in two German teaching practices. PARTICIPANTS: 24 interviews with 25 patients were conducted; 17 (68%) patients were male, the average age was 73.9 years (range 53-88 years). All patients suffered from CAD and had undergone at least one CC. Patients with known anxiety disorders were excluded from the study. RESULTS: The analysis identified six patient factors which contributed to or prevented the overuse of CC: (1) unquestioned acceptance of prescheduled appointments for procedures/convenience; (2) disinterest in and/or lack of disease-specific knowledge; (3) helplessness in situations with varying opinions on the required care; (4) fear of another cardiac event, (5) patient-physician relationship and (6) the patient's experience that repeat interventions did not result in a change of health status or care. CONCLUSIONS: Conducted in a country with documented overuse of CC, we showed that most patients trusted their physicians' recommendations for repeat coronary angiographies even if they were asymptomatic. Strategies to align physician adherence with guidelines and corresponding patient information are needed to prevent overuse.

Vaccination Status of Pneumococcal and Other Vaccines in 444 Liver Transplant Patients Compared to a Representative Population Sample.

BACKGROUND: Studies have documented deficits of pneumococcal and other vaccinations in kidney and lung transplant patients, but the vaccination status of liver transplant (LT) recipients is unknown. This cross-sectional study investigated the prevalence of immunizations among LT patients at a large university medical center compared to a representative general population sample. MATERIAL AND METHODS: In 2014, all LT patients (>18 years of age) were asked for their vaccination documents. The immunization rates for pneumococcal and other vaccine-preventable diseases were calculated. LT patients' rates for tetanus, diphtheria, and polio vaccinations were compared to a national reference group. Because these vaccinations are recommended for both groups, pneumococcal and influenza vaccination rates of LT patients were compared to those of seniors (>65 years of age) from a national sample. RESULTS: We found that 444 of 581 LT patients (76.4%) had evaluable vaccination documents. Only 60% of the patients received at least 1 pneumococcal vaccination. Insufficient immunization rates (≥1 vaccination/lifetime prevalence) were also documented for other vaccine-preventable diseases: hepatitis B 64%, hepatitis A 48%, tetanus 87%, diphtheria 79%, polio 72%, pertussis 38%, and seasonal influenza (the preceding season) 51%. Only 0.7% (n=3) of LT patients had received all vaccinations as recommended. Similar deficits were documented in the national sample: tetanus 96%, diphtheria 82%, polio 86%, and pertussis 35%. LT patients received pneumococcal vaccines twice as frequently compared to seniors (60% vs. 31%), while influenza vaccination rates were comparable (51% vs. 45%). CONCLUSIONS: In agreement with studies addressing other solid organ transplant recipients, vaccination coverage of LT patients and the general population needs to be improved.

Progressive chronic kidney disease in primary care: modifiable risk factors and predictive model.

OBJECTIVE: To determine the incidence and prevalence of CKD and of progressive GFR decline, to identify modifiable risk factors of and to develop a predictive risk model for progressive GFR decline in high risk primary care patients. METHODS: Retrospective observational study of 803 patients with or at high risk of CKD exclusively managed in primary care. Baseline data was collected in 2003, follow-up data in 2006. High risk was defined as inadequately controlled hypertension or diabetes, and GFR<60, progressive GFR decline as annual GFR decline >2.5mlmin(-1) 1.73m(-2). RESULTS: CKD was present in 25.4% at baseline and developed in further 13.7% during follow-up, 42.5% demonstrated progressive GFR decline. Obesity, proteinuria, heart failure, inadequate hypertension and diabetes control, lacking angiotensin-converting-enzyme-inhibitors or angiotensin-receptor-blockers, radio contrast, and dual renin-angiotensin-aldosterone-system blockade were identified as modifiable, independent risk factors of progressive GFR decline. The risk model, containing 7 readily obtainable variables, showed good discriminative ability. CONCLUSIONS: High risk primary care patients demonstrated high CKD prevalence and incidence, and rate of progressive GFR decline. Identified risk factors can be modified in primary care. Our risk model may aid primary care physicians to predict patients at high risk of progressive GFR decline.

Current equations estimating glomerular filtration rate in primary care: comparison and determinants.

OBJECTIVE: The aims of this study were to compare estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations, to assess the classification of chronic kidney disease (CKD) stages by both equations, and to identify factors associated with differences between both equations in patients with or at high risk of CKD managed in primary care. MATERIAL AND METHODS: This was an observational study of 803 patients with CKD, long-standing, severe hypertension and diabetes exclusively managed in primary care. Bias and precision between the two equations used to calculate eGFR were quantified as proposed by Bland and Altman. RESULTS: In 1534 eGFR calculations, mean eGFR(MDRD) was 0.8 ± 3.6 ml/min/1.73 m(2) higher than eGFR(CKD-EPI). Precision between the two equations was ±7.1 ml/min/1.73 m(2). Classification of CKD stages by MDRD or CKD-EPI equations agreed in 93.3% of cases. Age above 70 years, eGFR below 60 and above 120 ml/min/1.73 m(2) were associated with higher eGFR(MDRD) values; and age below 50 years and inadequately controlled hypertension with higher eGFR(CKD-EPI) values. CONCLUSIONS: Comparison of eGFR calculated by MDRD and CKD-EPI equations demonstrated no clinically relevant difference. In addition, CKD classification by both equations agreed highly. As both equations performed equally well, the simpler and more established MDRD equation should be preferred in patients with or at high risk of CKD managed in primary care. Patients' characteristics seem to account for previously reported differences in the performance of CKD-EPI and MDRD equations.