Effects of task shifting from primary care physicians to nurses: a protocol for an overview of systematic reviews.

INTRODUCTION: Task-shifting from primary care physicians (PCPs) to nurses is one option to better and more efficiently meet the needs of the population in primary care and to overcome PCP shortages. This protocol outlines an overview of systematic reviews to assess the effects of delegation or substitution by nurses of PCPs' activities regarding clinical, patient-relevant, professional and health services-related outcomes. METHODS AND ANALYSIS: We will conduct a systematic literature search for secondary literature in PubMed/MEDLINE, EMBASE, CINAHL and Cochrane databases. Systematic reviews, meta-analyses and Health Technology Assessments in German and English comprising randomised controlled trials and prospective controlled trials will be considered for inclusion. Search terms will include Medical Subject Headings combined with free text words. At least one-third of abstracts and full-text articles are reviewed by two independent reviewers. Methodological quality will be assessed using the Overview Quality Assessment Questionnaire. We will only consider reviews if they include controlled trials, if the profession that substituted or delegated tasks was a nurse, if the profession of the control was a PCP, if the assessed intervention was the same in the intervention and control group and if the Overview Quality Assessment Questionnaire score is ≥5. The corrected covered area will be calculated to describe the degree of overlap of studies in the reviews included in the study. We will report the overview according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. ETHICS AND DISSEMINATION: The overview of secondary literature does not require the approval of an Ethics Committee and will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42020183327.

MAPPinfo - mapping quality of health information: Validation study of an assessment instrument.

BACKGROUND: Health information is a prerequisite for informed choices-decisions, made by individuals about their own health based on knowledge and in congruence with own preferences. Criteria for development, content and design have been defined in a corresponding guideline. However, no instruments exist that provide reasonably operationalised measurement items. Therefore, we drafted the checklist, MAPPinfo, addressing the existing criteria with 19 items. OBJECTIVES: The current study aimed to validate MAPPinfo. METHODS: Five substudies were conducted subsequently at the Martin Luther University Halle-Wittenberg, Germany and the Medical University of Graz, Austria: (1) to determine content validity through expert reviews of the first draft, (2) to determine feasibility using 'think aloud' in piloting with untrained users, (3) to determine inter-rater reliability and criterion validity through a pretest on 50 health information materials, (4) to determine construct validity using 50 developers' self-declarations about development methods as a reference standard, (5) to determine divergent validity in comparison with the Ensuring Quality Information for Patients (EQIP) (expanded) Scale. The analyses used were qualitative methods and correlation-based methods for determining both inter-rater reliability and validity. RESULTS: The instrument was considered by experts to operationalise the existing guidelines convincingly. Health and nursing science students found it easy to understand and use. It also had good interrater reliability (mean of T coefficients = .79) and provided a very good estimate of the reference standard (Spearman's rho = .89), implying sound construct validity. Finally, comparison with the EQIP instrument revealed important and distinct areas of similarities and differences. CONCLUSIONS: The new instrument is ready for use as a screening instrument without the need for training. According to its underpinning concept the instrument exclusively comprises items which are justified by either ethics or research evidence, implying negligence of not yet evidence based, however, potentially important criteria. Further research is needed to complete the body of evidence-based criteria, aiming at an extension of the guideline and MAPPinfo. TRIAL REGISTRATION NUMBER: AsPredicted22546; date of registration: 24 July 2019.

MAPPinfo, mapping quality of health information: study protocol for a validation study of an assessment instrument.

INTRODUCTION: Health information is a prerequisite of informed decision-making. Criteria for development, content and presentation have recently been published in a corresponding guideline. Within a systematic search, 27 relevant checklists were identified, none of them, however, complying with the guideline or providing reasonably operationalised measurement items. Therefore, a draft of a checklist with 19 criteria was drafted. The current study aims at developing and validating this measure of quality. METHODS AND ANALYSIS: The validation design consists of five single studies to be conducted at the University of Halle-Wittenberg/Germany and Graz/Austria. (1) Achieving content validity through expert reviews of the first draft, (2) achieving feasibility using 'think aloud' in piloting with untrained users, (3) pretesting the instrument applied to health information materials without use of secondary sources: determining inter-rater reliability and criterion validity, (4) determining construct validity using information on proceedings and methods in the development process provided by the developers and (5) determining divergent validity in comparison with the Ensuring Quality Information for Patients (EQUIP) (expanded) Scale. The substudies will use varying samples of experts, students and developers and will apply the instrument to materials of various domains. Sample sizes will be adjusted to the particular research designs and questions. Analyses will employ qualitative methods, such as content analyses and discourse within the expert panel, and correlation-based methods both for determining inter-rater reliability and validity. ETHICS AND DISSEMINATION: The project is approved by the ethics committee of the Martin Luther University Halle-Wittenberg (approval number: 2019 115). Results will be published, and the instrument made accessible on public health platforms. It is meant to become a certification standard. MAPPinfo can be used as a screening instrument without training or secondary sources. Although developed in the German language, the instrument will be applicable also in other languages. TRIAL REGISTRATION NUMBER: AsPredected22546; date of registration: 24 July 2019. PROTOCOL VERSION: July 2020.

Cost-effectiveness analysis of case management for optimized antithrombotic treatment in German general practices compared to usual care - results from the PICANT trial.

BACKGROUND: By performing case management, general practitioners and health care assistants can provide additional benefits to their chronically ill patients. However, the economic effects of such case management interventions often remain unclear although how to manage the burden of chronic disease is a key question for policy-makers. This analysis aimed to compare the cost-effectiveness of 24 months of primary care case management for patients with a long-term indication for oral anticoagulation therapy with usual care. METHODS: This analysis is part of the cluster-randomized controlled Primary Care Management for Optimized Antithrombotic Treatment (PICANT) trial. A sample of 680 patients with German statutory health insurance was initially considered for the cost analysis (92% of all participants at baseline). Costs included all disease-related direct health care costs from the payer's perspective (German statutory health insurers) plus case management costs for the intervention group. A-Quality Adjusted Life Year (QALY) measurement (EQ-5D-3 L instrument) was used to evaluate utility, and incremental cost-effectiveness ratio (ICER) to assess cost-effectiveness. Mean differences were calculated and displayed with 95%-confidence intervals (CI) from non-parametric bootstrapping (1000 replicates). RESULTS: N = 505 patients (505/680, 74%) were included in the cost analysis (complete case analysis with a follow-up after 12 and 24 months as well as information on cost and QALY). After two years, the mean difference of direct health care costs per patient (€115, 95% CI [- 201; 406]) and QALYs (0.03, 95% CI [- 0.04; 0.11]) in the two groups was small and not significant. The costs of case management in the intervention group caused mean total costs per patient in this group to rise significantly (mean difference €503, 95% CI [188; 794]). The ICER was €16,767 per QALY. Regardless of the willingness of insurers to pay per QALY, the probability of the intervention being cost-effective never rose above 70%. CONCLUSIONS: A primary care case management for patients with a long-term indication for oral anticoagulation therapy improved QALYs compared to usual care, but was more costly. However, the results may help professionals and policy-makers allocate scarce health care resources in such a way that the overall quality of care is improved at moderate costs, particularly for chronically ill patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41847489 .

Chronic heart failure patients' experiences of German healthcare services: a protocol for a scoping review.

INTRODUCTION: Chronic heart failure (CHF) is a heterogeneous condition requiring complex treatment from diverse healthcare services. An increasingly holistic understanding of healthcare has resulted in contextual factors such as perceived quality of care, as well as patients' acceptance, preferences and subjective expectations of health services, all gaining in importance. How patients with CHF experience the use of healthcare services has not been studied within the scope of a systematic review in a German healthcare context. The aim of this scoping review is therefore to review systematically the experiences of patients affected by CHF with healthcare services in Germany in the literature and to map the research foci. Further objectives are to identify gaps in evidence, develop further research questions and to inform decision makers concerned with improving healthcare of patients living with CHF. METHODS AND ANALYSIS: This scoping review will be based on a broad search strategy involving systematic and comprehensive electronic database searches in MEDLINE, EMBASE, PsycINFO, PSYNDEX, CINAHL and Cochrane's Database of Systematic Reviews, grey literature searches, as well as hand searches through reference lists and non-indexed key journals. The methodological procedure will be based on an established six-stage framework for conducting scoping reviews that includes two independent reviewers. Data will be systematically extracted, qualitatively and quantitatively analysed and summarised both narratively and visually. To ensure the research questions and extracted information are meaningful, a patient representative will be involved. ETHICS AND DISSEMINATION: Ethical approval will not be required to conduct this review. Results will be disseminated through a clearly illustrated report that will be part of a wider research project. Furthermore, it is intended that the review's findings should be made available to relevant stakeholders through conference presentations and publication in peer-reviewed journals (knowledge transfer). Protocol registration in PROSPERO is not applicable for scoping reviews.

Choosing Wisely: assessment of current US top five list recommendations' trustworthiness using a pragmatic approach.

OBJECTIVES: Identification of sufficiently trustworthy top 5 list recommendations from the US Choosing Wisely campaign. SETTING: Not applicable. PARTICIPANTS: All top 5 list recommendations available from the American Board of Internal Medicine Foundation website. MAIN OUTCOME MEASURES/INTERVENTIONS: Compilation of US top 5 lists and search for current German highly trustworthy (S3) guidelines. Extraction of guideline recommendations, including grade of recommendation (GoR), for suggestions comparable to top 5 list recommendations. For recommendations without guideline equivalents, the methodological quality of the top 5 list development process was assessed using criteria similar to that used to judge guidelines, and relevant meta-literature was identified in cited references. Judgement of sufficient trustworthiness of top 5 list recommendations was based either on an 'A' GoR of guideline equivalents or on high methodological quality and citation of relevant meta-literature. RESULTS: 412 top 5 list recommendations were identified. For 75 (18%), equivalents were found in current German S3 guidelines. 44 of these recommendations were associated with an 'A' GoR, or a strong recommendation based on strong evidence, and 26 had a 'B' or a 'C' GoR. No GoR was provided for 5 recommendations. 337 recommendations had no equivalent in the German S3 guidelines. The methodological quality of the development process was high and relevant meta-literature was cited for 87 top 5 list recommendations. For a further 36, either the methodological quality was high without any meta-literature citations or meta-literature citations existed but the methodological quality was lacking. For the remaining 214 recommendations, either the methodological quality was lacking and no literature was cited or the methodological quality was generally unsatisfactory. CONCLUSIONS: 131 of current US top 5 list recommendations were found to be sufficiently trustworthy. For a substantial number of current US top 5 list recommendations, their trustworthiness remains unclear. Methodological requirements for developing top 5 lists are recommended.

[Choosing wisely--against overuse in healthcare systems--activities in Germany and Austria in geriatric medicine]. / Choosing Wisely--Gegen Überversorgung im Gesundheitswesen--Aktivitäten aus Deutschland und Österreich am Beispiel der Geriatrie.

In 2012, the American Board of Internal Medicine (ABIM) Foundation initiated the Choosing Wisely campaign to promote discussion between physicians and patients (or proxies) on decision-making in medicine, and to reduce the use of procedures and therapies which are not necessary, or harmful to patients. The American Geriatrics Society (AGS), the American Medical Directors Association and the Society of Post-Acute and Long-Term Medicine (AMDA) participated in this initiative and both published 10 recommendations on procedures that should be discussed and avoided. Furthermore, some scientific societies have also published recommendations concerning elderly patients. As the campaign attracted considerable international attention, an International Roundtable was established in 2014. In Germany a similar initiative to address overuse and underuse was established by the German Society of Internal Medicine (DGIM) in 2015. The German Society of Geriatrics (DGG) was invited to address subjects affecting elderly patients that are of relevance to the German health care system. As a member of the Commission of the Association of the Scientific Medical Societies in Germany (AWMF), it also participated actively in the development of a methods paper on how to prepare recommendations. The German College of General Practitioners and Family Physicians (DEGAM) has developed a new guideline on this topic and in Austria preliminary activities are already underway. A clear, transparent, structured and evidence-based approach may help avoid some of the methodological weaknesses to be found in the development of the U.S. recommendations. Whereas the U.S. campaign only addresses overuse, the German campaign will also address underuse and misuse.

[Practical experience with overviews of reviews--valuable decision aid or academic exercise?]. / Praxiserfahrungen mit Overviews of Reviews--wertvolle Entscheidungsunterstützung oder wissenschaftliche Fingerübung?

The "overview of reviews" has evolved as a method to aggregate information from systematic reviews. Based on research projects conducted by two Austrian institutions, this article aims to point out methods and perceived strengths and limitations of overviews of reviews and to discuss their application and constraints for different healthcare settings. The six analysed projects differed in their objectives as well as in the corresponding methodology. We identified the following strengths of the overviews of reviews performed: the overview of the evidence base on an issue, the rapid detection of the results of numerous reviews, the demonstration of evidence gaps and potential savings in time and resources. At the same time, the methodology could lead to a loss of information, limited relevance and to uncertainties regarding the robustness of the overall results. However, the heterogeneity of the methods used shows that the development of methods for overviews of reviews is still ongoing. Whether overviews of reviews provide valuable decision support depends on the research question and realistic expectations towards the method.

Colorectal cancer stage at diagnosis in migrants versus non-migrants (KoMigra): study protocol of a cross-sectional study in Germany.

BACKGROUND: In Germany, about 20% of the total population have a migration background. Differences exist between migrants and non-migrants in terms of health care access and utilisation. Colorectal cancer is the second most common malignant tumour in Germany, and incidence, staging and survival chances depend, amongst other things, on ethnicity and lifestyle. The current study investigates whether stage at diagnosis differs between migrants and non-migrants with colorectal cancer in an area of high migration and attempts to identify factors that can explain any differences. METHODS/DESIGN: Data on tumour and migration status will be collected for 1,200 consecutive patients that have received a new, histologically verified diagnosis of colorectal cancer in a high migration area in Germany in the previous three months. The recruitment process is expected to take 16 months and will include gastroenterological private practices and certified centres for intestinal diseases. Descriptive and analytical analysis will be performed: the distribution of variables for migrants versus non-migrants and participants versus non-participants will be analysed using appropriate χ2-, t-, F- or Wilcoxon tests. Multivariable, logistic regression models will be performed, with the dependent variable being the dichotomized stage of the tumour (UICC stage I versus more advanced than UICC stage I). Odds ratios and associated 95%-confidence intervals will be calculated. Furthermore, ordered logistic regression models will be estimated, with the exact stage of the tumour at diagnosis as the dependent variable. Predictors used in the ordered logistic regression will be patient characteristics that are specific to migrants as well as patient characteristics that are not. Interaction models will be estimated in order to investigate whether the effects of patient characteristics on stage of tumour at the time of the initial diagnosis is different in migrants, compared to non-migrants. DISCUSSION: An association of migration status or other socioeconomic variables with stage at diagnosis of colorectal cancer would be an important finding with respect to equal health care access among migrants. It would point to access barriers or different symptom appraisal and, in the long term, could contribute to the development of new health care concepts for migrants. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005056.

Increasing physical activity for the treatment of hypertension: a systematic review and meta-analysis.

BACKGROUND: Low physical activity has been identified as a major risk factor for cardiovascular disease. Medical societies therefore recommend increased physical activity be part of any antihypertensive therapy. OBJECTIVE: Focusing on patient-relevant outcomes such as mortality and cardiovascular events, this review was conducted to assess the long-term effects of interventions aiming at increasing physical activity in comparison with no such interventions on adult patients with essential hypertension. DATA SOURCES: We searched for high-quality systematic reviews in MEDLINE, EMBASE, Cochrane Database of Systematic Reviews (Cochrane Reviews), Database of Abstracts of Reviews of Effects (Other Reviews) and Health Technology Assessment Database (Technology Assessments) published between 1997 and February 2009 and for randomized controlled trials (RCTs) in MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials (Clinical Trials) published before September 2012. Additional studies were identified by hand searching reference lists of reviews. STUDY SELECTION: RCTs with at least 24 weeks' follow-up that evaluated the effect of increased physical activity on the blood pressure of adults with essential hypertension were included in our review. Primary outcomes were all-cause mortality, cardiovascular morbidity and mortality, end-stage renal disease, quality of life and adverse events. STUDY APPRAISAL AND SYNTHESIS METHODS: When appropriate, we used random effects meta-analyses to determine mean difference with 95 % confidence intervals for each endpoint. All data were analysed using the Review Manager software version 5.0.24 from the Cochrane Collaboration. RESULTS: None of the included nine trials, covering 891 patients with hypertension, provided sufficient data on patient-relevant outcomes such as mortality, cardiovascular events or injuries related to physical activity. Information on changes in systolic and diastolic blood pressure was provided for all included trials. The majority of the included RCTs reported that increased physical activity led to a decrease in systolic and diastolic blood pressure of 5-10 and 1-6 mmHg, respectively, but due to marked heterogeneity in the meta-analyses both for systolic and diastolic blood pressure (I² = 70.0 and 73.0 %), no effect estimates were provided. LIMITATIONS: About 50 % of the included trials were small, evaluating at most 20 participants per study group, and more than twothirds were deemed to have a high risk of bias. CONCLUSIONS: Although a decrease in blood pressure is shown to be a consequence of increased physical activity, RCTs of appropriate study size and quality that examine potential patient-relevant benefits or harms still need to be conducted to evaluate whether physical activity really improves the health of patients with essential hypertension.

Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data.

BACKGROUND: Uptake of self-testing and self-management of oral anticoagulation [corrected] has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in the evidence, including an estimate of the effect on time to death, first major haemorrhage, and thromboembolism. METHODS: We searched Ovid versions of Embase (1980-2009) and Medline (1966-2009), limiting searches to randomised trials with a maximally sensitive strategy. We approached all authors of included trials and requested individual patient data: primary outcomes were time to death, first major haemorrhage, and first thromboembolic event. We did prespecified subgroup analyses according to age, type of control-group care (anticoagulation-clinic care vs primary care), self-testing alone versus self-management, and sex. We analysed patients with mechanical heart valves or atrial fibrillation separately. We used a random-effect model method to calculate pooled hazard ratios and did tests for interaction and heterogeneity, and calculated a time-specific number needed to treat. FINDINGS: Of 1357 abstracts, we included 11 trials with data for 6417 participants and 12,800 person-years of follow-up. We reported a significant reduction in thromboembolic events in the self-monitoring group (hazard ratio 0·51; 95% CI 0·31-0·85) but not for major haemorrhagic events (0·88, 0·74-1·06) or death (0·82, 0·62-1·09). Participants younger than 55 years showed a striking reduction in thrombotic events (hazard ratio 0·33, 95% CI 0·17-0·66), as did participants with mechanical heart valve (0·52, 0·35-0·77). Analysis of major outcomes in the very elderly (age ≥85 years, n=99) showed no significant adverse effects of the intervention for all outcomes. INTERPRETATION: Our analysis showed that self-monitoring and self-management of oral coagulation is a safe option for suitable patients of all ages. Patients should also be offered the option to self-manage their disease with suitable health-care support as back-up. FUNDING: UK National Institute for Health Research (NIHR) Technology Assessment Programme, UK NIHR National School for Primary Care Research.

Benefit assessment of salt reduction in patients with hypertension: systematic overview.

OBJECTIVE: We assessed the benefits and harm of reduced salt intake in patients with essential hypertension focusing on patient-relevant outcomes and blood pressure. METHODS: A systematic search of five electronic databases was performed to identify high-quality secondary literature based on randomized controlled trials (RCTs). An update primary literature search (RCTs) was performed for the time period up to 2010 that was not covered by secondary literature. Major outcomes were death, cardiovascular morbidity/mortality, hospital stays, terminal renal failure, quality of life, and adverse events. Change in blood pressure was defined as surrogate parameter. RESULTS: Four different systematic reviews and two RCTs met the inclusion criteria. Only one review reported limited data on patient-relevant outcomes. Over an intervention period of up to 12 months, mean SBP was reduced by 3.6-8.0 mmHg in all reviews. For the same intervention period, a statistically significant advantage with regard to mean DBP reduction ranging from 1.9 to 2.8 mmHg was found in three reviews. The fourth publication reported a nonsignificant reduction (DBP reduction of 4.7 mmHg). None of the RCTs identified in the primary literature search update reported data on patient-relevant outcomes. However, both RCTs found blood pressure improvements with salt reduction. CONCLUSION: A benefit from a salt-reduced diet in patients with high blood pressure is not proven with regard to patient-relevant outcomes based on systematic reviews and RCTs published up to 2010. The results indicate a blood pressure-lowering effect through reduced salt intake in hypertensive patients.