Responsiveness of Subjective and Objective Measures of Pain and Function Following Operative Interventions for Musculoskeletal Conditions: A Narrative Review.

OBJECTIVE: Musculoskeletal (MSK) disorders affect ~50% of US adults and 75% of those over the age of 65, representing a sizable economic and disability burden. Outcome measures, both objective and subjective, help clinicians and investigators determine whether interventions to treat MSK conditions are effective. This narrative review qualitatively compared the responsiveness of different types of outcome measures, a key measurement characteristic that assesses an outcome measure's ability to detect change in patient status. METHODS: We evaluated elective orthopedic interventions as a model for assessing responsiveness because the great majority of patients improves following surgery. We searched for articles reporting responsiveness (quantified as effect size [ES]) of subjective and objective outcome measures after orthopedic surgery and included 16 articles reporting 17 interventions in this review. RESULTS: In 14 of 17 interventions, subjective function measures had an ES 10% greater than that of objective function measures. Two reported a difference in ES of <10%. The sole intervention that demonstrated higher ES of objective function used a composite measure. Sixteen interventions reported measures of subjective pain and/or mixed measures and subjective function. In nine interventions, subjective pain had a higher ES than subjective function by >10%, in three, subjective function had a higher ES than subjective pain by >10%, and in the remaining four, the difference between pain and function was <10%. CONCLUSION: These findings reinforce the clinical observation that subjective pain generally changes more than function following elective orthopedic surgery. They also suggest that subjective function measures are more responsive than objective function measures, and composite scores may be more responsive than individual performance tests.

Causal relationships between pain, medical treatments, and knee osteoarthritis: A graphical causal model to guide analyses.

OBJECTIVE: Randomized controlled trials (RCTs) are a gold standard for estimating the benefits of clinical interventions, but their decision-making utility can be limited by relatively short follow-up time. Longer-term follow-up of RCT participants is essential to support treatment decisions. However, as time from randomization accrues, loss to follow-up and competing events can introduce biases and require covariate adjustment even for intention-to-treat effects. We describe a process for synthesizing expert knowledge and apply this to long-term follow-up of an RCT of treatments for meniscal tears in patients with knee osteoarthritis (OA). METHODS: We identified 2 post-randomization events likely to impact accurate assessment of pain outcomes beyond 5 years in trial participants: loss to follow-up and total knee replacement (TKR). We conducted literature searches for covariates related to pain and TKR in individuals with knee OA and combined these with expert input. We synthesized the evidence into graphical models. RESULTS: We identified 94 potential covariates potentially related to pain and/or TKR among individuals with knee OA. Of these, 46 were identified in the literature review and 48 by expert panelists. We determined that adjustment for 50 covariates may be required to estimate the long-term effects of knee OA treatments on pain. CONCLUSION: We present a process for combining literature reviews with expert input to synthesize existing knowledge and improve covariate selection. We apply this process to the long-term follow-up of a randomized trial and show that expert input provides additional information not obtainable from literature reviews alone.

Factors Associated With Diagnostic Delay in Axial Spondyloarthritis: Impact of Clinical Factors and Social Vulnerability.

OBJECTIVE: Patients with axial spondyloarthritis (axSpA) often experience significant delay between symptom onset and diagnosis for reasons that are incompletely understood. We investigated associations between demographic, medical, and socioeconomic factors and axSpA diagnostic delay. METHODS: We identified patients meeting modified New York criteria for ankylosing spondylitis (AS) or 2009 Assessment of Spondyloarthritis International Society criteria for axSpA in the Mass General Brigham health care system between December 1990 and October 2021. We determined the duration of diagnostic delay, defined as the duration of back pain symptoms reported at diagnosis, as well as disease manifestations and specialty care prior to diagnosis from the electronic health record. We obtained each patient's Social Vulnerability Index (SVI) by mapping their address to the US Centers for Disease Control SVI Atlas. We examined associations among disease manifestations, SVI, and diagnostic delay using ordinal logistic regression. RESULTS: Among 554 patients with axSpA who had a median diagnostic delay of 3.8 years (interquartile range 1.1-10), peripheral arthritis (odds ratio [OR] 0.65, 95% confidence interval [CI] 0.45-0.93) and older age at symptom onset (OR 0.83, 95% CI 0.78-0.88 per five years) were associated with shorter delay. AS at diagnosis (OR 1.85, 95% CI 1.30-2.63), a history of uveitis prior to diagnosis (OR 2.77, 95% CI 1.73-4.52), and higher social vulnerability (defined as national SVI 80th to 99th percentiles; OR 1.99, 95% CI 1.06-3.84) were associated with longer diagnostic delay. CONCLUSION: Older age at back pain onset and peripheral arthritis were associated with shorter delay, whereas uveitis was associated with longer diagnostic delay. Patients with higher socioeconomic vulnerability had longer diagnostic delay independent of clinical factors.

The osteoarthritis prevention study (TOPS) - A randomized controlled trial of diet and exercise to prevent Knee Osteoarthritis: Design and rationale.

Background: Osteoarthritis (OA), the leading cause of disability among adults, has no cure and is associated with significant comorbidities. The premise of this randomized clinical trial is that, in a population at risk, a 48-month program of dietary weight loss and exercise will result in less incident structural knee OA compared to control. Methods/design: The Osteoarthritis Prevention Study (TOPS) is a Phase III, assessor-blinded, 48-month, parallel 2 arm, multicenter randomized clinical trial designed to reduce the incidence of structural knee OA. The study objective is to assess the effects of a dietary weight loss, exercise, and weight-loss maintenance program in preventing the development of structural knee OA in females at risk for the disease. TOPS will recruit 1230 ambulatory, community dwelling females with obesity (Body Mass Index (BMI) â€‹≥ â€‹30 â€‹kg/m2) and aged ≥50 years with no radiographic (Kellgren-Lawrence grade ≤1) and no magnetic resonance imaging (MRI) evidence of OA in the eligible knee, with no or infrequent knee pain. Incident structural knee OA (defined as tibiofemoral and/or patellofemoral OA on MRI) assessed at 48-months from intervention initiation using the MRI Osteoarthritis Knee Score (MOAKS) is the primary outcome. Secondary outcomes include knee pain, 6-min walk distance, health-related quality of life, knee joint loading during gait, inflammatory biomarkers, and self-efficacy. Cost effectiveness and budgetary impact analyses will determine the value and affordability of this intervention. Discussion: This study will assess the efficacy and cost effectiveness of a dietary weight loss, exercise, and weight-loss maintenance program designed to reduce incident knee OA. Trial registration: ClinicalTrials.gov Identifier: NCT05946044.

Assessment of Residual Pain and Dissatisfaction in Total Knee Arthroplasty: Methods Matter.

Background: Residual pain after total knee arthroplasty (TKA) refers to knee pain after 3 to 6 months postoperatively. The estimates of the proportion of patients who experience residual pain after TKA vary widely. We hypothesized that the variation may stem from the range of methods used to assess residual pain. We analyzed data from 2 prospective studies to assess the proportion of subjects with residual pain as defined by several commonly used metrics and to examine the association of residual pain defined by each metric with participant dissatisfaction. Methods: We combined participant data from 2 prospective studies of TKA outcomes from subjects recruited between 2011 and 2014. Residual pain was defined using a range of metrics based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score (0 to 100, in which 100 indicates worst), including the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS). We also examined combinations of MCID and PASS cutoffs. Subjects self-reported dissatisfaction following TKA, and we defined dissatisfied as somewhat or very dissatisfied at 12 months. We calculated the proportion of participants with residual pain, as defined by each metric, who reported dissatisfaction. We examined the association of each metric with dissatisfaction by calculating the sensitivity, specificity, positive predictive value, and Youden index. Results: We analyzed data from 417 subjects with a mean age (and standard deviation) of 66.3 ± 8.3 years. Twenty-six participants (6.2%) were dissatisfied. The proportion of participants defined as having residual pain according to the various metrics ranged from 5.5% to >50%. The composite metric Improvement in WOMAC pain score ≥20 points or final WOMAC pain score ≤25 had the highest positive predictive value for identifying dissatisfied subjects (0.54 [95% confidence interval, 0.35 to 0.71]). No metric had a Youden index of ≥50%. Conclusions: Different metrics provided a wide range of estimates of residual pain following TKA. No estimate was both sensitive and specific for dissatisfaction in patients who underwent TKA, underscoring that measures of residual pain should be defined explicitly in reports of TKA outcomes. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Radiographic Changes Five Years After Treatment of Meniscal Tear and Osteoarthritic Changes.

OBJECTIVE: Meniscal tear in persons aged ≥45 years is typically managed with physical therapy (PT), and arthroscopic partial meniscectomy (APM) is offered to those who do not respond. Prior studies suggest APM may be associated with greater progression of radiographic changes. METHODS: We assessed changes between baseline and 60 months in the Kellgren-Lawrence (KL) grade and OARSI radiographic score (including subscores for joint space narrowing and osteophytes) in subjects aged 45-85 years enrolled into a seven-center randomized trial comparing outcomes of APM with PT for meniscal tear, osteoarthritis changes, and knee pain. The primary analysis classified subjects according to treatment received. To balance APM and PT groups, we developed a propensity score and used inverse probability weighting (IPW). We imputed a 60-month change in the OARSI score for subjects who underwent total knee replacement (TKR). In a sensitivity analysis, we classified subjects by randomization group. RESULTS: We analyzed data from 142 subjects (100 APM, 42 PT). The mean ± SD weighted baseline OARSI radiographic score was 3.8 ± 3.5 in the APM group and 4.0 ± 4.9 in the PT group. OARSI scores increased by a mean of 4.1 (95% confidence interval [95% CI] 3.5-4.7) in the APM group and 2.4 (95% CI 1.7-3.2) in the PT group (P < 0.001) due to changes in the osteophyte component. We did not observe statistically significant differences in the KL grade. Sensitivity analyses yielded similar findings to the primary analysis. CONCLUSION: Subjects treated with APM had greater progression in the OARSI score because of osteophyte progression but not in the KL grade. The clinical implications of these findings require investigation.

An approach to virtual clinical trial site visits: Lessons from the MeTeOR trial.

Objective: To provide a framework for conducting clinical trial site visits virtually over videoconference, and to report on our experience doing so during the twelve-year follow-up of the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial. Design: Using published FDA guidance and prior literature, we created a structure for virtual site visits that prioritized monitoring for protocol compliance, safety, and data integrity. We conducted site visits in three stages: preparation for the visit, the virtual meeting itself, and follow-up. The preparation phase involved a review of relevant site-specific documents and a written report on the findings prior to the visit. The virtual visit itself was focused on any questions the site staff had about the pre-visit report, observing a mock study visit, touring physical spaces, and understanding the site staff's work environment. In the follow-up phase, we wrote a post-visit report summarizing the discussion during the visit and feedback given by the coordinating site. Results: We found that the virtual site visits conducted as part of the MeTeOR trial follow-up ran smoothly. Although we could not directly compare in-person and virtual site visits, site staff unanimously appreciated the efficiency and effectiveness of the virtual site visits. We noted that displaying physical workspaces over videoconferencing was difficult, and a notable drawback to this method. Conclusions: To our knowledge, this is the first published framework for conducting virtual clinical trial site visits. Conducting these visits virtually confer several advantages in terms of time, money, and efficiency.

Cost-Effectiveness of Weight-Loss Interventions Prior to Total Knee Replacement for Patients With Class III Obesity.

OBJECTIVE: Class III obesity (body mass index >40 kg/m2 ) is associated with higher complications following total knee replacement (TKR), and weight loss is recommended. We aimed to establish the cost-effectiveness of Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastrectomy (LSG), and lifestyle nonsurgical weight loss (LNSWL) interventions in knee osteoarthritis patients with class III obesity considering TKR. METHODS: Using the Osteoarthritis Policy model and data from published literature to derive model inputs for RYGB, LSG, LNSWL, and TKR, we assessed the long-term clinical benefits, costs, and cost-effectiveness of weight-loss interventions for patients with class III obesity considering TKR. We assessed the following strategies with a health care sector perspective: 1) no weight loss/no TKR, 2) immediate TKR, 3) LNSWL, 4) LSG, and 5) RYGB. Each weight-loss strategy was followed by annual TKR reevaluation. Primary outcomes were cost, quality-adjusted life expectancy (QALE), and incremental cost-effectiveness ratios (ICERs), discounted at 3% per year. We conducted deterministic and probabilistic sensitivity analyses to examine the robustness of conclusions to input uncertainty. RESULTS: LSG increased QALE by 1.64 quality-adjusted life-years (QALYs) and lifetime medical costs by $17,347 compared to no intervention, leading to an ICER of $10,600/QALY. RYGB increased QALE by 0.22 and costs by $4,607 beyond LSG, resulting in an ICER of $20,500/QALY. Relative to immediate TKR, LSG and RYGB delayed and decreased TKR utilization. In the probabilistic sensitivity analysis, RYGB was cost-effective in 67% of iterations at a willingness-to-pay threshold of $50,000/QALY. CONCLUSION: For patients with class III obesity considering TKR, RYGB provides good value while immediate TKR without weight loss is not economically efficient.

Cost-Effectiveness of Surgical Weight-Loss Interventions for Patients With Knee Osteoarthritis and Class III Obesity.

OBJECTIVE: Class III obesity (body mass index [BMI] ≥40 kg/m2 ) is associated with worse knee pain and total knee replacement (TKR) outcomes. Because bariatric surgery yields sustainable weight loss for individuals with BMI ≥40 kg/m2 , our objective was to establish the value of Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (LSG) in conjunction with usual care for knee osteoarthritis (OA) patients with BMI ≥40 kg/m2 . METHODS: We used the Osteoarthritis Policy model to assess long-term clinical benefits, costs, and cost-effectiveness of RYGB and LSG. We derived model inputs for efficacy, costs, and complications associated with these treatments from published data. Primary outcomes included quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs), all discounted at 3%/year. This analysis was conducted from a health care sector perspective. We performed sensitivity analyses to evaluate uncertainty in input parameters. RESULTS: The usual care + RYGB strategy increased the quality-adjusted life expectancy by 1.35 years and lifetime costs by $7,209, compared to usual care alone (ICER = $5,300/QALY). The usual care + LSG strategy yielded less benefit than usual care + RYGB and was dominated. Relative to usual care alone, both usual care + RYGB and usual care + LSG reduced opioid use from 13% to 4%, and increased TKR usage from 30% to 50% and 41%, respectively. For cohorts with BMI between 38 and 41 kg/m2 , usual care + LSG dominated usual care + RYGB. In the probabilistic sensitivity analysis, at a willingness-to-pay threshold of $50,000/QALY, usual care + RYGB and usual care + LSG were cost-effective in 70% and 30% of iterations, respectively. CONCLUSION: RYGB offers good value among knee OA patients with BMI ≥40 kg/m2 , while LSG may provide good value among those with BMI between 35 and 41 kg/m2 .

Objective performance tests assess aspects of function not captured by self-report in knee osteoarthritis.

Objective: Knee osteoarthritis (OA) can substantially limit function, which can be assessed both objectively and subjectively. We examined whether objective performance tests are associated with self-reported function. Methods: We analyzed baseline data from the Osteoarthritis Registry of Biomarker and Imaging Trajectories (ORBIT) of participants ≥40 years old with symptomatic and radiographic knee OA. Subjects completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Activities of Daily Living (ADL) scales and other assessments of pain and comorbidity. Subjects performed the timed single leg balance test (SLB), 30-s sit-to-stand (30s STS), Timed-Up-and-Go (TUG), and 40-m fast paced walk (40 â€‹m Walk). We used Pearson correlation coefficients to examine associations between performance and KOOS subscales. We adjusted for potential confounders using partial correlations. Results: We enrolled 101 subjects (mean age 63.7 (standard deviation (SD) 10.1), mean BMI 30.0 (SD 5.6), and 63% female). The mean (SD) values for the performance tests were: SLB 20.1 (18.9) seconds, 30s STS 11.7 (4.6) stands, TUG 9.4 (2.3) seconds, and 40 â€‹m Walk 27.6 (6.5) seconds. Correlations between performance tests and self-report measures did not exceed 0.39, with the absolute value of correlations between KOOS ADL and performance measures ranging from 0.24 to 0.39. Adjusted partial correlations were largely similar to the crude correlations. Conclusions: Self-reported function in persons with knee OA had weak to modest correlations with objective function. Objective performance tests capture elements of physical function that self-report data do not and point to the potential value of including objective measures of functional status in OA trials.

Impact of Preoperative and Incident Musculoskeletal Problematic Areas on Postoperative Outcomes After Total Knee Replacement.

OBJECTIVE: To examine impact of pre-existing and incident problematic musculoskeletal (MSK) areas after total knee replacement (TKR) on postoperative 60-month Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain/function scores. METHODS: Using data from a randomized controlled trial of subjects undergoing TKR for osteoarthritis, we assessed problematic MSK areas in six body regions before TKR and 12, 24, 36, and 48 months after TKR. We defined the following two variables: 1) density count (number of problematic MSK areas occurring after TKR; range 0-24) and 2) cumulative density count (problematic MSK areas both before and after TKR, categorized into four levels: no preoperative areas and density count of 0-1 [reference group]; no preoperative areas and density count of 2 or more; one or more preoperative areas and density count of 0-1; and one or more preoperative areas and density count of 2 or greater). We evaluated the associations between categorized 60-month WOMAC and cumulative density count by ordinal logistic regression. RESULTS: Among 230 subjects, 24% reported one or more preoperative problematic MSK area. After TKR, 75% reported a density count of 0 to 1; 25% reported a density count of 2 or more. Compared with the reference group, each cumulative density count category was associated with an increased odds of having a higher category of 60-month WOMAC pain score, as follows: 2.97 (95% confidence interval [CI], 1.48-5.98) for no preoperative problematic areas and density count of 2 or greater, 3.31 (95% CI, 1.64-6.66) for one or more preoperative problematic areas and density count of 0 to 1, and 2.85 (95% CI, 0.97-8.39) for one or more preoperative problematic areas and density count of 2 or greater. Similar associations were observed with 60-month WOMAC function score. CONCLUSION: In TKR recipients, the presence of problematic musculoskeletal areas beyond the index knee-preoperatively and/or postoperatively-was associated with worse 60-month WOMAC pain/function score.

Factors associated with use of antibiotic prophylaxis following dental procedures in total joint replacement recipients.

Background: Total joint replacement recipients (TJR) are at risk for prosthetic joint infection (PJI), particularly those with comorbidities such as diabetes mellitus (DM) and rheumatoid arthritis (RA). Methods: We mailed surveys to 1078 subjects undergoing primary TJR between 2011 and 2016 â€‹at an academic center. The survey asked about medical, dental, and orthopedic history and use of antibiotics prior to dental appointments. We generated adjusted relative risks (aRR) for using antibiotic prophylaxis less than always using Poisson regression, adjusting for demographic, clinical, and behavioral factors. Results: We received surveys from 639 subjects; 597 were eligible and formed the analytical sample. 66 â€‹% reported always using antibiotic prophylaxis. DM and RA were not associated with prophylaxis use. Factors associated with less frequent use included: BMI ≥30 (aRR â€‹= â€‹1.27, 95 â€‹% CI [1.01, 1.60]), dental cleanings <2 times/year (aRR â€‹= â€‹1.95, 95 â€‹% CI [1.56, 2.43]), and expressing little concern (compared to neutral) about getting PJI (aRR â€‹= â€‹1.23, 95 â€‹% CI [0.97, 1.55]), though this association was not statistically significant. Greater antibiotic use was reported in subjects who had ≥3 TJRs, (aRR â€‹= â€‹0.48, 95 â€‹% CI [0.29, 0.80]), underwent more invasive dental procedures (aRR â€‹= â€‹0.74, 95 â€‹% CI [0.59, 0.93]), and were concerned (vs. neutral) about PJI (aRR â€‹= â€‹0.53, 95 â€‹%CI [0.33, 0.84]). Conclusions: Two-thirds of TJR recipients in an academic center reported always using antibiotic prophylaxis prior to dental visits. Usage rates varied by demographics, BMI, number of TJRs, type of dental procedure, and behavioral factors -- but not by comorbidities associated with higher PJI risk.

Diabetes Remission Status During Seven-year Follow-up of the Longitudinal Assessment of Bariatric Surgery Study.

CONTEXT: Few studies have examined the clinical characteristics that predict durable, long-term diabetes remission after bariatric surgery. OBJECTIVE: To compare diabetes prevalence and remission rates during 7-year follow-up after Roux-en-Y gastric bypass (RYGB) and laparoscopic gastric banding (LAGB). DESIGN: An observational cohort of adults with severe obesity recruited between 2006 and 2009 who completed annual research assessments for up to 7 years after RYGB or LAGB. SETTING: Ten US hospitals. PARTICIPANTS: A total sample of 2256 participants, 827 with known diabetes status at both baseline and at least 1 follow-up visit. INTERVENTIONS: Roux-en-Y gastric bypass or LAGB. MAIN OUTCOME MEASURES: Diabetes rates and associations of patient characteristics with remission status. RESULTS: Diabetes remission occurred in 57% (46% complete, 11% partial) after RYGB and 22.5% (16.9% complete, 5.6% partial) after LAGB. Following both procedures, remission was greater in younger participants and those with shorter diabetes duration, higher C-peptide levels, higher homeostatic model assessment of ß-cell function (HOMA %B), and lower insulin usage at baseline, and with greater postsurgical weight loss. After LAGB, reduced HOMA insulin resistance (IR) was associated with a greater likelihood of diabetes remission, whereas increased HOMA-%B predicted remission after RYGB. Controlling for weight lost, diabetes remission remained nearly 4-fold higher compared with LAGB. CONCLUSIONS: Durable, long-term diabetes remission following bariatric surgery is more likely when performed soon after diagnosis when diabetes medication burden is low and beta-cell function is preserved. A greater weight-independent likelihood of diabetes remission after RYGB than LAGB suggests mechanisms beyond weight loss contribute to improved beta-cell function after RYGB.Trial Registration clinicaltrials.gov Identifier: NCT00465829.

Prevalence of Undiagnosed Subchondral Insufficiency Fractures of the Knee in Middle Age Adults with Knee Pain and Suspected Meniscal Tear.

OBJECTIVE: Symptomatic knee osteoarthritis (OA) and meniscal tear are often treated with weight-bearing exercises and without ordering advanced imaging (e.g. MRI). This may lead to missed diagnoses of subchondral insufficiency fracture of the knee (SIFK). Failure to diagnose SIFK has treatment implications, as patients with SIFK are typically managed with a period of reduced weight-bearing. The primary objective of this study is to determine the prevalence of undiagnosed SIFK among persons treated non-operatively for knee pain and suspected meniscal tear(s). METHODS: The randomized controlled trial, TeMPO (Treatment of Meniscal Problems and Osteoarthritis), enrolls subjects whose clinicians suspect concomitant meniscal tear and knee OA. TeMPO participants undergo MRI ordered by the study to confirm meniscal tear. All study-ordered MRIs revealing a fracture were reviewed by two study radiologists who noted features of the fracture and joint. We report prevalence of SIFK and clinical and imaging features on these subjects with 95% confidence intervals. RESULTS: Ten of the 340 study-ordered MRIs had SIFK, resulting in an estimated prevalence of 2.94% (95% CI: 1.15%, 4.71%). Eight of the ten participants with SIFK had fractures located medially. The femur was involved in five of these participants, tibia in four, and both in one. Five of the ten participants did not have meniscal tears. CONCLUSIONS: This is the only reported estimate of undiagnosed SIFK in adults with knee pain, to our knowledge. Approximately 3% of patients managed with weight-bearing exercise for suspected meniscal tear may have SIFK, a diagnosis typically treated with reduced weight-bearing approaches.

Psychometric properties of the Neuropathic Pain Scale (NPS) in a knee osteoarthritis population.

Objective: Symptoms resembling neuropathic pain (neuropathic-like symptoms) are prevalent in osteoarthritis (OA) populations. Scales that measure neuropathic-like symptoms frequently were established in groups with true neuropathic pain conditions and have not been assessed in OA. We assessed the psychometric properties of the Neuropathic Pain Scale (NPS) in subjects with OA undergoing total knee replacement (TKR). Design: In a prospective study of adults undergoing TKR for OA, we assessed baseline distributions, acceptability (completion rate), internal consistency (Cronbach's alpha), responsiveness 12 months post-TKR, and construct validity of the NPS. We performed factor analysis and created subscales from the items loading onto each retained factor. We evaluated subscale properties and calculated the proportion of total scores attributable to each subscale and compared this with the proportion expected if each item contributed equally. Results: Mean baseline NPS score among 263 participants was 42.7 (SD: 15.9). Cronbach's alpha was 0.88. Factor analysis produced two factors: "bothersome" (items: intense/sharp/dull/unpleasant/deep; Cronbach's alpha = 0.87), and "dysesthetic" (items: cold/sensitive/itchy/surface; alpha = 0.77). Bothersome items contributed more to total NPS scores (74%) than would be expected if each item contributed equally (50%). NPS scores correlated moderately with baseline pain and function, and decreased after TKR, with standardized response means (SRMs) of: total NPS: 1.77, Bothersome subscale: 2.03, Dysesthetic subscale: 0.70. Conclusions: The NPS had acceptable completion, internal consistency, and construct validity, but was not optimal for use in OA; Bothersome subscale items disproportionately drive total NPS scores and may fail to discriminate between nociceptive and neuropathic-like symptoms.

Stability of Measures of Pain Catastrophizing and Widespread Pain Following Total Knee Replacement.

OBJECTIVE: Pain catastrophizing and widespread pain are predictors of pain chronicity/severity. Gaps remain in our understanding of the extent to which each is a stable (trait) or dynamic (state) variable. We undertook this study to assess the stability of each variable from before to after total knee replacement (TKR) and whether changes are explained by pain improvements. METHODS: We used data from a prospective study of TKR recipients ages ≥40 years. Questionnaires included body pain diagrams assessing widespread pain, the Pain Catastrophizing Scale (PCS), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. We divided subjects into widespread pain groups (0 versus 1-2 versus ≥3 pain regions) and into low and high PCS score groups (<16 versus ≥16). We assessed changes in group membership from pre-TKR to 12 months post-TKR, then compared these changes between subjects with most and least WOMAC pain improvement. RESULTS: A total of 176 subjects completed scales at both time points; 64% were female, the mean age was 66 years, and baseline median WOMAC pain score was 40. In all, 71% of subjects in the high PCS score group improved to join the low PCS score group at follow-up. While 73 subjects (41%) changed widespread pain group, they were similarly likely to worsen and to improve. We found a statistically significant positive association of improvement in WOMAC pain score with improvement in PCS score (r = 0.31), but not widespread pain (r = -0.004). CONCLUSION: The PCS score reflects state-like aspects of catastrophizing that diminish along with pain. In contrast, widespread pain scores worsened and improved equally often, regardless of knee pain relief. The findings urge caution in interpreting PCS score and widespread pain as trait measures in musculoskeletal research.

Musculoskeletal Symptomatic Areas After Total Knee Replacement for Osteoarthritis.

OBJECTIVE: The objective of this study was to measure cumulative incidence and incidence rate and identify factors associated with new musculoskeletal (MSK) symptomatic areas after total knee replacement (TKR) for osteoarthritis (OA). METHODS: Using data from a randomized controlled trial of patients undergoing elective TKR for OA, we assessed for MSK symptomatic areas by region (neck, hands/wrists/arms/shoulders, back, hips, nonindex knee, and ankles/feet) at baseline (pre-TKR), and at 3, 6, 12, 24, 36, and 48 months post-TKR. Cumulative incidence and incidence rates were calculated for each region. Factors associated with incident MSK symptomatic areas were identified using generalized linear mixed models. Time to incident symptomatic area was assessed using Cox proportional hazards regression. RESULTS: Among 293 subjects, the cumulative incidence of any new MSK symptomatic area over 4 years was 45%; the incidence rate was 19.2 per 100 person-years. Body site-specific cumulative incidence and incidence rates were highest for nonindex knee and back. Predictors of incident MSK symptomatic areas included female sex (relative risk [RR] 1.64; 95% confidence interval [CI] 1.15-2.34), body mass index of 35 or higher (RR 1.27; 95% CI 0.88-1.85), Charlson Comorbidity Index 2 or more (RR 1.28; 95% CI 0.92-1.78), baseline index knee Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score greater than 40 (RR 1.39; 95% CI 0.99-1.95), and anxiety/depression (measured by the five-item Mental Health Index) (RR 1.70; 95% CI 1.20-2.40). CONCLUSION: Incident MSK symptomatic areas occurred in roughly half of recipients of TKR in the 4 years after the operation. Further study is needed to examine the long-term impact of MSK symptomatic areas on postoperative pain, function, and quality of life.

A consensus-based process identifying physical therapy and exercise treatments for patients with degenerative meniscal tears and knee OA: the TeMPO physical therapy interventions and home exercise program.

BACKGROUND: Knee osteoarthritis (OA) is prevalent and often associated with meniscal tear. Physical therapy (PT) and exercise regimens are often used to treat OA or meniscal tear, but, to date, few programs have been designed specifically for conservative treatment of meniscal tear with concomitant knee OA. Clinical care and research would be enhanced by a standardized, evidence-based, conservative treatment program and the ability to study the effects of the contextual factors associated with interventions for patients with painful, degenerative meniscal tears in the setting of OA. This paper describes the process of developing both a PT intervention and a home exercise program for a randomized controlled clinical trial that will compare the effectiveness of these interventions for patients with knee pain, meniscal tear and concomitant OA. METHODS: This paper describes the process utilized by an interdisciplinary team of physical therapists, physicians, and researchers to develop and refine a standardized in-clinic PT intervention, and a standardized home exercise program to be carried out without PT supervision. The process was guided in part by Medical Research Council guidance on intervention development. RESULTS: The investigators achieved agreement on an in-clinic PT intervention that included manual therapy, stretching, strengthening, and neuromuscular functional training addressing major impairments in range of motion, musculotendinous length, muscle strength and neuromotor control in the major muscle groups associated with improving knee function. The investigators additionally achieved agreement on a progressive, protocol-based home exercise program (HEP) that addressed the same major muscle groups. The HEP was designed to allow patients to perform and progress the exercises without PT supervision, utilizing minimal equipment and a variety of methods for instruction. DISCUSSION: This multi-faceted in-clinic PT program and standardized HEP provide templates for in-clinic and home-based care for patients with symptomatic degenerative meniscal tear and concomitant OA. These interventions will be tested as part of the Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial. TRIAL REGISTRATION: The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 on February 14, 2017. TeMPO was also approved by the Institutional Review Board at Partners HealthCare/Brigham and Women's Hospital.

Activity Impairment and Work Productivity Loss After Total Knee Arthroplasty: A Prospective Study.

BACKGROUND: Total knee arthroplasty (TKA) is increasingly performed among working-aged individuals, highlighting the importance of work-related outcomes. Therefore, the aim is to examine the extent of both activity impairment outside work and work productivity (absenteeism, presenteeism, at-work productivity loss) at 6 and 24 months post-TKA surgery. Additionally, associated risk factors with these outcomes were evaluated. METHODS: This analysis included 183 patients <70 years undergoing TKA who completed questionnaires pre-operatively and during follow-up. Outcomes were derived from the Work Productivity and Activity Impairment questionnaire and included activity impairment, absenteeism (sick leave), presenteeism (reduced work performance), and at-work productivity loss (overall work productivity loss). All outcomes were scaled 0%-100%, with higher percentages indicating higher impairments. Covariates included age, gender, education, pain catastrophizing, pain, function, psychological distress, and knee-related and health-related quality of life. Linear and logistic regression was used to assess associations between covariates and Work Productivity and Activity Impairment scores at follow-up. RESULTS: At 6 months, the mean activity impairment was 22.8% (standard deviation [SD] 23.5) dropping to 17.1% (23.1) by 24 months. Among workers, presenteeism was 18.4% (24.6) and at-work productivity loss was 20.8% (26.1). Both dropped significantly by 24 months to 14.2% (22.4) and 12.9% (20.9), respectively. Absenteeism levels were low at both time points. Pain catastrophizing was associated with all outcomes. CONCLUSION: This study showed that activity impairment and work productivity loss are common following TKA, decreased significantly over time, but still existed 2 years post-operatively. Those reporting high levels of pain catastrophizing may benefit from targeted rehabilitation guidance to reduce and possibly prevent activity impairment and work productivity loss.

Clinical outcomes and risk-factor analysis of the Ponseti Method in a low-resource setting: Clubfoot care in Haiti.

PURPOSE: The Ponseti Method has dramatically altered the management of clubfoot, with particular implications for limited-resource settings. We sought to describe outcomes of care and risk factors for sub-optimal results using the Ponseti Method in Haiti. METHODS: We conducted a records review of patients presenting from 2011-2015 to a CURE Clubfoot clinic in Port-au-Prince, Haiti. We report patient characteristics (demographics and clinical), treatment patterns (cast number/duration and tenotomy rates), and outcomes (relapse and complications). We compared treatment with benchmarks in high-income nations and used generalized linear models to identify risk factors for delayed presentation, increased number of casts, and relapse. RESULTS: Amongst 168 children, age at presentation ranged from 0 days (birth) to 4.4 years, 62% were male, 35% were born at home, 63% had bilateral disease, and 46% had idiopathic clubfeet. Prior treatment (RR 6.33, 95% CI 3.18-12.62) was associated with a higher risk of delayed presentation. Risk factors for requiring ≥ 10 casts included having a non-idiopathic diagnosis (RR 2.28, 95% CI 1.08-4.83) and higher Pirani score (RR 2.78 per 0.5 increase, 95% CI 1.17-6.64). Female sex (RR 1.54, 95% CI 1.01-2.34) and higher Pirani score (RR 1.09 per 0.5 increase, 95% CI 1.00-1.17) were risk factors for relapse. Compared to North American benchmarks, children presented later (median 4.1 wks [IQR 1.6-18.1] vs. 1 wk), with longer casting (12.5 wks [SD 9.8] vs. 7.1 wks), and higher relapse (43% vs. 22%). CONCLUSIONS: Higher Pirani score, prior treatment, non-idiopathic diagnosis, and female sex were associated with a higher risk of sub-optimal outcomes in this low-resource setting. Compared to high-income nations, serial casting began later, with longer duration and higher relapse. Identifying patients at risk for poor outcomes in a low-resource setting can guide counseling, program development, and resource allocation.