Efficacy of a computer based discontinuation strategy to reduce PPI prescriptions: a multicenter cluster-randomized controlled trial.

Deprescribing of inappropriate long-term proton pump inhibitors (PPI) is challenging and there is a lack of useful methods for general practitioners to tackle this. The objective of this randomized controlled trial was to evaluate the effectiveness of the electronic decision aid tool arriba-PPI on reduction of long-term PPI intake. Participants (64.5 ± 12.9 years; 54.4% women) with a PPI intake of at least 6 months were randomized to receive either consultation with arriba-PPI from their general practitioner (n = 1256) or treatment as usual (n = 1131). PPI prescriptions were monitored 6 months before, 6 and 12 months after study initiation. In 49.2% of the consultations with arriba-PPI, the general practitioners and their patients made the decision to reduce or discontinue PPI intake. At 6 months, there was a significant reduction by 22.3% (95% CI 18.55 to 25.98; p < 0.0001) of defined daily doses (DDD) of PPI. A reduction of 3.3% (95% CI - 7.18 to + 0.62) was observed in the control group. At 12 months, the reduction of DDD-PPI remained stable in intervention patients (+ 3.5%, 95% CI - 0.99 to + 8.03), whereas control patients showed a reduction of DDD-PPI (- 10.2%, 95% CI - 6.01 to - 14.33). Consultation with arriba-PPI led to reduced prescription rates of PPI in primary care practices. Arriba-PPI can be a helpful tool for general practitioners to start a conversation with their patients about risks of long-term PPI intake, reduction or deprescribing unnecessary PPI medication.

[General Practitioners' Experiences with COVID-19: a Survey After the First Wave of the Pandemic in March/April 2020]. / Erfahrungen von HausärztInnen mit COVID-19 und der Pandemie ­ ein Survey nach der ersten Pandemiewelle im März/April 2020.

BACKGROUND AND OBJECTIVES: The first wave of the COVID-19 pandemic (Mar-Apr 2020) posed significant challenges for primary care. The goal of this study was to analyse the burden of the crisis situation as experienced by the general practitioners (GPs) at its beginning and over the course of the pandemic and to identify factors predictive of the sense of being overburdened. METHODS: In this cross-sectional study, a total of 6300 randomly selected GPs in four federal states of Germany were contacted per post in order to survey changes in health care they provided and their psychological burden in the context of the pandemic between August and October 2020. RESULTS: The response rate was 23%; 46% of the participants were female. At the beginning of the pandemic, 40% of the participants experienced a high or a very high level of being overburdened; later on, it was only 10%. With increasing numbers of COVID patients, the sense of being overburdened increased, as also their perceived capability to care for COVID patients. Predictors of a sense of being overburdened were, among others, a high level of psychological stress, excessive organising efforts, poor capability to care for COVID patients, and scarce supply of protective equipment. CONCLUSION: Despite a sense of being overburdened initially, GPs felt increasingly capable of caring for COVID patients. To help GPs in future crisis situations like this pandemic, organization of care should be simplified to the extent possible so that they can focus on patient care.

Patients' perspectives on a patient-oriented electronic decision support tool to reduce overuse of proton pump inhibitors (arriba-PPI): a qualitative study in primary care.

BACKGROUND: To evaluate patients' perspectives and their experiences with a consultation involving a computer-assisted and patient-centered discontinuation strategy (arriba-PPI tool) as part of a German multicenter study on reducing the prescription of proton pump inhibitors (PPIs). METHODS: Qualitative in-depth telephone interviews on proton pump inhibitors with patients who had received an arriba-PPI tool-based counseling by their general practitioner (GP). A random sample of 30 patients was taken from study participants. Interviews were conducted in 2020 and analyzed using a thematic qualitative text analysis. RESULTS: Although this was meant to be the key to shared decision making with regard to PPI reduction, study participants mostly did not recall the visual features of the tool. However, a few patients remembered them very clearly. Above all, patients appreciated a trustful relationship with the GP as well as comprehensive, individualized counseling. CONCLUSION: Application of the arriba-PPI tool can support the decision process but can also hinder the consultation process if the tool is not properly embedded in the consultation. GPs using the arriba-PPI tool to support the shared decision-making process should consider the patients' and their own expectations on the benefit of the visual representation of the tool.

[Mapping as an Iterative Visualization Process: Insights into Regional Care Structures in the SARS-CoV-2 Pandemic]. / Mapping als iterativer Visualisierungsprozess ­ Einblicke in regionale Versorgungsstrukturen in der SARS-CoV-2 Pandemie.

OBJECTIVE: Little is known about the cooperation of different health care providers during the pandemic. The aim of this study was to develop a graphically mediated, deeper understanding of the processes involved, using a novel expert-supported visualization method, by taking a definite region in Baden-Württemberg as an example. METHODS: The development of an overall picture ("mapping") of the pandemic situation in the Ulm/Alb-Donau district was based on the "Knowledge Visualization" method in several phases. First, semi-structured interviews were conducted with local players in the district of Ulm and the Alb-Donau. The visualized individual perspectives were then presented in a joint video conference. This was followed by a moderated discussion, with the aim to agree on common strategies for care in the pandemic. This process was documented with the help of a visulization expert ("Visionom") in the form of a professionally prepared overall picture ("mapping"). RESULTS: All players showed great motivation and appreciated getting to know the perspectives of other regional players. The iterative visualization was strongly activating and stimulated reflection processes. Personal responsibilities proved to be not always clear, communication problems were revealed. A wish to continue the initiated process was expressed. CONCLUSION: Iterative visualizations can initiate implications at the level of action, metastructures and authorities. We recommend this method also for other questions related to local or regional structures.

Suitability of accelerometry as an objective measure for upper extremity use in stroke patients.

BACKGROUND: Upper limb (UL) paresis is one of the most common stroke consequences and significantly restricts patients in everyday life. Instruments objectively measuring direct arm use in stroke patients are lacking, but might be helpful to understand patients' impairment. Aiming to examine whether accelerometry is a suitable objective measure for everyday UL use in stroke patients, we conducted a systematic review on the association between accelerometer-derived measurements and clinical scales. METHODS: Articles were systematically searched in PubMed, Scopus, Cochrane Library, PeDro and LIVIVO through December 12th, 2021, screened for inclusion by AH, and subsequently independently screened by CK and MK. Disagreements were discussed until consensus. We included English and German peer-reviewed articles dealing with the validity of accelerometers as a measurement of UL use in stroke patients and eligible systematic reviews. Studies exclusively using accelerometry as an outcome parameter, book contributions, conference abstracts and case studies were excluded. Data extraction was conducted by AH and confirmed by CK focussing on study type, objective, accelerometer device, sample size, stroke status, assessments conducted, measurement method, wearing time and key results. We analysed all eligible articles regarding the correlation between accelerometry and other clinical assessments and the validity in accordance with the type of accelerometer. RESULTS: Excluding duplicates, the initial search yielded 477 records. In the 34 eligible studies accelerometers was used with a predominance of tri-axial accelerometery (n = 12) and only few with two-axial application (n = 4). Regarding measures to examine association to accelerometer data different clinical scales were applied depending on the setting, the degree of impairment and/or the status of stroke. Cut-off values to determine correlations varied largely; most significant correlations are reported for the MAL [Range 0.31- 0.84] and the ARAT [Range 0.15-0.79]. CONCLUSIONS: Accelerometers can provide reliable data about daily arm use frequency but do not supply information about the movements´ quality and restrictions on everyday activities of stroke patients. Depending on the context, it is advisable to use both, accelerometry and other clinical measures. According to the literature there is currently no accelerometer device most suitable to measure UL activity. High correlations indicate that multi-dimensional accelerometers should be preferred.

Evaluation of the German Version of the Adult Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5 as a Screening Tool for Adult Attention-Deficit/Hyperactivity Disorder in Primary Care.

Adult attention-deficit/hyperactivity disorder (ADHD) is common, but often undiagnosed. A valid and time-efficient screening tool for primary care is needed. Objective of this study is to evaluate the German version of the Adult ADHD Self-Report Scale for DSM-5 (ASRS-5) and its feasibility, acceptability, and reliability as a screening tool for adult ADHD in primary care. A multi-centered prospective, diagnostic study was performed. We recruited 262 patients in primary care practices and at an ADHD Outpatient Service of a department of psychiatry in Germany. Patients from 18 to 65 years with suspected or diagnosed ADHD were included by medical doctors, as well as non-ADHD patients as "negative controls." Participants filled in the ASRS-5 and a sociodemographic questionnaire. The Integrated Diagnosis of Adult ADHD, revised version (IDA-R) performed by trained interviewers was used for validation. Feasibility, acceptability, and credibility in primary care practices were examined through a semi-structured interview. The German version of the ASRS-5 showed comparable psychometric properties to the English original version (sensitivity 95.6% and specificity 72.3%). For factor structure, a parallel analysis suggested one latent dimension. Performing confirmatory factor analysis, the best fit was achieved for a general factor with one correlated error. Internal consistency results in Raykovs Omega = 0.86 and Cronbach's α = 0.88. The ASRS-5 was assessed positively in terms of feasibility, acceptability, and credibility by interviewed general practitioners. Potential problems were raised for "treatment options," "stigmatization," and "knowledge gaps." In conclusion, the German version of the ASRS-5 offers a promising tool to improve adult ADHD patients' diagnosis and healthcare.

Early or Delayed Onset of Food Intake in Time-Restricted Eating: Associations with Markers of Obesity in a Secondary Analysis of Two Pilot Studies.

Time-restricted eating (TRE) has rapidly gained interest in the public and the scientific community. One presumed mechanism of action is the adaptation of the eating-fasting rhythm to the evolutionary circadian rhythm of the metabolism. Study results regarding the suggestion that earlier beginning of food intake leads to better outcomes are heterogeneous. We conducted a secondary analysis of pooled data from two pilot studies on TRE to examine an association between the timing of onset of food intake with obesity-related outcomes. Participants (n = 99, 83 females aged 49.9 ± 10.8 years) were asked to restrict their daily eating to 8-9 h for three months. Tertiles of the onset of food intake were assessed for changes in anthropometry, blood lipid levels, and health-related quality of life. We detected no significant differences in outcomes between early (before 9:47), medium (9:47-10:50), and late onset (after 10:50) of food intake. However, the duration of the eating period was longest in the group with the earliest (8.6 ± 1.0 h) and shortest in the group with the latest onset (7.5 ± 0.8 h). Subsequently, fasting duration was longest in the last group (16.5 h). This may have compromised the results. More research is needed in this area to address this question.

[The Logic Model - a rationale for an encompassing evaluation framework of the German Competence Centers for Postgraduate Medical Education in general practice]. / Das Logische Modell als Grundlage für ein strukturiertes Konzept der Evaluation und Qualitätssicherung der Kompetenzzentren Weiterbildung Allgemeinmedizin.

BACKGROUND: The Competence Centers for Postgraduate Medical Education (KW) established throughout Germany represent complex programs to increase the efficiency and quality of postgraduate medical education in general practice. So-called Logic Models serve as the framework for evaluations and quality management processes of complex programs in many areas. The aim of this article is to develop such a model, using the example of the Competence Center in Baden-Württemberg (KWBW) in order to structure its complex program logic and use it as a framework for future evaluations and quality management processes. METHODS: The adaptation of the Logic Model to the KWBW took place in an informal, nominal group process with employees and participants of the program. RESULTS: We identified 76 core elements of the KWBW. These core elements were classified in one of the five pillars of the Logic Model (input, activity, output, outcome and impact) and categorized according to fields of action and target groups. DISCUSSION: The Logic Model, which was developed using the KWBW as an example, identifies and structures important core elements of a complex postgraduate medical training program for the first time. It seems to be well suited for visualizing the internal logic of this complex program and the interaction of the various elements within the KWBW. It can thus be used as the basis for a comprehensive and systematic evaluation concept and for quality assurance. CONCLUSION: The model is also a prerequisite for comparative research questions of other university programs for postgraduate medical education and thus offers an opportunity for cooperative development efforts. This article therefore contributes to promoting quality in continuing medical training.

Mixed-methods approach to develop an agreed concept on patient relevance: study protocol for the 'PRO patients study'.

INTRODUCTION: With respect to patient-centred care and shared decision-making, measuring care effects based on outcomes relevant to patients is becoming increasingly important. Recently, a scoping review of the international literature revealed a wide range of supposedly patient-relevant outcomes and found that there is neither a sound definition of patient relevance nor a consistent set of outcomes relevant to patients. To close this gap, this study aims to develop an agreed concept on patient relevance including a set of outcomes relevant to patients irrespective of diseases, which grades outcomes according to their importance. METHODS AND ANALYSIS: This prospective mixed-methods study will integrate the perspectives of patients across diseases, healthcare professionals and researchers. The consensus process will consist of four phases. Based on the results of the recent scoping review, a patient survey will be conducted first, followed by a multiprofessional group discussion. Finally, a two-round online Delphi approach based on data from the previous phases will be applied to agree on a concept. ETHICS AND DISSEMINATION: Ethics approval for the study was granted on 26 August 2020 by the Ethics Commission of Witten/Herdecke University (reference number: 156/2020). In the long run, the implementation of an agreed concept on patient relevance will help improve the comparability of study results regarding the patient benefit and thereby strengthen the role of patients in the decision-making process. Also, the experiences regarding grading outcomes according to importance will help to develop a method on how to individualise clinical trial outcomes according to each patient's individual specifics and priorities in order to more adequately represent the patient perspective in clinical research. TRIAL REGISTRATION NUMBER: Core Outcome Measures in Effectiveness Trials Initiative (registration number: 1685).

Opportunities and challenges of e-learning in vocational training in General Practice - a project report about implementing digital formats in the KWBW-Verbundweiterbildungplus.

Background: The task of the Competence Centers for vocational training (KW) is to increase the attractiveness and quality of vocational (=post-graduate) training in general practice. For this purpose, they offer, among other things, a structured seminar program for post-graduate trainees in general practice (GP-trainees). During the Covid-19 pandemic the seminar program of the KWBW-Verbundweiterbildungplus® in Baden-Württemberg was converted to digital formats. The goal of the paper is to evaluate the acceptance by the GP-trainees and lecturers, to describe experiences with the conversion to e-learning and to derive recommendations with regard to the future orientation of seminar programs in post-graduate as well as continuing medical education. The implementation was based on a modified Kern-cycle and aimed at offering eight teaching units of 45 minutes each to a large number of GP-trainees. It tried to maintain the high quality of content and education as well as the interactive character of the previous seminars. For this purpose, the events were designed as synchronous webinars (six units) with asynchronous preparation and post-processing (two units) according to the flipped classroom method. The evaluation by the participating GP-trainees and lecturers was performed online using a multi-center developed and pre-piloted questionnaire. Results and discussion: N=101 GP-trainees participated in the evaluation of five individual seminar days in the second quarter of 2020 (response rate 97%). 58% (N=59) of the trainees were satisfied or very satisfied with the implementation. 82% (n=83) rated pre-tasks as helpful. 99% (n=100) would participate in an online seminar again. For 52% (n=53) of the trainees, the attitude towards e-learning had changed positively. The main advantages mentioned were no travel, save in time and costs as well as increased flexibility. The main disadvantages mentioned were less personal interaction and technical obstacles. The high acceptance of the new digital format showed the fundamental potential of e-learning in continuing medical education. The experiences can be a source of inspiration for other departments and KW. However, it also shows that important goals of KW, such as the personal interaction of the peer group, could not be achieved. In the future, it is important to develop a suitable mix of presence and digital formats with the aim to improve the attractiveness as well as sustainability of continuing medical education.

Patient-relevant outcomes: what are we talking about? A scoping review to improve conceptual clarity.

BACKGROUND: With respect to patient-centered care, measuring care effects based on patient-relevant outcomes is becoming increasingly important. There is some uncertainty about what outcomes are particularly relevant to patients and who determines their relevance. To determine this, we conducted a scoping review of the international literature with the aim to improve the conceptual clarity regarding (1) the terminology used for supposedly patient-relevant outcomes, (2) the variety of outcomes considered patient-relevant, and (3) justifications for the choice of these specific outcomes. METHODS: We conducted a systematic search in Embase, PubMed (including Medline), Cochrane Central, Scopus, and Google Scholar with a special focus on article titles. Search terms included patient-relevant, patient-important, patient-preferred, and outcome(s), endpoint(s), parameter(s), indicator(s). We limited the search period from January 2000 to July 2019. Full-text articles reporting outcomes that were described as patient-relevant met the inclusion criteria. Two researchers independently analyzed all eligible articles applying quantitative and structuring content analysis. RESULTS: We identified 155 articles, 44 of which met the inclusion criteria. A content analysis revealed 35 different terms used with regard to patient-relevant outcomes. However, authors predominantly referred to patient-important outcomes (23 articles, 52.3%) and patient-relevant outcomes (17 articles, 38.6%). A structuring content analysis of all extracted outcomes revealed a total of 281 codes, pooled in 32 inductive categories. Among these, the following categories dominated: symptoms, adverse events/complications, survival/mortality, pain. In just 16 of the articles (36.4%), authors provided justifications for the choice of the outcome being based either on patient and/or expert opinions. In another 13 articles (29.5%), no justification was provided. CONCLUSION: This scoping review on patient-relevant outcomes was driven by the questions (1) what outcomes are particularly relevant to patients, and (2) who determines their relevance. We found a wide range of supposedly patient-relevant outcomes, with only one third of articles involving patients in the justification of the outcome selection. In view of this conceptual uncertainty it appears difficult to determine or even to compare a particular patient benefit of interventions. A set of generic outcomes relevant to patients would be helpful to contribute to a consistent understanding of patient relevance.

To what extent does therapy of chronic stroke patients address participation? A content analysis of ambulatory physical and occupational therapy based on the International Classification of Functioning, Disability, and Health framework.

Purpose: The study aim was to analyze whether ambulatory therapy of chronic stroke patients contains elements that specifically address "Activity and participation", and to what extent participation as a major goal in rehabilitation is realized in ambulatory care.Method: Qualitative and quantitative content analysis of standard therapy of 71 chronic stroke patients with upper limb impairment. 469 statements on therapy of 34 therapists were analyzed using data-driven and concept-driven coding based on the International Classification of Functioning, Disability and Health framework.Results: Almost half of therapy provided to stroke patients was related to "Upper extremity" (47.5%), as one out of seven identified main categories. Regarding International Classification of Functioning, Disability, and Health framework, 75.1% of therapeutic practices in ambulatory therapy covered "Body functions," but only 13.2% addressed "Activities and participation". Some statements contained specific therapeutic concepts (9.4%) or isolated notes (2.1%) and were not linkable to the International Classification of Functioning, Disability and Health framework.Conclusions: Ambulatory therapy of chronic stroke patients is related, in part, to participation. There is potential for an increase in participation by applying therapeutic approaches, which actively involve the patients in goal-setting and therapeutic exercises to specifically address activities and participation.Implications for rehabilitationTo realize participation as a major goal in the rehabilitation process ambulatory therapy of chronic stroke patients, one should focus on therapeutic approaches and exercises that specifically address activities and participation.Structured goal-setting, which actively involve patients, can be used to identify goals relevant to individual activities and participation.

Reduction of the long-term use of proton pump inhibitors by a patient-oriented electronic decision support tool (arriba-PPI): study protocol for a randomized controlled trial.

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.

Stroke patients' and non-professional coaches' experiences with home-based constraint-induced movement therapy: a qualitative study.

OBJECTIVE: To investigate the experiences of chronic stroke patients and non-professional coaches with home-based constraint-induced movement therapy (homeCIMT). DESIGN: Qualitative study embedded within a cluster randomized controlled trial investigating the efficacy of homeCIMT to improve the use of the affected arm in daily activities. SETTING: Patients' home environment. PARTICIPANTS: 13 stroke patients and 9 non-professional coaches' alias family members who had completed the four-week homeCIMT programme in the context of the HOMECIMT trial. INTERVENTIONS: Semi-structured interviews; qualitative data were analysed using the methodology of the hermeneutic phenomenological data analysis. RESULTS: We identified six themes in the qualitative analysis describing the experiences of patients and non-professional coaches with homeCIMT: (1) homeCIMT can be integrated into everyday life with varying degrees of success; (2) training together may produce positive experiences as well as strain; (3) self-perceived improvements during and following homeCIMT; (4) using the affected arm in everyday life is challenging; (5) subjective evaluation of and experiences with homeCIMT-specific exercises; and (6) impact of professional therapists' guidance and motivation during homeCIMT. Statements regarding theme five and six were only provided by patients, whereas the other themes contain both, the experiences of stroke patients and non-professional coaches. CONCLUSION: Patients' and non-professional coaches' narratives offer a detailed insight into the manifold experiences with the practical implementation of homeCIMT that may help improve implementing the homeCIMT programme and similar approaches involving increased training duration and intensity and/or involvement of family members.

The German version of the Functional Walking Categories (FWC): translation and initial validation.

BACKGROUND: Community ambulation is often affected after a stroke. However, no validated assessment in German to measure community ambulation on a participation level exists. OBJECTIVES: The purpose was to translate and cross-culturally adapt the Functional Walking Categories (FWC) into German and to assess its validity and reliability in patients with stroke. METHODS: Cross-cultural adaptation guidelines were used for translation. Face and content validity were established with the aid of an expert committee. A pilot study with patients after stroke in a neurological rehabilitation setting checked for concurrent validity using Kendall's tau and reliability using intraclass correlation coefficients. RESULTS: The results indicated that the German version of the FWC has adequate face and content validity. A total of 30 patients (mean age 62 ± 12.315 years, 56.7% female) participated in the study. The FWC correlated well with the Functional Ambulation Categories (tau-b = 0.783), cadence (tau-b = 0.640), gait velocity (tau-b = 0.628), the comfortable 10-m timed walk (tau-b = -0.629), and the fast 10-m timed walk (tau-b = -0.634). Moderate correlations were found between the FWC and step length (tau-b = 0.483) and the Timed Up and Go (tau-b = -0.520), respectively. Intrarater reliability was moderate (ICC = 0.651) while interrater reliability was excellent (ICC = 0.751) (all correlations p < 0.001). However, the study was designed as pilot study, thus, full psychometric property testing was not possible. CONCLUSIONS: The German FWC offers a reasonable tool for measuring community ambulation on participation level. However, a user manual seems to be helpful.

Protection against the overuse and underuse of health care - methodological considerations for establishing prioritization criteria and recommendations in general practice.

BACKGROUND: Initiatives such as "Choosing Wisely" in the USA and "Smarter Medicine" in Switzerland have published lists of widely overused health care services. The German initiative "Choosing Wisely Together (Gemeinsam Klug Entscheiden)" follows this example. The goal of our study was to prioritize important recommendations against the overuse and underuse of health care services. The final list of recommendations will be published in the German guideline "Protection against the overuse and underuse of health care". METHODS: First, a multidisciplinary expert panel established a catalogue of prioritization criteria. Second, we extracted all the recommendations from evidence- and consensus-based German College of General Practice and Family Medicine (DEGAM) guidelines and National Health Care Guidelines (NVL). Third, the recommendations were rated by two independent panels (general practitioners and other health care professionals involved/not involved in guideline development). The prioritization process was finalized in a consensus conference held by DEGAM's Standing Guideline Committee (SLK). RESULTS: Eleven prioritization criteria were established. A total of 782 recommendations were extracted and rated by 98 physicians and other health care professionals in a survey. In the voting process, more than 80% of the recommendations were eliminated. After the final consensus conference, twelve recommendations from DEGAM guidelines, nine DEGAM addenda and 17 NVL recommendations were chosen for inclusion in the guideline, for a total of 38 recommendations. CONCLUSION: The selection procedure proved helpful in identifying the highest priority recommendations with which to combat the overuse and underuse of health care services. To date, in Germany there has been no attempt to compile such a list by using a systematic and transparent methodology. Hence, the guideline that results from this process can fill an important gap.

Home-based constraint-induced movement therapy for patients with upper limb dysfunction after stroke (HOMECIMT): a cluster-randomised, controlled trial.

BACKGROUND: Constraint-induced movement therapy (CIMT) is recommended for patients with upper limb dysfunction after stroke, yet evidence to support the implementation of CIMT in ambulatory care is insufficient. We assessed the efficacy of home CIMT, a modified form of CIMT that trains arm use in daily activities within the home environment. METHODS: In this parallel, cluster-randomised controlled trial, we selected 71 therapy practices in northern Germany that treat adult patients with upper limb dysfunction after stroke. Practices were stratified by region and randomly allocated by an external biometrician (1:1, block size of four) using a computer-generated sequence. 37 practices were randomly assigned to provide 4 weeks of home CIMT and 34 practices to provide 4 weeks of standard therapy. Eligible patients had mild to moderate impairment of arm function at least 6 months after stroke and a friend or family member willing to participate as a non-professional coach. Patients of both groups received 5 h of professional therapist contact in 4 weeks. In the home CIMT group, therapists used the contact time to instruct and supervise patients and coaches in home CIMT. Patients in the standard therapy group received conventional physical or occupational therapy, but additional home training was not obligatory. All assessments were done by masked outcome assessors at baseline, after 4 weeks of intervention, and at 6 month follow-up. The primary outcomes were quality of movement, assessed by the Motor Activity Log (MAL-QOM, assessor-assisted self-reported), and performance time, assessed by the Wolf Motor Function Test (WMFT-PT, assessor-reported). Primary outcomes were tested hierarchically after 4 weeks of intervention and analysed by intention to treat, using mixed linear models. This trial is registered with ClinicalTrials.gov, NCT01343602. FINDINGS: Between July 11, 2011, and June 4, 2013, 85 of 156 enrolled patients were assigned home CIMT and 71 patients were assigned standard therapy. 82 (96%) patients in the home CIMT group and 71 (100%) patients in the standard therapy group completed treatment and were assessed at 4 weeks. Patients in both groups improved in quality of movement (MAL-QOM; change from baseline 0·56, 95% CI 0·41-0·71, p<0·0001 for home CIMT vs 0·31, 0·15-0·46, p=0·0003 for standard therapy). Patients in the home CIMT group improved more than patients in the standard therapy group (between-group difference 0·26, 95% CI 0·05-0·46; p=0·0156). Both groups also improved in motor function performance time (WMFT-PT; change from baseline -25·60%, 95% CI -36·75 to -12·49, p=0·0006 for home CIMT vs -27·52%, -38·94 to -13·94, p=0·0004 for standard therapy), but the extent of improvement did not differ between groups (2·65%, -17·94 to 28·40; p=0·8152). Nine adverse events (of which six were serious) were reported in the home CIMT group and ten (of which seven were serious) in the standard therapy group; however, none was deemed related to the study intervention. INTERPRETATION: Home-based CIMT can enhance the perceived use of the stroke-affected arm in daily activities more effectively than conventional therapy, but was not superior with respect to motor function. Further research is needed to confirm whether home CIMT leads to clinically significant improvements and if so to identify patients that are most likely to benefit. FUNDING: German Federal Ministry of Education and Research.

Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial.

BACKGROUND: Stroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified 'constraint-induced movement therapy (CIMT) at home') with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. 'CIMT at home' will be compared with conventional physical and occupational therapy ('therapy as usual'). METHODS/DESIGN: The study is a parallel cluster randomized controlled trial with therapy practices as clusters (n = 48). After written consent from the patients (n = 144), the therapists will be randomly assigned to treat either the intervention or the control group. Blinded external assessors will evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are the motor activity log (quality of arm and hand use) and the Wolf motor function test (arm and hand function). These assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes will be analyzed with mixed models, which consider the hierarchical structure of the data and will be adjusted to the baseline measurements and sex. The primary analysis will be the comparison of the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints will be tested at the significance level of 5% each in hierarchical order. DISCUSSION: A modification of the CIMT, feasible in the patients' homes (CIMT at home), appears to be a promising therapeutic approach in the ambulatory care of chronic stroke patients. With proven efficacy and practicality, a participation-oriented, stroke-specific treatment would be available in primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01343602.

Can a brief two-hour interdisciplinary communication skills training be successful in undergraduate medical education?

OBJECTIVE: To pilot-test feasibility, acceptance and learning-outcomes of a brief interdisciplinary communication skills training program in undergraduate medical education. METHODS: A two-hour interdisciplinary communication skills program with simulated patients was developed and pilot-tested with clinical students at Hamburg University. Five psychosocial specialties facilitated the training. Composite effects were measured qualitatively and quantitatively. RESULTS: Eighty students volunteered to participate in the pilot-program (intervention-group). Their evaluations of the program were very positive (1.1 on a six-point scale). Benefits were seen in feedback, increase of self-confidence, cross-disciplinary clinical and communication experience. Students who did not volunteer (n=206) served as the control-group. The intervention-group performed significantly better (p=0.023) in a primary care communication examination and female students performed better than males. Clinical teachers evaluated the pilot-training very positively with regard to learning-outcomes and feasibility. The positive results from the pilot-training led to implementation into the regular curriculum. CONCLUSIONS: A two-hour interdisciplinary communication skills training program is beneficial for medical students with regard to communication competencies, self-confidence and learning-outcomes. PRACTICE IMPLICATION: The training is feasible within given time-frames and limited staff resources. The high teaching load for small-group-training are split between five specialties. The concept might be an interesting option for other faculties.