Development and preliminary validation of a diagnostic prediction model to optimise outpatient management of patients with urolithiasis using urinary stones and intervention quality of life (USIQoL) measure.

PURPOSE: Patients with urinary calculi undergo resource-intensive follow-up. Application of a PROM, Urinary Stones and Intervention Quality of Life (USIQoL), can potentially optimise current practices if it matches the outcomes of traditional follow-up. Our objective was to develop, and conduct, a preliminary validation of the USIQoL based prediction model to aid triage. METHODS: We performed a two phase prospective cohort study. The 1st phase included development of the USIQoL-based decision model using multicentre data. The 2nd phase involved prospective single-blind external validation for the outpatient application. The aim was to evaluate correlations between the USIQoL scores and key predictors; clinical outcomes and global health ratings (EuroQoL EQ-5D). We used statistical analysis to validate USIQoL cut-off scores to aid triage and the decision to intervene. RESULTS: Of 503 patients invited, 91% (n = 455, Development [305] and Validation [150]; M = 308, F = 147) participated. The relationship between USIQoL domain scores and clinical outcomes was consistently significant (estimated odds: PPH 1.24, p < 0.001, 95% CI 1.13-1.36; PSH 1.22, p < 0.001, 95% CI 1.12-1.33). The ROC values for the model were ≥ 0.75. The optimum domain cut-off scores were derived with rising scores implying increased need to intervene. The model demonstrated satisfactory sensitivity (0.81-0.89) and specificity (0.36-0.47). CONCLUSIONS: The study demonstrates satisfactory correlation between the USIQoL and clinical outcomes making this model a valid aid for triage and optimising outpatient management with the cut-off scores able to identify high risk patients who need active treatment.

Establishing minimal clinically important differences for the quality of life scale QLICD-SLE for patients with systemic lupus erythematosus based on ROC curve.

The minimal clinically important difference (MCID) is an important concept with big appeal in a field struggling to interpret quality of life (QOL) and other patient-reported outcomes (PRO), is also a bridge between statistics and clinical medicine. This study uses the ROC curve to formulate the MCID value of the Quality of Life Instruments for Chronic Diseases of Systemic lupus erythematosus (QLICD-SLE V2.0) scale. Using the representative item "In general, would you say your health is" of the MOS item short form health survey(SF-36) as an anchor, the questionnaire of QLICD-SLE V2.0 and the anchor item were used to investigate the patients on the first day of hospitalization, and the day before the patient was discharged. 279 patients with lupus erythematosus were participated in this longitudinal follow-up study. The ROC curve was constructed by using the classification based on the anchor item as the gold standard and the difference score of the scale as the test variable. The cut-off point corresponding to the maximum value of the Youden index in the ROC curve is taken as the minimum clinical importance difference (MCID) value of the QLICD-SLE (V2.0) scale. The Results showed that the MCID of physical domain, psychological domain, social domain, general module, specific module and QLICD-SLE (V2.0) total scale are 8.3, 2.3, 2.5, 2.7, 9.2 and 3.2, respectively. Area under the ROC curve of QLICD-SLE (V2.0) is 0.898, P (Area = 0.5) < 0.001, the sensitivity is 100%, the specificity is 66.9%. It concluded that if the total scores after treatments changes at least 3.2 points positively, the treatment intervention can be considered as clinically significant. It is more convincing to use the corresponding cut-off point as the MCID for ROC curve method can visualize the sensitivity and specificity.

Several factors predict the achievement of the patient acceptable symptom state and minimal clinically important difference for patient-reported outcome measures following anterior cruciate ligament reconstruction: A systematic review.

PURPOSE: To summarize the predictors of the patient acceptable symptom state (PASS), minimal clinically important difference (MCID) and minimal important change (MIC) for patient-reported outcome measures (PROMs) following anterior cruciate ligament reconstruction (ACLR). METHODS: MEDLINE, PubMed and Embase were searched from inception to 5 January 2024. The authors adhered to PRISMA/R-AMSTAR guidelines, and the Cochrane Handbook for Systematic Reviews of Interventions. Data on statistical associations between predictive factors and PROMs were extracted. Inverse odds ratios (ORs) and confidence intervals (reverse group comparison) were calculated when appropriate to ensure comparative consistency. RESULTS: Thirteen studies comprising 21,235 patients (48.1% female) were included (mean age 29.3 years). Eight studies comprising 3857 patients identified predictors of PASS, including lateral extra-articular tenodesis (LET) (OR = 11.08, p = 0.01), hamstring tendon (HT) autografts (OR range: 2.02-2.63, p ≤ 0.011), age over 30 (OR range: 1.37-2.28, p ≤ 0.02), male sex (OR range: 1.03-1.32, p ≤ 0.01) and higher pre-operative PROMs (OR range: 1.04-1.21). Eight studies comprising 18,069 patients identified negative predictors of MCID or MIC, including female sex (OR = 0.93, p = 0.034), absence of HT autografts (OR = 0.70, p < 0.0001), higher pre-operative PROMs (OR = 0.76-0.84, p ≤ 0.01), meniscectomy (OR = 0.67, p = 0.014) and collision sports (OR = 0.02-0.60, p ≤ 0.05). CONCLUSION: Higher pre-operative PROMs, age over 30, male sex, LETs and HT autografts predicted PASS achievement. Lower pre-operative PROMs, male sex, non-collision sports, and lack of meniscectomies predicted MCID/MIC achievement. This review provides a comprehensive understanding of the predictors of clinically significant post-ACLR outcomes, thus improving clinical decision-making and the management of patient expectations. LEVEL OF EVIDENCE: Level IV.

Revision Total Knee Arthroplasty Achieves Minimal Clinically Important Difference Faster than Primary Total Knee Arthroplasty.

INTRODUCTION: Revision total knee arthroplasty (rTKA) remains underexplored regarding patient-reported outcome measures (PROMs), particularly in terms of time to reach Minimal Clinically Important Difference (MCID). This study addresses this gap by comparing the time to achieve MCID between primary TKA (pTKA) and rTKA patients, providing valuable insights into their recovery trajectories. METHODS: A total of 8,266 TKAs (7,618 pTKA and 648 rTKA) were retrospectively studied in a multi-institutional arthroplasty registry. Patients who completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical, PROMIS Physical Function Short Form 10a (PF-10a), and Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) questionnaires were identified by Current Procedural Terminology (CPT) codes. Survival curves with and without interval-censoring were utilized to evaluate the time to achieve MCID. RESULTS: Comparing the time to achieve MCID, rTKAs were significantly faster than pTKA for PROMIS Global Physical (3.5 versus 3.7 months, P = 0.004) and KOOS-PS (3.3 versus 4.2 months, P < 0.001), but similar for PROMIS PF-10a (4.4 versus 4.8 months, P = 0.057). Interval-censoring also showed similar trends with earlier times to achieve MCID for rTKAs for PROMIS Global Physical (0.6 to 0.61 versus 0.97 to 0.97 months, P = 0.009) and KOOS-PS (0.97 to 0.97 versus 1.47 to 1.47 months, P < 0.001), but not for PROMIS PF-10a (2.43 to 2.54 versus 1.90 to 1.91 months, P = 0.92). CONCLUSION: The present study revealed that the time to achieve MCID was faster in patients undergoing rTKA compared to those undergoing pTKA. These findings allow surgeons to reassure preoperative revision TKA patients that their recovery to a minimal clinically important difference postoperatively may be quicker than expected, especially when compared to their initial recovery after primary TKA.

Comparing Rates of Minimal Clinically Important Difference Between Manual and Robotic-Assisted Total Knee Arthroplasty.

BACKGROUND: Differences in patient-reported outcome measures (PROMs) between manual total knee arthroplasty (mTKA) and robotic-assisted TKA (rTKA) have not been adequately assessed. We compared the minimal clinically important difference for improvement (MCID-I) and Worsening (MCID-W) between mTKA and rTKA patients. METHODS: Patients who underwent primary TKA (874 mTKA, 439 rTKA) with complete pre-operative and one-year post-operative PROMs were retrospectively identified using a multi-hospital joint arthroplasty registry. Patient-Reported Outcomes Measurement Information System Physical Function Short Form 10a (PROMIS PF-10a), PROMIS Global - Physical, or Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) were collected. The MCID-I, MCID-W, and "no significant change" rates were calculated using distribution-based methods. Propensity-score matching was performed to control for confounding. RESULTS: Similar 90-day pulmonary embolism (P = 0.26), deep venous thrombosis (P = 0.67), and emergency department visit (P = 0.35) rates were found. The 90-day readmission rate for mTKA was 1.7 and 3.4% for rTKA (P = 0.08), and overall revision rates were 2.2% for mTKA and 0.7% for rTKA (P = 0.07). Revision-free survival was 99% at one and two years for both groups (P = 0.65 and P = 0.43, respectively). There were no differences in the proportion of patients achieving MCID-I or MCID-W for PROMIS PF-10a, PROMIS Global - Physical, or KOOS-PS. The MCID-I for PROMIS PF-10a was achieved in 65.5 and 62.2% of patients who had mTKA and rTKA, respectively (P = 0.32). CONCLUSION: Our study demonstrated similar complication rates, and MCID-I and MCID-W attainment rates between mTKA and rTKA patients. Future studies should assess MCID attainment rates in the long term and in larger cohorts, comparing mTKA and rTKA.

High Variability in Standardized Outcome Thresholds of Clinically Important Changes in Shoulder Instability Surgery: A Systematic Review.

PURPOSE: The purpose of this study was to examine reported MCID and PASS values for PROMs following shoulder instability surgery and assess variability in published values depending on the surgery performed. Secondarily, our aims were to describe the methods used to derive MCID and PASS values in the published literature, including anchor-based, distribution-based, or other approaches, and to assess the frequency of MCID and PASS usage in studies on shoulder instability surgery. METHODS: A systematic review of MCID and PASS values following Bankart, Latarjet, and Remplissage procedures was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). The Embase, Pubmed, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were queried from 1985 to 2023. Inclusion criteria included studies written in English, and studies reporting utilization MCID or PASS for patient reported outcome measures (PROMS) following Latarjet, Bankart, Remplissage approaches for shoulder instability surgery. Extracted data included study population characteristics, intervention characteristics, and outcomes of interest. Continuous data were described using median and range. Categorical variables, including PROMs reported and MCID/PASS methods, were described using percentages. As MCID is a patient-level metric and not a group-level metric, the authors validated that all included studies reported proportions (%) of subjects that met or exceeded the MCID. RESULTS: A total of 174 records were screened, and 8 studies were included in this review. MCID was the most widely utilized outcome threshold which was reported in all 8 studies, with only 2 studies reporting both the MCID and the PASS. The most widely studied PROMs were the American Shoulder and Elbow Surgeons (ASES) (range 5.65-9.6 for distribution MCID, 8.5 anchor MCID, 86 anchor PASS); Single Assessment Numeric Evaluation (SANE) (range 11.4-12.4 distribution MCID, 82.5-87.5 anchor PASS); visual analog scale (VAS) (range 1.1-1.7 distribution MCID, 1.5-2.5 PASS); Western Ontario Shoulder Instability Index (WOSI) (range 60.7-254.9 distribution MCID, 126.43 anchor MCID, 571-619.5 anchor PASS); and Rowe scores (range 5.6-8.4 distribution MCID, 9.7 anchor MCID). Notably, no studies reported on substantial clinical benefit (SCB) or maximal outcome improvement (MOI). CONCLUSION: Despite the wide array of available PROMs for assessing shoulder instability surgery outcomes, the availability of clinically significant outcome thresholds such as MCID and PASS remains relatively limited. While MCID has been the most frequently reported metric, there is considerable inter-study variability observed in their values. CLINICAL RELEVANCE: Knowing the outcome thresholds such as MCID and PASS of the PROMs frequently used to evaluate the results of glenohumeral stabilization surgery is fundamental, since they allow us to know what is a clinically significant improvement for the patient.

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.

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.

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.

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.

No Clinical Advantage of Harvesting a Patellar Bone Block Compared to All Soft Tissue Graft in Primary Quadriceps Tendon Anterior Cruciate Ligament Reconstruction.

PURPOSE: To compare patient-reported outcomes measurements (PROMs) and subsequent surgical interventions in patients treated with anterior cruciate ligament reconstruction (ACLR) using either quadriceps tendon autograft with a patellar bone block (bQT) or soft tissue only (sQT). METHODS: All ACLRs performed between 01.2010 and 03.2022 were prospectively followed for 24 months and retrospectively evaluated. All primary ACLRs with full 24 months of follow-up data, without any previous surgery or any additional ligamentous interventions, were matched for major ACL risk factors, including gender, age, Tegner activity level (TAL), pivoting sports, and concomitant injuries. PROMs (Lysholm score, Visual Analog Scale (VAS) for pain, and TAL) and subsequent surgical interventions were registered after 6, 12, and 24 months postoperative. Binary logistic regression was used to assess the influence of graft type, age, preinjury TAL, gender, pivoting sports and concomitant interventions on the need to undergo subsequent surgery. RESULTS: After matching, 246 patients were included in the final analysis. Both groups did not differ regarding any preoperative patient demographics or intraoperative details. At final follow-up, no significant difference in mean Lysholm score (sQT: 90.8±10.6, bQT: 91.8±10.6, p= .46), median TAL (sQT: 6 [1-10], bQT: 6 [1-10], p= .53) and VAS for pain (sQT: 0.7±1.1, bQT: 0.7±1.2, p= .70) was reported between both groups. 70.3% (sQT-A: 70.7%, bQT: 69.9%, p= .89) of patients returned to or exceeded their preinjury activity level. In terms of revision ACLR, there was no statistically significant difference between bQT (3.3%) and sQT (4.1%). Similarly, no difference was observed in contralateral ACLR (bQT: 7.3% sQT: 11.4%). Regression analysis indicated that none of the studied factors, including the use of a patellar bone block, influenced subsequent surgery, revision ACLR, or contralateral ACLR. CONCLUSION: Harvesting an additional patellar bone block in quadriceps tendon ACL reconstruction does not seem to impact postoperative patient-reported outcomes, ACL revision- or contralateral ACL reconstruction rates. LEVEL OF EVIDENCE: Level 3 - Cohort Study.

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.

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.

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.

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.

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.

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.