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.

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.

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.

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.

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.

Cerumen Impaction Removal in General Practices: A Comparison of Approved Standard Products.

BACKGROUND: Ear irrigation is a commonly used method for removing earwax in general practice. There is no firm evidence if no pre-treatment is as good as pre-treatment with various standard preparations. AIM: To assess the effectiveness of no pre-treatment compared to pre-treatment with commercially available cerumenolytics and to assess which preparation is best suited for pre-treatment. METHODS: This is a pragmatic observational study of patients with cerumen treated from a single GP with 3 different preparations or no preparation prior to standardized ear irrigation. Generalized linear mixed models with logit link function were performed to assess the effectiveness of pre-treatment with different preparations and no pre-treatment. The models were adjusted for age group (<70, ≥70) and sex. RESULTS: A total of 168 patients (298 ears, 58 % female, median age 65 years) consulted for obstructive cerumen, some of them several times. The cerumen was successfully removed in 70% (208/298). Comparing any preparation to no preparation (aggregated comparison), the odds ratio for complete clearance was 1.35 (95%confidence interval: 0.69-2.65). Comparing the preparations individually, the odds ratio of the docusate-sodium-based preparation was 1.87 (95% CI: 0.79-4.42) indicating a higher effectiveness. Although, not statistically significant. Ear irrigation was less successful for patients aged ≥ 70 years (OR = 0.48, 95% CI: 0.23-0.98). CONCLUSIONS: The aggregated comparison indicates a slight trend toward a higher effectiveness of any pre-treatment compared to no pre-treatment. The effect-size of docusate-sodium-based pre-treatment indicates a higher effectiveness of cerumen impaction removal. Nevertheless, superiority could not be shown conclusively according to the statistical significance given the restricted sample size.

Frequency of thyroid function tests and examinations in participants of a population-based study.

BACKGROUND: Thyroid disorders are common in the adult German population. Little is known about guideline implementation in clinical practice and the prevalence of diagnostic procedures in ambulatory care. The study aims to investigate the use of thyroid hormone measurements, thyroid ultrasound, thyroid scintiscan and associated costs in ambulatory care at population level. METHODS: Data were derived from two independent population-based cohorts of the Study of Health In Pomerania (SHIP). Ambulatory billing data from the Association of Statutory Health Insurance Physicians Mecklenburg-Vorpommern were individually linked for the period 2002-2016 with SHIP data. The main outcomes were the frequency of outpatient ultrasound, scintiscan, serum TSH level measurement, free triiodothyronine (fT3) and free thyroxine (fT4) measurement, TSH-receptor-antibodies and microsomal antibodies measurement within 1 year and 3 years prior to the study entrance of the participants. Multinomial logistic regression models were used to assess the association of age, sex, thyroid medication intake and Charlson-Comorbidity-Index with frequency of TSH measurements and ultrasound examinations. RESULTS: A total of 5552 participants (47% male, median age 55) were included in the analysis. 25% (1409/5552) had a diagnosed thyroid disorder or treatment, 40% (2191/5552) had clinical findings based on ultrasound or laboratory testing in SHIP only and 35% (1952/5552) neither a coded thyroid disorder or clinical finding nor thyroid medication. In the total study population 30% (1626/5552) received at least one TSH measurement, 6.8% (378/5552) at least one thyroid ultrasound and 2.6% (146/5552) at least one scintiscan within the past year before the study examination. Tests were performed more frequently in patients with thyroid medication and coded thyroid disorders. Hence, this group caused the highest expenditures. CONCLUSIONS: Given the high prevalence of thyroid disorders, diagnostic and monitoring tests should be used rationally with regard to costs. TSH levels should be monitored regularly in patients on thyroid medication. A consensus on monitoring frequency and iteration of monitoring of morphological thyroid disorders with TSH and ultrasound and specific guideline recommendations are needed. TRIAL REGISTRATION: Versorgungsforschung Deutschland (VfD_17_003880).

Evaluation of an ambulatory geriatric rehabilitation program - results of a matched cohort study based on claims data.

BACKGROUND: Ambulatory geriatric rehabilitation (AGR) is a multidisciplinary outpatient prevention program designed to decrease hospitalisation and dependence on nursing care in multimorbid patients ≥70 years of age. We evaluated the effectiveness of AGR compared to usual care on progression of nursing care levels, nursing home admissions, hospital admissions, incident fractures, mortality rate and total cost of care during a one-year follow-up period. METHODS: Analyses were based on claims data from the health insurance company AOK Nordost. Propensity Score matching was used to match 4 controls to each person receiving the AGR intervention. RESULTS: A total of 632 AGR participants and 2528 matched controls were included. The standardized mean difference of matching variables between cases and controls was small (mean: + 1.4%; range: - 4.4/3.9%). In AGR patients, the progression of nursing care levels (+ 2.2%, 95%CI: - 0.9 /5.3), nursing home admissions (+ 1.7%, 95%CI: - 0.1/3.5), hospital admissions (+ 1.1%, 95%CI: - 3.2/5.4), incident fractures (+ 11.1%, 95%CI: 7.3/15) and mortality rate (+ 1.2%, p = 0.20) showed a less favourable course compared to controls. The average total cost per AGR participant was lower than in the control group (- 353€, 95%CI: - 989€/282€), not including costs for AGR. CONCLUSIONS: Analysis based on claims data showed no clinical benefit from AGR intervention regarding the investigated outcomes. The slightly worse outcomes may reflect limitations in matching based on claims data, which may have insufficiently reflected morbidity and psychosocial factors. It is possible that the intervention group had poorer health status at baseline compared to the control group. TRIAL REGISTRATION: German Clinical Trials Register DRKS00008926, registered 29.07.2015.

[Effect of ambulatory geriatric rehabilitation on polypharmacy and potentially inappropriate medication-an observational study]. / Effekt der ambulanten geriatrischen Komplexbehandlung auf Polypharmazie und potenziell inadäquate Arzneimittel ­ eine Beobachtungsstudie.

BACKGROUND: Ambulatory geriatric rehabilitation (AGR) is a prevention program for multimorbid patients with the contractual agreement to prevent the need for care and hospital admissions and to promote self-sufficiency. It provides an opportunity to reduce the prevalence of polypharmacy and to discontinue potentially inadequate medication (PIM). AIM: The study investigated the effect of AGR on the number of drugs and PIM. MATERIAL AND METHODS: The observational longitudinal study was based on claims data from the statutory health insurance AOK Nordost. A comparison of the prescribed drugs with the PRISCUS list was performed. The study investigated the effect of AGR on the number of drugs prescribed and PIM in the period of two quarterly periods before and two quarterly periods after AGR. The numbers of prescribed statins, opioids, antidementia drugs, proton pump inhibitors and antidepressants were assessed and grouped into further prescriptions, new prescriptions and discontinued drug prescriptions. RESULTS: Out of 699 participants 682 (73% women, mean age 79 years, SD ± 5 years) were analyzed. The number of substances and PIM remained at the same levels after AGR. Psycholeptic, antiphlogistic and psychoanaleptic drugs were the most frequently prescribed PIM. The majority of statins, opioids, antidementia drugs, proton pump inhibitors and antidepressants were prescribed further. Antidementia drugs were the medication with the most newly started prescriptions. CONCLUSION: The AGR has no influence on the number of prescribed drugs and PIM. A structured drug review and a conversation with the general practitioner should be strengthened to improve drug safety and reduce polypharmacy as well as undertreatment.

[Prevalence of thyroid abnormality: a comparison of ambulatory claims data with data from a population-based study]. / Schilddrüsenveränderungen: Ein Vergleich ambulanter Abrechnungsdaten mit Daten einer populationsbasierten Studie.

BACKGROUND: Billing diagnoses are used for quality assurance, estimates of prevalence and resource allocation. Validity studies showed relevant limitations. In Germany, there are no population-based data on the agreement of outpatient billing diagnoses with clinical data of thyroid disorders. OBJECTIVES: The study investigated the agreement of ICD-diagnosed thyroid nodules, goitre, hyperthyroidism, hypothyroidism and thyroiditis with clinical and self-reported data from the population-based cohort study called the Study of Health in Pomerania (SHIP). MATERIALS AND METHODS: Billing data from the Association of Statutory Health Insurance Physicians Mecklenburg-Vorpommern were linked on an individual level for the period from 2002-2016 with data from SHIP. The agreement was evaluated using sensitivity, specificity and positive and negative predictive value (PPW, NPW). Data were weighted to ensure population representativeness. RESULTS: The data of 5746 participants were analysed (46% male, average age 55 years, SD [standard deviation] ± 15, min: 20 years, max: 93 years). Based on clinical data, 63% (3451/5511, missing values n = 235) and based on billing data 25% (1421/5746) of the participants had thyroid disorders. The sensitivity was 12-36%, the specificity was 84-98%, the PPW was highest for thyroid nodules (75%) and hypothyroidism (70%) and the NPW was between 63 and 94%, depending on the investigated thyroid disorder. CONCLUSIONS: Thyroid disorders are common and often undiagnosed. Billing data have a low sensitivity to identify clinically relevant thyroid disorders.

[Course of Treatment and Sustainability of Ambulatory Geriatric Rehabilitation - An Analysis of 128 Geriatric Patients]. / Behandlungsverläufe und Nachhaltigkeit der Ambulanten Geriatrischen Komplexbehandlung ­ eine Analyse von 128 geriatrischen Patienten.

AIM OF THE STUDY: The observational study aims to investigate the course of clinical outcomes of geriatric, multimorbid patients who received ambulatory geriatric rehabilitation (AGR) for four weeks. METHODS: Analyses were based on data from 128 patients. Basic geriatric assessment tests and the EQ5D-Scale were used before, directly after the intervention, as well as after 6 and 12 months. Data were analyzed using Mixed-Effects Regression-Models. RESULTS: AGR improved self-dependence, mobility, balance, risk of falls and general state of health. The cognitive conditions reduced slightly. CONCLUSIONS: The patient-related clinical endpoints indicate a positive influence of functional deficits.

[Patients Ability to Provide Information about Prescribed Drugs - a Cross-Sectional Study in Ten General Practice]. / Auskunftsfähigkeit von Patienten über ihre ärztlich verordneten Medikamente ­ Eine Querschnittstudie in zehn Allgemeinarztpraxen.

BACKGROUND: For the correct intake and safe handling of their own medication it is important that patients know about their own medication and can give certain information. This study examines what information patients can provide about their prescribed medication and which factors influence the ability to provide information. METHODS: A cross-sectional study was conducted. In 10 General Practice, 637 patients (participation rate 57 %) were asked about the name, dosage, frequency of intake and indication of their prescribed medication. The patient information were compared with the practice documentation. RESULTS: Patient data on the number of medications were 54 % consistent with the practice documentation. There is a relevant discrepancy between the documented drug prescription and the information provided by patients. The patients were best able to provide information about the names (75 %) of their medications and worst about the indication (47 %). The ability to provide information decreased in patients with ≥ 5 medications. An association between higher education and correct information was found. 65 % of the participants had a medication plan and 19 % used the plan to answer the questions. The possession of a medication plan showed no effect. However the use of a medication plan had an effect, which was even stronger in patients with ≥ 5 medications. CONCLUSION: Most patients did not use the medication plan, which is why the issue of a medication plan does not lead to better information. Technical solutions, such as centralized data storage, should be developed, which can guarantee the security of supply and drug therapy and the exchange between different physicians and institutions, regardless of an incomplete and often non-existent paper or electronic health card medication plan.

Evaluation of Ambulatory Geriatric Rehabilitation (EAGER): study protocol of a matched cohort study based on claims data.

BACKGROUND: Ambulatory geriatric rehabilitation (AGR) is a community based outpatient intervention which aims to improve physical function, maintain independent living of geriatric patients, avoiding hospitalisation and institutionalisation. It should therefore reduce health care costs. The objective of our study is to evaluate the effectiveness of AGR for frail elderly patients insured by the statutory health insurance AOK Nordost compared to care as usual. Outcome variables are progression to higher nursing care levels, admission to nursing home, incident fractures, hospital admission, ambulatory care sensitive hospital admissions, days spent in hospital, and health care costs. METHODS: This matched cohort study aims to estimate average treatment effects of AGR. For this purpose we will compare patients receiving AGR with matched patients receiving care as usual. Patients in the intervention group were treated between the years 2009 and 2013 from three centres in Mecklenburg-Vorpommern, Germany. Matching will be conducted using propensity score techniques. Claims data will be provided by the statutory health insurance AOK Nordost. The primary outcomes are the progression of nursing care levels, incident fractures, and admission to nursing home. Secondary outcomes are total and ambulatory care sensitive hospital admissions, and health care costs from the statutory health insurance perspective. Data will be analysed using appropriate regression models. DISCUSSION: This study aims to quantify the effectiveness of AGR. Results will be important for providers of AGR, policy makers and stakeholders to make informed decisions on whether to continue, modify or extend AGR. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) S00008926 , registered 29.07.2015.

Community-based intervention for depression management at the primary care level in Ha Nam Province, Vietnam: a cluster-randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of an intervention including psychoeducation and yoga for depression management at the primary healthcare level in one district in the Hà Nam province, Vietnam. METHOD: The Patient Health Questionnaire-9 (PHQ-9) was used for depression screening and follow-up. Screened patients were further diagnosed with the Mini-International Neuropsychiatric Diagnostic Interview, by a trained general doctor. A linear regression model, adjusted for age, gender and baseline PHQ-9 score was used to assess whether the intervention leads to decreased depression severity compared to standard care in the control communes. RESULTS: Both groups had similar PHQ-9 scores at baseline. The intervention group had on average significantly lower PHQ-9 scores after the intervention than the control group. Almost half of the patients in the intervention group recovered from depression, whereas nobody did in the control group. CONCLUSION: The results indicate that the intervention can be more effective than standard care in treating depression. The mean change of the PHQ-9 score after the intervention is deemed to be of clinical relevance.