Health and economic impact of improved glucose, blood pressure and lipid control among German adults with type 2 diabetes: a modelling study.

AIMS/HYPOTHESIS: The aim of this study was to estimate the long-term health and economic consequences of improved risk factor control in German adults with type 2 diabetes. METHODS: We used the UK Prospective Diabetes Study Outcomes Model 2 to project the patient-level health outcomes and healthcare costs of people with type 2 diabetes in Germany over 5, 10 and 30 years. We parameterised the model using the best available data on population characteristics, healthcare costs and health-related quality of life from German studies. The modelled scenarios were: (1) a permanent reduction of HbA1c by 5.5 mmol/mol (0.5%), of systolic BP (SBP) by 10 mmHg, or of LDL-cholesterol by 0.26 mmol/l in all patients, and (2) achievement of guideline care recommendations for HbA1c (≤53 mmol/mol [7%]), SBP (≤140 mmHg) or LDL-cholesterol (≤2.6 mmol/l) in patients who do not meet the recommendations. We calculated nationwide estimates using age- and sex-specific quality-adjusted life year (QALY) and cost estimates, type 2 diabetes prevalence and population size. RESULTS: Over 10 years, a permanent reduction of HbA1c by 5.5 mmol/mol (0.5%), SBP by 10 mmHg or LDL-cholesterol by 0.26 mmol/l led to per-person savings in healthcare expenditures of €121, €238 and €34, and 0.01, 0.02 and 0.015 QALYs gained, respectively. Achieving guideline care recommendations for HbA1c, SBP or LDL-cholesterol could reduce healthcare expenditure by €451, €507 and €327 and gained 0.03, 0.05 and 0.06 additional QALYs in individuals who did not meet the recommendations. Nationally, achieving guideline care recommendations for HbA1c, SBP and LDL-cholesterol could reduce healthcare costs by over €1.9 billion. CONCLUSIONS/INTERPRETATION: Sustained improvements in HbA1c, SBP and LDL-cholesterol control among diabetes patients in Germany can lead to substantial health benefits and reduce healthcare expenditures.

Healthcare costs of congenital cytomegalovirus (cCMV) disease in infants during the first two years of life: a retrospective German claims database analysis.

BACKGROUND: Congenital cytomegalovirus (cCMV) infection can cause severe neurological damage, growth retardation, hearing loss, and microcephaly in infants. We aimed at assessing healthcare costs of infants with recorded cCMV diagnosis in an administrative claims database in the first 2 years of life. METHODS: We conducted a retrospective, controlled cohort study using German claims data from the Institute for Applied Health Research Berlin (InGef) database. Incremental healthcare costs during the first and second year of life were assessed by matching (1:60) infants with cCMV diagnoses ≤ 90 days after birth (cCMV90 cohort) to infants without cCMV diagnosis ("representative" controls) and infants with cCMV diagnoses ≤ 21 days after birth plus specific symptoms (cCMV21-S) to infants without cCMV and any ICD-10-GM records (besides Z00-Z99) until 4th preventive health check-up ("healthy" controls). Due to missing data, mean imputation was applied for aids and remedies costs. RESULTS: We identified 54 and 24 infants born 2014-2018 for the cCMV90 and cCMV21-S cohorts, respectively. During the first year, mean (median) healthcare costs were significantly higher in cCMV90 cases vs. "representative" controls (€22,737 (€9759) vs. €3091 (€863), p < 0.001), with 87.2% inpatient costs. Healthcare costs for cCMV21-S cases compared to "healthy" controls were €34,498 (€20,924) vs. €680 (€569), p < 0.001. Differences decreased for both comparisons in the second year but remained statistically significant. CONCLUSIONS: cCMV comprises a considerable economic burden for the German healthcare system (€19,646 to €33,818 higher mean costs for infants with recorded cCMV diagnosis in the first year of life). Attempts should be made to reduce this burden.

Burden of CIN2+ diagnoses and conizations in women aged 18-45 years-a retrospective secondary data analysis of German statutory health insurance claims data.

PURPOSE: High grade cervical intraepithelial neoplasia (CIN2+) may progress to cervical cancer. They may be detected by screening and are usually treated by conization. This study aimed at assessing annual proportions of screening, prevalent and incident CIN2+ diagnoses, as well as proportions of (re-)conizations during 24 months follow-up after conization in Germany. METHODS: A descriptive retrospective claims data analysis of the years 2013-2018 was conducted using the InGef Research Database. Women aged 18-45 years with CIN2+ diagnoses were identified by ICD-10-GM codes (N87.1, N87.2, D06.-, and C53.-). Cervical conizations were identified by OPS codes (5-671.0* or 5-671.1*). Screening participation was identified by EBM codes (01730, 01733, 32819 or 32820). Annual proportions were calculated as women with the respective documented codes divided by all women in the respective age group per calendar year. RESULTS: Overall annual proportions of screened women spanned from 60.01 to 61.33% between 2013 and 2018. The overall annual prevalence of CIN2+ diagnoses (regardless of screening participation) ranged from 0.72 to 0.84% between 2013 and 2018, with highest proportions observed in women aged 27-45 years. Also, CIN2+ incidence was highest in women 27-45 years. Annual proportion of women undergoing conization was 0.24% in 2013 and 0.21% in 2018. During a 24-month follow-up period after conization, 2.91% of women underwent a re-conization 3 months or later after the initial conization. CONCLUSION: This analysis demonstrates a considerable burden of CIN2+, conizations and re-conizations in Germany, especially in women aged 27-45 years. This highlights the need for intensified prevention efforts such as expanding human papillomavirus (HPV) vaccination.

The times we are born into and our lifestyle choices determine our health trajectories in older age - Results from the KORA-Age study.

Health projections often extrapolate from observations in current ageing cohorts, but health in older age may depend not only on individual characteristics but also on a person's historical context. Our objective was to investigate how health deficit accumulation trajectories after age 65 differed in five adjacent birth cohorts and according to individual life course characteristics. Data originate from the 2008/09 KORA (Cooperative Health Research in the Region of Augsburg)-Age cohort study from Southern Germany and their 2012 and 2016 follow-ups. Deficit accumulation was assessed using a Frailty Index. The effects of birth cohort membership and individual life course characteristics on deficit accumulation trajectories were analyzed using generalized linear mixed models. Out of 2701 participants (49% male) from five birth cohorts (1919-23, 1924-28, 1929-33, 1934-38, 1939-43), we included 2512 individuals with 5560 observations. Frailty Index levels were higher for women, smokers, alcohol abstainers, obese participants and persons with a sedentary lifestyle or living below the poverty threshold. We found higher age-specific Frailty Index levels for the two most recent birth cohorts (e.g. 61%, CI: [13%; 130%] for the 1934-38 as compared to the 1919-23 cohort), but the rate of deficit accumulation with age (7% per life year, (CI: [5%, 9%]) was cohort-independent. Results indicate that the historical context (birth cohort membership) may influence the number of accumulated health deficits after age 65 in addition to poverty and other individual life course characteristics, but BMI, physical activity and smoking remain the modifiable risk factors offering the highest prevention potential.

Improved survival after resection of colorectal liver metastases in patients with unresectable lung metastases.

BACKGROUND: Modern systemic therapies considerably improve tumour control and thus open the possibility of new surgical approaches in metastatic colorectal cancer. In this retrospective clinical cohort with a comparison group, we investigated whether liver resection in a combined liver-lung-metastasised stage is justified if pulmonary disease is not resected. METHODS: From 283 patients treated in our institution between 2000 and 2014 for combined colorectal liver- and lung metastases, 35 patients had their pulmonary metastases left in situ while they were eligible for both treatment options: resection versus non-resection of liver metastases. Effectively, 15 of these patients received whereas 20 did not receive a liver resection. In these patients, we compared overall survival and determined risk factors that are associated with poor survival, applying a Cox-Proportional Hazards model. RESULTS: Patients whose liver metastases were resected showed significantly longer median survival compared to patients who did not undergo hepatic surgery (median 2.6 vs 1.5 years, P = 0.0182). The Cox-Proportional Hazards model revealed hepatic metastasectomy to be the strongest determinant of patient survival (HR 5.27; CI: (1.89, 14.65)). CONCLUSION: Our results suggest that surgical removal of liver metastases may be beneficial in selected patients even if concomitant lung metastases cannot be resected.

Being born in the aftermath of World War II increases the risk for health deficit accumulation in older age: results from the KORA-Age study.

Morbidity trends may result from cohort experiences in critical developmental age. Our objective was to compare the health status of 65-71 year-olds who were in critical developmental age before (1937-June 1945), during (June 1945-June 1948) and after (June 1948-1950) the early reconstruction and food crisis (ERFC) period in Germany following World War II. Data originate from the KORA (Cooperative Health Research in the Region of Augsburg)-Age study in Southern Germany. We used the 2008 baseline sample born 1937-1943 and the 2015 enrichment sample born 1944-1950. Health status was assessed as the number of accumulated health deficits using a Frailty Index (FI). Cohorts were defined based on co-occurrence of critical developmental age (gestation and the first 2 years of life) and the ERFC period. Cohort, age and sex effects on older-age health status were analyzed using generalized linear models. We included 590 (53% male) pre-war and war (PWW), 475 (51% male) ERFC and 171 post-currency reform (PCR) cohort participants (46% male). Adjusted for covariates, FI levels were significantly higher for the ERFC (Ratio 1.14, CL [1.06, 1.23]) but not for the PCR (Ratio 1.06, CL [0.94, 1.20]) as compared to the PWW cohort. Being in critical developmental age during the ERFC period increased FI levels in adults aged 65-71 years. Covariates did not explain these effects, suggesting a direct detrimental effect from being in critical developmental age during the ERFC period on older-age health. This expansion of morbidity in Germany was not detected in the PCR cohort.

Systematic Review and Meta-analysis of the Effectiveness of Implementation Strategies for Non-communicable Disease Guidelines in Primary Health Care.

BACKGROUND: As clinical practice guidelines represent the most important evidence-based decision support tool, several strategies have been applied to improve their implementation into the primary health care system. This study aimed to evaluate the effect of intervention methods on the guideline adherence of primary care providers (PCPs). METHODS: The studies selected through a systematic search in Medline and Embase were categorised according to intervention schemes and outcome indicator categories. Harvest plots and forest plots were applied to integrate results. RESULTS: The 36 studies covered six intervention schemes, with single interventions being the most effective and distribution of materials the least. The harvest plot displayed 27 groups having no effect, 14 a moderate and 21 a strong effect on the outcome indicators in the categories of knowledge transfer, diagnostic behaviour, prescription, counselling and patient-level results. The forest plot revealed a moderate overall effect size of 0.22 [0.15, 0.29] where single interventions were more effective (0.27 [0.17, 0.38]) than multifaceted interventions (0.13 [0.06, 0.19]). DISCUSSION: Guideline implementation strategies are heterogeneous. Reducing the complexity of strategies and tailoring to the local conditions and PCPs' needs may improve implementation and clinical practice.

Development of a complex intervention to improve participation of nursing home residents with joint contractures: a mixed-method study.

BACKGROUND: Joint contractures in nursing home residents limit the capacity to perform daily activities and restrict social participation. The purpose of this study was to develop a complex intervention to improve participation in nursing home residents with joint contractures. METHODS: The development followed the UK Medical Research Council framework using a mixed-methods design with re-analysis of existing interview data using a graphic modelling approach, group discussions with nursing home residents, systematic review of intervention studies, structured 2-day workshop with experts in geriatric, nursing, and rehabilitation, and group discussion with professionals in nursing homes. RESULTS: Graphic modelling identified restrictions in the use of transportation, walking within buildings, memory functions, and using the hands and arms as the central target points for the intervention. Seven group discussions with 33 residents revealed various aspects related to functioning and disability according the International Classification of Functioning, Disability and Health domains body functions, body structures, activities and participation, environmental factors, and personal factors. The systematic review included 17 studies with 992 participants: 16 randomised controlled trials and one controlled trial. The findings could not demonstrate any evidence in favour of an intervention. The structured 2-day expert workshop resulted in a variety of potential intervention components and implementation strategies. The group discussion with the professionals in nursing homes verified the feasibility of the components and the overall concept. The resulting intervention, Participation Enabling CAre in Nursing (PECAN), will be implemented during a 1-day workshop for nurses, a mentoring approach, and supportive material. The intervention addresses nurses and other staff, residents, their informal caregivers, therapists, and general practitioners. CONCLUSIONS: In view of the absence of any robust evidence, the decision to use mixed methods and to closely involve both health professionals and residents proved to be an appropriate means to develop a complex intervention to improve participation of and quality of life in nursing home residents. We will now evaluate the PECAN intervention for its impact and feasibility in a pilot study in preparation for an evaluation of its effectiveness in a definitive trial. TRIAL REGISTRATION: German clinical trials register, reference number DRKS00010037 (12 February 2016).

Male sex and poverty predict abrupt health decline: Deficit accumulation patterns and trajectories in the KORA-Age cohort study.

Ageing individuals differ both in their deficit accumulation (DA) trajectories and resulting DA patterns (improvement, stability, gradual or abrupt decline). This heterogeneity is still incompletely understood. The objectives of this study were thus to identify determinants of DA trajectories and DA patterns in people aged 65 and older. Data originates from the 2009 baseline assessment and 2012 follow-up of the KORA (Cooperative Health Research in the Region of Augsburg)-Age study from Southern Germany. DA was measured with a Frailty Index (FI). The effects of socio-demographic, socio-economic and lifestyle factors were analyzed using generalized linear mixed models and multinomial regressions. FI scores were available for 1076 participants at baseline (mean age 76years, 50% female) and 808 participants at follow-up. Higher baseline FI levels were significantly associated with higher age, female sex, lower physical activity, moderate alcohol consumption and obesity. Longitudinal increase in FI levels over 3years was 31% (CL: [-3%; 77%]) independent of all examined predictors. The most frequent DA patterns were stability (59%) and gradual decline (30%). Compared to stability, higher age, male sex and low income predicted (mostly fatal) abrupt decline. In conclusion, several factors are associated with FI levels at baseline whereas the change in FI levels over time seems hardly modifiable. Thus, future research should investigate if the same factors predicting older-age FI levels constitute predictors of DA onset earlier in life. Towards the end of life, being male with low income may increase the risk for abrupt decline, indicating need for early detection.

A high level of household physical activity compensates for lack of leisure time physical activity with regard to deficit accumulation: Results from the KORA-Age study.

INTRODUCTION: Aging is associated with increasing loss of physiological resilience and successive accumulation of physiological deficits. This can be measured through a frailty index which sums up symptoms, health conditions and impairments. One possible factor in preventing or delaying deficit accumulation is physical activity. The effect of leisure time physical activity on health is well investigated; however, the effect of household physical activity is less clear. The objective of this cross-sectional study was to examine the association of household physical activity with deficit accumulation while controlling for level of leisure time physical activity. METHODS: Data originates from the 2008 baseline assessment of the KORA (Cooperative Health Research in the Region of Augsburg)-Age study from Southern Germany. A frailty index of deficit accumulation (Deficit Accumulation Index, DAI) was constructed from 31 age-related health deficits. Physical activity was measured with the Physical Activity Scale for the Elderly (PASE). The association of deficit accumulation and physical activity was analyzed using negative binomial regression analysis. RESULTS: The participants' (n=960, mean age 76years, 49.0% female) DAI ranged from 0.00 to 0.68. Higher levels of both types of physical activity were statistically significantly associated with less deficit accumulation. Participants in the highest household (leisure time) physical activity quartile had 29% (30%) less deficits than participants in the respective lowest quartiles. CONCLUSION: High levels of household physical activity might compensate for low levels of leisure time physical activity in the prevention of deficit accumulation. Further research efforts investigating the temporal sequence of this association are needed.

An umbrella review of effectiveness and efficacy trials for app-based health interventions.

Health interventions based on mobile phone or tablet applications (apps) are promising tools to help patients manage their conditions more effectively. Evidence from randomized controlled trials (RCTs) on efficacy and effectiveness of such interventions is increasingly available. This umbrella review aimed at mapping and narratively summarizing published systematic reviews on efficacy and effectiveness of mobile app-based health interventions within patient populations. We followed a pre-specified publicly available protocol. Systematic reviews were searched in two databases from inception until August 28, 2023. Reviews that included RCTs evaluating integrated or stand-alone health app interventions in patient populations with regard to efficacy/effectiveness were considered eligible. Information on indications, outcomes, app characteristics, efficacy/effectiveness results and authors' conclusions was extracted. Methodological quality was assessed using the AMSTAR2 tool. We identified 48 systematic reviews published between 2013 and 2023 (35 with meta-analyses) that met our inclusion criteria. Eleven reviews included a broad spectrum of conditions, thirteen focused on diabetes, five on anxiety and/or depression, and others on various other indications. Reported outcomes ranged from medication adherence to laboratory, anthropometric and functional parameters, symptom scores and quality of life. Fourty-one reviews concluded that health apps may be effective in improving health outcomes. We rated one review as moderate quality. Here we report that the synthesized evidence on health app effectiveness varies largely between indications. Future RCTs should consider reporting behavioral (process) outcomes and measures of healthcare resource utilization to provide deeper insights on mechanisms that make health apps effective, and further elucidate their impact on healthcare systems.

Burden of sequelae and healthcare resource utilization in the first year of life in infants born with congenital cytomegalovirus (cCMV) infection in Germany: A retrospective statutory health insurance claims database analysis.

BACKGROUND: Congenital cytomegalovirus (cCMV) infection can have a broad range of manifestations. This study aimed to assess cCMV-associated sequelae and healthcare resource utilization (HCRU) in infants during the first year of life in Germany. METHODS: A retrospective, controlled cohort study using German claims data from the Institute for Applied Health Research Berlin (InGef) database was conducted. cCMV-associated sequelae and HCRU during the first year of life were assessed by matching (1:60) infants with at least one inpatient/outpatient cCMV diagnosis (ICD-10-GM: P35.1) ≤90 days after birth (cCMV90 cohort) and infants with at least one inpatient cCMV diagnosis plus specific sequelae ≤21 days after birth (cCMV21-S) to infants without cCMV or CMV (ICD-10-GM: B25) diagnosis (control group), respectively. Outcomes were analyzed during the first 365 days of life. RESULTS: Between 2014-2018, we identified 54 newborns for cCMV90 and 24 newborns for cCMV21-S cohort. Compared to the 3,240 and 1,440 controls, respectively, more cCMV90 infants (83.3% vs. 41.9%, p<0.01) presented with at least one sequela during the first year of life, including intrauterine growth retardation (42.6% vs. 5.3%, p<0.01), sensorineural hearing loss (SNHL) to deafness (38.9% vs. 2.2%, p<0.01), and motor development disorders (33.3% vs. 10.9%, p<0.01). Further, 13.0% of cCMV90 infants (vs. 2.3%, p<0.01) suffered from visual impairment. In cCMV21-S cohort, intrauterine growth retardation (79.2% vs. 6.0%, p<0.01), prematurity (54.2% vs. 7.3%, p<0.01), and motor development disorders (50.0% vs. 11.0%, p<0.01) were the most frequent sequelae. Infants in the cCMV90 and cCMV21-S cohort had, on average, 7.3 times and 9.5 times more hospitalizations and 2.0 times and 2.1 times more outpatient physician visits than their respective controls (p<0.01). Hospitalized infants with cCMV stayed, on average, significantly longer in hospital compared to their controls (cCMV90 cohort: 30.3 days vs. 9.0 days, p<0.01; cCMV21-S cohort: 46.5 days vs. 9.3 days, p<0.01). CONCLUSIONS: cCMV-infection shows a considerable disease and healthcare burden during the first year of life. More than 80% of the identified newborns with cCMV suffered from at least one associated sequela during the first year of life, including long-term sequelae such as SNHL (40%) and visual impairment (13%). Additional steps for prevention of cCMV infection and associated sequelae as well as a comprehensive monitoring of disease burden are needed.

Healthcare Costs and Resource Use Associated With Cervical Intraepithelial Neoplasia and Cervical Conization: A Retrospective Study of German Statutory Health Insurance Claims Data.

Background: Cervical intraepithelial neoplasia (CIN) can be a consequence of human papillomavirus (HPV) infection. High-grade CIN (CIN2/CIN3) may develop from persistent HPV infection and progress to cervical cancer if left untreated. Management of CIN includes conservative surveillance or ablation and excision by conization. Internationally, CIN and its treatment generate a considerable economic burden, but no current data regarding costs and resource use from the perspective of the German statutory health insurance exist. Objectives: The aim of this study was to explore the health economic burden in women with CIN diagnoses who either underwent cervical conization or were managed conservatively. Methods: We conducted a retrospective claims data analysis using the InGef Research Database from 2013 to 2018. Healthcare costs and resource utilization in a 24-month observation period (1:1:1 matching) were compared in 18- to 45-year-old women with CIN (1-3) who underwent a conization procedure (study cohort 1) and in women with CIN (1-3) who did not undergo conization (study cohort 2) to women with neither CIN nor conization (control group). Results: For each group, 2749 women were identified. Mean total healthcare costs after 24 months were higher in study cohort 1 (€4446, P<.01) and study cohort 2 (€3754, P=.09) compared with the control group (€3426). Comparing study cohort 1 and 2 to controls, mean differences were highest in age groups 41-45 years (cohort 1: €5115 vs €3354, P<.01; cohort 2: €4152 vs €3354, P=.14). Significantly more women were hospitalized at least once in study cohort 1 (57.46%, P<.01) and study cohort 2 (38.74%, P<.01) compared with the control group (31.14%). Frequency of outpatient physician visits was significantly higher in both study cohorts (43.23 visits, P<.01 and 38.60 visits, P<.01) compared with the control group (32.07 visits). Conclusion: Our results revealed 30% and 10% increased total healthcare costs in women with CIN undergoing invasive treatment (study cohort 1) and conservative management (study cohort 2), respectively, compared with a control group of women with no CIN in a 2-year follow-up period.

Living longer but less healthy: The female disadvantage in health expectancy. Results from the KORA-Age study.

OBJECTIVES: We explored the male-female health-survival paradox in the context of health expectancy (HE) at age 65 and thereafter, using three different morbidity measures and different severity cut-offs with and without adjustments for the share of nursing home residents. METHODS: HE at ages 65, 70, 75, 80, and 85 was estimated with the Sullivan method, linking morbidity prevalence from the KORA (Cooperative Health Research in the Region of Augsburg)-Age study to 2016 Bavarian mortality data. Morbidity measures comprised deficit accumulation (Frailty Index, FI, cut-offs 0.08 and 0.25), disability (Health Assessment Questionnaire-Disability Index, HAQ-DI, cut-off >0) and participation (Global Activity Limitation Indicator, GALI, "limited" vs "not limited"). RESULTS: Morbidity data were available for 4083 participants (52.7% female). HE was lower in women than in men at all ages. Differences in morbidity prevalence, absolute HE, and health proportions of life expectancy (relative HE) increased with age for FI ≥ 0.25 and GALI, but not for HAQ-DI > 0 and FI > 0.08. Accounting for the share of nursing home residents resulted in a slight reduction of HE estimates but had no impact on estimated sex differences. CONCLUSIONS: In HE at age 65 and thereafter, women's health disadvantage was larger than their life expectancy advantage over men.

Wealth and occupation determine health deficit accumulation onset in Europe - Results from the SHARE study.

While socio-economic characteristics have been shown to be associated with health deficit accumulation (DA) trajectories, their effect on the age at DA onset remains unclear. The objective of this study was to compare the median age at DA onset across nine European countries and to investigate the effects of income, occupation and wealth on DA onset after age 50. We used population samples aged 50 years and older from the SHARE (Survey of Health, Aging and Retirement in Europe) study. Participants from nine European countries with longitudinal data from at least three of the 2004/05, 2006/07, 2010/11, 2012/13 and 2014/15 waves were included in the analysis. A Frailty Index (FI, range 0-1) was constructed from 50 health deficits. DA onset was defined as having FI values > 0.08 in at least two consecutive measurements following an initial FI value ≤ 0.08. We investigated the effect of income, occupation and wealth on DA onset using a random effects model for time-to-event data. Potential confounding variables were identified using directed acyclic graphs. Out of 8616 (mean age 62 years, 49.0% female) participants initially at risk, 2640 (30.6%) experienced a subsequent DA onset. Median age at onset was 71 years overall, ranging from 66 years (Germany) to 76 years (Switzerland). Wealth and occupation were found to have significant effects on DA onset which decreased with age. In sum, the median age at DA onset differs between European countries. On an individual-level, wealth and occupation, but not income influence the age at DA onset.

Pilot cluster randomized controlled trial of a complex intervention to improve management of vertigo in primary care (PRIMA-Vertigo): study protocol.

OBJECTIVES: Vertigo and dizziness are highly prevalent symptoms in primary care, frequently misdiagnosed. Based on a thorough need assessment, INDICORE (INform, DIagnose, COmmunicate, REfer), an evidence-based complex intervention has been developed to transfer knowledge of specialized tertiary clinics to primary care providers (PCPs), improve the referral process and, ultimately, improve the functioning and quality of life of patients with vertigo/dizziness. The main objective of the PRIMA-Vertigo pilot study is to examine whether the INDICORE intervention is feasible and sufficiently promising to warrant a larger trial. METHODS: We plan to perform a single-blind, pragmatic cluster-randomized controlled pilot study with an accompanying process evaluation. PCPs will be the cluster units of randomization. Patients who consult these PCPs because of vertigo/dizziness symptoms will be included consecutively and considered the units of analysis. The intervention will be multi-faceted training on diagnostics targeted at the PCPs, supported by patient education material and a newly developed tool to structure the referral process. To balance the influence of non-specific effects, all clusters will receive generic communication training. EXPECTED RESULTS: The process evaluation aims to provide results on the acceptability and feasibility of the INDICORE intervention components to PCPs and patients. Additionally, this study will provide a first estimate of the likely effectiveness of the intervention on patients' quality of life, functioning and participation. CONCLUSIONS: The PRIMA-Vertigo pilot study will allow further tailoring of the INDICORE intervention to stakeholder needs before its effectiveness is evaluated in a large-scale main study.

Barriers and facilitators for the management of vertigo: a qualitative study with primary care providers.

BACKGROUND: Although the management of patients presenting with vertigo and dizziness in primary care has been reported to be inefficient, little is known about the primary care providers' (PCPs) perspectives, needs, and attitudes regarding vertigo management. The objective of this study was to understand which challenges and barriers PCPs see when diagnosing and treating patients presenting with vertigo or dizziness. Specifically, we wanted to identify facilitators and barriers of successful guideline implementation in order to inform the development of targeted interventions. METHODS: A theory-based interview structure was developed based on the implementation theory of capability, opportunity, and motivation for behaviour change (COM-B) using questions based on constructs from the Theoretical Domains Framework (TDF) and the Consolidated Framework for Implementation Research (CFIR). Transcripts of the semi-structured interviews were analysed using directed content analysis. The pathways through which guideline characteristics and supportive interventions affect the relationship between the PCPs' perceived capability, opportunity, and motivation as well as their practice of managing vertigo patients were graphically presented using the COM-B model structure. RESULTS: Twelve PCPs from Bavaria in Southern Germany participated in semi-structured interviews. Diagnostics posed the biggest challenge in vertigo management to the PCPs. Requirements for an acceptable guideline were stakeholder involvement in the development process, clarity of presentation, and high applicability. Guideline implementation might be effectively supported through educational meetings and sustained by organisational interventions. CONCLUSIONS: From the PCPs' perspective, both guideline characteristics and interventions supporting guideline implementation may help resolve challenges in vertigo management in primary care. These results should be used to guide future interventions in the primary care setting to ensure successful and targeted patient management.

Correction to: barriers and facilitators for the management of vertigo: a qualitative study with primary care providers.

After publication of the original article [1] it was brought to the authors' attention that a sentence was missing in the acknowledgement section. The full acknowledgement is included in this Correction article.

Developing and piloting a multifactorial intervention to address participation and quality of life in nursing home residents with joint contractures (JointConImprove): study protocol.

BACKGROUND: Joint contractures are common problems in frail older people in nursing homes. Irrespective of the exact extent of older individuals in geriatric care settings living with joint contractures, they appear to be a relevant problem. Also, the new emphasis on the syndrome of joint contractures, e. g. by the German statutory long term care insurance, led to an increase in assessment and documentation efforts and preventive interventions in clinical care. However, more attention should be paid to the actual situation of older individuals in nursing homes with prevalent joint contractures, particularly their experience of related activity limitations and participation restrictions. Thus, the aim of this study is 1) to develop a tailored intervention to improve functioning, and especially participation and quality of life in older residents with joint contractures in nursing homes and 2) to test the feasibility of the intervention accompanied by a rigorous process evaluation. METHODS: The complex intervention, which will be developed in this project follows the UK Medical Research Council (MRC) framework and integrates the perspectives of all potentially relevant user groups, from the affected individuals to clinicians and researchers. The development process will comprise a systematic literature review, reanalysis of existing data and the integration of the knowledge of the affected individuals and experts. The developed intervention including a comprehensive process evaluation will be pilot tested with residents with joint contractures in three nursing homes. DISCUSSION: The projected study will provide a tailored intervention to improve functioning, participation and quality of life in older residents with joint contractures in nursing homes. With this focus, the intervention will support patient relevant outcomes. The pilot study including process evaluation will offer a first opportunity to indicate the size of the intervention's effect and prepare further studies.