The Knee injury and Osteoarthritis Outcome Score (KOOS) for lateral tibial plateau fractures- relevance, reliability and responsiveness.

BACKGROUND: This study aimed to evaluate the patient-reported relevance, test-retest reliability, and responsiveness for each of the five KOOS subscales in patients with lateral tibial plateau fractures. METHODS: Adult patients with surgically treated lateral tibial plateau fractures (AO 41B) were included. The primary outcome measure was the KOOS subscales: Pain, Symptoms, Activity of Daily Living (ADL), Sport and Recreational Activities (Sport/rec), and kne-related Quality of Life (QOL). The KOOS was repeated at 14 and 15 days, six weeks, and 6 and 12 months. Content validity was partly evaluated by patients ranking the relevance of all the items in the KOOS, test-retest reliability by an interclass correlation coefficient, and responsiveness by effect size and based on 3 pre-defined hypotheses related the the global rating of change. RESULTS: Forty-one patients with a mean age of 54.8 years (ranging from 21 to 81 years) were included. The results showed an acceptable relevance of all the KOOS subscales. The test-retest reliability was moderate to high for all five subscales, with an interclass-correlation coefficient ranging from 0.6 to 0.9. At the 6- and 12-month follow-ups, the responsiveness showed large effect sizes for all the KOOS subscales, ranging from 0.9 to 2.1. Moderate to high correlations (r ≥ 0.4)was observed for the predefine hypotheses. CONCLUSION: The KOOS questionnaire showed acceptable relevance, high test-retest reliability and acceptable responsivness within one year following a lateral tibial plateau fracture. More research is needed for further validation of psychometric properties of KOOS for patients with lateral tibial plateau fractures.

Clinically most relevant psychometric properties of the Lower Extremity Functional Scale: a systematic review.

PURPOSE: To systematically review and summarize the literature on minimal detectable change (MDC) and minimal clinically important difference (MCID) values for the Lower Extremity Functional Scale (LEFS). METHODS: The databases that were searched included PubMed, Embase, Medline, and CINAHL, from database inception to August 2023. The inclusion criteria were studies that examined the MDC or MCID of the LEFS in various patient populations and languages. The data extracted included information regarding test-retest reliability, MDC, MCID, and the intervals between assessments. RESULTS: Twenty-four studies defined MDC and five studies MCID values for the LEFS. They review reported a wide range of MDC values, spanning 11 language versions and a variety of diagnoses, with testing intervals ranging from 1 day to 12 months. MCID values were defined with corresponding area under curve, specificity, and sensitivity metrics for three language versions and a variety of diagnoses across timeframes from 4 weeks to 12 months. CONCLUSIONS: The review defined MDC and MCID values that can be applied in clinical practice for the LEFS across a variety of timeframes, diagnoses, and languages. The findings of this study allow clinicians use the identified MDC and MCID values of the LEFS when interpreting clinical outcome data.

The systematic review identified 24 studies on the minimal detectable change (MDC) and five on the minimal clinically important difference (MCID) of the Lower Extremity Functional Scale (LEFS) across different timeframes, diagnoses, and language versions that can be applied in clinical practice.Clinicians can use the MDC and MCID values of the LEFS to make decisions regarding changes in patient scores over time.Clinicians should be cautious about interpreting the MDC and MCID values contextually, considering factors such as language, timeframe, and specific diagnoses.

Can the minimal clinically important difference (MCID) for the Oxford score, KOOS and its derivatives be identified in a French sample of total knee arthroplasties?

CONTEXT: To assess the effect of a surgical procedure on a patient, it is conventional to use clinical scores before and after the procedure, but it is increasingly common and recommended to weight the results of these scores with the notion of minimal clinically important difference ("MCID"). This MCID should be determined using either the data distribution method based on score variation, or the anchor method, which uses an external question to categorize the results. MCIDs vary from one population to another, and to our knowledge there has been no investigation in France for total knee arthroplasties (TKAs). We therefore conducted a prospective study on a population of TKAs in order to: 1) Define MCID in France on a population of TKAs for the Oxford score, KOOS (Knee injury and Osteoarthritis Outcome Score) and its derivatives, 2) Determine whether MCID for these scores in France is comparable to results in the literature. HYPOTHESIS: Is the MCID for total knee arthroplasty in France comparable to other results in the literature? MATERIAL AND METHOD: This was a prospective observational study in which 218 patients (85 men, 133 women) with a mean age of 72 years [27-90] who had undergone a primary TKA out of 300 initially included responded, before and after surgery, to the Oxford-12, KOOS and Forgotten Joint Score (FJS) questions (mean follow-up 24 months). MCID was calculated using the distribution method as well as the anchor method ("improvement 1 to 5" and "improvement yes or no"). RESULTS: At a mean follow-up of 24 months [18-36], the Oxford-12 score increased from 16 ± 8 [0-41] to 34 ± 11 [6-48] (p < 0.001), all components of the KOOS score were improved and the FJS at follow-up was 47 ± 32 [0-100]. For the anchor "improvement 1 to 5", there were 14 unimproved patients, 23 patients in identical condition and 179 patients improved by surgery. For the anchor "are you improved yes/no", there were 8 unimproved patients, 22 in identical condition and 187 surgically-improved patients. The mean MCID for all methods (anchor method and distribution) was 10 [7-13] for Oxford-12, 12 [12-12] for KOOS Symptom, 14 [12-17] for KOOS Pain, 12 [11-14] for KOOS Function, 14 [12-16] for KOOS Sport, 15 [15-16] for KOOS Quality of Life (QOL), 11 [10-12] for KOOS 12, 15 [12-18] for KOOS 12 Pa in. 12 [12-13] for KOOS 12 Function, 15 [15-15] for KOOS 12 QOL, 14 [13-14] for KOOS Physical Function Short-form (PS) and 14 [13-16] for KOOS Joint Replacement (JR). DISCUSSION: The MCID for the Oxford-12, KOOS and its derivatives scores in a French population is comparable to that observed in other populations in the literature. LEVEL OF EVIDENCE: IV; prospective study without control group.

The gap between statistical and clinical significance: time to pay attention to clinical relevance in patient-reported outcome measures of insomnia.

BACKGROUND: Appropriately defining and using the minimal important change (MIC) and the minimal clinically important difference (MCID) are crucial for determining whether the results are clinically significant. The aim of this study is to survey the status of randomized controlled trials (RCTs) for insomnia interventions to assess the inclusion and interpretation of MIC/MCID values. METHODS: We conducted a cross-sectional study to survey the status of RCTs for insomnia interventions to assess the inclusion and appropriate interpretation of MIC/MCID values. A literature search was conducted by searching the main sleep medicine journals indexed in PubMed, the Excerpta Medica Database (EMBASE), and the Cochrane Central Register of Controlled Trials (CENTRAL) to identify a broad range of search terms. We included RCTs with no restriction on the intervention. The included studies used the Insomnia Severity Index (ISI) or the Pittsburgh Sleep Quality Index (PSQI) questionnaire as the outcome measures. RESULTS: 81 eligible studies were identified, and more than one-third of the included studies used MIC/MCID (n = 31, 38.3%). Among them, 21 studies with ISI as the outcome used MIC defined as a relative decrease ranging from 3 to 8 points. The most frequently used MIC value was a 6-point decrease (n = 7), followed by 8-point (n = 6) and 7-point decrease (n = 4), a 4 to 5-points decrease (n = 3), and a 30% reduction from baseline; 6 studies used MCID values, ranging from 2.8 to 4 points. The most frequently used MCID value was a 4-point decrease in the ISI (n = 4). 4 studies with PSQI as the outcome used a 3-point change as the MIC (n = 2) and a 2.5 to 2.7-point difference as MCID (n = 2). 4 non-inferiority design studies considered interval estimation when drawing clinically significant conclusions in their MCID usage. CONCLUSIONS: The lack of consistent MIC/MCID interpretation and usage in outcome measures for insomnia highlights the urgent need for further efforts to address this issue and improve reporting practices.

Defining clinically relevant outcome thresholds for pain and function after osteochondral autograft transplantation of the knee.

PURPOSE: To define the minimal clinically important difference (MCID) for measures of pain and function at 2, 5 and 10 years after osteochondral autograft transplantations (OATs). METHODS: Patients undergoing OATs of the knee were identified from a prospectively maintained cartilage surgery registry. Baseline demographic, injury and surgical factors were collected. Patient-reported outcome scores (PROMs) were collected at baseline, 2-, 5- and 10-year follow-up, including the International Knee Documentation Committee (IKDC) score, Knee Outcome Survey Activities of Daily Living Scale (KOS-ADLS), Marx activity scale and Visual Analogue Scale (VAS) for pain. The MCIDs were quantified for each metric utilizing a distribution-based method equivalent to one-half the standard deviation of the mean change in outcome score. The percentage of patients achieving MCID as a function of time was assessed. RESULTS: Of 63 consecutive patients who underwent OATs, 47 (74.6%) patients were eligible for follow-up (surgical date before October 2021) and had fully completed preoperative PROMs. A total of 39 patients (83%) were available for a minimum 2-year follow-up, with a mean (±standard deviation) follow-up of 5.8 ± 3.4 years. The MCIDs were determined to be 9.3 for IKDC, 2.5 for Marx, 7.4 for KOS-ADLS and 12.9 for pain. At 2 years, 78.1% of patients achieved MCID for IKDC, 77.8% for Marx, 75% for KOS-ADLS and 57.9% for pain. These results were generally maintained through 10-year follow-ups, with 75% of patients achieving MCID for IKDC, 80% for Marx, 80% for KOS-ADLS and 69.8% for pain. CONCLUSIONS: The majority of patients achieved a clinically relevant outcome improvement after OATs of the knee, with results sustained through 10-year follow-up. Patients who experience clinically relevant outcome improvement after OATs in the short term continue to experience sustained benefits at longer-term follow-up. These data provide valuable prognostic information when discussing patient candidacy and the expected trajectory of recovery. LEVEL OF EVIDENCE: Level III.

MCID achievement in staged bilateral total knee arthroplasty: Are both joints created equal?

BACKGROUND: A notable portion of unilateral total knee arthroplasty (TKA) patients undergo arthroplasty of the contralateral knee. The aims of this study were to describe the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W) in staged bilateral TKAs (BTKAs) and identify factors associated with these outcomes. METHODS: Patients with staged BTKA were retrospectively reviewed. Demographics, surgery details, and Patient-Reported Outcome Measurement Information System Physical Function Short Form 10a (PROMIS PF10a) were collected. MCID-I and MCID-W were defined for PROMIS PF10a. Patients were stratified into nine groups based on the MCID achievement of the first and second TKA: (A) MCID-I, MCID- I, (B) MCID-I, Neutral, (C) MCID-I, MCID-W, (D) Neutral, MCID-I, (E) Neutral, Neutral, (F) Neutral, MCID-W, (G) MCID- W, MCID-I, (H) MCID-W, Neutral, (I) MCID-W, MCID-W. Neutral patients did not achieve either MCID-I or MCID-W. RESULTS: The final cohort consisted of 59 staged BTKA patients. In patients who achieved MCID-I in the first TKA, 39.1% achieved MCID-I again in the second TKA (A), 39.1% were neutral (B), and 21.7% achieved MCID-W (C) in the second TKA. However, 77.8% of those who achieved MCID-W in the first joint (n = 9) went on to achieve MCID-I (G) in the second TKA. Those who achieved MCID-I after both TKAs (A) had a longer staged interval than those who achieved first MCID-I, then MCID-W (C) (15 months vs 8 months, P = 0.0113). CONCLUSION: In staged BTKA, MCID achievement of the first TKA may not be associated with the outcome of the second TKA.

Preoperative subjective assessment of disease-specific quality of life significantly influenced the likelihood of achieving the minimal clinically important difference after surgical stabilization for recurrent lateral patellar instability.

PURPOSE: To evaluate which factors exert a predictive value for not reaching the minimal clinically important difference (MCID) in patients who underwent a tailored operative treatment for recurrent lateral patellar dislocation (RLPD). METHODS: A total of 237 patients (male/female 71/166; 22.4 ± 6.8 years) were included. The Banff Patellofemoral Instability Instrument 2.0 (BPII 2.0) and subjective rating of knee function and pain (numeric analogue scale [NAS]; 0-10) were used to evaluate patients' outcomes from pre- to postoperatively. Gender, age at the time of surgery, body mass index (BMI), nicotine abuse, psychiatric diseases, cartilage status and pathoanatomic risk factors were evaluated as potential predictors for achieving the MCID using univariate logistic regression analysis. RESULTS: The MCID for the BPII 2.0 was calculated at 9.5 points. Although the BPII 2.0 and NAS for knee function and pain improved significantly in the total cohort from pre- to postoperatively (all p < 0.001), 29 patients did not reach the MCID at the final follow-up. The analysis yielded that only the preoperative NAS for function and BPII 2.0 score values were significant predictors for reaching the MCID postoperatively. The optimal threshold was calculated at 7 (NAS function) and 65.2 points (BPII 2.0). Age at the time of surgery should be considered for patients with a preoperative BPII 2.0 score >62.5. CONCLUSION: The probability of reaching BPII 2.0 MCID postoperatively depends only on the preoperative BPII 2.0 value and subjective rating of knee function, as well as age at the time of surgery for patients undergoing surgical treatment of RLPD. Here, presented results can assist clinicians in advising and presenting patients with potential outcomes following treatment for this often complex and multifactorial pathology. LEVEL OF EVIDENCE: Level III.

Estimating minimal clinically important difference (MCID) for gastrointestinal symptoms in cystic fibrosis.

BACKGROUND: Minimal clinically important difference (MCID) is important to establish as a meaningful outcome in research when using patient reported outcome measures (PROMs). We determined the MCID using the distribution-based approach for three measurements used as part of the GALAXY study, which is an observational prospective study on gastrointestinal (GI) symptoms in cystic fibrosis (CF). METHODS: Four hundred and two persons with cystic fibrosis (PwCF) participated in the GALAXY study, all with baseline values available for all questionnaires. Mean age was 20.9 years (2.1- 61.1) with 75 females and 94 males under the age of 18 (42.04 %) and 118 females and 115 males aged 18 or older (57.99 %). MCID was measured for Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Upper Gastrointestinal Symptoms (PAGI-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL) and their subscales. Two distribution-based approaches, defined as multiplications of the standard deviation (SD) or standard error of the mean (SEM), were used to approximate the MCID. RESULTS: The two distribution-based approaches for determining the MCID estimates produced comparable results in trends in MCIDs across the subscales and total scores. In general, MCID estimates of subscales for all three measurements were higher than their total score MCIDs. The one-half SD- and SEM-based MCID estimates for total scores of each questionnaire are as follows: PAC-SYM: 0.26 and 0.14; PAGI-SYM: 0.32 and 0.15; PAC-QOL: 0.27 and 0.18, respectively. CONCLUSION: This paper establishes initial MCIDs estimated by the distribution-based approach for the PAC-SYM, PAGI-SYM and PAC-QOL that can now be used to evaluate interventional studies that may impact gastrointestinal symptoms in PwCF.

Defining the minimal clinically important difference for IKDC and KOOS scores for patients undergoing tibial tubercle osteotomy for patellofemoral pain or instability.

Purpose: The aim of the present study is to define the minimal clinically important difference (MCID) for International Knee Documentation Committee (IKDC) and Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients undergoing tibial tubercle osteotomy (TTO) for either (1) patellofemoral pain or (2) patellar instability. Methods: Patients undergoing TTO for either patellofemoral pain or patellar instability by one of two sports medicine fellowship-trained surgeons at a single institution between September 2014 and May 2023 were included in the study. IKDC and KOOS scores were collected preoperatively and minimum 1 year postoperatively. Distribution-based methods were used to calculate the MCID. Results: Seventy-seven patients (82 knees) were included, with a median age of 29.3 years (interquartile range [IQR]: 22.2-36.3 years) and a median BMI of 24.5 kg/m2 [IQR: 22.3-28.3 kg/m2]. Fifty-seven patients (74%) were female, and there were 40 right knees (49%). The median time to IKDC and KOOS score was 1.8 and 1.7 years, respectively. Forty-five patients (46 knees) underwent TTO for patellofemoral instability, and 32 patients (36 knees) underwent TTO for patellofemoral pain. The MCID was 11.5 for IKDC, 10.2 for KOOS pain, 10.1 for KOOS symptoms, 9.9 for KOOS ADL, 14.2 for KOOS sport and 14.2 for KOOS QoL for patients undergoing TTO for patellofemoral pain. The MCID was 11.2 for IKDC, 10.1 for KOOS pain, 10.6 for KOOS symptoms, 10.2 for KOOS ADL, 16.0 for KOOS sport and 13.2 for KOOS QoL for patients undergoing TTO for patellar instability. Conclusion: We define the MCIDs for commonly used patient-reported outcome measures for patients undergoing TTO for either patellofemoral pain or patellar instability. Level of Evidence: Level II.

The minimal important change (MIC) and minimal clinically important difference (MCID) of the patient and observer scar assessment scale (POSAS) 2.0.

BACKGROUND: The Patient and Observer Scar Assessment Scale (POSAS) is frequently used to assess scar quality after burns. It is important to be aware of the minimal important change (MIC) and the minimal clinically important difference (MCID) to establish if a POSAS score represents a clinically relevant change or difference. The aim of this study is to explore the MIC and MCID of POSAS version 2.0. METHODS: This prospective study included 127 patients with deep dermal burns that underwent split thickness skin grafting with a mean age of 44 years (range 0 - 87) and total body surface area burned of 10 % (range 0.5 - 55). POSAS data was obtained for one burn scar area at three, six, and 12 months after split skin grafting. At the second and third visits, patients rated the degree of clinical change in scar quality in comparison to the previous visit. At 12 months, they completed the POSAS for a second burn scar area and rated the degree of clinical difference between the two scar areas. Two anchor-based methods were used to determine the MIC and MCID. RESULTS: MIC values of the patient POSAS ranged from - 0.59 to - 0.29 between three and six months and from - 0.75 to - 0.38 between six and 12 months follow-up. Both had a poor discriminatory value. MCID values ranged from - 0.39 and - 0.08, with a better discriminatory value. CONCLUSION: Results suggest that patients consider minor differences (less than 0.75 on the 1-10 scale) in POSAS scores as clinically important scar quality changes. MCID values can be used to evaluate the effects of burn treatment and perform sample-size calculations.

Calculation of the minimal clinically important difference in operated patients with adult spine deformity: advantages of the ROC method and significance of prevalence in threshold selection.

PURPOSE: The Minimal Clinically Important Difference (MCID) is crucial to evaluate management outcomes, but different thresholds have been obtained in different works. Part of this variability is due to measurement error and influence of the database, both essential for calculating the MCID. The aim of this study was to introduce the association of the ROC method in the anchor-based MCID calculation for ODI, SRS-22r, and SF-36, to objectively set the threshold for the anchor-based MCID in an adult spine deformity (ASD) population. METHODS: Multicentric study based on a prospective database of consecutively operated ASD patients. An anchor question was used to assess patients' quality of life after surgery. Different approaches were used to calculate the MCID and then compared: SEM (Standard Error of Measurement), MDC (Minimal Detectable Change), and anchor-based MCID with ROC method. RESULTS: 516 patients were included. Those who responded with 6 and 7 to the anchor question were considered improved. The MCID ranges obtained with the ROC method exhibited the lowest variability. Prediction error rates ranged from 31% (SRS-22r) to 41% (SF-36 MCS). The MCID ranges spanned between 12 and 15 for ODI, 0.6 and 0.73 for SRS-22r, 6.62 and 7.41 for SF-36 PCS, and between 2.69 and 5.63 for SF-36 MCS. CONCLUSION: The ROC method proposes an MCID range with error rate, and can objectively determine the threshold for distinguishing improved and non-improved patients. As the MCID correlates with the utilized database and error of measurement, each study should compute its own MCID for each PROM to allow comparison among different publications. LEVEL OF EVIDENCE: II.

Determining minimal clinically important difference and patient-acceptable symptom state after arthroscopic isolated subscapularis repair.

Background: Minimal Clinically Important Difference (MCID) and Patient-Acceptable Symptomatic State (PASS) have emerged as patient-based treatment assessments. However, these have not been investigated in patients undergoing arthroscopic isolated subscapularis repair (AISR). The primary purpose of this study was to determine the MCID and PASS for commonly used patient-reported outcomes in individuals who underwent AISR. The secondary purpose was to assess potential associations between preoperative and intraoperative patient characteristics and the MCID and PASS. Methods: A retrospective analysis was conducted on prospectively collected data for patients who underwent primary AISR between 2011 and 2021 at a single institution, with minimum 2-year postoperative follow-up. Functional outcomes were assessed using the American Shoulder and Elbow Surgeons (ASES) score, Subjective Shoulder Value (SSV), and Visual Analog Scale (VAS) pain scale. The MCID was determined using the distribution-based method, while PASS was evaluated using area under the curve analysis. To investigate the relationship between preoperative variables and the achievement of MCID and PASS thresholds, Pearson and Spearman coefficient analyses were employed for continuous and noncontinuous variables, respectively. Results: A total of 77 patients with a mean follow-up of 58.1 months were included in the study. The calculated MCID values for VAS pain, ASES, and SSV were 1.2, 10.2, and 13.2, respectively. The PASS values for VAS pain, ASES, and SSV were 2.1, 68.8, and 68, respectively. There was no significant correlation between tear characteristics and the likelihood of achieving a MCID or PASS. Female sex, worker's compensation status, baseline VAS pain score, and baseline ASES score, exhibited weak negative correlations for achieving PASS for VAS pain and ASES. Conclusion: This study defined the MCID and PASS values for commonly used outcome measures at short-term follow-up in patients undergoing AISR. Tear characteristics do not appear to impact the ability to achieve a MCID or PASS after AISR. Female sex, worker's compensation claim, and low baseline functional scores have weak negative correlations with the achievement of PASS for VAS pain and ASES scores.

Trajectory of Recovery following ORIF for Distal Radius Fractures.

Background Distal radius fractures are commonly seen among the elderly, though studies examining their long-term outcomes are limited. Purpose The aim of this study was to describe the 5-year trajectory of recovery of distal radius fractures treated with open reduction and internal fixation (ORIF). Methods Patients with distal radius fractures (AO/OTA 23.A-C) treated by ORIF were prospectively studied. Patient-Rated Wrist Evaluation (PRWE) score was measured at baseline (preinjury recall) and postoperatively at 6 months, 1 year, and 5 years. Clinically relevant change in PRWE score was assessed using the minimal clinically important difference (MCID). Results A total of 390 patients were included, of which 75% completed 5-year follow-up. Mean baseline PRWE score was 1.25 (standard deviation, SD: 2.9). At 6 months, mean PRWE score was at its highest up to 20.2 (SD: 18.4; p < 0.01). A significant improvement in mean PRWE score was observed at 1 year down to 15.2 (SD: 17.6; p < 0.01); 44% of patients were still one MCID outside of their baseline PRWE score at 1 year. Further significant improvement in mean PRWE score occurred at 5 years down to 9.4 (SD: 13.4; p < 0.01); 29% of patients remained one MCID outside of their baseline PRWE score at 5 years. Conclusion Recovery after ORIF for distal radius fractures showed significant worsening after surgery, followed by significant improvements up to 1 year and between years 1 and 5, albeit to a lesser extent. Statistically and clinically relevant wrist pain and disability persisted at 5 years. Future research should examine different treatment modalities and include a nonoperative treatment arm for comparison. Level of Evidence Prognostic level II.

The variability of MCID, SCB, PASS, and MOI thresholds for PROMs in the reverse total shoulder arthroplasty literature: a systematic review.

BACKGROUND: Reverse total shoulder arthroplasty (RTSA) is a common procedure utilized to address degenerative pathologies of the glenohumeral joint and rotator cuff. Increased reliance on patient-reported outcome measures (PROMs) have placed emphasis on the utilization of the minimum clinically important difference (MCID), substantial clinical benefit (SCB), patient acceptable symptom state (PASS), and maximal outcome improvement (MOI) thresholds to assess the clinical efficacy of RTSA. In this study, we systematically reviewed the MCID, SCB, PASS, and MOI thresholds reported for PROMs following RTSA. METHODS: PubMed, Embase, MEDLINE, Cochrane Library, and Google Scholar were queried for articles from January 1, 2000 to August 31, 2023 reporting MCID, SCB, PASS, or MOI values for PROMs following RTSA. Patient demographic data, study characteristics, MCID/SCB/PASS/MOI thresholds, and threshold calculation methods were extracted. RESULTS: One hundred and forty-one articles were screened with 39 ultimately included, comprising 11,984 total patients that underwent RTSA. 34 (87%) studies reported MCID thresholds, 20 (51%) reported SCB, 5 (13%) reported PASS, and 2 (5%) reported MOI. 25/39 (64%) studies referenced a previous study when reporting MCID, SCB, PASS, or MOI values, 11 (28%) used an anchor-based method to calculate threshold values, 1 (3%) used a distribution-based method, and 2 (5%) used both anchor and distribution methods. There were 19 newly calculated MCID (11), SCB (5), PASS (1), and MOI (2) thresholds. For 5 of the 6 most utilized PROMs (ASES, SST, Constant, UCLA, and SPADI), the range of reported MCID values exceeded 50% of the most common threshold. For 3 of 6, the range of SCB values exceeded 25% of the most common threshold. CONCLUSION: There is substantial variability in the MCID and SCB threshold values reported in the RTSA literature. Standardizing the methodologic calculation and utilization of MCID, SCB, PASS, and MOI thresholds for RTSA may allow for improved assessment of PROMs.

Quantifying Patient Expectations for Total Knee Arthroplasty: Expectations for Improvement Are Greater Than Minimal Clinically Important Difference.

BACKGROUND: Achieving a minimal clinically important difference (MCID) in patient-reported outcomes following total knee arthroplasty (TKA) is common, yet up to 20% patient dissatisfaction persists. Unmet expectations may explain post-TKA dissatisfaction. No prior studies have quantified patient expectations using the same patient-reported outcome metric as used for MCID to allow direct comparison. METHODS: This was a prospective study of patients undergoing TKA with 5 fellowship-trained arthroplasty surgeons at one academic center. Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) domains were assessed. Expected PROMIS scores were determined by asking patients to indicate the outcomes they were expecting at 12 months postoperatively. Predicted scores were generated from a predictive model validated in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) dataset. T-tests were used to compare baseline, expected, and predicted PROMIS scores. Expected scores were compared to PROMIS MCID values obtained from the literature. Regression models were used to identify patient characteristics associated with high expectations. RESULTS: There were 93 patients included. Mean age was 67 years (range, 30 to 85) and 55% were women. Mean baseline PROMIS PF and PI was 34.4 ± 6.7 and 62.2 ± 6.4, respectively. Patients expected significant improvement for PF of 1.9 times the MCID (MCID = 11.3; mean expected improvement = 21.6, 95% confidence interval [CI] 19.6 to 23.5, P < .001) and for PI of 2.3 times the MCID (MCID = 8.9; mean expected improvement = 20.6, 95% CI 19.1-22.2, P < .001). Predicted scores were significantly lower than expected scores (mean difference = 9.5, 95% CI 7.7 to 11.3, P < .001). No unique patient characteristics were associated with high expectations (P > .05). CONCLUSIONS: To our knowledge, this study is the first to quantify preoperative patient expectations using the same metric as MCID to allow for direct comparison. Patient expectations for improvement following TKA are ∼2× greater than MCID and are significantly greater than predicted outcome scores. This discrepancy challenges currently accepted standards of success after TKA and indicates a need for improved expectation setting prior to surgery.

Time to Achieve the Minimal Clinically Important Difference in Primary Total Hip Arthroplasty: Comparison of Anterior and Posterior Surgical Approaches.

BACKGROUND: Controversy remains over outcomes between total hip arthroplasty approaches. This study aimed to compare the time to achieve the minimal clinically important difference (MCID) for the Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (HOOS-PS) and the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-Physical for patients who underwent anterior and posterior surgical approaches in primary total hip arthroplasty. METHODS: Patients from 2018 to 2021 with preoperative and postoperative HOOS-PS or PROMIS Global-Physical questionnaires were grouped by approach. Demographic and MCID achievement rates were compared, and survival curves with and without interval-censoring were used to assess the time to achieve the MCID by approach. Log-rank and weighted log-rank tests were used to compare groups, and Weibull regression analyses were performed to assess potential covariates. RESULTS: A total of 2,725 patients (1,054 anterior and 1,671 posterior) were analyzed. There were no significant differences in median MCID achievement times for either the HOOS-PS (anterior: 5.9 months, 95% confidence interval [CI]: 4.6 to 6.4; posterior: 4.4 months, 95% CI: 4.1 to 5.1, P = .65) or the PROMIS Global-Physical (anterior: 4.2 months, 95% CI: 3.5 to 5.3; posterior: 3.5 months, 95% CI: 3.4 to 3.8, P = .08) between approaches. Interval-censoring revealed earlier times of achieving the MCID for both the HOOS-PS (anterior: 1.509 to 1.511 months; posterior: 1.7 to 2.3 months, P = .87) and the PROMIS Global-Physical (anterior: 3.0 to 3.1 weeks; posterior: 2.7 to 3.3 weeks, P = .18) for both surgical approaches. CONCLUSIONS: The time to achieve the MCID did not differ by surgical approach. Most patients will achieve clinically meaningful improvements in physical function much earlier than previously believed. LEVEL OF EVIDENCE: Level III, Retrospective Comparative Study.

Minimal clinically important differences in six-minute walking distance in late-onset Pompe disease.

BACKGROUND: The minimal clinically important difference (MCID) is the smallest change in outcome that physicians or patients would consider meaningful and is relevant when evaluating disease progression or the efficacy of interventions. Studies of patients with late-onset Pompe disease (LOPD) have used the 6-min walk distance (6MWD) as an endpoint to assess motor function. However, an MCID for 6MWD (% predicted and meters) has yet to be established in LOPD. The objective of the study was to derive 6MWD MCID (% predicted and meters) with different analysis methods and for subgroups of different disease severity for LOPD. METHODS: Data from the PROPEL trial were used to calculate 6MWD MCID in the overall PROPEL population and subgroups of baseline severity as assessed by walking distance and body mass index (BMI), using anchor- and distribution-based approaches. RESULTS: The 6MWD MCIDs varied widely, depending on the method and subgroup, ranging from 2.27%-8.11% predicted for the overall LOPD population (23.7 m-57.2 m). For patients with baseline 6MWD < 150 m, MCIDs ranged from -0.74%-3.37% (-2.1 m-11.3 m). MCIDs increased with distance walked at baseline until a plateau was reached. For BMI subgroups, the MCIDs were generally lowest in obese patients. CONCLUSION: Our analysis shows that MCID depends on the chosen method and disease severity. The findings suggest that applying a single MCID to all patients can be misleading; consequently, a range of possible MCIDs should be considered. This may also be highly relevant for other neuromuscular diseases. This study provides a range of 6MWD MCIDs for LOPD, with lower MCIDs for more severe patients.

Depression State Correlates with Functional Recovery Following Elective Lumbar Spine Fusion.

OBJECTIVE: To determine how depression state impacts postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores and achievement of minimum clinically important difference (MCID) following lumbar fusion. Depression has been shown to negatively impact outcomes following numerous orthopedic surgeries. Situational and major clinical depression can differentially affect postoperative outcomes. METHODS: Adult patients undergoing elective 1-3 level lumbar fusion were reviewed. Patients with a formal diagnosis of major depression were classified as "clinically depressed" whereas patients with at least "mild" PROMIS Depression scores in the absence of formal depression diagnosis were deemed "situationally depressed." analysis of variance testing was used to assess differences within and between groups. Multivariate regression was used to identify features associated with the achievement of MCID. RESULTS: Two hundred patients were included. The average age was 65.9 ± 12.2 years. 75 patients (37.5%) were nondepressed, 66 patients (33.0%) were clinically depressed, and 59 patients (29.5%) were situationally depressed. Situationally depressed patients had worse preoperative physical function (PF) and pain interference (PI) scores and were more likely to have severe symptoms (P = 0.001, P = 0.001). All groups improved significantly from preoperative baseline scores. All groups met MCID PF at different rates, with highest proportion of situationally depressed reaching this metric (P = 0.03). Rates of achieving MCID PI were not significantly different between groups (P = 0.47). Situational depression was predictive of achieving MCID PF (P = 0.002) but not MCID PI. CONCLUSIONS: Our study investigated the relationship between depression and postoperative PROMIS scores and identified situationally depressed patients as having the worst preoperative impairment. Despite this, the situationally depressed cohort had the highest likelihood of achieving MCID PF, suggestive of a bidirectional relationship between lumbar degenerative disease and subclinical, situational depression. These findings may help guide preoperative counseling on expectations, and patient selection.

Reassessing the minimum 2-year follow-up standard after lumbar decompression surgery: a 2-month follow-up seems to be an acceptable minimum.

BACKGROUND CONTEXT: Academic orthopedic journals and specialty societies emphasize the importance of two-year follow-up for patient-reported outcome measures (PROMS) after spine surgery, but there are limited data evaluating the appropriate length of follow-up. PURPOSE: To determine whether PROMs, as measured by the Oswestry Disability Index (ODI), would change significantly after 2-months postoperatively after lumbar decompression surgery for disc herniation or spinal stenosis. STUDY DESIGN: Retrospective analysis of prospectively and consecutively enrolled patients undergoing lumbar decompression surgery between 2020 and 2021 from a single surgeon spine registry. PATIENT SAMPLE: One hundred sixty-nine patients. OUTCOME MEASURES: ODI, achievement of minimum clinically important difference (MCID), revisions. METHODS: Patients without a preoperative baseline score were excluded. Completion of the ODI questionnaire was assessed at the follow-up points. The median ODI was compared at time baseline, 2-month, 1-year and 2-year follow-up. Risk of reoperation was assessed with receiver operating characteristic (ROC) analysis to identify at-risk ODI thresholds of requiring reoperation. RESULTS: Median ODI significantly improved at all time points compared to baseline (median baseline ODI: 40; 2-month ODI: 16, p=.001; 1-year ODI: 11.1, p=.001; 2-year ODI: 8, p=.001). Posthoc analysis demonstrated no difference between 2-months, 1-year and 2-year postoperative ODI (p=.9, p=.468, p=.606). The MCID was met in 87.9% of patients at 2 months, 80.7% at 1 year, and 87.3% at 2 years postoperatively. Twelve patients (7.7%) underwent revision surgery between 2 months and 2 years after the index surgery (median time to revision: 5.6 months). ROC curve analysis demonstrated that an ODI score ≥24 points at 2-months yielded a sensitivity of 85.7% and a specificity of 71.8% for predicting revision after lumbar decompression (AUC=0.758; 95% CI: 0.613-0.903). The Youden optimal threshold value of ≥24 points at 2-month postop ODI yielded an odd ratio (OR) for revision of 15.3 (CI: 1.8-131.8; p=.004). The positive predictive value (PPV) and negative predictive value (NPV) were 15.4% and 98.8%, respectively. CONCLUSION: Two-year clinical follow-up may not be necessary for future peer-reviewed lumbar decompression surgery studies given that ODI plateaus at 8 weeks. Patients with a score ≥24 points at 2-months postoperatively have a higher risk of requiring a second surgery within the first 2 years and warrant continued follow-up.

Surgical treatment of Roussouly type 1 with realigning Roussouly spinal shape and improving SRS-Schwab modifier: effect on minimal clinically important difference.

PURPOSE: To evaluate outcomes of choosing different Roussouly shapes and improving in Schwab modifiers for surgical Roussouly type 1 patients. METHODS: Baseline (BL) and 2-year (2Y) clinical data of adult spinal deformity (ASD) patients presenting with Roussouly type 1 sagittal spinal alignment were isolated in the single-center spine database. Patients were grouped into Roussouly type 1, 2 and 3 with anteverted pelvis (3a) postoperatively. Schwab modifiers at BL and 2Y were categorized as follows: no deformity (0), moderate deformity (+), and severe deformity (++) for pelvic tilt (PT), sagittal vertical axis (SVA), and pelvic incidence and lumbar lordosis mismatch (PI-LL). Improvement in SRS-Schwab was defined as a decrease in the severity of any modifier at 2Y. RESULTS: A total of 96 patients (69.9 years, 72.9% female, 25.2 kg/m2) were included. At 2Y, there were 34 type 1 backs, 60 type 2 backs and only 2 type 3a. Type 1 and type 2 did not differ in rates of reaching 2Y minimal clinically important difference (MCID) for health-related quality of life (HRQOL) scores (all P > 0.05). Two patients who presented with type 3a had poor HRQOL scores. Analysis of Schwab modifiers showed that 41.7% of patients improved in SVA, 45.8% in PI-LL, and 36.5% in PT. At 2Y, patients who improved in SRS-Schwab PT and SVA had lower Oswestry disability index (ODI) scores and significantly more of them reached MCID for ODI (all P < 0.001). Patients who improved in SRS-Schwab SVA and PI-LL had more changes of VAS Back and Short Form-36 (SF-36) outcomes questionnaire physical component summary (SF-36 PCS), and significantly more reached MCID (all P < 0.001). By 2Y, type 2 patients who improved in SRS-Schwab grades reached MCID for VAS back and ODI at the highest rate (P = 0.003, P = 0.001, respectively), and type 1 patients who improved in SRS-Schwab grades reached MCID for SF-36 PCS at the highest rate (P < 0.001). CONCLUSION: For ASD patients classified as Roussouly type 1, postoperative improvement in SRS-Schwab grades reflected superior patient-reported outcomes while type 1 and type 2 did not differ in clinical outcomes at 2Y. However, development of type 3a should be avoided at the risk of poor functional outcomes. Utilizing both classification systems in surgical decision-making can optimize postoperative outcomes.