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Background Anticholinergic burden has been associated with adverse outcomes such as falls. To date, no gold standard measure has been identified to assess anticholinergic burden, and no conclusion has been drawn on which of the different measure algorithms best predicts falls in older patients from general practice. This study compared the ability of five measures of anticholinergic burden to predict falls. To account for patients’ individual susceptibility to medications, the added predictive value of typical anticholinergic symptoms was further quantified in this context. Methods and findings To predict falls, models were developed and validated based on logistic regression models created using data from two German cluster-randomized controlled trials. The outcome was defined as “≥ 1 fall” vs. “no fall” within a 6-month follow-up period. Data from the RIME study (n = 1,197) were used in model development, and from PRIMUM (n = 502) for external validation. The models were developed step-wise in order to quantify the predictive ability of anticholinergic burden measures, and anticholinergic symptoms. In the development set, 1,015 patients had complete data and 188 (18.5%) experienced ≥ 1 fall within the 6-month follow-up period. The overall predictive value of the five anticholinergic measures was limited, with neither the employed anticholinergic variable (binary / count / burden), nor dose-dependent or dose-independent measures differing significantly in their ability to predict falls. The highest c-statistic was obtained using the German Anticholinergic Burden Score (0.73), whereby the optimism-corrected c-statistic was 0.71 after interval validation using bootstrapping and 0.63 in the external validation. Previous falls and dizziness / vertigo had the strongest prognostic value in all models. Conclusions The ability of anticholinergic burden measures to predict falls does not appear to differ significantly, and the added value they contribute to risk classification in fall-prediction models is limited. Previous falls and dizziness / vertigo contributed most to model performance.

Multimorbidity is of an increasing importance for the health of both children and adults but research has hitherto focused on adult multimorbidity. Hence, public awareness, practice, and policy lack vital information about multimorbidity in childhood and adolescence. We convened an international and interdisciplinary group of experts from six nations to identify key priorities supported by published evidence to strengthen research for children and adolescent with multimorbidity. Future research is encouraged (1) to develop a conceptual framework to capture unique aspects of child and adolescent multimorbidity-including definitions, characteristic patterns of conditions for different age groups, its dynamic nature through childhood and adolescence, and understanding of severity and trajectories for different clusters of multiple chronic conditions, (2) to define new indices to classify the presence of multimorbidity in children and adolescents, (3) to improve the availability and linkage of data across countries, (4) to synthesize evidence on the global phenomenon of multimorbidity in childhood and adolescence and health inequalities, and (5) to involve children and adolescents in research relevant to their health.

Objectives: To develop and validate a prognostic model to predict deterioration in health-related quality of life (dHRQoL) in older general practice patients with at least one chronic condition and one chronic prescription. Study Design and Setting: We used individual participant data from five cluster-randomized trials conducted in the Netherlands and Germany to predict dHRQoL, defined as a decrease in EQ-5D-3 L index score of ≥5% after 6-month follow-up in logistic regression models with stratified intercepts to account for between-study heterogeneity. The model was validated internally and by using internal–external cross-validation (IECV). Results: In 3,582 patients with complete data, of whom 1,046 (29.2%) showed deterioration in HRQoL, and 12/87 variables were selected that were related to single (chronic) conditions, inappropriate medication, medication underuse, functional status, well-being, and HRQoL. Bootstrap internal validation showed a C-statistic of 0.71 (0.69 to 0.72) and a calibration slope of 0.88 (0.78 to 0.98). In the IECV loop, the model provided a pooled C-statistic of 0.68 (0.65 to 0.70) and calibration-in-the-large of 0 (−0.13 to 0.13). HRQoL/functionality had the strongest prognostic value. Conclusion: The model performed well in terms of discrimination, calibration, and generalizability and might help clinicians identify older patients at high risk of dHRQoL.

Background The progressive ageing of the population is leading to an increase in multimorbidity and polypharmacy, which in turn may increase the risk of hospitalization and mortality. The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process. Objective To assess the effectiveness and cost-effectiveness of the complex intervention MULTIPAP Plus, compared to usual care, in improving prescriptions for young-old patients (65-74 years old) with multimorbidity and polypharmacy in primary care. Methods/design This is a pragmatic cluster-randomized clinical trial with a follow-up of 18 months in health centres of the Spanish National Health System. Unit of randomization: family physician. Unit of analysis: patient. Population Patients aged 65–74 years with multimorbidity (≥ 3 chronic diseases) and polypharmacy (≥ 5 drugs) during the previous 3 months were included. Sample size n = 1148 patients (574 per study arm). Intervention Complex intervention based on the ARIADNE principles with three components: (1) family physician (FP) training, (2) FP-patient interview, and (3) decision-making support system. Outcomes The primary outcome is a composite endpoint of hospital admission or death during the observation period measured as a binary outcome, and the secondary outcomes are number of hospital admission, all-cause mortality, use of health services, quality of life (EQ-5D-5L), functionality (WHODAS), falls, hip fractures, prescriptions and adherence to treatment. Clinical and sociodemographic factors will be explanatory variables. Statistical analysis The main result is the difference in percentages in the final composite endpoint variable at 18 months, with its corresponding 95% CI. Adjustments by the main confounding and prognostic factors will be performed through a multilevel analysis. All analyses will be carried out in accordance to the intention-to-treat principle. Discussion It is important to prevent the cascade of negative health and health care impacts attributable to the multimorbidity-polypharmacy binomial. ICT-enhanced routine clinical practice could improve the prescription process in patient care. Trial registration ClinicalTrials.gov NCT04147130. Registered on 22 October 2019

Background To investigate patients’ perspectives on polypharmacy and the use of a digital decision support system to assist general practitioners (GPs) in performing medication reviews. Methods Qualitative interviews with patients or informal caregivers recruited from participants in a cluster-randomized controlled clinical trial (cRCT). The interviews were transcribed verbatim and analyzed using thematic analysis. Results We conducted 13 interviews and identified the following seven themes: the patients successfully integrated medication use in their everyday lives, used medication plans, had both good and bad personal experiences with their drugs, regarded their healthcare providers as the main source of medication-related information, discussed medication changes with their GPs, had trusting relationships with them, and viewed the use of digital decision support tools for medication reviews positively. No unwanted adverse effects were reported. Conclusions Despite drug-related problems, patients appeared to cope well with their medications. They also trusted their GPs, despite acknowledging polypharmacy to be a complex field for them. The use of a digital support system was appreciated and linked to the hope that reasons for selecting specific medication regimens would become more comprehensible. Further research with a more diverse sampling might add more patient perspectives. Trial registration ClinicalTrials.gov, NCT03430336. Registered on February 6, 2018. Supplementary Information The online version contains supplementary material available at 10.1186/s12875-021-01517-6.

© 2021 Elsevier B.V. The prevalence of multimorbidity and polypharmacy increases significantly with age and are associated with negative health consequences. However, most current interventions to optimize medication have failed to show significant effects on patient-relevant outcomes. This may be due to ineffectiveness of interventions themselves but may also reflect other factors: insufficient sample sizes, heterogeneity of population. To address this issue, the international PROPERmed collaboration was set up to obtain/synthesize individual participant data (IPD) from five cluster-randomized trials. The trials took place in Germany and The Netherlands and aimed to optimize medication in older general practice patients with chronic illness. PROPERmed is the first database of IPD to be drawn from multiple trials in this patient population and setting. It offers the opportunity to derive prognostic models with increased statistical power for prediction of patient-relevant outcomes resulting from the interplay of multimorbidity and polypharmacy. This may help patients from this heterogeneous group to be stratified according to risk and enable clinicians to identify patients that are likely to benefit most from resource/time-intensive interventions. The aim of this manuscript is to describe the rationale behind PROPERmed collaboration, characteristics of the included studies/participants, development of the harmonized IPD database and challenges faced during this process.

ObjectiveFormative evaluation of the implementation process for a digitally supported intervention in polypharmacy in Germany. Qualitative research was conducted within a cluster randomized controlled trial (C-RCT). It focused on understanding how the intervention influences behavior-related outcomes in the prescription and medication review process.Methods/settingTwenty-seven general practitioners (GPs) were included in the study in the two groups of the C-RCT, the intervention, and the wait list control group. Behavior-related outcomes were investigated using three-step data analysis (content analytic approach, documentary method, and design of a model of implementation pathways).ResultsContent analysis showed that physicians were more intensely aware of polypharmacy-related risks, described positive learning effects of the digital technology on their prescribing behavior, and perceived a change in communication with patients and pharmacists. Conversely, they felt uncertain about their own responsibility when prescribing. Three main dimensions were discovered which influenced adoption behavior: (1) the physicians’ interpretation of the relevance of pharmaceutical knowledge provided by the intervention in changing decision-making situations in polypharmacy; (2) their medical code of ethics for clinical decision making in the context of progressing digitalization; and (3) their concepts of evidence-based medicine on the basis of professional experiences with polypharmacy in primary care settings. In our sample, both simple and complex pathways from sensitization to adoption were observed. The resulting model on adoption behavior includes a paradigmatic description of different pathways and a visualization of different observed levels and applied methodological approaches. We assumed that the GP habitus can weaken or strengthen interventional effects towards intervention uptake. This formative evaluation strategy is beneficial for the identification of behavior-related implementation barriers and facilitators.ConclusionOur analyses of the adoption behavior of a digitally supported intervention in polypharmacy revealed both simple and complex pathways from awareness to adoption, which may impact the implementation of the intervention and therefore, its effectiveness. Future consideration of adoption behavior in the planning and evaluation of digitally supported interventions may enhance uptake and support the interpretation of effects.Trial registrationNCT03430336, 12 February 2018.

Introduction End-of-life care is an essential task performed by most healthcare providers and often involves decision-making about how and where patients want to receive care. To provide decision support to healthcare professionals and patients in this difficult situation, we will systematically review a knowledge cluster of the end-of-life care preferences of older patients with multimorbidity that we previously identified using an evidence map. Methods and analysis We will systematically search for studies reporting end-of-life care preferences of older patients (mean age ≥60) with multimorbidity (≥2 chronic conditions) in MEDLINE, CINAHL, PsycINFO, Social Sciences Citation Index, Social Sciences Citation Index Expanded, PSYNDEX and The Cochrane Library from inception to September 2019. We will include all primary studies that use quantitative, qualitative and mixed methodologies, irrespective of publication date and language. Two independent reviewers will assess eligibility, extract data and describe evidence in terms of study/population characteristics, preference assessment method and end-of-life care elements that matter to patients (eg, life-sustaining treatments). Risk of bias/applicability of results will be independently assessed by two reviewers using the Mixed-Methods Appraisal Tool. Using a convergent integrated approach on qualitative/quantitative studies, we will synthesise information narratively and, wherever possible, quantitatively. Ethics and dissemination Due to the nature of the proposed systematic review, ethics approval is not required. Results from our research will be disseminated at relevant (inter-)national conferences and via publication in peer-reviewed journals. Synthesising evidence on end-of-life care preferences of older patients with multimorbidity will improve shared decision-making and satisfaction in this final period of life. PROSPERO registration number CRD42020151862.

Background/research question: Although patient-centeredness has been embraced as a key principle in primary care consultations (‘Ariadne principles’), in clinical practice, it remains unclear how to elicit health-related preferences in older patients with multimorbidity, and how to[for full text, please go to the a.m. URL], Nützliche patientenrelevante Forschung; 21. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Objective: The objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elab-orate and explain CONSORT items in this regard.Study Design and Setting: As a first step in a multistage process and based on a systematic review of deprescribing trials, we elab-orated variation in design, intervention, and reporting of the included trials of the review. We identified items that were missed or insufficiently described, using the CONSORT and TIDieR checklists. The resulting list of items, which we considered relevant to be reported in deprescribing trials, were discussed in a single-round Delphi exercise and subsequently in a full-day face-to-face meeting with an international panel of 14 experts. We agreed on CONSORT items for further elaboration with regard to design and reporting of deprescribing trials.Results: We identified seven CONSORT items on trial design, participants, intervention, outcomes, flowchart, and harms, where the investigators of deprescribing trials should take into consideration specific aspects, such as whether or not to use placebo or how to inform participants.Conclusion: This article presents an elaboration to the CONSORT statement for the reporting of deprescribing trials. It may also support investigators in motivated design choices. (c) 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Background Unwanted anticholinergic effects are both underestimated and frequently overlooked. Failure to identify adverse drug reactions (ADRs) can lead to prescribing cascades and the unnecessary use of over-the-counter products. The objective of this systematic review and meta-analysis is to explore and quantify the frequency and severity of ADRs associated with amitriptyline vs. placebo in randomized controlled trials (RCTs) involving adults with any indication, as well as healthy individuals. Methods A systematic search in six electronic databases, forward/backward searches, manual searches, and searches for Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval studies, will be performed. Placebo-controlled RCTs evaluating amitriptyline in any dosage, regardless of indication and without restrictions on the time and language of publication, will be included, as will healthy individuals. Studies of topical amitriptyline, combination therapies, or including

Introduction Interaction of conditions and treatments, complicated care needs and substantial treatment burden make patient–physician encounters involving multimorbid older patients highly complex. To optimally integrate patients’ preferences, define and prioritise realistic treatment goals and individualise care, a patient-centred approach is recommended. However, the preferences of older patients, who are especially vulnerable and frequently multimorbid, have not been systematically investigated with regard to their health status. The purpose of this evidence map is to explore current research addressing health-related preferences of older patients with multimorbidity, and to identify the knowledge clusters and research gaps. Methods and analysis To identify relevant research, we will conduct searches in the electronic databases MEDLINE, EMBASE, PsycINFO, PSYNDEX, CINAHL, Social Science Citation Index, Social Science Citation Index Expanded and the Cochrane library from their inception. We will check reference lists of relevant articles and carry out cited reference research (forward citation tracking). Two independent reviewers will screen titles and abstracts, check full texts for eligibility and extract the data. Any disagreement will be resolved and consensus reached with the help of a third reviewer. We will include both qualitative and quantitative studies, and address preferences from the patients’ perspectives in a multimorbid population of 60 years or older. There will be no restrictions on the publication language. Data extraction tables will present study and patient characteristics, aim of study, methods used to identify preferences and outcomes (ie, type of preferences). We will summarise the data using tables and figures (ie, bubble plot) to present the research landscape and to describe clusters and gaps. Ethics and dissemination Due to the nature of the proposed evidence map, ethics approval will not be required. Results from our research will be disseminated by means of specifically prepared materials for patients, at relevant (inter)national conferences and via publication in peer-reviewed journals.

Background and Objective Discontinuation of inappropriate medication is widely recognized as an essential component of best prescribing practice. Physicians typically attempt to taper or stop medications on the basis of clinical experience, rather than using a systematic approach guided by evidence. We sought to evaluate if the reporting of deprescribing trials conducted in primary care is of sufficient quality and detail to allow replication in clinical practice. Methods This study presents a secondary analysis of data from a systematic review published in 2018, investigating the effects of discontinuation of chronic medication in primary care. Twenty-six publications reporting on 27 trials were included. The quality of reporting was assessed using the Template for Intervention Description and Replication (TIDieR) checklist. Results No study provided complete reporting on all TIDieR items. All studies provided a clear description and rationale for the intervention; however, details of the intervention were insufficiently reported in most studies, with high variability between studies. Consultation of secondary sources resulted in minimal additional information. Conclusions There are significant deficits in reporting methodological details of deprescribing interventions in primary care. It is likely that evidence-based deprescribing is not being implemented as routinely into health-care practice as it could be. Increasing the quality of intervention reporting is essential to avoid wastage of research resources and ought to be a focus for all discontinuation trials.

Astrogliosis and activation of microglia are hallmarks of prion diseases in humans and animals. Both were viewed to be rather independent events in disease pathophysiology, with proinflammatory microglia considered to be the potential neurotoxic species at late disease stages. Recent investigations have provided substantial evidence that a proinflammatory microglial cytokine cocktail containing TNF-α, IL-1α and C1qa reprograms a subset of astrocytes to change their expression profile and phenotype, thus becoming neurotoxic (designated as A1-astrocytes). Knockout or antibody blockage of the three cytokines abolish formation of A1-astrocytes, therefore, this pathway is of high therapeutic interest in neurodegenerative diseases. Since astrocyte polarization profiles have never been investigated in prion diseases, we performed several analyses and could show that C3+-PrPSc-reactive-astrocytes, which may represent a subtype of A1-astrocytes, are highly abundant in prion disease mouse models and human prion diseases. To investigate their impact on prion disease pathophysiology and to evaluate their potential therapeutic targeting, we infected TNF-α, IL-1α, and C1qa Triple-KO mice (TKO-mice), which do not transit astrocytes into A1, with prions. Although formation of C3+-astrocytes was significantly reduced in prion infected Triple-KO-mice, this did not affect the amount of PrPSc deposition or titers of infectious prions. Detailed characterization of the astrocyte activation signature in thalamus tissue showed that astrocytes in prion diseases are highly activated, showing a mixed phenotype that is distinct from other neurodegenerative diseases and were therefore termed C3+-PrPSc-reactive-astrocytes. Unexpectedly, Triple-KO led to a significant acceleration of prion disease course. While pan-astrocyte and -microglia marker upregulation was unchanged compared to WT-brains, microglial homeostatic markers were lost early in disease in TKO-mice, pointing towards important functions of different glia cell types in prion diseases. Electronic supplementary material The online version of this article (10.1186/s40478-019-0735-1) contains supplementary material, which is available to authorized users.

Multimorbidity (MM) is a widespread problem and it poses unsolved issues like the healthcare professionals' training. A training curriculum has been proposed, but it has not been sufficiently explored in a clinical context. The eMULTIPAP course is part of the MULTIPAP complex intervention, applied through a pragmatic controlled, cluster randomized clinical trial to general practitioners (GP) and his/her patients with MM with 12 months follow-up. The eMULTIPAP course is based on problem-based learning, constructivism and Ariadne principles. It has been assessed according to the Kirkpatrick model and has shown knowledge improvement and high applicability of learning with more motivation to consider MM in the clinical practice. It has also improved the Medication Appropriateness Index at 6-months and at 12- months. We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.

The complexity and heterogeneity of patients with multimorbidity and polypharmacyrenders traditional disease-oriented guidelines often inadequate and complicates clinical decision making. To address this challenge, guidelines have beendeveloped on multimorbidity or polypharmacy. To systematically analyse theirrecommendations, we conducted a systematic guideline review using the Ariadneprinciples for managing multimorbidity as analytical framework. The informationsynthesis included a multistep consensus process involving 18 multidisciplinaryexperts from seven countries. We included eight guidelines (four each onmultimorbidity and polypharmacy) and extracted about 250 recommendations. Theguideline addressed (i) the identification of the target population (riskfactors); (ii) the assessment of interacting conditions and treatments: medicalhistory, clinical and psychosocial assessment including physiological status and frailty, reviews of medication and encounters with healthcare providershighlighting informational continuity; (iii) the need to incorporate patientpreferences and goal setting: eliciting preferences and expectations, the processof shared decision making in relation to treatment options and the level ofinvolvement of patients and carers; (iv) individualized management: guidingprinciples on optimization of treatment benefits over possible harms, treatmentcommunication and the information content of medication/care plans; (v)monitoring and follow-up: strategies in care planning, self-management andmedication-related aspects, communication with patients including safetyinstructions and adherence, coordination of care regarding referral and dischargemanagement, medication appropriateness and safety concerns. The spectrum ofclinical and self-management issues varied from guiding principles to specificrecommendations and tools providing actionable support. The limited availability of reliable risk prediction models, feasible interventions of proveneffectiveness and decision aids, and limited consensus on appropriate outcomes ofcare highlight major research deficits. An integrated approach to bothmultimorbidity and polypharmacy should be considered in future guidelines.

Background Treatment complexity rises in line with the number of drugs, single doses, and administration methods, thereby threatening patient adherence. Patients with multimorbidity often need flexible, individualised treatment regimens, but alterations during the course of treatment may further increase complexity. The objective of our study was to explore medication changes in older patients with multimorbidity and polypharmacy in general practice. Methods We retrospectively analysed data from the cluster-randomised PRIMUM trial (PRIoritisation of MUltimedication in Multimorbidity) conducted in 72 general practices. We developed an algorithm for active pharmaceutical ingredients (API), strength, dosage, and administration method to assess changes in physician-reported medication data during two intervals (baseline to six-months: ∆1; six- to nine-months: ∆2), analysed them descriptively at prescription and patient levels, and checked for intervention effects. Results Of 502 patients (median age 72 years, 52% female), 464 completed the study. Changes occurred in 98.6% of patients (changes were 19% more likely in the intervention group): API changes during ∆1 and ∆2 occurred in 414 (82.5%) and 338 (67.3%) of patients, dosage alterations in 372 (74.1%) and 296 (59.2%), and changes in API strength in 158 (31.5%) and 138 (27.5%) respectively. Administration method changed in 79 (16%) of patients in both ∆1 and ∆2. Simvastatin, metformin and aspirin were most frequently subject to alterations. Conclusion Medication regimens in older patients with multimorbidity and polypharmacy changed frequently. These are mostly due to discontinuations and dosage alterations, followed by additions and restarts. These findings cast doubt on the effectiveness of cross-sectional assessments of medication and support longitudinal assessments where possible. Trial registration. 1. Prospective registration: Trial registration number: NCT01171339; Name of registry: ClinicalTrials.gov; Date of registration: July 27, 2010; Date of enrolment of the first participant to the trial: August 12, 2010. 2. Peer reviewed trial registration: Trial registration number: ISRCTN99526053; Name of registry: Controlled Trials; Date of registration: August 31, 2010; Date of enrolment of the first participant to the trial: August 12, 2010. Electronic supplementary material The online version of this article (10.1186/s12875-018-0825-3) contains supplementary material, which is available to authorized users.

Older people often suffer from multiple diseases. Therefore, universal cross-disease outcomes (e.g. functional status, quality of life, overall survival) are more relevant than disease-specific outcomes, and a range of potential outcomes are needed for medical decision-making. To assess how patient-relevant outcomes have penetrated randomized controlled trials (RCTs), reporting of these outcomes was reviewed in heart failure trials that included patients with multimorbidity. We systematically reviewed RCTs (Jan 2011–June 2012) and evaluated reported outcomes. Heart failure was chosen as condition of interest as this is common among older patients with multimorbidity. The main outcome was the proportion of RCTs reporting all-cause mortality, all-cause hospital admission, and outcomes in four domains of health, i.e. functional, signs and symptoms, psychological, and social domains. Of the 106 included RCTs, 50 (47 %) reported all-cause mortality and cardiovascular mortality and 29 (27 %) reported all-cause hospitalization and cardiovascular hospitalization. Of all trials, 68 (64 %) measured outcomes in the functional domain, 80 (75 %) in the domain of signs and symptoms, 65 (61 %) in the psychological domain, and 59 (56 %) in the social domain. Disease-specific instruments were more often used than non-disease-specific instruments. This review shows increasing attention for more patient-relevant outcomes; this is promising and indicates more awareness of the importance of a variety of outcomes desirable for patients. However, patients’ individual goal attainments were universally absent. For continued progress in patient-centred care, efforts are needed to develop these outcomes, study their merits and pitfalls, and intensify their use in research. Electronic supplementary material The online version of this article (doi:10.1007/s10741-015-9476-9) contains supplementary material, which is available to authorized users.

Background Although polypharmacy can cause adverse health outcomes, patients often know little about their medication. A regularly conducted medication review (MR) can help provide an overview of a patient’s medication, and benefit patients by enhancing their knowledge of their drugs. As little is known about patient attitudes towards MRs in primary care, the objective of this study was to gain insight into patient-perceived barriers and facilitators to the implementation of an MR. Methods We conducted a qualitative study with a convenience sample of 31 patients (age ≥ 60 years, ≥3 chronic diseases, taking ≥5 drugs/d); in Hesse, Germany, in February 2016. We conducted two focus groups and, in order to ensure the participation of elderly patients with reduced mobility, 16 telephone interviews. Both relied on a semi-structured interview guide dealing with the following subjects: patients’ experience of polypharmacy, general design of MRs, potential barriers and facilitators to implementation etc. Interviews were audio-recorded, transcribed verbatim, and analysed by two researchers using thematic analysis. Results Patients’ average age was 74 years (range 62–88 years). We identified barriers and facilitators for four main topics regarding the implementation of MRs in primary care: patient participation, GP-led MRs, pharmacist-led MRs, and the involvement of healthcare assistants in MRs. Barriers to patient participation concerned patient autonomy, while facilitators involved patient awareness of medication-related problems. Barriers to GP-led MRs concerned GP’s lack of resources while facilitators related to the trusting relationship between patient and GP. Pharmacist-led MRs might be hindered by a lack of patients’ confidence in pharmacists’ expertise, but facilitated by pharmacies’ digital records of the patients’ medications. Regarding the involvement of healthcare assistants in MRs, a potential barrier was patients’ uncertainty regarding the extent of their training. Patients could, however, imagine GPs delegating some aspects of MRs to them. Conclusions Our study suggests that patients regard MRs as beneficial and expect indications for their medicines to be checked, and possible interactions to be identified. To foster the implementation of MRs in primary care, it is important to consider barriers and facilitators to the four identified topics. Electronic supplementary material The online version of this article (10.1186/s12875-017-0707-0) contains supplementary material, which is available to authorized users.

Background In oldest-old patients (>80), few trials showed efficacy of treating hypertension and they included mostly the healthiest elderly. The resulting lack of knowledge has led to inconsistent guidelines, mainly based on systolic blood pressure (SBP), cardiovascular disease (CVD) but not on frailty despite the high prevalence in oldest-old. This may lead to variation how General Practitioners (GPs) treat hypertension. Our aim was to investigate treatment variation of GPs in oldest-olds across countries and to identify the role of frailty in that decision. Methods Using a survey, we compared treatment decisions in cases of oldest-old varying in SBP, CVD, and frailty. GPs were asked if they would start antihypertensive treatment in each case. In 2016, we invited GPs in Europe, Brazil, Israel, and New Zealand. We compared the percentage of cases that would be treated per countries. A logistic mixed-effects model was used to derive odds ratio (OR) for frailty with 95% confidence intervals (CI), adjusted for SBP, CVD, and GP characteristics (sex, location and prevalence of oldest-old per GP office, and years of experience). The mixed-effects model was used to account for the multiple assessments per GP. Results The 29 countries yielded 2543 participating GPs: 52% were female, 51% located in a city, 71% reported a high prevalence of oldest-old in their offices, 38% and had >20 years of experience. Across countries, considerable variation was found in the decision to start antihypertensive treatment in the oldest-old ranging from 34 to 88%. In 24/29 (83%) countries, frailty was associated with GPs’ decision not to start treatment even after adjustment for SBP, CVD, and GP characteristics (OR 0.53, 95%CI 0.48–0.59; ORs per country 0.11–1.78). Conclusions Across countries, we found considerable variation in starting antihypertensive medication in oldest-old. The frail oldest-old had an odds ratio of 0.53 of receiving antihypertensive treatment. Future hypertension trials should also include frail patients to acquire evidence on the efficacy of antihypertensive treatment in oldest-old patients with frailty, with the aim to get evidence-based data for clinical decision-making. Electronic supplementary material The online version of this article (doi:10.1186/s12877-017-0486-4) contains supplementary material, which is available to authorized users.

La multimorbilidad, definida como la presencia de dos o más enfermedades crónicas en un mismo individuo, conlleva consecuencias negativas para la persona e importantes retos para los sistemas sanitarios. En atención primaria, donde recae esencialmente la atención de este grupo de pacientes, la consulta es más compleja que la de un paciente con una única enfermedad debido, entre otros, al hecho de tener que manejar mayor cantidad de información clínica, disponer de poca evidencia científica para abordar la multimorbilidad, y tener que coordinar la labor de múltiples profesionales para garantizar la continuidad asistencial. Además, para poder implementar correctamente los planes de tratamiento en estos pacientes es necesario un proceso de toma de decisiones compartida médico-paciente. Entre las distintas herramientas disponibles para apoyar dicho proceso, recientemente se ha desarrollado una dirigida específicamente a pacientes con multimorbilidad en atención primaria y que se describe en el presente artículo: los principios Ariadne. Multimorbidity, defined as the coexistence of two or more chronic conditions in one same individual, has negative consequences for people suffering from it and it poses a real challenge for health systems. In primary care, where most of these patients are attended, the clinical management of multimorbidity can be a complex task due, among others, to the high volume of clinical information that needs to be handled, the scarce scientific evidence available to approach multimorbidity, and the need for coordination among multiple health providers to guarantee continuity of care. Moreover, the adequate implementation of the care plan in these patients requires a process of shared decision making between patient and physician. One of the available tools to support this process, which is specifically directed to patients with multimorbidity in primary care, is described in the present article: the Ariadne principles.

Patients with multimorbidity have complex health needs but, due to the current traditional disease-oriented approach, they face a highly fragmented form of care that leads to inefficient, ineffective, and possibly harmful clinical interventions. There is limited evidence on available integrated and multidimensional care pathways for multimorbid patients. An expert consensus meeting was held to develop a framework for care of multimorbid patients that can be applied across Europe, within a project funded by the European Union; the Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS). The experts included a diverse group representing care providers and patients, and included general practitioners, family medicine physicians, neurologists, geriatricians, internists, cardiologists, endocrinologists, diabetologists, epidemiologists, psychologists, and representatives from patient organizations. Sixteen components across five domains were identified (Delivery of Care; Decision Support; Self Management Support; Information Systems and Technology; and Social and Community Resources). The description and aim of each component are described in these guidelines, along with a summary of key characteristics and relevance to multimorbid patients. Due to the lack of evidence-based recommendations specific to multimorbid patients, this care model needs to be assessed and validated in different European settings to examine specifically how multimorbid patients will benefit from this care model, and whether certain components have more importance than others., final draft, peerReviewed

ObjectiveTo improve medication appropriateness and adherence in elderly patients with multimorbidity, we developed a complex intervention involving general practitioners (GPs) and their healthcare assistants (HCA). In accordance with the Medical Research Council guidance on developing and evaluating complex interventions, we prepared for the main study by testing the feasibility of the intervention and study design in a cluster randomised pilot study. Setting20 general practices in Hesse, Germany. Participants100 cognitively intact patients ≥65 years with ≥3 chronic conditions, ≥5 chronic prescriptions and capable of participating in telephone interviews; 94 patients completed the study. InterventionThe HCA conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision-support system (CDSS), the GPs discussed medication intake with patients and adjusted their medication regimens. The control group continued with usual care. Outcome measuresFeasibility of the intervention and required time were assessed for GPs, HCAs and patients using mixed methods (questionnaires, interviews and case vignettes after completion of the study). The feasibility of the study was assessed concerning success of achieving recruitment targets, balancing cluster sizes and minimising drop-out rates. Exploratory outcomes included the medication appropriateness index (MAI), quality of life, functional status and adherence-related measures. MAI was evaluated blinded to group assignment, and intra-rater/inter-rater reliability was assessed for a subsample of prescriptions. Results10 practices were randomised and analysed per group. GPs/HCAs were satisfied with the interventions despite the time required (35/45 min/patient). In case vignettes, GPs/HCAs needed help using the CDSS. The study made no patients feel uneasy. Intra-rater/inter-rater reliability for MAI was excellent. Inclusion criteria were challenging and potentially inadequate, and should therefore be adjusted. Outcome measures on pain, functionality and self-reported adherence were unfeasible due to frequent missing values, an incorrect manual or potentially invalid results. ConclusionsIntervention and trial design were feasible. The pilot study revealed important limitations that influenced the design and conduct of the main study, thus highlighting the value of piloting complex interventions. Trial registration numberISRCTN99691973; Results.

Adverse clinical outcomes have been associated with cumulative anticholinergic burden (to which low-potency as well as high-potency anticholinergic medicines contribute). The clinical indications for which anticholinergic medicines are prescribed (and thus the 'phenotype' of patients with anticholinergic burden) have not been established. We sought to establish the overall prevalence of prescribing of anticholinergic medicines, the prevalence of prescribing of low-, medium- and high-potency anticholinergic medicines, and the clinical indications for which the medicines were prescribed in an older primary care population. This was a cross-sectional analysis of a cohort study of Australian early-career general practitioners' (GPs') clinical consultations - the Registrar Clinical Encounters in Training (ReCEnT) study. In ReCEnT, GPs collect detailed data (including medicines prescribed and their clinical indication) for 60 consecutive patients, on up to three occasions 6 months apart. Anticholinergic medicines were categorized as levels 1 (low-potency) to 3 (high-potency) using the Anticholinergic Drug Scale (ADS). During 2010-2014, 879 early-career GPs (across five of Australia's six states) conducted 20 555 consultations with patients aged 65 years or older, representing 35 506 problems/diagnoses. Anticholinergic medicines were prescribed in 10·4% [95% CIs 9·5-10·5] of consultations. Of the total anticholinergic load of prescribed medicines ('community anticholinergic load') 72·7% [95% CIs 71·0-74·3] was contributed by Level 1 medicines, 0·8% [95% CIs 0·5-1·3] by Level 2 medicines and 26·5% [95% CIs 24·8-28·1] by Level 3 medicines. Cardiac (40·0%), Musculoskeletal (16·9%) and Respiratory (10·6%) were the most common indications associated with Level 1 anticholinergic prescription. For Level 2 and 3 medicines (combined data), Psychological (16·1%), Neurological (16·1%), Musculoskeletal (15·7%) and Urological (11·1%) indications were most common. Anticholinergic medicines are frequently prescribed in Australian general practice, and the majority of the 'community' anticholinergic burden is contributed by 'low'-anticholinergic potency medicines whose anticholinergic effects may be largely 'invisible' to prescribing GPs. Furthermore, the clinical 'phenotype' of the patient with high anticholinergic burden may be very different to common stereotypes (patients with urological, psychological or neurological problems), potentially making recognition of risk of anticholinergic adverse effects additionally problematic for GPs.

Background: Physician's prescribing preference is increasingly used as an instrumental variable in studies of therapeutic effects. However, differences in prescribing patterns among physicians may reflect differences in preferences or in case-mix. Furthermore, there is debate regarding the possible assumptions for point estimation using physician's preference as an instrument. \ud \ud Methods: A survey was sent to general practitioners (GPs) in The Netherlands, the United Kingdom, New Zealand, Ireland, Switzerland, and Germany, asking whether they would prescribe levothyroxine to eight fictitious patients with subclinical hypothyroidism. We investigated (1) whether variation in physician's preference was observable and to what extent it was explained by characteristics of GPs and their patient populations and (2) whether the data were compatible with deterministic and stochastic monotonicity assumptions.\ud \ud Results: Levothyroxine prescriptions varied substantially among the 526 responding GPs. Between-GP variance in levothyroxine prescriptions (logit scale) was 9.9 (95% confidence interval: 8.0, 12) in the initial mixed effects logistic model, 8.3 (6.7, 10) after adding a fixed effect for country and 8.2 (6.6, 10) after adding GP characteristics. The occurring prescription patterns falsified the deterministic monotonicity assumption. All cases in all countries were more likely to receive levothyroxine if a different case of the same GP received levothyroxine, which is compatible with the stochastic monotonicity assumption. The data were incompatible with this assumption for a different definition of the instrument. \ud \ud Conclusions: Our study supports the existence of physician's preference as a determinant in treatment decisions. Deterministic monotonicity will generally not be plausible for physician's preference as an instrument. Depending on the definition of the instrument, stochastic monotonicity may be plausible.

Item does not contain fulltext Poor adherence to treatment regimens has long been recognized as a substantial roadblock to achieving better outcomes for patients. Non-adherence to medications affects the quality and length of life and has been associated with negative health outcomes and increasing healthcare costs. The problem of non-adherence is particularly troublesome in older patients who are affected by multiple chronic diseases and for this reason receive multiple treatments. To date, no single intervention strategy has been shown to be effective in improving adherence across all patients, conditions, and settings. Between September and October 2014, a group of experts in geriatrics, pharmacology, epidemiology, and public health applied a modified RAND appropriateness method to reach a consensus on the possible best interventions to improve adherence in older individuals. Seven interventions were identified, classified based on their target (patient, therapy, and public health/society): (1) Comprehensive Geriatric Assessment, (2) patient (and caregiver) education to improve patient empowerment, (3) optimization of treatment, (4) use of adherence aids, (5) physician and other healthcare professionals' education, (6) adherence assessment, (7) facilitating access to medicine by service integration. For each intervention, experts assessed (a) target population, (b) health professionals potentially involved in the intervention, (c) strategies/instruments needed for implementation, and (d) time of the intervention. Interventions that target adherence must combine different approaches targeting the complex aspects of older adults in a holistic approach. Tackling non-adherence, with its complexity, requires a multi-stakeholder patient-centred approach acting in a defined framework of interactions in which the different players may provide different services but are integrated with one another.

Background. Deficits in the care of depression lead to poor medication adherence, which increases the risk of an unfavourable outcome for this care. This review evaluates effects on symptoms and medication adherence of case management in primary health care.Method. A systematic literature search was performed. The quality of the studies was rated according to the Cochrane Effective Practice and Organization of Care Group (EPOC) criteria. To conduct a subgroup analysis interventions were classified as either ‘standard’ or ‘complex’ case management.Results. Thirteen studies met the inclusion criteria. In a meta-analysis we calculated a standard mean difference/effect size on symptom severity after 6–12 months of −0·40 (95% CI −0·60 to –0·20). Patients in the intervention groups were more likely to achieve remission after 6–12 months [relative risk (RR) 1·39, 95% CI 1·30–1·48]. The relative risk for clinical response was 1·82 (95% CI 1·68–2·05). Patients in intervention groups had better medication adherence than the control group (RR 1·5, 95% CI 1·28–1·86). We found heterogeneous results when assessing effects of different types of intervention.Conclusions. We conclude that case management improves management of major depression in primary health-care settings.

Background: There is limited evidence about the impact of treatment for subclinical hypothyroidism, especially among older people. Aim: To investigate the variation in GP treatment strategies for older patients with subclinical hypothyroidism depending on country and patient characteristics. Design and setting: Case-based survey of GPs in the Netherlands, Germany, England, Ireland, Switzerland, and New Zealand. Method: The treatment strategy of GPs (treatment yes/no, starting-dose thyroxine) was assessed for eight cases presenting a woman with subclinical hypothyroidism. The cases differed in the patient characteristics of age (70 versus 85 years), vitality status (vital versus vulnerable), and thyroid-stimulating hormone (TSH) concentration (6 versus 15 mU/L). Results: A total of 526 GPs participated (the Netherlands n = 129, Germany n = 61, England n = 22, Ireland n = 21, Switzerland n = 262, New Zealand n = 31; overall response 19%). Across countries, differences in treatment strategy were observed. GPs from the Netherlands (mean treatment percentage 34%), England (40%), and New Zealand (39%) were less inclined to start treatment than GPs in Germany (73%), Ireland (62%), and Switzerland (52%) (P = 0.05). Overall, GPs were less inclined to start treatment in 85-year-old than in 70-year-old females (pooled odds ratio [OR] 0.74 [95% confidence interval [CI] = 0.63 to 0.87]). Females with a TSH of 15 mU/L were more likely to get treated than those with a TSH of 6 mU/L (pooled OR 9.49 [95% CI = 5.81 to 15.5]). Conclusion: GP treatment strategies of older people with subclinical hypothyroidism vary largely by country and patient characteristics. This variation underlines the need for a new generation of international guidelines based on the outcomes of randomised clinical trials set within primary care

Objectives: To develop a framework to identify and classify interactions within and among treatments and conditions and to test this framework with guidelines on chronic heart failure (CHF) and its frequent comorbidity.Study Design and Setting: Text analysis of evidence-based clinical practice guidelines on CHF and 18 conditions co-occurring in >= 5% of CHF patients (2-4 guidelines per disease). We extracted data on interactions between CHF and comorbidity and key recommendations on diagnostic and therapeutic management. From a subset of data, we derived 13 subcategories within disease-disease (Di-Di-I), disease-drug (Di-D-I), drug-drug interactions (DDI) and synergistic treatments. We classified the interactions and tested the interrater reliability, refined the framework, and agreed on the matrix of interactions.Results: We included 48 guidelines; two-thirds provided information about comorbidity. In total, we identified N = 247 interactions (on average, 14 per comorbidity): 68 were Di-Di-I, 115 were Di-D-I, 12 were DDI, and 52 were synergisms. All 18 comorbidities contributed at least one interaction.Conclusion: The interaction matrix provides a structure to present different types of interactions between an index disease and comorbidity. Guideline developers may consider the matrix to support clinical decision making in multimorbidity. Further research is needed to show its relevance to improve guidelines and health outcomes. (C) 2014 Elsevier Inc. All rights reserved.

Introduction Multimorbidity is a major concern in primary care. Nevertheless, evidence of prevalence and patterns of multimorbidity, and their determinants, are scarce. The aim of this study is to systematically review studies of the prevalence, patterns and determinants of multimorbidity in primary care. Methods Systematic review of literature published between 1961 and 2013 and indexed in Ovid (CINAHL, PsychINFO, Medline and Embase) and Web of Knowledge. Studies were selected according to eligibility criteria of addressing prevalence, determinants, and patterns of multimorbidity and using a pretested proforma in primary care. The quality and risk of bias were assessed using STROBE criteria. Two researchers assessed the eligibility of studies for inclusion (Kappa = 0.86). Results We identified 39 eligible publications describing studies that included a total of 70,057,611 patients in 12 countries. The number of health conditions analysed per study ranged from 5 to 335, with multimorbidity prevalence ranging from 12.9% to 95.1%. All studies observed a significant positive association between multimorbidity and age (odds ratio [OR], 1.26 to 227.46), and lower socioeconomic status (OR, 1.20 to 1.91). Positive associations with female gender and mental disorders were also observed. The most frequent patterns of multimorbidity included osteoarthritis together with cardiovascular and/or metabolic conditions. Conclusions Well-established determinants of multimorbidity include age, lower socioeconomic status and gender. The most prevalent conditions shape the patterns of multimorbidity. However, the limitations of the current evidence base means that further and better designed studies are needed to inform policy, research and clinical practice, with the goal of improving health-related quality of life for patients with multimorbidity. Standardization of the definition and assessment of multimorbidity is essential in order to better understand this phenomenon, and is a necessary immediate step.

Multimorbidity is a health issue mostly dealt with in primary care practice. As a result of their generalist and patient-centered approach, long-lasting relationships with patients, and responsibility for continuity and coordination of care, family physicians are particularly well placed to manage patients with multimorbidity. However, conflicts arising from the application of multiple disease oriented guidelines and the burden of diseases and treatments often make consultations challenging. To provide orientation in decision making in multimorbidity during primary care consultations, we developed guiding principles and named them after the Greek mythological figure Ariadne. For this purpose, we convened a two-day expert workshop accompanied by an international symposium in October 2012 in Frankfurt, Germany. Against the background of the current state of knowledge presented and discussed at the symposium, 19 experts from North America, Europe, and Australia identified the key issues of concern in the management of multimorbidity in primary care in panel and small group sessions and agreed upon making use of formal and informal consensus methods. The proposed preliminary principles were refined during a multistage feedback process and discussed using a case example. The sharing of realistic treatment goals by physicians and patients is at the core of the Ariadne principles. These result from i) a thorough interaction assessment of the patient’s conditions, treatments, constitution, and context; ii) the prioritization of health problems that take into account the patient’s preferences – his or her most and least desired outcomes; and iii) individualized management realizes the best options of care in diagnostics, treatment, and prevention to achieve the goals. Goal attainment is followed-up in accordance with a re-assessment in planned visits. The occurrence of new or changed conditions, such as an increase in severity, or a changed context may trigger the (re-)start of the process. Further work is needed on the implementation of the formulated principles, but they were recognized and appreciated as important by family physicians and primary care researchers. Please see related article: http://www.biomedcentral.com/1741-7015/12/222. Electronic supplementary material The online version of this article (doi:10.1186/s12916-014-0223-1) contains supplementary material, which is available to authorized users.

Older patients, suffering from numerous diseases and taking multiple medications are the rule rather than the exception in primary care. A manifold of medical conditions are often associated with poor outcomes, and their multiple medications raise additional risks of polypharmacy. Such patients account for most healthcare expenditures. Effective approaches are needed to manage such complex patients in primary care. This paper describes the results of a scoping exercise, including a two-day workshop with 17 professionals from six countries, experienced in general practice and primary care research as well as epidemiology, clinical pharmacology, gerontology and methodology. This was followed by a consensus process investigating the challenges and core questions for multimorbidity research in primary care from a clinical perspective and presents examples of the best research practice. Current approaches in measuring and clustering multimorbidity inform policy-makers and researchers, but research is needed to provide support in clinical decision making. Multimorbidity presents a complexity of conditions leading to individual patient's needs and demanding complex processes in clinical decision making. The identification of patterns presupposes the development of strategies on how to manage multimorbidity and polypharmacy. Interventions have to be complex and multifaceted, and their evaluation poses numerous methodological challenges in study design, outcome measurement and analysis. Overall, it can be seen that complexity is a main underlying theme. Moreover, flexible study designs, outcome parameters and evaluation strategies are needed to account for this complexity. © 2014 Informa Healthcare.

Introduction Most studies conducted at general practices investigate complex interventions and increasingly use cluster-randomised controlled trail (c-RCT) designs to do so. Our primary objective is to evaluate how frequently complex interventions are shown to be more, equally or less effective than routine care in c-RCTs with a superior design. The secondary aim is to discover whether the quality of a c-RCT determines the likelihood of the complex intervention being effective. Methods and analysis All c-RCTs of any design that have a patient-relevant primary outcome and with a duration of at least 1 year will be included. The search will be performed in three electronic databases (MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews (CDSR)). The screening process, data collection, quality assessment and statistical data analyses (if suitably similar and of adequate quality) will be performed in accordance with requirements of the Cochrane Handbook for Systematic Reviews of Interventions. A feasibility project was carried out that was restricted to a search in MEDLINE and the CCTR for c-RCTs published in 1 of the 8 journals that are most relevant to general practice. The process from trial selection to data collection, assessment and results presentation was piloted. Of the 512 abstracts identified during the feasibility search, 21 studies examined complex interventions in a general practice setting. Extrapolating the preliminary search to include all relevant c-RCTs in three databases, about 5000 abstracts and 150 primary studies are expected to be identified in the main study. 14 studies included in the feasibility project (67%) did not show a positive effect on a primary patient-relevant end point. Ethics and dissemination Ethical approval is not being sought for this review. Findings will be disseminated via peer-reviewed journals that frequently publish articles on the results of c-RCTs and through presentations at international conferences. Trial registration number PROSPERO CRD201400923.

Helt grundlæggende er der behov for at undersøge forløbene for kræftdiagnostik. Sådanne forløb bør beskrives efter præcise retningslinjer, så man har milepæle og tidsintervaller, der kan sammenlignes på tværs af studier, på tværs af grupper, og på tværs af forskellige sundhedsvæsener. Denne artikel afrapporterer et stort internationalt arbejde med at fastlægge procedurer for, hvorledes man måler tidsintervaller i forbindelse med kræftdiagnostik, og hvorledes de blev behandlet i videnskabelige undersøgelser. Samtidig vil disse definitioner kunne benyttes i monitoreringer i sundhedsvæsener. Early diagnosis is a key factor in improving the outcomes of cancer patients. A greater understanding of the pre-diagnostic patient pathways is vital yet, at present, research in this field lacks consistent definitions and methods. As a consequence much early diagnosis research is difficult to interpret. A consensus group was formed with the aim of producing guidance and a checklist for early cancer-diagnosis researchers. A consensus conference approach combined with nominal group techniques was used. The work was supported by a systematic review of early diagnosis literature, focussing on existing instruments used to measure time points and intervals in early cancer-diagnosis research. A series of recommendations for definitions and methodological approaches is presented. This is complemented by a checklist that early diagnosis researchers can use when designing and conducting studies in this field. The Aarhus checklist is a resource for early cancer-diagnosis research that should promote greater precision and transparency in both definitions and methods. Further work will examine whether the checklist can be readily adopted by researchers, and feedback on the guidance will be used in future updates.

Patients with chronic heart failure have complex care needs which can be addressed by case management interventions. Monitoring lists for heart failure were developed and tested as part of a trial evaluating primary care-based case management of patients with heart failure (HICMan).Design and characteristics of the monitoring lists used during the HICMan trial are described in order to evaluate technical feasibility and time expenditure. In a secondary analysis of data from the HICMan trial descriptive statistics were used.Two checklists were developed on the basis of evidence-based guidelines to regularly monitor heart failure patients by phone and home visits. These checklists contain questions about heart failure symptoms and signs (precursors) of clinical deterioration. Ninety-seven heart failure patients (64 NYHA class I/II, 33 NYHA class III) were monitored for 12 months. Eighteen critical incidents like acute angina pectoris or acute dyspnoea occurred during the study, two of them leading to immediate hospital admissions. Patients with NYHA class III had significantly more potentially clinically relevant incidents than patients with NYHA class I/II. Mean [SD, range] time expenditure for telephone monitoring was 10min [± 5min, 2 to 38min], for home visits 53min [± 13min, 18 to 90min]. Both monitoring lists appeared to be plausible and feasible tools for the primary care-based case management of heart failure patients.

Background Evidence-based guidelines have the potential to improve healthcare. However, their de-novo-development requires substantial resources – especially for complex conditions, and adaptation may be biased by contextually influenced recommendations in source guidelines. In this paper we describe a new approach to guideline development – the systematic guideline review method (SGR), and its application in the development of an evidence-based guideline for family physicians on chronic heart failure (CHF). Methods A systematic search for guidelines was carried out. Evidence-based guidelines on CHF management in adults in ambulatory care published in English or German between the years 2000 and 2004 were included. Guidelines on acute or right heart failure were excluded. Eligibility was assessed by two reviewers, methodological quality of selected guidelines was appraised using the AGREE instrument, and a framework of relevant clinical questions for diagnostics and treatment was derived. Data were extracted into evidence tables, systematically compared by means of a consistency analysis and synthesized in a preliminary draft. Most relevant primary sources were re-assessed to verify the cited evidence. Evidence and recommendations were summarized in a draft guideline. Results Of 16 included guidelines five were of good quality. A total of 35 recommendations were systematically compared: 25/35 were consistent, 9/35 inconsistent, and 1/35 un-rateable (derived from a single guideline). Of the 25 consistencies, 14 were based on consensus, seven on evidence and four differed in grading. Major inconsistencies were found in 3/9 of the inconsistent recommendations. We re-evaluated the evidence for 17 recommendations (evidence-based, differing evidence levels and minor inconsistencies) – the majority was congruent. Incongruity was found where the stated evidence could not be verified in the cited primary sources, or where the evaluation in the source guidelines focused on treatment benefits and underestimated the risks. The draft guideline was completed in 8.5 man-months. The main limitation to this study was the lack of a second reviewer. Conclusion The systematic guideline review including framework development, consistency analysis and validation is an effective, valid, and resource saving-approach to the development of evidence-based guidelines.

Although our example of the dilemma of prescribing β blockers in asthma was a little outmoded,1 2 recent summaries of products characteristics, including those for metoprolol, bisoprolol, propranolol, and nebivolol, state that these …

In Germany, primary healthcare for patients with chronic diseases needs to be improved. Taking the example of depression, congestive heart failure, diabetes and diseases of the musculoskeletal system we analyzed to which extent the 'Chronic Care Model' allows for improvements.Diagnosis-specific health assessment; adaptation of the 'Chronic Care Model' to the German healthcare system; peer reviewed discussions of the potentials for improving primary care of the chronically ill. RESULTS/DISCUSSION OF THE HEALTHCARE SITUATION: 1) Diagnosis and therapy of chronic diseases comply insufficiently with the evidence. 2) Patients are too passive and/or receive only little effective support. 3) Treatments are often uncoordinated and fragmented. 4) The follow-up of treatment results is often neglected. 5) Approaches to indicated diseases are promising.The'Chronic Care Model' could improve chronic care in Germany. Disease Management Programs (DMP) should amend multimorbidity and individual healthcare and/or facilitate implementation in general practice.

Chronic diseases and multimorbidity are becoming a fundamental challenge for primary care which already requires a very high input of resources. Due to their broad range and continuity, general practices play a major role, but are poorly prepared to succeed in the structured healthcare of chronically ill patients. The reality of care in everyday practice is primarily characterized by the 'tyranny of the urgent', and such a reaction to acute problems leads to noticeable deficits in permanent care. Part one of a two-part article series asks to what extent demographic changes and medical progress are responsible for this development. Meanwhile, a large quantity of empirical evidence indicates that results improve when case management is implemented for chronically ill patients. Though disease management programs are being increasingly established in Germany, many general practices are only poorly prepared for their tangible implementation in everyday routine. The comparison of two case studies shows how the primary care of chronically ill patients might look like in the future. On the basis of both scientific evidence and the globally acknowledged 'Chronic Care Model', part two of the article looks at sustainable strategies and special tools which allow for an adequate care of chronically ill patients in general practice.

Background Osteoarthritis (OA) has a high prevalence in primary care. Conservative, guideline orientated approaches aiming at improving pain treatment and increasing physical activity, have been proven to be effective in several contexts outside the primary care setting, as for instance the Arthritis Self management Programs (ASMPs). But it remains unclear if these comprehensive evidence based approaches can improve patients' quality of life if they are provided in a primary care setting. Methods/Design PraxArt is a cluster randomised controlled trial with GPs as the unit of randomisation. The aim of the study is to evaluate the impact of a comprehensive evidence based medical education of GPs on individual care and patients' quality of life. 75 GPs were randomised either to intervention group I or II or to a control group. Each GP will include 15 patients suffering from osteoarthritis according to the criteria of ACR. In intervention group I GPs will receive medical education and patient education leaflets including a physical exercise program. In intervention group II the same is provided, but in addition a practice nurse will be trained to monitor via monthly telephone calls adherence to GPs prescriptions and advices and ask about increasing pain and possible side effects of medication. In the control group no intervention will be applied at all. Main outcome measurement for patients' QoL is the GERMAN-AIMS2-SF questionnaire. In addition data about patients' satisfaction (using a modified EUROPEP-tool), medication, health care utilization, comorbidity, physical activity and depression (using PHQ-9) will be retrieved. Measurements (pre data collection) will take place in months I-III, starting in June 2005. Post data collection will be performed after 6 months. Discussion Despite the high prevalence and increasing incidence, comprehensive and evidence based treatment approaches for OA in a primary care setting are neither established nor evaluated in Germany. If the evaluation of the presented approach reveals a clear benefit it is planned to provide this GP-centred interventions on a much larger scale.

In 2002 the German "Curriculum Evidence-based Medicine" was made available by the Agency for Quality in Medicine and the German Network for Evidence-based Medicine. Its primary aim was to train practising medical doctors. We adapted the curriculum for participants of a postgraduate Master of Public Health course and a course for medical students. The two groups differ from the main target group regarding both their baseline knowledge and the objectives of their respective training courses. Here we report how the curriculum was adapted. The curriculum was adjusted in several ways: The postgraduate course focused on case studies with public health relevance. Beyond the obligatory modules, the focus was on training skills in searching and assessing secondary and tertiary evidence like systematic reviews or health technology assessments. In addition, the health policy context for evidence based medicine in Germany was analysed. In the course that aimed at medical students we included the module "Critical Appraisal of a Survey". At the beginning of each case study, the frequency and relevance of the health problems were elaborated. Apart from case studies on therapeutic interventions we also presented studies on diagnosis, prognosis and screening to demonstrate that evidence-based clinical decision making is feasible for the whole spectrum of questions arising from patient care. The curriculum proved to be adaptive to the needs of heterogeneous groups of participants. In this article we provide a detailed list of practical recommendations for courses for students of Public Health and Medicine.

BACKGROUND: Case management by health care assistants in small primary care practices provides unclear benefit for improving depression symptoms. OBJECTIVE: To determine whether case management provided by health care assistants in small primary care practices is more effective than usual care in improving depression symptoms and process of care for patients with major depression. DESIGN: Cluster randomized, controlled trial. A central automated system generated the randomization scheme, which was stratified by urban and rural practices; allocation sequence was concealed until groups were assigned. SETTING: 74 small primary care practices in Germany from April 2005 to September 2007. PATIENTS: 626 patients age 18 to 80 years with major depression. INTERVENTION: Structured telephone interview to monitor depression symptoms and support for adherence to medication, with feedback to the family physician. MEASUREMENTS: Depression symptoms at 12 months, as measured by the Patient Health Questionnaire-9 (PHQ-9); secondary outcomes were patient assessment of chronic illness care, adherence to medication, and quality of life. RESULTS: A total of 310 patients were randomly assigned to case management and 316 to usual care. At 12 months, 249 intervention recipients and 278 control patients were assessed; 555 patients were included in a modified intention-to-treat-analysis (267 intervention recipients vs. 288 control patients). Compared with control patients, intervention recipients had lower mean PHQ-9 values in depression symptoms (-1.41 [95% CI, -2.49 to -0.33]; P = 0.014), more favorable assessments of care (3.41 vs. 3.11; P = 0.011), and increased treatment adherence (2.70 vs. 2.53; P = 0.042). Quality-of-life scores did not differ between groups. LIMITATION: Patients, health care assistants, family physicians, and researchers were not blinded to group assignment, and 12-month follow-up of patients was incomplete. CONCLUSION: Case management provided by primary care practice-based health care assistants may reduce depression symptoms and improve process of care for patients with major depression more than usual care. PRIMARY FUNDING SOURCE: German Ministry of Education and Research.

Background Chronic congestive heart failure (CHF) is a complex disease with rising prevalence, compromised quality of life (QoL), unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP) can improve patients' QoL. Methods/Design HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific self-management, (non)pharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation). Patients from control group receive usual care by their GPs, who were introduced to guideline-oriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ), depression and anxiety disorders (PHQ-9, GAD-7), adherence (EHFScBS and SANA), quality of care measured by an adapted version of the Patient Chronic Illness Assessment of Care questionnaire (PACIC) and NT-proBNP. In addition, comprehensive clinical data are collected about health status, comorbidity, medication and health care utilisation. Discussion As the targeted patient group is mostly cared for and treated by GPs, a comprehensive primary care-based guideline implementation including somatic, psychosomatic and organisational aspects of the delivery of care (HICMAn) is a promising intervention applying proven strategies for optimal care. Trial registration Current Controlled Trials ISRCTN30822978.