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.

Guideline-Adherent Physiotherapy for Patients With Hip and Knee Osteoarthritis in Germany: Protocol for an Implementation Research Project Using the Theoretical Domains Framework and the Behavior Change Wheel.

BACKGROUND: Hip and knee osteoarthritis is common and leads to pain, stiffness, and disability. Clinical practice guidelines provide recommendations based on the best available evidence to assist health care professionals and patients in clinical decision-making. However, several studies have reported a gap between guideline recommendations and clinical practice in physiotherapy. Improved implementation strategies and the removal of existing barriers may facilitate the transfer of evidence into clinical practice and contribute to optimized quality of care. OBJECTIVE: This paper presents the protocol for a study that aims to describe the current physiotherapy practice in patients with hip and knee osteoarthritis and to investigate physiotherapists' adherence to clinical practice guidelines, to identify and specify barriers to and facilitators of guideline use and implementation, and to develop and pilot test a theory-based tailored implementation intervention aiming to increase guideline use in osteoarthritis care. METHODS: The research project is divided into 4 parts. During the first part, we will conduct a nationwide web-based survey among German physiotherapists to evaluate the current management of hip and knee osteoarthritis and to evaluate whether treatment aligns with guideline recommendations. Subsequently, semistructured interviews will be conducted to specify barriers to and facilitators of guideline use and implementation among physiotherapists (part 2). On the basis of these findings, in part 3, we will develop a theory-driven implementation intervention based on the Theoretical Domains Framework and the Behavior Change Wheel, which will be evaluated in a controlled pilot study in terms of effectiveness, feasibility, and acceptability (part 4). RESULTS: Data collection of the web-based survey among German physiotherapists (part 1) was completed in December 2021. The semistructured interviews (part 2) were conducted between January and September 2023. Recruitment of physiotherapy practices to participate in the development of the implementation intervention is expected to start in January 2024. CONCLUSIONS: This research project aims to develop a theory-driven implementation intervention to facilitate the transfer of evidence from hip and knee osteoarthritis guidelines in physiotherapy practice. We hypothesize that successful implementation will lead to increased guideline adherence in physiotherapists, which in turn will improve the quality of care. The results from our project will provide valuable knowledge concerning the development process and effectiveness of tailored implementation interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47834.

Physiotherapy for patients with hip and knee osteoarthritis in Germany: a survey of current practice.

BACKGROUND: Osteoarthritis (OA) of the hip and the knee is common and leads to pain, stiffness and disability. Clinical practice guidelines (CPG) provide recommendations to assist healthcare professionals in clinical decision-making. Although evidence-based physiotherapy has been shown to be effective in the management OA, a gap between clinical practice and guideline recommendations exists. Little is known about OA management provided by physiotherapists in Germany and whether treatment aligns with CPGs. The objectives of this study were (1) to investigate the current physiotherapy practice in patients with hip and/or knee OA in Germany, (2) to evaluate physiotherapists' adherence to guideline recommendations and (3) to explore barriers and facilitators to guideline use. METHODS: A cross-sectional online survey was conducted among physiotherapists. The questionnaire collected information on demographic characteristics, physiotherapists' management of hip and knee OA and the use of CPGs in clinical practice. Guideline adherence was evaluated by comparing the survey findings with guideline recommendations. Full adherence was assumed if all recommended treatment options were chosen. RESULTS: In total, 447 (74.9%) of 597 eligible physiotherapists completed the survey. Data from 442 participants (mean age 41.2 ± 12.8 years; 288 female (65.1%)) were included in the analysis. The most common treatment choices for both hip and knee OA were exercise therapy (hip OA: 424/442, 95.9%; knee OA: 426/442, 96.4%), self-management advice (hip OA: 413/442, 93.2%; knee OA: 395/442, 89.4%) and education (hip OA: 325/442, 73.5%; knee OA: 331/442, 74.9%), followed by manual therapy (hip OA: 311/442, 70.4%; knee OA: 311/442, 70.4%) and joint traction (hip OA: 208/442, 47.1%; knee OA: 199/442, 45.0%). Full guideline adherence was found in 17.2% (76/442) of physiotherapists for hip OA management and in 8.6% (38/442) for knee OA. Less than half of the respondents (212/430, 49.3%) were aware of an OA guideline. CONCLUSIONS: In accordance with current guideline recommendations, most physiotherapists provide exercise therapy and education for patients with hip and/or knee OA. Interventions with low or conflicting evidence were also frequently provided. The limited awareness of existing OA guidelines and the low guideline adherence indicate an insufficient implementation of CPGs in German physiotherapy practice. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00026702). Registered 14 October 2021.

Smartphone-assisted training with education for patients with hip and/or knee osteoarthritis (SmArt-E): study protocol for a multicentre pragmatic randomized controlled trial.

INTRODUCTION: Hip and knee osteoarthritis are associated with functional limitations, pain and restrictions in quality of life and the ability to work. Furthermore, with growing prevalence, osteoarthritis is increasingly causing (in)direct costs. Guidelines recommend exercise therapy and education as primary treatment strategies. Available options for treatment based on physical activity promotion and lifestyle change are often insufficiently provided and used. In addition, the quality of current exercise programmes often does not meet the changing care needs of older people with comorbidities and exercise adherence is a challenge beyond personal physiotherapy. The main objective of this study is to investigate the short- and long-term (cost-)effectiveness of the SmArt-E programme in people with hip and/or knee osteoarthritis in terms of pain and physical functioning compared to usual care. METHODS: This study is designed as a multicentre randomized controlled trial with a target sample size of 330 patients. The intervention is based on the e-Exercise intervention from the Netherlands, consists of a training and education programme and is conducted as a blended care intervention over 12 months. We use an app to support independent training and the development of self-management skills. The primary and secondary hypotheses are that participants in the SmArt-E intervention will have less pain (numerical rating scale) and better physical functioning (Hip Disability and Osteoarthritis Outcome Score, Knee Injury and Osteoarthritis Outcome Score) compared to participants in the usual care group after 12 and 3 months. Other secondary outcomes are based on domains of the Osteoarthritis Research Society International (OARSI). The study will be accompanied by a process evaluation. DISCUSSION: After a positive evaluation, SmArt-E can be offered in usual care, flexibly addressing different care situations. The desired sustainability and the support of the participants' behavioural change are initiated via the app through audio-visual contact with their physiotherapists. Furthermore, the app supports the repetition and consolidation of learned training and educational content. For people with osteoarthritis, the new form of care with proven effectiveness can lead to a reduction in underuse and misuse of care as well as contribute to a reduction in (in)direct costs. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00028477. Registered on August 10, 2022.

Adherence to evidence-based practice across healthcare professionals in Germany: results from a cross-sectional, nationwide survey.

BACKGROUND: Adherence to evidence-based practice (EBP) is considered a key competence to improve healthcare quality. In this study, we aimed to describe the EBP adherence of healthcare professionals working in Germany and to explore barriers and facilitators regarding the implementation of EBP in clinical practice. METHODS: A nationwide online survey was performed among healthcare professionals in Germany from January to April 2018 using the German version of the Evidence-based Practice Inventory (EBPI) questionnaire for a comprehensive assessment of adherence to EBP. Univariate logistic regression analyses were performed to explore the association between demographic and professional determinants and each EBPI dimension. RESULTS: We analysed data of 889 participants, including 318 physical therapists, 154 occupational therapists, 137 midwifes and 280 participants of six other healthcare professions. Approximately 70% of the participants generally demonstrated a positive attitude towards EBP and believed that EBP was useful in clinical practice. Broadly, 80% of the respondents evaluated themselves as being able to enact EBP behaviour in clinical practice. In contrast, less than 70% preferred to use quantitative information instead of their intuition to inform their habitual clinical behaviour. Still, 20 to 30% reported that EBP did not sufficiently account for their clinical experience and differences between patients. The strongest facilitators to EBP adherence across at least three dimensions of the EBPI were the availability of ≥ 60 min for scientific literature at work (OR: 9.67; 95% CI: 5.86; 16.30), followed by a master or higher academic degree (OR: 9.09, 95% CI: 5.86; 14.28) and the involvement in ≥ 1 scientific publication (OR: 7.06, 95% CI: 5.10; 9.85). CONCLUSIONS: This study showed that healthcare professionals in Germany in general had a positive attitude towards EBP although they currently do not consider EBP principles in its entirety. The most important determinant positively influencing a healthcare professional's decision to perform EBP was the time available for scientific literature at work. German healthcare professionals experience similar barriers towards the implementation of EBP in clinical practice compared to other international healthcare settings. These barriers should be targeted by future research. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00013792). Registered 19 January 2018.

Tailored GuideLine Implementation in STrokE Rehabilitation (GLISTER) in Germany. Protocol of a Mixed Methods Study Using the Behavior Change Wheel and the Theoretical Domains Framework.

Objective: Evidence-based guidelines are important for informing clinical decision-making and improving patient outcomes. There is inconsistent usage of guidelines among physical therapists involved in stroke rehabilitation, suggesting the existence of a gap between theory and practice. Addressing the German guideline "evidence-based rehabilitation of mobility after stroke (ReMoS)," the aims of this project are (1) to describe the current physical therapy practice within the context of stroke rehabilitation in Germany, (2) to evaluate barriers and facilitators of guideline usage, (3) to develop, and (4) to pilot test a theory-based, tailored implementation intervention for the benefit of guideline recommendations. Materials and Methods: This study uses a stepwise mixed methods approach for implementing a local guideline. A self-reported online questionnaire will be used to survey the current physical therapy practice in stroke rehabilitation. The same survey and systematic-mixed methods review will be used to evaluate the barriers and facilitators of guideline usage quantitatively. Semi-structured interviews will add a qualitative perspective on factors that influence ReMoS guideline implementation. The Behavior Change Wheel and Theoretical Domains Framework will be used to support the development of a tailored implementation intervention which will be pilot tested in a controlled study. Patient and physical therapy-related outcomes, as well as the appropriateness, such as acceptance and feasibility of the tailored implementation intervention, will be analyzed. Conclusion: This will be the first endeavor to implement a guideline in German stroke rehabilitation with a focus on changing care provider behavior based on the knowledge of current practice and determining factors using a tailored and theory-based intervention.

Current physical therapy practice and implementation factors regarding the evidence-based 'Rehabilitation of Mobility after Stroke (ReMoS)' guideline in Germany: a cross-sectional online survey.

BACKGROUND: Evaluation of the current physical therapy practice for German stroke rehabilitation with respect to the 'Rehabilitation of Mobility after Stroke (ReMoS)' guideline recommendations and the associated implementation factors. METHODS: A descriptive cross-sectional study employing an online survey was performed among German physical therapists in 2019. The survey consisted of three sections with open and closed questions: 1) self-reported use of ReMoS recommendations, 2) barriers of guideline use and 3) socio-demographic characteristics. The benchmark level for guideline adherent physical therapy was set at > 80%. RESULTS: Data from 170 questionnaires were eligible for analysis. Participants' mean age was 41.6 years, 69.4% were female, while 60.1% had no academic degree. The ReMoS guideline was unknown to 52.9% of the responders. Out of all the 46 ReMoS guideline recommendations, only 'intensive walking training without a treadmill' was reported to be performed in a guideline adherent manner. Respondents usually denied any personal limitations, such as limited knowledge, or that the ReMoS guideline did not fit their routine practice. CONCLUSIONS: Among German physical therapists, the ReMoS guideline is not well-known and many interventions are not performed as recommended, illustrating the discrepancies between the ReMoS guideline recommendations and current physical therapy practice. Interventions aimed at overcoming this gap should consider both knowledge of existing barriers and facilitators of guideline usage. TRIAL REGISTRATION: The study was retrospectively registered to the German Clinical Trials Register ( DRKS00026681 ).

[Adherence to and influencing factors of evidence-based practice in physiotherapeutic care in Germany: a cross-sectional study]. / Adhärenz und Einflussfaktoren evidenzbasierter Praxis in der physiotherapeutischen Versorgung in Deutschland ­ eine Querschnittstudie.

BACKGROUND: The implementation of evidence-based practice (EBP) is a central goal in health care. As in other areas, the transfer of scientific knowledge into clinical practice is very delayed or incomplete in physiotherapy. The primary aim of the present study is to describe the adherence to EBP among physiotherapists working in Germany. The secondary goal is the exploratory analysis of selected factors influencing the implementation of EBP. METHODS: The present exploratory analysis is based on the data of physiotherapists who participated in a cross-sectional study on the use of EBP by health care professionals (study registration no.: DRKS00013792). The participants in the online survey completed the "Evidence-based Practice Inventory", a questionnaire with five dimensions used to quantify the adherence to EBP. Univariable and multivariable regression analysis was used to examine the associations between various sociodemographic characteristics and EBP. RESULTS: 318 physiotherapists participated in the survey (age: 37±12 years; 60 % female; professional experience: 14±11 years). Approximately 70-80 % of the participants, in principle, had a positive attitude towards EBP and perceived EBP as helpful and useful in clinical practice. About 60 % of the respondents felt able to apply the principles of the EBP (e. g., acquisition, appraisal and application of external evidence). However, the data also showed that the implementation of EBP in clinical physiotherapeutic care is insufficient. For example, only 20 % of the respondents reported that their facility paid great attention to applying the principles of the EBP in decision-making, and only about a third of the respondents said that they frequently searched for or used external evidence. The strongest facilitators of EBP include the participation in scientific publications and more than one hour per week to read scientific literature at work. CONCLUSION: In principle, physiotherapists in Germany have a positive attitude towards EBP, but currently do not adequately take into account the principles of EBP. These factors should be further analyzed and targeted through effective interventions.

Physical therapy for patients with low back pain in Germany: a survey of current practice.

BACKGROUND: Low back pain (LBP) is one of the most common musculoskeletal disorders worldwide. The National Disease Management Guideline (NVL) "Non-specific LBP" is a practical decision-making aid for both physicians and non-medical professionals in Germany to improve quality of health care. Although LBP is the most frequent diagnosis resulting in physical therapy treatment, information on the current management of patients with LBP and guideline adherence is limited. The objective of this study was to evaluate the current physical therapy management of patients with LBP in Germany, and to explore guideline adherence to the NVL "Non-specific LBP" recommendations. METHODS: An online survey among physical therapists working in Germany was conducted based on the recommendations given in the NVL "Non-specific LBP". Participants were recruited using a snowball sampling approach and invited to complete the questionnaire. Guideline adherence was evaluated by comparing the survey findings with the recommendations of the NVL. RESULTS: In total, 1361 physical therapists (41 years of age (SD 11); 839 female, 514 male; 16 years of clinical experience (SD 10)) completed the survey. Fifty percent (n = 675) of our respondents adhered to the recommendations of the NVL on the therapeutic diagnostic process, and 72% (n = 973) to the recommendations concerning treatment. The guideline adherence across the entire management process (i.e., both diagnosis and treatment) of LBP was 38% (n = 513). German physical therapists predominantly provide active interventions, e.g., exercise therapy, but also use interventions with low or conflicting evidence, respectively. Massage and Kinesio Taping were frequently used despite being not recommended. Less than one third of study participants (n = 400, 29%) answered to know the NVL or had dealt with its recommendations. CONCLUSIONS: In the management of LBP, overall guideline adherence among German physical therapists was 38% with higher adherence in the treatment section than in the physical therapeutic diagnostic process. Widespread employment of implementation strategies and removal of existing barriers against the application of evidence-based guidelines could facilitate the transfer of scientific evidence into clinical practice and contribute to optimize the quality of health care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00012607). Registered 04 October 2017.

Effects of a movement control and tactile acuity training in patients with nonspecific chronic low back pain and control impairment - a randomised controlled pilot study.

BACKGROUND: Nonspecific chronic low back pain (NSCLBP) is a heterogeneous condition that is associated with complex neuromuscular adaptations. Exercise is a widely administered treatment, but its effects are small to moderate. Tailoring patient-specific exercise treatments based on subgroup classification may improve patient outcomes. OBJECTIVE: In this randomised controlled pilot study, our objective was to compare the feasibility and possible effects of a specific sensorimotor treatment (SMT) with those of a general exercise (GE) programme on patients with NSCLBP and control impairment (CI). METHODS: Patients with NSCLBP and CI were randomised into an SMT or a GE programme spanning 6 sessions each. The feasibility criteria included the study design, assessments, interventions and magnitudes of effects, and costs. Adverse events were documented. Primary (pain, physical function, and quality of life) and secondary outcomes were assessed three times: twice at baseline (t1a and t1b) to estimate parameter stability and once after the intervention (t2). RESULTS: Two-hundred and twenty-seven patients were screened to include 34 participants with NSCLBP and CI. Both treatment programmes and the assessments seemed feasible because their durations and contents were perceived as adequate. The total cost per participant was €321. Two adverse events occurred (one not likely related to the SMT, one likely related to the GE intervention). The SMT showed a tendency for superior effects in terms of pain severity (SMT t1a 3.5, t2 1.1; GE t1a 3.0, t2 2.0), pain interference (SMT t1a 1.9, t2 0.4; GE t1a 1.5, t2 0.9), physical component of quality of life (SMT t1a 39, t2 46; GE t1a 45, t2 48), and movement control. CONCLUSIONS: The SMT approach proposed in this study is feasible and should be tested thoroughly in future studies, possibly as an addition to GE. To ensure the detection of differences in pain severity between SMT and GE in patients with NSCLBP with 80% power, future studies should include 110 patients. If the current results are confirmed, SMT should be considered in interventions for patients with NSCLBP and CI. TRIAL REGISTRATION: Registered in the German Register for Clinical Trials (Trial registration date: November 11, 2016; Trial registration number: DRKS00011063 ; URL of trial registry record); retrospectively registered.

Patient, physiotherapist and surgeon endorsement of the core domain set for total hip and total knee replacement in Germany: a study protocol for an OMERACT initiative.

INTRODUCTION: There is a lack of harmonising measures for clinical trials on total joint replacement (TJR) that would allow for results from TJR studies to be compared or pooled. The Outcome Measures in Rheumatology (OMERACT) TJR core domain set is already endorsed among patients and physicians in the USA and Australia. Physiotherapists use different types of measurements compared to orthopaedic surgeons while both make substantial contributions to research in the field of TJR. To achieve consensus on core measurements sets, patients, physiotherapists and orthopaedic surgeons need to achieve consensus on the core domains for TJR trials. METHODS AND ANALYSIS: For this multistage study, first, the OMERACT TJR core domain set survey will be translated to German and validated according to WHO guidelines. Next, the TJR core domain set will be considered for endorsement in different German stakeholder groups including patients, physiotherapists and orthopaedic surgeons. ETHICS AND DISSEMINATION: Ethical approval for this protocol was given by the ethics committee of the Brandenburg University of Technology Cottbus-Senftenberg (BTU-CS, EK 2019-2). This article is based on the protocol version 2.5 from 6 May 2020. Anonymous data will be presented only. We will publish the results in peer-reviewed publications and at international conferences. TRIAL REGISTRATION NUMBER: German Clinical Trials Registry (DRKS00016015).

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.

Cross-cultural adaptation, internal consistency, test-retest reliability and feasibility of the German version of the evidence-based practice inventory.

BACKGROUND: A psychometrically robust measurement instrument is prerequisite to tailor and monitor interventions aiming to improve evidence-based practice (EBP). The recently developed "Evidence-based Practice Inventory" (EBPI) questionnaire (five dimensions) provides a sound inventory for a comprehensive assessment of adherence to EBP, and identification of barriers and facilitators for EBP. The aims of this study were to establish a German language version of the EBPI and to examine the instrument's reliability in a diverse sample of healthcare professionals. METHODS: The English version of the EBPI was translated, adopted and subsequently test-retest reliability of the German language EBPI was examined in a nationwide online survey. Participants working in Germany were invited to complete the questionnaire twice. For each EBPI dimension, internal consistency reliability (Cronbach's alpha) and the relative test-retest reliability (intraclass correlation coefficient, ICC) were calculated. The standard error of measurement, limits of agreement and minimal detectable change values were estimated to quantify measurement error. RESULTS: A German language version of the EBPI was established. In the online survey, the EBPI was initially completed by 889 healthcare professionals. At follow-up, 344 individuals (39%) completed the questionnaire (74% female; mean work experience: 13.6 years). The ICCs for the five dimensions varied between 0.78 and 0.86. The standard error of measurement varied between 6.5 and 8.8% of the respective dimension scale range, and the limits of agreement between 24 and 37%. For internal consistency reliability, alpha varied between 0.64 and 0.90. There were neither floor nor ceiling effects, nor any other relevant feasibility issues. CONCLUSIONS: The German language EBPI can be used to assess EBP adherence of healthcare professionals in clinical practice, and to identify barriers and facilitators for an EBP conform behaviour. Results on test-retest reliability indicate that the EBPI produces reliable scores when used for group comparisons, but the questionnaire seems insufficiently reliable for individual measurements over time. Methods of item response theory or Rasch measurement theory should be used for further evaluation and revision of the EBPI, informed by the results of this study. TRIAL REGISTRATION: German Clinical Trials Register ( DRKS00013792 ). Registered 19 January 2018.

The OMERACT Core Domain Set for Clinical Trials of Shoulder Disorders.

OBJECTIVE: To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process. METHODS: At OMERACT 2018, the OMERACT Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants. RESULTS: The qualitative review (n = 8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction, was also identified, but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71% agreement, includes 4 "mandatory" trial domains: pain, function, patient global - shoulder, and adverse events including death; and 4 "important but optional" domains: participation (recreation/work), sleep, emotional well-being, and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set. CONCLUSION: OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain.

Evaluation of a New Exercise Program in the Treatment of Scapular Dyskinesis.

An abnormal motion of the scapula, or scapular dyskinesis (SD), can be effectively treated through conservative therapy. The aim of this study is to evaluate a new specific exercise program to restore normal position. A standardized and specific exercise program was created. In a prospective multi-center approach, patients were randomized into two groups: one group received the specific exercise program over a period of six weeks and the controls received massage therapy. The visual-analog scale, QuickDASH score, SICK scapula rating scale, hand press-up position test, lateral scapular slide test and internal rotation of the shoulder were evaluated. Twenty-eight patients were included in the study: fifteen in the exercise group and thirteen in the control group. Pain levels on the visual analog scale (VAS) were significantly reduced in both groups (exercise p=0.007; control p=0.004). The scores for QuickDASH (p=0.001), SICK scapula rating scale (p=0.003) and hand press-up position test (p=0.026) were significantly improved in the exercise group only. Scapula-focused exercise programs, as well as massage therapy, can effectively relieve pain in patients with SD. However, scapula-focused exercises resulted, specifically, in greater improvement of shoulder function.

Developing a core outcome domain set to assessing effectiveness of interdisciplinary multimodal pain therapy: the VAPAIN consensus statement on core outcome domains.

Interdisciplinary multimodal pain therapy (IMPT) is a biopsychosocial treatment approach for patients with chronic pain that comprises at least psychological and physiotherapeutic interventions. Core outcome sets (COSs) are currently developed in different medical fields to standardize and improve the selection of outcome domains, and measurement instruments in clinical trials, to make trial results meaningful, to pool trial results, and to allow indirect comparison between interventions. The objective of this study was to develop a COS of patient-relevant outcome domains for chronic pain in IMPT clinical trials. An international, multiprofessional panel (patient representatives [n = 5], physicians specialized in pain medicine [n = 5], physiotherapists [n = 5], clinical psychologists [n = 5], and methodological researchers [n = 5]) was recruited for a 3-stage consensus study, which consisted of a mixed-method approach comprising an exploratory systematic review, a preparing online survey to identify important outcome domains, a face-to-face consensus meeting to agree on COS domains, and a second online survey (Delphi) establishing agreement on definitions for the domains included. The panel agreed on the following 8 domains to be included into the COS for IMPT: pain intensity, pain frequency, physical activity, emotional wellbeing, satisfaction with social roles and activities, productivity (paid and unpaid, at home and at work, inclusive presentism and absenteeism), health-related quality of life, and patient's perception of treatment goal achievement. The complexity of chronic pain in a biopsychosocial context is reflected in the current recommendation and includes physical, mental, and social outcomes. In a subsequent step, measurement instruments will be identified via systematic reviews.

Indication Criteria for Total Knee Arthroplasty in Patients with Osteoarthritis - A Multi-perspective Consensus Study.

Background and Objectives Knee osteoarthritis (OA) is a significant public health burden. Rates of total knee arthroplasty (TKA) in OA vary substantially between geographical regions, most likely due to the lack of standardised indication criteria. We set out to define indication criteria for the German healthcare system for TKA in patients with knee OA, on the basis of best evidence and transparent multi-stakeholder consensus. Methods We undertook a complex mixed methods study, including an iterative process of systematic appraisal of existing evidence, Delphi consensus methods and stakeholder conferences. We established a consensus panel representing key German national societies of healthcare providers (orthopaedic surgeons, rheumatologists, pain physicians, psychologists, physiotherapists), payers, and patient representatives. A priori defined consensus criteria were at least 70% agreement and less than 20% disagreement among the consensus panel. Agreement was sought for (1) core indication criteria defined as criteria that must be met to consider TKA in a normal patient with knee OA, (2) additional (not obligatory) indication criteria, (3) absolute contraindication criteria that generally prohibit TKA, and (4) risk factors that do not prohibit TKA, but usually do not lead to a recommendation for TKA. Results The following 5 core indication criteria were agreed within the panel: 1. intermittent (several times per week) or constant knee pain for at least 3 - 6 months; 2. radiological confirmation of structural knee damage (osteoarthritis, osteonecrosis); 3. inadequate response to conservative treatment, including pharmacological and non-pharmacological treatment for at least 3 - 6 months; 4. adverse impact of knee disease on patient's quality of life for at least 3 - 6 months; 5. patient-reported suffering/impairment due to knee disease. Additional indication criteria, contraindication criteria, and risk factors for adverse outcome were also agreed by a large majority within the multi-perspective stakeholder panel. Conclusion The defined indication criteria constitute a prerequisite for appropriate provision of TKA in patients with knee OA in Germany. In eligible patients, shared-decision making should eventually determine if TKA is performed or not. The next important steps are the implementation of the defined indication criteria, and the prospective investigation of predictors of success or failure of TKA in the context of routine care provision in Germany.

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.