Evidence-based and Patient-centered Indication for Knee Arthroplasty - Update of the Guideline. / Evidenzbasierte und patientenorientierte Indikationsstellung zur Knieendoprothese ­ Update der Leitlinie.

Knee arthroplasty is one of the most frequently performed operations in Germany, with approximately 170000 procedures per year. It is therefore essential that physicians should adhere to an appropriate, and patient-centered indication process. The updated guideline indication criteria for knee arthroplasty (EKIT-Knee) contain recommendations, which are based on current evidence and agreed upon by a broad consensus panel. For practical use, the checklist has also been updated.For this guideline update, a systematic literature research was conducted in order to analyse (inter-)national guidelines and systematic reviews focusing on osteoarthritis of the knee and knee arthroplasty, to answer clinically relevant questions on diagnostic, predictors of outcome, risk factors and contraindications.Knee arthroplasty should solely be performed in patients with radiologically proven moderate or severe osteoarthritis of the knee (Kellgren-Lawrence grade 3 or 4), after previous non-surgical treatment for at least three months, in patients with high subjective burden with regard to knee-related complaints and after exclusion of possible contraindications (infection, comorbidities, BMI ≥ 40 kg/m2). Modifiable risk factors (such as smoking, diabetes mellitus, anaemia) should be addressed and optimised in advance. After meeting current guideline indications, a shared decision-making process between patients and surgeons is recommended, in order to maintain high quality surgical management of patients with osteoarthritis of the knee.The update of the S2k-guideline was expanded to include unicondylar knee arthroplasty, the preoperative optimisation of modifiable risk factors was added and the main indication criteria were specified.

[Register-based research and clinical studies : Possibilities, limitations and perspectives]. / Registerbasierte Forschung und klinische Studien : Möglichkeiten, Limitationen, Perspektiven.

Register-based research offers a good opportunity to generate knowledge on questions from the clinical practice. Methodologically high-quality register studies can complement clinical studies, especially for questions that cannot be answered with randomized controlled trials (RCT). The ad hoc committee on healthcare data of the German Network for Health Services Research (DNVF) has set methodological guidelines for register-based studies with a manual for methods and the use of healthcare data. The methodological advantages of both approaches can be integrated through RCTs embedded in registers. In Germany there is a diverse register landscape as shown by the register report commissioned by the Federal Ministry of Health, which, however, show a varying degree of internationally recognized quality criteria. The relevance of register-based studies for the clinical practice (e. g. guideline development) is shown in the examples of applications cited in the article. Although a lot has already been done here in Germany with existing register data, sustainable coordination and promotion of the research infrastructure and research culture, especially in international comparison are necessary.

[Routine Practice Data for Health Care Analyses: Part 3 of the Manual]. / Versorgungsnahe Daten für Versorgungsanalysen ­ Teil 3 des Manuals.

Analyses of health and health care (hereafter referred to as "health care analyses") usually aim to make transparent the structures, processes, results and interrelationships of health care and to record the degree to which health care systems and their actors have achieved their goals. Health care-related data are an indispensable source of data for many health care analyses. A prerequisite for the examination of a degree of goal achievement is first of all an agreement on those goals that are to be achieved by the system and its substructures, as well as the identification of the determinants of the achievement of the objectives. Primarily it must be examined how safely, effectively and patient-centred systems, facilities and service providers are operating. It also addresses issues of need, accessibility, utilisation, timeliness, appropriateness, patient safety, coordination, continuity, and health economic efficiency and equity of health care. The results of health care include system services (outputs), on the one hand, and results (outcomes), on the other, whereby the results (patient-reported outcomes) and experiences (patient-reported experiences) reported are of particular importance. Health care analyses answer basic questions of health care research: who does what, when, how, why and with which resources and effects in routine health care. Health care analyses thus provide the necessary findings and key figures to further develop health care in order to improve the quality of health care. The applications range from capacity analyses to following innovations up to the concept of regional and supra-regional monitoring of the quality of care given to the population. Given the progress of digitalisation in Health Care, direct data from the care processes will be increasingly available for health care research. This can support care givers significantly if the findings of the studies are applied precisely and correctly within an adequate methodological frame. This can lead to measurable improved health care quality for patients. Data from the process of health care provision have a high potential. Their use needs the same scientific scrutiny as in all other scientific studies.

[Necessity and Ways to Develop Care Goals for the Health System in Germany - a Position Paper of the DNVF]. / Notwendigkeit und Wege zur Entwicklung von Versorgungszielen für das Gesundheitssystem in Deutschland ­ ein Positionspapier des DNVF.

Goals for health and health care are an indispensable basic requirement for a functioning health care system. The dilemma of the German health care system is that it has not been designed in a planned way, but that it has grown historically. In recent years, it has developed through the free play of forces into what it is today. The OECD characterizes the current state as follows: The costs of the German health system do not correspond to the often only average health outcomes for the population. To meet the legal requirements (especially SGB V §§ 12, 27 and 70), health care/the health system in Germany needs concrete goals. An orientation towards health care goals entails measures on all levels of health care: on the macro level (overall system/total population), on the meso level (subdivided according to regions, specific population groups, etc.) as well as on the micro level (patients and health care providers). Based on national and international experiences, this position paper of the DNVF e.V. (German Network for health services research) shows the potential of how operationalised health care targets can ensure effective, affordable and high-quality health care. The coalition agreement of the current government propagates a reorientation with patient-related health care goals. Now it is important to derive concrete and realisable goals from this declaration of intent and to involve all important groups in the process. In addition, values and ethical standards for implementation shall be agreed upon in this process. The Health Ministry (BMG) should facilitate and promote the process of societal will-building for the definition of national health care goals. This requires a clear political will. As a result, the National Health Care Goals are available at the end of the process, which are published and maintained together with evidence-based facts as well as valid and resilient data in a Manual "National Health Care Goals". The operational responsibility for implementation could lie with the newly to be founded Federal Institute of Public Health, as already announced in the agreement of the governing coalition. The DNVF is willing to actively participate in the development of health care targets.

RENaBack: low back pain patients in rehabilitation-study protocol for a multicenter, randomized controlled trial.

BACKGROUND: Millions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country. METHODS: The aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG). DISCUSSION: An improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers. TRIAL REGISTRATION: DRKS, DRKS00020373 . Registered on 15 April 2020.

[Routine Practice Data for Evaluating Intervention Effects: Part 2 of the Manual]. / Versorgungsnahe Daten zur Evaluation von Interventionseffekten: Teil 2 des Manuals.

The evaluation of intervention effects is an important domain of health services research. The ad hoc commission for the use of routine practice data of the German Network for Health Services Research (DNVF) therefore provides this second part of its manual focusing on the use of routine practice data for the evaluation of intervention effects. First, we discuss definition issues and the importance of contextual factors. Subsequently, general requirements for planning, data collection and analysis as well as concrete examples for the evaluation of intervention effects for the 3 fields of application regarding pharmacotherapy, nonpharmaceutical interventions as well as complex interventions are elaborated. We consider scenarios in which no information from randomized controlled trials (RCTs) comparing the two groups directly is yet available or in which RCTs are already available but an extension of the research question is required. In all examples either with or without randomization, the first and foremost question is always whether the data source is suitable for the specific research question. Most of the examples chosen are from oncology trials, because the necessary data are already available for Germany, at least in some form. Finally, the manual discusses possible challenges for future use of these data.

Health systems strengthening to arrest the global disability burden: empirical development of prioritised components for a global strategy for improving musculoskeletal health.

INTRODUCTION: Despite the profound burden of disease, a strategic global response to optimise musculoskeletal (MSK) health and guide national-level health systems strengthening priorities remains absent. Auspiced by the Global Alliance for Musculoskeletal Health (G-MUSC), we aimed to empirically derive requisite priorities and components of a strategic response to guide global and national-level action on MSK health. METHODS: Design: mixed-methods, three-phase design.Phase 1: qualitative study with international key informants (KIs), including patient representatives and people with lived experience. KIs characterised the contemporary landscape for MSK health and priorities for a global strategic response.Phase 2: scoping review of national health policies to identify contemporary MSK policy trends and foci.Phase 3: informed by phases 1-2, was a global eDelphi where multisectoral panellists rated and iterated a framework of priorities and detailed components/actions. RESULTS: Phase 1: 31 KIs representing 25 organisations were sampled from 20 countries (40% low and middle income (LMIC)). Inductively derived themes were used to construct a logic model to underpin latter phases, consisting of five guiding principles, eight strategic priority areas and seven accelerators for action.Phase 2: of the 165 documents identified, 41 (24.8%) from 22 countries (88% high-income countries) and 2 regions met the inclusion criteria. Eight overarching policy themes, supported by 47 subthemes, were derived, aligning closely with the logic model.Phase 3: 674 panellists from 72 countries (46% LMICs) participated in round 1 and 439 (65%) in round 2 of the eDelphi. Fifty-nine components were retained with 10 (17%) identified as essential for health systems. 97.6% and 94.8% agreed or strongly agreed the framework was valuable and credible, respectively, for health systems strengthening. CONCLUSION: An empirically derived framework, co-designed and strongly supported by multisectoral stakeholders, can now be used as a blueprint for global and country-level responses to improve MSK health and prioritise system strengthening initiatives.

[Manual for Methods and Use of Routine Practice Data for Knowledge Generation]. / Manual für Methoden und Nutzung versorgungsnaher Daten zur Wissensgenerierung.

" There are more and more good reasons for using existing care data, with the focus in particular on the use of register data. The associated, clearly structured methodological procedure has so far been insufficiently combined, prepared and presented transparently. The German Network for Health Services Research (DNVF) has therefore set up an ad hoc commission for the use of routine practice data (RWE/RWD). The rapid report prepared by IQWiG on the scientific development of concepts for "generation of care-related data and their evaluation for the purpose of benefit assessment of medicinal products according to § 35a SGB V" is an essential step for the use of register data for the generation of evidence. The "Memorandum Register - Update 2019" published by DNVF 2020 also describes the requirements and methodological foundations of registers. Best practice examples from oncology, which are based on the uniform oncological basic data set for clinical cancer registration (§ 65c SGB V), show, for example, that guidelines can be checked and recommendations for guidelines and necessary interventions can be derived in the sense of knowledge-generating health services research using register data. At the same time, however, there are no clear quality requirements and structured formal and content-related procedures in the areas of data consolidation, data verification and the use of specific methods depending on the question at hand. The previously inconsistent requirements are to be revised and a method guide for the use of suited data is to be developed and published. The first chapter of the manual on methods of care-related data explains the objective and structure of the manual. It explains why the use of the term "routine practice data" is more effective than the use of the terms Real Word Data (RWD) and Real World Evidence (RWE). By avoiding the term "real world" it should be emphasized in particular that high-quality research can also be based on routine practice data (e. g. register-based comparative studies).

Why Rehabilitation must have priority during and after the COVID-19-pandemic: A position statement of the Global Rehabilitation Alliance.

COVID-19 has become a pandemic with strong influence on health systems. In many cases it leads to a disruption of rehabilitation service provision. On the other hand, rehabilitation must be an integral part of COVID-19 management. Rehabilitation for COVID-19 should start from acute and early post-acute care and needs to be continued in the post-acute and long-term rehabilitation phase. Of course, it should follow specific safety protocol. Additionally, rehabilitation must be kept available for all other people who are in need. From the perspective of health system, the Global Rehabilitation Alliance urges decision makers to ensure that rehabilitation services will be available for all patients with COVID-19 in the acute, post-acute and long-term phase. Additionally, it must be ensured that all other persons with rehabilitation need have access to rehabilitation services. Rehabilitation services must be equipped with personal protection equipment and follow strict hygiene measures. In particular, rehabilitation must be accessible for vulnerable populations. For that reason, rehabilitation must be kept a health priority during the COVID-19 pandemic and given adequate financial resources. Last but not least, scientific studies should be performed to clarify the impact of the pandemic on rehabilitation services as well as on the needs for rehabilitation of COVID-19 patients.

Quality Improvement Initiatives in Fragility Fracture Care and Prevention.

PURPOSE OF REVIEW: This review sought to describe quality improvement initiatives in fragility fracture care and prevention. RECENT FINDINGS: A major care gap persists throughout the world in the secondary prevention of fragility fractures. Systematic reviews have confirmed that the Fracture Liaison Service (FLS) model of care is associated with significant improvements in rates of bone mineral density testing, initiation of osteoporosis treatment and adherence with treatment for individuals who sustain fragility fractures. Further, these improvements in the processes of care resulted in significant reductions in refracture risk and lower post-fracture mortality. The primary challenge facing health systems now is to ensure that best practice is delivered effectively in the local healthcare setting. Publication of clinical standards for FLS at the organisational and patient level in combination with the establishment of national registries has provided a mechanism for FLS to benchmark and improve their performance. Major efforts are ongoing at the global, regional and national level to improve the acute care, rehabilitation and secondary prevention for individuals who sustain fragility fractures. Active participation in these initiatives has the potential to eliminate current care gaps in the coming decade.

Epidemiology of hip fractures : Systematic literature review of German data and an overview of the international literature.

BACKGROUND: Hip fractures are regarded as a worldwide epidemic and a major public health concern. Changing risk factors, local differences and temporal trends contribute to the particular epidemiology of hip fractures. This overview gives a comprehensive insight into the epidemiology of hip fractures and reviews where German data have contributed to the literature. METHODS: The review of the epidemiology of hip fractures in Germany is based on a systematic literature search in PubMed. Information about the global epidemiology of hip fractures was provided by a selective literature review focusing on specific aspects of the epidemiology of hip fractures. RESULTS: Hip fracture rates vary more than 100-fold between different countries. In most high-income countries, a rise in age-standardized hip fracture rates was observed until the 1980s and 1990s and a decrease thereafter. Such a decrease has not been observed for Germany so far. Many factors, diseases and drugs have been found to be associated with hip fractures and there is some evidence that fracture risk in later life is already programmed during fetal life and early childhood. Of the hip fracture burden 50% occur in people with disability and in need of care. In nursing homes approximately 4 fractures can be expected in 100 women per year. In people with intellectual or developmental disabilities comparable risks of hip fracture occur 10-40 years earlier than in the general population. Incidence of disability, institutionalization and death are frequent consequences of hip fractures. CONCLUSION: The epidemiology of hip fractures is characterized by a high burden of disease, local differences, temporal trends, well-defined high-risk populations and many established risk factors.

A random-perturbation therapy in chronic non-specific low-back pain patients: a randomised controlled trial.

The purpose of the study was to assess the effectiveness of a specific rehabilitation therapy for chronic non-specific low-back pain patients, based on a random/irregular functional perturbation training induced by force disturbances to the spine. Forty patients (20 controls and 20 in the perturbation-based group) finished the whole experimental design. A random-perturbation exercise, which included variable and unpredictable disturbances, was implemented in the therapy of the perturbation-based group (13 weeks, two times per week and 1.5 h per session). The participants of the control group did not receive any specific training. Low-back pain, muscle strength, and neuromuscular control of spine stability were investigated before and after the therapy using the visual analog scale, maximal isometric and isokinetic contractions, nonlinear time series analysis, and by determining the stiffness and damping of the trunk after sudden perturbations. The perturbation-based therapy reduced patient's low-back pain (35%), increased muscle strength (15-22%), and trunk stiffness (13%), while no significant changes were observed in the control group. It can be concluded that the proposed therapy has the potential to enhance trunk muscle capability as well as sensory information processing within the motor system during sudden loading and, as a consequence, improve the stabilization of the trunk.