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.

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.

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.

[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.

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.

Total knee arthroplasty in post-traumatic osteoarthritis is more challenging, but results in similar patient satisfaction - An analysis of 1646 cases.

BACKGROUND: Patients with post-traumatic osteoarthritis (PTOA) present a variety of technical challenges to surgeons. Surgical parameters, complication rates and patient-reported outcomes (PROs) have been reported as detrimental in total knee arthroplasty (TKA) for PTOA. The purpose of this study was to compare these variables and satisfaction with the results of TKA in patients with post-traumatic osteoarthritis with a matched-pair cohort of primary osteoarthritis (POA). METHODS: A registry-embedded prospective case-control study was performed. Of a total of 1646 TKAs, 155 were performed due to PTOA between 2012 and 2019. One-hundred and thirty-six could be one-to-one propensity score-matched to patients with POA undergoing primary TKA based on similar patient demographic variables. Outcomes investigated included operation time, estimated blood loss, types of implants, postoperative complications and PROs pre- and 1 year postoperatively as well as satisfaction with the results of surgery. Sub-cohort analysis was performed for patients with prior fracture and soft tissue trauma, respectively. RESULTS: Surgical parameters were significantly different in disadvantages of PTOA: operation time (P < 0.001), estimated blood loss (P < 0.001), blood transfusions (P = 0.039), type of implants (P < 0.001). Manipulation under anaesthesia (MUA) was necessary more often in the PTOA fracture group (odds ratio 5.01, (95% confidence interval 1.04; 24.07). PRO demonstrated no substantial differences after 1 year. Satisfaction with the results of TKA was as equally high in all cohorts. CONCLUSIONS: This study demonstrated that TKAs in patients with PTOA require higher surgical effort but can result in similar PROs and satisfaction compared to POA, regardless of the underlying trauma.

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.

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.

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.

Regional responsibility and coordination of appropriate inpatient care capacities for patients with COVID-19 - the German DISPENSE model.

As of late 2019, the COVID-19 pandemic has been a challenge to health care systems worldwide. Rapidly rising local COVID-19 incidence rates, result in demand for high hospital and intensive care bed capacities on short notice. A detailed up-to-date regional surveillance of the dynamics of the pandemic, precise prediction of required inpatient capacities of care as well as a centralized coordination of the distribution of regional patient fluxes is needed to ensure optimal patient care. In March 2020, the German federal state of Saxony established three COVID-19 coordination centers located at each of its maximum care hospitals, namely the University Hospitals Dresden and Leipzig and the hospital Chemnitz. Each center has coordinated inpatient care facilities for the three regions East, Northwest and Southwest Saxony with 36, 18 and 29 hospital sites, respectively. Fed by daily data flows from local public health authorities capturing the dynamics of the pandemic as well as daily reports on regional inpatient care capacities, we established the information and prognosis tool DISPENSE. It provides a regional overview of the current pandemic situation combined with daily prognoses for up to seven days as well as outlooks for up to 14 days of bed requirements. The prognosis precision varies from 21% and 38% to 12% and 15% relative errors in normal ward and ICU bed demand, respectively, depending on the considered time period. The deployment of DISPENSE has had a major positive impact to stay alert for the second wave of the COVID-19 pandemic and to allocate resources as needed. The application of a mathematical model to forecast required bed capacities enabled concerted actions for patient allocation and strategic planning. The ad-hoc implementation of these tools substantiates the need of a detailed data basis that enables appropriate responses, both on regional scales in terms of clinic resource planning and on larger scales concerning political reactions to pandemic situations.

EFORT recommendations for off-label use, mix & match and mismatch in hip and knee arthroplasty.

Off-label use is frequently practiced in primary and revision arthroplasty, as there may be indications for the application of implants for purposes outside the one the manufacturers intended.Under certain circumstances, patients may benefit from selective application of mix & match. This can refer to primary hip arthroplasty (if evidence suggests that the combination of devices from different manufacturers has superior results) and revision hip or knee arthroplasty (when the exchange of one component only is necessary and the invasiveness of surgery can be reduced).Within the EFORT 'Implant and Patient Safety Initiative', evidence- and consensus-based recommendations have been developed for the safe application of off-label use and mix & match in primary as well as revision hip and knee arthroplasty.Prior to the application of a medical device for hip or knee arthroplasty off-label and within a mix & match situation, surgeons should balance the risks and benefits to the patient, obtain informed consent, and document the decision process appropriately.Nevertheless, it is crucial for surgeons to only combine implants that are compatible. Mismatch of components, where their sizes or connections do not fit, may have catastrophic effects and is a surgical mistake.Surgeons must be fully aware of the features of the components that they use in off-label indications or during mix & match applications, must be appropriately trained and must audit their results.Considering the frequent practice of off-label and mix & match as well as the potential medico-legal issues, further research is necessary to obtain more data about the appropriate indications and outcomes for those procedures. Cite this article: EFORT Open Rev 2021;6:982-1005. DOI: 10.1302/2058-5241.6.210080.

Total Hip Replacement for Osteoarthritis-Evidence-Based and Patient-Oriented Indications.

BACKGROUND: Total Hip Replacement (THR) belongs to the most common inpatient operations in Germany, with over 240 000 procedures performed per year. 90% of the artificial joints are still functional at 15 years, and up to 60% at 20 years after surgery. It is essential that the indications for such procedures should be uniform, appropriate, and patient-oriented. METHODS: This review is based on publications retrieved by a systematic literature search for national and international guidelines and systematic reviews on the topic of hip osteoarthritis and THR. RESULTS: THR should be performed solely with radiologically demonstrated advanced osteoarthritis of the hip (Kellgren and Lawrence grade 3 or 4), after at least three months of conservative treatment, and in the presence of high subjective distress due to symptoms arising from the affected hip joint. Contraindications include refractory infection, acute or chronic accompanying illnesses, and BMI ≥= 40 kg/m2. Patients should stop smoking at least one month before surgery. In patients with diabetes mellitus, preoperative glycemic control to an HbA1c value below 8% is advisable. It is recommended that patients should lower their weight below a BMI of 30 kg/m2. CONCLUSION: The decision to perform THR should be taken together by both the physician and the patient when the expected treatment benefit outweighs the risks. Evidence suggests that a worse preoperative condition is associated with a poorer surgical outcome.

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.

Machine learning for identifying relevant publications in updates of systematic reviews of diagnostic test studies.

Updating systematic reviews is often a time-consuming process that involves a lot of human effort and is therefore not conducted as often as it should be. The aim of our research project was to explore the potential of machine learning methods to reduce human workload. Furthermore, we evaluated the performance of deep learning methods in comparison to more established machine learning methods. We used three available reviews of diagnostic test studies as the data set. In order to identify relevant publications, we used typical text pre-processing methods. The reference standard for the evaluation was the human-consensus based on binary classification (inclusion, exclusion). For the evaluation of the models, various scenarios were generated using a grid of combinations of data preprocessing steps. Moreover, we evaluated each machine learning approach with an approach-specific predefined grid of tuning parameters using the Brier score metric. The best performance was obtained with an ensemble method for two of the reviews, and by a deep learning approach for the other review. Yet, the final performance of approaches strongly depends on data preparation. Overall, machine learning methods provided reasonable classification. It seems possible to reduce human workload in updating systematic reviews by using machine learning methods. Yet, as the influence of data preprocessing on the final performance seems to be at least as important as choosing the specific machine learning approach, users should not blindly expect a good performance by solely using approaches from a popular class, such as deep learning.

Methods of spatial cluster detection in rare childhood cancers: Benchmarking data and results from a simulation study on nephroblastoma.

The potential existence of spatial clusters in childhood cancer incidence is a debated topic. Identification of rare disease clusters in general may help to better understand disease etiology and develop preventive strategies against such entities. The incidence of newly diagnosed childhood malignancies under 15 years of age is 140/1,000,000. In this context, the subgroup of nephroblastoma represents an extremely rare entity with an annual incidence of 7/1,000,000. We evaluated widely used statistical approaches for spatial cluster detection in childhood cancer (Ref. Schündeln et al., 2021, Cancer Epidemiology). For the simulation study, random high risk clusters of 1 to 50 adjacent districts (NUTS-level 3, nomenclature des unités territoriales statistiques) were generated on the basis of the 402 German administrative districts. Each cluster was simulated with different relative risk levels (1 to 100). For each combination of cluster size and risk level 2000 iterations were performed. Simulated data was then analyzed by three local clustering tests: Besag-Newell method, spatial scan statistic and the Bayesian Besag-York-Mollié approach (fit by Integrated Nested Laplace Approximation). The performance characteristics of all three methods were systematically documented (sensitivity, specificity, positive/negative predictive values, exact- and minimum power, correct classification, positive/negative diagnostic likelihood and false positive/negative rate). This data article links to a Mendeley online repository which includes the raw data of simulated high-risk clusters and simulated cases on the district level for an all-childhood-malignancy scenario as well as for cases of nephroblastoma. These data was used for the evaluation of the three cluster detection methods. The R code for simulation and analysis are available from GitHub. The article also includes analyzed data summarizing the performance of the cluster detection tests in very rare disease entities, using the example of simulated nephroblastoma cases. The raw data from the study can be used for benchmarking analyses applying different spatial statistical methods systematically and evaluating their performance characteristics comparatively. The analyzed data from the nephroblastoma example can be useful to interpret the performance of the three applied local cluster detection tests in the setting of extremely rare disease entities. As a practical application, data and R code can be used for performance analyses when planning to establish surveillance systems for rare disease entities.

Statistical methods for spatial cluster detection in childhood cancer incidence: A simulation study.

BACKGROUND AND OBJECTIVE: The potential existence of spatial clusters in childhood cancer incidence is a debated topic. Identification of such clusters may help to better understand etiology and develop preventive strategies. We evaluated widely used statistical approaches to cluster detection in this context. METHODS: Incidence of newly diagnosed childhood cancer (140/1,000,000 children under 15 years) and nephroblastoma (7/1,000,000) was simulated. Clusters of defined size (1-50) were randomly assembled on the district level in Germany. Each cluster was simulated with different relative risk levels (1-100). For each combination 2000 iterations were done. Simulated data was then analyzed by three local clustering tests: Besag-Newell method, spatial scan statistic and Bayesian Besag-York-Mollié with Integrated Nested Laplace Approximation approach. The operating characteristics (sensitivity, specificity, predictive values, power and correct classification) of all three methods were systematically described. RESULTS: Performance varied considerably within and between methods, depending on the simulated setting. Sensitivity of all methods was positively associated with increasing size, incidence and RR of the high-risk area. Besag-York-Mollié showed highest specificity for minimally increased RR in most scenarios. The performance of all methods was lower in the nephroblastoma scenario compared with the scenario including all cancer cases. CONCLUSION: This study illustrates the challenge to make reliable inferences on the existence of spatial clusters based on single statistical approaches in childhood cancer. Application of multiple methods, ideally with known operating characteristics, and a critical discussion of the joint evidence seems recommendable when aiming to identify high-risk clusters.

Use of Physical Therapy in Patients With Osteoarthritis in Germany: An Analysis of a Linkage of Claims and Survey Data.

OBJECTIVE: To examine the utilization of physical therapy (PT) and predictors for its use in individuals with osteoarthritis (OA) while focusing on sociodemographic and disease-related factors. METHODS: For this cross-sectional study, 657,807 patients (age 30-79 years) diagnosed with hip, knee, or polyarticular OA were identified in claims data. In 2016, a questionnaire including information on disease status, demography, and socioeconomics was sent to a random sample of 8,995 patients stratified by sex, age, and type of diagnosis. Claims data from 2016 included the utilization and type of PT, as well as the prescribing medical specialist, and were linked to questionnaire data. Multivariable logistic regression was conducted to determine variables associated with the use of PT. RESULTS: In total, 3,564 (40%) patients completed the questionnaire and agreed to linking questionnaire and claims data (69% female, mean age 66.5 years). In 2016, 50% of the study population received PT at least once, and women received it more frequently than men (53% versus 43%). Most PT was prescribed by orthopedists (45%) and general practitioners (32%). Multivariable logistic regression showed that women, higher household income, having both hip and knee OA, lower functional status, higher disease activity, and individuals living in the eastern, southern, and western states of Germany were associated with an increased utilization of PT. CONCLUSION: Considering current guideline recommendations and that more than one-third of OA patients with high functional impairment and/or pain did not receive PT in the last 12 months, there is considerable potential for improvement. This is especially true for men and individuals with a low income.

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.