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Balancing stroke prevention and risk of bleeding in patients with atrial fibrillation (AF) is challenging. Direct oral anticoagulants (DOACs) are by now considered standard of care for treating patients with AF in international guidelines. Our objective was to assess the safety of long-term intake of DOACs in older adults with AF. We included RCTs in elderly (≥ 65 years) patients with AF. A systematic search in MEDLINE and EMBASE was performed on 19 April 2022. For determination of risk of bias, the RoB 2 tool was applied. We pooled outcomes using random-effects meta-analyses. The quality of evidence was assessed using GRADE. Eleven RCTs with a total of 63,374 patients were identified. Two RCTs compared apixaban with either warfarin or aspirin, four edoxaban with either placebo, aspirin, or vitamin K antagonists (VKAs), two dabigatran with warfarin and three rivaroxaban with warfarin. DOACs probably reduce mortality in elderly patients with AF (HR 0.89 95%CI 0.77 to 1.02). Low-dose DOACs likely reduce bleeding compared to VKAs (HR ranged from 0.47 to 1.01). For high-dose DOACS the risk of bleeding varied widely (HR ranged from 0.80 to 1.40). We found that low-dose DOACs probably decrease mortality in AF patients. Moreover, apixaban and probably edoxaban are associated with fewer major or clinically relevant bleeding (MCRB) events compared to VKAs. For dabigatran and rivaroxaban, the risk of MCRB varies depending on dose. Moreover, subgroup analyses indicate that in the very old (≥ 85) the risk for MCRB events might be increased when using DOACs. Registration: PROSPERO: CRD42020187876. [ABSTRACT FROM AUTHOR]

Background: Regular physical activity has multiple health benefits, especially in older people. Therefore, the World Health Organization recommends at least 2.5 h of moderate physical activity per week. The aim of the POWER Study was to investigate whether volunteer-assisted walking improves the physical performance and health of older people. Methods: We approached people aged 65 years and older with restricted mobility due to physical limitations and asked them to participate in this multicentre randomised controlled trial. The recruitment took place in nursing homes and the community setting. Participants randomly assigned to the intervention group were accompanied by volunteer companions for a 30–50 min walk up to three times a week for 6 months. Participants in the control group received two lectures that included health-related topics. The primary endpoint was physical function as measured with the Short Physical Performance Battery (SPPB) at baseline and 6 and 12 months. The secondary and safety endpoints were quality of life (EQ-5D-5L), fear of falling (Falls Efficacy Scale), cognitive executive function (the Clock Drawing Test), falls, hospitalisations and death. Results: The sample comprised 224 participants (79% female). We failed to show superiority of the intervention with regard to physical function (SPPB) or other health outcomes in the intention-to-treat analyses. However, additional exploratory analyses suggest benefits in those who undertook regular walks. The intervention appears to be safe regarding falls. Conclusions: Regular physical activity is essential to preserve function and to improve health and quality of life. Against the background of a smaller-than-planned sample size, resulting in low power, and the interference of the COVID-19 pandemic, we suggest that community based low-threshold interventions deserve further exploration. Trial registration: The trial was registered with the German Clinical Trials Register (www.germanctr.de), with number DRKS00015188 on 31/08/2018. [ABSTRACT FROM AUTHOR]

Background: The term potentially inadequate medication (PIM) is used to describe substances that may be unsuitable for use in the elderly and should be avoided. The PRISCUS list, published in 2010, was the first catalog of PIM designed for the German drug market to become adopted in practice. While 24% of German patients aged ≥ 65 years were prescribed at least one PIM per year in 2009, the proportion in 2019 was only 14.5%. Methods: In a three-round Delphi process, experts from clinical practice and research evaluated whether selected substances are PIM for the elderly. The participants were provided with dedicated literature including systematic reviews carried out for the particular purposes of this project. Results: Fifty-nine persons took part in the Delphi process and, in addition, contributed comments and therapeutic alternatives. Altogether, 187 substances were classed as PIM. One hundred thirty-three of the substances now listed were not in the original PRISCUS list: these include some oral antidiabetics, all of the selective COX-2 inhibitors, and moderately long acting benzodiazepines such as oxazepam. For some other substances, e.g., proton pump inhibitors (PPI), the advisability of treatment for more than 8 weeks was considered as potentially inappropriate, as was the use of ibuprofen in doses >1200 mg/day and for more than 1 week without PPI. Risperidone for more than 6 weeks is also PIM. Conclusion: The new, greatly extended PRISCUS list must now be validated in epidemiological and prospective studies and its practicability in routine daily use must be verified. [ABSTRACT FROM AUTHOR]

Our study was carried out as part of updating the I Potentially inappropriate medications list in the elderly i in Germany (henceforth termed "the PRISCUS list").[1] This included a three-round Delphi process to derive the list of PIMs. Our aim was to investigate the process of providing information and the importance of different sources of information in the context of developing a PIM list. Altogether, 187 substances were classed as PIM.[4] We conducted a closed follow-up survey of all experts who took part in the assessment of PIM for the update of the PRISCUS list. [Extracted from the article]

Background: Adrenergic alpha-1 receptor antagonists (alpha-1 antagonists) are frequently used medications in the management of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) and in the management of therapy-resistant arterial hypertension, two conditions frequently found in older adults. This systematic review aims at presenting a complete overview of evidence over the benefits and risks of alpha-1 antagonist treatment in people ≥ 65 years, and at deriving recommendations for a safe application of alpha-1 antagonists in older adults from the evidence found.Methods: A comprehensive literature search was performed (last update March 25th 2022) including multiple databases (Medline/Pubmed, Embase, the Cochrane Library) and using the PICOS framework to define search terms. The selection of the studies was done by two independent reviewers in a two-step approach, followed by a systematic data extraction. Quality appraisal was performed for each study included using standardised appraisal tools. The studies retrieved and additional literature were used for the development of recommendations, which were rated for strength and quality according to the GRADE methodology.Results: Eighteen studies were included: 3 meta-analyses, 6 randomised controlled trials and 9 observational trials. Doxazosin in the management of arterial hypertension was associated with a higher risk of cardiovascular disease, particularly heart failure, than chlorthalidone. Regarding treatment of LUTS suggestive of BPH, alpha-1 antagonists appeared to be effective in the relief of urinary symptoms and improvement of quality of life. They seemed to be less effective in preventing disease progression. Analyses of the risk profile indicated an increase in vasodilation related adverse events and sexual adverse events for some agents. The risk of falls and fractures as well as the effects of long-term treatment remained unclear. All meta-analyses and 5 out of 6 interventional studies were downgraded in the quality appraisal. 7 out of 9 observational studies were of good quality.Conclusions: It cannot be recommended to use doxazosin as first-line antihypertensive agent neither in older adults nor in younger patients. In the management of BPH alpha-1 antagonists promise to effectively relieve urinary symptoms with uncertainty regarding their efficacy in preventing long-term progression events. [ABSTRACT FROM AUTHOR]

Background: Systematic reviews that synthesize safety outcomes pose challenges (e.g. rare events), which raise questions for grading the strength of the body of evidence. This is maybe one reason why in many potentially inappropriate medication (PIM) lists the recommendations are not based on formalized systems for assessing the quality of the body of evidence such as GRADE. In this contribution, we describe specifications and suggest adaptions of the GRADE system for grading the quality of evidence on safety outcomes, which were developed in the context of preparing a PIM-list, namely PRISCUS.Methods: We systematically assessed each of the five GRADE domains for rating-down (study limitations, imprecision, inconsistency, indirectness, publication bias) and the criteria for rating-up, considering if special considerations or revisions of the original approach were indicated. The result was gathered in a written document and discussed in a group-meeting of five members with various background until consensus. Subsequently, we performed a proof-of-concept application using a convenience sample of systematic reviews and applied the approach to systematic reviews on 19 different clinical questions.Results: We describe specifications and suggest adaptions for the criteria "study limitations", imprecision, "publication bias" and "rating-up for large effect". In addition, we suggest a new criterion to account for data from subgroup-analyses. The proof-of-concept application did not reveal a need for further revision and thus we used the approach for the systematic reviews that were prepared for the PRISCUS-list. We assessed 51 outcomes. Each of the proposed adaptions was applied. There were neither an excessive number of low and very low ratings, nor an excessive number of high ratings, but the different methodological quality of the safety outcomes appeared to be well reflected.Conclusion: The suggestions appear to have the potential to overcome some of the challenges when grading the methodological quality of harms and thus may be helpful for producers of evidence syntheses considering safety. [ABSTRACT FROM AUTHOR]

Background: Person-centred care (PCC) has been suggested as the preferred model of dementia care in all settings. The EPCentCare study showed that an adapted PCC approach was difficult to implement and had no effect on prescription of antipsychotics in nursing home residents in Germany. This paper reports the qualitative process evaluation to identify facilitators and barriers of the implementation of PCC in German nursing homes from the perspective of participating practice development champions. Methods: Five individual and 14 group interviews were conducted with 66 participants (staff and managers) from 18 nursing homes. The analysis was based on inductive coding to identify factors influencing the PCC implementation process. Identified factors were systematised and structured by mapping them to the four constructs (coherence, cognitive participation, collective action, reflexive monitoring) of the Normalization Process Theory (NPT) as a framework that explains implementation processes. Results: Facilitating implementation factors included among others broadening of the care perspective (coherence), tolerance development within the care team regarding challenging behaviour (cognitive participation), testing new approaches to solutions as a multi-professional team (collective action), and perception of effects of PCC measures (reflexive monitoring). Among the facilitating factors reported in all the NPT constructs, thus affecting the entire implementation process, were the involvement of relatives, multi-professional teamwork and effective collaboration with physicians. Barriers implied uncertainties about the implementation and expectation of a higher workload (coherence), concerns about the feasibility of PCC implementation in terms of human resources (cognitive participation), lack of a person-centred attitude by colleagues or the institution (collective action), and doubts about the effects of PCC (reflexive monitoring). Barriers influencing the entire implementation process comprised insufficient time resources, lack of support, lack of involvement of the multi-professional team, and difficulties regarding communication with the attending physicians. Conclusions: The findings provide a comprehensive and detailed overview of facilitators and barriers structured along the implementation process. Thus, our findings may assist both researchers and clinicians to develop and reflect more efficiently on PCC implementation processes in nursing homes. Trial registration: ClinicalTrials.gov identifier: NCT02295462; November 20, 2014. [ABSTRACT FROM AUTHOR]

Background: Some capability dimensions may be more important than others in determining someone's well-being, and these preferences might be dependent on ill-health experience. This study aimed to explore the relative preference weights of the 16 items of the German language version of the OxCAP-MH (Oxford Capability questionnaire-Mental Health) capability instrument and their differences across cohorts with alternative levels of mental ill-health experience.Methods: A Best-Worst-Scaling (BWS) survey was conducted in Austria among 1) psychiatric patients (direct mental ill-health experience), 2) (mental) healthcare experts (indirect mental ill-health experience), and 3) primary care patients with no mental ill-health experience. Relative importance scores for each item of the German OxCAP-MH instrument were calculated using Hierarchical Bayes estimation. Rank analysis and multivariable linear regression analysis with robust standard errors were used to explore the relative importance of the OxCAP-MH items across the three cohorts.Results: The study included 158 participants with complete cases and acceptable fit statistic. The relative importance scores for the full cohort ranged from 0.76 to 15.72. Findings of the BWS experiment indicated that the items Self-determination and Limitation in daily activities were regarded as the most important for all three cohorts. Freedom of expression was rated significantly less important by psychiatric patients than by the other two cohorts, while Having suitable accommodation appeared significantly less important by the expert cohort. There were no further significant differences in the relative preference weights of OxCAP-MH items between the cohorts or according to gender.Conclusions: Our study indicates significant between-item but limited mental ill-health related heterogeneity in the relative preference weights of the different capability items within the OxCAP-MH. The findings support the future development of preference-based value sets elicited from the general population for comparative economic evaluation purposes. [ABSTRACT FROM AUTHOR]

The objective was to assess the changes in quality of life (QoL) and patient satisfaction of chronically ill patients in general practices in Salzburg (Austria) and South Tyrol (Italy) after implementation of a combined intervention addressing quality of care of general practitioners (GPs). Furthermore, the correlation between QoL/patient satisfaction and quality of care provided by the GPs (measured by a quality score based on quality indicators [QIs]) was investigated. The non‐controlled pre–post study involved GPs and patients with chronic conditions. The intervention consisted of self‐audit, benchmarking and quality circles. QIs were extracted in the participating practices in 2012 (preintervention) and 2014 (postintervention). Before and after the intervention, a patient survey was conducted including EQ‐5D (measuring health‐related QoL), a patient participation scale and parts of the European Task Force on Patient Evaluations of General Practice questionnaire (measuring patient satisfaction). Mann–Whitney U‐tests, chi‐square tests and Spearman's rank correlation were applied for statistical analysis. Fifty‐six GPs participated in the study. 1,710 patients returned the questionnaire in 2012, and 1,374 in 2014. Mean EQ‐5D index (QoL) was similar in Salzburg and South Tyrol in both years: 2012 Salzburg 0.85 (95% CI 0.84–0.87), South Tyrol 0.85 (95% CI 0.84–0.86); 2014 Salzburg 0.84 (95% CI 0.83–0.86), South Tyrol 0.84 (95% CI 0.83–0.86). Patient satisfaction was higher in Salzburg than in South Tyrol at baseline (EUROPEP: mean percentage of best response 61.5% vs. 49.1%, p < 0.000) and also at follow‐up (61.9% vs. 49.2%; p < 0.000). No significant correlation between quality score and QoL/patient satisfaction was detected. Thus, the impact of the intervention was not significant within the intermediate time periods analysed in the study. Improvements in quality of care do not necessarily also improve patient‐relevant outcomes, which are probably more associated with other factors than with medical quality (e.g. availability of the GP, waiting times and communication‐related issues). [ABSTRACT FROM AUTHOR]

The aim of the current study is to perform model calculations on the possible use of SARSCoV-2-rapid point-of-care tests as mass tests, using the quality criteria extracted from evidence-based research as an example for the Federal Republic of Germany. In addition to illustrating the problem of false positive test results, these calculations are used to examine their possible influence on the 7-day incidence. For a substantial period of time, this parameter formed the decisive basis for decisions on measures to protect the population in the wake of the COVID pandemic, which were taken by the government. Primarily, model calculations were performed for a base model of 1,000,000 SARS-CoV- 2-rapid point-of-care tests per week using various sensitivities and specificities reported in the literature, followed by sequential testing of the test positives obtained by a SARS-CoV-2 PCR test. Furthermore, a calculation was performed for an actual maximum model based on self-test contingents by the German Federal Ministry of Health. Assuming a number of 1,000,000 tests per week at a prevalence of 0.5%, a high number of false positive test results, a low positive predictive value, a high negative predictive value, and an increase in the 7-day incidence due to the additional antigen rapid tests of approx. 5/100,000 were obtained. A previous maximum calculation based on contingent numbers for self-tests given by the German Federal Ministry of Health even showed an additional possible influence on the 7-day incidence of 84.6/100,000. The model calculations refer in each case to representative population samples that would have to be drawn if the successive results were comparable which should be given, as far-reaching actions were based on this parameter. The additionally performed SARS-CoV-2-rapid point-of-care tests increase the 7-day incidence in a clear way depending on the number of tests and clearly show their dependence on the respective number of tests. SARS-CoV-2-rapid point-of-care tests as well as the SARS-CoV-2-PCR test method should both be used exclusively in the presence of corresponding respiratory symptoms and not in symptom-free persons. [ABSTRACT FROM AUTHOR]

Background: Evidence regarding clinically relevant effects of interventions aiming at reducing polypharmacy is weak, especially for the primary care setting. This study was initiated with the objective to achieve clinical benefits for older patients (aged 75+) by means of evidence-based reduction of polypharmacy (defined as ≥8 prescribed drugs) and inappropriate prescribing in general practice.Methods: The cluster-randomised controlled trial involved general practitioners and patients in a northern-Italian region. The intervention consisted of a review of patient's medication regimens by three experts who gave specific recommendations for drug discontinuation. Main outcome measures were non-elective hospital admissions or death within 24 months (composite primary endpoint). Secondary outcomes were drug numbers, hospital admissions, mortality, falls, fractures, quality of life, affective status, cognitive function.Results: Twenty-two GPs/307 patients participated in the intervention group, 21 GPs/272 patients in the control group. One hundred twenty-five patients (40.7%) experienced the primary outcome in the intervention group, 87 patients (32.0%) in the control group. The adjusted rates of occurrence of the primary outcome did not differ significantly between the study groups (intention-to-treat analysis: adjusted odds ratio 1.46, 95%CI 0.99-2.18, p = 0.06; per-protocol analysis: adjusted OR 1.33, 95%CI 0.87-2.04, p = 0.2). Hospitalisations as single endpoint occurred more frequently in the intervention group according to the unadjusted analysis (OR 1.61, 95%CI 1.03-2.51, p = 0.04) but not in the adjusted analysis (OR 1.39, 95%CI 0.95-2.03, p = 0.09). Falls occurred less frequently in the intervention group (adjusted OR 0.55, 95%CI 0.31-0.98; p = 0.04). No significant differences were found regarding the other outcomes. Definitive discontinuation was obtained for 67 (16.0%) of 419 drugs rated as inappropriate. About 6% of the prescribed drugs were PIMs.Conclusions: No conclusive effects were found regarding mortality and non-elective hospitalisations as composite respectively single endpoints. Falls were significantly reduced in the intervention group, although definitive discontinuation was achieved for only one out of six inappropriate drugs. These results indicate that (1) even a modest reduction of inappropriate medications may entail positive clinical effects, and that (2) focusing on evidence-based new drug prescriptions and prevention of polypharmacy may be more effective than deprescribing.Trial Registration: Current Controlled Trials (ID ISRCTN: 38449870), date: 11/09/2013. [ABSTRACT FROM AUTHOR]

Background: Systematic strategies promoting quality of care in general practice are yet under-represented in several European countries.Objective: This interventional study assessed whether a combined intervention (self-audit, benchmarking, quality circles) improved quality of care in Salzburg, Austria and South Tyrol, Italy. The present publication reports the Italian results.Methods: We developed quality indicators for general practice in a consensus process based on pre-existing quality programmes. The indicators addressed diagnosis and treatment regarding eight common chronic conditions. A quality score comprising 91 indicators was calculated (0-5 points per indicator depending on fulfilment, maximum 455 points). We collected anonymous data from the electronic health records of the participating physicians in 2012, 2013 and 2014. Wilcoxon signed-rank tests were used for pre-post analysis.Results: Thirty-six GPs participated in the study. The median quality score increased significantly from 177.0 points at baseline to 272.0 points at the second follow-up (P = 0.000). Improvements concerned process and intermediate outcome indicators particularly between baseline and the first follow-up.Conclusion: Performance was relatively low at baseline and improved considerably, mainly in the first study period. The intervention investigated in this study can serve as a model for future quality programmes. A customized electronic health record for the implementation of this intervention as well as standardized and consistent documentation by GPs is a prerequisite. Use of a limited set of quality indicators (QIs) and regular QI modification is probably advisable to increase the benefits. Long-term prospective studies should investigate the impact of QI-based interventions on end-result outcomes. [ABSTRACT FROM AUTHOR]

Background: A precondition for developing strategies to reduce polypharmacy and its well-known harmful consequences is to study its epidemiology and associated factors. The objective of this study was to analyse the prevalence of polypharmacy (defined as ≥8 prescribed drugs), of potentially inappropriate medications (PIMs) and major drug-drug interactions (DDIs) among community-dwelling general practice patients aged ≥75 years and to identify characteristics being associated with polypharmacy.Methods: This cross-sectional study is derived from baseline data (patients' demographic/biometric characteristics, diagnoses, medication-related data, cognitive/affective status, quality of life) of a northern-Italian cluster-RCT. PIMs and DDIs were assessed using the 2012 Beers criteria and the Lexi-Interact® database. Data were analysed using descriptive methods, Wilcoxon rank-sum tests, Fisher's exact tests and Spearman correlations.Results: Of the eligible patients aged 75+, 13.4% were on therapy with ≥8 drugs. Forty-three general practitioners and 579 patients participated in the study. Forty five point nine percent of patients were treated with ≥1 Beers-listed drugs. The most frequent PIMs were benzodiazepines/hypnotics (19.7% of patients) and NSAIDs (6.6%). Sixty seven point five percent of patients were exposed to ≥1 major DDI, 35.2% to ≥2 major DDIs. Antithrombotic/anticoagulant medications (30.4%) and antidepressants/antipsychotics (23.1%) were the most frequently interacting drugs. Polypharmacy was significantly associated with a higher number of major DDIs (Spearman's rho 0.33, p < 0.001) and chronic conditions (Spearman's rho 0.20, p < 0.001), higher 5-GDS scores (thus, lower affective status) (Spearman's rho 0.12, p = 0.003) and lower EQ-5D-5L scores (thus, lower quality of life) (Spearman's rho - 0.14, p = 0.001). Patients' age/sex, 6-CIT scores (cognitive status), BMI or PIM use were not correlated with the number of drugs.Conclusions: The prevalence of polypharmacy, PIMs and major DDIs was considerable. Results indicate that physicians should particularly observe their patients with multiple conditions, reduced health and affective status, independently from other patients' characteristics. Careful attention about indication, benefit and potential risk should be paid especially to patients on therapy with specific drug classes identified as potentially inappropriate or prone to major DDIs in older persons (e.g., benzodiazepines, NSAIDs, protonic pump inhibitors, antithrombotics/anticoagulants, antidepressants/antipsychotics).Trial Registration: The cluster-RCT on which this cross-sectional analysis is based was registered with Current Controlled Trials Ltd. (ID ISRCTN: 38449870 ) on 2013-09-11. [ABSTRACT FROM AUTHOR]

Background: The treatment of upper respiratory tract infections (URTIs) accounts for the majority of antibiotic prescriptions in primary care, although an antibiotic therapy is rarely indicated. Non-clinical factors, such as time pressure and the perceived patient expectations are considered to be reasons for prescribing antibiotics in cases where they are not indicated. The improper use of antibiotics, however, can promote resistance and cause serious side effects. The aim of the study was to clarify whether the antibiotic prescription rate for infections of the upper respiratory tract can be lowered by means of a short (2 x 2.25h) communication training based on the MAAS-Global-D for primary care physicians. Methods: In total, 1554 primary care physicians were invited to participate in the study. The control group was formed from observational data. To estimate intervention effects we applied a combination of difference-in-difference (DiD) and statistical matching based on entropy balancing. We estimated a corresponding multi-level logistic regression model for the antibiotic prescribing decision of German primary care physicians for URTIs. Results: Univariate estimates detected an 11-percentage-point reduction of prescriptions for the intervention group after the training. For the control group, a reduction of 4.7% was detected. The difference between both groups in the difference between the periods was -6.5% and statistically significant. The estimated effects were nearly identical to the effects estimated for the multi-level logistic regression model with applied matching. Furthermore, for the treatment of young women, the impact of the training on the reduction of antibiotic prescription was significantly stronger. Conclusions: Our results suggest that communication skills, implemented through a short communication training with the MAAS-Global-D-training, lead to a more prudent prescribing behavior of antibiotics for URTIs. Thereby, the MAAS-Global-D-training could not only avoid unnecessary side effects but could also help reducing the emergence of drug resistant bacteria. As a consequence of our study we suggest that communication training based on the MAAS-Global-D should be applied in the postgraduate training scheme of primary care physicians. [ABSTRACT FROM AUTHOR]

Objective: We sought to investigate the experiences of general practitioners (GPs) with an electronic decision support tool to reduce inappropriate polypharmacy in older patients (the PRIMA-eDS [Polypharmacy in chronic diseases: Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support] tool) in a multinational sample of GPs and to quantify the findings from a prior qualitative study on the PRIMA-eDS-tool.Materials and Methods: Alongside the cluster randomized controlled PRIMA-eDS trial, a survey was conducted in all 5 participating study centers (Bolzano, Italy; Manchester, United Kingdom; Salzburg, Austria; Rostock, Germany; and Witten, Germany) between October 2016 and July 2017. Data were analyzed using descriptive statistics and chi-square tests.Results: Ninety-one (n = 160) percent of the 176 questionnaires were returned. Thirty-two percent of the respondents reported that they did not cease drugs because of the medication check. The 68% who had discontinued drugs comprise 57% who had stopped on average 1 drug and 11% who had stopped 2 drugs or more per patient. The PRIMA-eDS tool was found to be useful (69%) and the recommendations were found to help to increase awareness (86%). The greatest barrier to implementing deprescribing recommendations was the perceived necessity of the medication (69%). The majority of respondents (65%) would use the electronic medication check in routine practice if it was part of the electronic health record.Conclusions: GPs generally viewed the PRIMA-eDS medication check as useful and as informative. Recommendations were not always followed due to various reasons. Many GPs would use the medication check if integrated into the electronic health record. [ABSTRACT FROM AUTHOR]

Background antipsychotic drugs are regularly prescribed as first-line treatment for neuropsychiatric symptoms in persons with dementia although guidelines clearly prioritise non-pharmacological interventions. Objective we investigated a person-centred care approach, which has been successfully evaluated in nursing homes in the UK, and adapted it to German conditions. Design a 2-armed 12-month cluster-randomised controlled trial. Setting nursing homes in East, North and West Germany. Methods all prescribing physicians from both study arms received medication reviews for individual patients and were offered access to 2 h of continuing medical education. Nursing homes in the intervention group received educational interventions on person-centred care and a continuous supervision programme. Primary outcome: proportion of residents receiving at least one antipsychotic prescription after 12 months of follow-up. Secondary outcomes: quality of life, agitated behaviour, falls and fall-related medical attention, a health economics evaluation and a process evaluation. Results the study was conducted in 37 nursing homes with n = 1,153 residents (intervention group: n = 493; control group: n = 660). The proportion of residents with at least one antipsychotic medication changed after 12 months from 44.6% to 44.8% in the intervention group and from 39.8 to 33.3% in the control group. After 12 months, the difference in the prevalence was 11.4% between the intervention and control groups (95% confidence interval: 0.9–21.9; P = 0.033); odds ratio: 1.621 (95% confidence interval: 1.038–2.532). Conclusions the implementation of a proven person-centred care approach adapted to national conditions did not reduce antipsychotic prescriptions in German nursing homes. Trial registration ClinicalTrials.gov NCT02295462. [ABSTRACT FROM AUTHOR]

Background: Thiazides are commonly prescribed to older people for the management of hypertension. The objective of this study was to identify the evidence on the risks and benefits of their use among adults aged ≥65 years and to develop recommendations to reduce potentially inappropriate use.Methods: Systematic review (SR) of the literature covering six databases. We applied a staged search approach, where each search was undertaken only if the previous one did not yield high quality results. Searches 1 and 2 identified relevant SRs and meta-analyses published up to December 2015 from all databases. Search 3 identified additional individual interventional studies (IS) and observational studies (OS) not identified by the preceding searches. We included all studies evaluating the effect of thiazides on patient-relevant outcomes in the management of hypertension with a sufficient number of participants aged ≥65 years or a subgroup analysis based on age. Two independent reviewers extracted data and carried out quality appraisal. Recommendations were developed using the GRADE methodology.Results: Searches 1 to 3 were performed. We included 34 articles reporting on 12 IS and 4 OS. Mean ages ranged from 59 to 83.8 years. Four studies had performed a subgroup analysis by age. Information on comorbidity, polypharmacy and frailty of the participants was scarce or not available. The IS compared thiazides to placebo or other antihypertensive drugs and evaluated cardiovascular endpoints or all-cause-mortality as primary outcomes. The OS investigated the association between thiazide use and the risk of gout, fractures and adverse effects. Our results suggest that thiazides are efficacious in preventing cardiovascular events for this population group. Low-dose regimens of thiazides may be safer than high-dose (low quality of evidence), and a history of gout may increase the risk of adverse events (low quality of evidence). Three recommendations were developed.Conclusions: The use of low dose treatment with thiazides for the management of hypertension in adults aged 65 and older seems justified, unless a history of gout is present. The quality of the evidence is low and studies rarely describe characteristics of the participants such as polypharmacy and frailty. Further good quality studies are needed. [ABSTRACT FROM AUTHOR]

Background: The benefit from a blood pressure lowering therapy with beta blockers may not outweigh its risks, especially in older populations. The aim of this study was to look for evidence on risks and benefits of beta blockers in older adults and to use this evidence to develop recommendations for the electronic decision support tool of the PRIMA-eDS project.Methods: Systematic review of the literature using a stage approach with searches for systematic reviews and meta-analyses first, and individual studies only if the previous searches are inconclusive. The target population were older adults (≥65 years old) with hypertension. We included studies reporting on the effectiveness and/or safety of beta blockers on clinically relevant endpoints (e.g. mortality, cardiovascular events, and stroke) in the management of hypertension. The recommendations were developed according to the GRADE methodology.Results: Fifteen studies were included, comprising one meta-analysis, four randomized controlled trials, six secondary analyses of randomized controlled trials and four observational studies. Seven studies involved only older adults and eight studies reported subgroup analyses by age. With regard to a composite endpoint (death, stroke or myocardial infarction) beta blockers were associated with a higher risk of events then were other antihypertensive agents. Further, beta blockers showed no benefit compared to other antihypertensive agents or placebo regarding mortality. They appear to be less effective than other antihypertensive agents in reducing cardiovascular events. Contradictory results were found regarding the effect of beta blockers on stroke. None of the studies explored the effect on quality of life, hospitalisation, functional impairment/status, safety endpoints or renal failure.Conclusion: The quality of current evidence to interpret the benefits of beta blockers in hypertension is rather weak. It cannot be recommended to use beta blockers in older adults as first line agent for hypertension. [ABSTRACT FROM AUTHOR]

Background: Metformin is usually prescribed as first line therapy for type 2 diabetes mellitus (DM2). However, the benefits and risks of metformin may be different for older people. This systematic review examined the available evidence on the safety and efficacy of metformin in the management of DM2 in older adults. The findings were used to develop recommendations for the electronic decision support tool of the European project PRIMA-eDS.Methods: The systematic review followed a staged approach, initially searching for systematic reviews and meta-analyses first, and then individual studies when prior searches were inconclusive. The target population was older people (≥65 years old) with DM2. Studies were included if they reported safety or efficacy outcomes with metformin (alone or in combination) for the management of DM2 compared to placebo, usual or no treatment, or other antidiabetics. Using the evidence identified, recommendations were developed using GRADE methodology.Results: Fifteen studies were included (4 intervention and 11 observational studies). In ten studies at least 80% of participants were 65 years or older and 5 studies reported subgroup analyses by age. Comorbidities were reported by 9 studies, cognitive status was reported by 4 studies and functional status by 1 study. In general, metformin showed similar or better safety and efficacy than other specific or non-specific active treatments. However, these findings were mainly based on retrospective observational studies. Four recommendations were developed suggesting to discontinue the use of metformin for the management of DM2 in older adults with risk factors such as age > 80, gastrointestinal complaints during the last year and/or GFR ≤60 ml/min.Conclusions: On the evidence available, the safety and efficacy profiles of metformin appear to be better, and certainly no worse, than other treatments for the management of DM2 in older adults. However, the quality and quantity of the evidence is low, with scarce data on adverse events such as gastrointestinal complaints or renal failure. Further studies are needed to more reliably assess the benefits and risks of metformin in very old (>80), cognitively and functionally impaired older people. [ABSTRACT FROM AUTHOR]

Background: Oral anticoagulants are used for stroke prevention in patients with atrial fibrillation, the most common cardiac arrhythmia in older adults. The aim of our study was to identify the evidence on the risks and benefits of anticoagulant use among adults aged ≥65 years with atrial fibrillation and to develop recommendations to reduce inappropriate use with a primary focus on new oral anticoagulants. Methods: Systematic review (SR) with search in six databases (up to 12/2016). We included SRs/meta-analyses (MAs) with participants ≥65 years old with atrial fibrillation treated with oral anticoagulation. Two independent reviewers performed study selection, data extraction and quality appraisal. Recommendations were developed based on the evidence identified following a modified GRADE approach. Results: Thirty-eight SRs/MAs were included, drawing on evidence from 74 individual experimental studies. The mean age ranged from 68.2 to 73 years. Treatments investigated included vitamin K antagonists (VKA), new oral anticoagulants (NOACs), platelet aggregation inhibitors (PAI), placebo and no treatment. Comorbidities were reported in 23 SRs, but none reported on frailty status, cognitive status or polypharmacy. Sixteen SRs based on only 3-8 RCTs and thus conveying a significant overlap of studies evaluated the effectiveness of NOACs compared to warfarin. NOACs demonstrated at least equivalent ability to reduce stroke as VKA and a considerably lower risk (OR 0.37 to RR 0.50) of haemorrhagic stroke/intracranial bleeding. Seven SRs were identified comparing VKA to placebo. These revealed a substantial reduction in risk of stroke and mortality for VKA (RR 0.30-0.46)), outweighing an increased risk of bleeding (RR 1.04-3.63) associated with anticoagulation. Eight SRs evaluated the efficacy of VKA compared to PAI: overall, VKA were associated with a lower risk of stroke (OR 0.51-0.68)) and a comparable risk of major bleeding. Conclusions: Anticoagulation treatment using VKA in older people with atrial fibrillation appears beneficial in comparison to PAI and placebo. New oral anticoagulants appear to reduce haemorrhagic strokes and intracranial bleedings more effectively than VKAs and should be considered especially in patients with low TTR (time in therapeutic range)/labile INR (International Normalized Ratio). However, to determine if these results are applicable to all older people, further studies should provide information on frailty, significant impaired renal function, polypharmacy and cognitive status of the participants. Funded by the 7th framework programme of the European Union. [ABSTRACT FROM AUTHOR]

Background: Platelet aggregation inhibitors (PAI) are among the most frequently prescribed drugs in older people, though evidence about risks and benefits of their use in older adults is scarce. The objectives of this systematic review are firstly to identify the risks and benefits of their use in the prevention and treatment of vascular events in older adults, and secondly to develop recommendations on discontinuing PAI in this population if risks outweigh benefits.Methods: Staged systematic review consisting of three searches. Searches 1 and 2 identified systematic reviews and meta-analyses. Search 3 included controlled intervention and observational studies from review-articles not included in searches 1 and 2. All articles were assessed by two independent reviewers regarding the type of study, age of participants, type of intervention, and clinically relevant outcomes. After data extraction and quality appraisal we developed recommendations to stop the prescribing of specific drugs in older adults following the Grading of Recommendations Assessment Development and Evaluation (GRADE) methodology.Results: Overall, 2385 records were screened leading to an inclusion of 35 articles reporting on 22 systematic reviews and meta-analyses, 11 randomised controlled trials, and two observational studies. Mean ages ranged from 57.0 to 84.6 years. Ten studies included a subgroup analysis by age. Overall, based on the evaluated evidence, three recommendations were formulated. First, the use of acetylsalicylic acid (ASA) for primary prevention of cardiovascular disease (CVD) in older people cannot be recommended due to an uncertainty in the risk-benefit ratio (weak recommendation; low quality of evidence). Secondly, the combination of ASA and clopidogrel in patients without specific indications should be avoided (strong recommendation; moderate quality of evidence). Lastly, to improve the effectiveness and reduce the risks of stroke prevention therapy in older people with atrial fibrillation (AF) and a CHA2DS2-VASc score of ≥ 2, the use of ASA for the primary prevention of stroke should be discontinued in preference for the use of oral anticoagulants (weak recommendation; low quality of evidence).Conclusions: The use of ASA for the primary prevention of CVD and the combination therapy of ASA and clopidogrel for the secondary prevention of vascular events in older people may not be justified. The use of oral anticoagulants instead of ASA in older people with atrial fibrillation may be recommended. Further high quality studies with older adults are needed. [ABSTRACT FROM AUTHOR]

Background: Preventable drug-related hospital admissions can be associated with drugs used in diabetes and the benefits of strict diabetes control may not outweigh the risks, especially in older populations. The aim of this study was to look for evidence on risks and benefits of DPP-4 inhibitors in older adults and to use this evidence to develop recommendations for the electronic decision support tool of the PRIMA-eDS project.Methods: Systematic review using a staged approach which searches for systematic reviews and meta-analyses first, then individual studies only if prior searches were inconclusive. The target population were older people (≥65 years old) with type 2 diabetes. We included studies reporting on the efficacy and/or safety of DPP-4 inhibitors for the management of type 2 diabetes. Studies were included irrespective of DPP-4 inhibitors prescribed as monotherapy or in combination with any other drug for the treatment of type 2 diabetes. The target intervention was DPP-4 inhibitors compared to placebo, no treatment, other drugs to treat type 2 diabetes or a non-pharmacological intervention.Results: Thirty studies (reported in 33 publications) were included: 1 meta-analysis, 17 intervention studies and 12 observational studies. Sixteen studies were focused on older adults and 14 studies reported subgroup analyses in participants ≥65, ≥70, or ≥75 years. Comorbidities were reported by 26 studies and frailty or functional status by one study. There were conflicting findings regarding the effectiveness of DPP-4 inhibitors in older adults. In general, DPP-4 inhibitors showed similar or better safety than placebo and other antidiabetic drugs. However, these safety data are mainly based on short-term outcomes like hypoglycaemia in studies with HbA1c control levels recommended for younger people. One recommendation was developed advising clinicians to reconsider the use of DPP-4 inhibitors for the management of type 2 diabetes in older adults with HbA1c <8.5% because of scarce data on clinically relevant benefits of their use. Twenty-two of the included studies were funded by pharmaceutical companies and authored or co-authored by employees of the sponsor.Conclusions: Other than the surrogate endpoint of improved glycaemic control, data on clinically relevant benefits of DPP-4 inhibitors in the treatment of type 2 diabetes mellitus in older adults is scarce. DPP-4 inhibitors might have a lower risk of hypoglycaemia compared to other antidiabetic drugs but data show conflicting findings for long-term benefits. Further studies are needed that evaluate the risks and benefits of DPP-4 inhibitors for the management of type 2 diabetes mellitus in older adults, using clinically relevant outcomes and including representative samples of older adults with information on their frailty status and comorbidities. Studies are also needed that are independent of pharmaceutical company involvement. [ABSTRACT FROM AUTHOR]

Background: Multimorbidity and polypharmacy are common in older people. Assessment tools or lists of criteria aimed at supporting prescription decisions for older people exist, but have often been based on expert opinion with insufficient consideration of the evidence available. The present paper describes the methods we are using to systematically review the existing evidence on the efficacy and safety of the most commonly prescribed drugs for older people in the management of their chronic medical conditions and to develop recommendations to reduce inappropriate prescriptions for incorporation into the Comprehensive Medication Review (CMR) tool developed by the PRIMA-eDS European project.Methods: We selected the 20 most relevant drugs/drug classes in terms of prescription volumes and risk of hospitalisation for older people and the most relevant indications for the most common chronic conditions among older people and a total of 35 distinct drug-indication pairs were chosen. Based on clinical considerations we collapsed some indications together, reducing the 35 pairs to a final total of 22 separate systematic reviews (SR). A common methodology will be used for each individual SR, based on the methodological manuals of the Cochrane collaboration and the PRISMA statement for reporting systematic reviews. Our search strategy will have a staged approach where we initially search for systematic reviews and meta-analyses, but if relevant reviews are not found, then search for individual studies (controlled intervention and observational studies). Our pilot work and initial scoping of the literature suggested that very few, relevant individual trials or existing systematic reviews have researched or reported exclusively on older people. Therefore, sufficient data might not be available to perform meta-analysis but we will provide a narrative synthesis describing characteristics and findings of included studies. The collected evidence will be used to construct recommendations on when not to use or to discontinue a drug, or when to reduce its dose. Recommendations will be developed in team meetings using the GRADE methodology to reflect the strength of the recommendation and the quality of the evidence. Recommendations will be built into the CMR tool.Discussion: This protocol has been prepared for a series of systematic reviews which will provide research-based evidence to develop recommendations to reduce inappropriate polypharmacy in older people as part of the CMR tool of the PRIMA-eDS project. [ABSTRACT FROM AUTHOR]

Background: This study aimed to explore if group-based peer support as an additional component to a disease management programme (DMP) in type 2 diabetes can reduce the number of prescribed drugs; hospital admissions; and length of hospital stay and therefore be a cost-effective model. Methods: Controlled study based on a secondary data analysis of a cluster randomized trial. Our study population was general practitioners and patients in the province of Salzburg. The 24-months intervention consisted of regular group meetings facilitated by trained peer supporters. The groups exercised together, discussed diabetes related topics, and received support by professionals. Data was anonymously collected on clusters through the statutory health insurance. Results: Data were available of 118 (82.5%,17 clusters of the patients in the original randomized trial) participants in the intervention and 143 (77.3%,19 clusters) in the control groups. The length of hospital stay was shorter in the intervention groups compared with controls. The mean difference during the 24-month study period was -40.13 days (95% CI - 78.54 to - 1.71, P = 0.041) in favour of the intervention groups. No differences were seen in the number of prescribed drugs and hospital admission. Estimated yearly savings by reducing the length of hospital stay was €1660.60 per patient. Conclusion: A group-based peer support programme as an additional component of a DMP in type 2 diabetes is a promising approach to optimize diabetes care and to enhance lifestyle interventions in primary care. Peer support seems to reduce length of hospital stay and could therefore be a cost-effective model. [ABSTRACT FROM AUTHOR]

Guideline adherence of general practitioners (GP) regarding treatment of chronic conditions shows room for improvement. Thus, concepts have to be designed to promote quality of care. The aim of the interventional study 'Improvement of Quality by Benchmarking' was to assess whether quality can be improved by self-auditing, benchmarking and quality circles in Salzburg (Austria) and South Tyrol (Italy). In this publication we present the Austrian results. Quality indicators were developed in a consensus process for eight chronic diseases based on pre-existing quality management systems. A quality score consisting of 35 indicators was calculated (0-5 points per indicator depending on fulfilment, maximum 175 points). Data were extracted from the electronic health records of participating practices in 2012, 2013 and 2014. A statistical pre-post analysis was performed using Wilcoxon signed-rank tests. A total of 20 GPs participated in the project. The mean quality score increased from 62.0 at baseline to 84.0 at the second follow-up ( p = 0.003). Regarding the individual quality indicators, strong improvements were achieved between baseline and first follow-up, especially in process indicators concerning documentation. Between the first and second follow-up, quality remained in most cases at the same level. The validity of results is limited because of structural and technical problems. Due to the uncontrolled pre-post design we cannot exclude external influences on the results. Nevertheless, the intervention was able to improve measured quality of care. Barriers were detected that should be considered in a possible implementation of quality control programs. [ABSTRACT FROM AUTHOR]

Aim The aim of the present study was to explore the impact of strategies to reduce polypharmacy on mortality, hospitalization and change in number of drugs. Methods Systematic review and meta-analysis: a systematic literature search targeting patients ≥65 years with polypharmacy (≥4 drugs), focusing on patient-relevant outcome measures, was conducted. We included controlled studies aiming to reduce polypharmacy. Two reviewers independently assessed studies for eligibility, extracted data and evaluated study quality. Results Twenty-five studies, including 10 980 participants, were included, comprising 21 randomized controlled trials and four nonrandomized controlled trials. The majority of the included studies aimed at improving quality or the appropriateness of prescribing by eliminating inappropriate and non-evidence-based drugs. These strategies to reduce polypharmacy had no effect on all-cause mortality (odds ratio 1.02; 95% confidence interval 0.84, 1.23). Only single studies found improvements, in terms of reducing the number of hospital admissions, in favour of the intervention group. At baseline, patients were taking, on average, 7.4 drugs in both the intervention and the control groups. At follow-up, the weighted mean number of drugs was reduced (−0.2) in the intervention group but increased (+0.2) in controls. Conclusions There is no convincing evidence that the strategies assessed in the present review are effective in reducing polypharmacy or have an impact on clinically relevant endpoints. Interventions are complex; it is still unclear how best to organize and implement them to achieve a reduction in inappropriate polypharmacy. There is therefore a need to develop more effective strategies to reduce inappropriate polypharmacy and to test them in large, pragmatic randomized controlled trials on effectiveness and feasibility. [ABSTRACT FROM AUTHOR]

Background: Multimorbidity is increasing in aging populations with a corresponding increase in polypharmacy as well as inappropriate prescribing. Depending on definitions, 25-50 % of patients aged 75 years or older are exposed to at least five drugs. Evidence is increasing that polypharmacy, even when guidelines advise the prescribing of each drug individually, can potentially cause more harm than benefit to older patients, due to factors such as drug-drug and drug-disease interactions. Several approaches reducing polypharmacy and inappropriate prescribing have been proposed, but evidence showing a benefit of these measures regarding clinically relevant endpoints is scarce. There is an urgent need to implement more effective strategies. We therefore set out to develop an evidence-based electronic decision support (eDS) tool to aid physicians in reducing inappropriate prescribing and test its effectiveness in a large-scale cluster-randomized controlled trial.Methods: The "Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations" (PRIMA)-eDS tool is a tool comprising an indication check and recommendations for the reduction of polypharmacy and inappropriate prescribing based on systematic reviews and guidelines, the European list of inappropriate medications for older people, the SFINX-database of interactions, the PHARAO-database on adverse effects, and the RENBASE-database on renal dosing. The tool will be evaluated in a cluster-randomized controlled trial involving 325 general practitioners (GPs) and around 3500 patients across five study centres in the United Kingdom, Germany, Austria and Italy. GP practices will be asked to recruit 11 patients aged 75 years or older who are taking at least eight medications and will be cluster-randomized after completion of patient recruitment. Intervention GPs will have access to the PRIMA-eDS tool, while control GPs will treat their patients according to current guidelines (usual care) without access to the PRIMA-eDS tool. After an observation time of 2 years, intervention and control groups will be compared regarding the primary composite endpoint of first non-elective hospitalization or death.Discussion: The principal hypothesis is that reduction of polypharmacy and inappropriate prescribing can improve the clinical composite outcome of hospitalization or death. A positive result of the trial will contribute substantially to the improvement of care in multimorbidity. The trial is necessary to investigate not only whether the reduction of polypharmacy improves outcome, but also whether GPs and patients are willing to follow the recommendations of the PRIMA-eDS tool.Trial Registration: This trial has been registered with Current Controlled Trials Ltd. on 31 July 2014 (ISRCTN10137559). [ABSTRACT FROM AUTHOR]

Aim. Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients. Methods. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n=337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. Results. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI −0.08 to 0.36%, p=0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p=0.046) compared to the intervention group. Conclusion. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. Trial Registration. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077). [ABSTRACT FROM AUTHOR]

Aim. Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients. Methods. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n=337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. Results. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI −0.08 to 0.36%, p=0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p=0.046) compared to the intervention group. Conclusion. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. Trial Registration. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077). [ABSTRACT FROM AUTHOR]

Background: There is limited valid data available on CAM procedures for chronic joint and neuropathic pain in primary care in Germany. Indiviual CAM qualifications of the general practitioners (GPs) and the potential of cost reduction through CAM treatment are almost unknown. The aim of this pilot trial preceding the main study is to examine the survey mode, to estimate the response rate by GPs with or without an additional qualification for CAM, and to identify the status quo in therapeutic approaches for chronic pain disorders in primary care. Methods: This is a cross-sectional study with an ex post facto design among German GPs consisting of 2 parts: In a first step, a pilot trial precedes the main study targeting 200 GPs with and 200 GPs without additional qualification in CAM in a selected region. Results: The results of the CUPCIG study comprise the distribution of pain types treated in primary care practices, the GPs' attitude toward complementary pain therapy, pharmacological or CAM treatment, the estimate of cost reduction through CAM treatment of pain, the application of diverse CAM procedures, and biographical data. Discussion: The CUPCIG study serves to compile pain therapy approaches in primary care in Germany with respect to the individual CAM expertise of the GPs. © 2015 S. Karger GmbH, Freiburg [ABSTRACT FROM AUTHOR]

Background: The majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions. Methods/design: The study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12 months of follow-up. Secondary outcomes are residents' quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study. Discussion: To improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected. Trial registration: ClinicalTrials.gov: NCT02295462 [ABSTRACT FROM AUTHOR]

Introduction Medication safety incidents occur in all health care sectors and cause considerable morbidity and mortality, with 8.5% of all related incidents reported estimated to occur in primary care. A common incident classification system could facilitate collective learning from the analysis of medication-related errors and improve patient safety Objective The objective of this study was to assess the validity of a new classification system of medication safety incidents in primary care in Poland. Methods Analysis of data from a descriptive, cross-sectional, self-reported survey on the Learning from International Networks about Errors and Understanding Safety in Primary Care ( LINNEAUS Euro- PC) medication safety incident classification for primary care with assessment of 10 case-based clinical scenarios done by doctors and pharmacists form community-based family medicine clinics and pharmacies in Lodz. Main outcome measures The percentages of overall agreement on judgements and a fixed-marginal multirater kappa (κ) coefficient as statistical measures of interrater agreement for categorical items. Results The overall agreement levels were: category 1 - 86.3%; category 2 - 85.6%; category 3 - 72.1%; category 4 - 71.8%; and category 5 - 70.4%. The interrater agreement between the 15 evaluators varied as follows: category 1 fixed-marginal κ = 0.144; category 5 fixed-marginal κ = 0.565; category 3 fixed-marginal κ = 0.607; category 4 fixed-marginal κ = 0.634; and category 2 fixed-marginal κ = 0.807. Conclusions This is the first known study on levels of agreement on the perception of medication safety incidents and assessment of the validity of a related classification system in primary health care in Poland. Interrater agreement in this study was surprisingly high, but still leaves room for improvement. [ABSTRACT FROM AUTHOR]

The article discusses the research methods and findings of the international Developing and validating Disease Management Evaluation methods for European health care systems (DISMEVAL) project. The real-world impact of exemplary European disease management practices was investigated in six countries using advanced analytic techniques.

Background: Chronic obstructive pulmonary disease (COPD) is a major public health burden and profoundly affects individuals suffering from the disease. However, the majority of subjects with COPD are still undiagnosed. Objectives: To evaluate COPD prevalence and detection strategies for COPD in the primary-care setting. Methods: The study was conducted in a random sample of general practitioner (GP) offices in Salzburg (Austria). A questionnaire and post-bronchodilator (PBD) spirometry was administered to patients aged ≥40 years. Nonreversible airway obstruction was considered when PBD FEV1/FVC was <0.70. Severity of spirometrically defined COPD was graded according to the GOLD recommendations. Results: 60 GP offices were randomly selected for study participation, however only 30 (50.0%) were willing to participate. 1,230 of 9,820 (12.52%) patients consented to the protocol. Quality of PBD spirometry was evaluated, and 882 (71.7%) met ATS/ERS quality criteria. 7.5% (95% CI: 5.7-9.4%) of the patients had COPD grade II+ (FEV1/FVC <0.7 and FEV1 <80% of predicted), but only 22.4% of them reported a prior physician's diagnosis of COPD. Similar results were seen for the 2005 Salzburg BOLD (Burden of Obstructive Lung Disease) sample with regard to COPD GOLD II+ prevalence (10.7%) and proportion of underdiagnosis (82.3%). Conclusion: COPD in the primary-care setting is as prevalent and underdiagnosed as reported recently for the BOLD study. The surprisingly low participation rate of GPs and patients indicates that prevention of COPD is not a health priority, and that awareness for COPD has to heightened before case-finding strategies will be successful. © 2013 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Purpose Improving medication safety has become a major topic in all clinical settings. Information technology (IT) can play an important role to prevent adverse drug events (ADEs), but data on the effectiveness of IT interventions are controversial. The objective of this paper is to provide a systematic review about the effects of IT interventions on medication safety in primary care. Data sources PubMed, International Pharmaceutical Abstracts, EMBASE, Cochrane Database of Systematic Reviews, handsearching reference lists from full-text articles. Study selection Randomized controlled trials (RCTs), if interventions based on IT, performed in primary care and outcomes reported on medication safety. Data extraction Study characteristics and outcome data independently extracted by two reviewers. Disagreement resolved by discussion with a third reviewer. Results of data synthesis Out of 3918 studies retrieved, 10 RCTs met the inclusion criteria. Of the six studies evaluating computerized provider order entry (CPOE) with clinical decision support (CDS) only 3 studies effectively reduced unsafe prescribing. Both pharmacist-led IT interventions decreased the prescription of potentially inappropriate medication or unsafe prescribing in pregnancy. No reduction of ADEs was achieved by a web program or a TeleWatch system intervention. Conclusion Only 5 of 10 RCTs revealed a reduction of medication errors. CPOE with CDS was effective if targeted at a limited number of potentially inappropriate medications. The positive results of pharmacist-led IT interventions indicate that IT interventions with inter-professional communication appear to be effective. The unequivocal results of the included RCTs stress the necessity of rigorous evaluation prior to large-scale implementation. [ABSTRACT FROM PUBLISHER]

The patients’ active participation in their medical care is important for patients with chronic diseases. Measurements of patient activation are needed for studies and in clinical practice. This study aims to validate the Patient Activation Measure 13 (PAM13-D) in German-speaking primary care patients. This international cross-sectional multicentre study enrolled consecutively patients from primary care practices in three German-speaking countries: Germany, Austria, and Switzerland. Patients completed the PAM13-D questionnaire. General Self-Efficacy scale (GSE) was used to assess convergent validity. Furthermore Cronbach’s alpha was performed to assess internal consistency. Exploratory factor analysis was used to evaluate the underlying factor structure of the items. We included 508 patients from 16 primary care practices in the final analysis. Results were internally consistent, with a Cronbach’s alpha of 0.84. Factor analysis revealed one major underlying factor. The mean values of the PAM13-D correlated significantly (r = 0.43) with those of the GSE. The German PAM13 is a reliable and valid measure of patient activation. Thus, it may be useful in primary care clinical practice and research. [ABSTRACT FROM AUTHOR]

Background: The prescription of statins is an evidence-based treatment to reduce the risk of cardiovascular events in patients with elevated cardiovascular risk or with a cardiovascular disorder (CVD). In spite of this, many of these patients do not receive statins. Methods: We evaluated the impact of a brief educational intervention in cardiovascular prevention in primary care physicians' prescribing behaviour regarding statins beyond their participation in a randomised controlled trial (RCT). For this, prescribing data of all patients > 35 years who were counselled before and after the study period were analysed (each n > 75000). Outcome measure was prescription of Hydroxymethylglutaryl-CoA Reductase Inhibitors (statins) corresponding to patients' overall risk for CVD. Appropriateness of prescribing was examined according to different risk groups based on the Anatomical Therapeutic Chemical Classification System (ATC codes). Results: There was no consistent association between group allocation and statin prescription controlling for risk status in each risk group before and after study participation. However, we found a change to more significant drug configurations predicting the prescription of statins in the intervention group, which can be regarded as a small intervention effect. Conclusion: Our results suggest that an active implementation of a brief evidence-based educational intervention does not lead to prescription modifications in everyday practice. Physician's prescribing behaviour is affected by an established health care system, which is not easy to change. [ABSTRACT FROM AUTHOR]

Background. Chronic diseases affect more than half of the population ≥75 years of age in developed countries. Prescription medication use increases with age. Depending on definition, 25–80% of elderly are exposed to polypharmacy. Polypharmacy increases the risk of hospitalization, interactions and adverse drug reactions. Objective. To examine the frequency of medication errors in patients with polypharmacy treated in general practice. Methods. The medications of 169 patients with polypharmacy treated in 22 GP surgeries in Austria were analysed. The analysis identified (i) medication errors, including non-evidence-based medications, dosing errors and potentially dangerous interactions in all patients and (ii) potentially inappropriate medications (PIMs) in the subgroup of elderly patients (≥65 years). Results. The patients took on average 9.1±3.0 medications per day. The maximum, in one patient, was 20 medications per day. Some 93.5% had at least one non-evidence-based medication. On average, 2.7±1.66 medications per patient were found to be not indicated. At least one dosing error was found in 56.2% of all patients. One potential interaction of the most severe degree (category X interaction) was detected in 1.8% (n = 3) and two such interactions in 0.6% (n = 1). These combinations should have been avoided. Of the 169 patients, 158 were elderly (≥65 years). Of these seniors, 37.3% (n = 59) had at least one PIM according to the PRISCUS list for the elderly. Conclusion. The frequency of medication errors is high in patients with polypharmacy in primary care. Development of strategies (e.g. external medication review) is required to counteract medication errors. [ABSTRACT FROM AUTHOR]

Background: Self-management support is a key component of effective chronic care management, yet in practice appears to be the least implemented and most challenging. This study explores whether and how self-management support is integrated into chronic care approaches in 13 European countries. In addition, it investigates the level of and barriers to implementation of support strategies in health care practice. Methods: We conducted a review among the 13 participating countries, based on a common data template informed by the Chronic Care Model. Key informants presented a sample of representative chronic care approaches and related self-management support strategies. The cross-country review was complemented by a Dutch case study of health professionals' views on the implementation of self-management support in practice. Results: Self-management support for chronically ill patients remains relatively underdeveloped in Europe. Similarities between countries exist mostly in involved providers (nurses) and settings (primary care). Differences prevail in mode and format of support, and materials used. Support activities focus primarily on patients' medical and behavioral management, and less on emotional management. According to Dutch providers, self-management support is not (yet) an integral part of daily practice; implementation is hampered by barriers related to, among others, funding, IT and medical culture. Conclusions: Although collaborative care for chronic conditions is becoming more important in European health systems, adequate self-management support for patients with chronic disease is far from accomplished in most countries. There is a need for better understanding of how we can encourage both patients and health care providers to engage in productive interactions in daily chronic care practice, which can improve health and social outcomes. [ABSTRACT FROM AUTHOR]

Background: Patients do not always receive guideline-adherent therapy, yet little is known about the underlying causes on the patients' side. We quantified non-guideline-adherent treatment of chronic diseases (diabetes mellitus, hypertension, cardiovascular disease, heart failure, atrial fibrillation) in primary care and analysed the causes from the physician's as well as the patient's view. Methods: With the intention to analyze the frequency and causes of non-guideline-adherent treatment of patients with chronic diseases, we drew a random sample of 124 general practitioners (GP) in Salzburg, Austria, of which 58 (46.8%) participated. In the participating GP surgeries, we consecutively recruited 501 patients with at least one of the target-diseases and checked the guideline conformity of treatment using 9 quality indicators. We then interviewed the patients as well as the general practitioners regarding factors affecting deviation from guideline recommendations. Results: Of the 501 patients, a total of 1224 quality indicators could be analysed. Non-adherence to guideline recommendations were present in 16.8% (n = 205, 95% CI 14.7 to 18.8%) of all quality indicators. In 61.5% of these cases (n = 126, 95% CI 53.0 to 70.0%) the treatment was wrongly judged as not recommended by the physicians. In 10.2% (n = 21, 95% CI 0 to 23.2%) physicians attributed non-adherence to patient's non-compliance, and in 10.7% (n = 22, 95% CI 0 to 23.7%) to an adverse drug event, whereas only 5.4% (n = 11, 95% CI 0 to 18.7%) of nonadherence was related to an adverse drug event reported by the patients. Patients were unaware regarding the reason for non-adherent therapy in 64.4% (n = 132, 95% CI 56.2 to 72.6%) of the quality indicators. In 20.0% (n = 41, 95% CI 7.8 to 32.2%) patients regarded a drug as not needed. Conclusions: Guideline adherence in chronic care was relatively good in our study sample, but still leaving room for improvement. Physicians' lack of knowledge and patients' lack of awareness account for about 70% of non-adherence, indicating the necessity to improve physician education, and patient involvement. In about 30% of the quality indicators not fulfilled, non-adherence is due to other reasons like adverse drug events or patients not willing to take a recommended drug. [ABSTRACT FROM AUTHOR]

Background: Disease Management Programmes (DMPs) are proposed to enhance the quality of care, to improve health outcomes and to reduce costs. Yet, the evidence regarding the effectiveness of such structured approaches remains uncertain. Randomized controlled trials (RCTs) represent the gold standard of evaluation for complex interventions. However, most of the evidence derives from non-randomized or even uncontrolled trials. We therefore tried to assess the impact of a randomized control group on the interpretation of DMP effectiveness. Methods: We analyzed the data of a RCT on a DMP for diabetes type 2 by creating two scenarios. The first solely includes data of the intervention group (n = 649), representing an ‘uncontrolled pre-test–post-test analysis’. The second comprehends all data (n = 1489) of the ‘randomized controlled analysis’. HbA1c was used as the primary outcome measure for metabolic control in diabetes. Depending on either scenario, we calculated relative and absolute risk reduction regarding clinically relevant endpoints and estimated costs by extrapolating our results according to the UK Prospective Diabetes Study (UKPDS) findings. Results: The HbA1c reduction attributed to the DMP was 0.41% (uncontrolled analysis) vs. 0.13% (controlled comparison). Estimations of relative risk reduction for cardiovascular disease were 4.6% vs. 1.4%. The estimated numbers needed to treat (NNT) to avoid one myocardial infarction within 10 years differed from 125 (uncontrolled analysis) to 417 patients (controlled comparison), which led to a substantial scenario-dependent difference in cost estimations. Conclusion: Uncontrolled pre-test–post-test evaluation might lead to crucial overestimation of DMP effectiveness. We therefore recommend randomized controlled evaluations prior to long-term implementation. [ABSTRACT FROM PUBLISHER]

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The growing recognition of care fragmentation is causing many countries to explore new approaches to healthcare delivery that can bridge the boundaries between professions, providers and institutions and so better support the rising number of people with chronic health problems. This paper examines the role of the regulatory, funding and organisational context for the development and implementation of approaches to chronic care, using examples from Austria, Germany and the Netherlands. We find that the three countries have implemented a range of policies and approaches to achieve better coordination within and across the primary and secondary care interface and so better meet the needs of patients with chronic conditions. This has involved changes to the regulatory framework to support more coordinated approaches to care (Austria, Germany), coupled with financial incentives (Austria, Germany) or changes in payment systems (the Netherlands). What is common to the three countries is the comparative ‘novelty’ of policies and approaches aimed at fostering coordinated care; however, the evidence of their impact remains unclear. [ABSTRACT FROM PUBLISHER]

Copyright of Wiener Klinische Wochenschrift is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: The diagnosis of coronary heart disease (CHD) is a challenge for primary care physicians (PCPs). We studied the further course of 57 patients who presented to their PCPs with chest pain and were initially misdiagnosed as not having CHD as the cause of chest pain. Methods: The 57 misdiagnosed patients were among 1249 consecutive patients aged 35 and above who presented with chest pain to 74 different PCPs (35% of the 209 PCPs initially invited to participate in the study). For each patient, the PCPs recorded the initial history and physical findings and the course over the ensuing six months. An independent interdisciplinary reference panel reviewed all of the data and retrospectively determined each patient's most likely cause of chest pain at the time of inclusion in the study. Results: For 405 patients (32.4%), the PCPs rated the probability that CHD was the cause of chest pain at 0 to 5%. The reference panel retrospectively diagnosed CHD as the cause of chest pain in 180 patients. The PCPs correctly diagnosed CHD as the cause of chest pain in 123 (68.3%) of these patients and failed to diagnose CHD as the cause of chest pain in 57 of them (31.7%). 26 (45.6%) of the 57 misdiagnosed patients had a history of CHD. Even when the diagnosis of CHD as the cause of chest pain was missed, the PCPs often ordered an ECG (42 of 57 patients, or 73.7%) or re -ferred the patient to a cardiologist or internist (20 of 57 patients, or 35.1%). Conclusion: Primary care physicians diagnose CHD with moderate sensitivity. Even when they initially fail to make the diagnosis, they often order further tests and consultations that ultimately lead to a correct diagnosis of CHD. [ABSTRACT FROM AUTHOR]