Patient reported outcome measures (PROMs) as primary and secondary outcomes in total hip and knee arthroplasty randomized controlled trials: a systematic review.

BACKGROUND: Significant heterogeneity exists regarding patient reported outcome measures (PROMs) used in total hip (THA) and knee (TKA) arthroplasty randomized controlled trials (RCTs). This study investigates the PROMs used as primary and secondary outcomes in contemporary arthroplasty RCTs. METHODS: A literature search identified THA and TKA RCTs that were published in top ten impact factor orthopaedic journals from 2017 to 2021. Screening identified 241 trials: 76 THA, 157 TKA, and eight combined. Data were extracted to identify PROMs utilized as either primary or secondary outcomes and the time period of measurement. RESULTS: Visual Analog Scale (VAS) Pain was the most reported primary PROM in THA (9.2%) and TKA (22.9%) trials. This was followed by Numeric Rating Scale (NRS) Pain (7.9%) and the Harris Hip score (6.6%) in THA trials and NRS Pain (4.5%) and the Knee Society score (4.5%) in TKA trials. Many THA (37.0%) and TKA (52.1%) trials did not clearly specify primary outcome time points. Only pain scales were reported at time points less than one week, while various joint-specific functional outcomes were reported at later time points. As secondary outcomes, the Harris Hip score (28.9%) was most common in THA trials and the Knee Society score (26.1%) was most common in TKA trials. Indeterminate primary or secondary outcomes were reported in 18.2% of studies. CONCLUSIONS: Contemporary THA and TKA trials exhibit heterogeneity of PROMs as study outcomes after the first postoperative week. Our findings highlight the need for consensus in PROM reporting and better methodological reporting to improve the interpretability of RCT outcomes. PROSPERO REGISTRATION NUMBER: CRD42022337255.

KOOS score maps were externally validated to inform knee arthroplasty shared decision making.

PURPOSE: 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. METHODS: 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 (Κw) agreement coefficients and actual versus predicted differences in scores. RESULTS: The 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 Κw ranging from 0.43 to 0.73. Score maps predicted actual item scores within ± 1 point at least 94% of the time. Findings for the KOOS Function, daily activity subscale items were similar. CONCLUSIONS: Score 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 OF EVIDENCE: Level III prognostic study.

Examination of Randomized Trials and Corresponding Trial Registry Entries: Registration Timing and Primary Outcome Analysis in the Journal of Arthroplasty.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Physical Therapy Use, Costs, and Value for Latent Classes of Good vs Poor Outcome in Patients Who Catastrophize About Their Pain Prior to Knee Arthroplasty.

OBJECTIVE: To examine use, costs, and value of physical therapy (PT) among subgroups. DESIGN: We conducted an observational study of data from a randomized trial of a pain coping skills intervention. Good and poor outcome subgroups were determined based on Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain and Physical Function scores. The use and costs of PT care as well as changes in WOMAC Pain and Physical Function scores over 4 time periods during a 1-year follow-up were reported. We compared the number of PT visits, total PT costs, and cost per 1-unit improvement in WOMAC scores for the 2 latent subgroups. SETTING: Five academic medical centers. PARTICIPANTS: Patients who catastrophized about their pain prior to knee arthroplasty (N=384). INTERVENTIONS: Pain coping skills training, arthritis education, and usual care. MAIN OUTCOME MEASURES: The WOMAC Pain Scale was the primary outcome. RESULTS: The value of PT was lower and the cost of PT was higher for poor vs good outcome subgroups beginning 2 months after knee arthroplasty. For example, during the 2- to 6-month period, participants in the poor outcome subgroup incurred a PT cost of $5181.22 per 1-unit improvement in WOMAC Pain compared with $437.87 per 1-unit improvement in WOMAC Pain for the good outcome subgroup (P<.001). From the 6- to 12-month period, WOMAC scores worsened for the poor outcome subgroup, indicating no benefit from PT. CONCLUSIONS: Patients in 2 latent classes demonstrated clinically important differences in value of PT. Future research should identify rehabilitation-based interventions that reduce utilization and enhance effectiveness for patients at high risk for poor outcome.

Quantitative contrast enhanced dual energy CT to predict avascular necrosis: a feasibility study of proximal humerus fractures.

BACKGROUND: Avascular necrosis is a delayed complication of proximal humerus fractures that increases the likelihood of poor clinical outcomes. CT scans are routinely performed to guide proximal humerus fracture management. We hypothesized iodine concentration on post-contrast dual energy CT scans identifies subjects who develop avascular necrosis and ischemia due to compromised blood flow. MATERIALS AND METHODS: 55 patients with proximal humerus fractures enrolled between 2014 and 2017 underwent clinical, radiographic and contrast enhanced dual energy CT assessment. Iodine densities of the humeral head and the glenoid (control) were measured on CT. Subjects managed with open reduction internal fixation or conservatively (non-surgical) were followed for up to two years for radiographic evidence of avascular necrosis. Arthroplasty subjects underwent histopathologic evaluation for ischemia of the resected humeral head. RESULTS: 17 of 55 subjects (30.9%) were treated conservatively, 21 (38.2%) underwent open reduction internal fixation and 17 of 55 (30.9%) underwent arthroplasty. Of the 38 subjects treated conservatively or with ORIF, 20 (52.6%) completed 12 months of follow up and 14 (36.8%) 24 months of follow up. At 12 months follow up, two of 20 subjects (10%) and at 24 months 3 of 14 subjects (21.4%) developed avascular necrosis. At 12 months, the mean humerus/glenoid iodine ratio was 1.05 (standard deviation 0.24) in subjects with AVN compared to 0.91 (0.24) in those who did not. At 24 months, subjects with avascular necrosis had a mean humerus/glenoid iodine concentration ratio of 1.06 (0.17) compared to 0.924 (0.21) in those who did not. Of 17 arthroplasty subjects, 2 had severe ischemia and an iodine ratio of 1.08 (0.30); 5 had focal ischemia and a ratio of 1.00 (0.36); and 8 no ischemia and a ratio of 0.83 (0.08). CONCLUSIONS: Quantifying iodine using dual energy CT in subjects with proximal humerus fractures is technically feasible. Preliminary data suggest higher humeral head iodine concentration may increase risk of avascular necrosis; however, future studies must enroll and follow enough subjects managed with open reduction internal fixation or conservatively for two or more years to provide statistically significant results. Trial Registrations NCT02170545 registered June 23, 2014, ClinicalTrials.gov.

Classifications of good versus poor outcome following knee arthroplasty should not be defined using arbitrary criteria.

A recently published paper by te Molder and colleagues in BMC Musculoskeletal Disorders confirmed prior reports indicating that definitions of good versus poor outcome cutoff scores for relevant knee arthroplasty outcomes including pain and function are heterogeneous and that this heterogeneity prevents generalizable inferences. In this Correspondence, we highlight an additional and, in our view, a more important problem with the substantial literature on this topic. There also is high homogeneity in that all studies relied on arbitrarily defined cutoff scores to differentiate good versus poor outcome. We discuss this problem and propose a method to avoid repeating the same problem in future studies designed to group patients into those with good versus those with poor outcome following knee arthroplasty.

Prevalence and Predictors of Symptom Resolution and Functional Restoration in the Index Knee After Knee Arthroplasty: A Longitudinal Study.

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.

Preoperative Risk Factors for Postoperative Falls in Persons Undergoing Hip or Knee Arthroplasty: A Longitudinal Study of Data From the Osteoarthritis Initiative.

OBJECTIVE: To identify preoperative risk factors associated with posthospitalization falls over an approximate 2-year postoperative period in patients undergoing both hip and knee arthroplasty. DESIGN: A longitudinal cohort design. SETTING: Communities surrounding 4 urban university-based medical centers. PARTICIPANTS: Adults (N = 596) with hip or knee arthroplasty over a 9-year period and followed yearly. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The primary outcome measure was a self-reported history of falls over the 2-year postoperative period. A fall was recorded when the participant reported landing on the floor or ground. Preoperative predictors of falls derived from previous evidence included preoperative fall history, depressive symptom severity, narcotic use, age, activity level, and comorbidity. Multinomial regression analysis was performed to determine factors that predicted either a single fall or multiple falls during a 2-year postoperative period. RESULTS: Preoperative predictors of multiple postoperative falls were a preoperative history of falls, depressive symptoms, and hip vs knee arthroplasty. Patients with hip arthroplasty were more than twice as likely (odds ratio, 2.26; 95% confidence interval, 1.21-4.20) as patients with knee arthroplasty to have multiple self-reported falls in the first 2 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 in 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 after hip or knee arthroplasty.

Do Pain Coping and Pain Beliefs Associate With Outcome Measures Before Knee Arthroplasty in Patients Who Catastrophize About Pain? A Cross-sectional Analysis From a Randomized Clinical Trial.

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 (ß = 0.12, p = 0.007) and higher pain catastrophizing (ß = 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.

Construct validation and correlates of preoperative expectations of postsurgical recovery in persons undergoing knee replacement: baseline findings from a randomized clinical trial.

BACKGROUND: A patient's recovery expectations prior to knee arthroplasty influence postsurgical outcome and satisfaction but a unidimensional measure of expectation has not been reported in the literature. Our primary purpose was to determine the extent to which a patient expectations scale reflects a unidimensional construct. Our second purpose was to identify pre-operative variables associated with patients' expectations. We hypothesized that previously identified predictors of the latent expectation scale score would be associated with expectations and that previously unexplored variables of pain catastrophizing, depressive and anxiety symptoms, self-efficacy and number of painful body regions would also associate with pre-operative expectations. METHODS: Our randomized clinical trial had 384 patients assessed prior to knee replacement surgery. The expectations scale along with several predictor variables including WOMAC, psychological distress, and sociodemographic variables were obtained. Confirmatory factor analysis tested the unidimensionality of the measure and structural equation modeling identified predictors of the latent expectations measure. RESULTS: The expectations scale was found to be unidimensional with superior model fit (χ2 = 1.481; df = 2; p = 0.224; RMSEA = 0.035; 90% CI = [0-0.146]; CFI = 0.999; TLI = 0.993). The only variable significantly associated with expectations in the multivariate model was self-efficacy. CONCLUSIONS: The expectations scale used in our study demonstrated unidimensionality and has strong potential for clinical application. Poor self-efficacy is a potential target for intervention given its independent association with expectation. Addressing expectations directly and indirectly through self-efficacy assessment may assist in better aligning patient's expectations with likely outcome. TRIAL REGISTRATION: ClinicalTrials.gov NCT01620983 .

External Validation of a Prognostic Model for Predicting Nonresponse Following Knee Arthroplasty.

BACKGROUND: Instruments designed to predict the extent of pain and function following knee arthroplasty (KA) recovery has strong potential to guide patients and clinicians in shared decision making. Our purpose was to test the external validity of a recently developed prognostic instrument designed to estimate the probability of nonresponse following KA. METHODS: We used data from the Osteoarthritis Initiative (OAI), a 9-year multisite National Institutes of Health study designed to examine the natural history of knee osteoarthritis in 4796 subjects. A total of 427 subjects underwent KA over the study period. Dowsey et al examined the prognostic role of obesity, general mental health, pain and function, and Kellgren and Lawrence knee osteoarthritis grades. Calibration of the prognostic model was determined using a calibration curve. The c-statistic was used to indicate discrimination of the model. RESULTS: In the primary analysis, 63 (19.3%) of 326 subjects in OAI were classified as nonresponders. The calibration curve generated from OAI data indicated poor calibration relative to the recently developed instrument. Discrimination as measured by the c-statistic was 0.76. CONCLUSION: The external validity of the prognostic instrument was partially supported. While discrimination of the model was very similar to the recently developed instrument, calibration was poor indicating poor agreement between actual vs predicted probabilities of nonresponse. Western Ontario and McMaster Universities Arthritis Index and Kellgren and Lawrence grades show strong potential for use in future prognostic model development. Measurements of general mental health and obesity were not prognostic for nonresponse.

A longitudinal comparative study of falls in persons with knee arthroplasty and persons with or at high risk for knee osteoarthritis.

OBJECTIVES: we determined the yearly prevalence of single and multiple falls in persons with or at risk of knee osteoarthritis (OA) and persons undergoing knee arthroplasty over an 8-year period. We also compared annual fall rates among persons with and without knee arthroplasty to determine if fall rates are associated with knee arthroplasty. METHODS: we studied 4,200 persons from the Osteoarthritis Imitative (OAI), a National Institutes of Health funded prospective study of persons 45-79 years and conducted from 2004 to 2012. All either had knee OA or were at risk of developing knee OA but did not have knee arthroplasty. The surgical group comprised 413 persons who underwent knee arthroplasty. Key fall risk factors were assessed at yearly study visits. Graphical depictions illustrated single and multiple fall trajectories. Multinomial regression adjusted for potential confounders compared fall rates for those with and without knee arthroplasty. RESULTS: fall rate trajectories for the two samples were generally flat and fall rates were similar. For the arthroplasty sample, fall rates did not increase in the immediate perioperative period relative to earlier and later periods. No differences in fall rates were found among the arthroplasty and non-arthroplasty samples after adjustment for potential confounding (P > 0.05). CONCLUSIONS: fall rates were generally stable and similar over an 8-year period among persons with and without knee arthroplasty. Clinicians should not assume that persons undergoing knee arthroplasty are at greater risk for falls either before or after surgery as compared to persons with or at risk for knee OA.

What Is the Relationship Between Depressive Symptoms and Pain During Functional Tasks in Persons Undergoing TKA? A 6-year Perioperative Cohort Study.

BACKGROUND: Preoperative depressive symptoms have been shown in some but not all studies to be associated with poor self-reported pain and function outcomes. In addition, depressive symptoms after surgery have been shown to improve relative to preoperative levels. QUESTIONS/PURPOSES: We hypothesized that (1) preoperative depressive symptoms would predict postoperative pain; (2) depressive symptoms would decrease after surgery; and (3) preoperative depressive symptoms would increase as the scheduled surgery date approached. METHODS: Data from the Osteoarthritis Initiative, a National Institutes of Health-funded prospective multiyear cohort study, were used in this retrospective analysis. Persons from four communities were eligible if they had radiographic knee osteoarthritis or were at risk for developing knee osteoarthritis based on occupational, medical history, or body weight risk factors. A total of 4796 persons participated and rates of followup were 80% or greater over the course of the study. Participants completed a validated depressive symptom scale and the Knee Injury and Osteoarthritis Outcome Scale pain scale each year for 3 years before and 3 years after TKA. Latent growth curve modeling was used to model intercepts and slopes of pre- and postoperative depression and pain. Preoperative trajectories and intercepts were then used to predict postoperative pain and depressive symptoms adjusting for confounding variables. RESULTS: After adjustment for potential confounding, we found no evidence that preoperative depressive symptoms predicted postoperative pain with function (estimate, 0.1; 95% confidence interval, -0.31 to 0.50; p = 0.64) or that depressive symptoms were reduced after surgery (z = 0.06, p = 0.80). We also found no evidence to indicate that preoperative depressive symptoms increased as the date of surgery approached (linear slope = 0.28, SE = 0.19, p = 0.15). CONCLUSIONS: Preoperative and postoperative depressive symptoms in patients before and after TKA did not appreciably change over a 6-year perioperative period. Patient depressive symptoms were not reduced after surgery and did not appear to be related to less pain postoperatively. Our findings of no association between preoperative depressive symptom severity and postoperative pain and no reduction in postoperative depressive symptoms run counter to other available evidence, potentially attributable, in part, to a data collection process that occurred outside of orthopaedic surgeons' offices. Future research is needed to more fully explore the potential role of social desirability, the concept that patients respond in a way that they think the researcher or clinician wants them to respond in lieu of responding in a way that truly reflects the patient's status. Social desirability may influence a TKA patient's pain and function outcome assessment. LEVEL OF EVIDENCE: Level I, prognostic study.