Dementia in primary care – results of the implementation of a cluster randomized controlled trial

Background: Dementia represents a major global health burden, affecting not only individuals but the society. In Germany, primary care physicians (PCPs) have a central role in the provision of dementia care. However, well-developed, and novel research approaches are urgently needed to improve primary health care for patients with dementia (PwD). The main aim of the present dissertation was to generate evidence from different stages of the implementation of the research project DemTab: Tablet-based outpatient care of people with dementia (DemTab Study). Methods: Based on the DemTab Study, a two-arm, cluster randomized controlled trial aiming at developing and evaluating a tablet-based intervention to improve guideline-based dementia care in primary care, three manuscripts were published as part of the dissertation. The manuscripts represent outcomes and evidence from three different stages of the implementation. Results: All three manuscripts provide valuable input to the field of dementia research as well as the implementation of research in primary care prior to the final evaluation of the effectiveness of an intervention. Results of Manuscript I included a detailed study protocol, which was published prior to the recruitment of study’s participants. Results of Manuscript II indicated an overall PCPs recruitment rate of about 5%, with the most efficient strategy being recruitment though primary care research networks. Further, on average PCPs successfully recruited four PwD (range: 1 – 11 PwD). Results of Manuscript III indicated high levels of adherence to the German S3 Dementia Guideline among PCPs (71%). Further, a significant association between adherence to the German S3 Dementia Guideline and higher numbers of patients was found (γ10 = - 5.58, CI = - 10.97, - 0.19, p = .04). However, no association between adherence to the German S3 Dementia Guideline and PwD's quality of life was found (γ10 = -.86, CI = - 4.18, 2.47, p = .61). Conclusion: First, the present dissertation outlines that while study protocols represent an important tool to foster methodological standards of trial implementation, violations, particularly in dementia research, may occur. Second, present results highlight the potential of primary care research networks and the importance to include PCP’s interests and perspectives when conducting research. Third, overall adherence to guideline recommendations is high among PCPs, although variations across specific recommendations are being observed. Implications: Future dementia research should consider more adaptable and pragmatic trials and PCP’s interests, experiences, and perspectives should be included in all stages of research to ensure successful recruitment and implementation. Finally, while PCPs overall adherence to the German S3 Dementia Guideline is observable, specific aspects of dementia care require more attention. Results of the present dissertation will be incorporated in the final evaluation of the trial.Hintergrund: Demenzerkrankungen stellen weltweit eine große gesundheitliche Belastung dar, die nicht nur den Einzelnen, sondern auch die Gesellschaft betrifft. In Deutschland spielen Hausärzt:innen (HA) eine zentrale Rolle in der Versorgung der Demenz. Um die hausärztliche Versorgung von Patient:innen mit Demenz (PmD) zu verbessern, werden jedoch dringend neue Forschungsansätze benötigt. Das Hauptziel der vorliegenden Dissertation war es, Ergebnisse und Erkenntnisse aus verschiedenen Phasen der Umsetzung des Forschungsprojektes DemTab: Tabletbasierte ambulante Versorgung von Menschen mit Demenz zu generieren: Methoden: Auf der Grundlage der DemTab-Studie, einer zweiarmigen, cluster-randomisierten kontrollierten Studie zur Entwicklung und Evaluierung einer tablet-basierten Intervention zur Verbesserung der leitlinienbasierten Demenzversorgung in der Primärversorgung, wurden im Rahmen der Dissertation drei Manuskripte veröffentlicht. Die Manuskripte stellen Ergebnisse aus drei verschiedenen Phasen der Implementierung der DemTab-Studie dar. Ergebnisse: Manuskript I enthielten ein detailliertes Studienprotokoll, welches vor der Rekrutierung von Studienteilnehmenden veröffentlicht wurde. Ergebnisse von Manuskript II zeigten eine HA Rekrutierungsrate von etwa 5 %, wobei die effizienteste Strategie die Rekrutierung über Forschungsnetzwerke in der Primärversorgung darstellte. Im Durchschnitt wurden pro Praxis vier PmD (Spanne: 1 - 11 MmD) erfolgreich rekrutiert. Ergebnisse von Manuskript III deuten auf eine hohe Adhärenz der S3-Leitlinie Demenzen durch HA (71 %). Außerdem wurde festgestellt, dass die Leitlinienadhärenz signifikant mit einer höheren Anzahl von Patient:innen assoziiert ist (γ10 = - 5,58, CI = - 10,97, -0,19, p = .04). Jedoch wurde kein Zusammenhang zwischen der Leitlinienadhärenz und der Lebensqualität von PmD festgestellt (γ10 = -.86, CI = - 4.18, 2.47, p = .61). Schlussfolgerung: Erstens zeigt die vorliegende Dissertation, dass Studienprotokolle zwar ein wichtiges Instrument zur Förderung methodischer Standards bei der Durchführung von Studien darstellen, jedoch Verstöße, insbesondere in der Demenzforschung, beobachtbar sind. Zweitens unterstreichen die Ergebnisse der Rekrutierung das Potenzial von Forschungsnetzwerken in der Primärversorgung und die Bedeutung der Einbeziehung von HA bei der Durchführung von Forschung. Drittens ist die Befolgung der Leitlinienempfehlungen insgesamt hoch, auch wenn Unterschiede bei den einzelnen Empfehlungen zu beobachten sind. Implikationen: Künftige interventionelle Forschung in der Demenzversorgung sollte anpassungsfähigere und pragmatischere Studiendesigns in Betracht ziehen. Darüber hinaus sollte die Forschung die Interessen, Erfahrungen und Perspektiven von HA einbeziehen und bestimmten Aspekten der Demenzversorgung sollte mehr Aufmerksamkeit geschenkt werden. Die Ergebnisse der vorliegenden Dissertation werden in die abschließende Auswertung der DemTab-Studie einfließe

A retrospective analysis of the health and social situation of homeless people in Berlin: study protocol

Background: Homelessness is often described as both a driver and a consequence of poor health, social exclusion and economic marginalisation. The present protocol provides a detailed description of the study Examining the health situation of homeless people in Berlin: a retrospective analysis of data from the health centre for the homeless of the Jenny De la Torre Foundation from 2006 to 2020 (GIG study). The primary objective of the GIG study is to describe and analyse the social and health situation of homeless people in Berlin. Methods: A retrospective secondary data analysis of an anonymous full census of medical records for the years 2006 until 2020 from a health centre for homeless people will be carried out. The main outcome is the description and analysis of the social and health situation of homeless people in Berlin. Total and cross-sectional sample characteristics will be presented in a descriptive analysis using Chi-Square Test, Mann-Whitney-U-Test or independent t-Test as appropriate to test (sub) group differences. Further, outcomes will be analysed using finite mixture modelling in order to distinguish different types of social and health conditions. Latent variable regressions will be applied in order to identify sociodemographic and disease-related factors associated with decreasing health conditions. Discussion: Given the high number of homeless individuals in Germany, it is of great importance to examine their social and health situation in order to gain a better understanding of challenges and needs of homeless people and work on new approaches and solutions to effectively address these. Trail registration: The study was prospectively registered with the German Clinical Trials Register (trial registration number: DRKS00021172). Registered 26 June 2020

Depression in primary care and the role of evidence-based guidelines: cross-sectional data from primary care physicians in Germany

Background: Depression is the most common mental health burden worldwide. Primary care physicians (PCPs) play a key role in the care provision for people with depression. The first objective of the present study was to examine the health care situation of depression in primary care, focusing on the cooperation between PCPs and mental health specialists. Secondly, we aimed at examining the role of the German S3 Guideline for Unipolar Depression in the primary care provision. Methods: Data of N = 75 PCPs were analysed from a cross-sectional online survey. Analysis of descriptive information on the current status of primary health care and depression was conducted. Further, to examine factors that are related to the usage of guidelines, multiple regression was performed. Results: Only 22.1% of PCPs described the quality of cooperation with ambulatory mental health specialist as good. The most frequent problems in the cooperation were of structural nature (49.3%, long waiting list, few therapy units, as well as barriers in the communication and the information exchange). With regard to the role of the guideline, 65% of PCPs reported never or seldom using the guideline and 31.7% of PCPs perceived the guideline as not useful at all. In addition, perceived usefulness of the S3 guideline was positively associated with the usage of the guideline. Results of the logistic regression revealed a significant association between the usage of the German S3 Guideline for Unipolar Depression and rating of perceived usefulness of the guideline (OR: 4.771; 95% CI: 2.15-10.59; p < 0.001). Conclusion: This study highlights the central role of PCPs and demonstrates major barriers in the outpatient health care provision of depression. Present findings suggest a strong need for collaborative health care models to resolve obstacles resulting from fragmented mental health care systems. Finally, reported perceived barriers in the implementation of the German S3 Guideline for Unipolar Depression indicate the urge to involve PCPs in the development of evidence-based guidelines, in order to ensure a successful implementation and usage of guidelines in clinical practice

Recruiting general practitioners and patients with dementia into a cluster randomised controlled trial: strategies, barriers and facilitators

Background: Recruitment of general practitioners (GPs) and their patients is reported as one of the most challenging steps when undertaking primary care research. The present paper describes the recruitment process of a cluster randomised controlled trial (cRCT) aiming to improve dementia care in the primary care setting. Methods: Recruitment data was analysed descriptively using frequency tables to investigate comparisons of recruitment rates and results of different recruitment strategies as well as reasons for participation and non-participation of GPs, patients with dementia (PwD) and their caregivers. Results: Over a period of 23 months, N = 28 GPs were successfully included in the cRCT. This represents an overall recruitment rate of 4.6%. The most efficient strategy in terms of high response and low labour-intensity involved the dissemination of calls for participation in a GP research network. Most frequently reported reasons for GP's participation were Improvement of patient's well-being (n = 22, 79%) followed by Interest in dementia research (n = 18, 64%). The most common reasons for non-participation were Lack of time (n = 71, 34%) followed by Not interested in participation (n = 63, 30%). On a patient level, N = 102 PwD were successfully recruited. On average, each GP referred about n = 7 PwD (range: 1-17; mdn = 6; IQR = 3.5) and successfully recruited about n = 4 PwD (range: 1-11; mdn = 3; IQR = 3.5). Conclusion: First, our findings propose GP research networks as a promising strategy to promote recruitment and participation of GPs and their patients in research. Second, present findings highlight the importance of including GPs and their interests in specific research topics in early stages of research in order to ensure a successful recruitment. Finally, results do not support cold calls as a successful strategy in the recruitment of GPs

In situ analysis of the influence of twinning on the strain hardening rate and fracture mechanism in AZ31B magnesium alloy

The influence of twinning on the strain hardening rate and fracture mechanism in AZ31B magnesium alloy was studied in this work by in situ microstructural analysis during tensile testing in a chamber of scanning electron microscope. Three types of samples used in this study were obtained by (1) extrusion (as-supplied), (2) I-ECAP and (3) I-ECAP followed by side upsetting. Microstructures, textures and mechanical properties were examined after each processing step. An analytical equation was used to describe flow stress curves of the samples which exhibited various modes of deformation (1) only by slip, (2) dominated by tensile twinning followed by slip and (3) dominated by contraction twinning followed by slip. It was shown that tensile twinning increases strain hardening rate, while the opposite is observed for contraction twinning. The effective Schmid factors for slip in volumes deformed by tensile and contraction twinning were determined in this work using modelling approach as 0.215 and 0.45, respectively. Contraction twinning was also revealed to be responsible for an earlier fracture of the extruded sample subjected to tension, since microcracking was shown explicitly to be initiated within twins

Concordance of self- and informant-rated depressive symptoms in nursing home residents with Dementia: cross-sectional findings

Background: Depression is highly prevalent in nursing home residents living with moderate to severe dementia. However, assessing depressive symptoms in residents with dementia can be challenging and may vary by rater perspective. We aimed to investigate the concordance of, and factors associated with self- and informant-rated depressive symptoms in nursing home residents with dementia. Methods: Cross-sectional data was collected from N= 162 nursing home residents with dementia (age: 53-100; 74% women). Self-ratings were assessed with the Geriatric Depression Scale, while the depression and anxiety items of the Neuropsychiatric Inventory were used for informant-ratings. Cohen's Kappa was calculated to determine the concordance of both measures and of each with antidepressant medication. Multivariate associations with sociodemographic variables, self- and informant-rated quality of life, dementia stage, neuropsychiatric symptoms, functional status and antidepressant medication were analysed with linear mixed models and generalized estimating equations. Results: Concordance between self- and single item informant-rated depressive symptoms was minimal (Cohen's Kappa = .22, p= .02). No concordance was found for self-reported depressive symptoms and the combined informant-rated depression-anxiety score. Self-reported depression was negatively associated with self-rated quality of life (beta=-.32; 95%CI: -.45 to -.19, p< .001), informant-rated quality of life (beta=-.25; 95%CI: -.43 to -.07, p= .005) and functional status (beta=-.16; 95%CI: -.32 to -.01, p= .04), whilst single item informant-rated depression revealed negative associations with informant-rated quality of life (beta =-.32; 95%CI: -.52 to .13, p=.001) and dementia stage (beta=-.31; 95%CI: -.52 to -.10, p = .004). The combined informant-rated depression-anxiety score showed negative associations with self-rated quality of life (beta=-.12; 95%CI: -.22 to -.03, p = .01) and dementia stage (beta = -.37; 95%CI: -.67 to -.07, p= .02) and a positive association with neuropsychiatric symptoms (beta = .30; 95%CI: .10 to .51, p= .004). No concordance was found with antidepressant medication. Conclusions: In line with our expectations, low agreement and unique association patterns were found for both measures. These findings indicate that both instruments address different aspects of depression and underline the need for comprehensive approaches when it comes to detecting signs of clinically relevant depressive symptoms in dementia

Perceived need for treatment and non-utilization of outpatient psychotherapy in old age: two cohorts of a nationwide survey

Beackground: Older adults with mental health problems may benefit from psychotherapy; however, their perceived need for treatment in relation to rates of non-utilization of outpatient psychotherapy as well as the predisposing, enabling, and need factors proposed by Andersen's Model of Health Care Utilization that account for these differences warrant further investigation. Methods: We used two separate cohorts (2014 and 2019) of a weighted nationwide telephone survey in Germany of German-speaking adults with N=12,197 participants. Across the two cohorts, 12.9% (weighted) reported a perceived need for treatment for mental health problems and were selected for further analyses. Logistic Generalized Estimation Equations (GEE) was applied to model the associations between disposing (age, gender, single habiting, rural residency, general health status), enabling (education, general practitioner visit) non-utilization of psychotherapy (outcome) across cohorts in those with a need for treatment (need factor). Results: In 2014, 11.8% of 6087 participants reported a perceived need for treatment due to mental health problems. In 2016, the prevalence increased significantly to 14.0% of 6110 participants. Of those who reported a perceived need for treatment, 36.4% in 2014 and 36.9%in 2019 did not see a psychotherapist - where rates of non-utilization of psychotherapy were vastly higher in the oldest age category (59.3/52.5%; 75+) than in the youngest (29.1/10.7%; aged 18-25). Concerning factors associated with non-utilization, multivariate findings indicated participation in the cohort of 2014 (OR 0.94), older age (55-64 OR 1.02, 65-74 OR 1.47, 75+ OR 4.76), male gender (OR 0.83), lower educational status (OR 0.84), rural residency (OR 1.38), single habiting (OR 1.37), and seeing a GP (OR 1.39) to be related with non-utilization of psychotherapy; general health status was not significantly associated with non-utilization when GP contact was included in the model. Conclusion: There is a strong age effect in terms of non-utilization of outpatient psychotherapy. Individual characteristics of both healthcare professionals and patients and structural barriers may add to this picture. Effective strategies to increase psychotherapy rates in those older adults with unmet treatment needs are required

Dementia care and the role of guideline adherence in primary care: cross-sectional findings from the DemTab study

Background: General practitioners (GPs) play a key role in the care of people with dementia (PwD). However, the role of the German Dementia Guideline in primary care remains unclear. The main objective of the present study was to examine the role of guideline-based dementia care in general practices. Methods: A cross-sectional analysis of data obtained from the DemTab study was conducted. Descriptive analyses of sociodemographic and clinical characteristics for GPs (N = 28) and PwD (N = 91) were conducted. Adherence to the German Dementia Guideline of GPs was measured at the level of PwD. Linear Mixed Models were used to analyze the associations between adherence to the German Dementia Guideline and GP factors at individual (age, years of experience as a GP, frequency of utilization of guideline, perceived usefulness of guideline) and structural (type of practice, total number of patients seen by a participating GP, and total number of PwD seen by a participating GP) levels as well as between adherence to the German Dementia Guideline and PwD's quality of life. Results: Self-reported overall adherence of GPs was on average 71% (SD = 19.4, range: 25-100). Adherence to specific recommendations varied widely (from 19.2 to 95.3%) and the majority of GPs (79.1%) reported the guideline as only partially or somewhat helpful. Further, we found lower adherence to be significantly associated with higher numbers of patients (gamma 10 = - 5.58, CI = - 10.97, - 0.19, p = .04). No association between adherence to the guideline and PwD's quality of life was found (gamma 10 = -.86, CI = - 4.18, 2.47, p = .61). Conclusion: The present study examined the role of adherence to the German Dementia Guideline recommendations in primary care. Overall, GPs reported high levels of adherence. However, major differences across guideline recommendations were found. Findings highlight the importance of guidelines for the provision of care. Dementia guidelines for GPs need to be better tailored and addressed. Further, structural changes such as more time for PwD may contribute to a sustainable change of dementia care in primary care

Canagliflozin and renal outcomes in type 2 diabetes and nephropathy

BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to &lt;90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], &gt;300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of &lt;15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P&lt;0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P&lt;0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years