Socioeconomic differences in the utilization of diagnostic imaging and non-pharmaceutical conservative therapies for spinal diseases.

BACKGROUND: A different utilization of health care services due to socioeconomic status on the same health plan contradicts the principle of equal treatment. We investigated the presence and magnitude of socioeconomic differences in utilization of diagnostic imaging and non-pharmaceutical conservative therapies for patients with spinal diseases. METHODS: The cohort study based on routine healthcare data from Germany with 11.7 million patient-years between 2012 and 2016 for patients with physician-confirmed spinal diseases (ICD-10: M40-M54), occupation and age 20 to 64 years. A Poisson model estimated the effects of the socioeconomic status (school education, professional education and occupational position) for the risk ratio of receiving diagnostic imaging (radiography, computed tomography, magnetic resonance imaging) and non-pharmaceutical conservative therapies (physical therapy including exercise therapy, manual therapy and massage, spinal manipulative therapy, acupuncture). RESULTS: Patients received diagnostic imaging in 26%, physical therapy in 32%, spinal manipulative therapy in 25%, and acupuncture in 4% of all patient-years. Similar to previous survey-based studies higher rates of utilization were associated with higher socioeconomic status. These differences were most pronounced for manual therapy, exercise therapy, and magnetic resonance imaging. CONCLUSIONS: The observed differences in health care utilization were highly related to socioeconomic status. Socioeconomic differences were higher for more expensive health services. Further research is necessary to identify barriers to equitable access to health services and to take appropriate action to decrease existing social disparities.

The INDICATE Knee expectations survey detects general patient treatment goals for total knee arthroplasty and the influence of demographic factors on patients expectations.

PURPOSE: Post-operative outcome after total knee arthroplasty (TKA) in the treatment of end-stage osteoarthritis correlates strongly with pre-operative impairment-driven patient treatment goals. However, a clinical tool for measuring patient treatment goals in correlation to impairments is still missing, which impedes patient-oriented indication in TKA. METHODS: Patients scheduled for TKA were recruited in four German hospitals. All patients were handed the INDICATE Knee Score pre-operatively. The score contains 31 treatment goals with respective impairments, subdivided into seven categories. They were asked to rank all treatment goals and impairments on a 3-point scale. Treatment goals and impairments were then checked for frequency of occurrence. Correlation of goal and impairment was tested. Analysis for associations of treatment goals and different cohort characteristics (age, sex, BMI) was conducted. RESULTS: 1.298 patients were included in the study. Seven treatment goals were categorised as "main goal" from more than 90% of all patients ("knee pain", "range of motion", "walking distance", "overall physical function", "climbing stairs", "quality of life", "implant survival"). Comparing age groups, there were significant associations towards higher expectations regarding working, physical and sports related treatment goals in younger patients (< 65y) ("ability to work" (P ≤ .001), "sports activities" (P ≤ .001), "sex life" (P ≤ .001), "dependence on help of others" (P = .015), "preventing secondary impairment" (P = .03), "dependence on walking aids" (P = .005)). Higher BMI resulted in increasing relevance of "weight reduction" (P ≤ .001), "climbing stairs" (P = .039) "global health status" (P = .015) and "long standing" (P = .007) as a "main goal". Analysis for differences in treatment goals regarding sex showed women choosing more treatment goals as "main goals" than men. CONCLUSION: Seven treatment goals which were expected by > 90% in our collective can be classified as general treatment goals for TKA. Demographic factors (age, sex, BMI) were significantly associated with patients' expectations for TKA. We conclude physicians should clearly assess their patients' demands prior to TKA to maximise post-operative outcome. LEVEL OF EVIDENCE: Prognostic Level III.

[Concepts to support dynamic updating processes of guidelines and their practical implementation-Systematic literature review]. / Konzepte zur Unterstützung dynamischer Aktualisierungsprozesse von Leitlinien und ihre Implementierung in der Praxis ­ systematische Literaturrecherche.

BACKGROUND: Clinical practice guidelines (CPG), which are crucial for evidence-based healthcare, should be kept up to date, especially on topics where emerging evidence could modify one of the recommendations with implications for the healthcare service; however, an updating process, which is practicable for guideline developers as well as users represents a challenge. OBJECTIVE: This article provides an overview of the currently discussed methodological approaches for the dynamic updating of guidelines and systematic reviews. MATERIAL AND METHODS: As part of a scoping review, a literature search was conducted in the databases MEDLINE, EMBASE (via Ovid), Scopus, Epistemonikos, medRxiv, as well as in study and guideline registers. Concepts on the dynamic updating of guidelines and systematic reviews or dynamically updated guidelines and systematic reviews or their protocols published in English or German were included. RESULTS: The publications included most frequently described the following main processes that must be adapted in dynamic updating processes 1) the establishment of continuously working guideline groups, 2) networking between guidelines, 3) the formulation and application of prioritization criteria, 4) the adaptation of the systematic literature search and 5) the use of software tools for increased efficiency and digitalization of the guidelines. CONCLUSION: The transformation to living guidelines requires a change in the needs for temporal, personnel and structural resources. The digitalization of guidelines and the use of software to increase efficiency are necessary instruments, but alone do not guarantee the realization of living guidelines. A process in which dissemination and implementation must also be integrated is necessary. Standardized best practice recommendations on the updating process are still lacking.

Indication for spinal surgery: associated factors and regional differences in Germany.

BACKGROUND: Rising surgery rates have raised questions about the indications for spinal surgery. The study investigated patient-level and regional factors associated with spinal surgery for patients with spinal diseases. METHODS: We undertook a cohort study based on routine healthcare data from Germany of 18.4 million patients within 60.9 million episodes of two patient-years before a possible spinal surgery in the time period 2008 to 2016. Using a Poisson model, the effects of a broad range of patient-related (sociodemographic, morbidity, social status), disease- and healthcare-related (physicians' specialty, conservative treatments) and regional variables were analyzed. RESULTS: There was substantial regional heterogeneity in the occurrence of spinal surgery which decreased by only one quarter when controlling for the various determinants assessed. Previous musculoskeletal and mental health disorders as well as physical therapy were associated with a lower probability of surgery in the fully-adjusted model. Prescriptions for pain medication and consultations of specialists were associated with a higher probability of surgery. However, the specific severity of the vertebral diseases could not be taken into account in the analysis. Furthermore, a substantial proportion of patients with surgery did not receive a consultation with an outpatient specialist (29.5%), preoperative diagnostics (37.0%) or physical therapy (48.3%) before hospital admission. CONCLUSION: This large study on spinal diseases in Germany highlights important patterns in medical care of spinal diseases and their association with the probability of spinal surgery. However, only a relatively small proportion of the regional heterogeneity in spinal surgery could be explained by the extensive consideration of confounders, which suggests the relevance of other unmeasured factors like physicians' preferences.

Ask Patients What They Expect! A Survey Among Patients Awaiting Total Hip Arthroplasty in Germany.

BACKGROUND: Total hip arthroplasty (THA) is an elective surgery. Therefore, patient satisfaction with the results of surgery is paramount. The association between fulfillment of patients' expectations and satisfaction is well known. The aim of this study was to identify key expectations of patients with hip osteoarthritis awaiting THA. METHODS: A mixed-methods approach was used, consisting of two sequential parts. The questionnaire was developed based on literature review and focus group interviews. A nationwide survey was conducted in 21 orthopedic departments within Germany. RESULTS: Out of 691 obtained questionnaires, 636 were analyzed (mean age = 65.7 years (±11.3), 56.1% female). A majority of patients (≥75%) reported more than 20 complaints as 'present' due to hip osteoarthritis. A total of 9 key expectations were identified, which were reported by more than 75% of the patients as 'mandatory' for a successful THA. The identified key expectations were related to pain, range of motion, walking abilities, gait pattern, transitions, leisure and sports activities, awareness of the affected hip, satisfaction with health or life, and compensatory posture. A consistently high correlation was found between the complaints and the corresponding expectations. CONCLUSION: The expectations of patients have greatly expanded. In this study, a set of mandatory key expectations shared by the majority of patients was identified. The likelihood of fulfillment of key expectations should be assessed for weighing benefits and harms of available treatment options during the indication process. In addition, the results of this study might be used as a resource for shared decision-making.

Indication Criteria for Total Hip Arthroplasty in Patients with Hip Osteoarthritis-Recommendations from a German Consensus Initiative.

Background: Osteoarthritis of the hip (hip OA) is a leading cause of pain and disability in elderly people. If non-surgical therapies become ineffective, patients may consider total hip arthroplasty (THA). The biggest challenge in recommending a THA is identifying patients for whom the benefits of this procedure outweigh the potential risks. The aim of this initiative was to develop a clinical practice guideline with accompanying algorithm to guide consultations on THA, supported by a pocket-sized checklist. Methods: The initiative "Evidence- and consensus-based indication criteria for total hip replacement (EKIT-Hip)" used a stepwise approach, starting with an inauguration workshop, where a multidisciplinary German stakeholder panel from various scientific societies agreed on the working process. A Project Coordinating Group (PCG) was formed, and it performed a comprehensive systematic literature search of guidelines and systematic reviews related to the indication criteria for THA, as well as factors influencing outcomes. Based on best-available evidence, preliminary recommendations were formulated by the PCG and discussed with the stakeholder panel during a consensus meeting. In addition, the panel was asked to assess the feasibility of an extracted algorithm and to approve a final checklist. Results: In total, 31 recommendations were approved by 29 representatives of 23 societies. These were used to underpin an algorithm (EKIT-Algorithm), which indicates the minimum requirements for a THA (confirmed diagnosis of hip OA, present and documented individual burden of illness, ineffectiveness of non-surgical therapies, and absence of any contraindications). Once these criteria are fulfilled, further considerations should encompass the medical implications of modifiable risk factors and patients' individual treatment goals, as discussed during shared decision making. The subsequently developed checklist (EKIT-Checklist) lists relevant criteria for decision making. Conclusions: Adherence to the EKIT-Algorithm, conveniently accessed via the EKIT-Checklist, should improve the standardization of decision making leading to a recommendation for THA. By applying minimum requirements and patient-related risk factors, as well as considering patients' individual goals, it is possible to identify patients for whom the benefits of THA may exceed the potential risks.

An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial.

BACKGROUND: Total knee replacement (TKR) is one of the most commonly performed routine procedures in the world. Prognostic studies indicate that the number of TKR will further increase constituting growing burden on healthcare systems. There is also substantial regional heterogeneity in TKR rates within and between countries. Despite the known therapeutic effects, a subset of patients undergoing TKR does not benefit from the procedure as intended. To improve the appropriateness of TKR indication, the EKIT initiative ("evidence and consensus based indication critera for total arthroplasty") developed a clinical guideline for Germany on the indication of TKR. This guideline is the basis for a digital medical decision aid (EKIT tool) to facilitate shared decision making (SDM) in order to improve decision quality for elective surgery. The aim of this cluster randomized trial is to investigate the effectiveness of the EKIT tool on decision quality. METHODS: The Value-based TKR study is a prospective pragmatic multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT). The EKIT tool provides (1) a systematic presentation of individual patient and disease-specific information (symptoms, expectations), (2) the fulfillment of the indication criteria and (3) health information about safety and effectiveness of TKR. All study sites will follow routine care as control clusters until the start of the intervention. In total, there will be 10 clusters (study sites) and 6 sequential steps over 16 month, with clusters receiving the intervention with a minimum 2 months of standard routine care. The primary outcome is patients' decision quality measured with the Decision Quality Instrument (DQI)-Knee Osteoarthritis questionnaire. Furthermore, we will collect information on global patient satisfaction, patient reported outcome measures and the fulfilment of the individual expectations 12 months after SDM. The power calculation yielded an estimated power of 89% using robust Poisson regression under the following assumptions: 10 study sites with a total of N=1,080 patients (including a dropout rate of 11%), a 10% increase in decision quality due to the use of the EKIT tool, and a significance level of 5%. DISCUSSION: There is a high potential for transferring the intervention into routine practice if the evaluation is positive. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04837053 . Registered on 08/04/2021.

[Decision for total hip arthroplasty-the surgeons' view]. / Indikationsstellung zur Hüfttotalendoprothese ­ die ärztliche Perspektive.

BACKGROUND: The decision for total hip arthroplasty (THA) is based on pain, loss of function, radiological changes and failed conservative therapy. These criteria are rarely based on systematic research and have not been integrated in generally accepted treatment guidelines. Aim of our study was, therefore, to analyse which decision criteria German orthopaedic and trauma surgeons use in order to recommend THA for patients with hip osteoarthritis. MATERIALS AND METHODS: From 10/2019 to 07/2020 we conducted a nation-wide survey among 218 orthopaedic and trauma surgeons about their criteria for and against THA surgery, as well as their treatment objectives. RESULTS: 147 fully completed questionnaires were analysed. Pain (99%), limitation of movement (99%), as well as impairment of walking distance (97%), and the subjective burden (97%) were the most frequent criteria. 97% and 96% of surgeons consider prescription of analgesics and physical therapy, as well as a lack of their effectiveness, as criteria for THA. 87% see radiological changes grade Kellgren & Lawrence III as threshold. A recommendation against surgery is triggered by obesity (BMI ≥ 40 kg/m2) in 48% and by the presence of an active infection in 96%. CONCLUSIONS: Current surgeons' practice criteria of recommendations for THA in Germany seem to reflect widely nationally and internationally discussed recommendations. Particular attention is given to patient factors like pain, loss of function and subjective burden, as well as previous conservative treatment and contraindications, like poorly controlled diabetes or an active infection, whereas morbid obesity is not seen as contraindication by all surgeons.

Comparison of different rating scales for the use in Delphi studies: different scales lead to different consensus and show different test-retest reliability.

BACKGROUND: Consensus-orientated Delphi studies are increasingly used in various areas of medical research using a variety of different rating scales and criteria for reaching consensus. We explored the influence of using three different rating scales and different consensus criteria on the results for reaching consensus and assessed the test-retest reliability of these scales within a study aimed at identification of global treatment goals for total knee arthroplasty (TKA). METHODS: We conducted a two-stage study consisting of two surveys and consecutively included patients scheduled for TKA from five German hospitals. Patients were asked to rate 19 potential treatment goals on different rating scales (three-point, five-point, nine-point). Surveys were conducted within a 2 week period prior to TKA, order of questions (scales and treatment goals) was randomized. RESULTS: Eighty patients (mean age 68 ± 10 years; 70% females) completed both surveys. Different rating scales (three-point, five-point and nine-point rating scale) lead to different consensus despite moderate to high correlation between rating scales (r = 0.65 to 0.74). Final consensus was highly influenced by the choice of rating scale with 14 (three-point), 6 (five-point), 15 (nine-point) out of 19 treatment goals reaching the pre-defined 75% consensus threshold. The number of goals reaching consensus also highly varied between rating scales for other consensus thresholds. Overall, concordance differed between the three-point (percent agreement [p] = 88.5%, weighted kappa [k] = 0.63), five-point (p = 75.3%, k = 0.47) and nine-point scale (p = 67.8%, k = 0.78). CONCLUSION: This study provides evidence that consensus depends on the rating scale and consensus threshold within one population. The test-retest reliability of the three rating scales investigated differs substantially between individual treatment goals. This variation in reliability can become a potential source of bias in consensus studies. In our setting aimed at capturing patients' treatment goals for TKA, the three-point scale proves to be the most reasonable choice, as its translation into the clinical context is the most straightforward among the scales. Researchers conducting Delphi studies should be aware that final consensus is substantially influenced by the choice of rating scale and consensus criteria.

Which disease-related factors influence patients' and physicians' willingness to consider joint replacement in hip and knee OA? Results of a questionnaire survey linked to claims data.

BACKGROUND: A great heterogeneity in total joint replacement (TJR) rates has been reported for osteoarthritis (OA), most likely arising from a gap between patients' and physicians' views on the need for TJR. The purpose of this study therefore was to analyze potential cofactors which might influence the desire of patients to undergo TJR and physicians' willingness to discuss surgery with their patients. METHODS: A total of 8995 patients in Germany with a claims data diagnosis of hip or knee OA or polyarthrosis were asked to complete a questionnaire for this cross-sectional study of sociodemographic factors, indicators of current joint function (WOMAC score), willingness to undergo TJR and whether they had already discussed TJR with a physician. The overall response rate was 40%. Responders with polyarthrosis and individuals without current or chronic symptoms in the corresponding joints, pain in already replaced joints or simultaneous symptomatic hip and knee OA were excluded. We linked the survey results to claims data. Separate logistic regression models were used to assess which parameters were associated with patients' willingness to undergo TJR and physicians' discussion of surgery. RESULTS: We analyzed 478 hip OA and 932 knee OA patients. Just 17% with hip OA and 14% with knee OA were willing to undergo TJR, although 44 and 45% had already discussed surgery with their physicians. Patients' willingness was associated with higher WOMAC scores, a deterioration of symptoms over the last 2 years, and previous TJR for another joint. The discussion with a physician was influenced by the impact on personal life and previous arthroplasty. Older age (odds Ratio (OR) 1.2 per 10 years), male sex (OR 0.69 vs female), longer symptom duration (OR 1.08 per 5 years), deterioration of symptoms (OR 2.0 vs no change/improvement), a higher WOMAC score (OR 1.3 per 10% deterioration) and reduced well-being (OR 1.1 per 10% deterioration) were associated with physician discussion in knee OA patients. CONCLUSIONS: The proportion of patients willing to undergo TJR is lower than the proportion in whom physicians discuss surgery. While previous TJR seems to enhance patients' and surgeons' willingness, the influence of other cofactors is heterogeneous.

Core outcome domains in incontinence-associated dermatitis research.

AIM: To report the development of a core set of outcome domains for clinical research involving adults with incontinence-associated dermatitis or at risk, independently from any geographical location or skin colour. BACKGROUND: The management of incontinence-associated dermatitis is important in caring for incontinent patients. The lack of comparability of clinical trial outcomes is a major challenge in the field of evidence-based incontinence-associated dermatitis prevention and treatment. Core outcome sets may therefore be helpful to improve the value of clinical incontinence-associated dermatitis research. DESIGN: Systematic literature review, patient interviews and consensus study using Delphi procedure. METHODS: A list of outcome domains was generated through a systematic literature review (no date restrictions-April 2016), consultation of an international steering committee and three patient interviews. The project team reviewed and refined the outcome domains prior to starting a three-round Delphi procedure conducted between April-September 2017. The panellists, including healthcare providers, researchers and industry were invited to rate the importance of the outcome domains. RESULTS: We extracted 1,852 outcomes from 244 articles. Experts proposed 56 and patients 32 outcome domains. After refinement, 57 panellists from 17 countries rated a list of 58 outcome domains. The final list of outcome domains includes erythema, erosion, maceration, IAD-related pain and patient satisfaction. CONCLUSION: Erythema, erosion, maceration, incontinence-associated dermatitis -related pain and patient satisfaction are the most important outcome domains to be measured in incontinence-associated dermatitis trials. Based on this international consensus on what to measure, the question of how to measure these domains now requires consideration. Registration: This project has been registered in the Core Outcome Measures in Effectiveness Trials (COMET Initiative) database and is part of the Cochrane Skin Group-Core Outcomes Set Initiative (CSG-COUSIN).

[Prescription frequency of physical therapy and analgesics before total hip and knee arthroplasy : An epidemiological analysis of routine health care data from Germany]. / Verordnungshäufigkeit physikalischer Therapien und Analgetika vor dem Einsatz einer Hüft- bzw. Kniegelenks-Endoprothese : Eine versorgungsepidemiologische Analyse basierend auf GKV-Routinedaten aus Deutschland.

BACKGROUND: Osteoarthritis of the hip or knee joint is a widespread disease with a strong influence on the quality of life. At present, the extent of conservative treatment with physical therapies and analgesics before the use of a total joint arthroplasty (TJA) of the hip or knee is largely unclear in Germany. OBJECTIVES: The aim was to analyze the prescription frequency according to regional and socio-demographic factors. MATERIALS AND METHODS: Based on routine health care data from BARMER insurance, patients who received a TJA of the hip or knee from 2011 to 2013 were analyzed. Included were consistently insured patients with the main discharge diagnosis of osteoarthritis who did not receive any further TJA for eight quarters before and after replacement. The prescription frequency of physical therapies and analgesics, stratified according to age groups, gender, number of comorbidities and federal state was analyzed. RESULTS: 40,242 persons with hip TJA and 35,652 persons with knee TJA were included. In the year prior to surgery, 49.4% of patients (hip TJA: 49.9%; knee TJA: 48.9%) received at least one physical therapy and 81.0% were prescribed analgesics. Regionally, the prescription frequency of physical therapies for hip TJA varied between 35.7% (Bremen) and 70.6% (Saxony) and for knee TJA between 37.6% (Saarland) and 66.9% (Saxony). CONCLUSION: The prescription frequency of physical therapy does not fully correspond to current treatment recommendations. The prescription of physical therapies in the year before the TEP shows regional differences, with fundamentally lower prescription frequencies in the former states of West Germany.

Reliability of specific physical examination tests for the diagnosis of shoulder pathologies: a systematic review and meta-analysis.

BACKGROUND: Shoulder pain in the general population is common and to identify the aetiology of shoulder pain, history, motion and muscle testing, and physical examination tests are usually performed. OBJECTIVE: The aim of this systematic review was to summarise and evaluate intrarater and inter-rater reliability of physical examination tests in the diagnosis of shoulder pathologies. METHODS: A comprehensive systematic literature search was conducted using MEDLINE, EMBASE, Allied and Complementary Medicine Database (AMED) and Physiotherapy Evidence Database (PEDro) through 20 March 2015. Methodological quality was assessed using the Quality Appraisal of Reliability Studies (QAREL) tool by 2 independent reviewers. RESULTS: The search strategy revealed 3259 articles, of which 18 finally met the inclusion criteria. These studies evaluated the reliability of 62 test and test variations used for the specific physical examination tests for the diagnosis of shoulder pathologies. Methodological quality ranged from 2 to 7 positive criteria of the 11 items of the QAREL tool. CONCLUSIONS: This review identified a lack of high-quality studies evaluating inter-rater as well as intrarater reliability of specific physical examination tests for the diagnosis of shoulder pathologies. In addition, reliability measures differed between included studies hindering proper cross-study comparisons. TRIAL REGISTRATION NUMBER: PROSPERO CRD42014009018.

What Do Patients Expect From Total Knee Arthroplasty? A Delphi Consensus Study on Patient Treatment Goals.

BACKGROUND: Although total knee arthroplasty (TKA) is among the most frequent orthopedic procedures for end-stage knee osteoarthritis (OA), systematically developed patient treatment goals for this elective intervention are missing. This constitutes a relevant barrier toward patient-centered healthcare. METHODS: A Delphi consensus study was conducted. Patients who were candidates for TKA were recruited through 11 outpatient orthopedic surgeons, 4 physiotherapists, and a patient organization in Germany. The initial questionnaire included 20 potential treatment goals derived from a systematic review on outcomes assessed in TKA trials. Patients were asked to rate these potential treatment goals as "main goal," "secondary goal," or "no goal." It was specified that a main goal must be met to consider TKA as successful. Patients could add further goals which were included in the next questionnaire together with a feedback on their own and the group's previous rating. Patients could then confirm or revise their responses to find group consensus, which was defined as ≥70% of participants rating a treatment goal as main goal. RESULTS: From initial 108 participants, 93 (86%) completed the study. Consensus was achieved that symptom reduction ("pain reduction," "improvement of stability"), functional improvements (improvement of "physical function," "range of motion," "walking distance," "walking stairs," "physical activity"), "improvement of quality of life," and prevention and safety concerns ("prevention from secondary impairments," "long implant survival") are the main treatment goals of patients who are candidates for TKA. CONCLUSION: Physicians should consider patient treatment goals in routine clinical decision making to meet the requirements of patient-centered healthcare. Researchers should consider those treatment goals in effectiveness studies on TKA.

Outcome Assessment in Total Knee Arthroplasty: A Systematic Review and Critical Appraisal.

BACKGROUND: The Outcome Measures in Rheumatology (OMERACT) initiative developed a core outcome set (COS) of domains to assess effectiveness of interventions for knee osteoarthritis. These domains (pain, physical function, patient global assessment, imaging at 1 year) should be assessed in every trial to make research evidence meaningful and comparable. We systematically evaluated and critically appraised the use of measurement instruments and outcome domains in prospective studies evaluating patients with knee osteoarthritis undergoing total knee arthroplasty (TKA) and assessed their accordance with the OMERACT COS. METHODS: Literature search was performed until August 26, 2014, in Medline and Embase. Clinical trials and prospective observational studies with ≥50 participants and a follow-up of ≥1 year were included. We collected general study characteristics, comprehensive information on measurement instruments, and corresponding domains used. RESULTS: This systematic review identified low accordance of used outcome domains with the OMERACT COS of domains published in 1997. Only 4 of 100 included studies included all recommended core domains. Pain (85% of studies) and physical function (86%) were assessed frequently, whereas patient global assessment (21%) and joint imaging (≥1 year; 27%) were rarely assessed. There was substantial heterogeneity in the use of measurement instruments (n = 111) investigating TKA. CONCLUSION: More efforts are required to implement the existing COS. In addition, a more consistent use of adequate measurement instruments is important to make research evidence on TKA more relevant, better comparable, and thus more useful for guideline developers and clinical decision makers.

Evaluation of a Digital Decision Aid for Knee Replacement Surgery.

BACKGROUND: We studied whether an individualized digital decision aid can improve decision-making quality for or against knee arthroplasty. METHODS: An app-based decision aid (EKIT tool) was developed and studied in a stepped-wedge, cluster-randomized trial. Consecutive patients with knee osteoarthritis who were candidates for knee replacement were included in 10 centers in Germany. All subjects were asked via app on a tablet about their symptoms, prior treatments, and preferences and goals for treatment. For the subjects in the intervention group, the EKIT tool was used in the doctor-patient discussion to visualize the individual disease burden and degree of fulfillment of the indication criteria, and structured information on knee arthroplasty was provided. In the control group, the discussion was conducted without the EKIT tool in accordance with the local standard in each participating center. The primary endpoint was the quality of the patient's decision on the basis of the discussion of indications, as measured with the Hip and Knee Quality Decision Instrument (HK-DQI). (Registration number: ClinicalTrials.gov:NCT04837053). RESULTS: 1092 patients were included, and data from 1055 patients were analyzed (616 in the intervention group and 439 in the control group). Good decision quality, as rated by the HKDQI, was achieved by 86.0% of patients in the intervention group and 67.4% of patients in the control group (relative risk, 1.24; 95 % confidence interval, [1.15; 1.33]). CONCLUSION: A digital decision aid significantly improved the quality of decision-making for or against knee replacement surgery. The widespread use of this instrument may have an even larger effect, as this trial was conducted mainly in hospitals with high case numbers.

Evidence gaps in conservative non-pharmacological interventions and guideline implementation for high-burden non-communicable diseases: protocol for an overview of reviews.

Non-communicable diseases (NCDs) represent a high burden for the society and affected individuals. Conservative non-pharmacological interventions play a first-line role in the treatment and management of most NCDs. Systematic reviews (SRs) provide the highest level of evidence and significantly influence clinical decision-making. The primary aim of this study is to provide an overview of the evidence on the effectiveness of recommended conservative non-pharmacological interventions for highly burdensome NCDs. The secondary aim is to provide an overview of the evidence for guideline implementation. A literature search was performed in Medline (PubMed), EMBASE and Cochrane CENTRAL. Six reviewers will, in duplicate, independently screen and select studies following eligibility criteria. The population will include individuals with NCDs from disease categories chosen based on WHO burden of disease data and the importance of conservative rehabilitation for their management. Eligible interventions will encompass conservative non-pharmacological approaches recommended by clinical practice guidelines (ie, physical, psychological and education/advice). Eligible comparator will include no or minimal intervention and other competitive interventions. Outcomes will comprise proposed core outcomes for the respective diseases, including patient-reported (eg, pain) and performance-based (eg, physical functioning) outcomes. SRs published in the last 5 years as peer-reviewed journal article in the English language will be eligible. The overview will be reported in accordance with the Preferred Reporting Items for Overviews of reviews.

Supporting regional pandemic management by enabling self-service reporting-A case report.

BACKGROUND: The COVID-19 pandemic revealed a need for better collaboration among research, care, and management in Germany as well as globally. Initially, there was a high demand for broad data collection across Germany, but as the pandemic evolved, localized data became increasingly necessary. Customized dashboards and tools were rapidly developed to provide timely and accurate information. In Saxony, the DISPENSE project was created to predict short-term hospital bed capacity demands, and while it was successful, continuous adjustments and the initial monolithic system architecture of the application made it difficult to customize and scale. METHODS: To analyze the current state of the DISPENSE tool, we conducted an in-depth analysis of the data processing steps and identified data flows underlying users' metrics and dashboards. We also conducted a workshop to understand the different views and constraints of specific user groups, and brought together and clustered the information according to content-related service areas to determine functionality-related service groups. Based on this analysis, we developed a concept for the system architecture, modularized the main services by assigning specialized applications and integrated them into the existing system, allowing for self-service reporting and evaluation of the expert groups' needs. RESULTS: We analyzed the applications' dataflow and identified specific user groups. The functionalities of the monolithic application were divided into specific service groups for data processing, data storage, predictions, content visualization, and user management. After composition and implementation, we evaluated the new system architecture against the initial requirements by enabling self-service reporting to the users. DISCUSSION: By modularizing the monolithic application and creating a more flexible system, the challenges of rapidly changing requirements, growing need for information, and high administrative efforts were addressed. CONCLUSION: We demonstrated an improved adaptation towards the needs of various user groups, increased efficiency, and reduced burden on administrators, while also enabling self-service functionalities and specialization of single applications on individual service groups.

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.