Minimally Clinically Important Difference (MCID) Is a Low Bar

Patients don't care about “statistical” significance. Patient-centered outcome measures focus on “clinical” significance and include minimal clinically important difference (MCID), patient acceptable symptomatic state (PASS), substantial clinical benefit (SCB), and maximal outcome improvement (MOI). “Minimal” is a low bar. MCID neither addresses whether patients are satisfied nor whether they have derived a substantial benefit. MCID is commonly reported allowing comparison between studies, and MCID can be calculated retrospectively, so reporting MCID is acceptable. However, we also need to report PASS, SCB, and, in unique patients like high-level athletes, we may also need to report MOI to adjust for high pretreatment scores and a ceiling effect. Finally, threshold scores are patient-level metrics and must be reported as percentage of patients who meet the threshold, not reported as to whether, as a group, the mean score for the cohort meets the threshold or not (which is a common error).     

Should We Aim to Help Patients “Feel Better” or “Feel Good” After Total Hip Arthroplasty? Determining Factors Affecting the Achievement of the Minimal Clinically Important Difference and Patient Acceptable Symptom State

BackgroundRecent attempts have been made to use preoperative patient-reported outcome measure (PROM) thresholds as prior authorization criteria based on the assumption that patients who have higher baseline scores are less likely to achieve the minimal clinically important difference (MCID). This study aimed to identify factors affecting the achievement of MCID and patient acceptable symptom state (PASS) after total hip arthroplasty (THA), and to determine the overlap between the two outcomes.MethodsWe identified 3,581 primary, unilateral THAs performed at a single practice in 2015-2019. PROMs including Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) and 12-item Short Form Health Survey were collected preoperatively and 1-year postoperatively. The likelihood of attaining PASS according to attainment of MCID was assessed. Multivariable regression was used to identify independent predictors of MCID and PASS.ResultsIn total, 79.8% achieved MCID and 73.6% achieved PASS for HOOS-JR. Approximately 1 in 7 patients who achieved MCID did not eventually achieve PASS. Worse preoperative HOOS-JR (odd ratio 0.933) was associated with MCID attainment. Better preoperative HOOS-JR (odd ratio 1.015) was associated with PASS attainment. Men, lower body mass index, better American Society of Anesthesiologists score, and better preoperative 12-item Short Form Health Survey mental score were predictors of MCID and PASS. Age, race, ethnicity, Charlson Comorbidity Index, and smoking status were not significant predictors.ConclusionPreoperative PROMs were associated with achieving MCID and PASS after THA, albeit in opposite directions. Clinicians should strive to help patients “feel better” and “feel good” after surgery. Preoperative PROMs should not solely be used to prioritize access to care.     

How Should We Define Clinically Significant Outcome Improvement on the iHOT-12?

Background

There is increased emphasis on efficiently administering patient-reported outcome measures (PROMs). The International Hip Outcome Tool-12 (iHOT-12) is a short-form version of the iHOT-33, and relatively little is known about clinically significant outcomes using the iHOT-12.

Questions/Purposes

The purpose of this study was to define minimal clinically important difference (MCID) and patient acceptable symptomatic state (PASS) for the iHOT-12 and to identify predictors for achieving these psychometric end points in patients undergoing arthroscopic treatment of femoroacetabular impingement (FAI).

Methods

Data was prospectively collected and retrospectively analyzed as part of an institutional hip preservation repository. One hundred and twenty patients were included; mean age and body mass index (BMI) were 38.7 years and 25.9, respectively. A majority of patients were female (67.5%) and white (81.7%) and participated in recreational sports (79.2%). The iHOT-12 was administered pre-operatively and at 1-year follow-up to patients undergoing primary hip arthroscopy for FAI. The following anchor question was also asked at 1-year follow-up: “Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?” MCID was calculated using a distribution-based method. Receiver-operating characteristic analysis with area under the curve was used to confirm the significance of the PASS threshold.

Results

Mean iHOT-12 scores improved from 35.6 at pre-operative assessment to 70.7 at 1-year follow-up. Patients indicating satisfaction with their outcome improved from 37.5 pre-operatively to 79.0 at 1-year follow-up. MCID value for the iHOT-12 was 13.0. The PASS threshold was 63.0, indicating an excellent predictive value that patients scoring above this threshold were likely to have met an acceptable symptom state. Worker’s compensation patients and those with increased BMI were less likely to achieve PASS; lower pre-operative iHOT-12 score was predictive for achieving MCID, and achieving MCID was predictive for achieving PASS.

Conclusion

This is the first study to define PASS and MCID for the iHOT-12, which measures clinically significant outcome improvement comparably to that of other commonly used hip PROMs. As its use becomes more widespread, the iHOT-12 data-points presented in this study can be used to determine clinically significant improvement of patient-reported outcomes.

     

The Paradox of Patient-Reported Outcome Measures: Should We Prioritize “Feeling Better” or “Feeling Good” After Total Knee Arthroplasty?

BackgroundThe use of preoperative patient-reported outcome measure (PROM) thresholds for patient selection in arthroplasty care has been questioned recently. This study aimed to identify factors affecting achievement of the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) after total knee arthroplasty (TKA) and determine the overlap between the two outcomes.MethodsWe identified 1,239 primary, unilateral TKAs performed at a single institution in 2015-2019. PROMs including the Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) and 12-item Short Form Health Survey (SF-12) were collected preoperatively and 1-year postoperatively. The likelihood of attaining PASS as per attainment of MCID was assessed. A multivariable regression was used to identify predictors of MCID and PASS.ResultsIn total, 71.3% achieved MCID and 75.5% achieved PASS for KOOS-JR. Only 7.7% achieved MCID but not PASS, whereas almost twice this number did not achieve MCID but did achieve PASS (11.9%). Poorer preoperative KOOS-JR (OR 0.925), better SF-12 physical (OR 1.025), and mental (OR 1.027) were associated with MCID attainment. In contrast, better preoperative KOOS-JR (OR 1.030) and SF-12 mental (OR 1.025) were associated with PASS attainment. Age, gender, race, ethnicity, body mass index, Charlson index, American Society of Anesthesiologists classification, and smoking status were not significant predictors.ConclusionPreoperative PROMs were associated with achieving MCID and PASS after TKA, albeit some positively and some negatively. In the era of value-based care, clinicians should not only strive to help patients “feel better” but also ensure that patients “feel good” after surgery. This study does not support the use of PROMs in prioritizing access to care.     

Our Measure of Medical Research Should Be Appreciable Benefit to the Patient

The clinical relevance of research is much more important than statistical significance. Patient-reported outcome measures (PROM) are the strongest determinants of satisfaction as the result of an intervention or treatment. Outcomes can be measured in terms of the minimal clinically important difference (MCID) detectable by a patient, bearing in mind that “detectable” includes worsening as well as improvement. Patient-acceptable symptomatic state (PASS) and substantial clinical benefit (SCB) ultimately correlate with whether patients are happy or willing to undergo an intervention again. These measures should not be reported in terms of group means, where outliers could distort the score. These measures should be reported in terms of the proportion of individual patients whose scores cross the meaningful thresholds of satisfaction.     

Determination of minimum clinically important difference (MCID) in pain,disability, and quality of life after revision fusion for symptomatic pseudoarthrosis

Background contextSpinal surgical outcome studies rely on patient reported outcome (PRO) measurements to assess the effect of treatment. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lacks a direct clinical meaning. As a result, the concept of minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. Post hoc anchor-based MCID methods have not been applied to the surgical treatment for pseudoarthrosis.PurposeTo determine the most appropriate MCID values for visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) in patients undergoing revision lumbar arthrodesis for symptomatic pseudoarthrosis.Study design/ settingRetrospective cohort study.MethodsIn 47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), and general health utility (EQ-5D) were assessed preoperatively and 2 years postoperatively. Four subjective post hoc anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for two separate anchors (health transition index (HTI) of SF-36 and satisfaction index).ResultsAll patients were available for a 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs; Mean change score: BP-VAS (2.3±2.6; p<.001), ODI (8.6%±13.2%; p<.001), SF-12 PCS (4.0±6.1; p=.01), and EQ-5D (0.18±0.19; p<.001). The four MCID calculation methods generated a wide range of MCID values for each of the PROs (BP-VAS: 2.0–3.2; ODI: 4.0%–16.6%; SF-12 PCS: 3.2–6.1; and EQ-5D: 0.14–0.24). There was no difference in response between anchors for any patient, suggesting that HTI and satisfaction anchors are equivalent in this patient population. The wide variations in calculated MCID values between methods precluded any ability to reliably determine what the true value is for meaningful change in this disease state.ConclusionsUsing subjective post hoc anchor-based methods of MCID calculation, MCID after revision fusion for pseudoarthrosis varies by as much as 400% per PRO based on the calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 points for SF-12. These wide variations and low values of MCID question the face validity of such calculation techniques, especially when applied to heterogeneous disease and patient groups with a multitude of psychosocial confounders such as failed back syndromes. The variability of MCID thresholds observed in our study of patients undergoing revision lumbar fusion for pseudoarthrosis raises further questions to whether ante hoc or Delphi methods may be a more valid and consistent technique to define clinically meaningful, patient-centered changes in PRO measurements.     

Preoperative patient activation predicts minimum clinically important difference for PROMIS pain and physical function in patients undergoing elective spine surgery

BACKGROUND CONTEXTPatient activation is a patient's willingness to take independent actions to manage their own health care.PURPOSEThe goal of this study is to determine whether preoperative patient activation measure (PAM) predicts minimum clinically important difference (MCID) for Patient-Reported Outcomes Measurement Information System (PROMIS) pain, physical function, depression, and anxiety for patients undergoing elective spine surgery.STUDY DESIGN/SETTINGRetrospective review.PATIENT SAMPLEA single-institution, academic database of patients undergoing elective spine surgery.OUTCOME MEASUREMCID at 1-year follow-up for PROMIS pain, physical function, depression and anxiety.METHODSWe retrospectively reviewed a single-institution, academic database of patients undergoing elective spine surgery. Preoperative patient activation was evaluated using the PAM-13 survey, which was used to stratify patients into four activation stages. Primary outcome variable was achieving MCID at 1-year follow-up for PROMIS pain and physical function. Multivariable logistic regression analysis was used to determine impact of patient activation on PROMIS pain and the physical function.RESULTSOf the 430 patients, 220 (51%) were female with a mean age of 58.2±16.8. Preoperatively, 34 (8%) were in activation stage 1, 45 (10%) in stage 2, 98 (23%) in stage 3, and 253 (59%) in stage 4. At 1-year follow up, 248 (58%) achieved MCID for PROMIS physical function, 256 (60%) achieved MCID for PROMIS pain, 151 (35.28%) achieved MCID for PROMIS depression, and 197 (46%) achieved MCID for PROMIS anxiety. For PROMIS physical function, when compared to patients at stage 1 activation, patients at stage 2 (aOR:3.49, 95% CI:1.27, 9.59), stage 3 (aOR:3.54, 95% CI:1.40, 8.98) and stage 4 (aOR:7.88, 95% CI:3.29, 18.9) were more likely to achieve MCID. For PROMIS pain, when compared against patients at stage 1, patients at stage 3 (aOR:2.82, 95% CI:1.18, 6.76) and stage 4 (aOR:5.44, 95% CI:2.41, 12.3) were more likely to achieve MCID. For PROMIS depression, when compared against patients at stage 1, patients at stage 4 were more likely to achieve MCID (Adjusted Odds Ratio (aOR):2.59, 95% CI:1.08–6.19). For PROMIS anxiety, when compared against patients at stage 1, stage 3 (Adjusted Odds Ratio (aOR):3.21, 95% CI:1.20–8.57), and stage 4 (aOR:5.56, 95% CI:2.20–14.01) were more likely to achieve MCID.CONCLUSIONPatients at higher stages of activation were more likely to achieve MCID for PROMIS pain, physical function, depression, and anxiety at 1-year follow-up. Routine preoperative assessment of patient activation may help identify patients at risk of poor outcomes.     

Editorial Commentary: Preoperative Exercise,Workers’ Compensation,Diabetes, Lateral Extra-Articular Tenodesis,and Return to Sport Determine Patient Satisfaction After Anterior Cruciate Ligament Reconstruction

Patient-reported outcome measures (PROMs) have been developed and used as the primary determinant of successful patient-centered results. The patient acceptable symptomatic state delineates an absolute value for PROMs indicating that patients are satisfied with their outcome. When this metric is used for anterior cruciate ligament reconstruction, patients reach a satisfactory outcome at between 6 and 8 months postoperatively, and more than 90% reach a satisfactory outcome at 12 months. Preoperative variables such as preoperative exercise, Workers’ Compensation, and diabetes impact patient outcomes, whereas preoperative PROMs and use of the anteromedial portal technique for femoral tunnel drilling have a limited impact on satisfaction. Iliotibial band tenodesis shows a large impact on satisfactory outcomes; however, this result may be affected by patient demographic issues (selection bias). Ultimately, a “satisfactory” outcome is a very general term and may not necessarily apply to active athletes desiring a return to competitive sport. Thus, the patient acceptable symptomatic state should be interpreted in combination with a surgeon’s experience. Ultimately, the success of a surgical procedure could be determined, in large part, based on the patient’s individual preoperative expectations.     

Identifying Aseptic Revision Total Knee Arthroplasty Diagnoses That Achieve Minimal Clinically Important Difference and Patient Acceptable Symptom State

BackgroundMinimal clinically important difference (MCID) defines a meaningful clinical change in patient-reported outcome measures. Patient acceptable symptom state (PASS) provides a patient-reported outcome measures threshold value to indicate a satisfactory clinical state. MCID and PASS for revision total knee arthroplasty (rTKA) are ill-defined. Moreover, it is unknown whether diagnosis influences the likelihood of achieving MCID or PASS. The purpose of this study was to calculate MCID for aseptic rTKA and compare the percentage of patients achieving MCID and PASS per diagnosis.MethodsAn institutional registry of rTKA was used. First-time aseptic rTKA were included. Demographics, revision diagnosis, preoperative Knee Injury and Osteoarthritis Outcome Score, Jr (KOOS Jr), and 1-year postoperative KOOS Jr were recorded. The 1-year postoperative KOOS Jr PASS score was available. MCID was calculated using distribution-based methods. Three hundred fifty eight first-time aseptic rTKAs were analyzed. The 3 most common diagnoses were aseptic loosening (n = 156), instability (n = 109), and stiffness (n = 37).ResultsThe mean KOOS Jr 1-year postoperative MCID for rTKA was 10.3. Overall, 75.4% achieved MCID and 56.9% achieved PASS. The percentage of patients per diagnosis achieving MCID and PASS, respectively, were periprosthetic fracture (100, 44), aseptic loosening (94, 60), implant fracture (88, 63), stiffness (60, 38), instability (59, 61), polyethylene wear/osteolysis (57, 57), and metal allergy (44, 33).ConclusionAseptic rTKA MCID is 10.3 for KOOS Jr at 1 year postoperatively. rTKA outcomes vary depending on preoperative diagnosis. Even in diagnoses with a high proportion of MCID achieved, less than 2/3 of patients achieved PASS, suggesting rTKA provides noticeable improvement but may not return patients to a satisfactory state.     

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     

Is there a threshold of preoperative function that predicts failure to achieve clinically significant outcomes after total and reverse shoulder arthroplasty?

BackgroundThe purpose of this study was to determine if there is a threshold of preoperative function that is predictive of postoperative outcomes and the likelihood of achieving clinically significant outcomes following shoulder arthroplasty (SA).MethodsWe retrospectively identified patients who underwent a primary SA at our institution. Patients with preoperative and postoperative American Shoulder and Elbow Surgeons scores (ASES) were included in our analysis. A receiver operating characteristic (ROC) analysis was utilized to reach a preoperative ASES threshold correlated with achievement of the following clinically significant outcomes: minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptom state. This analysis was performed for our entire SA cohort and subanalyzed for total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA). Fischer exact tests were used to analyze categorical data while continuous data were analyzed using t-tests. For the ROC, area under the curve (AUC) was calculated, along with bootstrap 95% confidence intervals and P values, with <0.05 as significant.ResultsA total of 516 patients were included (164 TSA and 352 RSA). ROC analysis yielded a preoperative ASES above 54 as predictive of failure to achieve MCID for all SAs (AUC, 0.77; P < .001), above 49 for TSA (AUC 0.74, P < .001), and above 56 for RSA (AUC 0.79, P < .001). Patients with preoperative ASES scores above 54 were significantly less likely to achieve MCID (odds ratio 5.1, P < .001) and SCB (odds ratio 7.2, P < .001); however, they had higher postoperative ASES scores (84 vs. 78, P < .001). A preoperative ASES score of 73 corresponded to a 50% chance of achieving MCID. ROC analysis also yielded a preoperative ASES score above 51 as predictive of failure to achieve SCB for all SA, TSA, and RSA (AUC: 0.79, 0.78, and 0.80, respectively, all P < .001). A preop ASES score of 52 corresponded to a 50% chance of achieving SCB.ConclusionPreoperative ASES scores above 49-56 are predictive of failure to achieve MCID and SCB following TSA and RSA. Although patients above these preoperative thresholds achieve higher absolute ASES scores at the final follow-up, they experienced less relative improvement from baseline. This will help surgeons counsel individual patients about appropriate expectations after arthroplasty.     

Predictors of failure to achieve minimal clinical important difference for pain and disability after mechanical diagnosis and therapy (MDT)-based multimodal rehabilitation for neck pain: a retrospective analysis of 4998 patients

Purpose

To determine predictors of failure to achieve minimal clinical important difference (MCID) for pain and disability at discharge after mechanical diagnosis and therapy (MDT)-based multimodal rehabilitation for neck pain (NP).

Methods

Pre- and post-treatment numerical pain rating scale (NPRS) and neck disability index (NDI) in patients with mechanical NP were analysed in this retrospective study. Multivariate analysis was performed to investigate the effect of covariates such as age, gender, lifestyle, body mass index, presentation, diabetes, osteoporosis, response to repeated movement testing, treatment sessions, compliance rate, and pre-treatment NPRS and NDI scores on failure to achieve MCID of ≥ 30% for NPRS and NDI scores post-treatment.

Results

In the 4998 patients analysed for this study, 7% and 14.5% of patients failed to achieve MCID for NPRS and NDI scores, respectively, at the end of treatment. Age > 70 years, diabetes, osteoporosis, partial or non-response to repeated movements, lesser treatment sessions, and lower compliance rate were associated with increased risk for failure to achieve MCID for NPRS and NDI scores. A higher pre-treatment NDI score was associated with failure to achieve MCID for NPRS score, whereas lower pre-treatment NPRS and NDI scores were associated with failure to achieve MCID for NDI score.

Conclusion

Although MDT-based multimodal rehabilitation helped to achieve significant reduction in pain and disability in mechanical NP, several baseline risk factors were associated with failure to achieve MCID for pain and disability after treatment. Identifying and modifying these factors as part of rehabilitation treatment may help to achieve better outcomes in mechanical NP.

     

What is an acceptable outcome of treatment before it begins? Methodological considerations and implications for patients with chronic low back pain

Understanding changes in patient-reported outcomes is indispensable for interpretation of results from clinical studies. As a consequence the term “minimal clinically important difference” (MCID) was coined in the late 1980s to ease classification of patients into improved, not changed or deteriorated. Several methodological categories have been developed determining the MCID, however, all are subject to weaknesses or biases reducing the validity of the reported MCID. The objective of this study was to determine the reproducibility and validity of a novel method for estimating low back pain (LBP) patients’ view of an acceptable change (MCID_pre) before treatment begins. One-hundred and forty-seven patients with chronic LBP were recruited from an out-patient hospital back pain unit and followed over an 8-week period. Original and modified versions of the Oswestry disability index (ODI), Bournemouth questionnaire (BQ) and numeric pain rating scale (NRS_pain) were filled in at baseline. The modified questionnaires determined what the patient considered an acceptable post-treatment outcome which allowed us to calculate the MCID_pre. Concurrent comparisons between the MCID_pre, instrument measurement error and a retrospective approach of establishing the minimal clinically important difference (MCID_post) were made. The results showed the prospective acceptable outcome method scores to have acceptable reproducibility outside measurement error. MCID_pre was 4.5 larger for the ODI and 1.5 times larger for BQ and NRS_pain compared to the MCID_post. Furthermore, MCID_pre and patients post-treatment acceptable change was almost equal for the NRS_pain but not for the ODI and BQ. In conclusion, chronic LBP patients have a reasonably realistic idea of an acceptable change in pain, but probably an overly optimistic view of changes in functional and psychological/affective domains before treatment begins.     

Editorial Commentary: The Alphabet Soup of Understanding Clinical Shoulder Research: MCID (Minimal Clinically Important Difference), PASS (Patient Acceptable Symptomatic State), SCB (Substantial Clinical Benefit), and Now . . . MOI (Maximal Outcome Improvement)

A variety of metrics have been developed for the purposes of understanding how to use and interpret patient self-reported functional outcome scores after treatment. Among these, the maximal outcome improvement (MOI) can now be added to the list. Limitations of other metrics including the minimal clinically important difference, patient acceptable symptomatic state, and substantial clinical benefit are ceiling effects if starting function is relatively high. The MOI now provides a measure of improvement based on the patient’s total range of possible improvement to determine whether a satisfactory state was achieved. The value of the other measures, such as the minimal clinically important difference, is in interpreting studies comparing treatments to determine clinical significance as opposed to statistical significance, as well as performing sample size calculation for prospective studies, but may be limited in interpreting the outcomes of individual patients. The MOI provides a metric—in this case for patients after arthroscopic rotator cuff repair—that can be easily used in the clinic for assessment of improvement in an individual patient’s function without limitations resulting from how good or bad his or her initial function is.     

Editorial Commentary: Degeneration of Acetabular Cartilage of any Degree Is a Predictor of Worse Outcome After Hip Arthroscopy for Labral Repair and Femoroacetabular Impingement Syndrome: The Greater the Damage,the Worse the Outcome

As the volume of hip arthroscopy continues to rise, determining appropriate indications for the procedure is of paramount importance. Outcomes can be predicted based on well-powered studies focused on determining which patients meet thresholds for achieving the minimal clinically important difference, the patient acceptable symptomatic state, and substantial clinical benefit after treatment. Recent research has shown that acetabular cartilage damage predicts lesser outcomes, and the more advanced the damage, the worse the results. What is concerning is that even the smallest degree of chondromalacia with fibrillation is a negative predictor of achieving the patient acceptable symptomatic state. In contrast, greater than 3 mm of joint space, no cysts, no dysplasia, younger age, lower alpha angle, preoperative 12-item International Hip Outcome Tool score greater than 48.5, and proper version all predict significant improvement after hip arthroscopy.     

Metrics of Clinically Important Changes in Total Hip Arthroplasty: A Systematic Review

BackgroundAlthough patient-reported outcome measures (PROMs) have become a regularly used metric, there is little consensus on the methodology used to determine clinically relevant postoperative outcomes. We systematically reviewed the literature for studies that have identified metrics of clinical efficacy after total hip arthroplasty (THA) including minimal clinically important difference (MCID), patient acceptable symptom state (PASS), minimal detectable change (MDC), and substantial clinical benefit (SCB).MethodsA systematic review examining quantitative metrics for assessing clinical improvement with PROMs following THA was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using the MEDLINE database from 2008 to 2020. Inclusion criteria included full texts, English language, primary THA with minimum 1-year follow-up, use of metrics for assessing clinical outcomes with PROMs, and primary derivations of those metrics. Sixteen studies (24,487 THA patients) met inclusion criteria and 11 different PROMs were reported.ResultsMCIDs were calculated using distribution methods in 7 studies (44%), anchor methods in 2 studies (13%), and both methods in 2 studies (13%). MDC was calculated in 2 studies, PASS was reported in 1 study using anchor-based method, and SCB was calculated in 1 study using anchor-based method.ConclusionThere is a lack of consistency in the literature regarding the use and interpretation of PROMs to assess patient satisfaction. MCID was the most frequently reported measure, while MDC, SCB, and PASS were used relatively infrequently. Method of derivation varied based on the PROM used; distribution method was more frequently used for MCID.     

Elevated Body Mass Index Is a Risk Factor for Failure to Achieve the Knee Disability and Osteoarthritis Outcome Score-Physical Function Short Form Minimal Clinically Important Difference Following Total Knee Arthroplasty

BackgroundThe aims of this study are (1) to assess the association between body mass index (BMI) and failure to achieve the 1-year Knee Disability and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) minimal clinically important difference (MCID) for total knee arthroplasty (TKA) patients and (2) to determine if there is a BMI threshold beyond which the risk of failing to achieve the MCID is significantly increased.MethodsA regional arthroplasty registry was queried for TKA patients from 2016 to 2019 with completion of preoperative and 1-year postoperative KOOS-PS. The MCID threshold was derived using a distribution-based approach. Demographic and patient-reported outcome measure variables were collected. BMI was analyzed continuously and categorically using cutoffs defined by the Centers for Disease Control and Prevention. The association between failure to achieve 1-year MCID and BMI was analyzed using multiple logistic regression. A BMI threshold was determined using the Youden index and receiver operating characteristic curve.ResultsIn total, 1059 TKAs were analyzed. BMI assessed continuously was significantly associated with failure to achieve the KOOS-PS MCID (odds ratio 1.03, 95% confidence interval 1.00-1.05, P = .025). Analysis of BMI categorically revealed that “overweight” (25-30 kg/m²), “obese class I” (30-35 kg/m²), “obese class II” (35-40 kg/m²), and “obese class III” (>40 kg/m²) patients faced 77%, 76%, 83%, and 106% greater risk, respectively, of failing to achieve the KOOS-PS MCID compared to “normal BMI” (<25 kg/m²) patients.ConclusionElevated BMI was associated with an increased risk of failure to achieve the 1-year KOOS-PS MCID following TKA.     

Characterizing MCID and assessing the role of preoperative PROMIS scores in predicting outcomes for reverse total shoulder arthroplasty at 2-year follow-up

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) has gained more ground as a reliable and efficient means of collecting patient outcomes in different shoulder surgeries. The purpose of this study is to determine if preoperative PROMIS scores are able to predict improvement in postoperative PROMIS scores and anchor this data to determine if a patient will achieve MCID after reverse total shoulder arthroplasty (RTSA). We hypothesize that preoperative PROMIS will significantly correlate, with anchor questions allowing clinicians to predict which patients are most likely to achieve MCID after RTSA.MethodsThree PROMIS CAT forms (PROMIS Upper Extremity Physical Function CAT v2.0 (“PROMIS-UE”), PROMIS Pain Interference v1.1 (“PROMIS-PI”), and PROMIS Depression v1.0 (“PROMIS-D”)) were provided to all patients scheduled to undergo RTSA by board-certified shoulder and elbow surgeons at 1 institution. Demographic data was collected, including age, median household income, zip code, body mass index, sex, smoking status, and race. All patients enrolled in the study were contacted and asked the same 3 anchor questions pertaining to the 3 PROMIS CAT forms above.ResultsA total of 71 patients (52.1% male) were included in our cohort with an average age of 67.8 years (standard deviation, 8.4). Mean follow-up time point was 21.4 months (standard deviation, 9.9) after surgery. Neither preoperative PROMIS-UE, nor preoperative PROMIS-PI showed any significant predictive ability to achieve their respective domain MCIDs (AUC: 0.564 and 0.631, respectively). PROMIS-UE and PROMIS-PI improved to a significant degree at an average 21.4 months postoperatively from 29.2 ± 5.8 and 63.8 ± 4.8 to 39.8.9 ± 8.9 and 50.0 ± 9.7, respectively. Improvements in PRMOIS-D scores were insignificant at average 21.4 months (Baseline: 49.8 ± 8.0 vs. 44.5 ± 9.4 at final follow-up). Using anchor-based analysis to determine MCID, we found the following MCID values for PROMIS-UE, PROMIS-PI, and PROMIS-D: 7.0, -6.6, and -3.9, respectively. ROC analysis revealed MCID values for PROMIS-UE, PI, and D as 7.0, -6.6, and -3.9 respectively (AUC: 0.743, 0.805, 0.601). SCB values for PROMIS-UE, PI, and D were identified as 8.4, -12.1, and -4.0, respectively (AUC: 0.883, 0.932, 0.652).ConclusionsPROMIS-UE and PROMIS-PI questionnaires can adequately assess the symptoms and outcomes of RTSA patients out to two years postoperatively. Preoperative baseline PROMIS-UE, PROMIS-PI, and PROMIS-D scores cannot adequately predict achievement of MCID in patients indicated for primary RTSA when using anchor-based methods at final follow-up, and should not be used to counsel patients on surgery or guide postoperative treatment.Level of EvidenceLevel II; Retrospective Cohort Study     

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.