Extravertebral low back pain: a scoping review.

BACKGROUND: Low back pain (LBP) is one of the most common reasons for consultation in general practice. Currently, LBP is categorised into specific and non-specific causes. However, extravertebral causes, such as abdominal aortic aneurysm or pancreatitis, are not being considered. METHODS: A systematic literature search was performed across MEDLINE, Embase, and the Cochrane library, complemented by a handsearch. Studies conducted between 1 January 2001 and 31 December 2020, where LBP was the main symptom, were included. RESULTS: The literature search identified 6040 studies, from which duplicates were removed, leaving 4105 studies for title and abstract screening. Subsequently, 265 publications were selected for inclusion, with an additional 197 publications identified through the handsearch. The majority of the studies were case reports and case series, predominantly originating from specialised care settings. A clear distinction between vertebral or rare causes of LBP was not always possible. A range of diseases were identified as potential extravertebral causes of LBP, encompassing gynaecological, urological, vascular, systemic, and gastrointestinal diseases. Notably, guidelines exhibited inconsistencies in addressing extravertebral causes. DISCUSSION: Prior to this review, there has been no systematic investigation into extravertebral causes of LBP. Although these causes are rare, the absence of robust and reliable epidemiological data hinders a comprehensive understanding, as well as the lack of standardised protocols, which contributes to a lack of accurate description of indicative symptoms. While there are certain disease-specific characteristics, such as non-mechanical or cyclical LBP, and atypical accompanying symptoms like fever, abdominal pain, or leg swelling, that may suggest extravertebral causes, it is important to recognise that these features are not universally present in every patient. CONCLUSION: The differential diagnosis of extravertebral LBP is extensive with relatively low prevalence rates dependent on the clinical setting. Clinicians should maintain a high index of suspicion for extravertebral aetiologies, especially in patients presenting with atypical accompanying symptoms.

Prednisolone Versus Colchicine for Acute Gout in Primary Care: statistical analysis plan for the pragmatic, multicenter, randomized, and double-blinded COPAGO non-inferiority trial.

BACKGROUND: To date, colchicine and prednisolone are two effective therapies for the treatment of acute gout but have never been compared directly in a randomized clinical trial. In addition, in previous trials of treating acute gout patients with concomitant comorbidities were often excluded due to contraindications to naproxen. STUDY DESIGN: This pragmatic, prospective, double-blind, double-dummy, parallel-group, randomized, non-inferiority trial compares prednisolone with colchicine in terms of non-inferiority in patients with acute gout. Patients presenting to their general practitioner with acute gout can be included if the gout attack has occurred within the last 2 days. A total of 60 practices in the vicinity of three university medical centers (Greifswald, Göttingen, and Würzburg) participate in the study. The intervention group receives 30 mg prednisolone for 5 days, while the group of standard care receives low-dose colchicine (day 1: 1.5 mg; days 2-5: 1 mg). The first dose of treatment is provided at day 0 when patients present to the general practitioner due to an acute gout attack. From day 0 to day 6, patients will be asked to complete a study diary on daily basis regarding pain quantification. For safety reasons, potential side effects and the course of systolic blood pressure are also assessed. STATISTICAL ANALYSIS PLAN: N = 314 patients have to be recruited to compensate for 10% of dropout and to allow for showing non-inferiority of prednisolone compared to colchicine with a power of 90%. We use permuted block randomization with block sizes of 2, 4, and 6 to avoid imbalanced treatment arms in this multi-center study; patients are randomized in a 1:1 ratio. The absolute level of pain on day 3 (in the last 24 h) is the primary outcome and measured on a numerical rating scale (NRS: 0-10). Using a multiple linear regression model adjusted for age, sex, and pain at baseline, prednisolone is considered non-inferior if the effect estimate including the confidence intervals is lower than a margin of 1 unit on the NRS. Average response to treatment, joint swelling and tenderness, physical function of the joint, and patients' global assessment of treatment success are secondary outcomes. DISCUSSION: The trial will provide evidence from a direct comparison of colchicine and prednisolone regarding their efficacy of pain reduction in acute gout patients of primary care and to indicate possible safety signals. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05698680 first posted on January 26, 2023 (retrospectively registered).

Prednisolone Versus Colchicine for Acute Gout in Primary Care (COPAGO): protocol for a two-arm multicentre, pragmatic, prospective, randomized, double-blind, controlled clinical trial of prednisolone and colchicine for non-inferiority with a parallel group design.

BACKGROUND: Gout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute inflammatory reactions. There are various approved drugs that can be prescribed for pain relief during an acute gout attack. However, to date, no direct comparison of efficacy of colchicine and prednisolone for the treatment of acute gout attacks has been investigated. Furthermore, the majority of previous research studies were not only conducted in tertiary centres but also excluded patients with common comorbidities due to contraindications to naproxen. METHODS: This pragmatic, prospective, double-blind, double-dummy, parallel-group, randomized, non-inferiority trial investigates whether prednisolone (intervention) is non-inferior to treatment with colchicine (active control) in patients with acute gout. Adult patients presenting with acute gout to their general practitioners in 60 practices across 3 university sites (Greifswald, Göttingen, and Würzburg) are eligible to participate in the study. Participants in the intervention group receive 30 mg prednisolone for 5 days. Those in the control group receive low-dose colchicine (day 1: 1.5 mg; days 2-5: 1 mg). The primary outcome is the absolute level of the most severe pain on day 3 (in the last 24 h) measured with an 11-item numerical rating scale. Day 0 is the day patients take their study medication for the first time. They are then asked to fill out a study diary the same time each day for pain quantification. Pain scores are used for comparison between the two medications. Secondary outcomes are average response to treatment, swelling, tenderness and physical function of the joint, patients' global assessment of treatment success, use of additional pain medication and non-pharmacological pain therapies. For safety reasons, potential side effects and course of systolic blood pressure are assessed. DISCUSSION: This trial will provide evidence on the effectiveness of pain reduction and side effects of colchicine and prednisolone in acute gout in primary care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05698680 first posted on January 26, 2023 (retrospectively registered). URL of trial registry record: https://clinicaltrials.gov/study/NCT05698680.

Effect evaluation of a tele-neurologic intervention in primary care in a rural area in Germany-the NeTKoH study protocol of a stepped-wedge cluster randomized trial.

BACKGROUND: Neurological disorders account for a large and increasing proportion of the global burden of disease. Therefore, it is important to strengthen the management of neurologic care, particularly in rural areas. The use of tele-neurology in primary care in rural areas is internationally considered to have the potential to increase access to health care services and improve the quality of care in these underserved areas. NeTKoH aims to address the existing knowledge gap regarding the effects of a tele-neurologic intervention in primary care under real-world conditions in a rural area in Germany. METHODS: NeTKoH is a cluster-randomized controlled trial with a stepped-wedge design involving 33 outpatient general practitioner's (GP) offices (clusters) in a rural area in Northeast Germany. During 11 predetermined steps, all clusters are randomized before they cross over into groups from the control to the intervention arm. The targeted sample size is 1,089 patients with neurologic symptoms that are continuously being recruited. In the intervention arm, tele-neurologic consultations will be provided via a face-to-face video conferencing system with a neurologic expert at a university hospital. The control arm will receive usual care. The primary outcome is the proportion of neurologic problems being solved at the GP's office. Secondary outcomes will comprise hospital stays and days, time until neurologic specialist appointments and diagnostics, patients' health status and quality of life, outpatient and inpatient referrals. A concurrent observational study, together with a process, implementation, and health economic evaluation, will also be conducted. DISCUSSION: Using a stepped-wedge cluster design in a real-life situation can help with logistic challenges and enhance the motivation of the participating GPs, as all, at some point, will be in the intervention phase. With the additional implementation evaluation pertaining to external validity, an observational study, and a health economic evaluation, NeTKoH will be able to provide an extensive evaluation for health policy decision-makers regarding the uptake into standard care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00024492). Date registered: September 28, 2021. Date and protocol version: June 2023, version 1.

[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.

The Preventiometer - reliability of a cardiovascular multi-device measurement platform and its measurement agreement with a cohort study.

BACKGROUND: Multimedia multi-device measurement platforms may make the assessment of prevention-related medical variables with a focus on cardiovascular outcomes more attractive and time-efficient. The aim of the studies was to evaluate the reliability (Study 1) and the measurement agreement with a cohort study (Study 2) of selected measures of such a device, the Preventiometer. METHODS: In Study 1 (N = 75), we conducted repeated measurements in two Preventiometers for four examinations (blood pressure measurement, pulse oximetry, body fat measurement, and spirometry) to analyze their agreement and derive (retest-)reliability estimates. In Study 2 (N = 150), we compared somatometry, blood pressure, pulse oximetry, body fat, and spirometry measurements in the Preventiometer with corresponding measurements used in the population-based Study of Health in Pomerania (SHIP) to evaluate measurement agreement. RESULTS: Intraclass correlations coefficients (ICCs) ranged from .84 to .99 for all examinations in Study 1. Whereas bias was not an issue for most examinations in Study 2, limits of agreement for most examinations were very large compared to results of similar method comparison studies. CONCLUSION: We observed a high retest-reliability of the assessed clinical examinations in the Preventiometer. Some disagreements between Preventiometer and SHIP examinations can be attributed to procedural differences in the examinations. Methodological and technical improvements are recommended before using the Preventiometer in population-based research.

Association of Anemia with Clinical Symptoms Commonly Attributed to Anemia-Analysis of Two Population-Based Cohorts.

BACKGROUND: Fatigue, dyspnea, and lack of energy and concentration are commonly interpreted as indicative of symptomatic anemia and may thus play a role in diagnostic and therapeutic decisions. OBJECTIVE: To investigate the association between symptoms commonly attributed to anemia and the actual presence of anemia. METHODS: Data from two independent cohorts of the Study of Health in Pomerania (SHIP) were analyzed. Interview data, laboratory data, and physical examination were individually linked with claims data from the Association of Statutory Health Insurance Physicians. A complete case analysis using logistic regression models was performed to evaluate the association of anemia with symptoms commonly attributed to anemia. The models were adjusted for confounders such as depression, medication, insomnia, and other medical conditions. RESULTS: A total of 5979 participants (53% female, median age 55) were included in the analysis. Of those, 30% reported fatigue, 16% reported lack of energy, 16% reported lack of concentration, and 29% reported dyspnea and/or weakness. Anemia was prevalent in about 6% (379). The symptoms were more prevalent in participants with anemia. However, participants with anemia were older and had a poorer health status. There was no association in multivariate logistic regression models between the symptoms fatigue, lack of concentration, dyspnea, and/or weakness and anemia. Anemia was associated (OR: 1.45; 95% CI: 1.13-1.86) with lack of energy in the multivariate analysis. Other factors such as depression, insomnia, and medication were more strongly associated with the symptoms. CONCLUSION: The clinical symptoms commonly attributed to anemia are unspecific and highly prevalent both in non-anemic and anemic persons. Even in the presence of anemia, other diagnoses should be considered as causes such as depression, heart failure, asthma, and COPD, which are more closely associated with the symptoms. Further diagnostic research is warranted to explore the association of symptoms in different subgroups and settings in order to help clinical decision making.

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.

Monitoring and management of chronic kidney disease in ambulatory care - analysis of clinical and claims data from a population-based study.

BACKGROUND: Although chronic kidney disease (CKD) is highly prevalent in the general population, little research has been conducted on CKD management in ambulatory care. Objective was to assess management and quality of care by evaluating CKD coding in ambulatory care, patient diagnosis awareness, frequency of monitoring and whether appropriate patients are referred to nephrology. METHODS: Clinical data from the population-based cohort Study of Health in Pomerania (SHIP-START) were matched with claims data of the Association of Statutory Health Insurance Physicians. Quality of care was evaluated according international and German recommendations. RESULTS: Data from 1778 participants (56% female, mean age 59 years) were analysed. 10% had eGFR < 60 ml/min/1.73m2 (mean age 74 years), 15% had albuminuria. 21% had CKD as defined by KDIGO. 20% of these were coded and 7% self-reported having CKD. Coding increased with GFR stage (G3a 20%, G3b 61%, G4 75%, G5 100%). Serum creatinine and urinary dip stick testing were billed in the majority of all participants regardless of renal function. Testing frequency partially surpassed recommendations. Nephrology consultation was billed in few cases with stage G3b-G4. CONCLUSION: CKD coding increased with stage and was performed reliably in stages ≥ G4, while CKD awareness was low. Adherence to monitoring and referral criteria varied, depending on the applicability of monitoring criteria. For assessing quality of care, consent on monitoring, patient education, referral criteria and coordination of care needs to be established, accounting for patient related factors, including age and comorbidity. TRIAL REGISTRATION: This study was prospectively registered as DRKS00009812 in the German Clinical Trials Register (DRKS).

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.

Referral criteria for chronic kidney disease: implications for disease management and healthcare expenditure-analysis of a population-based sample.

BACKGROUND: Clinical practice guidelines recommend specialist referral according to different criteria. The aim was to assess recommended and observed referral rate and health care expenditure according to recommendations from: • Kidney Disease Improving Global Outcomes (KDIGO,2012) • National Institute for Health and Care Excellence (NICE,2014) • German Society of Nephrology/German Society of Internal Medicine (DGfN/DGIM,2015) • German College of General Practitioners and Family Physicians (DEGAM,2019) • Kidney failure risk equation (NICE,2021) METHODS: Data of the population-based cohort Study of Health in Pomerania were matched with claims data. Proportion of subjects meeting referral criteria and corresponding health care expenditures were calculated and projected to the population of Mecklenburg-Vorpommern. RESULTS: Data from 1927 subjects were analysed. Overall proportion of subjects meeting referral criteria ranged from 4.9% (DEGAM) to 8.3% (DGfN/DGIM). The majority of patients eligible for referral were ≥ 60 years. In subjects older than 60 years, differences were even more pronounced, and rates ranged from 9.7% (DEGAM) to 16.5% (DGfN/DGIM). Estimated population level costs varied between €1,432,440 (DEGAM) and €2,386,186 (DGfN/DGIM). From 190 patients with eGFR < 60 ml/min, 15 had a risk of end stage renal disease > 5% within the next 5 years. CONCLUSIONS: Applying different referral criteria results in different referral rates and costs. Referral rates exceed actually observed consultation rates. Criteria need to be evaluated in terms of available workforce, resources and regarding over- and underutilization of nephrology services.

Validation of Cardiovascular Risk Prediction by the Arriba Instrument.

BACKGROUND: It is recommended in cardiovascular prevention guidelines that treatment should be based on overall cardiovascular risk. The arriba instrument has been widely used for this purpose in Germany. The aim of this study is to validate risk prediction by arriba with the aid of morbidity and mortality data from the population- based Study of Health in Pomerania. METHODS: In a longitudinal analysis, the arriba instrument was used to calculate the 10-year overall cardiovascular risk at baseline for subjects who had not sustained any prior cardiovascular event. Cardiovascular event rates were determined from follow-up data, and discrimination and calibration measures for the risk determination algorithm were calculated. RESULTS: Data from 1973 subjects (mean age 51 ± 13 years, 48% men) were included in the analysis. After a median follow-up of 10.9 years, cardiovascular events had occurred in 196 subjects, or 9.8%. The ratio of predicted to observed event rate was 0.8 (95% confidence interval: [0.5; 1.1]), 1.3 [1.0; 1.8], and 1.1 [0.8; 1.4] for subjects at low, intermediate, and high cardiovascular risk, respectively. Arriba underestimated cardiovascular event rates in women and overestimated them in persons aged 30-44 and 45-59. The area under curve was 0.84 [95% CI 0.81; 0.86]. CONCLUSION: The discrimination scores of the arriba instrument resemble those of SCORE-Germany and PROCAM, but a better adjustment to the target population would be desirable. The results support the recommendation of the German Guideline for Cardiovascular Risk Counseling in General Practice for the use of the arriba instrument. An unresolved problem is the failure to consider intervention effects, resulting in an overall mild overestimation of risk.

Association of Lumbar MRI Findings with Current and Future Back Pain in a Population-based Cohort Study.

STUDY DESIGN: Population-based cohort study. OBJECTIVE: We examined associations between common lumbar degenerative changes observed on magnetic resonance imaging (MRI) and present or future low back pain (LBP). SUMMARY OF BACKGROUND DATA: The association between lumbar MRI degenerative findings and LBP is unclear. Longitudinal studies are sparse. METHODS: Participants (n = 3369) from a population-based cohort study were imaged at study entry, with LBP status measured at baseline and 6-year follow-up. MRI scans were reported on for the presence of a range of MRI findings. LBP status was measured on a 0 to 10 scale. Regression models were used to estimate the cross-sectional and longitudinal associations between individual and multiple MRI findings and LBP severity. Separate longitudinal analyses were conducted for participants with and without baseline pain. RESULTS: MRI findings were present in persons with and without back pain at baseline. Higher proportions were found in older age groups. 76.4% of participants had a least one MRI finding and 8.3% had five or more different MRI findings. Cross-sectionally, most MRI findings were slightly more common in those with LBP and pain severity was slightly higher in those with MRI findings (ranging from 0.06 for high intensity zone to 0.83 for spondylolisthesis). In the longitudinal analyses, we found most MRI findings were not associated with future LBP-severity regardless of the presence or absence of baseline pain. Compared to zero MRI findings, having multiple MRI findings (five or more) was associated with mildly greater pain-severity at baseline (0.84; 0.50-1.17) and greater increase in pain-severity over 6 years in those pain free at baseline (1.21; 0.04-2.37), but not in those with baseline pain (-0.30; -0.99 to 0.38). CONCLUSION: Our study shows that the MRI degenerative findings we examined, individually or in combination, do not have clinically important associations with LBP, with almost all effects less than one unit on a 0 to 10 pain scale.Level of Evidence: 3.

Predicting Physician Consultations for Low Back Pain Using Claims Data and Population-Based Cohort Data-An Interpretable Machine Learning Approach.

(1) Background: Predicting chronic low back pain (LBP) is of clinical and economic interest as LBP leads to disabilities and health service utilization. This study aims to build a competitive and interpretable prediction model; (2) Methods: We used clinical and claims data of 3837 participants of a population-based cohort study to predict future LBP consultations (ICD-10: M40.XX-M54.XX). Best subset selection (BSS) was applied in repeated random samples of training data (75% of data); scoring rules were used to identify the best subset of predictors. The rediction accuracy of BSS was compared to randomforest and support vector machines (SVM) in the validation data (25% of data); (3) Results: The best subset comprised 16 out of 32 predictors. Previous occurrence of LBP increased the odds for future LBP consultations (odds ratio (OR) 6.91 [5.05; 9.45]), while concomitant diseases reduced the odds (1 vs. 0, OR: 0.74 [0.57; 0.98], >1 vs. 0: 0.37 [0.21; 0.67]). The area-under-curve (AUC) of BSS was acceptable (0.78 [0.74; 0.82]) and comparable with SVM (0.78 [0.74; 0.82]) and randomforest (0.79 [0.75; 0.83]); (4) Conclusions: Regarding prediction accuracy, BSS has been considered competitive with established machine-learning approaches. Nonetheless, considerable misclassification is inherent and further refinements are required to improve predictions.

[Perspective of General Practitioners on Management of Non-dialysis Chronic Kidney Disease - a Qualitative Study]. / Management der nicht dialysepflichtigen chronischen Niereninsuffizienz aus hausärztlicher Sicht ­ eine qualitative Studie.

BACKGROUND: Chronic Kidney Disease (CKD) is a common diagnosis in older age due to age dependent kidney function decline, as well as an increase in causative diseases like diabetes mellitus and arterial hypertension. The condition knows a long asymptomatic phase in the early stages, and only a small part of the patient will progress to end stage renal disease requiring renal replacement therapy. Patients with CKD are generally managed by General Practitioners (GPs). OBJECTIVES: The aim of the study was to evaluate the perspectives of German GPs on management of patients with non-dialysis CKD. METHODS: There were 5 focus group discussions with a maximum of 5 GPs (n = 22). The material was recorded and transcribed to be analyzed by content analysis. RESULTS: The most important treatment measures at the CKD were the optimization of causative diseases, medication adjustment and referral for nephrologist consultation. GPs stressed the individual management of their CKD patients. CONCLUSION: GPs reported that their decisions about CKD management were based on Individual patient factors such as high age or multimorbidity.

The course of thyroid nodules and thyroid volume over a time period of up to 10 years: a longitudinal analysis of a population-based cohort.

OBJECTIVE: Thyroid disorders are common. Information on the long-term progression of morphologic disorders is scarce. The aim of this study was to describe the course of thyroid nodules and volume over a period of up to 10 years. DESIGN AND METHODS: Data from the population-based Study of Health in Pomerania were used for longitudinal analysis of 10 years, on average. Billing data from the Association of Statutory Health Insurance Physicians were matched to the data to exclude participants with thyroid surgery, radioiodine therapy and thyroid carcinoma. Changes in the number and size of thyroid nodules and thyroid volume were observed using ultrasound. RESULTS: A total of 1270 participants were included (53% female, median age at baseline 51 years). The proportion of subjects with at least one thyroid nodule increased from 34.9 to 47.5% after 10 years. The majority of participants had an unchanged or reduced number of nodules. About one-quarter had at least one nodule of size ≥ 1 cm. The proportion of participants with goitre increased from 35 to 37% after 10 years. Nevertheless, individual thyroid volume increased by < 1 mL (95% CI: 0.38-3.66) after adjusting for age and BMI irrespective of thyroid medication. CONCLUSION: Thyroid nodules and goitre are common. After 10 years, the number of nodules did not increase in about 70% of people. This proportion did not differ substantially when excluding people with thyroid medication. Thyroid volume increased slightly over the follow-up period. These changes do not seem clinically relevant. Our results support a more restrictive approach regarding follow-up diagnostics in asymptomatic patients with thyroid nodules or minimally enlarged thyroid.

[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.

European* clinical practice recommendations on opioids for chronic noncancer pain - Part 1: Role of opioids in the management of chronic noncancer pain.

BACKGROUND: Opioid use for chronic non-cancer pain (CNCP) is complex. In the absence of pan-European guidance on this issue, a position paper was commissioned by the European Pain Federation (EFIC). METHODS: The clinical practice recommendations were developed by eight scientific societies and one patient self-help organization under the coordination of EFIC. A systematic literature search in MEDLINE (up until January 2020) was performed. Two categories of guidance are given: Evidence-based recommendations (supported by evidence from systematic reviews of randomized controlled trials or of observational studies) and Good Clinical Practice (GCP) statements (supported either by indirect evidence or by case-series, case-control studies and clinical experience). The GRADE system was applied to move from evidence to recommendations. The recommendations and GCP statements were developed by a multiprofessional task force (including nursing, service users, physicians, physiotherapy and psychology) and formal multistep procedures to reach a set of consensus recommendations. The clinical practice recommendations were reviewed by five external reviewers from North America and Europe and were also posted for public comment. RESULTS: The key clinical practice recommendations suggest: (a) first optimizing established non-pharmacological treatments and non-opioid analgesics and (b) considering opioid treatment if established non-pharmacological treatments or non-opioid analgesics are not effective and/or not tolerated and/or contraindicated. Evidence- and clinical consensus-based potential indications and contraindications for opioid treatment are presented. Eighteen GCP recommendations give guidance regarding clinical evaluation, as well as opioid treatment assessment, monitoring, continuation and discontinuation. CONCLUSIONS: Opioids remain a treatment option for some selected patients with CNCP under careful surveillance. SIGNIFICANCE: In chronic pain, opioids are neither a universal cure nor a universally dangerous weapon. They should only be used for some selected chronic noncancer pain syndromes if established non-pharmacological and pharmacological treatment options have failed in supervised pain patients as part of a comprehensive, multi-modal, multi-disciplinary approach to treatment. In this context alone, opioid therapy can be a useful tool in achieving and maintaining an optimal level of pain control in some patients.

European clinical practice recommendations on opioids for chronic noncancer pain - Part 2: Special situations.

BACKGROUND: Opioid use for chronic non-cancer pain (CNCP) is under debate. In the absence of pan-European guidance on this issue, a position paper was commissioned by the European Pain Federation (EFIC). METHODS: The clinical practice recommendations were developed by eight scientific societies and one patient self-help organization under the coordination of EFIC. A systematic literature search in MEDLINE (up until January 2020) was performed. Two categories of guidance are given: Evidence-based recommendations (supported by evidence from systematic reviews of randomized controlled trials or of observational studies) and Good Clinical Practice (GCP) statements (supported either by indirect evidence or by case-series, case-control studies and clinical experience). The GRADE system was applied to move from evidence to recommendations. The recommendations and GCP statements were developed by a multiprofessional task force (including nursing, service users, physicians, physiotherapy and psychology) and formal multistep procedures to reach a set of consensus recommendations. The clinical practice recommendations were reviewed by five external reviewers from North America and Europe and were also posted for public comment. RESULTS: The European Clinical Practice Recommendations give guidance for combination with other medications, the management of frequent (e.g. nausea, constipation) and rare (e.g. hyperalgesia) side effects, for special clinical populations (e.g. children and adolescents, pregnancy) and for special situations (e.g. liver cirrhosis). CONCLUSION: If a trial with opioids for chronic noncancer pain is conducted, detailed knowledge and experience are needed to adapt the opioid treatment to a special patient group and/or clinical situation and to manage side effects effectively. SIGNIFICANCE: If a trial with opioids for chronic noncancer pain is conducted, detailed knowledge and experience are needed to adapt the opioid treatment to a special patient group and/or clinical situation and to manage side effects effectively. A collaboration of medical specialties and of all health care professionals is needed for some special populations and clinical situations.