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OBJECTIVE: Chronic pain is known to be an important construct in clinical practice and a particular form of chronic pain, high-impact chronic pain (HICP), has gained recent interest and attention by pain clinicians, epidemiologists, and clinical researchers. The purpose of our Topical Review is to describe the historical development of measures of HICP and to explore the psychometric properties of HICP as well as to present alternative measurement methods. METHODS: We identified strengths and weaknesses of the psychometric characteristics of HICP measures. Limitations of existing HICP measures were discussed and summarized and alternatives to current methods were proposed. RESULTS: HICP operational definitions show variability across studies. All definitions cannot be correct, but which ones are incorrect cannot be determined as there is no gold standard. Random measurement error and recall bias are among the other limitations of current HICP measures. Model-based definitions of HICP, the discrete (for epidemiologic applications) and continuous (for clinical applications) latent variable models are discussed as likely superior alternatives to current methods. CONCLUSIONS: Limitations of existing HICP methods are discussed and alternative development approaches to HICP measures are presented. The use of either discrete or continuous latent variable models would improve upon the psychometric characteristics of current HICP evidence. Examples are used to illustrate the benefits of latent variable models over traditional observed variable conceptualizations as the measurement of HICP continues to develop. SIGNIFICANCE STATEMENT: This work takes the position that current methods of measuring high impact chronic pain (HICP) likely contain substantial error. We have endorsed an alternative approach for several psychometrically grounded reasons. We recommend that future work consider the discrete latent variable framework for dichotomous measures of HICP and the continuous latent variable framework for continuous measures of HICP. The paper provides illustrative examples of these methods for a different patient reported measure that is lacking a gold standard, much like HICP measures.
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Objective: To determine, in a head-to-head comparison, which of two RAND-based knee replacement appropriateness criteria is optimal based on comparison to an externally validated method of judging good versus poor outcome. Design: Longitudinal data from the Osteoarthritis Initiative (OAI) and the Multicenter Osteoarthritis Study (MOST) were combined to produce a dataset of 922 persons with knee arthroplasty, 602 of which had adequate data for RAND classification and had their surgery within one year prior to a study visit. Data were used to determine appropriateness classification (i.e., Appropriate, Inconclusive, Rarely Appropriate) using modified versions of the first-generation and second-generation Escobar system. Growth curve analyses and multivariable regression were used to compare the two systems. Results: Neither system associated with the gold standard measure of good versus poor outcome. Distributions of appropriateness categories for the second-generation system were inconsistent with current evidence for knee arthroplasty outcome. For example, 16% of participants were classified as Appropriate and 64% as Rarely Appropriate for pain outcome. Distributions for the first-generation system aligned with current evidence. Conclusion: The first-generation modified version of the Escobar appropriateness system is superior to the newer version but neither version associated with our gold standard growth curve analyses. Both systems only differentiate between patient classification groups preoperatively and up to ten months following surgery. Reliance on appropriateness criteria to inform long-term outcome is not warranted.
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INTRODUCTION: Interpretations of patient-reported outcome measures following knee arthroplasty lack context and typically do not account for costs, risks and benefits compared to an alternative treatment. The primary purpose of our paper is to estimate expectations patients have for pain and function destination outcome, six-months following surgery relative to the outcome expected if knee arthroplasty was not done. Secondary purposes were to determine if statistically significant changes in the smallest worthwhile six-month outcome occurred following an interactive discussion and to assess the construct validity of the expected six-month outcome obtained at baseline. METHODS: This was a secondary analysis of a prospective longitudinal cohort study of 121 patients undergoing knee arthroplasty. Smallest worthwhile effect estimates were determined and expected six-month KOOS Pain and Function, daily activity measures were established during a pre-operative visit. RESULTS: The average six-month expected (the destination of interest) KOOS Pain score was 75 (IQR = 64 to 86) and the average KOOS Function, daily activity score was 74 (IQR = 59 to 86). The smallest worthwhile effect discussion led to significant changes in expected destination scores. For example, KOOS Pain expected outcome changed from 87.7 (9.8) to 75.0 (13.6), a statistically significant reduction in expected outcome (t(119) = 16.942, p < 0.001. CONCLUSION: Six-month expected KOOS outcomes following knee arthroplasty were established and approximate the average six-month outcomes reported in the literature. Validity of these estimates was established. These data can be used to aid shared decision-making discussions regarding patient expectations of knee arthroplasty outcomes during a patient encounter.
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Artroplastia de Reemplazo de Rodilla , Humanos , Femenino , Masculino , Anciano , Persona de Mediana Edad , Estudios Prospectivos , Estudios Longitudinales , Medición de Resultados Informados por el Paciente , Dimensión del Dolor , Resultado del Tratamiento , Dolor Postoperatorio/etiología , Actividades Cotidianas , DolorRESUMEN
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.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Medición de Resultados Informados por el Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Dimensión del DolorRESUMEN
OBJECTIVE: Poor outcome after knee arthroplasty (KA), a common major surgery worldwide, reportedly occurs in approximately 20% of patients. These patients demonstrate minimal improvement, at least moderate knee pain, and difficulty performing many routine daily activities. The purposes of our study were to comprehensively determine poor outcome risk after KA and to identify predictors of poor outcome. METHODS: Data from 565 participants with KA in the Osteoarthritis Initiative and the Multicenter Osteoarthritis studies were used. Previously validated latent class analyses (LCAs) of good versus poor outcome trajectories of Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain and Disability were generated to describe minimal improvement and poor final outcome. The modified Escobar RAND appropriateness system was used to generate classifications of appropriate, inconclusive, and rarely appropriate. Multivariable prediction models included LCA-based good versus poor outcome, modified Escobar classifications, and evidence-driven preoperative prognostic variables. RESULTS: Modified Escobar appropriateness classifications were nonsignificant predictors of WOMAC Pain good versus poor outcomes, indicating the methods provide independent outcome estimates. For WOMAC Pain and WOMAC Disability, approximately 34% and 45% of participants, respectively, had a high probability of either minimal improvement via "rarely appropriate" classifications or poor outcome via LCA. In multivariable prediction models, greater contralateral knee pain consistently predicted poor outcome (eg, odds ratio 1.21, 95% confidence interval 1.10-1.33). CONCLUSION: Appropriateness criteria and LCA estimates provided combined poor outcome estimates that were approximately double the commonly reported poor outcome of 20%. Rates of poor outcome could be reduced if clinicians screened patients using appropriateness criteria and LCA predictors before surgery to optimize outcome.
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Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla , Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Osteoartritis de la Rodilla/cirugía , Estudios Longitudinales , Dimensión del Dolor , Análisis de Clases Latentes , Resultado del Tratamiento , Evaluación de la Discapacidad , Estudios de Cohortes , PronósticoRESUMEN
Opioid use and dosage following knee arthroplasty (KA) has not been reported for subgroups with persistent moderate pain versus rapidly improving mild pain, externally validated from prior work. We determined if opioid use and dosage varied for persons classified into these externally validated subgroups. A secondary purpose determined if bodily pain scores are associated with the outcome subgroup. This was a secondary analysis of a prospective no-effect randomized clinical trial conducted on 384 participants with pain catastrophizing and scheduled for KA. Data were collected preoperatively and at 2-, 6-, and 12-month following surgery. Two-piece latent class growth curve analyses applied previously validated pain outcomes to determine subgroup outcome trajectories for the proportion of opioid users and oral morphine equivalent (OME) dosages. Substantial trajectory separation was found for opioid use and OME. Specifically, the average OME dosage for the persistent moderate pain subgroup was more than double that for the other outcome subgroup. The average preoperative opioid daily OME dosage for 170 patients reporting opioid use was 24.94 (95% [confidence interval] CI = 20.52, 29.38). Bodily pain was consistently higher for the persistent moderate pain subgroup compared to the other subgroup. Outcome subgroups in patients with pain catastrophizing demonstrated substantial differences in opioid use and dosage and were predicted by high pain catastrophizing, more bodily pain, and changes in bodily pain over time. The persistent moderate pain subgroup is at greater risk of opioid use and greater opioid dosages and should be targeted for preoperative screening and interventions to reduce opioid use and potential opioid misuse. PERSPECTIVE: More frequent and higher opioid dosage following KA was found for the persistent moderate pain subgroup compared to the other subgroup. Patients with persistent pain had worse catastrophizing, contralateral and ipsilateral lower extremity pain, low back pain, and whole body pain compared to the rapidly improving mild pain subgroup.
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BACKGROUND: The extent to which chronic bodily pain changes following total knee arthroplasty (TKA) is unknown. We determined the extent of chronic bodily pain changes at 1 year following TKA. METHODS: Data from our randomized trial of pain coping skills, which revealed no effect of the studied interventions, were used. The presence and severity of chronic pain in 16 body regions, excluding the surgically treated knee, were determined prior to and 1 year following surgery. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale was used to quantify the extent of surgical knee pain. Latent change score (LCS) models were used to determine the extent to which true chronic bodily pain scores change after TKA. RESULTS: The mean age of the sample of 367 participants was 63.4 ± 8.0 years, and 247 (67%) were female. LCS analyses showed significant 20% to 54% reductions in pain in the surgically treated lower limb (not including the surgically treated knee), pain in the non-surgically treated lower limb, and whole body pain. In bivariate LCS analyses, greater improvement in the WOMAC pain score, indicating surgical benefit of TKA, led to greater improvement in all 4 bodily pain areas beyond the surgically treated knee, even after controlling for the latent change in pain catastrophizing. CONCLUSIONS: Clinically important chronic bodily pain reductions occurred following TKA and may be causally linked to the surgical procedure. Reduction in chronic bodily pain in sites other than the surgically treated knee is an additional benefit of TKA. LEVEL OF EVIDENCE: Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence.
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Artroplastia de Reemplazo de Rodilla , Dolor Crónico , Osteoartritis de la Rodilla , Humanos , Femenino , Persona de Mediana Edad , Anciano , Masculino , Resultado del Tratamiento , Articulación de la Rodilla/cirugía , Pronóstico , Dolor Crónico/etiología , Osteoartritis de la Rodilla/cirugíaRESUMEN
SYNOPSIS: Responder analyses are methods for analyzing randomized controlled trials, which purport to identify individuals or subgroups of study participants who experienced a "clinically meaningful" improvement from a treatment. Unfortunately, responder analyses have numerous methodological shortcomings, which preclude inferences concerning individual response to treatments and, thus, adoption into clinical practice. In this Viewpoint, we summarize 2 major limitations of responder analyses: (1) their thresholds of success involve arbitrary criteria and (2) responder analyses do not capture true individual treatment effects. J Orthop Sports Phys Ther 2023;53(XX):1-3. Epub: 20 June 2023. doi:10.2519/jospt.2023.11853.
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Ensayos Clínicos Controlados Aleatorios como Asunto , HumanosRESUMEN
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.
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Artroplastia de Reemplazo de Rodilla , Traumatismos de la Rodilla , Osteoartritis de la Rodilla , Humanos , Estudios de Cohortes , Estudios Transversales , Toma de Decisiones Conjunta , Medición de Resultados Informados por el Paciente , Osteoartritis de la Rodilla/cirugía , Traumatismos de la Rodilla/cirugía , Dolor/cirugía , Calidad de VidaRESUMEN
BACKGROUND: 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. METHODS: 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. RESULTS: The SCEPTER trial is currently recruiting and enrolling participants. CONCLUSIONS: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT04142177.
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Dolor Crónico , Terapia Cognitivo-Conductual , Dolor de la Región Lumbar , Humanos , Dolor de Espalda , Dolor Crónico/terapia , Dolor Crónico/psicología , Terapia Cognitivo-Conductual/métodos , Dolor de la Región Lumbar/terapia , Dolor de la Región Lumbar/psicología , Resultado del TratamientoRESUMEN
OBJECTIVE: To determine whether 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 1 year after knee arthroplasty (KA). METHODS: We used data from Knee Arthroplasty Skills Training for Pain (KASTPain), a 1-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 2 exemplar outcome measures (Euroquol visual analog scale single-item self-rated health and 4-item pain ratings) and compared with 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. RESULTS: 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 with PASS. CONCLUSIONS: 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 patient-reported outcome measures of KA outcome. Clinicians and researchers should rely on latent class analyses over PASS to differentiate between outcome subgroups after KA.
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Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla , Humanos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Estudios Longitudinales , Análisis de Clases Latentes , Osteoartritis de la Rodilla/diagnóstico , Osteoartritis de la Rodilla/cirugía , Dolor , Resultado del Tratamiento , Medición de Resultados Informados por el PacienteRESUMEN
OBJECTIVE: Expected outcomes (e.g., expected survivorship after a cancer treatment) have improved decision-making around treatment options in many clinical fields. Our objective was to evaluate the effect of expected values of 3 widely available total knee arthroplasty (TKA) outcomes (risk of serious complications, time to revision, and improvement in pain and function at 2 years after surgery) on clinical recommendation of TKA. METHODS: The RAND/University of California Los Angeles appropriateness criteria method was used to evaluate the role of the 3 expected outcomes in clinical recommendation of TKA. The expected outcomes were added to 5 established preoperative factors from the modified Escobar appropriateness criteria. The 8 indication factors were used to develop 279 clinical scenarios, and a panel of 9 clinicians rated the appropriateness of TKA for each scenario as inappropriate, inconclusive, and appropriate. Classification tree analysis was applied to these ratings to identify the most influential of the 8 factors in discriminating TKA appropriateness classifications. RESULTS: Ratings for the 279 appropriateness scenarios deemed 34.4% of the scenarios as appropriate, 40.1% as inconclusive, and 25.5% as inappropriate. Classification tree analyses showed that expected improvement in pain and function and expected time to revision were the most influential factors that discriminated among the TKA appropriateness classification categories. CONCLUSION: Our results showed that clinicians would use expected postoperative outcome factors in determining appropriateness for TKA. These results call for further work in this area to incorporate estimates of expected pain/function and revision outcomes into clinical practice to improve decision-making for TKA.
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Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla , Humanos , Toma de Decisiones Clínicas , Dolor , Articulación de la Rodilla , Resultado del TratamientoRESUMEN
Objectives: We examined two potential causal pathways that could be intervention targets to enhance knee arthroplasty outcomes. Data from a no-effect trial of persons with moderate to high pain catastrophizing were used to determined whether pain catastrophizing, depressive symptoms causally mediate the effect of preoperative general health on postoperative knee pain and functional difficulty. Methods: We used natural-effects models to conduct causal mediation analyses using the preoperative dichotomized EQ-5D-5L general health measure as the exposure, 2-month postoperative pain catastrophizing, depressive symptoms, and localized knee pain as potential mediators, and 12-month dichotomized Western Ontario and McMaster's University Osteoarthritis Index (WOMAC) Pain and Function scores reflecting good versus poor outcome as the outcomes. Results: Estimates of the indirect (mediating) effect suggested that pain catastrophizing mediated the effect of preoperative general health on 12-month WOMAC pain score by increasing odds of a good outcome by 8% (natural indirect effect odds ratio â= â1.08, 95% CI: 0.88, 1.29). The direction of mediating effects and their magnitude were similar for depressive symptoms; Sensitivity analyses suggested similar magnitudes and mediating effects to those reported for the main analyses. Conclusions: Our findings suggested that pain catastrophizing and depressive symptoms have a mediating role on the effect of baseline general health on self-reported pain and function outcomes. These findings support the continued treatment of pain catastrophizing and depressive symptoms as viable targets for interventions to potentially enhance pain and function outcomes for patients with moderate to high levels of psychological distress prior to surgery.