Reassessing and Extending the European Standards of Care for Newborn Health: How to Keep Reference Standards in Line with Current Evidence.

The European Standards of Care for Newborn Health (ESCNH) were launched in 2018. After three years, the first standards were reassessed and revised to align with current evidence. Moreover, new standards regarding emerging topics were developed. The aim of this paper is to outline the approach adopted for reassessing, revising and developing new standards for the ESCNH. We established a systematic approach to reassess the ESCNH including a public and an expert consultation. The public consultation was open to all stakeholders for feedback whereas the expert consultation followed a targeted consultation method. For developing new standards, a similar process to the original development was implemented. Overall, 20 standards were reassessed and six standards were developed. For the revision process, 23 experts were involved in the targeted consultation method and 253 questionnaires were completed via the open consultation. We demonstrated a systematic approach to update and extend reference standards, which can be applied by other developers of standards. Thereby, we highlighted that including a public and an expert consultation is crucial to improve quality and to ensure that all stakeholder perspectives are integrated.

Assessing needs-based supply of physicians: a criteria-led methodological review of international studies in high-resource settings.

BACKGROUND: Many health systems embrace the normative principle that the supply of health services ought to be based on the need for healthcare. However, a theoretically grounded framework to operationalize needs-based supply of healthcare remains elusive. The aim of this paper is to critically assess current methodologies that quantify needs-based supply of physicians and identify potential gaps in approaches for physician planning. To this end, we propose a set of criteria for consideration when estimating needs-based supply. METHODS: We conducted searches in three electronic bibliographic databases until March 2020 supplemented by targeted manual searches on national and international websites to identify studies in high-resource settings that quantify needs-based supply of physicians. Studies that exclusively focused on forecasting methods of physician supply, on inpatient care or on healthcare professionals other than physicians were excluded. Additionally, records that were not available in English or German were excluded to avoid translation errors. The results were synthesized using a framework of study characteristics in addition to the proposed criteria for estimating needs-based physician supply. RESULTS: 18 quantitative studies estimating population need for physicians were assessed against our criteria. No study met all criteria. Only six studies sought to examine the conceptual dependency between need, utilization and supply. Apart from extrapolations, simulation models were applied most frequently to estimate needs-based supply. 12 studies referred to the translation of need for services with respect to a physician's productivity, while the rest adapted existing population-provider-ratios. Prospective models for estimating future care needs were largely based on demographic predictions rather than estimated trends in morbidity and new forms of care delivery. CONCLUSIONS: The methodological review shows distinct heterogeneity in the conceptual frameworks, validity of data basis and modeling approaches of current studies in high-resource settings on needs-based supply of physicians. To support future estimates of needs-based supply, this review provides a workable framework for policymakers in charge of health workforce capacity planning.

Regional variations in multimorbidity burden among office-based physicians in Germany.

BACKGROUND: Multimorbidity is associated with higher utilization of healthcare services. However, many countries do not consider multimorbidity when estimating physician supply. The main aim of this study was to assess how regional multimorbidity levels can be integrated when estimating the need for office-based physician supply. METHODS: Claims data were used to measure and compare the proportions of multimorbid patients of GPs, ophthalmologists, orthopaedic specialists and neurologists, and examine spatial variations through Bernoulli cluster analysis of regional multimorbidity levels. To explore the interrelationship between current capacities and spatial occurrence of high-rate clusters, clusters were compared with the current supply of physicians. RESULTS: About 17 239 488 individuals out of approximately 67 million records were classified as multimorbid. Multimorbidity levels varied greatly between physician disciplines (31.5-60.1%). Bernoulli cluster analysis demonstrated that many high-rate areas were found for all specialized physicians, but clusters varied partially by size and location. The comparison with current physician supply at cluster level showed that more than a third of clusters with a significantly higher share of morbid patients seeing a GP are met, on an average, by GP supply below targeted values. In turn, clusters with significantly higher multimorbidity levels of specialized physicians were met, on an average, by supply that exceeded targeted values. CONCLUSION: Our study offers an approach to how to include discipline-specific multimorbidity at area level when estimating physician supply and discusses its relevance. The outcomes of our article can be used by policymakers to advance current planning strategies and to improve the quality of office-based care.

A pressing need for research to reduce nutritional uncertainties in preterm infant care: Findings from a European roundtable discussion with parent representatives.

INTRODUCTION: Other than for agreement that own mother's milk is the optimum feed, nutritional practice for very preterm babies varies widely. As part of the development of a randomised controlled trial to address preterm nutrition uncertainties, and with the help of the European Foundation for the Care of Newborn Infants (EFCNI), we sought the views of parents across Europe. METHODS: We held two roundtable discussions about the proposed trial, inviting the participation of parents and preterm adults through EFCNI. We sought their views and prior knowledge of preterm nutrition uncertainties, treatment comparisons and opinions on specific aspects of design such as cluster versus individual randomisation. We used thematic Framework Analysis to explore the data. RESULTS: There were 11 participants (two men and nine women) from six European countries. Nine were parents and two were preterm adults. Participants strongly supported the need for research to improve care. However, we found little knowledge of methods to resolve uncertainties in care, and wide variation in information provided to parents during their baby's neonatal unit stay. No parent recalled a member of the clinical staff having told them about nutrition uncertainties. CONCLUSIONS: Present-day best practice is to involve parents, patients, and the public in all stages of clinical research from design to dissemination and implementation. To strengthen involvement and participation we suggest there is need to improve knowledge of research methods. Clinicians may find it helpful to receive training on how to explain clinical uncertainties, and methods to resolve these.

Improving the continuity and coordination of ambulatory care through feedback and facilitated dialogue-a study protocol for a cluster-randomised trial to evaluate the ACD study (Accountable Care in Germany).

BACKGROUND: Patients in Germany are free to seek care from any office-based physician and can always ask for multiple opinions on a diagnosis or treatment. The high density of physicians and the freedom to choose among them without referrals have led to a need for better coordination between the multiple health professionals treating any given patient. The objectives of this study are to (1) identify informal networks of physicians who treat the same patient population, (2) provide these physicians with feedback on their network and patients, using routine data and (3) give the physicians the opportunity to meet one another in facilitated network meetings. METHODS: The Accountable Care Deutschland (ACD) study is a prospective, non-blinded, cluster-randomised trial comprising a process and economic evaluation of informal networks among 12,525 GPs and office-based specialists and their 1.9 million patients. The units of allocation are the informal networks, which will be randomised either to the intervention (feedback and facilitated meetings) or control group (usual care). The informal networks will be generated by identifying connections between office-based physicians using complete datasets from the Regional Associations of Statutory Health Insurance (SHI) Physicians in Hamburg, Schleswig Holstein, North Rhine and Westphalia Lip, as well as data from three large statutory health insurers in Germany. The physicians will (a) receive feedback on selected indicators of their own treatment activity and that of the colleagues in their network and (b) will be invited to voluntary, facilitated network meetings by their Regional Association of SHI physicians. The primary outcome will be ambulatory-care-sensitive hospitalisations at baseline, at the end of the 2-year intervention period, and at six months and at 12 months after the end of the intervention period. Data will be analysed using the intention-to-treat principle. A pilot study preceded the ACD study. DISCUSSION: Cochrane reviews show that feedback can improve everyday medical practice by shedding light on previously unknown relationships. Providing physicians with information on how they are connected with their colleagues and what the outcomes are of care delivered within their informal networks can help them make these improvements, as well as strengthen their awareness of possible discontinuities in the care they provide. TRIAL REGISTRATION: German Clinical Trials Register DRKS00020884 . Registered on 25 March 2020-retrospectively registered.

Implementation of an integrated care programme to avoid fragility fractures of the hip in older adults in 18 Bavarian hospitals - study protocol for the cluster-randomised controlled fracture liaison service FLS-CARE.

BACKGROUND: The economic and public health burden of fragility fractures of the hip in Germany is high. The likelihood of requiring long-term care and the risk of suffering from a secondary fracture increases substantially after sustaining an initial fracture. Neither appropriate confirmatory diagnostics of the suspected underlying osteoporosis nor therapy, which are well-recognised approaches to reduce the burden of fragility fractures, are routinely initiated in the German healthcare system. Therefore, the aim of the study FLS-CARE is to evaluate whether a coordinated care programme can close the prevention gap for patients suffering from a fragility hip fracture through the implementation of systematic diagnostics, a falls prevention programme and guideline-adherent interventions based on the Fracture Liaison Services model. METHODS: The study is set up as a non-blinded, cluster-randomised, controlled trial with unequal cluster sizes. Allocation to intervention group (FLS-CARE) and control group (usual care) follows an allocation ratio of 1:1 using trauma centres as the unit of allocation. Sample size calculations resulted in a total of 1216 patients (608 patients per group distributed over 9 clusters) needed for the analysis. After informed consent, all participants are assessed directly at discharge, after 3 months, 12 months and 24 months. The primary outcome measure of the study is the secondary fracture rate 24 months after initial hip fracture. Secondary outcomes include differences in the number of falls, mortality, quality-adjusted life years, activities of daily living and mobility. DISCUSSION: This study is the first to assess the effectiveness and cost-effectiveness/utility of FLS implementation in Germany. Findings of the process evaluation will also shed light on potential barriers to the implementation of FLS in the context of the German healthcare system. Challenges for the study include the successful integration of the outpatient sector as well as the future course of the coronavirus pandemic in 2020 and its influence on the intervention. TRIAL REGISTRATION: German Clinical Trial Register (DRKS) 00022237 , prospectively registered 2020-07-09.

Improving care coordination for patients with cardiac disease: Study protocol of the randomised controlled new healthcare programme (Cardiolotse).

INTRODUCTION: A lack of effective coordination and communication between ambulatory care physicians and hospitals, including the lack of follow-up care, poses a challenge to the recovery process of patients suffering from cardiac disease, often resulting in rehospitalisation and adverse outcomes. This innovative care programme aims to bridge the gap between ambulatory and hospital care. A key element of this programme is specifically trained care managers (Cardiolotse) who provide post-discharge support, access to additional resources and help the patient to navigate successfully through the healthcare system. MATERIAL AND METHODS: The study is set up as a prospective, randomised, controlled trial. Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation. Sample size calculations resulted in 1454patients per group after adjusting for potential non-compliance. All participants are surveyed at discharge, after 3 and 12 months. The primary outcome of the study is the 12-month rehospitalisation rate. Secondary outcomes include differences in length of hospital stay, mortality, quality-adjusted life years, costs and patient satisfaction. Statistical analysis and economic evaluation will be complemented by a process evaluation. DISCUSSION: The new healthcare programme is designed to support patients when leaving hospital with cardiac conditions by easing the transition between sectors through access to Cardiolotses and individualised care plans. We hypothesise that the programme reduces rehospitalisation and improves clinically relevant patient outcomes. TRIAL REGISTRATION: German Clinical Trial Register, DRKS00020424. Registered 2020-06-18, http://www.drks.de/DRKS00020424.

Do Austrian "INTEGRI (integrated care) projects" comply with international definitions and concepts?

One of the biggest challenges for European healthcare systems is the fragmentation of care. To overcome this challenge, integrated care (IC) approaches have been recently implemented. To further improve this method, current and past projects must be monitored and evaluated. However, since the definition of IC is very indistinct and varies significantly in literature, key elements have to be defined. The study design selected was a mixed-methods study that includes two approaches: a systematic literature review and qualitative content analysis of the data provided by the Ludwig Boltzmann Institute. Nine key elements of IC projects were identified in the literature review and subsequently compared with the main features coded from previous INTEGRI applications. The results showed that 41 of the applications presented seven or more criteria in their official submission form. The conclusion of the results can be drawn as a justification and validation of the INTEGRI criteria. Although the results are positive on the whole, three recommendations on possible improvements are given.