Impact of early unanticipated revision surgery on health-related quality of life after adult spinal deformity surgery

Background Context

Revision surgery represents a major event for patients undergoing adult spinal deformity (ASD) surgery. Previous reports suggest that ASD surgery has minimal or no impact on health-related-quality of life (HRQOL) outcomes.

Patient Acceptable Symptom State for the Forgotten Joint Score in Primary Total Knee Arthroplasty

BackgroundIn order to better understand the clinical benefits of total knee arthroplasty (TKA) and improve the interpretability of the Forgotten Joint Score (FJS-12), the establishment of a meaningful change in score is necessary. The purpose of this study is to determine the threshold of the FJS-12 for detecting the patient acceptable symptom state (PASS) following primary TKA.MethodsWe retrospectively reviewed all patients who underwent elective, primary TKA and answered both the FJS-12 and the Knee Injury Osteoarthritis Outcome Survey, Joint Replacement KOOS, JR surveys 1-year postoperatively. The questionnaires were administered via a web-based electronic application. KOOS, JR score was used as the anchor. The anchor for PASS calculation should relate pain, physical function, and patient satisfaction. Two statistical methods were employed: (1) the receiver operating characteristic (ROC) curve point; (2) 75^th percentile of the cumulative percentage curve of patients who had the KOOS, JR score difference larger than the cut-off value.ResultsThis study included 457 patients. The mean 1-year FJS-12 score was 42.6 ± 27.8. The mean 1-year KOOS, JR score was 68.0 ± 17.2. A high positive correlation between FJS-12 and KOOS, JR was found (r = 0.72, P < .001) making the KOOS, JR a valid external anchor. The threshold score of the FJS-12 which maximized the sensitivity and specificity for detecting a PASS was 33.3 (AUC = 0.78, 95% CI [0.74, 0.83]). The cut-off value computed with the 75^th percentile approach was 77.1 (95% CI [73.9, 81.5]).ConclusionThe PASS threshold for the FJS-12 was 33.3 and 77.1 at 1-year follow-up after primary TKA using the receiver operating characteristic (ROC) curve and 75^th percentile approaches, respectively. These values can be used to assess the successful achievement of a forgotten joint.Level III EvidenceRetrospective Cohort Study.     

Minimum clinically important difference for the American Shoulder and Elbow Surgeons score after revision shoulder arthroplasty

BackgroundPatients undergoing revision total shoulder arthroplasty (TSA) typically achieve smaller improvements in outcome measurements than those undergoing primary TSA. The minimum clinically important difference (MCID) in the American Shoulder and Elbow Surgeons (ASES) questionnaire for primary shoulder arthroplasty ranges from 13.6 to 20.9, but the MCID for revision shoulder arthroplasty remains unclear. This study aims to define the MCID in ASES score for revision TSA and ascertain patient factors that affect achieving the MCID threshold.MethodsPatients were identified from an institutional shoulder arthroplasty database. Prospective data collected included demographic variables, prior shoulder surgeries, primary and revision implants, indication for revision, and pre- and postoperative ASES scores. All patients provided informed consent to participate. An anchor-based method was used with a binary answer choice. The MCID was calculated using the receiver-operator curve (ROC) method, and the sensitivity, specificity, and area under the curve were obtained from the ROC. MCID values were compared between groups using Student's t-test. Multivariate logistic regression modeling was used to determine significant predictors for reaching MCID. Significance was defined as P< .05.ResultsA total of 46 patients underwent revision TSA with minimum 2-year follow-up. The MCID using ROC method was 16.7 with 71% sensitivity and 62% specificity. There was a trend toward males being more likely to reach MCID after revision arthroplasty (P= .058). There were also trends toward increased forward flexion and abduction range of motion in patients who met MCID (P= .08, P= .07). Multivariate logistic regression modeling demonstrated male sex to be associated with achieving MCID (P= .03), while younger age and fewer prior shoulder surgeries demonstrated a trend to association with achieving MCID (P= .06, P= .10).ConclusionThe MCID for ASES score in patients undergoing revision shoulder arthroplasty is similar to previously reported MCID values for patients undergoing primary shoulder arthroplasty. Younger, male patients with fewer prior shoulder surgeries were more likely to achieve MCID after revision TSA.Level of EvidenceLevel III; Retrospective Comparative Treatment Study     

Development of Machine Learning Algorithms to Predict Clinically Meaningful Improvement for the Patient-Reported Health State After Total Hip Arthroplasty

BackgroundFailure to achieve clinically significant outcome (CSO) improvement after total hip arthroplasty (THA) imposes a potential cost-to-risk imbalance in the context of bundle payment models. Patient perception of their health state is one component of such risk. The purpose of the current study is to develop machine learning algorithms to predict CSO for the patient-reported health state (PRHS) and build a clinical decision-making tool based on risk factors.MethodsA retrospective review of primary THA patients between 2014 and 2017 was performed. Variables considered for prediction included demographics, medical history, preoperative PRHS, and modified Harris Hip Score. The minimal clinically important difference (MCID) for the PRHS was calculated using a distribution-based method. Five supervised machine learning algorithms were developed and assessed by discrimination, calibration, Brier score, and decision curve analysis.ResultsOf 616 patients, a total of 407 (69.2%) achieved the MCID for the PRHS. The random forest algorithm achieved the best performance in the independent testing set not used for algorithm development (c-statistic 0.97, calibration intercept −0.05, calibration slope 1.45, Brier score 0.054). The most important factors for achieving the MCID were preoperative PRHS, preoperative opioid use, age, and body mass index. Individual patient-level explanations were provided for the algorithm predictions and the algorithms were incorporated into an open access digital application available here: https://sorg-apps.shinyapps.io/THA_PRHS_mcid/.ConclusionThe current study created a clinical decision-making tool based on partially modifiable risk factors for predicting CSO after THA. The tool demonstrates excellent discriminative capacity for identifying those at greatest risk for failing to achieve CSO in their current health state and may allow for preoperative health optimization.     

Are claims of equivalency in digestive diseases trials supported by the evidence?

BACKGROUND & AIMS: Traditionally, randomized controlled trials (RCTs) have attempted to show the superiority of one intervention over another. However, when effective treatment already exists, it is sometimes more useful to prove that an intervention is equivalent, or at least not inferior, to the standard of care. Our aim was to determine whether claims of equivalency in digestive diseases trials are supported by the evidence. METHODS: Medline was searched for RCTs published between 1989 and 2002 using the MeSH headings "exp therapeutic equivalency" and "exp digestive diseases" and the text words "equivalence," "equal," "equals," or "equivalent," yielding 902 articles. Of these, 73 articles met the inclusion criteria. These articles were evaluated using previously published criteria for equivalency. RESULTS: Of the included articles, 33% stated an a priori research aim of equivalency, 92% reported differences of <20% between "equal" interventions, 34% set an equivalency boundary and tested it appropriately, and 19% performed a sample size calculation for equivalency. Overall, 12% of the reviewed articles met all 5 criteria. Fifty-two percent of our sample inappropriately used a failed superiority test (i.e., a P value > 0.05) as statistical "proof" of equivalency. Nonsurgical trials and those published between 1996 and 2002 were more likely to meet criteria than were surgical trials (P = 0.07) or trials published before 1996 (P = 0.003). CONCLUSIONS: Claims of equivalency between interventions in digestive diseases trials tend to be poorly supported by the evidence. Erroneous claims of equivalency are potentially dangerous and may lead to substandard patient care.     

Clinimetrics corner: a closer look at the minimal clinically important difference (MCID)

Minimal clinically important difference (MCID) scores are commonly used by clinicians when determining patient response to treatment and to guide clinical decision-making during the course of treatment. For research purposes, the MCID score is often used in sample size calculations for adequate powering of a study to minimize the false-positives (type 1 errors) and the false-negatives (type 2 errors). For clinicians and researchers alike, it is critical that the MCID score is a valid and stable measure. A low MCID value may result in overestimating the positive effects of treatment, whereas a high MCID value may incorrectly classify patients as failing to respond to treatment when in fact the treatment was beneficial. The wide range of methodologies for calculating the MCID score results in varied outcomes, which leads to difficulties with interpretation and application. This clinimetrics corner outlines key factors influencing MCID estimates and discusses limitations with the use of the MCID in both clinical and research practice settings.     

The Minimal Clinically Important Difference for PROMIS Physical Function in Patients With Thumb Carpometacarpal Arthritis

Background: This study was performed to determine the minimal clinically important difference (MCID) of Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) for patients with thumb carpometacarpal (CMC) arthritis. Methods: This study retrospectively analyzed data from 152 adults receiving surgical and nonsurgical care for unilateral thumb CMC arthritis at a single institution between January 2016 and January 2018. Patients completed PROMIS PF v1.2/2.0 CAT at each visit. At follow-up, patients also completed two 6-item anchor questions assessing the degree of perceived improvement. Statistical testing analyzed the ability of the clinical anchor to discriminate levels of improvement. An anchor-based MCID estimate was calculated as the mean PROMIS PF change score in the mild improvement group. The anchor-based MCID value was examined for the influence of patient age, initial and final PROMIS scores, and follow-up interval. A distribution-based MCID value was calculated incorporating the standard error of measurement and effect size. Results: The change in PROMIS PF scores was significantly different between encounters where patients reported no change, mild improvement, and much improvement. The anchor-based MCID estimate for PROMIS PF was 3.9 (95% confidence interval, 3.3-4.7). Individual MCID values were weakly correlated with the final absolute PROMIS PF score but did not correlate with patient age, time between visits, or the initial absolute PROMIS PF score. The distribution-based MCID value was 3.5 (95% confidence interval, 3.1-3.9). Conclusions: The estimated range of MCID values for PROMIS PF is 3.5 to 3.9 points in patients treated for thumb CMC arthritis.     

Lower Quadriceps Rate of Force Development Is Associated With Worsening Physical Function in Adults With or at Risk for Knee Osteoarthritis: 36-Month Follow-Up Data From the Osteoarthritis Initiative

Objective

To determine the association between quadriceps rate of force development (RFD) and decline in self-reported physical function and objective measures of physical performance.