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To determine if Patient Acceptable Symptom State (PASS), a single-item deterministic binary measure of pain and function outcome satisfaction leads to better differentiation of outcome classification versus latent class analysis probability-based outcome subgroups one-year following knee arthroplasty (KA).We used data from KASTPain, a one-year no-effect multicenter randomized clinical trial of participants with KA along with prior work that developed and externally validated good and poor outcome trajectories. Confirmatory latent class analyses were conducted on two exemplar outcome measures (EQ VAS single-item self-rated health and 4-Item pain ratings) and compared to PASS scores. Separation of trajectories were used to compare good and poor latent class self-rated health/4-item pain trajectories and PASS score trajectories.Prevalence rates for poor outcomes were 10% for self-rated health and 20% for 4-item pain and PASS. Probabilistic latent class derived classifications of self-rated health and 4-item pain outcomes outperformed PASS in separating growth trajectories. The effect size point estimates for 12-month 4-item pain scale score separation was approximately 3 times larger for latent class analyses as compared to PASS.When used for outcome classification, observed PASS scores consistently underperform relative to probabilistic latent class-derived subgroups of pain and self-rated health outcome. PASS is a weak substitute for probabilistic classification of other PROMs of KA outcome. Clinicians and researchers should rely on latent class analyses over PASS to differentiate between outcome subgroups following KA.

The Knee injury and Osteoarthritis Outcome Survey (KOOS) profile of outcome measures are among the most commonly used outcome measures in knee arthroplasty (KA). The purpose was to develop and externally validate "score maps" (one-page figural depictions of most likely scores) for KOOS Pain and Function subscales to facilitate a variety of clinical decisions related to shared decision making prior to KA.Presurgical KA data collected within 1 year of surgery and obtained in two independent studies were used in this cross-sectional study. Score maps were designed to be easily understandable, single-page graphical depictions of predicted KOOS Pain, and KOOS Function, daily activity subscales. To create the score maps, individual item scores from one dataset were used to determine the most probable responses for each item for the entire range of possible scores. Predicted KOOS score maps were derived from Osteoarthritis Initiative (OAI) data and externally validated using an independent single site KA cohort study. Score map predicted scores from OAI were compared to actual presurgical KOOS subscale scores using Weighted Kappa (ΚThe score maps derived from OAI and applied to actual scores in the validation sample demonstrated moderate to substantial chance-corrected agreement for both KOOS Pain and KOOS Function, daily activity subscale items. For example, KOOS Pain score map scores applied to the external validation dataset showed chance-corrected agreement with ΚScore maps derived from OAI data agreed with actual KOOS scores obtained on an independent dataset at an acceptable degree of precision. Easy-to-use KOOS Pain and Function, daily activity score maps have potential to facilitate a variety of important clinical decisions during discussions between patients and surgeons prior to KA.Level III prognostic study.

Chronic low back pain (cLBP) is a common and highly disabling problem world-wide. Although many treatment options exist, it is unclear how to best sequence the multitude of care options to provide the greatest benefit to patients.The Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER) trial uses a pragmatic, randomized, stepped design. Enrollment targets 2529 participants from 20 Veterans Affairs (VA) medical centers. Participants with chronic low back pain will first be randomized to one of three options: 1) an internet-based self-management program (Pain EASE); 2) a tailored physical therapy program (Enhanced PT); or 3) continued care with active monitoring (CCAM), a form of usual care. Participants not achieving a 30% or 2-point reduction on the study's primary outcome (Brief Pain Inventory Pain Interference (BPI-PI) subscale), 3 months after beginning treatment may undergo re-randomization in a second step to cognitive behavioral therapy for chronic pain, spinal manipulation therapy, or yoga. Secondary outcomes include pain intensity, back pain-related disability, depression, and others. Participants will be assessed every three months until 12 months after initiating their final trial therapy. Companion economic and implementation analyses are also planned.The SCEPTER trial is currently recruiting and enrolling participants.Trial results will inform treatment decisions for the stepped management of chronic low back pain - a common and disabling condition. Additional analyses will help tailor treatment selection to individual patient characteristics, promote efficient resource use, and identify implementation barriers of interventions.clinicaltrials.gov Identifier: NCT04142177.

Traditionally, the minimal clinically important difference (MCID) is used to judge the meaningfulness of outcomes in total knee arthroplasty (TKA). However, MCID estimates do not consider patient costs, potential side effects, and inconveniences. MCIDs vary substantially across TKA studies and have several conceptual and psychometric problems. A more scientifically sound alternative for estimating benefits patients expect TKA is the smallest worthwhile effect (SWE), measured with the benefit-harm trade-off method.We recruited 121 participants and followed them for 6 months after surgery. All participants completed Knee Injury and Osteoarthritis Score (KOOS) Pain and Function, and underwent an interview using the benefit-harm trade-off method.The absolute SWE at the 50th percentile (approximating the average patient) was 31 points KOOS Pain improvement and 28 points for KOOS Function, daily living. Construct validity was supported with strong associations between meeting SWE (yes or no) and satisfaction with 6-month outcome (yes or no) using Pearson Chi Square (24.5, P 0.001).Current MCID-based methods for interpreting KOOS change scores have flaws while the SWE method is conceptually superior. We determined the SWE of TKA that would justify the costs, risks, and inconveniences of surgery. SWE estimates suggest that patients expect a substantially greater change in KOOS scores than would be expected using MCID estimates. Clinicians can use SWE estimates when discussing likely outcomes and potential TKA benefits and risks with their patients.

Scores from patient reported outcome measures (PROMs) are challenging to interpret for both clinicians and patients. PROMs obtained prior to knee arthroplasty (KA) could be used to inform important decisions related to KA made by both patients and clinicians. The purpose of this study was to develop a "score map" to allow for efficient and meaningful use of PROMs scores for patients considering KA.Knee arthroplasty data obtained between one day and twelve months preoperatively from two multicenter studies were combined and used to develop and test the accuracy of a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale score map. To develop the score map, individual item scores were used to determine the most probable responses to items for the entire range of possible WOMAC Pain scores. Predicted WOMAC Pain scores, using the most probable response for each possible score on the score map, were compared to actual presurgical WOMAC Pain scores using Weighted Kappa (ΚData from 780 patients were used in the analyses. The score map predicted WOMAC Pain scores and showed substantial agreement with actual WOMAC Pain scores ΚThe WOMAC Pain score map has potential for facilitating a variety of important clinical decisions and discussions between patients and practitioners during healthcare encounters related to KA candidacy. For example, by comparing a patents' scores to literature-based estimates, patients may better understand how their WOMAC Pain scores compare to other persons who underwent KA, how much a score may change, on average, after surgery and whether this change might be acceptable to them.

Aims: The American Academy of Pediatrics recommends “parents to incorporate supervised, awake ‘prone play’ in their infant’s routine to support motor development and minimize the risk of plagiocephaly”. The purpose of this feasibility study was to compare usual care to a reward contingency–based intervention, developed to increase prone tolerance and improve motor skills. Methods: Ten full-term infants, 3–6- months old, with poor prone tolerance were randomized to either the Education group or Reward contingency group. Each group participated in three parent education sessions and 15 intervention sessions, over the period of three weeks. Infants in the Reward contingency group used the Prone Play Activity Center, a technology developed to reinforce motor behavior of infants in prone position. Intervention frequency and parent feedback data determined the feasibility of the interventions. Results: Infants in the Reward contingency group practiced a median of 12 of the 15 anticipated intervention sessions in the Prone Play Activity Center. These infants used the device for a mean of 18 minutes per day. Parents of infants in the Education group practiced a median of 10 sessions of the 15 anticipated intervention sessions. Conclusion: The reward contingency–based intervention is feasible for use in a future clinical trial with some modifications.

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.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.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.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.

Physical therapy is routinely delivered to patients after discharge from the hospital following knee arthroplasty. Posthospitalization physical therapy is thought to be beneficial, particularly for those patients most at risk of poor outcome, the subgroup with persistent function-limiting pain, despite an apparently successful surgery. Research teams have undertaken 3 large-scale multicenter Phase 3 randomized clinical trials designed specifically for patients at risk of poor outcome following knee arthroplasty. All 3 trials screened for poor outcome risk using different methods and investigated different physical therapist interventions delivered in different ways. Despite the variety of types of physical therapy and mode of delivery, all trials found no effects of the enhanced treatment compared with usual care. In all cases, usual care required a lower dosage of physical therapy compared with the enhanced interventions. This Perspective compares and contrasts the 3 trials, speculates on factors that could explain the no-effect findings, and proposes areas for future study designed to benefit the poor outcome phenotype.

Objective.In late 2017, the American Academy of Orthopaedic Surgeons (AAOS) published an appropriateness classification system using the RAND/University of California, Los Angeles (UCLA) approach for patients with hip osteoarthritis (OA). We determined the contribution of predictor variables in the system to final classification, rated as “appropriate,” “may be appropriate,” or “rarely appropriate” for hip arthroplasty.Methods.An AAOS-appointed expert panel developed 270 clinical vignettes incorporating all permutations of 5 evidence-driven indication variables associated with hip arthroplasty outcome or need. Indication variables were age, function-limiting pain severity, radiographic hip OA severity, hip motion, and presence of modifiable prognostic risk factors. Multinomial regression determined the relative contribution of each variable and a classification tree method determined variable combinations contributing to final classification.Results.Patient age and hip OA severity were the dominant predictors of appropriateness classification in both statistical models. Function-limiting pain made a slight contribution relative to age and hip OA severity while hip motion and the presence of modifiable prognostic factors did not meaningfully contribute to final classification. The regression model explained about 99% of the variance and the classification tree had an accuracy of 87.8%.Conclusion.Classification for hip arthroplasty appropriateness in the AAOS system is driven almost exclusively by age and OA severity. Function-limiting pain, a major reason patients seek surgery, contributes only slightly to the AAOS appropriateness criteria. The system relies heavily on traditional variables of patient age and radiographic hip OA severity. Future study of actual patient outcomes is needed to further test the validity of the AAOS system.

Pain catastrophizing has been identified as a prognostic indicator of poor outcome following knee arthroplasty. Interventions to address pain catastrophizing, to our knowledge, have not been tested in patients undergoing knee arthroplasty. The purpose of this study was to determine whether pain coping skills training in persons with moderate to high pain catastrophizing undergoing knee arthroplasty improves outcomes 12 months postoperatively compared with usual care or arthritis education. METHODS: A multicenter, 3-arm, single-blinded, randomized comparative effectiveness trial was performed involving 5 university-based medical centers in the United States. There were 402 randomized participants. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale, measured at baseline, 2 months, 6 months, and 12 months following the surgical procedure. RESULTS: Participants were recruited from January 2013 to June 2016. In 402 participants, 66% were women and the mean age of the participants (and standard deviation) was 63.2 ± 8.0 years. Three hundred and forty-six participants (90% of those who underwent a surgical procedure) completed a 12-month follow-up. All 3 treatment groups had large improvements in 12-month WOMAC pain scores with no significant differences (p > 0.05) among the 3 treatment arms. No differences were found between WOMAC pain scores at 12 months for the pain coping skills and arthritis education groups (adjusted mean difference, 0.3 [95% confidence interval (CI), −0.9 to 1.5]) or between the pain coping and usual-care groups (adjusted mean difference, 0.4 [95% CI, −0.7 to 1.5]). Secondary outcomes also showed no significant differences (p > 0.05) among the 3 groups. CONCLUSIONS: Among adults with pain catastrophizing undergoing knee arthroplasty, cognitive behaviorally based pain coping skills training did not confer pain or functional benefit beyond the large improvements achieved with usual surgical and postoperative care. Future research should develop interventions for the approximately 20% of patients undergoing knee arthroplasty who experience persistent function-limiting pain. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Prospective trial registration enhances transparency and rigor of trial reporting. We conducted an in-depth examination of randomized clinical trials (RCTs) published in The Journal of Arthroplasty (JOA) from 2010 to 2020 and their associated trial registries.We examined all RCTs published in the JOA during the even years between 2010 and 2020. We determined the proportion of trials that were registered and prospectively registered as well as the extent of consistency between primary outcome characteristics in the trials vs the registries. Trial characteristics published between 2010 and 2014 were compared to trials published between 2016 and 2020.A total of 57 (33.7%) of 169 primary RCTs over the study period reported being registered and of these, 20 (11.8%) were prospectively registered. For the registered primary RCTs, 75% reported primary outcome findings that were inconsistent with the corresponding registry. Trial registration proportion substantially improved from 13.6% between 2010 and 2014 to 53% between 2016 and 2020 (z-test = -5.315, P.001).High proportions of retrospectively registered or unregistered trials and a very high proportion of inconsistencies in reporting of primary outcomes compared to the trial registries were found. These data argue for a well-developed strategy by JOA to enhance editorial policies, reviewer and editorial board member training and oversight, and improved arthroplasty researcher awareness to improve the current state of RCT reporting in JOA.

Summary Objective To determine whether good versus poor outcome trajectories and predictors of poor outcome obtained in a derivation study could be replicated in an independent sample of persons undergoing knee arthroplasty (KA). Methods We used data from TRIO-POPULAR, a prospective cohort study of 926 participants who underwent KA in the United Kingdom. The participants were assessed preoperatively and 6-weeks, 6- and 12-months postoperatively. The Oxford Knee Score was the primary outcome and a variety of pre-operative predictors of outcome were selected. The outcome measure and the predictors were selected to most closely align with a previously published derivation study of good versus poor outcome. Confirmatory two-piece latent class growth curve analyses were used to model outcome and regression was used to identify predictors of outcome class. Results Trajectories for the Oxford Knee Scores from TRIO-POPULAR replicated trajectories for WOMAC Pain and Function scores from the previously published derivation study. Multivariable predictors of poor outcome were pain catastrophizing (odds ratio = 1.125, 95% CI = 1.048, .206, p = 0.001) and comorbidity (odds ratio = 1.134, 95%CI = 1.049, 1.227, p = 0.002. Pain catastrophizing also predicted poor outcome in the derivation study. Conclusions Good and poor outcome trajectories replicated those found in the previously published derivation study. Our model-based method produces stable outcome trajectories despite using data from different countries and participants with substantively different characteristics. Predictors of poor outcome were somewhat inconsistent between the cross-validation and derivation studies. Pain catastrophizing was the only consistent poor outcome predictor.

Nishida and colleagues conducted a Phase III placebo-controlled repeated knee injection study on persons with radiographically confirmed symptomatic knee osteoarthritis (1). This design allows for the determination of true effects of the active ingredient (diclofenac etalhyaluronate) over that attributable to placebo (contextual) injection effects and non-specific effects (2). My comments on the trial relate to three issues.

Objective Physical therapy visit number and timing following knee arthroplasty (KA) are variable in daily practice. The extent to which the number and timing of physical therapy visits are associated with current and future pain and function—and, alternatively, whether pain and function are associated with the number of future physical therapy visits following KA—are unknown. The purpose of this study was to determine temporal and reciprocal associations between the number of physical therapy visits and future pain and function in people with KA. Methods A cross-lagged panel design was applied to a secondary analysis of data from a randomized clinical trial of patients with pain catastrophizing. The 326 participants underwent KA and completed at least 7 of 9 health care diaries over the year following surgery. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function subscales were completed preoperatively and multiple times during follow-up. Separate cross-lagged panel analyses were conducted for WOMAC pain and physical function. Results From surgery to 2 months postsurgery, reciprocal associations were generally not found between physical therapy visit number and future pain or function. From 2 to 6 months postsurgery, a greater number of physical therapy weekly visits were associated with higher (worse) 6-month pain and function. Higher (worse) WOMAC pain at 2 and 6 months led to more visits from 2 to 6 and 6 to 12 months, respectively. Conclusions Higher pain scores 2 months postsurgery were associated with higher physical therapy use in the 2 to 6 months following surgery. However, patients with increased physical therapy use from 2 to 6 months had significantly higher pain scores 6 months postsurgery. Those patients with persistent pain 6 months postsurgery were higher users of physical therapy 6 to 12 months postsurgery. This reciprocal positive association between pain and physical therapy during this time period suggests minimal benefit of physical therapy despite an increased physical therapy use for patients with higher pain. Impact This is the first study to determine the association between the number and timing of physical therapy visits and current and future pain and function. Based on the results, physical therapy might not be a cost-effective strategy to treat patients with persistent pain following KA.

We examined the intertester reliability of patellofemoral compartment (PFC) osteoarthritis (OA) severity using magnetic resonance images (MRI) and a modified Kellgren and Lawrence (K&L) system. Second, we determined if these grades were associated with clinical tests of PFC involvement or self-reported pain/difficulty with stair climbing. Third, we assessed the association between PFC OA severity and knee pain or disability, after accounting for potential confounders including tibiofemoral OA severity. We examined the 9-year Osteoarthritis Initiative data from 114 subjects in the year prior to undergoing knee arthroplasty. The weighted kappa (κw) was used to determine intertester reliability, and the Pearson chi-square was used to assess associations among PFC OA scores and clinical tests. Multiple regressions were used to determine independent associations between self-reported pain/function and PFC OA. Reliability was substantial (κw = 0.73 (SE = 0.05)). Chi-square associations between PFC OA severity and clinical tests were not significant (p > 0.05). Multiple regression models between PFC OA and self-reported pain or function scores were not significant (p > 0.05). MRI-based measures of PFC OA were highly reliable indicating that musculoskeletal radiologists can reliably grade the PFCs of subjects using MRI. The extent of PFC OA is not associated with either clinical tests of PFC involvement or activities associated with PFC pain in persons with moderate to severe symptomatic tibiofemoral and PFC OA.

Publication spin, in the context of randomised clinical trials, is defined as ‘use of specific reporting strategies, from whatever motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results’ (p. 2059).1 In our view, a secondary but clinically important alternative type of publication spin is reliance on statistically significant findings without regard to potential clinical implications of the estimated effects. The American Statistical Association (ASA) has commented on this issue, stating a statistically significant effect does not inform its size or importance.2 A later editorial more explicitly states that conclusions not be based solely on statistical significance.3 We believe the recently published trial by Berenbaum and colleagues4 meets our secondary definition of publication spin and does not meet the recommendation endorsed by the ASA. Berenbaum and colleagues conducted a three-arm phase III randomised …

Objective The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale quantifies knee pain severity with activities of daily living, but the potential impact of pain in other body regions on WOMAC pain scores has not been explored using a causal modeling approach. The purpose of this study was to determine if pain in other areas of the body impact WOMAC pain scores, a phenomenon referred to as “crosstalk.” Methods Cross-sectional datasets were built from public use data available from the Osteoarthritis Initiative (OAI) and the Multicenter Osteoarthritis Study (MOST). The WOMAC Pain Scale and generic hip, knee, ankle, foot and back pain measures were included. Three nested regression models grounded in causally based classical test theory determined the extent of crosstalk. Improvements in the coefficient of determination across the 3 models were used to determine the presence of crosstalk. Results Causal modeling provided evidence of crosstalk in both OAI and MOST datasets. For example, in OAI, multiple statistical models demonstrated significant increases in coefficient of determination values (P Conclusions Crosstalk appears to be a clinically important source of error in the WOMAC Pain Scale, particularly for patients with a larger number of painful body regions and when contralateral knee joint pain is more severe. Impact Statement This study has important implications for arthritis research. It also should raise clinician awareness of the threat to score interpretation and the need to consider the extent of pain in other body regions when interpreting WOMAC pain scores.

Background Research on the role of trait versus state characteristics of a variety of measures among persons experiencing pain has been a focus for the past few decades. Studying the trait versus state nature of the Pain Catastrophizing Scale (PCS) and the Patient Health Questionnaire (PHQ-8) depression scale would be highly informative given both are commonly measured in pain populations and neither scale has been studied for trait/state contributions. Methods The PHQ-8 and PCS were obtained on persons undergoing knee arthroplasty at baseline, 2-, 6- and 12-month post-surgery (N = 402). The multi-trait generalization of the latent trait-state model was used to partition trait and state variability in PCS and PHQ-8 item responses simultaneously. A set of variables were used to predict trait catastrophizing and trait depression. Results For total scores, the latent traits and latent states explain 63.2% (trait = 43.2%; state = 20.0%) and 50.2% (trait = 29.4%; state = 20.8%) of the variability in PCS and PHQ-8, respectively. Patients with a high number of bodily pain sites, high levels of anxiety, young patients and African-American patients had high levels of trait catastrophizing and trait depression. The PCS and the PHQ-8 consist of both enduring trait and dynamic state characteristics, with trait characteristics dominating for both measures. Conclusion Clinicians and researchers using these scales should not assume the obtained measurements solely reflect either trait- or state-based characteristics. Significance Clinicians and researchers using the PCS or PHQ-8 scales are measuring both state and trait characteristics and not just trait- or state-based characteristics.

Daniel L Riddle,1 James D Slover,2 Dennis C Ang,3 Matthew J Bair,4 Kurt Kroenke,5 Robert A Perera,6 Levent Dumenci7 1Departments of Physical Therapy, Orthopaedic Surgery and Rheumatology, Virginia Commonwealth University, Richmond, VA, USA; 2Department of Orthopaedic Surgery, New York University Langone Medical Center, New York, NY, USA; 3Department of Rheumatology, Wake Forest University School of Medicine, Raleigh, NC, USA; 4Department of Medicine, VA Center for Health Information and Communication, Indiana University School of Medicine, Indianapolis, IN, USA; 5Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; 6Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA; 7College of Public Health, Temple University, Philadelphia, PA, USA Background: Opioid use rates prior to knee arthroplasty (KA) among people who catastrophize about their pain are unknown. We determined prevalence of opioid use and compared patterns of preoperative opioid use and oral morphine equivalent (OME), a measure of daily opioid dose, across varied geographic sites. We also determined which baseline variables were associated with opioid use and OME.Patients and methods: Preoperative opioid use data described type of opioid, dosage, and frequency among 397 patients scheduled for KA. Demographic, knee-related pain, and psychological distress dimensions were examined to identify variables associated with opioid use and opioid dose (OME). Opioid use prevalence and OME were compared across the four sites. A three-level censored regression determined variables associated with opioid use and OME.Results: The overall opioid use prevalence was 31.7% (95% confidence interval [CI] = 27.0, 36.3) and varied across sites from 15.9% (95% CI = 9.0, 22.8) to 51.2% (95% CI = 40.5, 61.9). After adjustment, patients using opioids were more likely to be younger, African American, and have higher self-efficacy and comorbidity scores (P < 0.05). The only variable independently associated with OME was lower depressive symptoms (P < 0.05).Conclusion: People who catastrophized prior to KA did not demonstrate increased preoperative opioid use based on current evidence, but variation in the prevalence of opioid use across study sites was substantial. Variables associated with opioid use were non-modifiable demographic and comorbidity variables. Keywords: pain, catastrophizing, opioid, knee, arthroplasty

OBJECTIVE: The primary purpose was to identify preoperative risk factors associated with post-hospitalization falls over an approximate 2-year postoperative period in patients undergoing hip and knee arthroplasty. DESIGN: The study utilized a longitudinal cohort design. SETTING: Participants were recruited from communities surrounding four urban university-based medical centers. PARTICIPANTS: All participants underwent hip or knee arthroplasty over a 9-year study period and were followed yearly in the Osteoarthritis Initiative study. MAIN OUTCOME MEASURE: The primary outcome measure was a self-reported history of falls over the two-year postoperative period. A fall was recorded when the participant reported landing on the floor or ground. Preoperative predictors of falls derived from prior evidence included preoperative fall history, depressive symptom severity, narcotic use, age, activity level and comorbidity. Multinomial regression analysis was applied to determine factors that predicted either a single fall or multiple falls during a two-year postoperative period. RESULTS: Preoperative predictors of multiple postoperative falls were a preoperative history of falling, depressive symptoms and hip versus knee arthroplasty. Patients with hip arthroplasty were more than twice as likely (Odds Ratio = 2.26, 95% CI = 1.21, 4.20) as patients with knee arthroplasty to have multiple self-reported falls in the first two postoperative years. No predictors were found for persons who reported falling only once postoperatively. Findings were generally supported in a sensitivity analysis. CONCLUSIONS: Clinicians involved with the pre-and postoperative care of persons undergoing hip or knee arthroplasty can use these findings to inform fall risk screening and intervention delivery to reduce fall risk in patients who are at risk for multiple falls following hip or knee arthroplasty.

Objectives To determine the prevalence of a 1- to 2-year postsurgical pain-free state and pain plus symptom-free state as well as functional restoration after knee arthroplasty (KA) and to identify predictors of these outcomes. Design Cohort study. Setting Communities of 4 sites. Participants Consecutive participants (N=383) who underwent KA on at least 1 knee during the first 8 years of the study (mean age, 67.95±8.5y; 61.4% women; n=235). Interventions Not applicable. Main Outcome Measures A composite pain score included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale and 2 generic pain rating scales. Composite pain plus other symptoms scores included 3 pain scales, a stiffness scale, and, in addition, the Knee injury and Osteoarthritis Outcome Score Symptoms scale. The WOMAC Function scale was used to quantify functional status. Prevalence estimates and predictors of a pain-free state, symptom-free state, and a fully functioning state were determined. Results A sample of 383 participants with KA was studied, and of these, 34.1% (95% confidence interval [CI], 29.3%–39.2%; n=131) had a composite score of 0 for pain. A total of 14.1% (95% CI, 10.8%–18.1%; n=54) had a composite score of 0, indicating a symptom-free state, whereas 29.0% (95% CI, 24.4%–34.0%; n=111) achieved a score of 0 on the WOMAC Function scale. Conclusions The prevalence of complete pain relief was 34%, the prevalence of complete pain and symptom relief was 14%, and the prevalence of complete functional restoration was 29% after KA. Participants who are older and with lower (better) WOMAC Pain scores were more likely to be pain-free after surgery. These data collected from a community-based sample have the potential to inform clinicians screening patients for KA consultation in a shared decision-making discussion to better align patient expectations with the most likely outcome.

BACKGROUND Pain-coping strategies and appraisals are responses to the pain experience. They can influence patient-reported and physical performance outcome measures in a variety of disorders, but the associations between a comprehensive profile of pain-coping responses and preoperative pain/function and physical performance measures in patients scheduled for knee arthroplasty have not been examined. Patients with moderate to high pain catastrophizing (a pain appraisal approach associated with an exaggerated focus on the threat value of pain) may represent an excellent study population in which to address this knowledge gap. QUESTIONS/PURPOSES We asked the following questions among patients with high levels of pain catastrophizing who were scheduled for TKA: (1) Do maladaptive pain responses correlate with worse self-reported pain intensity and function and physical performance? (2) Do adaptive pain-coping responses show the opposite pattern? As an exploratory hypothesis, we also asked: (3) Do maladaptive responses show more consistent associations with measures of pain, function, and performance as compared with adaptive responses? METHODS A total of 384 persons identified with moderate to high levels of pain catastrophizing and who consented to have knee arthroplasty were recruited. The sample was 67% (257 of 384) women and the mean age was 63 years. Subjects were consented between 1 and 8 weeks before scheduled surgery. All subjects completed the WOMAC pain and function scales in addition to a comprehensive profile of pain coping and appraisal measures and psychologic health measures. Subjects also completed the Short Physical Performance Battery and the 6-minute walk test. For the current study, all measures were obtained at a single point in time at the preoperative visit with no followup. Multilevel multivariate multiple regression was used to test the hypotheses and potential confounders were adjusted for in the models. RESULTS Maladaptive pain responses were associated with worse preoperative pain and function measures. For example, the maladaptive pain-coping strategy of guarding and the pain catastrophizing appraisal measures were associated with WOMAC pain scores such that higher guarding scores (β = 0.12, p = 0.007) and higher pain catastrophizing (β = 0.31, p < 0.001) were associated with worse WOMAC pain; no adaptive responses were associated with better WOMAC pain or physical performance scores. Maladaptive responses were also more consistently associated with worse self-reported and performance-based measure scores (six of 16 associations were significant in the hypothesized direction), whereas adaptive responses did not associate with better scores (zero of 16 scores were significant in the hypothesized direction). CONCLUSIONS The maladaptive responses of guarding, resting, and pain catastrophizing were associated with worse scores on preoperative pain and performance measures. These are pain-related responses surgeons should consider when assessing patients before knee arthroplasty. TKA candidates found to have these pain responses may be targets for treatments that may improve postoperative outcome given that these responses are modifiable. Future intervention-based research should target this trio of maladaptive pain responses to determine if intervention leads to improvements in postsurgical health outcomes. LEVEL OF EVIDENCE Level I, prognostic study.

Profiling recovery following knee replacement (KR) is a focus of substantial research interest because KR surgery has become one of the most common major surgical procedures. In the United States, for example, approximately one million KRs are performed annually. Additionally, there is substantial clinical practice and research interest in the study of poor pain outcome and predictors of poor pain outcome following KR.

Objective The assessment of racial differences in pain and function outcome following knee arthroplasty (KA) has received little attention despite very substantial literature exploring a variety of other prognostic factors. The present study was undertaken to determine whether race was associated with KA outcome after accounting for potential confounding factors. Methods We conducted a secondary analysis of a randomized clinical trial of 384 participants with moderate-to-high pain catastrophizing who underwent KA. Preoperative measures included race/ethnicity status as well as a variety of potential confounders, including socioeconomic status, comorbidity, and bodily pain. Outcome measures were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scales as well as performance measures. Linear mixed-effects models compared outcomes over a 1-year follow-up period for African American versus non-African American participants. Results WOMAC pain scores differences for African American versus non-African American participants averaged ~2 points in unadjusted analyses and 1-1.5 points in adjusted analyses. In adjusted analyses, follow-up WOMAC function scores differed by 6 points for African Americans compared to non-African Americans (P = 0.002). Conclusion African Americans generally had worse pain, function, and performance prior to KA and worse scores after surgery, but differences were small and attenuated by ~25-50% after adjustment for potential confounding. Only WOMAC function scores showed clinically important postsurgical differences in adjusted analyses. Clinicians should be aware that after adjustment for potential confounders, African Americans have approximately equivalent outcomes compared to others, with the exception of WOMAC function score.

OBJECTIVE Shared decision-making (SDM) is a strongly endorsed approach by which patients and clinicians work together to formulate a sensible care plan. The present study was undertaken to conduct a systematic review of SDM trials in patients considering knee arthroplasty (KA) to characterize how SDM was supported and the impact on care received. METHODS We searched multiple bibliographic databases from inception to December 31, 2019. A pair of reviewers working independently selected studies for inclusion, extracted data, and evaluated each trial's risk of bias. RESULTS We found 6 eligible randomized trials (4 included KA and hip arthroplasty), all of which tested the same proprietary decision aid (DA) (Treatment Choices for Hip or Knee Osteoarthritis), with some adding other materials to support SDM. These trials, all of which had moderate-to-high risk of bias, focused on assessing the effect of the DA on patient knowledge about the options while not explicitly supporting other aspects of SDM, such as choice awareness, deliberation, or decision-making. One trial found an increase in the number of African American patients undergoing KA in the 12 months following the intervention. No other trials found that SDM impacts clinical outcomes. CONCLUSION Evidence for SDM in patients considering KA is mostly limited to a single DA. While use of this DA improves patient knowledge about their treatment options, this tool has not been shown to promote SDM, impact treatment decisions, or satisfaction with care. Future work should seek to support SDM directly and assess effects on treatment decisions, functional outcomes, and satisfaction.

Objective Evidence supports the validity of total knee arthroplasty (TKA) appropriateness classification based on the RAND Corporation and University of California Los Angeles system.The system, however, is ~2 decades old, and the science and clinical application of TKA has changed dramatically. We undertook this study to describe the methods used to develop a second-generation system and to examine the structure of the system to determine the extent to which each of the indication criteria informed appropriateness. Methods Multivariable multinomial regression analyses determined the extent to which each of the 8 individually analyzed indication criteria informed appropriateness judgments. Classification tree analysis illustrates how the indication criteria, in combination, led to judgments of appropriate, inappropriate, or uncertain. Results An expert panel selected 8 indication criteria (i.e., age, knee pain, function, radiographic osteoarthritis severity, osteoarthritis location, psychological factors, pain catastrophizing, and comorbidities). A total of 1,008 clinical scenarios were written, based on the criteria. Regression analyses indicated that age, knee pain, function, and radiographic severity dominated prediction of appropriateness, while the other criteria played a smaller role. Classification tree analysis confirmed the regression findings. Conclusion Our second-generation classification system, which incorporates contemporary indicators of TKA prognosis and risk, demonstrated preliminary evidence for utility in clinical practice.

Background Patients considering knee arthroplasty (KA) and consulting orthopedic surgeons use different criteria to judge surgical appropriateness with surgeons placing high priority on osteoarthritis (OA) severity and age while patients place greatest emphasis on pain severity. In the face of fluctuating symptoms and high rates of bilateral knee OA, selection of the optimal knee for KA surgery can be challenging. This study examined osteoarthritis and symptom severity profiles of index versus contralateral knees of persons preparing for KA. Methods The nine-year Osteoarthritis Initiative data from 427 participants and five-year Multicenter Osteoarthritis Study data from 377 participants undergoing KA were included. The Western Ontario and McMaster Universities Osteoarthritis Index Pain, Function, and Stiffness Scales for both knees and radiographic readings were obtained at the visit prior to knee arthroplasty. Radar plots illustrated symptom and OA severity. Prevalence estimates of the proportion of contralateral knees with comparable or worse symptoms and OA severity relative to the index knee were reported. Results The prevalence of comparable or worse knee OA on the contralateral knees as compared with index knees is 26% (95% CI = 22%, 30%). Prevalence of the same or worse WOMAC Pain for the contralateral knees relative to the index knees is 17% (95% CI = 14%, 21%). Conclusions The prevalence of comparable/worse knee OA or symptoms on the contralateral knees relative to index knees of persons undergoing unilateral KA is substantial. Methods for selecting the surgical knee should be reconsidered for this substantial subgroup of patients.

Despite being one of the most common indications for surgery, data on the types of meniscus tear that should be treated surgically are limited. Improving patient selection requires agreement on meniscus tear description. This study evaluates a simple MRI tear classification system for inter-observer agreement. Knee MRI examinations from 57 subjects from the Osteoarthritis Initiative cohort were reviewed by two sub-specialty trained, musculoskeletal radiologists. Based on two pulse sequences, each meniscus was classified by: tear or no tear; location of tear in anterior, middle or posterior third or multiple thirds; and displaced or non-displaced radial, horizontal, longitudinal or complex tear pattern. A tear was defined as signal abnormality extending to the surface on at least two images and displacement as more than 2 mm of extrusion or separation measured orthogonal to the tear plane. Kappa, weighted Kappa and percentage agreement were calculated. For the medial meniscus, Kappa and percentage agreement estimates were, respectively: the presence of tear, 0.79 and 89.5%; tear with displacement, 0.70 (weighted Kappa) and 66.0%; tear description, 0.47 and 61.4%; tear location, 0.64 and 79.0%. For the lateral meniscus, estimates were: the presence of tear, 0.75 and 89.5%; tear with displacement, 0.81 (weighted Kappa) and 86.0%; tear description, 0.56 and 78.9%; tear location, 0.74 and 87.7%. The strength of agreement between readers was moderate to substantial underscoring the challenge of meniscus tear classification.

Background Associative learning is the ability to discover a relationship between two or more events. We combined principles of learning and technology to develop a paradigm to assess associative learning in prone. Purpose The purpose of this study was to determine whether 3- to 6-month-old infants can demonstrate: (1) short-term learning of an association between their upper body movements in prone and activation of a toy, and (2) retention of the association learned on day 1, 24 hours later. Methods Twenty-eight infants who were 3 to 6 months of age and who were typically developing were tested for 2 consecutive days in an instrumented play gym. Both days of testing had a baseline and 4 acquisition phases (2 minutes each). During the acquisition phase, the toy activated for a maximum of 10 seconds when the infant's head was above a threshold. A criterion was set a priori to distinguish infants as short-term learners and retainers of the association learned on day 1. Results Of 28 infants, 22 and 14 infants completed all phases of the testing on day 1 and day 2, respectively. Fourteen (50%) of the infants met the criteria for short-term learners. On day 2, there was an analyzable sample of 9 short-term learners. Three of the 12 short-term learners (25%) demonstrated retention on day 2. Conclusion Consistent with prior infant motor learning research, half of the infants demonstrated associative learning in this novel assessment in prone; however, based on study criteria, the infants had limited retention of the association on day 2.