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Background Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: Meetings of peer support groups Personalised telephone-based health coaching for patients with low literacy and/or low patient activation Personalised patient feedback A browser-based web portal Methods Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention. Discussion If the intervention proves effective, it may be included into the DMPs for T2DM and CHD. Trial registration The study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network (https://www.drks.de/drks_web/setLocale_EN.do) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

Objective Due to the increasing concerns about polypharmacy, there is a growing need for clinical recommendations for drug discontinuation. This requires studies investigating the process on several levels. This paper addresses the methodological problems of drug discontinuation trials (DDTs). To that end, we offer a new typology of research aims and corresponding methodological recommendations for trials evaluating drug discontinuation. Study Design and Setting Multi-stage development process, including literature search and expert panels. Results Clinical trials are only required in cases of scientific uncertainty. We identified three situations of uncertainty associated with drug discontinuation from which we derived three study types: 1) Uncertainty regarding the effectiveness and/or safety of a drug; 2) Uncertainty regarding the procedure of discontinuing a previously taken drug; 3) Uncertainty regarding the effectiveness of complex strategies used to discontinue one or more drugs. We developed specific methodological recommendations for each study type. Conclusion We offer a comprehensive definition of research aims, study designs, and methodological recommendations regarding DDTs. The typology we propose can help investigators clarify their research aims and study design. The type-specific methodological recommendation should improve the quality of future drug discontinuation trials.

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.

BackgroundWe aim to assess the safety of dipeptidylpeptidase-4 inhibitors (DPP4s) in older type 2 diabetes patients with inadequate glycaemic control. MethodsWe included RCTs in older (≥65 years) patients with type 2 diabetes. The intervention group was treated with any DPP4. A systematic search in MEDLINE and EMBASE was performed in December 2020. For assessing risk of bias, the RoB 2 tool was applied. The quality of evidence was assessed using GRADE. We pooled outcomes using random-effects meta-analyses. ResultsWe identified 16 RCTs that included 19,317 patients with a mean age >70 years. The mean HbA1c ranged between 7.1g/dl and 10.0g/dl.Adding DPP4s to standard alone care may increase mortality slightly (RR 1.04; 0.89-1.21). Adding DPP4s to standard care increases the risk for hypoglycaemia (RR 1.08; 95%CI 1.01-1.16), but difference in overall adverse events is negligible.DPP4s added to standard care likely reduce mortality compared to sulfonylureas (RR 0.88; 0.75-1.04). DPP4s probably reduce the risk for hypoglycaemia compared to sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible.There is insufficient evidence on hospitalizations, falls, fractures, renal impairment, and pancreatitis. Conclusion There is no evidence that DPP4s in addition to standard care decrease mortality but DPP4s increase hypoglycaemia risk. Second-line therapy in older patients should be considered cautiously because even in drugs with a good safety profile like DPP4s. In the case second-line treatment is necessary, DPP4s appear to be superior to sulfonylureas. RegistrationPROSPERO: CRD42020210645

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.

PurposeOur objective was to assess the safety of long-term intake of DOACs in older adults with atrial fibrillation (AF). MethodsWe included RCTs in elderly (≥65 years) patients with AF. A systematic search in MEDLINE and EMBASE was performed on 9/11/2020. 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.ResultsTen RCTs with a total of 61,948 patients were identified. Seven RCTs included patients with AF-only and three with AF who received PCI and additional antiplatelet-therapy. Two RCTs compared apixaban with either warfarin or aspirin, three 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-only (HR 0.89 95%CI 0.78 to 1.02). We did not find any RCT that reported mortality in elderly AF-PCI patients. Low-dose DOACs likely reduce bleeding compared to VKAs (HR ranged from 0.47 to 1.01). High-dose edoxaban reduces major or clinically relevant bleeding (MCRB) compared to VKAs (HR 0.82 95%CI 0.73 to 0.93) but high-dose dabigatran or rivaroxaban increase MCRB (HR 1.15 95%CI 1.02 to 1.30).Conclusion We found that low-dose DOACs probably decrease mortality in AF-only patients. Moreover, apixaban and edoxaban are associated with fewer MCRB compared to VKAs. For dabigatran and rivaroxaban, the risk of MCRB varies depending on dose.

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 p 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.

Background Seasonal affective disorder (SAD) is a seasonal pattern of recurrent depressive episodes that is often treated with second-generation antidepressants (SGAs), light therapy, or psychotherapy. Objectives To assess the efficacy and safety of second-generation antidepressants (SGAs) for the treatment of seasonal affective disorder (SAD) in adults in comparison with placebo, light therapy, other SGAs, or psychotherapy. Search methods This is an update of an earlier review first published in 2011. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 1) in the Cochrane Library (all years), Ovid MEDLINE, Embase, and PsycINFO (2011 to January 2020), together with the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR) (all available years), for reports of randomised controlled trials (RCTs). We hand searched the reference lists of all included studies and other systematic reviews. We searched ClinicalTrials.gov for unpublished/ongoing trials. We ran a separate update search for reports of adverse events in the Ovid databases. SELECTION CRITERIA: For efficacy we included RCTs of SGAs compared with other SGAs, placebo, light therapy, or psychotherapy in adult participants with SAD. For adverse events we also included non-randomised studies. Data collection and analysis Two review authors independently screened abstracts and full-text publications against the inclusion criteria. Data extraction and 'Risk of bias' assessment were conducted individually. We pooled data for meta-analysis where the participant groups were similar, and the studies assessed the same treatments with the same comparator and had similar definitions of outcome measures over a similar duration of treatment. Main results In this update we identified no new RCT on the effectiveness of SGAs in SAD patients. We included 2 additional single-arm observational studies that reported on adverse events of SGAs. For efficacy we included three RCTs of between five and eight weeks' duration with a total of 204 participants. For adverse events we included two RCTs and five observational (non-randomised) studies of five to eight weeks' duration with a total of 249 participants. All participants met the DSM (Diagnostic and Statistical Manual of Mental Disorders) criteria for SAD. The average age ranged from 34 to 42 years, and the majority of participants were female (66% to 100%). Results from one trial with 68 participants showed that fluoxetine (20/36) was numerically superior to placebo (11/32) in achieving clinical response; however, the confidence interval (CI) included both a potential benefit as well as no benefit of fluoxetine (risk ratio (RR) 1.62, 95% CI 0.92 to 2.83, very low-certainty evidence). The number of adverse events was similar in both groups (very low-certainty evidence). Two trials involving a total of 136 participants compared fluoxetine versus light therapy. Meta-analysis showed fluoxetine and light therapy to be approximately equal in treating seasonal depression: RR of response 0.98 (95% CI 0.77 to 1.24, low-certainty evidence), RR of remission 0.81 (95% CI 0.39 to 1.71, very low-certainty evidence). The number of adverse events was similar in both groups (low-certainty evidence). We did not identify any eligible study comparing SGA with another SGA or with psychotherapy. Two RCTs and five non-randomised studies reported adverse event data on a total of 249 participants who received bupropion, fluoxetine, escitalopram, duloxetine, nefazodone, reboxetine, light therapy, or placebo. We were only able to obtain crude rates of adverse events, therefore caution is advised regarding interpretation of this information. Between 0% and 100% of participants who received an SGA suffered an adverse event, and between 0% and 25% of participants withdrew from the study due to adverse events. Authors' conclusions Evidence for the effectiveness of SGAs is limited to one small trial of fluoxetine compared with placebo showing a non-significant effect in favour of fluoxetine, and two small trials comparing fluoxetine against light therapy suggesting equivalence between the two interventions. The lack of available evidence precluded us from drawing any overall conclusions on the use of SGAs for SAD. Further, larger RCTs are required to expand and strengthen the evidence base on this topic, and should also include comparisons with psychotherapy and other SGAs. Data on adverse events were sparse, and a comparative analysis was not possible. The data we obtained on adverse events is therefore not robust, and our confidence in the data is limited. Overall, up to 25% of participants treated with SGAs for SAD withdrew from the study early due to adverse events.

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.

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

Objective To evaluate the effects of a computerised decision support tool for comprehensive drug review in elderly people with polypharmacy. Design Pragmatic, multicentre, cluster randomised controlled trial. Setting 359 general practices in Austria, Germany, Italy, and the United Kingdom. Participants 3904 adults aged 75 years and older using eight or more drugs on a regular basis, recruited by their general practitioner. Intervention A newly developed electronic decision support tool comprising a comprehensive drug review to support general practitioners in deprescribing potentially inappropriate and non-evidence based drugs. Doctors were randomly allocated to either the electronic decision support tool or to provide treatment as usual. Main outcome measures The primary outcome was the composite of unplanned hospital admission or death by 24 months. The key secondary outcome was reduction in the number of drugs. Results 3904 adults were enrolled between January and October 2015. 181 practices and 1953 participants were assigned to electronic decision support (intervention group) and 178 practices and 1951 participants to treatment as usual (control group). The primary outcome (composite of unplanned hospital admission or death by 24 months) occurred in 871 (44.6%) participants in the intervention group and 944 (48.4%) in the control group. In an intention-to-treat analysis the odds ratio of the composite outcome was 0.88 (95% confidence interval 0.73 to 1.07; P=0.19, 997 of 1953 v 1055 of 1951). In an analysis restricted to participants attending practice according to protocol, a difference was found favouring the intervention (odds ratio 0.82, 95% confidence interval 0.68 to 0.98; 774 of 1682 v 873 of 1712, P=0.03). By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change −0.42 v 0.06: adjusted mean difference −0.45, 95% confidence interval −0.63 to −0.26; P Conclusions In intention-to-treat analysis, a computerised decision support tool for comprehensive drug review of elderly people with polypharmacy showed no conclusive effects on the composite of unplanned hospital admission or death by 24 months. Nonetheless, a reduction in drugs was achieved without detriment to patient outcomes. Trial registration Current Controlled Trials ISRCTN10137559 .

Background Proton pump inhibitors (PPIs) are increasingly being prescribed, although long-term use is associated with multiple side effects. Therefore, an electronic decision support tool with the aim of reducing the long-term use of PPIs in a shared decision-making process between general practitioners (GPs) and their patients has been developed. The developed tool is a module that can be added to the so-called arriba decision support tool, which is already used by GPs in Germany in routine care. In this large-scale cluster-randomized controlled trial we evaluate the effectiveness of this arriba-PPI tool. Methods The arriba-PPI tool is an electronic decision support system that supports shared decision-making and evidence-based decisions around the long-term use of PPIs at the point of care. The tool will be evaluated in a cluster-randomized controlled trial involving 210 GP practices and 3150 patients in Germany. GP practices will be asked to recruit 20 patients aged ≥ 18 years regularly taking PPIs for ≥ 6 months. After completion of patient recruitment, each GP practice with enrolled patients will be cluster-randomized. Intervention GP practices will get access to the software arriba-PPI, whereas control GPs will treat their patients as usual. After an observation period of six months, GP practices will be compared regarding the reduction of cumulated defined daily doses of PPI prescriptions per patient. Discussion Our principal hypothesis is that the application of the arriba-PPI tool can reduce PPI prescribing in primary care by at least 15% compared to conventional strategies used by GPs. A positive result implies the implementation of the arriba-PPI tool in routine care. Trial registration German Clinical Trials Register, DRKS00016364. Registered on 31 January 2019.

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.

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.

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.

Background Within the EU-funded project PRIMA-eDS (Polypharmacy in chronic diseases: Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support) an electronic decision support tool (the “PRIMA-eDS-tool”) was developed for general practitioners (GPs) to reduce inappropriate medication in their older polypharmacy patients. After entering patient data relevant to prescribing in an electronic case report form the physician received a comprehensive medication review (CMR) on his/her screen displaying recommendations regarding missing indications, necessary laboratory tests, evidence-base of current medication, dose adjustments for renal malfunction, potentially harmful drug-drug interactions, contra-indications, and possible adverse drug events. We set out to explore the usage of the PRIMA-eDS tool and the adoption of the recommendations provided by the CMR to optimise the tool and prepare it for its future implementation. Methods In a qualitative study carried out in North Rhine-Westphalia, Germany, 21 GPs using the PRIMA-eDS tool within the PRIMA-eDS study were interviewed. Interviews encompassed the GPs’ attitudes regarding use of the electronic case report form and the CMR, their response to the recommendations, and the implementation of the tool into daily practice routine. The collected data were analysed applying thematic qualitative text analysis. Results GPs found the patient data entry into the electronic case report form to be inconvenient and time-consuming. The CMR was conducted often outside practice hours and without the patient present. GPs found that the PRIMA-eDS CMR provided relevant information for and had several positive effects on the caring process. However, they encountered several barriers when wanting to change medication. Conclusions It is unlikely that the PRIMA-eDS CMR will be used in the future as it is now as patient data entry is too time-consuming. Several barriers towards deprescribing medications were found which are common in deprescribing studies. Given the positive attitude towards the CMR, a new way of entering patient data into the PRIMA-eDS tool to create the CMR needs to be developed. Electronic supplementary material The online version of this article (10.1186/s12875-018-0789-3) contains supplementary material, which is available to authorized users.

Background Type 2 diabetes is a chronic disease associated with poorer health outcomes and decreased health related quality of life (HRQoL). The aim of this analysis was to explore the impact of a disease management programme (DMP) in type 2 diabetes on HRQoL. A multilevel model was used to explain the variation in EQ-VAS. Methods A cluster-randomized controlled trial—analysis of the secondary endpoint HRQoL. Our study population were general practitioners and patients in the province of Salzburg. The DMP “Therapie-Aktiv” was implemented in the intervention group, and controls received usual care. Outcome measure was a change in EQ-VAS after 12 months. For comparison of rates, we used Fisher’s Exact test; for continuous variables the independent T test or Welch test were used. In the multilevel modeling, we examined various models, continuously adding variables to explain the variation in the dependent variable, starting with an empty model, including only the random intercept. We analysed random effects parameters in order to disentangle variation of the final EQ-VAS. Results The EQ-VAS significantly increased within the intervention group (mean difference 2.19, p = 0.005). There was no significant difference in EQ-VAS between groups (mean difference 1.00, p = 0.339). In the intervention group the improvement was more distinct in women (2.46, p = 0.036) compared to men (1.92, p = 0.063). In multilevel modeling, sex, age, family and work circumstances, any macrovascular diabetic complication, duration of diabetes, baseline body mass index and baseline EQ-VAS significantly influence final EQ-VAS, while DMP does not. The final model explains 28.9% (EQ-VAS) of the total variance. Most of the unexplained variance was found on patient-level (95%) and less on GP-level (5%). Conclusion DMP “Therapie-Aktiv” has no significant impact on final EQ-VAS. The impact of DMPs in type 2 diabetes on HRQoL is still unclear and future programmes should focus on patient specific needs and predictors in order to improve HRQoL. Trial registration Current Controlled trials Ltd., ISRCTN27414162

Background Polypharmacy is common in older people and associated with potential harms. The aim of this study was to analyse the characteristics of an older multimorbid population with polypharmacy and to identify factors contributing to excessive polypharmacy in these patients. Methods This cross-sectional analysis is based on the PRIMA-eDS trial, a large randomised controlled multicentre study of polypharmacy in primary care. Patients’ baseline data were used for analysis. A number of socioeconomic and medical data as well as SF-12-scores were entered into a generalized linear mixed model to identify variables associated with excessive polypharmacy (taking ≥10 substances daily). Results Three thousand nine hundred four participants were recruited. Risk factors significantly associated with excessive polypharmacy were frailty (OR 1.45; 95% CI 1.22–1.71), > 8 diagnoses (OR 2.64; 95% CI 2.24–3.11), BMI ≥30 (OR 1.18; 95% CI 1.02–1.38), a lower SF-12 physical health composite score (OR 1.47; 95% CI 1.26–1.72), and a lower SF-12 mental health composite score (OR 1.33; 95% CI 1.17–1.59) than the median of the study population (≤36.6 and ≤ 48.7, respectively). Age ≥ 85 years (OR 0.83; 95% CI 0.70–0.99) led to a significantly lower risk for excessive polypharmacy. No association with excessive polypharmacy could be found for female sex, low educational level, and smoking. Regarding the study centres, being recruited in the UK led to a significantly higher risk for excessive polypharmacy compared to being recruited in Germany 1/Rostock (OR 1.71; 95% CI 1.27–2.30). Being recruited in Germany 2/Witten led to a slightly significant lower risk for excessive polypharmacy compared to Germany 1/Rostock (OR 0.74; 95% CI 0.56–0.97). Conclusions Frailty, multimorbidity, obesity, and decreased physical as well as mental health status are risk factors for excessive polypharmacy. Sex, educational level, and smoking apparently do not seem to be related to excessive polypharmacy. Physicians should especially pay attention to their frail, obese patients who have multiple diagnoses and a decreased health-related quality of life, to check carefully whether all the drugs prescribed are evidence-based, safe, and do not interact in an unfavourable way. Trial registration This trial has been registered with Current Controlled Trials Ltd. on 31 July 2014 (ISRCTN10137559). Electronic supplementary material The online version of this article (10.1186/s12875-018-0795-5) contains supplementary material, which is available to authorized users.

Contains fulltext : 153117.pdf (Publisher’s version ) (Open Access) BACKGROUND: Drug treatment is an important clinical process in primary care that is associated with risk of error and adverse events. OBJECTIVE: To review currently available research evidence on the topic and to develop a framework, which can help to guide improvement of medication safety. METHODS: Systematic reviews were performed on adverse drug events (ADE), their preventability, and on available tools and methods to improve medication safety with a particular focus on information technology. Consensus methods were used to develop a framework to guide the improvement of medication safety based on the findings of our literature review. RESULTS: The median prevalence rate of ADEs in primary care patients was 12.8%. Only a median of 16.5% of ADEs were preventable and thus could be classified as medication errors. Our review of information technology interventions found that only about half of the studies found a reduction of medication errors. In both reviews, the wide range between studies emphasizes the necessity of a validated medication error classification system. Another important aspect of medication safety appears to be a general lack of safety culture in primary care, which led us to the development of the Salzburg medication safety framework (SaMSaF), based on the MaPSaF tool to improve patient safety. The tool proved to be feasible and useful in a pilot study with several GP practices. CONCLUSION: A number of tools and interventions to investigate and enhance medication safety have been identified. Further research is necessary to implement and evaluate current concepts.

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 The PRIMA-eDS study was supported by a grant from the European Commission within the 7th Framework Programme (Grant No. 305388–2). The work of YVM was also supported by a grant from the NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre. The publication charge was funded by the University of Witten/Herdecke

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. The PRIMA-eDS study was supported by a grant from the European Commission within the 7th Framework Programme (Grant No. 305388–2). The work of YVM was also supported by a grant from the NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre. Publication of this article was funded by the UK National Institute for Health Research School for Primary Care Research, University of Manchester.

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

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. The PRIMA-eDS study was supported by a grant from the European Commission within the 7th Framework Programme (Grant No. 305388–2). The work of YVM was also supported by a grant from the NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre. Publication of this article was funded by the UK National Institute for Health Research School for Primary Care Research, University of Manchester.

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. The PRIMA-eDS study was supported by a grant from the European Commission within the 7th Framework Programme (Grant No. 305388–2). The work of YVM was also supported by a grant from the NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre. The publication charge was funded by the University of Witten/Herdecke.

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. The PRIMA-eDS study was supported by a grant from the European Commission within the 7th Framework Programme (Grant No. 305388–2). The work of YVM was also supported by a grant from the NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre. The publication charge was funded by the University of Witten/Herdecke.

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 The PRIMA-eDS study was supported by a grant from the European Commission within the 7th Framework Programme (Grant No. 305388–2). The work of YVM was also supported by a grant from the NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre. Publication of this article was funded by the UK National Institute for Health Research School for Primary Care Research, University of Manchester

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.

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.

Summary 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.

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=337participated (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 inHbA1cchange 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 onHbA1cand 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).

We evaluated the disease management programme (DMP) “Therapie Aktiv” for diabetes mellitus type 2 during the first year of implementation in a cluster-randomised controlled trial (RCT), which revealed an improvement of process quality, but only insignificant effects on HbA1c. To further analyse the effects of the DMP we followed up participants of the RCT for another year. After completion of the RCT, the study was continued as an open observational trial. By patient’s choice, three groups were formed. Group 1 (DMP/DMP): interventions of the RCT (DMP), who remained in the DMP; group 2 (Control/DMP): controls of the RCT (usual care), who participated in the DMP during the second year; group 3 (Control/Control): controls of the RCT (usual care), who remained as controls. Primary outcome measure: HbA1c. Secondary outcome measures: BMI, lipids, blood pressure and measures of process quality. Only 801 of 1,489 RCT participants completed the study (53.8 %). Group 1: n = 355; group 2: n = 335; group 3: n = 111. After 2 years, pre-post-analysis revealed a significant reduction of HbA1c (0.37 %, p

Purpose It has been shown that morbidity and mortality, associated with falls in older persons, can be reduced by physical activity. Many previous programs for prevention of falls were too demanding to be implemented. We aimed to test the feasibility and acceptability of a program of regular lay people, assisted outdoor walking for nursing home residents including a possible impact on the prevention of falls. Patients and methods We included five nursing homes; whereof three were assigned for the intervention and two for the control group. Inclusion criteria were age above 65 years and increased risk of falls. The intervention group (n = 32) benefited from regular assisted outdoor walking, the control group (n = 20) did not practice physical activities. We evaluated participants at the start of the study (T0) and after 6 months (T1) for history of falls, physical and cognitive impairment. In addition, we performed qualitative interviews with nursing home managers. Results The program was evaluated positively by the participating nursing homes. Half of the participants reported an improvement in their general condition, general mood and walking ability. There was a slight intervention effect on depressive symptoms, but no differences between intervention and control group in the proportion of falls, in regard to risk of falls and functional status (daily activities). Conclusions This study shows the feasibility of implementing a simple program of outdoor walking for older people in nursing homes. A sufficiently powered randomized controlled trial is necessary to prove the effectiveness and safety of our approach.

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.

Preoperative evaluation is aimed at prevention of complications and risk stratification. Routine testing should be abandoned in favour of selective ordering according to contemporary guidelines. This study was conducted to calculate the possible economic impact of a Web-based preoperative diagnostic guideline prior to its implementation in the state of Salzburg, Austria.Prospective observational cohort study.The study was carried out in a secondary care hospital in Salzburg (Schwarzach).Data from 1363 consecutive patients scheduled for elective surgery from 1 September to 30 November 2007 were collected: demographic data, medical history, surgical procedure, preoperative tests and findings. The data were entered into the preoperative diagnostic guideline software and the guideline-adherent recommendations were compared with the investigations performed, with special attention to duplicate examinations.A total of 5879 tests were documented and analysed. In 65.6% of patients, guideline-adherent evaluation would have indicated only basic requirements, but 3380 additional tests were carried out. In all, 81.7% of tests were identified as nonadherent based on the preoperative diagnostic guideline software and 226 duplicate tests were performed. Possible savings per 1000 patients would be €26 287 if preoperative diagnostic guideline recommendations were followed exactly and €1076 if duplicated tests were avoided. According to a generalised linear model (Gamma model), an increase of 1 year of age leads to an increase of costs by a factor of 1.020.These data indicate a considerable potential for improvement in process quality and cost reduction by using structured preoperative assessment with computer-assisted implementation of a guideline.

Objective: Most medications are prescribed, dispensed, and administered in ambulatory care settings, yet little information exists on the adverse effects of drugs in this setting. This review was conducted to estimate the prevalence of adverse drug events (ADEs) and the proportion of preventable ADEs in ambulatory care settings; compare data for different age groups including children, adults, and elderly patients; and review drug classes most commonly associated with ADEs. Data Sources: Four electronic databases–PubMed (1966-March 2011), International Pharmaceutical Abstracts (1970-March 2011), EMBASE (1980-March 2011), and the Cochrane Database of Systematic Reviews (1993-March 2011)—were systematically searched for published data. Bibliographies of retrieved articles were searched individually for additional relevant studies. Study Selection: A standardized definition of an ADE was used to select studies in populations living in the community, with medical visits to primary care facilities, nonspecialty ambulatory care facilities, and/or admissions to a hospital for medication-related adverse events. Data Extraction: Data were extracted using a standardized table. Forty-three studies met our inclusion criteria. Data Synthesis: The median ADE prevalence rate for retrospective studies was 3.3% (interquartile range [IQR] 2.3-7.1%) vs 9.65% (IQR 3.3-17.35%) for prospective studies. Median preventable ADE rates in ambulatory care–based studies were 16.5%, and 52.9% for hospital-based studies. Median prevalence rates by age group ranged from 2.45% for children to 5.27% for adults, 16.1% for elderly patients, and 3.45% for studies including all ages. Conclusions: Despite a recent increase in publications on ADEs in the ambulatory care setting, most studies remain hospital based. Notable differences in prevalence rates by age groups and by responsible drug categories provide guidance on how to direct attention toward effective targets for improvement of medication safety in ambulatory care settings.

Aim To estimate how accurately general practitioners’ (GP) assessed the probability of coronary heart disease in patients presenting with chest pain and analyze the patient management decisions taken as a result. Methods During 2005 and 2006, the cross-sectional diagnostic study with a delayed-type reference standard included 74 GPs in the German state of Hesse, who enrolled 1249 consecutive patients presenting with chest pain. GPs recorded symptoms and findings for each patient on a report form. Patients and GPs were contacted 6 weeks and 6 months after the patients’ visit to the GP. Data on chest complaints, investigations, hospitalization, and medication were reviewed by an independent panel, with coronary heart disease being the reference condition. Diagnostic properties (sensitivity, specificity, and predictive values) of the GPs’ diagnoses were calculated. Results GPs diagnosed coronary heart disease with the sensitivity of 69% (95% confidence interval [CI], 62-75) and specificity of 89% (95% CI, 87-91), and acute coronary syndrome with the sensitivity of 50% (95% CI, 36-64) and specificity of 98% (95% CI, 97-99). They assumed coronary heart disease in 245 patients, 41 (17%) of whom were referred to the hospital, 77 (31%) to a cardiologist, and 162 (66%) to electrocardiogram testing. Conclusions GPs’ evaluation of chest pain patients, based on symptoms and signs alone, was not sufficiently accurate for diagnosing or excluding coronary heart disease or acute coronary syndrome.

Background Diagnosing the aetiology of chest pain is challenging. There is still a lack of data on the diagnostic accuracy of signs and symptoms for acute coronary events in low-prevalence settings. Aim To evaluate the diagnostic accuracy of symptoms and signs in patients presenting to general practice with chest pain. Design of study Cross-sectional diagnostic study with delayed-type reference standard. Setting Seventy-four general practices in Germany. Method The study included 1249 consecutive patients presenting with chest pain. Data were reviewed by an independent reference panel, with coronary heart disease (CHD) and an indication for urgent hospital admission as reference conditions. Main outcome measures were sensitivity, specificity, likelihood ratio, predictive value, and odds ratio (OR) for non-trauma patients with a reference diagnosis. Results Several signs and symptoms showed strong associations with CHD, including known vascular disease (OR = 5.13; 95% confidence interval [CI] = 2.83 to 9.30), pain worse on exercise (OR = 4.27; 95% CI = 2.31 to 7.88), patient assumes cardiac origin of pain (OR = 3.20; 95% CI = 1.53 to 6.60), cough present (OR = 0.08; 95% CI = 0.01 to 0.77), and pain reproducible on palpation (OR = 0.27; 95% CI = 0.13 to 0.56). For urgent hospital admission, effective criteria included pain radiating to the left arm (OR = 8.81; 95% CI = 2.58 to 30.05), known clinical vascular disease (OR = 7.50; 95% CI = 2.88 to 19.55), home visit requested (OR = 7.31; 95% CI = 2.27 to 23.57), and known heart failure (OR = 3.53; 95% CI = 1.14 to 10.96). Conclusion Although individual criteria were only moderately effective, in combination they can help to decide about further management of patients with chest pain in primary care.

Chest wall syndrome (CWS) is the most frequent aetiology of chest pain in a primary care setting.The aims of the study are to describe the epidemiology, clinical characteristics and prognosis of CWS and to provide a simple decision rule for diagnosis.We included 1212 consecutive patients with chest pain aged 35 years and older attending 74 GPs. GPs recorded symptoms and findings of each patient and provided follow-up information. An independent interdisciplinary reference panel reviewed clinical data of every patient and decided about the aetiology of chest pain at the time of patient recruitment. Multivariable regression analysis was performed to identify clinical predictors that help to rule in or out the diagnosis of CWS.GPs diagnosed pain originating from the chest wall in 46.6% of all patients. In most patients, pain was localized retrosternal (52.0%) and/or on the left side (69.2%). In total, 28.0% of CWS patients showed persistent pain and most patients reported no temporal association of pain (72.3%). In total, 55.4% of patients still had chest pain after 6 months. A simple score containing four determinants (localized muscle tension, stinging pain, pain reproducible by palpation and absence of cough) shows an area under the receiver operating characteristic curve of 0.78 (95% confidence interval: 0.75-0.81).This study broadens the knowledge about pain characteristics and the diagnostic accuracy of selected signs and symptoms for CWS. A simple four-point score can help the GP in the diagnostic workup of chest pain patients.

Objective To assess the feasibility and outcome of measuring the theory of planned behaviour (TPB) in patients receiving routine counselling versus counselling with a decision aid (DA) during primary care consultation on cardiovascular risk prevention. Methods A DA was developed, based on models of shared decision-making (SDM) and the TPB. We evaluated the impact of the intervention in a randomized controlled trial. Main outcomes were previously reported. To assess the intermediate social cognitive processes and our theoretical framework, we evaluated the impact of the intervention on a TPB scale. Results The TPB scale showed satisfactory measurement properties. Factor analysis (main component analysis, confirmatory model) could mostly replicate the assumptions of the model. 44% of variance of the behavioural intention to adhere to the decision after counselling was explained in linear regression models. Of the TPB components, only attitude towards the decision and moral norm were significantly more positive in the intervention. No difference was found with regard to intention to adhere to the decision. High risk resulted in higher values of the TPB components in both groups. Conclusion Most DAs are developed and tested without explicitly referring to a theoretical model of psychosocial processes. The TPB may serve as a useful theoretical framework. Practice Implications Trials on DAs demonstrate positive effects on psychological outcomes of patients without leading to better objective health results. Our study might contribute to an explanation: DAs might not cause stronger adherence to decisions even though one's attitude towards the decision becomes more positive.

Objectives Chronic obstructive pulmonary disease (COPD) as a multisystemic disease has a measurable and biologically explainable impact on the auditory function detectable in the laboratory. This study tries to clarify if COPD is also a significant and clinically relevant risk factor for hearing impairment detectable in the general practice setting. Design Retrospective matched cohort study with selection of patients diagnosed with COPD. Setting 12 general practices in Lower Austria. Participants Consecutive patients >35 years with a diagnosis of COPD who consulted 1 of 12 single-handed GPs in 2009 and 2010 were asked to participate. Those who agreed were individually 1:1 matched with controls according to age, sex, hypertension, diabetes, coronary heart disease and chronic heart failure. Main outcome measures Sensorineural hearing impairment as assessed by pure tone audiometry, answers of three questions concerning a self-perceived hearing problem, application of the whispered voice test and the score of the Hearing Inventory for the Elderly, Screening Version (HHIE-S). Results 194 patients (97 pairs of 194 cases and controls) with a mean age of 65.5 (SD 10.2) were tested. Univariate conditional logistic regression resulted in significant differences in the mean bone conduction hearing loss and in the total score of HHIE-S, in the multiple conditional regression model, only smoking (p Conclusions The results of this study do not support the hypothesis that there is an association between COPD and hearing impairment which, if found, would have allowed better management of patients with COPD.

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.

Background: Case-based teaching is an effective method to train medical knowledge and skills. Virtual patients (VPs) can also facilitate this experience. The aim of this article is to identify existing patient simulation programmes in German language, to check for existing primary care specific content and to outline possibilities to integrate VPs in (undergraduate) medical education. Methods: To identify patient simulation software a search was conducted in the digital libraries and databases Medline, EMBASE und ERIC, and in the e-learning databases KELDAmed, LRSMed and Caseport. Interim results of a telephone survey of e-learning activities in primary care teaching at German universities were also included as a control measure. Information about accessibility and utilization of suitable programmes for other university departments was gained by the respective websites and telephone contact. Results: Six university and two commercial programmes were identified, displaying different didactic concepts. Content specific for primary care was only identified via the telephone survey. Conclusion: There is only a limited number of German patient simulation programmes, but a decision towards the most suitable programme depends highly on local circumstances. Virtual patients offer many possibilities, but are hardly used in primary care teaching in Germany. Initiatives for cooperation across university borders exist to enable a more effective utilisation of VPs, but so far are limited by university politics and finances.

Background: The risk of atherosclerotic cardiovascular disease can be reduced by early detection and treatment of risk factors. The German Health Screening (GHS) according to §25 SGBV which includes the measurement of the cholesterol level is aimed at this risk reduction. This study investigates which consequences are drawn from the results of the cholesterol screening. Methods: We analized the data of all patients from ten general practice-surgeries that participated in the GHS in the 3 rd and 4 th quarter of 2004 regarding known diagnoses, results of the GHS and medication before, immediately after and six months after the GHS. Results: 27.1/28.6% (women/men) of the patients were already known to be hyperlipidemic. In only 7.0/7.3% of the cases the GHS led to a new diagnosis of hyperlipidemia, while in 64.2/63.6% a cholesterol level >200 mg/dl was measured. Only 9.7/1.1% of the patients with high cardiovascular risk (>15% risk of a cardiovascular event in 10 years) received new treatment with a statin. In secondary prevention only in 2.0/6.5% statintherapy was initiated. In many cases this medication was discontinued during the following six months. Conclusion: These results show clearly that especially in high risk patients the consequences drawn from the screening are insufficient.

The risks associated with surgery are elevated in patients with diabetes mellitus. For this reason, preoperative diagnostics frequently include the measurement of blood glucose and haemoglobin A1c (HbA1c), but it is unclear whether these tests contribute to improved perioperative or postoperative outcomes.This systematic review aimed to evaluate the evidence that preoperative testing for blood glucose and HbA1c might influence the following outcome parameters: changes in clinical management; mortality; and the incidence of perioperative and postoperative complications in patients undergoing elective, noncardiac surgery.We performed a systematic search of the literature from January 2001 to March 2013, thus updating a review carried out by the National Institute for Health and Clinical Excellence (NICE) up to the year 2001.Controlled studies including cohort and case-control studies with a population of at least 60 patients were eligible.The search retrieved 1346 records (including hand-search). Twenty-two studies met all inclusion criteria and were included in the review. Fifteen cohort and two case-control studies evaluated the effectiveness of preoperative blood glucose testing and nine studies the effectiveness of testing HbA1c. Four of the included studies evaluated both tests. There were no data derived from high-quality studies supporting routine preoperative testing for blood glucose or HbA1c in otherwise healthy adult patients undergoing elective noncardiac surgery. Only in vascular and orthopaedic surgery may screening identify patients at an increased risk.Preoperative blood glucose testing and testing for HbA1c is not required in nondiabetic patients unless there are clinical sings arousing suspicion. Patients scheduled for vascular and orthopaedic surgery carry an elevated risk justifying preoperative testing for blood glucose or HbA1c as a screening tool.