[Development of quality indicators for the care of patients with chronic kidney disease : Results of a structured consensus process using the Delphi technique]. / Entwicklung von Qualitätsindikatoren für die Versorgung von Patient:innen mit chronischer Nierenerkrankung : Ergebnisse einer strukturierten Konsensfindung mittels Delphi-Verfahrens.

BACKGROUND: Chronic kidney disease (CKD) is a common condition, especially in the elderly. In order to prevent progression and complications of the disease, guideline-adherent outpatient care of patients with CKD should be prioritized. Quality indicators (QIs) can be used to measure and evaluate the quality of ambulatory care for patients with CKD. QIs specifically made for evaluating CKD care in Germany are not yet available. The goal of this work was to develop QIs for the quality assessment of outpatient care for patients over the age of 70 with CKD not requiring dialysis. MATERIALS AND METHODS: QIs were operationalized from the recommendations of the German national guideline for CKD and others were proposed based on a published review of international QIs. The resulting QIs were divided into sets based on routine data (e.g., health insurance billing data) and data collection in practices (chart review). A panel of experts from various disciplines as well as a patient representative evaluated the proposed QIs in a two-stage Delphi process via online survey in October 2021 and January 2022 and a final consensus conference in March 2022. In addition, ranking lists of the most important QIs from each set were created. RESULTS: An incidence indicator and a prevalence indicator were established; these were not subject to vote. Further, 21 QIs were voted upon by the expert panel. The seven most important QIs in each set (billing data or chart review) were selected. Only one QI was rated by the expert panel as not suitable for additional use in adults under the age of 70 years. DISCUSSION: The QIs will enable the evaluation of the quality of outpatient care for patients with CKD with the long-term aim of optimizing guideline-adherent outpatient care.

Postgraduate medical training in Germany: A narrative review.

The structure and content of the training phase following completion of medical school, referred to in most countries as postgraduate medical training, varies between countries. The purpose of this article is to give national and international readers an overview of the organisation and structure of postgraduate medical training in Germany. The content and duration of postgraduate training in Germany are stipulated by state medical boards, officially termed associations (Landesärztekammer). In a periodically updated decree, the federal German medical association (Bundesärztekammer) provides a template for postgraduate medical training structure (Musterweiterbildungsordnung), which is adapted by the state medical associations. Admission to postgraduate medical training in Germany takes place by way of open, free-market selection. Based on the traditional assumption that junior doctors acquire all necessary clinical skills "on the job", formal education in the form of seminars, lectures, or preorganised, detailed rotation plans through various specialties or wards is largely absent. Requirements for postgraduate medical training focus on the fulfilment of broad categories of rotations rather than specific content or gaining competencies. With few exceptions, no structured educational programs with curricular learning objectives exist. Limited funding impedes program development and expansion. Junior doctors bear the primary organisational responsibility in their training, which often results in extended training times and dissatisfaction. Structured training programs which prioritise skill-building and formal education are needed to support junior doctors and ensure their competence in primary and specialty care.

Concordance of Patient Expectations Regarding Guideline Recommendations for Management of Psychosocial Factors in Low Back Pain: A Cross-sectional Study.

BACKGROUND: Guidelines for low back pain (LBP) management recommend addressing psychosocial risk factors such as stress and depression, which have been shown to play a prognostic role in nonspecific LBP. LBP management has been found to diverge from published recommendations. The reasons why remain unclear and may be related to patient views and expectations regarding the causes and treatment of LBP. OBJECTIVES: We examined the degree to which patient views regarding psychosocial factors coincided with core recommendations and statements of the German national guideline for nonspecific LBP, as well as factors affecting those views. STUDY DESIGN: Cross-sectional study. SETTING: Data were gathered from June 2018 through September 2018 in 13 general practices in Mecklenburg-Wets Pomerania, Germany. METHODS: Practice staff approached all patients entering the practice, regardless of the reason for consultation, during 3 consecutive days and offered study participation. After providing informed consent, patients received a questionnaire to complete prior to consultation. Nonresponse bias was addressed by using inverse probability weights. Descriptive analysis and multivariate logistic regression models were performed. RESULTS: A total of 977 patient questionnaires were included in the analysis. One-third to one-half of the patients disagreed and one-third agreed that psychological problems and their treatment play a role in LBP management. A significant proportion (13-25%) was undecided. However, relaxation techniques were well accepted. Patients with higher education levels, poorer health status, and more severe LBP but no pain medication in the last 12 months were more likely to expect psychosocial diagnostics and treatment and regarded relaxation techniques as potentially helpful. More severe pain and lower levels of education were associated with disagreement with guideline recommendations and statements regarding management of psychosocial factors. LIMITATIONS: Recall bias is possible, as patients were asked to recall their LBP history. However, we limited the recall time to the last 12 months. Data on income, employment status and co-morbidities were not collected and may have affected the responses. However, educational status, health status, and age were collected. CONCLUSION: A significant portion of patients did not agree that psychosocial aspects should be addressed in LBP. Pain severity, health status, level of education, and previous treatment experience appear to affect patient views. These results highlight the importance of careful patient counseling regarding psychosocial factors and screening for psychosocial problems in LBP, when indicated. Additionally, educational initiatives may help bring patient expectations into agreement with recommendations.

Effects of whole-body MRI on outpatient health service costs: a general-population prospective cohort study in Mecklenburg-Vorpommern, Germany.

OBJECTIVE: Whole-body MRI (wb-MRI) is increasingly used in research and screening but little is known about the effects of incidental findings (IFs) on health service utilisation and costs. Such effects are particularly critical in an observational study. Our principal research question was therefore how participation in a wb-MRI examination with its resemblance to a population-based health screening is associated with outpatient service costs. DESIGN: Prospective cohort study. SETTING: General population Mecklenburg-Vorpommern, Germany. PARTICIPANTS: Analyses included 5019 participants of the Study of Health in Pomerania with statutory health insurance data. 2969 took part in a wb-MRI examination in addition to a clinical examination programme that was administered to all participants. MRI non-participants served as a quasi-experimental control group with propensity score weighting to account for baseline differences. PRIMARY AND SECONDARY OUTCOME MEASURES: Outpatient costs (total healthcare usage, primary care, specialist care, laboratory tests, imaging) during 24 months after the examination were retrieved from claims data. Two-part models were used to compute treatment effects. RESULTS: In total, 1366 potentially relevant IFs were disclosed to 948 MRI participants (32% of all participants); most concerned masses and lesions (769 participants, 81%). Costs for outpatient care during the 2-year observation period amounted to an average of €2547 (95% CI 2424 to 2671) for MRI non-participants and to €2839 (95% CI 2741 to 2936) for MRI participants, indicating an increase of €295 (95% CI 134 to 456) per participant which corresponds to 11.6% (95% CI 5.2% to 17.9%). The cost increase was sustained rather than being a short-term spike. Imaging and specialist care related costs were the main contributors to the increase in costs. CONCLUSIONS: Communicated findings from population-based wb-MRI substantially impacted health service utilisation and costs. This introduced bias into the natural course of healthcare utilisation and should be taken care for in any longitudinal analyses.

[Patient safety in the treatment of rheumatic diseases : Laboratory monitoring in methotrexate treatment]. / Patientensicherheit in der Rheumatherapie : Labormonitoring bei Methotrexat.

BACKGROUND: Methotrexate (MTX) is the most commonly prescribed disease-modifying drug in the treatment of rheumatic diseases. Regular laboratory testing is recommended to recognize side effects, such as hepatotoxicity and myelotoxicity as well as decreases in renal function that may cause toxic MTX accumulation. Additionally, folic acid is recommended as prophylaxis against specific side effects. In this study we investigated whether laboratory monitoring and prescription of folic acid took place according to published recommendations. MATERIAL AND METHODS: Claims data from the statutory health insurance from 1 January 2009 to 31 December 2013 were retrospectively analyzed. A total of 40,087 adults with a rheumatic diagnosis (ICD10 codes M05-M18), no malignant disease and no previous MTX prescription within 12 months were extracted from the InGef (Institute for Applied Health Research in Berlin, formerly Health Risk Institute) research database. The frequency of recommended laboratory testing, appointments with rheumatologists and the prescription of folic acid prophylaxis were investigated. RESULTS: Of the patients 12,451 began treatment with MTX in the observation period. Between 42% and 46% of recommended blood counts, liver values and kidney function tests and 14% of urinalyses were performed according to recommendations. Of the patients 84% were seen regularly by a rheumatologist and 74% received a prescription for prophylactic folic acid. Serious conditions potentially resulting from MTX treatment were observed in 0.7-3.5 cases/1000 person years. DISCUSSION: Laboratory monitoring in the context of MTX treatment is carried out less frequently than recommended in the literature. Potential MTX-associated serious complications are rare from a practice perspective. On the one hand solutions are needed for a better coordination of laboratory monitoring. On the other hand more empirical evidence is needed regarding the benefits of laboratory monitoring and the appropriate intervals thereof.

Ivy leaf (Hedera helix) for acute upper respiratory tract infections: an updated systematic review.

PURPOSE: Acute cough due to viral upper respiratory tract infections (URTIs) and bronchitis is a common reason for patients to seek medical care. Non-antibiotic over-the-counter cough medications such as ivy leaf extract are frequently used but their efficacy is uncertain. Our purpose was to update our previous systematic review and evaluate the effectiveness and tolerability of ivy leaf in the treatment of acute URTIs in adult and pediatric populations. METHODS: We searched MEDLINE, EMBASE, the Cochrane Library, and clinical trial registries from December 2009 to January 2020. Randomized controlled trials (RCTs), controlled clinical trials (CCTs), and observational studies (OSs) investigating ivy leaf mono- or combination preparations were included. Two independent reviewers assessed records for eligibility and risk of bias and performed data extraction. RESULTS: Six RCTs, 1 CCT, and 4 OSs were identified. Since the publication of our previous review, the number of RCTs has increased. All studies concluded that ivy leaf extract is an effective and safe option for the treatment of cough due to URTIs and bronchitis. Three RCTs reported a more rapid reduction in cough severity and/or frequency under ivy leaf treatment. The clinical significance of these effects appears to be minimal. No serious adverse effects were reported. The overall quality of reporting was low and the risk of bias was high. CONCLUSIONS: Ivy leaf preparations are safe for use in cough due to acute URTIs and bronchitis. However, effects are minimal at best and of uncertain clinical importance.

Concordance of patient beliefs and expectations regarding the management of low back pain with guideline recommendations - a cross-sectional study in Germany.

BACKGROUND: Low back pain is a common reason for patients to seek medical care. Physician non-adherence to clinical guidelines has been observed. We investigated the extent to which patient expectations correspond to recommendations of the German national guideline for management of low back pain (G-LBP) and whether patient characteristics, history of LBP and previous treatment experience are associated with expectations. METHODS: A cross-sectional study including patients from 13 general practices was conducted. Data were collected using a questionnaire. Inverse probability weights were used to address non-response bias. Descriptive analysis and multivariate logistic regression models were performed. RESULTS: A total of 977 patients were included in analyses (median age 57 years, 39% male). 75% of patients reported experiencing LBP currently or within the last year. More than 65% indicated they would agree to forgo further examinations if their LBP was judged by their physician to be of no serious concern. This was associated with the highest level of education and no prior imaging, and negatively associated with good-to-poor health status and moderate-to-severe pain intensity. 40% of participants expected imaging. The highest educational level, female gender and no prior imaging were associated with a decreased expectation of imaging. 70% expected prescriptions for massages. Females, participants with good-to-poor health status, current LBP or LBP in the last 12 months had an increased expectation for massages. Expectations for injection therapy (45%) were mainly associated with previous injections. Expectations for physiotherapy (64%) were associated with female gender, lower educational level, good-to-poor health status, current LBP or in the last 12 months. The perspective that daily activities should be continued (66%) was associated with female gender and higher educational level. Participants who agreed to the statement 'There is no effective treatment for LBP' (11%) had a poor health status, current LBP and a severe pain intensity. CONCLUSION: Patient views regarding LBP management are partially concordant with guideline recommendations and are strongly influenced by previous treatment experiences and education level. Exploration of patient expectations and experiences in LBP treatment may help minimize dissatisfaction of patients expecting treatments not endorsed by guidelines and simultaneously increase physician guideline adherence.

The effects of incidental findings from whole-body MRI on the frequency of biopsies and detected malignancies or benign conditions in a general population cohort study.

Magnetic resonance imaging (MRI) yields numerous tumor-related incidental findings (IFs) which may trigger diagnostics such as biopsies. To clarify these effects, we studied how whole-body MRI IF disclosure in a population-based cohort affected biopsy frequency and the detection of malignancies. Laboratory disclosures were also assessed. Data from 6753 participants in the Study of Health in Pomerania (SHIP) examined between 2008 and 2012 were utilized. All underwent laboratory examinations and 3371 (49.9%) a whole-body MRI. Electronic biopsy reports from 2002 to 2017 were linked to participants and assigned to outcome categories. Biopsy frequency 2 years pre- and post-SHIP was investigated using generalized estimating equations with a negative-binomial distribution. Overall 8208 IFs (laboratory findings outside reference limits: 6839; MRI: 1369) were disclosed to 4707 participants; 2271 biopsy reports belonged to 1200 participants (17.8%). Of these, 938 biopsies occurred pre-SHIP; 1333 post-SHIP (event rate/100 observation years = 6.9 [95% CI 6.5; 7.4]; 9.9 [9.3; 10.4]). Age, cancer history, recent hospitalization, female sex, and IF disclosure were associated with higher biopsy rates. Nonmalignant biopsy results increased more in participants with disclosures (post-/pre-SHIP rate ratio 1.39 [95% CI 1.22; 1.58]) than without (1.09 [95% CI 0.85; 1.38]). Malignant biopsy results were more frequent post-SHIP (rate ratio 1.74 [95% CI 1.27; 2.42]). Biopsies increased after participation in a population-based cohort study with MRI and laboratory IF disclosure. Most biopsies resulted in no findings and few malignancies were diagnosed, indicating potential overtesting and overdiagnosis. A more restrictive policy regarding IF disclosure from research findings is required.

Impact of whole-body MRI in a general population study.

This study examined the long-term impact of whole-body MRI and the disclosure of incidental findings on quality of life (QoL) and depressive symptoms in a general population cohort. Analyses were conducted among 4420 participants of the Study of Health in Pomerania SHIP-Trend cohort, of which 2188 received a whole-body MRI examination. A 2.5-year postal follow-up of SHIP-Trend (response: 86%) included the Short Form Health Survey (SF-12), based on which the Mental Health Component Summary Score (MCS), and Physical Health Component Summary Score (PCS) were computed. The Patient Health Questionnaire (PHQ-9) was applied to assess depressive symptoms. Generalized estimation equation models were used to assess intervention effects, and statistical weights were applied to account for selective attrition. MRI participants had higher levels of education and employment than nonparticipants. Mean QoL indicators differed little at baseline between MRI participants and nonparticipants. Intervention effects per year on depression and QoL were negligible in (1) MRI participants versus nonparticipants [PCS: unstandardized ß = -0.06 (95% CI -0.30 to 0.18); MCS: ß = -0.01 (95% CI -0.29 to 0.29); PHQ-9: 0.08 (-0.03 to 0.18)], and (2) MRI participants with a disclosed incidental finding versus those without [PCS: ß = -0.03 (-0.39 to 0.33); MCS: ß = -0.26 (95% CI -0.65 to 0.13); PHQ-9: 0.03 (-0.10 to 0.15)]. The body site of the finding had only minor effects on the course of our studied outcomes. Whole-body MRI can be implemented in a population-based study without long-term effects on QoL indicators and depressive symptoms. This does not exclude the possibility of effects on more subtle psychosocial outcomes, such as health concerns or health behaviour, all of which require further attention.