Citations

Abstract: “Big data” refers to a growing field of large database research. Administrative data, a subset of big data, includes information from insurance claims, electronic medical records, and registries that can be useful for investigating novel research questions. While its use provides salient advantages, potential researchers relying on big data would benefit from knowing about how these databases are coded, common errors they may encounter, and how to best use large data to address various research questions. In the first section of this paper, Dr. Nicholas A. Bedard addresses the four major pitfalls to avoid with diagnosis and procedure codes in administrative data. In the next section, Dr. Jeffrey N. Katz et al. focus on the strengths and limitations of administrative data, suggesting methods to mitigate these limitations. Lastly, Dr. Elena Losina et al. review the uses and misuses of large databases for cost-effectiveness research, detailing methods for careful economic evaluations.

ObjectiveWe examined the cost‐effectiveness of treatment strategies for concomitant meniscal tear and knee osteoarthritis (OA) involving arthroscopic partial meniscectomy surgery and physical therapy (PT).MethodsWe used the Osteoarthritis Policy Model, a validated Monte Carlo microsimulation, to compare three strategies, 1) PT‐only, 2) immediate surgery, and 3) PT + optional surgery, for participants whose pain persists following initial PT. We modeled a cohort with baseline meniscal tear, OA, and demographics from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial of arthroscopic partial meniscectomy versus PT. We estimated risks and costs of arthroscopic partial meniscectomy complications and accounted for heightened OA progression post surgery using published data. We estimated surgery use rates and treatment efficacies using MeTeOR data. We considered a 5‐year time horizon, discounted costs, and quality‐adjusted life‐years (QALYs) 3% per year and conducted sensitivity analyses. We report incremental cost‐effectiveness ratios.ResultsRelative to PT‐only, PT + optional surgery added 0.0651 QALY and $2,010 over 5 years (incremental cost‐effectiveness ratio = $30,900 per QALY). Relative to PT + optional surgery, immediate surgery added 0.0065 QALY and $3080 (incremental cost‐effectiveness ratio = $473,800 per QALY). Incremental cost‐effectiveness ratios were sensitive to optional surgery efficacy in the PT + optional surgery strategy. In the probabilistic sensitivity analysis, PT + optional surgery was cost‐effective in 51% of simulations at willingness‐to‐pay thresholds of both $50,000 per QALY and $100,000 per QALY.ConclusionFirst‐line arthroscopic partial meniscectomy has a prohibitively high incremental cost‐effectiveness ratio. Under base case assumptions, second‐line arthroscopic partial meniscectomy offered to participants with persistent pain following initial PT is cost‐effective at willingness‐to‐pay thresholds between $31,000 and $473,000 per QALY. Our analyses suggest that arthroscopic partial meniscectomy can be a high‐value treatment option for patients with meniscal tear and OA when performed following an initial PT course and should remain a covered treatment option.

ObjectiveTo estimate the risk of magnetic resonance imaging (MRI)–based structural changes in knee osteoarthritis (OA) among individuals with meniscal tear and knee OA, using MRIs obtained at baseline and 18 and 60 months after randomization in a randomized controlled trial of arthroscopic partial meniscectomy (APM) versus physical therapy (PT).MethodsWe used data from the Meniscal Tear in Osteoarthritis Research (METEOR) trial. MRIs were read using the MRI OA Knee Score (MOAKS). We used linear mixed‐effects models to examine the association between treatment group and continuous MOAKS summary scores, and Poisson regression to assess categorical changes in knee joint structure. Analyses assessed changes in OA between baseline and month 18 and between months 18 and 60. We performed both intention‐to‐treat and as‐treated analyses.ResultsThe analytic sample included 302 participants. For both treatment groups, more OA changes were seen during the early interval than during the later interval. ITT analysis revealed that, between baseline and month 18, APM was significantly associated with an increased risk of having a worsening cartilage surface area score, involving both any worsening across all knee joint subregions (risk ratio [RR] 1.35 [95% confidence interval (95% CI) 1.14, 1.61]) and the number of subregions damaged (RR 1.44 [95% CI 1.13, 1.85]) having a worsening effusion‐synovitis score (RR 2.62 [95% CI 1.32, 5.21]), and having ≥1 additional subregion with osteophytes (RR 1.24 [95% CI 1.02, 1.50]). Significant associations were detected between months 18 and 60 only for having any subregion with a worsening osteophyte score (RR 1.28 [95% CI 1.04, 1.58]).ConclusionThese findings suggest that the association between APM and MRI‐based structural changes in knee OA is most apparent during the initial 18 months after surgery. The reason for attenuation of this association over longer follow‐up merits further investigation.

ObjectiveMiddle‐aged subjects with meniscal tear treated with arthroscopic partial meniscectomy (APM) experience greater progression of damage to joint structures on imaging than subjects treated nonoperatively. It is unclear whether these changes are clinically relevant. The goal of this study was to assess whether worsening in magnetic resonance imaging (MRI)–assessed tissue damage over 18 months leads to subsequent worsening in knee pain over the subsequent 3.5 years.MethodsWe used data from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial of APM versus physical therapy for subjects ages ≥45 years with knee pain, cartilage damage, and meniscal tear. We assessed whether change in cartilage surface area damage score (and other structural measures) from baseline to 18 months, assessed on MRI with the MRI Osteoarthritis Knee Score (MOAKS) system, was associated with change in Knee Injury and Osteoarthritis Outcome Score (KOOS) pain score (range 0–100; 100 = worst) from 18 to 60 months.ResultsThe primary analysis included 168 subjects with complete MRI data at baseline and 18 months and KOOS data at 18 and 60 months. We did not observe clinically important associations between change in cartilage surface area score between baseline and 18 months and change in pain scores from 18 to 60 months. Pain scores in the worst tertile for cartilage surface area damage score progression worsened by 0.45 points more than in the best tertile (95% confidence interval –4.45, 5.35). Similarly, we did not observe clinically important associations between changes in bone marrow lesions, osteophytes, or synovitis and subsequent pain.ConclusionWe did not observe clinically important associations between early changes in cartilage damage and other structural measures and worsening in pain over the subsequent 3.5 years. Further follow‐up is required to assess this association over a longer follow‐up period.

ObjectivePatients with meniscal tears reporting meniscal symptoms such as catching or locking have traditionally undergone arthroscopy. The present study was undertaken to investigate whether patients with meniscal tears who report meniscal symptoms have greater improvement with arthroscopic partial meniscectomy (APM) than physical therapy (PT).MethodsWe used data from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial, which randomized participants with knee osteoarthritis (OA) and meniscal tear to APM or PT. The frequency of each meniscal symptom (clicking, catching, popping, intermittent locking, giving way, swelling) was measured at baseline and 6 months. We used linear regression models to determine whether the difference in improvement in Knee Injury and Osteoarthritis Outcome Score (KOOS) pain score at 6 months between patients treated with APM versus PT was modified by the presence of each meniscal symptom. We also determined the percentage of participants with resolution of meniscal symptoms by treatment group.ResultsWe included 287 participants. The presence (versus absence) of any of the meniscal symptoms did not modify the improvement in KOOS pain score between APM versus PT by >0.5 SD (all P interaction >0.05). APM led to greater resolution of intermittent locking and clicking than PT (locking 70% versus 46%, clicking 41% versus 25%). No difference in resolution of the other meniscal symptoms was observed.ConclusionMeniscal symptoms were not associated with improved pain relief. Although symptoms of clicking and intermittent locking had a greater reduction in the APM group, the presence of meniscal symptoms in isolation should not inform clinical decisions surrounding APM versus PT in patients with meniscal tear and knee OA.

ObjectiveTo determine the 5‐year outcome of treatment for meniscal tear in osteoarthritis.MethodsWe examined 5‐year follow‐up data from the Meniscal Tear in Osteoarthritis Research trial (METEOR) of physical therapy versus arthroscopic partial meniscectomy. We performed primary intent‐to‐treat (ITT) and secondary as‐treated analyses. The primary outcome measure was the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain scale; total knee replacement (TKR) was a secondary outcome measure. We used piecewise linear mixed models to describe change in KOOS pain. We calculated 5‐year cumulative TKR incidence and used a Cox model to estimate hazard ratios (HRs) for TKR, with 95% confidence intervals (95% CIs).ResultsThree hundred fifty‐one participants were randomized. In the ITT analysis, the KOOS pain scores were ~46 (scale of 0 [no pain] to 100 [most pain]) at baseline in both groups. Pain scores improved substantially in both groups over the first 3 months, continued to improve through the next 24 months (to ~18 in each group), and were stable at 24–60 months. Results of the as‐treated analyses of the KOOS pain score were similar. Twenty‐five participants (7.1% [95% CI 4.4–9.8%]) underwent TKR over 5 years. In the ITT model, the HR for TKR was 2.0 (95% CI 0.8–4.9) for subjects randomized to the arthroscopic partial meniscectomy group, compared to those randomized to the physical therapy group. In the as‐treated analysis, the HR for TKR was 4.9 (95% CI 1.1–20.9) for subjects ultimately treated with arthroscopic partial meniscectomy, compared to those treated nonoperatively.ConclusionPain improved considerably in both groups over 60 months. While ITT analysis revealed no statistically significant differences following TKR, greater frequency of TKR in those undergoing arthroscopic partial meniscectomy merits further study.

ObjectiveThe present study was undertaken to evaluate changes in knee magnetic resonance imaging (MRI) findings over the course of 18 months in subjects with osteoarthritic change and meniscal tear treated with arthroscopic partial meniscectomy (APM) or nonoperatively with physical therapy (PT).MethodsWe used 18‐month follow‐up data from the Meniscal Tear in Osteoarthritis Research Trial. MRI results were read with reference to the MRI Osteoarthritis Knee Score. We focused on 18‐month change in bone marrow lesions (BMLs), cartilage thickness, cartilage surface area, osteophyte size, effusion‐synovitis, and Hoffa‐synovitis. We used multinomial logistic regression to assess associations between MRI‐based changes in each feature and treatment type.ResultsA total of 351 subjects were randomized, and 225 had both baseline and 18‐month MRI results. In both treatment groups, patients experienced substantial changes in several MRI‐based markers. In 60% of the APM group, versus 33% of the PT group, cartilage surface area damage advanced in ≥2 subregions (adjusted odds ratio 4.2 [95% confidence interval 2.0–9.0). Patients who underwent APM also had greater advancement in scores for osteophytes and effusion‐synovitis. We did not find significant associations between treatment type and change in cartilage thickness, BMLs, or Hoffa‐synovitis.ConclusionThis cohort of patients with meniscal tear and osteoarthritis showed marked advancement in MRI‐based features over 18 months. Patients treated with APM showed more advancement in some features compared to those treated nonoperatively. The clinical relevance of these early findings is unknown and requires further study.

Objective Synovitis is a prevalent feature in patients with knee osteoarthritis ( OA ) and meniscal tear and is associated with pain and cartilage damage. Patient‐reported swelling is also prevalent in this population. The aim of this study was to investigate the cross‐sectional association between patient‐reported swelling and effusion‐synovitis detected by magnetic resonance imaging ( MRI ) in patients with OA and meniscal tear. Methods We used baseline data from a multicenter, randomized controlled trial, Meniscal Tear in Osteoarthritis Research ( METEOR ). MRI ‐identified effusion‐synovitis, a proxy for effusion and synovitis on noncontrast MRI s, was graded as none/small versus medium/large. Using MRI ‐identified effusion‐synovitis as the gold standard, we assessed the sensitivity, specificity, and positive predictive value of patient self‐reported swelling in the previous week (none, intermittent, constant) to detect effusion and synovitis. Results We analyzed data from 276 patients. Twenty‐five percent of patients reported no swelling, 40% had intermittent swelling, and 36% had constant swelling. Fifty‐two percent had MRI ‐identified medium/large–grade effusion‐synovitis. As compared with MRI ‐identified effusion‐synovitis, any patient‐reported swelling (versus none) had a sensitivity of 84% (95% confidence interval [95% CI ] 77–89), a specificity of 34% (95% CI 26–43), and a positive predictive value of 57% (95% CI 54–61). A history of constant swelling (versus none or intermittent) showed a sensitivity of 46% (95% CI 37–54), a specificity of 75% (95% CI 67–82), and a positive predictive value of 66% (95% CI 58–74). Conclusion We found that the sensitivity and specificity of patient‐reported swelling were modest when compared with effusion‐synovitis detected by MRI . These data urge caution against using patient‐reported swelling as a proxy of inflammation manifesting as effusion‐synovitis.

Objective This collaboration between the American College of Rheumatology and the American Association of Hip and Knee Surgeons developed an evidence‐based guideline for the perioperative management of antirheumatic drug therapy for adults with rheumatoid arthritis (RA), spondyloarthritis (SpA) including ankylosing spondylitis and psoriatic arthritis, juvenile idiopathic arthritis (JIA), or systemic lupus erythematosus (SLE) undergoing elective total hip (THA) or total knee arthroplasty (TKA). Methods A panel of rheumatologists, orthopedic surgeons specializing in hip and knee arthroplasty, and methodologists was convened to construct the key clinical questions to be answered in the guideline. A multi‐step systematic literature review was then conducted, from which evidence was synthesized for continuing versus withholding antirheumatic drug therapy and for optimal glucocorticoid management in the perioperative period. A Patient Panel was convened to determine patient values and preferences, and the Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of evidence and the strength of recommendations, using a group consensus process through a convened Voting Panel of rheumatologists and orthopedic surgeons. The strength of the recommendation reflects the degree of certainty that benefits outweigh harms of the intervention, or vice versa, considering the quality of available evidence and the variability in patient values and preferences. Results The guideline addresses the perioperative use of antirheumatic drug therapy including traditional disease‐modifying antirheumatic drugs, biologic agents, tofacitinib, and glucocorticoids in adults with RA, SpA, JIA, or SLE who are undergoing elective THA or TKA. It provides recommendations regarding when to continue, when to withhold, and when to restart these medications, and the optimal perioperative dosing of glucocorticoids. The guideline includes 7 recommendations, all of which are conditional and based on low‐ or moderate‐quality evidence. Conclusion This guideline should help decision‐making by clinicians and patients regarding perioperative antirheumatic medication management at the time of elective THA or TKA. These conditional recommendations reflect the paucity of high‐quality direct randomized controlled trial data.

ObjectiveThis collaboration between the American College of Rheumatology and the American Association of Hip and Knee Surgeons developed an evidence‐based guideline for the perioperative management of antirheumatic drug therapy for adults with rheumatoid arthritis (RA), spondyloarthritis (SpA) including ankylosing spondylitis and psoriatic arthritis, juvenile idiopathic arthritis (JIA), or systemic lupus erythematosus (SLE) undergoing elective total hip (THA) or total knee arthroplasty (TKA).MethodsA panel of rheumatologists, orthopedic surgeons specializing in hip and knee arthroplasty, and methodologists was convened to construct the key clinical questions to be answered in the guideline. A multi‐step systematic literature review was then conducted, from which evidence was synthesized for continuing versus withholding antirheumatic drug therapy and for optimal glucocorticoid management in the perioperative period. A Patient Panel was convened to determine patient values and preferences, and the Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of evidence and the strength of recommendations, using a group consensus process through a convened Voting Panel of rheumatologists and orthopedic surgeons. The strength of the recommendation reflects the degree of certainty that benefits outweigh harms of the intervention, or vice versa, considering the quality of available evidence and the variability in patient values and preferences.ResultsThe guideline addresses the perioperative use of antirheumatic drug therapy including traditional disease‐modifying antirheumatic drugs, biologic agents, tofacitinib, and glucocorticoids in adults with RA, SpA, JIA, or SLE who are undergoing elective THA or TKA. It provides recommendations regarding when to continue, when to withhold, and when to restart these medications, and the optimal perioperative dosing of glucocorticoids. The guideline includes 7 recommendations, all of which are conditional and based on low‐ or moderate‐quality evidence.ConclusionThis guideline should help decision‐making by clinicians and patients regarding perioperative antirheumatic medication management at the time of elective THA or TKA. These conditional recommendations reflect the paucity of high‐quality direct randomized controlled trial data.