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Unlabelled: Total knee replacement effectively relieves arthritis pain but improvement in physical function varies. A clearer understanding of the patient attributes associated with differing levels of functional gain after TKR is critical to surgical decision making. We reviewed 8050 primary, unilateral TKR patients enrolled in a prospective registry between 2000 and 2005 who had complete data. We evaluated associations between 12-month function (SF12/PCS) and preoperative gender, age, BMI, emotional health (MCS), knee diagnosis, quadriceps strength, and physical function (PCS). More than 98% of patients reported pain relief (KS pain score). At 12 months, mean PCS gain was 13.6 points, but the distribution was bimodal. The mean gain in PCS in the 63% of patients with greater improvement was 21 (SD = 7), and 4.1 (SD = 7) in the remaining 37%. Increased likelihood of poor functional gain was associated with older age, body mass index (BMI) over 40, lower MCS, and poor quadriceps strength. While two-thirds of patients reported functional gain well above national average at 12 months post-TKR, 37% reported limited functional improvement. Further understanding of the patient attributes associated with limited improvement will guide the design of innovative strategies to improve functional outcomes.Level Of Evidence: Level II, prognostic study. See the Guidelines for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Background: The American Academy of Orthopaedic Surgeons (AAOS) Appropriate Use Criteria (AUC) for Surgical Management of Osteoarthritis of the Knee (2016) and Management of Osteoarthritis of the Hip (2017) are intended to provide treatment recommendations for osteoarthritis (OA). This study examined the agreement of AUC appropriateness classifications with arthroplasty surgeon recommendations for total knee arthroplasty (TKA) and total hip arthroplasty (THA)., Methods: The cohort included 558 OA patients (397 knee, 161 hip) referred to a specialty arthroplasty clinic. Surgeons completed the online AAOS AUC patient profiles to generate appropriateness ratings. Surgeons' recommendations for treatment were recorded. We performed univariate and bivariate analyses to evaluate relationships between AUC appropriateness and surgeon recommendations., Results: The knee OA AUC classified TKA as "appropriate" for 309 (77.8%) of the 397 knee OA patients. Surgeons recommended TKA for 123 (31.0%), resulting in 46.8% (n = 186) higher rate of "appropriate" classification by AUC than TKA recommendation by surgeons. Weighted Cohen's κ demonstrated slight agreement (κ = 0.06, 95% confidence interval: 0.04, 0.09) between AUC appropriateness and surgeon TKA recommendation. The hip OA AUC classified THA as "appropriate" for 98 (60.9%) of the 161 hip OA patients. Surgeons recommended THA for 76 (47.2%), resulting in 13.7% (n = 22) higher rate of "appropriate" classification by AUC than THA recommendation by surgeons. Weighted Cohen's κ demonstrated moderate agreement (κ = 0.47, 95% confidence interval: 0.37, 0.57) between the AUC appropriateness classification and the surgeon's THA recommendation., Conclusions: AAOS AUC guidelines indicated surgical appropriateness significantly more than arthroplasty surgeons. AUC agreed slightly with surgeons for TKA and moderately for THA., (© 2024 The Authors.)

Background: Social-emotional risk for subsequent behavioral health problems can be identified at toddler age, a period where prevention has a heightened impact. This study aimed to meaningfully engage pediatric clinicians, given the emphasis on health promotion and broad reach of primary care, to prepare an Implementation Research Logic Model to guide the implementation of a screening and referral process for toddlers with elevated social-emotional risk., Method: Using an adaptation of a previously published community partner engagement method, six pediatricians from community health centers (CHCs) comprised a Clinical Partner Work Group. The group was engaged in identifying determinants (barriers/facilitators), selecting and specifying strategies, strategy-determinant matching, a modified Delphi approach for strategy prioritization, and user-centered design methods. The data gathered from individual interviews, two group sessions, and a follow-up survey resulted in a completed Implementation Research Logic Model., Results: The Clinical Partner Work Group identified 16 determinants, including barriers (e.g., patient access to electronic devices) and facilitators (e.g., clinician buy-in). They then selected and specified 14 strategies, which were prioritized based on ratings of feasibility, effectiveness, and priority. The highest-rated strategies (e.g., integration of the screener into the electronic health record) provided coverage of all identified barriers and comprised the primary implementation strategy "package" to be used and tested., Conclusions: Clinical partners provided important context and insights for implementation strategy selection and specification to support the implementation of social-emotional risk screening and referral in pediatric primary care. The methodology described herein can improve partner engagement in implementation efforts and increase the likelihood of success. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Objective: To determine whether county-level or patient-level social risk factors are associated with patient-reported outcomes after total knee replacement when added to the comprehensive joint replacement risk-adjustment model., Data Sources and Study Setting: Patient and outcomes data from the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement cohort were merged with the Social Vulnerability Index from the Centers for Disease Control and Prevention., Study Design: This prospective longitudinal cohort measured the change in patient-reported pain and physical function from baseline to 12 months after surgery. The cohort included a nationally diverse sample of adult patients who received elective unilateral knee replacement between 2012 and 2015., Data Collection/extraction Methods: Using a national network of over 230 surgeons in 28 states, the cohort study enrolled patients from diverse settings and collected one-year outcomes after the surgery. Patients <65 years of age or who did not report outcomes were excluded., Principal Findings: After adjusting for clinical and demographic factors, we found patient-reported race, education, and income were associated with patient-reported pain or functional scores. Pain improvement was negatively associated with Black race (CI = -8.71, -3.02) and positively associated with higher annual incomes (≥$45,00) (CI = 0.07, 2.33). Functional improvement was also negatively associated with Black race (CI = -5.81, -0.35). Patients with higher educational attainment (CI = -2.35, -0.06) reported significantly less functional improvement while patients in households with three adults reported greater improvement (CI = 0.11, 4.57). We did not observe any associations between county-level social vulnerability and change in pain or function., Conclusions: We found patient-level social factors were associated with patient-reported outcomes after total knee replacement, but county-level social vulnerability was not. Our findings suggest patient-level social factors warrant further investigation to promote health equity in patient-reported outcomes after total knee replacement., (© 2023 The Authors. Health Services Research published by Wiley Periodicals LLC on behalf of Health Research and Educational Trust.)

Background: The Hip Disability and Osteoarthritis Outcome Score Joint Replacement (HOOS JR) and Knee Injury and Osteoarthritis Outcome Score Joint Replacement (KOOS JR) scores represent pain and dysfunction as a single number ranging from 0 (extreme pain and dysfunction) to 100 (no pain or functional limitations). However, scores between 0 and 100 lack a simple interpretation because they reflect varying combinations of pain levels and dysfunction. Given that most adverse events and improvement occur within the first 90 days after surgery, a deeper understanding of the level of pain and dysfunction may reveal missed opportunities for patient care., Questions/purposes: (1) What does a given preoperative or postoperative HOOS JR and KOOS JR score indicate about pain and ability to perform daily activities? (2) How much of a change in score (that is, delta) is needed to indicate significant improvement in pain control and daily functioning?, Methods: The Michigan Arthroplasty Registry Collaborative Quality Initiative contains more than 95% of THAs and TKAs performed in Michigan. Between January 2017 and March 2019, 84,175 people in the registry underwent primary THA or TKA and were potentially eligible for this retrospective, comparative study of the first 90 postoperative days. Eighty-four percent (70,608 of 84,175) were excluded because their surgeons did not attain a target survey collection proportion of 70% and another 6% (5042) were missing covariate information or surveys, leaving 10% (8525) for analysis. The mean age and percentage of women were 65 ± 11 years and 55% (2060 of 3716), respectively, for patients undergoing THA and 67 ± 9 years and 61% (2936 of 4809), respectively, for those undergoing TKA. There were no clinically meaningful differences between patients who were analyzed and those who were excluded except for lower representation of non-White patients in the analyzed group. For interpretation, patient responses to Question 7 (pain) and Question 6 (function) from the Patient-Reported Outcomes Measurement Information System global items (PROMIS-10) were dichotomized into "much pain" (rating of pain 4 to 10 of 10) versus "less pain" (rating of ≤ 3) and "good function" (able to perform most activities) versus "poor function" (not able to perform most activities) and combined into four pain-function categories. We examined the mean preoperative and postoperative HOOS JR and KOOS JR scores for each pain-function category, adjusted for patient characteristics. We calculated the size of the delta associated with an increase to a more favorable category postoperatively (versus staying in the same or worse category) via multivariable logistic regression that controlled for patient characteristics., Results: Patients in the least favorable "much pain, poor function" category preoperatively had adjusted mean scores of 40 (95% confidence interval 39 to 41) for both the HOOS JR and KOOS JR. Those with mixed levels of pain and function had mean scores between 46 and 55. Those in the most favorable "less pain, good function" category had means of 60 (95% CI 58 to 62) and 59 (95% CI 58 to 61) for the HOOS JR and KOOS JR, respectively. The adjusted delta to achieve a pain level of ≤ 3 or the ability to perform most activities was 30 (95% CI 26 to 36) on the HOOS JR and 27 (95% CI 22 to 29) on the KOOS JR scales., Conclusion: These adjusted means of the HOOS JR and KOOS JR provide context for understanding the levels of pain and dysfunction for individuals as well for patients reported in other studies. Potential quality improvement efforts could include tracking the proportion of patients with THA or TKA who achieved a sufficient delta to attain pain levels of ≤ 3 or the ability to perform most activities. Future studies are needed to understand pain and function represented by the HOOS JR and KOOS JR at 1 to 2 years, how these may differ by patient subgroups, and whether scores can be improved through quality improvement efforts., Level of Evidence: Level III, therapeutic study., Competing Interests: Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2023 by the Association of Bone and Joint Surgeons.)

Seven knowledge domains were originally defined for the learning health system (LHS) scientist. To assess proficiency in each of these domains, we developed and published an assessment tool for use by emerging LHS scientists and training programs. (LHS, October 2022). In mid-2022, the AHRQ adopted an eighth LHS knowledge domain, Equity and Justice. The addition of this eighth domain emphasizes the importance and centrality of equity in the LHS and improvement science. To extend our prior LHS competency assessment, we developed a proficiency assessment for the new equity and justice domain. Content experts and trainees iteratively defined, reviewed, and edited the assessment criteria. The items were developed by trainees and experts at one LHS training center with experience conducting research focused on healthcare inequities among marginalized populations. The proficiency assessment criteria for the Equity domain apply the same four levels of mastery: "no exposure," "foundational awareness," "emerging," and "proficient" as were used for original competencies. LHS training programs can use these proficiency criteria to monitor skills among emerging scientists across the eight domains, with particular attention to equity and justice., Competing Interests: One author (Patricia D. Franklin) receives funding from the Agency for Healthcare Research and Quality to lead a Learning Health System K12 training program. However, no authors have a conflict of interest with the work presented in this manuscript., (© 2023 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)

Objective: Expected outcomes (e.g., expected survivorship after a cancer treatment) have improved decision-making around treatment options in many clinical fields. Our objective was to evaluate the effect of expected values of 3 widely available total knee arthroplasty (TKA) outcomes (risk of serious complications, time to revision, and improvement in pain and function at 2 years after surgery) on clinical recommendation of TKA., Methods: The RAND/University of California Los Angeles appropriateness criteria method was used to evaluate the role of the 3 expected outcomes in clinical recommendation of TKA. The expected outcomes were added to 5 established preoperative factors from the modified Escobar appropriateness criteria. The 8 indication factors were used to develop 279 clinical scenarios, and a panel of 9 clinicians rated the appropriateness of TKA for each scenario as inappropriate, inconclusive, and appropriate. Classification tree analysis was applied to these ratings to identify the most influential of the 8 factors in discriminating TKA appropriateness classifications., Results: Ratings for the 279 appropriateness scenarios deemed 34.4% of the scenarios as appropriate, 40.1% as inconclusive, and 25.5% as inappropriate. Classification tree analyses showed that expected improvement in pain and function and expected time to revision were the most influential factors that discriminated among the TKA appropriateness classification categories., Conclusion: Our results showed that clinicians would use expected postoperative outcome factors in determining appropriateness for TKA. These results call for further work in this area to incorporate estimates of expected pain/function and revision outcomes into clinical practice to improve decision-making for TKA., (© 2022 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

High-income nations have established that early diagnosis and preventive treatment reduces early deaths in sickle cell disease (SCD). However, in low-/middle-income countries where SCD is common, attrition from clinical care is common. Reasons for poor retention in care are multi-factorial and poorly understood. The objective of this study was to identify factors that influence caregiver decision-making around chronic health care needs of a child with SCD. We conducted an exploratory sequential mixed methods study of caregivers of children diagnosed with SCD during a newborn screening program in Liberia. Caregivers completed questionnaires and semi-structured interviews designed to identify drivers of health decision-making. Interviews were digitally recorded, transcribed, coded, and analyzed using semi-structured thematic analysis to identify themes. Data integration occurred by using quantitative results to expand and clarify the qualitative themes. Twenty-six caregivers participated in the study. The mean age of the child at the interview was 43.7 months. Five themes influencing health decisions were identified: grief, the importance of support networks, stigma, perceived benefits, and the burden of chronic disease. The five themes crossed multiple domains of a socioecological model and identified complex interactions between family, community, social and cultural norms, and organizational structures. This study highlights the importance of community awareness of SCD and appropriate health communication by healthcare workers. Healthcare decision-making is multifactorial and complex. These results provide a framework for improving retention in care. In a low-resource country such as Liberia, much can be done by leveraging existing resources and cultural practices., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Tubman and Dr. Franklin receive travel support from the American Society of Hematology Consortium for Newborn Screening in Africa (CONSA). CONSA has no role in the study design, writing, or reviewing of this manuscript., (Copyright: © 2023 Udhayashankar et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Electronic health records (EHRs) have the potential to facilitate consistent clinical data capture to support excellence in patient care, quality improvement, and knowledge generation. Despite widespread EHR use, the vision to transform health care system and its data to a "learning health care system" generating knowledge from real-world data is limited by the lack of consistent, structured clinical data., Objective: The purpose of this paper was to demonstrate the design of a web-based structured clinical intervention data capture system and its evaluation in practice. The use case was ambulatory physical therapy (PT) treatment after total knee replacement (TKR), one of the most common and costly procedures today., Methods: To identify the PT intervention type and intensity (or dose) used to treat patients with knee arthritis following TKR, an iterative user-centered design process refined an initial list of PT interventions generated during preliminary chart reviews. Input from practicing physical therapists and national and international experts refined and categorized the interventions. Next, a web-based, hierarchical structured system for intervention and intensity documentation was designed and deployed., Results: The PT documentation system was implemented by 114 physical therapists agreeing to record all interventions at patient visits. Data for 161 patients with 2615 PT visits were entered by 83 physical therapists. No technical problems with data entry were reported, and data entry required less than 2 minutes per visit. A total of 42 (2%) interventions could not be categorized and were recorded using free text., Conclusions: The use of user-centered design principles provides a road map for developing clinically feasible data capture systems that employ structured collection of uniform data for use by multiple practitioners across institutions to complement and augment existing EHRs. Secondarily, these data can be analyzed to define best practices and disseminate knowledge to practice., (©Patricia D Franklin, Carol A Oatis, Hua Zheng, Marie D Westby, Wilfred Peter, Jeremie Laraque-Two Elk, Joseph Rizk, Ellen Benbow, Wenjun Li. Originally published in JMIR Rehabilitation and Assistive Technology (https://rehab.jmir.org), 27.10.2022.)

Introduction: Learning health systems (LHS) science is fundamentally a transdisciplinary field. To capture the breadth of the competencies of an LHS scientist, AHRQ and national experts defined a series of 42 competencies across seven domains that support success. Clinicians, researchers, and leaders who are new to the LHS field can identify and prioritize proficiency development among these domains. In addition, existing leaders and researchers will assemble teams of experts who together represent the LHS science domains. To serve LHS workforce development and proficiency assessment, the AHRQ-funded ACCELERAT K12 training program recruited domain experts and trainees to define and operationalize items to include in an LHS Competency Assessment to support emerging and existing LHS scientists in prioritizing and monitoring proficiency development., Methods: Sequential interviews with 18 experts iteratively defined skills and tasks to illustrate stage in proficiency, and its progression, for each of 42 competencies in the seven LHS expertise domains: systems science; research questions and standards of scientific evidence; research methods; informatics; ethics of research and implementation in health systems; improvement and implementation science; and engagement, leadership, and research management. An educational assessment expert and LHS scientist refined the assessment criteria at each stage to use parallel language across domains. Last, current trainees reviewed and pilot tested the assessment and the LHS Competency Assessment was further refined using their feedback. The assessment framework was informed by Bloom's revised taxonomy of educational objectives (Anderson and Krathwohl, A taxonomy for learning, teaching, and assessing: A revision of Bloom's taxonomy of educational objectives, 2001) where learning progresses from recalling, defining, understanding, and awareness at the lower levels of the taxonomy, to applying and adopting and finally to creating, designing, and critiquing at the upper levels of the taxonomy. We also developed assessment criteria that could be used for longer term assessment of direct performance. Van der Vleuten et al. (Best Pract Res Clin Obstetr Gynaecol. 2010;24(6):703-719) define longer term direct assessment methods as assessment that occurs over a period ranging from weeks to even years and involves multiple assessment methods and exposure to the learner's work over an extended period., Results: This experience report describes the content of the LHS Competency Assessment. For each domain and competency, the assessment lists examples of evidence to support expertise at each level of proficiency: no exposure; foundational (awareness/understanding); emerging (early application); and proficient (application with a high level of skill). Trainees begin with baseline standard assessment tables, where they can indicate no exposure or mark the foundational and emerging skills with which they have competence. For domains where foundational and emerging skills have been achieved, users can move on to assessment tables that list evidence of proficiency., Conclusion: The LHS Competency Assessment offers consistent, graded criteria across the seven LHS domains to guide trainees and mentors to evaluate progress from no experience to foundational knowledge, emerging proficiency, and proficiency. The assessment can also be used to design training and mentoring for those newly exposed to LHS science and for those with key expertise who wish to expand LHS expertise., (© 2022 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)

Introduction: The learning health system (LHS) aligns science, informatics, incentives, stakeholders, and culture for continuous improvement and innovation. The Agency for Healthcare Research and Quality and the Patient-Centered Outcomes Research Institute designed a K12 initiative to grow the number of LHS scientists. We describe approaches developed by 11 funded centers of excellence (COEs) to promote partnerships between scholars and health system leaders and to provide mentored research training., Methods: Since 2018, the COEs have enlisted faculty, secured institutional resources, partnered with health systems, developed and implemented curricula, recruited scholars, and provided mentored training. Program directors for each COE provided descriptive data on program context, scholar characteristics, stakeholder engagement, scholar experiences with health system partnerships, roles following program completion, and key training challenges., Results: To date, the 11 COEs have partnered with health systems to train 110 scholars. Nine (82%) programs partner with a Veterans Affairs health system and 9 (82%) partner with safety net providers. Clinically trained scholars (n = 87; 79%) include 70 physicians and 17 scholars in other clinical disciplines. Non-clinicians (n = 29; 26%) represent diverse fields, dominated by population health sciences. Stakeholder engagement helps scholars understand health system and patient/family needs and priorities, enabling opportunities to conduct embedded research, improve outcomes, and grow skills in translating research methods and findings into practice. Challenges include supporting scholars through roadblocks that threaten to derail projects during their limited program time, ranging from delays in access to data to COVID-19-related impediments and shifts in organizational priorities., Conclusions: Four years into this novel training program, there is evidence of scholars' accomplishments, both in traditional academic terms and in terms of moving along career trajectories that hold the potential to lead and accelerate transformational health system change. Future LHS training efforts should focus on sustainability, including organizational support for scholar activities., Competing Interests: With the exception of Francis D. Chesley, Jr., all authors are grantees of the program that is the subject of this paper., (© 2022 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)

Background: Applications of patient-reported outcome measures (PROMs) for individual patient management are expanding with the support of digital tools. Providing PROM-based information to patients can potentially improve care experiences and outcomes through informing and activating patients. This study explored patients' perspectives on the benefits of receiving feedback on PROMs in the context of a web-based personalized decision report to guide care for their hip or knee osteoarthritis., Methods: This qualitative descriptive interview study was nested in a pragmatic clinical trial of a personalized report, which includes descriptive PROM scores and predicted postoperative PROM scores. Patients completed a semi-structured interview within 6 weeks of an office visit with an orthopaedic surgeon. Only patients who reported receiving the report and reviewing it with the surgeon and/or a health educator were included. Data were iteratively analyzed using a combination of deductive and inductive coding strategies., Results: Twenty-five patients aged 49-82 years (60% female, 72% surgical treatment decision) participated and described three primary benefits of the PROM feedback within the report: 1. Gaining Information About My Health Status, including data teaching new information, confirming what was known, or providing a frame of reference; 2. Fostering Communication Between Patient and Surgeon, encompassing use of the data to set expectations, ask and answer questions, and facilitate shared understanding; and 3. Increasing My Confidence and Trust, relating to the treatment outcomes, treatment decision, and surgeon., Conclusions: Patients identified actual and hypothetical benefits of receiving feedback on PROM scores in the context of a web-based decision report, including advantages for those who had already made a treatment decision before seeing the surgeon. Findings provide insight into patients' perspectives on how digital PROM data can promote patient-centered care. Results should be considered in the context of the homogeneous sample and complex trial. While participants perceived value in this personalized report, questions remain regarding best practices in patient-facing data presentation and engagement., Trial Registration: ClinicalTrials.gov, NCT03102580. Registered on 5 April 2017., (© 2022. The Author(s).)

Objective: To develop a claims-based model to predict persistent high-dose opioid use among patients undergoing total knee replacement (TKR)., Methods: Using Medicare claims (2010-2014), we identified patients ages ≥65 years who underwent TKR with no history of high-dose opioid use (mean >25 morphine milligram equivalents [MMEs]/day) in the year prior to TKR. We used group-based trajectory modeling to identify distinct opioid use patterns. The primary outcome was persistent high-dose opioid use in the year after TKR. We split the data into training (2010-2013) and test (2014) sets and used logistic regression with least absolute shrinkage and selection operator regularization, utilizing a total of 83 preoperative patient characteristics as candidate predictors. A reduced model with 10 prespecified variables, which included demographic characteristics, opioid use, and medication history was also considered., Results: The final study cohort included 142,089 patients who underwent TKR. The group-based trajectory model identified 4 distinct trajectories of opioid use (group 1: short-term, low-dose; group 2: moderate-duration, low-dose; group 3: moderate-duration, high-dose; and group 4: persistent high-dose). The model predicting persistent high-dose opioid use achieved high discrimination (receiver operating characteristic area under the curve [AUC] 0.85 [95% confidence interval (95% CI) 0.84-0.86]) in the test set. The reduced model with 10 predictors performed equally well (AUC 0.84 [95% CI 0.84-0.85])., Conclusion: In this cohort of older patients, 10.6% became persistent high-dose (mean 22.4 MME/day) opioid users after TKR. Our model with 10 readily available clinical factors may help identify patients at high risk of future adverse outcomes from persistent opioid use after TKR., (© 2021 American College of Rheumatology.)

Introduction: More than 1 million elective total hip and knee replacements are performed annually in the USA with 2% risk of clinical pulmonary embolism (PE), 0.1%-0.5% fatal PE, and over 1000 deaths. Antithrombotic prophylaxis is standard of care but evidence is limited and conflicting. We will compare effectiveness of three commonly used chemoprophylaxis agents to prevent all-cause mortality (ACM) and clinical venous thromboembolism (VTE) while avoiding bleeding complications., Methods and Analysis: Pulmonary Embolism Prevention after HiP and KneE Replacement is a large randomised pragmatic comparative effectiveness trial with non-inferiority design and target enrolment of 20 000 patients comparing aspirin (81 mg two times a day), low-intensity warfarin (INR (International Normalized Ratio) target 1.7-2.2) and rivaroxaban (10 mg/day). The primary effectiveness outcome is aggregate of VTE and ACM, primary safety outcome is clinical bleeding complications, and patient-reported outcomes are determined at 1, 3 and 6 months. Primary data analysis is per protocol , as preferred for non-inferiority trials, with secondary analyses adherent to intention-to-treat principles. All non-fatal outcomes are captured from patient and clinical reports with independent blinded adjudication. Study design and oversight are by a multidisciplinary stakeholder team including a 10-patient advisory board., Ethics and Dissemination: The Institutional Review Board of the Medical University of South Carolina provides central regulatory oversight. Patients aged 21 or older undergoing primary or revision hip or knee replacement are block randomised by site and procedure; those on chronic anticoagulation are excluded. Recruitment commenced at 30 North American centres in December 2016. Enrolment currently exceeds 13 500 patients, representing 33% of those eligible at participating sites, and is projected to conclude in July 2024; COVID-19 may force an extension. Results will inform antithrombotic choice by patients and other stakeholders for various risk cohorts, and will be disseminated through academic publications, meeting presentations and communications to advocacy groups and patient participants., Trial Registration: NCT02810704., Competing Interests: Competing interests: VDP, JWE, CME, PDF, KLG, SZG, RI, CAL, JM and LM receive funding from PCORI in support of their work pursuant to this trial. JWE reports honoraria and grant support from Astra Zeneca, Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb/Pfizer, Daiichi Sankyo, Glaxo Smith Kline, Janssen, Sanofi Aventis and Eli Lilly as well as a personal award from the Heart and Stroke Foundation. PDF reports grant support from PCORI, NIAMS, AHRQ and DePuy outside the submitted work. SZG reports grant support from Bayer, Boehringer-Ingelheim, BMS, Boston Scientific's BTG EKOS, Daiichi, Janssen, and NHLBI, and other from Bayer and Boehringer-Ingelheim outside the submitted work. JM reports grant support from the Patient Centered Outcomes Research Institute during the conduct of the study; personal fees from Novartis, Viking, Pluristem and UCB outside of the submitted work., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: An increased focus on patient-reported outcome measures (PROMs) has led to a proliferation of these measures in orthopaedic surgery. Mandating a single PROM in clinical and research orthopaedics is not feasible given the breadth of data already collected with older measures and the emergence of psychometrically superior measures. Creating crosswalk tables for scores between measures allows providers to maintain control of measure choice. Furthermore, crosswalk tables permit providers to compare scores collected with older outcome measures with newly collected ones. Given the widespread use of the newer Patient-reported Outcome Measure Information System Physical Function (PROMIS PF) and the established Knee Outcome and Osteoarthritis Score (KOOS), it would be clinically useful to link these two measures., Question/purpose: Can the KOOS Function in Activities of Daily Living (ADL) subscale be robustly linked to the PROMIS PF to create a crosswalk table of equivalent scores that accurately reflects a patient's reported physical function level on both scales?, Methods: We sought to establish a common standardized metric for collected responses to the PROMIS PF and the KOOS ADL to develop equations for converting a PROMIS PF score to a score for the KOOS-ADL subscale and vice versa. To do this, we performed a retrospective, observational study at two academic medical centers and two community hospitals in an urban and suburban healthcare system. Patients 18 years and older who underwent TKA were identified. Between January 2017 and July 2020, we treated 8165 patients with a TKA, 93% of whom had a diagnosis of primary osteoarthritis. Of those, we considered patients who had completed a full KOOS and PROMIS PF 10a on the same date as potentially eligible. Twenty-one percent (1708 of 8165) of patients were excluded because no PROMs were collected at any point, and another 67% (5454 of 8165) were excluded because they completed only one of the required PROMs, leaving 12% (1003 of 8165) for analysis here. PROMs were collected each time they visited the health system before and after their TKAs. Physical function was measured by the PROMIS PF version 1.0 SF 10a and KOOS ADL scale. Analyses to accurately create a crosswalk of equivalent scores between the measures were performed using the equipercentile linking method with both unsmoothed and log linear smoothed score distributions., Results: Crosswalks were created, and adequate validation results supported their validity; we also created tables to allow clinicians and clinician scientists to convert individual patients' scores easily. The mean difference between the observed PROMIS PF scores and the scores converted by the crosswalk from the KOOS-ADL scores was -0.08 ± 4.82. A sensitivity analysis was conducted, confirming the effectiveness of these crosswalks to link the scores of two measures from patients both before and after surgery., Conclusion: The PROMIS PF 10a can be robustly linked to the KOOS ADL measure. The developed crosswalk table can be used to convert PROMIS PF scores from KOOS ADL and vice versa., Clinical Relevance: The creation of a crosswalk table between the KOOS Function in ADL subscale and PROMIS PF allows clinicians and researchers to easily convert scores between the measures, thus permitting greater choice in PROM selection while preserving comparability between patient cohorts and PROM data collected from older outcome measures. Creating a crosswalk, or concordance table, between the two scales will facilitate this comparison, especially when pooling data for meta-analyses., Competing Interests: All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request. Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members., (Copyright © 2021 by the Association of Bone and Joint Surgeons.)

Background: Patient-reported outcome measures (PROMs) are validated questionnaires that are completed by patients. Arthroplasty registries vary in PROM collection and use. Current information about registry collection and use of PROMs is important to help improve methods of PROM data analysis, reporting, comparison, and use toward improving clinical practice., Questions/purposes: To characterize PROM collection and use by registries, we asked: (1) What is the current practice of PROM collection by arthroplasty registries that are current or former members of the International Society of Arthroplasty Registries, and are there sufficient similarities in PROM collection between registries to enable useful international comparisons that could inform the improvement of arthroplasty care? (2) How do registries differ in PROM administration and demographic, clinical, and comorbidity index variables collected for case-mix adjustment in data analysis and reporting? (3) What quality assurance methods are used for PROMs, and how are PROM results reported and used by registries? (4) What recommendations to arthroplasty registries may improve PROM reporting and facilitate international comparisons?, Methods: An electronic survey was developed with questions about registry structure and collection, analysis, reporting, and use of PROM data and distributed to directors or senior administrators of 39 arthroplasty registries that were current or former members of the International Society of Arthroplasty Registries. In all, 64% (25 of 39) of registries responded and completed the survey. Missing responses from incomplete surveys were captured by contacting the registries, and up to three reminder emails were sent to nonresponding registries. Recommendations about PROM collection were drafted, revised, and approved by the International Society of Arthroplasty Registries PROMs Working Group members., Results: Of the 25 registries that completed the survey, 15 collected generic PROMs, most frequently the EuroQol-5 Dimension survey; 16 collected joint-specific PROMs, most frequently the Knee Injury and Osteoarthritis Outcome Score and Hip Disability and Osteoarthritis Outcome Score; and 11 registries collected a satisfaction item. Most registries administered PROM questionnaires within 3 months before and 1 year after surgery. All 16 registries that collected PROM data collected patient age, sex or gender, BMI, indication for the primary arthroplasty, reason for revision arthroplasty, and a comorbidity index, most often the American Society of Anesthesiologists classification. All 16 registries performed regular auditing and reporting of data quality, and most registries reported PROM results to hospitals and linked PROM data to other data sets such as hospital, medication, billing, and emergency care databases. Recommendations for transparent reporting of PROMs were grouped into four categories: demographic and clinical, survey administration, data analysis, and results., Conclusion: Although registries differed in PROM collection and use, there were sufficient similarities that may enable useful data comparisons. The International Society of Arthroplasty Registries PROMs Working Group recommendations identify issues that may be important to most registries such as the need to make decisions about survey times and collection methods, as well as how to select generic and joint-specific surveys, handle missing data and attrition, report data, and ensure representativeness of the sample., Clinical Relevance: By collecting PROMs, registries can provide patient-centered data to surgeons, hospitals, and national entities to improve arthroplasty care., Competing Interests: Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2021 by the Association of Bone and Joint Surgeons.)

Importance: Studies to date have not comprehensively examined pain experience after total knee arthroplasty (TKA). Discrete patterns of pain in this period might be associated with pain outcomes at 6 to 12 months after TKA., Objectives: To examine patterns of individual post-TKA pain trajectories and to assess their independent associations with longer-term pain outcome after TKA., Design, Setting, and Participants: This prospective cohort study combined data from a national US TKA cohort with ancillary pain severity data at 2 weeks and 8 weeks after the index TKA using a numeric rating scale. All participants received primary, unilateral TKA within the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) national network of community sites in 22 states or at the lead site (University of Massachusetts Medical School). Participants had a date of surgery between May 1, 2013, and December 1, 2014. The data analysis was performed between January 13, 2015, and July 5, 2016., Exposures: Pain trajectories in the postoperative period (8 weeks)., Main Outcomes and Measures: Index knee pain at 6 months after TKA using the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain scale. Group-based trajectory methods examined the presence of pain trajectories in the postoperative period (8 weeks) and assessed whether trajectories were independently associated with longer-term pain (6 months)., Results: The cohort included 659 patients who underwent primary TKA with complete data at 4 points (preoperative, 2 weeks, 8 weeks, and 26 weeks). Their mean (SD) age was 67.1 (8.0) years, 64.5% (425 of 659) were female, the mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) was 30.77 (5.66), 94.5% (613 of 649) were white, and the mean (SD) preoperative 36-Item Short Form Health Survey physical component summary and mental component summary scores were 34.1 (8.2) and 53.8 (11.4), respectively. Two pain trajectory subgroups were identified at 8 weeks after TKA: patients who experienced fast pain relief in the first 8 weeks after TKA (fast pain responders, composing 72.4% [477 of 659] of the sample) and patients who did not (slow pain responders, composing 27.6% [182 of 659] of the sample). After adjusting for patient factors, the pain trajectory at 8 weeks after TKA was independently associated with the mean KOOS pain score at 6 months, with a between-trajectory difference of -11.3 (95% CI, -13.9 to -8.7)., Conclusions and Relevance: The trajectory among slow pain responders at 8 weeks after surgery was independently associated with improved but greater persistent index knee pain at 6 months after TKA compared with that among fast pain responders. Early identification of patients with a trajectory of slow pain response at 8 weeks after TKA may offer an opportunity for interventions in the perioperative period to potentially improve the long-term pain outcomes after TKA.

Objective: To examine patterns of prescription opioid use before total joint replacement (TJR) and factors associated with continuous use of opioids before TJR., Design: We conducted an observational cohort study among Medicare enrollees aged ≥65 years who underwent TJR between 2010 and 2014. Preoperative opioid use was defined as having any opioid prescription in the 12-month period before TJR. Patients who had an opioid prescription every month for a 12-month period were defined as continuous users. We examined patients' demographics, pain-related conditions, medication use, other comorbidities, healthcare utilization and their association with use of opioids before TJR., Results: A total of 473,781 patients underwent TJR:,155,516 THR and 318,265 TKR. Among the total cohort, 60.2% patients had any use of opioids and of those, 12.4% used opioids at least once a month continuously over the 12-month baseline period. Correlates of continuous opioid use included African American race (OR = 2.14, 95% confidence intervals (CI) = 2.01-2.28, compared to White patients), history of drug abuse (OR = 5.18, 95% CI = 3.95-6.79) and back pain (OR = 2.32, 95% CI = 2.24-2.39)., Conclusions: In this large cohort of patients undergoing TJR, over 60% ever used opioids and 12.4% of them continuously used opioids in the 12-month prior to surgery. Utilization of opioids became more frequent and high-dosed near the surgery. History of drug abuse, back pain, and African American race were strongly associated with continuous use of opioids preoperatively. Further research is needed to determine short-term and long-term risks of preoperative use of opioids in TJR patients and to optimize pre- and post-TJR pain management of patients with arthritis., (Copyright © 2019 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.)

Objective: Although total knee replacement (TKR) surgery is highly prevalent and generally successful, functional outcomes post-TKR vary widely. Most patients receive some physical therapy (PT) following TKR, but PT practice is variable and associations between specific content and dose of PT interventions and functional outcomes are unknown. Research has identified exercise interventions associated with better outcomes but studies have not assessed whether such evidence has been translated into clinical practice. We characterized the content, dose, and progression of usual post-acute PT services following TKR, and examined associations of specific details of post-acute PT with patients' 6-month functional outcomes., Methods: Post-acute PT data were collected from patients who were undergoing primary unilateral TKR and participating in a clinical trial of a phone-based coaching intervention. PT records from the terminal episode of care were reviewed and utilization and exercise content data were extracted. Descriptive statistics and linear regression models characterized PT treatment factors and identified associations with 6-month outcomes., Results: We analyzed 112 records from 30 PT sites. Content and dose of specific exercises and incidence of progression varied widely. Open chain exercises were utilized more frequently than closed chain (median 21 [interquartile range (IQR) 4-49] versus median 13 [IQR 4-28.5]). Median (IQR) occurrence of progression of closed and open chain exercise was 0 (0-2) and 1 (0-3), respectively. Shorter timed stair climb was associated with greater total number of PT interventions and use and progression of closed chain exercises., Discussion: Data suggest that evidence-based interventions are underutilized and dose may be insufficient to obtain optimal outcomes., (© 2018, American College of Rheumatology.)

Importance: Prescription opioid use is common among patients with moderate to severe knee osteoarthritis before undergoing total knee replacement (TKR). Preoperative opioid use may be associated with worse clinical and safety outcomes after TKR., Objective: To determine the association of preoperative opioid use among patients 65 years and older with mortality and other complications at 30 days post-TKR., Design, Setting, and Participants: This cohort study used claims data from January 1, 2010, to December 31, 2014, from a random sample of US Medicare enrollees 65 years and older who underwent TKR. Based on opioid dispensing in 360 days prior to TKR, patients were classified as continuous (≥1 opioid dispensing in each of the past 12 months) or intermittent (any dispensing of opioids in the past 12 months but not continuous use) opioid users or as opioid-naive patients (no opioids dispensed in the past 12 months). Data analyses were conducted from October 3, 2017, to November 8, 2018., Main Outcomes and Measures: Primary outcomes included in-hospital mortality and 30-day post-TKR mortality, hospital readmission, and revision operation. Secondary safety outcomes at 30 days post-TKR included opioid overdose and vertebral and nonvertebral fracture. Multivariable Cox proportional hazards models estimated hazard ratios (HRs) and 95% CIs., Results: Of 316 593 patients (mean [SD] age, 73.9 [5.8] years; 214 677 [67.8%] women) who underwent TKR, 22 895 (7.2%) were continuous opioid users, 161 511 (51.0%) were intermittent opioid users, and 132 187 (41.7%) were opioid naive. In-hospital mortality occurred in 276 patients (0.09%). At 30 days post-TKR, 828 patients (0.26%) died, 16 786 patients (5.30%) had hospital readmission, and 921 patients (0.29%) had a revision operation. All primary and secondary outcomes occurred more frequently among continuous opioid users compared with opioid-naive patients. Compared with opioid-naive patients and after adjusting for demographic characteristics, combined comorbidity score, number of different prescription medications, and frailty, continuous opioid users had greater risk of revision operations (HR, 1.63; 95% CI, 1.15-2.32), vertebral fractures (HR, 2.37; 95% CI, 1.37-4.09), and opioid overdose (HR, 4.82; 95% CI, 1.36-17.07) at 30 days post-TKR. However, after adjusting covariates, there were no statistically significant differences in in-hospital (HR, 1.18; 95% CI, 0.73-1.90) or 30-day (HR, 1.05; 95% CI, 0.73-1.51) mortality between continuous opioid users and opioid-naive patients., Conclusions and Relevance: After adjusting for baseline risk profiles, including comorbidities and frailty, continuous opioid users had a higher risk of revision operations, vertebral fractures, and opioid overdose at 30 days post-TKR but not of in-hospital or 30-day mortality, compared with opioid-naive patients. These results highlight the need for better understanding of patient characteristics associated with chronic opioid use to optimize preoperative assessment of overall risk after TKR.

Background: Mental health has been shown to improve after total hip arthroplasty (THA). Little is known about the role of pain and function in this context. We assessed whether change in mental health was associated with improvement in pain and function 1 year post-surgery., Methods: This prospective study included patients enrolled in a THA registry from 2010 to 2014. We examined the mental component score (MCS) before and 1 year post-surgery, and 1-year change, in association with Western Ontario McMaster Universities (WOMAC) pain and function scores. All scores were normalized, ranging from 0 to 100 (larger score indicating better outcome). Analyses were adjusted for potential confounders., Results: Our study included 610 participants, of which 53% were women. Descriptive statistics are as follows: the average (SD) for age (years) was 68.5 (11.8), and for BMI was 26.9 (4.9). In addition, the MCS average (SD) at baseline was 44.7 (11.2), and at 1-year after THA was 47.5 (10.5). The average change from baseline to 1-year post-THA in MCS was 2.8 (95% CI: 1.9, 3.6), for an effect size of 0.26. As for the WOMAC pain score, the average change from baseline to 1-year post-THA was 44.2 (95%CI: 42.4, 46.0), for an effect size of 2.5. The equivalent change in WOMAC function was 38.1 (95% CI: 36.2, 40.0), for an effect size of 2.0. Results from multivariable analysis controlling for covariates showed that an improvement of 10 points in the 1-year change in pain score resulted in a 0.78 point (95%: CI 0.40, 1.26) increase in the 1-year change in MCS, whereas a 10-point improvement in the 1-year change in function was associated with a 0.94 point (95% CI: 0.56, 1.32) increase., Conclusions: Mental health significantly improved from baseline to 1-year post-THA. Greater improvement in pain and function was associated with greater improvement in mental health 1 year post-THA.

Objective: To develop 12-item short forms (KOOS-12, HOOS-12) of the 42-item Knee injury and Osteoarthritis Outcome Score (KOOS) and 40-item Hip disability and Osteoarthritis Outcome Score (HOOS) that represent the full-length instruments sufficiently to provide joint-specific pain, function and quality of life (QOL) domain and summary joint impact scores. This paper describes KOOS-12 and HOOS-12 item selection. Subsequent papers will examine KOOS-12 and HOOS-12 reliability, validity and responsiveness., Design: Items were selected based on qualitative information from patients, clinicians and KOOS/HOOS translators and analysis of data from 1,395 knee osteoarthritis (OA) and 1,281 hip OA patients from the FORCE-TJR cohort who completed KOOS or HOOS before and after total joint replacement (TJR). Item response theory models and computerized adaptive test (CAT) simulations were used to identify items that best measured patients' levels of pain and function pre- and post-TJR. KOOS-12/HOOS-12 items were selected based on content, coverage of a wide measurement range, high item information, item usage in CAT simulations, scale-level properties (reliability, validity, responsiveness), and qualitative information., Results: KOOS-12 and HOOS-12 each included a pain frequency item and three items measuring pain during increasingly difficult activities (sitting/lying, walking, up/down stairs); function items about standing, rising from sitting, getting in/out of a car, and twisting/pivoting (KOOS-12) or walking on an uneven surface (HOOS-12); and the original 4-item QOL scale., Conclusions: This study demonstrated the benefits of examining patient-reported outcome measures using modern psychometric methods, to create short forms with diverse content that provide domain-specific and summary joint impact scores., (Copyright © 2019 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.)

Objective: To evaluate reliability, validity and responsiveness of HOOS-12, a 12-item short form of the 40-item Hip disability and Osteoarthritis Outcome Score (HOOS). HOOS-12 provides Pain, Function and Quality of Life (QOL) scale scores and a summary hip impact score., Design: Data from 1,273 FORCE-TJR hip osteoarthritis (OA) patients who completed HOOS before and six and 12 months after total hip replacement (THR) were analyzed. HOOS-12 includes a pain frequency item and three items measuring pain during increasingly difficult (sitting/lying, walking, stairs) activities; function items about standing, rising from sitting, getting in/out of a car, and walking on an uneven surface; and the 4-item HOOS QOL scale. Percent computable scale scores, floor and ceiling effects, internal consistency reliability, validity (scale correlations, tests of known groups validity using one-way analysis of variance (ANOVA)), and responsiveness (effect sizes (ES), standardized response means (SRM)) were compared for HOOS-12, full-length HOOS, HOOS-PS and HOOS, JR., Results: Internal consistency reliability was above 0.70 for all HOOS-12 scales and above 0.90 for the HOOS-12 Summary score. Validity and responsiveness of HOOS-12 Pain, Function and QOL scales were satisfactory and reached similar conclusions as comparable full-length HOOS scales. The HOOS-12 Summary score was highly responsive in discriminating between groups who differed in global ratings of post-THR change in physical capabilities and had high ES and SRM standardized response means., Conclusions: HOOS-12 was a reliable and valid alternative to HOOS in THR patients with moderate to severe OA and provided three domain-specific and summary hip impact scores with substantially reduced respondent burden., (Copyright © 2019 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.)

Objective: To evaluate the variation in long-term opioid use in osteoarthritis (OA) patients according to geography and health care access., Methods: We designed an observational cohort study among OA patients undergoing total joint replacement (TJR) in the Medicare program (2010 through 2014). The independent variables of interest were the state of residence and health care access, which was quantified at the primary care service area (PCSA) level as categories of number of practicing primary care providers (PCPs) and categories of rheumatologists per 1,000 Medicare beneficiaries. The percentage of OA patients taking long-term opioids (≥90 days in the 360-day period immediately preceding TJR) within each PCSA was the outcome variable in a multilevel, generalized linear regression model, adjusting for case-mix at the PCSA level and for policies, including rigor of prescription drug monitoring programs and legalized medical marijuana, at the state level., Results: A total of 358,121 patients with advanced OA, with a mean age of 74 years, were included from 4,080 PCSAs. The unadjusted mean percentage of long-term opioid users varied widely across states, ranging from 8.9% (Minnesota) to 26.4% (Alabama), and this variation persisted in the adjusted models. Access to PCPs was only modestly associated with rates of long-term opioid use between PCSAs with highest (>8.6) versus lowest (<3.6) concentration of PCPs (adjusted mean difference 1.4% [95% confidence interval 0.8%, 2.0%]), while access to rheumatologists was not associated with long-term opioid use., Conclusion: We note a substantial statewide variation in rates of long-term treatment with opioids in OA, which is not fully explained by the differences in access to health care providers, varying case-mix, or state-level policies., (© 2019, American College of Rheumatology.)

Objective: To evaluate reliability, validity and responsiveness of KOOS-12, a 12-item short form of the 42-item Knee injury and Osteoarthritis Outcome Score (KOOS) that provides Pain, Function and Quality of Life (QOL) scale scores and a summary knee impact score., Design: Data from 1,392 knee osteoarthritis (OA) patients from the FORCE-TJR research cohort who completed KOOS before and 6 and 12 months after total knee replacement (TKR) were analyzed. KOOS-12 includes a pain frequency item and three items measuring pain during increasingly difficult (sitting/lying, walking, stairs) activities; function items about standing, rising from sitting, getting in/out of a car, and twisting/pivoting; and the 4-item KOOS QOL scale. Percent computable scale scores, floor and ceiling effects, internal consistency reliability, validity (scale correlations, tests of known groups validity using one-way analysis of variance (ANOVA)) and responsiveness (effect sizes, standardized response means) were compared for the KOOS-12, full-length KOOS, KOOS-PS and KOOS, JR., Results: Internal consistency reliability was above 0.70 for all KOOS-12 scales and ≥0.90 for the KOOS-12 Summary score. Validity and responsiveness of KOOS-12 Pain, Function and QOL scales was satisfactory and reached similar conclusions as comparable full-length KOOS scales. The KOOS-12 Summary score was most responsive in discriminating between groups who differed in global ratings of post-TKR change in physical capabilities and had the highest effect sizes and standardized response means., Conclusions: KOOS-12 was a reliable and valid alternative to KOOS in TKR patients with moderate to severe OA and provided three domain-specific and summary knee impact scores with substantially reduced respondent burden., (Copyright © 2019 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.)

Background: Data-driven surgical decisions will ensure proper use and timing of surgical care. We developed a Web-based patient-centered treatment decision and assessment tool to guide treatment decisions among patients with advanced knee osteoarthritis who are considering total knee replacement surgery., Objective: The aim of this study was to examine user experience and acceptance of the Web-based treatment decision support tool among older adults., Methods: User-centered formative and summative evaluations were conducted for the tool. A sample of 28 patients who were considering total knee replacement participated in the study. Participants' responses to the user interface design, the clarity of information, as well as usefulness, satisfaction, and acceptance of the tool were collected through qualitative (ie, individual patient interviews) and quantitative (ie, standardized Computer System Usability Questionnaire) methods., Results: Participants were older adults with a mean age of 63 (SD 11) years. Three-quarters of them had no technical questions using the tool. User interface design recommendations included larger fonts, bigger buttons, less colors, simpler navigation without extra "next page" click, less mouse movement, and clearer illustrations with simple graphs. Color-coded bar charts and outcome-specific graphs with positive action were easiest for them to understand the outcomes data. Questionnaire data revealed high satisfaction with the tool usefulness and interface quality, and also showed ease of use of the tool, regardless of age or educational status., Conclusions: We evaluated the usability of a patient-centered decision support tool designed for advanced knee arthritis patients to facilitate their knee osteoarthritis treatment decision making. The lessons learned can inform other decision support tools to improve interface and content design for older patients' use., (©Hua Zheng, Milagros C Rosal, Wenjun Li, Amy Borg, Wenyun Yang, David C Ayers, Patricia D Franklin. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 30.04.2018.)

Background: Outcomes after total knee (TKA) and hip (THA) arthroplasty are often generalized internationally. Patient-dependent factors and preoperative symptom levels may differ across countries. We compared preoperative patient and clinical characteristics from two large cohorts, one in Switzerland, the other in the US., Methods: Patient characteristics were collected prospectively on all elective primary TKAs and THAs performed at a large Swiss hospital and in a US national sample. Data included age, sex, education level, BMI, diagnosis, medical co-morbidities, PROMs (WOMAC pain/function), global health (SF-12)., Results: Six thousand six hundred eighty primary TKAs (US) and 823 TKAs (Swiss) were evaluated. US vs. Switzerland TKA patients were younger (mean age 67 vs. 72 years.), more obese (BMI ≥30 55% vs. 43%), had higher levels of education, more cardiac disease. Swiss patients had lower preoperative WOMAC pain scores (41 vs. 52) but pre-operative physical disability were comparable. 4,647 primary THAs (US) and 1,023 THAs (Swiss) were evaluated. US vs. Switzerland patients were younger (65 vs. 68 years.), more obese (BMI ≥30: 38% vs. 24%), had higher levels of education, more diabetes. Swiss patients had lower preoperative WOMAC pain scores (40 vs. 48 points). Physical disability was reported comparable, but Swiss patients indicated lower mental health scores., Conclusion: We found substantial differences between US and Swiss cohorts in pre-operative patient characteristics and pain levels, which has potentially important implications for cross-cultural comparison of TKA/THA outcomes. Reports from national registries lack detailed patient information while these data suggest the need for adequate risk adjustment of patient factors.

Objective: To define a minimum Standard Set of outcome measures and case-mix factors for monitoring, comparing, and improving health care for patients with clinically diagnosed hip or knee osteoarthritis (OA), with a focus on defining the outcomes that matter most to patients., Methods: An international working group of patients, arthroplasty register experts, orthopedic surgeons, primary care physicians, rheumatologists, and physiotherapists representing 10 countries was assembled to review existing literature and practices for assessing outcomes of pharmacologic and nonpharmacologic OA therapies, including surgery. A series of 8 teleconferences, incorporating a modified Delphi process, were held to reach consensus., Results: The working group reached consensus on a concise set of outcome measures to evaluate patients' joint pain, physical functioning, health-related quality of life, work status, mortality, reoperations, readmissions, and overall satisfaction with treatment result. To support analysis of these outcome measures, pertinent baseline characteristics and risk factor metrics were defined. Annual outcome measurement is recommended for all patients., Conclusion: We have defined a Standard Set of outcome measures for monitoring the care of people with clinically diagnosed hip or knee OA that is appropriate for use across all treatment and care settings. We believe this Standard Set provides meaningful, comparable, and easy to interpret measures ready to implement in clinics and/or registries globally. We view this set as an initial step that, when combined with cost data, will facilitate value-based health care improvements in the treatment of hip and knee OA., (© 2016, The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.)

Background: Patient-reported outcome measures (PROMs) are increasingly in demand for outcomes evaluation by hospitals, administrators, and policymakers. However, assessing total hip arthroplasty (THA) through such instruments is challenging because most existing measures of hip health are lengthy and/or proprietary., Questions/purposes: The objective of this study was to derive a patient-relevant short-form survey based on the Hip disability and Osteoarthritis Outcome Score (HOOS), focusing specifically on outcomes after THA., Methods: We retrospectively evaluated patients with hip osteoarthritis who underwent primary unilateral THA and who had completed preoperative and 2-year postoperative PROMs using our hospital's hip replacement registry. The 2-year followup in this population was 81% (4308 of 5351 patients). Of these, 2371 completed every item on the HOOS before surgery and at 2 years, making them eligible for the formal item reduction analysis. Through semistructured interviews with 30 patients, we identified items in the HOOS deemed qualitatively most important to patients with hip osteoarthritis. The original HOOS has 40 items, the four quality-of-life items were excluded a priori, five were excluded for being redundant, and one was excluded based on patient-relevance surveys. The remaining 30 items were evaluated using Rasch modeling to yield a final six-item HOOS, Joint Replacement (HOOS, JR), representing a single construct of "hip health." We calculated HOOS, JR scores for the Hospital for Special Surgery (HSS) cohort and validated this new score for internal consistency, external validity (versus HOOS and WOMAC domains), responsiveness to THA, and floor and ceiling effects. Additional external validation was performed using calculated HOOS, JR scores in collaboration with the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) nationally representative joint replacement registry (n = 910)., Results: The resulting six-item PROM (HOOS, JR) retained items only from the pain and activities of daily living domains. It showed high internal consistency (Person Separation Index, 0.86 [HSS]; 0.87 [FORCE]), moderate to excellent external validity against other hip surveys (Spearman's correlation coefficient, 0.60-0.94), very high responsiveness (standardized response means, 2.03 [95% CI, 1.84-2.22] [FORCE]; and 2.38 [95% CI, 2.27-2.49] [HSS]), and favorable floor (0.6%-1.9%) and ceiling (37%-46%) effects. External validity was highest for the HOOS pain (Spearman's correlation coefficient, 0.87 [95% CI, 0.86-0.89] [HSS]; and 0.87 [95% CI, 0.84-0.90] [FORCE]) and HOOS activities of daily living (Spearman's correlation coefficient, 0.94 [95% CI, 0.93-0.95] [HSS]; and 0.94 [95% CI, 0.93-0.96] [FORCE]) domains in the HSS validation cohort and the FORCE-TJR cohort., Conclusions: The HOOS, JR provides a valid, reliable, and responsive measure of hip health for patients undergoing THA. This short-form PROM is patient relevant and efficient., Level of Evidence: Level III, diagnostic study.

Background: Medicare is rapidly moving toward using patient-reported outcome measures (PROMs) for outcomes assessment and justification of orthopaedic and other procedures. Numerous measures have been developed to study knee osteoarthritis (OA); however, many of these surveys are long, disruptive to clinic flow, and result in incomplete data capture and/or low followup rates. The Knee injury and Osteoarthritis Outcome (KOOS) physical function short-form (KOOS-PS), while shorter, ignores pain, which is a primary concern of patients with advanced knee OA., Questions/purposes: Our objective was to derive and validate a short-form survey focused on the patient with end-stage knee OA undergoing TKA., Methods: Using our hospital's knee replacement registry, we retrospectively identified 2291 patients with knee OA who underwent primary unilateral TKA and had completed preoperative and 2-year postoperative PROMs. We assessed 30 items from the 42-item KOOS that were quantitatively most difficult for patients to perform before TKA and qualitatively most relevant to patients with end-stage knee OA. Rasch analysis identified the KOOS, JR, a seven-item instrument, representing a single dimension, which we define as "knee health" because it reflects aspects of pain, symptom severity, and activities of daily living (ADL) including movements or activities that are directly relevant and difficult for patients with advanced knee OA. We assessed the internal consistency, external validity (versus KOOS and WOMAC domains), responsiveness, and floor and ceiling effects of the KOOS, JR. External validation was performed using calculated KOOS, JR scores in collaboration with a nationally representative joint replacement registry, the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR)., Results: Internal consistency for the KOOS, JR was high (Person Separation Index, 0.84; and 0.85 [FORCE]), external validity against other validated knee surveys was excellent (Spearman correlation coefficient, ρ 0.54-0.91), particularly for the KOOS pain (ρ 0.89 [95% CI, 0.88-0.91] Hospital for Special Surgery [HSS]; and 0.91 [95% CI, 0.90-0.93] [FORCE]) and KOOS ADL (ρ 0.87 [95% CI, 0.85-0.88] [HSS]; and 0.84 [95% CI, 0.81-0.87] [FORCE]). The KOOS, JR responsiveness (standardized response means, 1.79 [95% CI, 1.70-1.88] [HSS]; and 1.70 [95% CI, 1.54-1.86] [FORCE]) was high and floor 0.4-1.2%) and ceiling (18.8-21.8%) effects were favorable., Conclusions: The new short knee PROM, the KOOS, JR, provides a single score representing "knee health" as it combines pain, symptoms, and functional limitations in a single score. This short-form PROM is patient-relevant and efficient., Level of Evidence: Level III, diagnostic study.

Background: As the number of primary total knee arthroplasties (TKAs) performed in the United States increases, policymakers have questioned whether the indications and timing of TKA have evolved so that surgery is offered earlier., Questions/purposes: We analyzed data from a US national TKA cohort to evaluate variation in surgeon selection criteria for elective unilateral TKA based on preoperative patient-reported pain and function scores., Methods: Preoperative SF-36 (Physical Component Summary [PCS]/physical function) scores and Knee Injury and Osteoarthritis Outcome Score (KOOS) (pain, activities of daily living/function) of 4900 patients undergoing elective unilateral TKA enrolled in this national database of prospectively followed patients from 22 states were evaluated. The 25th, 50th, and 75th percentile pain and function scores for patients cared for in 24 orthopaedic offices with 20 or more patients in the database were compared to assess whether consistent preoperative criteria are used in selecting patients undergoing TKA across settings., Results: The preoperative global function (PCS median, 32.6; national norm, 50; SD, 10) and knee-specific function (KOOS median, 51.5; maximum score, 100; SD, 17) percentile scores represented substantial patient disability, because both values approached 2 SDs below ideal. Consistency in patients across 24 surgeon offices, and more than 100 surgeons, was noted because site-specific medians varied from the national median by less than the minimum clinically important change., Conclusions: These data suggest that despite the rapidly growing use of TKA, surgeons in the participating sites use consistent patient criteria in scheduling TKA. Today's patients report significant pain and disability, supporting the need for TKA.

Introduction: Patient-reported outcomes (PROs) are rarely included in quality monitoring systems, surgeon comparative feedback reports, or registries. We present the design and implementation of a secure website in a federally funded research program-Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR)-to return comparative PRO reports to participating surgeons, in addition to including traditional quality measures, in order to monitor and improve quality and health outcomes., Methods: The surgeon-specific comparative PRO reports were designed and structured based on user input for content, data elements, integration, and display. Three questions are addressed regarding the knee and hip joint symptom profiles of patients before TJR, as well as outcomes of surgery. The website is organized with a hierarchical structure to display data at national, practice, and individual surgeon levels, and provides a comprehensive site-level executive summary and surgeon-level data reports that can be downloaded., Early Results: As of September 2014, over 22,000 patients were enrolled from more than 130 surgeons in 22 states. The reporting website was launched in September 2012 and has been updated quarterly for all surgeons to review their site- and individual-specific outcomes data compared to national benchmarks., Discussion: In this novel system, quarterly comparative surgeon feedback extends beyond traditional measures of complication rates to include PROs of pain relief and functional gain. We anticipate that this enhanced data will facilitate patient-centered quality improvement (QI) and outcomes research from the registry. As the Centers for Medicare & Medicaid Services (CMS) and other insurers consider future implementation of PROs, surgeons will increasingly need comparative data by which to self-monitor their practice outcomes.

Objective: Prevalence of total knee replacement (TKR) is large and growing but functional outcomes are variable. Physical therapy (PT) is integral to functional recovery following TKR but little is known about the quantity or content of PT delivered. Purposes of this study were to describe the amount and exercise content of PT provided in the terminal episode of PT care following TKR and to examine factors associated with utilization and content., Methods: Subjects included participants in a clinical trial of behavioral interventions for patients undergoing primary unilateral TKR who had completed the 6-month study evaluation. PT records were requested from 142 consecutive participants who had completed their post-TKR rehabilitation, 102 in/out patient care, and 40 in homecare. Information on utilization and exercises was extracted from a retrospective review of the PT records., Results: We received 90 (88%) outpatient and 27 (68%) homecare PT records. Records showed variability in timing, amount and content of PT. Patients receiving outpatient PT had more visits and remained in PT longer (p<0.001). Exercises known in the TKR literature were utilized more frequently in the outpatient setting (p=0.001) than in home care. Records from both settings had limited documentation of strengthening progression., Conclusions: The study reveals considerable variability in timing, utilization and exercise content of PT following TKR and suggests sub-optimal exercise for strengthening. While methods we employed document variability, improved systematic PT documentation and in-depth research are needed to identify optimal timing, utilization and content of PT following TKR.

Background: Total joint arthroplasty (TJA) registries traditionally have focused on implant longevity and rates of revision surgery. Registries would benefit from the addition of standardized patient-reported outcomes (PROs) such as pain relief and improved physical function. However, PROs have not been routinely adopted, and their incorporation into TJA registries presents challenges., Questions/purposes: We review current PRO use by existing national registries, challenges to integrating PROs in national registries, lessons from national registries that have integrated PROs, and suggestions to guide future adoption of PROs., Methods: We conducted a literature search of papers addressing PRO use in national knee and hip arthroplasty registries, resulting in 15 articles. These publications were supplemented by discussions with thought leaders from international registries. WHERE ARE WE NOW?: Some national TJA registries are collecting PROs and valuable research is emerging. However, challenges exist, such as selecting suitable PROs, selection bias in countries without government-mandated participation for all hospitals, and challenges with missing data. WHERE DO WE NEED TO GO?: The ideal system will incorporate PROs into TJA registries. In so doing, it will be important to choose suitable PROs and develop innovative methods to collect PROs to ensure complete data and sustainability. HOW DO WE GET THERE?: New methods are required to meet the challenges related to registry design, logistics of PRO collection, and registry cost and sustainability. Modifications to the traditional hospital- and implant-centric design and new procedures to collect complete data from both patients and clinicians may be necessary. For instance, England and Wales, New Zealand, and Sweden developed methods to collect PROs after TJA directly from patients and a US TJA registry collects PROs as the primary outcome. Finally, to assure long-term sustainability, PRO data must be valuable to multiple stakeholders, including patients, clinicians, researchers, and policy makers.

Background: Good orthopaedic care requires a knowledge of the patient's history of musculoskeletal pain and associated limitations in daily function. Standardized measures of patient-reported outcomes (PROs) can provide this information. Integrating PROs into routine orthopaedic patient visits can provide key information to monitor changes in symptom severity over time, support shared clinical care decisions, and assess treatment effectiveness for quality initiatives and value-based reimbursement. WHERE ARE WE NOW?: Although standardized, validated PRO surveys are routinely used in clinical and comparative effectiveness research, they are not consistently or efficiently collected in clinical practice. WHERE DO WE NEED TO GO?: Ideally, PROs need to be collected directly from patients before their surgeon visit so the data are readily available to the surgeon and patient at the time of the office visit. In addition, PROs should be integrated in the electronic health record to monitor patient status over time. HOW DO WE GET THERE?: PRO integration in clinical practice requires minor modifications to the office flow, some additional staff to facilitate collection, and the technical infrastructure to score, process, and store the responses. We document successful office procedures for collecting PROs in one busy orthopaedic clinic and some suggested methods to extend this model to the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) consortium of 121 surgeons where the process is centralized and staff obtained consent to send the PRO directly to the patient's home. Both methods are options for the broader adoption of office-based PROs.

Background: The integrity of behavioral intervention trials depends on consistent intervention delivery, and uniform, comprehensive process data collection. It can be challenging in practice due to complex human interactions involved., Objective: We sought to design a system to support the fidelity of intervention delivery and efficient capture of qualitative and quantitative process data for a telephone-delivered behavioral counseling intervention to increase physical activity and function after total knee replacement surgery., Methods: A tailored system was designed to prompt the intervention coach in the delivery of a 5 step counseling protocol to support intervention fidelity across patients. System features included structured data components, automated data exchange functions, user-friendly data capture screens, and real-time surveillance reporting. The system structured the capture of patient goals and open-ended conversation., Results: The system recorded intervention process data from each of 12 sessions held with the 92 intervention patients. During the trial, 992 telephone sessions were conducted, and more than 97% (4816/4960) of intervention process data fields were completed in the system. The coach spent 5-10 minutes preparing for each counseling call using system-generated summaries of historical data and 10-15 minutes entering intervention process data following each telephone session., Conclusions: This intervention delivery system successfully supported the delivery of a structured behavioral counseling intervention and collection of intervention process data. It addressed the unique needs of clinical behavioral intervention trials, and had promising potential to facilitate high-fidelity translation of the intervention to broad clinical practice and Web-based multicenter clinical trials in the future.

Background: US adults report suboptimal physical activity and fruit and vegetable intake. Innovative strategies to promote healthy behaviors are needed. Employee health promotion programs have been associated with reductions in health risks but are labor-intensive and costly to implement. E-mail and Web-based worksite programs have the potential to reach a broad adult population and to provide a cost-effective approach to employee wellness programming., Objective: To assess the feasibility of using sequential e-mail messages to promote physical activity and increase fruit and vegetable intake among employed adults., Methods: Employees at one worksite of a large insurance company in New York State were invited to participate. Interested workers provided written consent. After completing a baseline survey, participants received daily e-mails, Monday through Friday, for 26 weeks. The e-mails provided (a) succinct strategies to encourage physical activity or increase fruit and vegetable intake and (b) links to detailed Web-based information and tools. Program reach was assessed by the number of e-mails opened, measures of sustained participation over 6 months, and the number of health-related Web-links clicked., Results: Of 960 employees, 388 (40%) consented to participate; of these, 345 (89%) completed the baseline health survey. After 6 months, 70% of the 345 participants had opened 50% or more of the daily e-mails. In addition, 75% of participants continued to open at least one e-mail a week through week 26 of the study. E-mail opening rates did not vary by gender, age, income, education, ethnicity, or baseline health behavior., Conclusions: The rate of enrollment and sustained participation document the feasibility, broad reach, employee acceptance, and potential value of using electronic communications for health promotion in the workplace.