Quality Initiatives in Foot and Ankle Surgery

Quality initiatives in orthopedics and traumatology are becoming more and more popular worldwide. They can include both mandatory and voluntary methods, such as standardized mandatory surveys, compulsory quality reports, registries, personal certificates, or launching centers of excellence, which means a certification of a whole department. Even in foot and ankle surgery registries, certifications and centers of excellence have been established. This chapter provides an overview of different approaches used to improve quality of care in patients with foot and ankle disorders. We present different methods in use today and discuss their key characteristics

Längenänderungen der menschlichen Unterarmmuskeln in vivo

Die im intakten Organismus auftretenden Längenänderungen aller das Handgelenk überquerenden Muskeln wurden mit einem 5-MHz Ultraschall-Parallelscanner an je 12 weiblichen und männlichen Probanden quantifiziert. Die Längen der Muskelbäuche wurden von der maximalen Dehnung bis zur maximalen Verkürzung bestimmt. Als Nullstellung wurde die vollständige Streckung der Hand- und Fingergelenke angenommen. Für den gesamten Bewegungsumfang (durchschnittlich 120,9o +/- 17,8$^{o}$) waren die Längenänderungen mit 13,0 % - 25,2 %, bezogen auf die Länge in Nullstellung, viel geringer, als die in der Muskelphysiologie aus Messungen an isolierten Froschmuskeln angenommen Werte von 70 %. Die maximal entwickelte Muskelkraft wurde erfaßt. Gegenüber der 'Nullstellung' (100%) lag bei maximaler Dehnung bzw. Verkürzung eine deutliche Kraftreduktion vor (58,4 bzw. 59,9 %). Überlegungen zu möglichen Ursachen des beobachteten Kraftverlustes wurden durch Vergl. mit den für Längen und Kraft publizierten Daten angestellt

Intraoperative damage to surgical gloves during various operations on the musculoskeletal system: a multicenter study

Introduction!#!Various orthopedic surgical procedures cause mechanical stress for gloves. In some cases, sharp-edged objects impact on the glove surfaces. The systematic description of lesions is still missing.!##!Methods!#!2289 gloves from 409 surgeries [primary hip and knee arthroplasties (PA), revisions arthroplasties (RA) and arthroscopic shoulder, hip and knee surgery (AY)] from 3 clinics were examined for lesions using water tightening test according to the European norm EN 455-1.!##!Results!#!Arthroscopies showed the lowest rate of operations with damaged gloves (6.9%). Depending on clinic, 32.7% and 59.2% of PA surgeries generated damaged gloves, while in RA, these numbers rose to 76.0% and 72.8%, respectively. In PA and RA, the most affected finger was the index finger, whereas in arthroscopies, more damage occurred on the middle finger and the thumb. The size of the lesions was rather small with the vast majority being 1 mm or 2 mm in size.!##!Conclusion!#!All investigated interventions led to glove lesions. With increasing mechanical stress, the number of glove defects increased. EN 455 does not account for the intraoperative tear risk. Stricter requirements for gloves should be introduced. Glove change intervals should be defined and implemented, and new materials should be developed

Pilot study for the registry of complications in rheumatic diseases from the German Society of Surgery (DGORh) : evaluation of methods and data from the first 1000 patients

Objective: Most patients suffering with rheumatic diseases who undergo surgical treatment are receiving immune-modulating therapy. To determine whether these medications affect their outcomes a national registry was established in Germany by the German Society of Surgery (DGORh). Data from the first 1000 patients were used in a pilot study to identify relevant corisk factors and to determine whether such a registry is suitable for developing accurate and relevant recommendations. Design and participants: Data were collected from patients undergoing surgical treatments with their written consent. A second consent form was used, if complications occurred. During this pilot study, in order to obtain a quicker overview, risk factors were considered only in patients with complications. Only descriptive statistical analysis was employed in this pilot study due to limited number of observed complications and inhomogeneous data regarding the surgery and the medications the patients received. Analytical statistics will be performed to confirm the results in a future outcome study. Results: Complications occurred in 26 patients and were distributed equally among the different types of surgeries. Twenty one of these patients were receiving immune-modulating therapy at the time, while five were not. Infections were observed in 2.3% of patients receiving and in 5.1% not receiving immunosuppression. Conclusions: Due to the low number of cases, inhomogeneity in the diseases and the treatments received by the patients in this pilot study, it is not possible to develop standardised best-practice recommendations to optimise their care. Based on this observation we conclude that in order to be suitable to develop accurate and relevant recommendations a national registry must include the most important and relevant variables that impact the care and outcomes of these patients

DNVF-Memorandum III - Methods for Health Services Research, Part 4-Concept and Methods for Organizational Health Services Research Chapter 2-Methodological Approaches for Organizational Health Services Research: Measures, Data Sources, Data Collection and Data Analysis

Organizational health services research is still a relatively young field of research in Germany which is of increasing interest. The German Network Health Services Research e.V. (DNVF e.V.) published in 2009 - supported by expert associations and individual members of the DNVF - a guide on Methods for organizational health services research of the Memorandum III, part 1 [1]. Originating from this publication and facilitated by the increasing relevance of the field, a necessity to refine the conceptual and methodological basis became evident. The update and extension of the publication from 2009 consists of 3 chapters: (1) Definition and concept of organizational health services research, (2) Methodological approaches in organizational health services research: indicators, data sources, data collection and data analysis, (3) Methodological approaches for the design, evaluation and implementation of complex interventions in healthcare organizations. The aim of the second chapter is to derive methodological requirements and characteristics of organizational health services research - based on the unique characteristics of the research field presented in chapter 1

Advances in biology and mechanics of rotator cuff repair

High initial fixation strength, mechanical stability and biological healing of the tendon-to-bone interface are the main goals after rotator cuff repair surgery. Advances in the understanding of rotator cuff biology and biomechanics as well as improvements in surgical techniques have led to the development of new strategies that may allow a tendon-to-bone interface healing process, rather than the formation of a fibrovascular scar tissue. Although single-row repair remains the most cost-effective technique to address a rotator cuff tear, some biological intervention has been recently introduced to improve tissue healing and clinical outcome of rotator cuff repair. Animal models are critical to ensure safety and efficacy of new treatment strategies; however, although rat shoulders as well as sheep and goats are considered the most appropriate models for studying rotator cuff pathology, no one of them can fully reproduce the human condition. Emerging therapies involve growth factors, stem cells and tissue engineering. Experimental application of growth factors and platelet-rich plasma demonstrated promising results, but has not yet been transferred into standardized clinical practice. Although preclinical animal studies showed promising results on the efficacy of enhanced biological approaches, application of these techniques in human rotator cuff repairs is still very limited. Randomized controlled clinical trials and post-marketing surveillance are needed to clearly prove the clinical efficacy and define proper indications for the use of combined biological approaches. The following review article outlines the state of the art of rotator cuff repair and the use of growth factors, scaffolds and stem cells therapy, providing future directions to improve tendon healing after rotator cuff repair.LEVEL OF EVIDENCE: Expert opinion, Level V

Versorgungsnahe Daten zur Evaluation von Interventionseffekten: Teil 2 des Manuals

Zusammenfassung Die Evaluation von Interventionseffekten ist eine wichtige Domane der Versorgungsforschung. Die vom Deutschen Netzwerk Versorgungsforschung (DNVF) ins Leben gerufene Ad hoc Kommission zur Nutzung versorgungsnaher Daten beschaftigt sich in diesem zweiten Teil des Manuals deshalb mit der Nutzung dieser Daten zur Evaluation von Interventionseffekten. Zunachst erfolgt dabei eine Aufarbeitung der Begriffsbestimmung und Diskussion zur Bedeutung von Kontextfaktoren. Anschlie ss end werden sowohl allgemeine Anforderungen an Planung, Datenerhebung und Auswertung sowie konkrete Beispiele zur Evaluation von Interventionseffekten fur die 3 Anwendungsfelder Arzneimitteltherapie, nicht-medikamentose Ma ss nahmen sowie komplexe Interventionen herausgearbeitet. Dabei werden sowohl Szenarien betrachtet, bei denen bisher keine Informationen aus direkt vergleichenden randomisierten kontrollierten Studien (RCTs) vorliegen bzw. bereits RCTs vorhanden sind, jedoch eine Erweiterung der Fragestellung erforderlich ist. Im Zentrum steht bei allen Beispielen an erster Stelle immer die Frage, ob die Datenquelle fur die entsprechende Forschungsfrage geeignet ist und zwar unabhangig davon, ob eine Studie mit oder ohne Randomisierung durchgefuhrt wird. Die gewahlten Beispiele stammen gro ss tenteils aus der Onkologie, weil die hierfur notwendigen Daten zumindest in Ansatzen bereits fur Deutschland vorliegen. Abschlie ss end diskutiert das Manual mogliche Herausforderungen fur eine zukunftige Nutzung dieser Daten. Abstract 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

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 evalua-tion 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)

Routine Practice Data for Health Care Analyses: Part 3 of the Manual

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

DNVF-Memorandum III - Methods for Health Services Research, Part 4-Concept and Methods for Organizational Health Services Research: Short Version

Organizational health services research in Germany is of increasing relevance. Based on the guide on methods for organizational health services research of the Memorandum III, part 1 from the year 2009, the fundamentals and standards have now been refined. The memorandum captures the theoretical framework, basic methodological approaches and methods in health services research for the design, evaluation and implementation of complex interventions in healthcare organizations