[Effects of the Risk of Recourse Claims on the Work of General Practitioners and Orthopedists - A Nationwide Survey]. / Auswirkungen der Regressgefahr auf die Tätigkeit von Hausärzt*innen und Orthopäd*innen ­ Bundesweite Befragung.

OBJECTIVE: The aim of this study was to investigate the influence of the perceived risk of recourse claims and the extent of personal recourse experience among general practitioners (GPs) and orthopedists in private practice. METHODS: A four-page questionnaire on the effects and consequences of the threat of recourse or recourse actually experienced was sent to a nationwide random sample of 1000 GPs and 1000 orthopedists. RESULTS: The response rate was 41% for GPs and 39% for orthopedists; 47% of the participating GPs and 55% of the orthopedists stated that the risk of recourse was a heavy burden in everyday practice, 37/47% that it had a strong influence on their medical practice. 51/25% stated that they referred to a (different) specialist at least occasionally despite the indication of a prescription. 72% of GPs and 59% of orthopedists had recourse at least once, 36 and 19%, respectively more than 3 times. 18% of GPs and 26% of orthopedists had experienced recourse claims of more than € 5000. The emotional burden caused by the worst regress was perceived by 72 and 78%, respectively of those affected by recourse as severe or very severe. CONCLUSION: The risk of recourse can have a strong impact on the work of GPs and orthopedists in private practice. Recourse is often felt to be emotionally stressful and sometimes seen as inhibiting establishing a practice.

Lessons learned from applying established cut-off values of questionnaires to detect somatic symptom disorders in primary care: a cross-sectional study.

Introduction: Based on two diagnostic accuracy studies in high-prevalence settings, two distinctly different combinations of cut-off values have been recommended to identify persons at risk for somatic symptom disorder (SSD) with the combination of the Patient-Health Questionnaire-15 (PHQ-15) and the Somatic Symptom Disorder-B Criteria Scale (SSD-12). We investigated whether the reported sensitivity and specificity of both recommended cut-off combinations are transferable to primary care. Methods: In a cross-sectional study, 420 unselected adult primary care patients completed PHQ-15 and SSD-12. Patients scoring ≥9 and ≥ 23 (recommended cut-off combination #1) or ≥ 8 and ≥ 13 (recommended cut-off combination #2) were considered test-positive for SSD, respectively. To assess the validity of the reported sensitivity and specificity in different low- to high-prevalence settings, we compared correspondingly expected proportions of test positives to the proportion observed in our sample. Results: Based on combination #1, 38 participants (9%) were found to be test positive, far fewer than expected, based on the reported values for sensitivity and specificity (expected minimum frequency 30% with a true prevalence ≥1%). This can only be explained by a lower sensitivity and higher specificity in primary care. For combination #2, 98 participants (23%) were test positive, a finding consistent with a true prevalence of SSD of 15% or lower. Discussion: Our analyzes strongly suggest that the sensitivity and specificity estimates reported for combination #1 are not applicable to unselected primary care patients and that the cut-off for the SSD (≥23) is too strict. Cut-off combination #2 seems more applicable but still needs to be tested in studies that compare screening findings by questionnaires with validated diagnostic interviews as reference standards in primary care populations.

Diminished Short- and Long-Term Antibody Response after SARS-CoV-2 Vaccination in Hemodialysis Patients.

Short-term studies have shown an attenuated immune response in hemodialysis patients after COVID-19-vaccination. The present study examines how antibody response is maintained after vaccination against SARS-CoV-2 in a large population of hemodialysis patients from six outpatient dialysis centers. We retrospectively assessed serum antibody levels against SARS-CoV-2 spike protein and nucleocapsid protein (electrochemiluminescence immunoassays, Roche Diagnostics) after COVID-19-vaccination in 298 hemodialysis and 103 non-dialysis patients (controls), comparing early and late antibody response. Compared to a non-dialysis cohort hemodialysis patients showed a favorable but profoundly lower early antibody response, which decreased substantially during follow-up measurement (median 6 months after vaccination). Significantly more hemodialysis patients had anti-SARS-CoV-2-S antibody titers below 100 U/mL (p < 0.001), which increased during follow-up from 23% to 45% but remained low in the control group (3% vs. 7%). In multivariate analysis, previous COVID-19 infections (p < 0.001) and female gender (p < 0.05) were significantly associated with higher early as well as late antibody vaccine response in hemodialysis patients, while there was a significant inverse correlation between patient age and systemic immunosuppression (p < 0.001). The early and late antibody responses were significantly higher in patients receiving vaccination after a SARS-CoV-2 infection compared to uninfected patients in both groups (p < 0.05). We also note that a higher titer after complete immunization positively affected late antibody response. The observation, that hemodialysis patients showed a significantly stronger decline of SARS-CoV-2 vaccination antibody titers within 6 months, compared to controls, supports the need for booster vaccinations to foster a stronger and more persistent antibody response.

The formalin test does not probe inflammatory pain but excitotoxicity in rodent skin.

The most widely used formalin test to screen antinociceptive drug candidates is still apostrophized as targeting inflammatory pain, in spite of strong opposing evidence published. In our rat skin-nerve preparation ex vivo, recording from all classes of sensory single-fibers (n = 32), 30 units were transiently excited by formaldehyde concentrations 1-100 mM applied to receptive fields (RFs) for 3 min, C and Aδ-fibers being more sensitive (1-30 mM) than Aß-fibers. From 30 mM on, ~1% of the concentration usually injected in vivo, all RFs were defunctionalized and conduction in an isolated sciatic nerve preparation was irreversibly blocked. Thus, formaldehyde, generated a state of 'anesthesia dolorosa' in the RFs in so far as after a quiescent interphase all fibers with unmyelinated terminals developed a second phase of vigorous discharge activity which correlated well in time course and magnitude with published pain-related behaviors. Sural nerve filament recordings in vivo confirmed that higher formalin concentrations (> 42 mM) have to be injected to the skin to induce this second phase of discharge. Patch-clamp and calcium-imaging confirmed TRPA1 as the primary transducer of formaldehyde (10 mM) effects on mouse sensory neurons. However, stimulated CGRP release from isolated skin of TRPA1+/+ and TRPA1-/- mice showed a convergence of the saturating concentration-response curves at 100 mM formaldehyde, which did not occur with nerve and trachea preparations. Finally, skin-nerve recordings from C and Aδ-fibers of TRPA1-/- mice revealed a massive reduction in formaldehyde (30 mM)-evoked discharge. However, the remaining activity was still biphasic, thus confirming additional unspecific excitotoxic actions of the fixative that diffuses along still excitable axons as previously published. The multiplicity of formaldehyde's actions requires extensive discussion and literature review, leading to a fundamental reevaluation of the formalin test.

[Experiences with Regional Medical Coordinators in Ambulatory Care in the Early COVID-19 Phase 2020 in Bavaria: Survey of Regional Ambulatory Coordinators and General Practitioners]. / Erfahrungen mit Versorgungsärzt*innen in der frühen COVID-19-Phase 2020 in Bayern ­ Befragung von Versorgungs- und Hausärzt*innen.

BACKGROUND: During the state of emergency in Bavaria in the early Corona phase 2020, some physicians in ambulatory care were appointed as regional medical coordinators (RMCs). The aim of the present study was to evaluate this newly introduced but temporary position. METHODS: In November 2020, a paper-based questionnaire was sent out to all 85 RMCs who could be identified through an internet research and to all 197 teaching practices of the Institute of General Practice and Health Services Research at the Technical University of Munich. The data analysis was descriptive and anonymised. RESULTS: Overall, 75 (88%) RMCs and 156 (79%) general practitioners (GPs) were included. 97% of the RMCs and 67% of the GPs assessed the introduction of RMCs in ambulatory care as reasonable, but also as an intervention concerning the self-administration of physicians (RMCs: 59% and GPs: 42%). 37% of the GPs stated that RMCs should be avoided as far as possible in future pandemic situations. Overall, GPs with more intensive contact to an RMC showed higher levels of agreement. Both groups rated the collaboration and communication strategies of politics, authorities and the Bavarian Association of Statutory Health Insurance Physicians as difficult and often contradictory. However, most of the RMCs assessed the cooperation with politics and authorities at the local level as positive. The lack of medical protective equipment at the beginning of the pandemic was judged critically by both groups of the respondents. CONCLUSIONS: The establishment of RMCs in the early Corona phase 2020 in Bavaria was considered sensible by almost all RMCs and the majority of the surveyed GPs. For the future, it seems necessary to involve primary care physicians more intensively and permanently in decision-making processes and to strengthen existing structures.

Molecular diagnosis of kidney transplant failure based on urine.

In light of the organ shortage, there is a great responsibility to assess postmortal organs for which procurement has been consented and to increase the life span of transplanted organs. The former responsibility has moved many centers to accept extended criteria organs. The latter responsibility requires an exact diagnosis and, if possible, omission of the harmful influence on the transplant. We report the course of a kidney transplant that showed a steady decline of function over a decade, displaying numerous cysts of different sizes. Clinical workup excluded the most frequent causes of chronic transplant failure. The filed allocation documents mentioned the donor's disease of oral-facial-digital syndrome, a rare ciliopathy, which can also affect the kidney. Molecular diagnosis was performed by culturing donor tubular cells from the recipient´s urine more than 10 years after transplantation. Next-generation panel sequencing with DNA from tubular urinary cells revealed a novel truncating mutation in OFD1, which sufficiently explains the features of the kidney transplants, also found in the second kidney allograft. Despite this severe donor disease, lifesaving transplantation with good long-term outcome was enabled for 5 recipients.

Do general practice patients with and without appointment differ? Cross-sectional study.

BACKGROUND: Even in practices with a comprehensive appointment system a minority of patients walks in without prior notice, sometimes causing problems for practice service quality. We aimed to explore differences between patients consulting primary care practices with and without appointment. METHODS: Consecutive patients visiting five primary care practices without an appointment and following patients with an appointment were asked to fill in a four-page questionnaire addressing socio-demographic characteristics, the reason for encounter, urgency of seeing a physician, depressive, somatic and anxiety symptoms, personality traits, and satisfaction with the practice. Physicians also documented the reason for encounter and assessed the urgency. Data were analyzed using univariate and multivariate methods. RESULTS: Two hundred fifty-one patients without and 250 patients with appointment participated. Patients without appointment were significantly younger (mean age 44 vs. 50 years) and reported less often chronic diseases (29% vs. 45%). Also, reasons for encounter differed (e.g., 27% vs. 16% with a respiratory problem). Patients' ratings of urgency did not differ between groups (p = 0.46), but physicians rated urgency higher among patients without appointment (p < 0.001). In logistic regression analyses younger age, male gender, absence of chronic disease, positive screening for at least one mental disorder, low values on the personality trait openness for experience, a high urgency rating by the physician, and a respiratory or musculoskeletal problem as reason for encounter were significantly associated with a higher likelihood of being a patient without appointment. CONCLUSIONS: In this study, younger age and a high urgency rating by physicians were the variables most consistently associated with the likelihood of being a patient without appointment. Overall, differences between patients seeking general practices with a comprehensive appointment system without prior notice and patients with appointments were relatively minor.

Validity of the Somatic Symptom Disorder-B Criteria Scale (SSD-12) in primary care.

Aim: The Somatic Symptom Disorder-B Criteria Scale (SSD-12) assesses the psychological features of DSM-5 somatic symptom disorder. The purpose of the current study was to investigate the psychometric characteristics and validity of the 12-item instrument to demonstrate its suitability in primary care. Method: The study was designed as a cross-sectional survey set in five primary care practices from Munich, Germany (n = 501, 52.0% female, mean age 47 ± 16 years). Item and scale characteristics, as well as measures of reliability and validity, were determined. Results: The SSD-12 has good item characteristics and excellent reliability (Cronbach's α = 0.92). Confirmatory factor analyses provided evidence to support a general factor model of the SSD-12 in primary care (comparative fit index > 0.98, Tucker-Lewis index > 0.98, root mean square error of approximation = 0.090, 90% confidence interval: 0.078-0.102). SSD-12 total sum-score was significantly associated with somatic symptom burden (r = 0.48, P < 0.001), general anxiety (r = 0.54, P < 0.001) and depressive symptoms (r = 0.60, P < 0.001). At the group level, SSD-12 scores could differentiate between different patient groups (e.g. with and without chronic illness). Conclusions: The SSD-12 appears to be a reliable, valid and time-efficient self-report measure of the psychological characteristics related to the experience of somatic symptoms which is suitable for primary care. Future research should evaluate its responsiveness to treatment and feasibility as a screening tool in different clinical settings.

Improving patients privacy with Pseudonymization.

e-Health requires the sharing of patient related data when and where necessary. Electronic health records promise to improve communication between health care providers, thus leading to better quality of patients' treatment and reduced costs. As highly sensitive patient information provides a promising goal (e.g., for attackers), there is an increasing social and political pressure to guarantee patients privacy. This paper presents the new system PIPE (Pseudonymization of Information for Privacy in e-Health), that differs from existing approaches in its ability to securely integrate primary and secondary usage of health data.

Sympathetic vasoconstrictor reflex pattern in patients with complex regional pain syndrome.

Twenty patients suffering from complex regional pain syndrome (CRPS) and 21 healthy control subjects were examined to evaluate sympathetic reflex vasoconstriction. The mean age of the 12 female and eight male patients was 48.9 (21-72) years. At the time of investigation the median duration of the disease was 8.5 weeks (2-70). Twenty-one healthy subjects were investigated for control. Different maneuvers, such as the veno-arteriolar reflex (VAR), inspiratory gasp (IG), cold pressor test (CP) and mental arithmetic (MA), were employed to induce vasoconstriction while the cutaneous blood flow of the affected and the contralateral limb was recorded. In addition, the skin temperature of both limbs was measured by infrared thermography. In 14 of 20 patients and in 14 of 21 control subjects vasoconstriction due to the provocation tests could be measured, while the remaining six patients and seven controls showed vasodilatation in at least one test, and by that they were excluded from analysis of vasoconstrictor reflex pattern. After thermoregulatory adaptation skin temperature was not different between the affected and the unaffected limb. Sympathetic reflex vasoconstriction triggered by MA which represents cortical generated, moderate vasoconstrictor stimulus, was significantly reduced on the affected limb (102.9% of prestimulus period) when compared to the control limb (85.0%, P < 0.002) or to controls (84.8%, P < 0.001). VAR (pure postganglionic), IG and CP (both spinal and supraspinal), representing stronger vasoconstrictor stimuli, revealed no significant side to side difference of sympathetic vasoconstriction and no significant difference as compared to controls. In conclusion our findings prove impairment of sympathetic vasoconstrictor activity after central vasoconstrictor stimulation in CRPS, and possible mechanisms are discussed.