Minimal clinically important difference in Alzheimer's disease: Rapid review.

INTRODUCTION: We conducted a rapid systematic review of minimal clinically important differences (MCIDs) for Alzheimer's disease (AD) trial endpoints. METHODS: Two reviewers searched EMBASE, MEDLINE, and PubMed from inception to June 4, 2023. RESULTS: Ten articles were retrieved. For mild cognitive impairment (MCI), a change of +2 to +3 points on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), +1 points on the Clinical Dementia Rating scale sum of boxes (CDR-SB), -5 points on the integrated Alzheimer's Disease Rating Scale (iADRS), or -1 to -2 points on the Mini-Mental State Examination (MMSE) was considered meaningful. For patients with mild AD, a change of +3 on the ADAS-Cog, +2 points on CDR-SB, -9 points on the iADRS, or -2 points on the MMSE was considered meaningful. For patients with moderate to severe AD, a change of +2 points on the CDR-SB or a change of -1.4 to -3 points on the MMSE was considered meaningful. CONCLUSION: This review identified previously published MCIDs for AD trial endpoints. Input from patients and caregivers will be needed to derive more meaningful endpoints and thresholds. HIGHLIGHTS: This systematic rapid review identified thresholds for minimal clinically important differences (MCIDs) for recently used Alzheimer's disease (AD) trial endpoints: Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), Clinical Dementia Rating scale sum of boxes (CDR-SB), integrated Alzheimer's Disease Rating Scale (iADRS), Mini-Mental State Examination (MMSE). MCIDs were higher for more severe stages of AD. Average treatment effects in recent trials of anti-amyloid disease modifying monoclonal antibodies are lower than previously published MCIDs. In future trials of disease modifying treatments for AD, the proportion of participants in each treatment group that experienced a clinically meaningful decline could be reported. More work is needed to incorporate the values and preferences of patients and care partners in deriving MCIDs.

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.

Clinical Significance Thresholds in Primary and Revision Latarjet Procedures With Comparable Outcome Achievements.

BACKGROUND: Given the variability across populations and settings, defining the MCID and the PASS for the Rowe and ASOSS scores and patients undergoing primary and revision Latarjet it is essential to have accurate benchmarks relevant to these groups when interpreting clinical results. PURPOSE: To determine the minimal clinically important difference (MCID) and Patient Acceptable Symptom State (PASS) thresholds for the visual analog scale (VAS) for pain during sports, Athletic Shoulder Outcome Scoring System (ASOSS), and Rowe scores after primary and revision Latarjet procedures for treatment of shoulder instability. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 3. METHODS: Between January 2018 and January 2020, a retrospective review of 149 patients undergoing primary Latarjet (n = 82) and revision Latarjet (n = 67) to treat shoulder instability was performed in a single institution. Patient-reported outcome measures were collected preoperatively and 1 year postoperatively. The delta was defined as the change between the pre- and postoperative scores. Distribution-based and anchored-based approaches were used to estimate the MCID and the PASS, respectively. The optimal cutoff point and the percentage of patients achieving those thresholds were also calculated. RESULTS: The distribution-based MCIDs after primary Latarjet were 1.1, 7.5, and 9.6 for the VAS, Rowe, and ASOSS scores, respectively. The rates of patients who achieved the MCID thresholds were 93.9%, 98.7%, and 100% for the VAS, Rowe, and ASOSS scores, respectively. The PASS thresholds after primary Latarjet were ≤1, ≥90, and ≥85 for the VAS, Rowe, and ASOSS scores, respectively. The percentages of patients who achieved PASS thresholds were 82.9%, 89%, and 86.5% for the VAS, Rowe, and ASOSS scores, respectively. The distribution-based MCIDs after revision Latarjet were 0.6, 6.2, and 3.4 for the VAS, Rowe, and ASOSS scores, respectively. The rates of patients who achieved MCID thresholds were 89.3%, 100%, and 100% for the VAS, Rowe, and ASOSS scores, respectively. The PASS thresholds were ≤3, ≥87, and ≥86 after revision Latarjet for the VAS, Rowe, and ASOSS scores, respectively. The rates of patients who achieved the PASS thresholds were 88%, 88%, and 91% for the VAS, Rowe, and ASOSS, respectively. CONCLUSION: This study identified useful values for the MCID and PASS thresholds in VAS, Rowe, and ASOSS scores after primary and revision Latarjet procedures for treating shoulder instability. Most patients achieved MCID and PASS benchmarks, indicating successful primary and revision Latarjet procedure outcomes. These metrics can serve as valuable parameters when analyzing parameters in future studies and have the potential to enhance patient care by optimizing treatment strategies and surgical decision making.

The Best Exercise Modality and Dose for Reducing Pain in Adults With Low Back Pain: A Systematic Review With Model-Based Bayesian Network Meta-analysis.

OBJECTIVE: To quantify the dose-response relationship between overall and specific exercise modalities and pain, in patients with nonspecific chronic low back pain (LBP). DESIGN: Systematic review with Bayesian network meta-analysis. LITERATURE SEARCH: We searched the Medline, Embase, Web of Science, Cochrane Library, Scopus, and SPORTDiscus databases from inception to June 2023. STUDY SELECTION CRITERIA: We included randomized controlled trials of exercise interventions in adults with nonspecific chronic LBP and at least 1 pain outcome reported at the main trial end point. DATA SYNTHESIS: A random-effects network meta-analysis was conducted. We assessed risk of bias using the Cochrane Risk of Bias Tool 2.0, and used the GRADE approach to judge the certainty of evidence for each outcome. RESULTS: Eighty-two trials were included (n = 5033 participants). We found a nonlinear dose-response relationship between total exercise and pain in patients with nonspecific chronic LBP. The maximum significant response was observed at 920 MET minutes (standardized mean difference = -1.74; 95% credible intervals: -2.43, -1.04). The minimal clinically important difference for achieving meaningful pain improvement was 520 MET minutes per week. The dose to achieve minimal clinically important difference varied by type of exercise; Pilates was the most effective. The certainty of the evidence was very low to moderate for all outcomes. CONCLUSION: The dose-response relationship of different exercise modalities to improve pain in patients with nonspecific chronic LBP had a U-shaped trajectory and low- to moderate-certainty evidence. The clinical effect was most pronounced with Pilates exercise. J Orthop Sports Phys Ther 2024;54(5):1-13. Epub 8 March 2024. doi:10.2519/jospt.2024.12153.

Effect of age and gender in rates of achieving minimal clinically important difference and patient-acceptable symptom state 2 years after arthroscopic superior capsular reconstruction.

PURPOSE: This study aimed to evaluate patient-reported outcome measures (PROMs) and the effects of gender and age on achieving clinically significant outcomes in patients undergoing arthroscopic superior capsular reconstruction (ASCR) with a minimum 2-year follow-up. METHODS: Patients undergoing ASCR for irreparable rotator cuff tear between 2013 and 2020 were reviewed. Preoperative and minimum 2-year postoperative PROMs were collected, including American Shoulder and Elbow Surgeons (ASES), Constant, single assessment numeric evaluation (SANE), and visual analog scale (VAS) scores. Minimal clinically important difference (MCID) and patient-acceptable symptomatic state (PASS) were calculated for each functional score and analyzed according to age and gender. The percentages of patients achieving MCID and PASS were recorded. RESULTS: The study included 83 patients, with a mean follow-up of 3.5 ± 1.4 years. Significant improvements were found in ASES, Constant, SANE, and VAS for all groups based on gender and age. Based on receiver-operating characteristic curves, all scores had acceptable areas under the curve for PASS. Values for PASS and MCID were 81.5 and 10.3 for ASES; 61.5 and 6.2 for Constant; 82.5 and 11.5 for SANE and 1.5 and 1.1 for VAS, respectively. Analysis of achieving MCID and PASS showed no difference between the groups in the majority of outcome measures. However, female patients achieved the SANE thresholds for PASS at significantly higher rates than male patients. Patients ≥65 years old achieved ASES and Constant thresholds for MCID at significantly higher rates than patients ˂65 years old. CONCLUSION: Most patients achieved MCID and PASS at a 2-year follow-up. Patients showed comparable rates of MCID and PASS achievement on most outcome tools based on age and gender. Female patients achieved PASS on SANE at significantly higher rates than male patients and older patients achieved MCID on ASES and Constant at higher rates than young patients. Thus, age is a stronger factor for achieving MCID than gender. LEVEL OF EVIDENCE: Level II.

Physical function and activity of patients after open abdominal surgery: a prospective cohort study comparing the clinimetric properties of two outcome measures.

OBJECTIVES: To measure and compare the clinimetric properties of the Chelsea Critical Care Physical Assessment (CPAx) and Physical Function in Intensive Care Test-scored (PFIT-s) for assessment of physical function and activity. DESIGN: Prospective cohort design using crossover-randomisation of the sequence in which participants were assessed with CPAx and PFIT-s. SETTING: Surgical and transplant intensive care units (ICU) in an academic hospital. PARTICIPANTS: Adults who underwent elective open abdominal surgery. Consecutive sampling was used to enrol 69 participants. INTERVENTIONS: Physical function and activity were assessed on ICU days one, three, five and at ICU discharge using the CPAx and PFIT-s in random order. MAIN OUTCOME MEASURES: Responsiveness to change, minimal clinically important difference (MCID), floor and ceiling effect, and convergent validity. RESULTS: CPAx demonstrated a large responsiveness (effect size index (ESI)= 0.83) and PFIT-s moderate responsiveness (ESI=0.73) to change in scores. MCID for CPAx was 2.1 (standard error of measurement (SEM) 1.1) and for PFIT-s 0.6 (SEM=0.3). CPAx had no floor effect and a small ceiling effect (9%, n = 6) at ICU discharge compared to 2% (n = 1) floor and 48% (n = 32) ceiling effects of PFIT-s. Moderate convergent validity was found for both tools at ICU admission (n = 67, r = 0.62, p < 0.001) and discharge (n = 67, r = 0.51, p < 0.001). CONCLUSION: CPAx is most responsive to changes in physical function and activity scores, has no floor and limited ceiling effects and moderate convergent validity, and is recommended for similar cohorts. CONTRIBUTION OF THE PAPER.

Anchor-based minimal important difference values are often sensitive to the distribution of the change score.

PURPOSE: Anchor-based studies are today the most popular approach to determine a minimal important difference value for an outcome variable. However, a variety of construction methods for such values do exist. This constitutes a challenge to the field. In order to distinguish between more or less adequate construction methods, meaningful minimal requirements can be helpful. For example, minimal important difference values should not reflect the intervention(s) the patients are exposed to in the study used for construction, as they should later allow to compare interventions. This requires that they are not sensitive to the distribution of the change score observed. This study aims at investigating to which degree established construction methods fulfil this minimal requirement. METHODS: Six constructions methods were considered, covering very popular and recently suggested methods. The sensitivity of MID values to the distribution of the change score was investigated in a simulation study for these six construction methods. RESULTS: Five out of six construction methods turned out to yield MID values which are sensitive to the distribution of the change score to a degree that questions their usefulness. Insensitivity can be obtained by using construction methods based solely on an estimate of the conditional distribution of the anchor variable given the change score. CONCLUSION: In future the computation of MID values should be based on construction methods avoiding sensitivity to the distribution of the change score.

Minimal clinically important differenceof fatigue severity scale in patients with chronic stroke.

BACKGROUND: One of the most prevalent symptoms of stroke is fatigue. Fatigue severity scale is the most often used tool for evaluating fatigue in stroke patients, its minimal clinically important difference threshold has not been determined. This study aimed to identify the minimal clinically important difference of fatigue severity scale in stroke patients. METHODS: All study participants were examined using fatigue severity scale and multidimensional fatigue symptom inventory-short form before and after the intervention. The 6-week intervention combined graded activity training and pacing therapy employed to reduce fatigue severity. Participants reported changes in their fatigue severity after the intervention with the global rating of change and visual analog scale. The minimal clinically important difference of the fatigue severity scale calculated using both anchor- and distribution-based methods. RESULTS: A total of 117 stroke patients were included in the study. Using multidimensional fatigue symptom inventory-short form, global rating of change, and visual analog scale as an anchor, the minimal clinically important difference of fatigue severity scale was obtained at 3.5, 4.5, and 4.5, respectively. The minimal clinically important difference for fatigue severity scale varied from 4.28 to 12.90 using the distribution-based method, with SEM = 4.28 displaying the best sensitivity and specificity for use as minimal clinically important difference. CONCLUSIONS: The minimal clinically important difference value for the fatigue severity scale was estimated at 3.5_12.90 using anchor-based and distribution-based methods. The study's results can be utilized to understand the effectiveness of fatigue interventions in stroke patients in clinical and research settings.

Minimal clinically important difference in maxillofacial trauma patients: a prospective cohort study.

The present study estimated the minimal clinically important difference (MCID) for pain on a visual analogue scale - numerical rating scale (VAS-NRS) and mean bite force (MBF) in patients treated for maxillofacial trauma (MFT). This cohort study included 120 MFT patients treated according to AO principles. Preoperative and four-week postoperative pain on the VAS-NRS, and MBF were measured to calculate MCIDs as indicators of functional rehabilitation. The patient's perspective of the treatment was assessed using a four-item anchor question. The MCID was determined by two anchor-based approaches, namely, the change difference (CD) method and receiver operating characteristic (ROC) curve method. According to the CD method, the MCID for pain was 2.4 and the MBF was 147.9 N. Based on the ROC curve, the MCID for pain was 2.5 (sensitivity 91.7%, specificity 47.2%) and MBF was 159.1 N (sensitivity 71.4%, specificity 61.1%). This study demonstrated a high sensitivity (>70%) for MCID, which implies that pain reduction of 2.4-2.5 points on the VAS-NRS and a gain in MBF of 147.9-159.1N are clinically relevant for patients treated for MFT.

Pooled Minimal Clinically Important Differences of the Mini-Balance Evaluation Systems Test in Patients With Early Subacute Stroke: A Multicenter Prospective Observational Study.

OBJECTIVE: Balance problems are common in patients with stroke, and the Mini-Balance Evaluation Systems Test (Mini-BESTest) is a reliable and valid assessment tool for measuring balance function. Determining the minimal clinically important difference (MCID) is crucial for assessing treatment effectiveness. This study aimed to determine the MCID of the Mini-BESTest in patients with early subacute stroke. METHODS: In this prospective multicenter study, 53 patients with early subacute stroke undergoing rehabilitation in inpatient units were included. The mean age of the patients was 72.6 (SD = 12.2) years. The Mini-BESTest, which consists of 14 items assessing various aspects of balance function, including anticipatory postural adjustments, postural responses, sensory orientation, and dynamic gait, was used as the assessment tool. The global rating of change (GRC) scales completed by the participants and physical therapists were used as external anchors to calculate the MCID. The GRC scale measured subjective improvement in balance function, ranging from -3 (very significantly worse) to +3 (very significantly better), with a GRC score of ≥+2 considered as meaningful improvement. Four methods were used to calculate the MCID: mean of participants with GRC of 2, receiver operating characteristic-based method, predictive modeling method, and adjustment of the predictive modeling method based on the rate of improvement. From the MCID values obtained using these methods, a single pooled MCID value was calculated. RESULTS: The MCID values for the Mini-BESTest obtained through the 4 methods ranged from 3.2 to 4.5 points when using the physical therapist's GRC score as the anchor but could not be calculated using the participant's GRC score. The pooled MCID value for the Mini-BESTest was 3.8 (95% CI = 2.9-5.0). CONCLUSIONS: The Mini-BESTest MCID obtained in this study is valuable for identifying improvements in balance function among patients with early subacute stroke. IMPACT: Determination of the MCID is valuable for evaluating treatment effectiveness. The study findings provide clinicians with practical values that can assist in interpreting Mini-BESTest results and assessing treatment effectiveness.

Estimating the minimal clinically important difference of shoulder functional scores after arthroscopic rotator cuff repair: a prospective study.

INTRODUCTION: The minimal clinically important difference (MCID) is a valuable tool for patient-based outcome analysis, for which limited data is available in the literature, especially after arthroscopic rotator cuff repair (ARCR). Although several studies have reported MCID after ARCR, few have studied the impact of various clinical factors such as Diabetes, pseudoparalysis, type of cuff repair, and retear over MCID. This study attempts to determine the MCID in shoulder functional scores after ARCR and the impact of various factors on MCID. METHODS: 144 patients undergoing ARCR were prospectively evaluated at six and 12 months by ASES and UCLA scores. MCID for American Shoulder and Elbow Surgeons (ASES) and the University of California and Los Angeles (UCLA) scores were calculated using an anchor-based and distribution-based approach. MCID was also calculated for diabetic and non-diabetic patients, smokers vs. non-smokers, presence or absence of pseudoparalysis, type of cuff repair (single row vs. suture bridge), and presence of retears. Uni- and multivariate analysis was performed to identify factors affecting the MCID of both scores. RESULTS: Mean MCID for ASES score was 13.3 and 16.6 using an anchor-based and distribution-based approach, respectively. For the UCLA score, the mean MCID was 10.0 and 12.6 by anchor-based and 12.6 by distribution-based approach, respectively. Patients with higher pre-operative ASES scores demonstrated lower MCID values. No significant difference was observed in MCID scores of diabetic vs. non-diabetic patients, smoker vs. non-smoker, patients with or without pseudoparalysis, and type of cuff repair. The age, gender, and presence of retear did not affect MCID values. CONCLUSION: This study establishes the MCID values of ASES and UCLA scores for rotator cuff repair by anchor and distribution methods. No patient or surgical factors appear to affect the MCID except pre-operative ASES scores. STUDY DESIGN: Prospective cohort, Level II.

Diagnosis-Specific Thresholds of the Minimal Clinically Important Difference and Patient Acceptable Symptom State for KOOS After Total Knee Arthroplasty.

UPDATE: This article was updated on May 1, 2024 because of a previous error, which was discovered after the preliminary version of the article was posted online. The byline that had read "Ahmed K. Emara, MD 1 *, Ignacio Pasqualini, MD 1 *, Alison K. Klika, MS 1 , Melissa N. Orr, BS 1 , Pedro J. Rullán, MD 1 , Nicolas S. Piuzzi, MD 1 , and the Cleveland Clinic Arthroplasty Group†" now reads "Ahmed K. Emara, MD 1 *, Ignacio Pasqualini, MD 1 *, Yuxuan Jin, MS 1 , Alison K. Klika, MS 1 , Melissa N. Orr, BS 1 , Pedro J. Rullán, MD 1 , Nicolas S. Piuzzi, MD 1 , and the Cleveland Clinic Arthroplasty Group†". BACKGROUND: Literature-reported minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds for patient-reported outcome measures demonstrate marked variability. The purpose of this study was to determine the minimal detectable change (MDC), MCID, and PASS thresholds for the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subdomain, Physical Function Short Form (PS), and Joint Replacement (JR) among patients with osteoarthritis (OA) who underwent primary total knee arthroplasty (TKA). METHODS: A prospective cohort of 6,778 patients who underwent primary TKA was analyzed. Overall, 1-year follow-up was completed by 5,316 patients for the KOOS Pain, 5,018 patients for the KOOS PS, and 4,033 patients for the KOOS JR. A total of 5,186 patients had an OA diagnosis; this group had an average age of 67.0 years and was 59.9% female and 80.4% White. Diagnosis-specific MDCs and MCIDs were estimated with use of a distribution-based approach. PASS values were estimated with use of an anchor-based approach, which corresponded to a response to a satisfaction question at 1 year postoperatively. RESULTS: The MCID thresholds for the OA group were 7.9 for the KOOS Pain, 8.0 for the KOOS PS, and 6.7 for the KOOS JR. A high percentage of patients achieved the MCID threshold for each outcome measure (KOOS Pain, 95%; KOOS PS, 88%; and KOOS JR, 94%). The MDC 80% to 95% confidence intervals ranged from 9.1 to 14.0 for the KOOS Pain, 9.2 to 14.1 for the KOOS PS, and 7.7 to 11.8 for the KOOS JR. The PASS thresholds for the OA group were 77.7 for the KOOS Pain (achieved by 73% of patients), 70.3 for the KOOS PS (achieved by 68% of patients), and 70.7 for the KOOS JR (achieved by 70% of patients). CONCLUSIONS: The present study provided useful MCID, MDC, and PASS thresholds for the KOOS Pain, PS, and JR for patients with OA. The diagnosis-specific metrics established herein can serve as benchmarks for clinically meaningful postoperative improvement. Future research and quality assessments should utilize these OA-specific thresholds when evaluating outcomes following TKA. Doing so will enable more accurate determinations of operative success and improvements in patient-centered care. LEVEL OF EVIDENCE: Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence.

Predictors of achieving minimal clinically important difference in functional status for elderly patients with degenerative lumbar spinal stenosis undergoing lumbar decompression and fusion surgery.

OBJECTIVE: To identify the predictors for the achievement of minimal clinically important difference (MCID) in functional status among elderly patients with degenerative lumbar spinal stenosis (DLSS) undergoing lumbar decompression and fusion surgery. METHODS: Patients who underwent lumbar surgery for DLSS and had a minimum of 1-year follow-up were included. The MCID achievement threshold for the Oswestry Disability Index (ODI) was set at 12.8. General patient information and the morphology of lumbar paraspinal muscles were evaluated using comparative analysis to identify influencing factors. Multiple regression models were employed to identify predictors associated with MCID achievement. A receiver operating characteristic (ROC) curve analysis was conducted to determine the optimal cut-off values for predicting functional recovery. RESULTS: A total of 126 patients (46 males, 80 females; mean age 73.0 ± 5.9 years) were included. The overall rate of MCID achievement was 74.6%. Patients who achieved MCID had significantly higher psoas major muscle attenuation (43.55 vs. 39.23, p < 0.001) and preoperative ODI (51.5 vs. 41.6, p < 0.001). Logistic regression showed that elevated psoas major muscle attenuation (p = 0.001) and high preoperative ODI scores (p = 0.001) were independent MCID predictors. The optimal cut-off values for predicting MCID achievement were found to be 40.46 Hounsfield Units for psoas major muscle attenuation and 48.14% for preoperative ODI. CONCLUSION: Preoperative psoas major muscle attenuation and preoperative ODI were reliable predictors of achieving MCID in geriatric patients undergoing lumbar decompression and fusion surgery. These findings offer valuable insights for predicting surgical outcomes and guiding clinical decision-making in elderly patients.

Minimal clinically important difference in the World Health Organization Quality of Life Brief (WHOQOL-BREF) for adults with neurofibromatosis.

PURPOSE: This study aimed to estimate minimal clinically important difference (MCID) values for the World Health Organization Quality of Life Brief version (WHOQOL-BREF) among adults with neurofibromatosis (NF). An MCID is needed to demonstrate clinical meaningfulness of interventions for NF. METHODS: We estimated MCID for the WHOQOL-BREF: the quality of life (QoL) measure recommended by the Response Evaluation in Neurofibromatosis and Schwannomatosis International Collaboration. We used data from 228 clinical trial participants with NF type 1, NF type 2-related schwannomatosis, or schwannomatosis (SCHWN) who completed 10 weeks of a virtual group mind-body program targeting resiliency or a time- and attention-matched control. Following established guidelines, we estimated MCIDs using both anchor-based and distribution-based methods for physical, psychological, social relationships, and environmental domains of the WHOQOL-BREF. RESULTS: MCID results varied across method and QoL domain. Three anchor-based methods, average change (AC), change difference (CD), and regression (REG), yielded the most consistent and comparable MCID across QoL domains. Based on these methods, we recommend ranges for each QoL domain: Physical QoL (3.9-7.3), Psychological QoL (4.7-8.1), Social QoL (2.6-5.9), and Environmental QoL (4.1-6.6). CONCLUSION: Establishing a rigorous MCID for QoL in NF is a critical step toward evaluating meaningful change in response to psychosocial interventions.

The MCID of the PROMIS physical function instrument for operatively treated tibial plateau fractures.

INTRODUCTION: Understanding minimal clinically important differences (MCID) in patient reported outcome measurement are important in improving patient care. The purpose of this study was to determine the MCID of Patient-Reported Outcome Measurement System (PROMIS) Physical Function (PF) domain for patients who underwent operative fixation of a tibial plateau fracture. METHODS: All patients with tibial plateau fractures that underwent operative fixation at a single level 1 trauma center were identified by Current Procedural Terminology codes. Patients without PROMIS PF scores or an anchor question at two-time points postoperatively were excluded. Anchor-based and distribution-based MCIDs were calculated. RESULTS: The MCID for PROMIS PF scores was 4.85 in the distribution-based method and 3.93 (SD 14.01) in the anchor-based method. There was significantly more improvement in the score from the first postoperative score (<7 weeks) to the second postoperative time (<78 weeks) in the improvement group 10.95 (SD 9.95) compared to the no improvement group 7.02 (SD 9.87) in the anchor-based method (P < 0.001). The percentage of patients achieving MCID at 7 weeks, 3 months, 6 months, and 1 year were 37-42 %, 57-62 %, 80-84 %, and 95-87 %, respectively. DISCUSSION: This study identified MCID values for PROMIS PF scores in the tibial plateau fracture population. Both MCID scores were similar, resulting in a reliable value for future studies and clinical decision-making. An MCID of 3.93 to 4.85 can be used as a clinical and investigative standard for patients with operative tibial plateau fractures.

Editorial Commentary: Utility of Patient-Reported Outcome Threshold Scores to Estimate Patient Satisfaction: 'Let's Ask the Patient!'

The reporting and analysis of patient-reported outcome measures have come a long way. Since the concept of the minimally clinically important difference was first introduced in 1989, threshold scores have grown to include substantial clinical benefit and patient acceptable symptomatic state (PASS). The initial motivation for developing these thresholds was rooted in separating clinical significance from statistical. These thresholds provide insight into the relationship between scores on patient-reported outcome measures (PROM) and patient-reported improvement and satisfaction. It follows that in order to evaluate PROM scores, the best method for deriving the threshold typically uses an anchor-based methodology, i.e., "ask the patient." Specifically, patients are asked how much change they've experienced and whether they consider their current state to be satisfactory. The responses to these questions are compared with the scores on PROMs to find outcome thresholds that best separate patients who reported no improvement from those who reported minimal improvement, substantial improvement, and satisfaction with their current state of health (PASS). The PASS is of particular importance as it speaks to what arguably matters most to patients-a satisfactory state of health. Finally, viewing the PASS from the perspective of variation from study to study rather than as a uniform classifier is needed to make use of the growing number of papers reporting these thresholds. Examining differences in PASS values across papers can provide insight into how well PROM scores reflect patient satisfaction in different settings.

Mental Health Effects on the Minimal Clinically Important Difference in Total Joint Arthroplasty.

INTRODUCTION: The effect of mental health on patient-reported outcome measures is not fully understood in total joint arthroplasty (TJA). Thus, we investigated the relationship between mental health diagnoses (MHDs) and the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W) in primary TJA and revision TJA (rTJA). METHODS: Retrospective data were collected using relevant Current Procedural Terminology and MHDs International Classification of Diseases, 10th Revision, codes with completed Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form, Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form, Patient-reported Outcomes Measurement Information System (PROMIS)-Physical Function Short Form 10a, PROMIS Global-Mental, or PROMIS Global-Physical questionnaires. Logistic regressions and statistical analyses were used to determine the effect of a MHD on MCID-I/MCID-W rates. RESULTS: Data included 4,562 patients (4,190 primary TJAs/372 rTJAs). In primary total hip arthroplasty (pTHA), MHD-affected outcomes for Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (MCID-I: 81% versus 86%, P = 0.007; MCID-W: 6.0% versus 3.2%, P = 0.008), Physical Function Short Form 10a (MCID-I: 68% versus 77%, P < 0.001), PROMIS Global-Mental (MCID-I: 38% versus 44%, P = 0.009), and PROMIS Global-Physical (MCID-I: 61% versus 73%, P < 0.001; MCID-W: 14% versus 7.9%, P < 0.001) versus pTHA patients without MHD. A MHD led to lower rates of MCID-I for PROMIS Global-Physical (MCID-I: 56% versus 63%, P = 0.003) in primary total knee arthroplasty patients. No effects from a MHD were observed in rTJA patients. DISCUSSION: The presence of a MHD had a prominent negative influence on pTHA patients. Patients who underwent rTJA had lower MCID-I rates, higher MCID-W rates, and lower patient-reported outcome measure scores despite less influence from a MHD. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Editorial Commentary: The Minimal Clinically Important Difference Is Less Important Than It Sounds: Patients Seek to Achieve Substantial Clinical Benefits and Not Minimally Perceptible Improvements When They Undergo Arthroscopic Surgery.

The minimal clinically important difference (MCID) is a frequently reported metric for describing within-patient improvement in patient-reported outcome measures (PROMs). It was originally defined by Jaeschke et al. as "the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient's management." The latter part of this statement is often omitted, and this results in a loss of the originally intended value through lack of sufficient clinical importance to change management. Other pitfalls in the use of the MCID include that they are population- and condition-specific. As such, MCIDs lack external validity and cannot easily be extrapolated from one study to another. Furthermore, broadly different values can be obtained depending on the calculation method used. This makes the MCID an unhelpful metric when seeking to understand the true efficacy of a given intervention. The Food and Drug Administration recommends anchor-based methodologies (which take into account patient perception), over distribution-based methods (which are purely statistical and do not account for clinical meaningfulness to patients). Regardless, it should be noted that even anchor-based methodologies are susceptible to statistical bias, and measures are apt to be influenced by the regression to mean phenomena, where the value of the preintervention scores and their relationship to postintervention scores can bias estimates of the MCID. Finally, when using MCIDs, one must consider that they are a low bar. This means that patients do not undergo treatment to achieve minimally perceptible clinical improvements; instead, they undergo treatment with the hope of achieving substantial clinical benefit or a patient acceptable symptom state, and so these are more appropriate individual-level metrics to consider when evaluating clinically meaningful outcomes of treatment.

Editorial Commentary: Artificial Intelligence Analysis of Biomedical, Large, Clinical Registry Data Using Machine Learning Requires Tens of Thousands of Subjects and a Focus on Substantial Clinical Benefit: Minimal Clinically Important Difference Is too Low a Bar.

As the field of arthroscopic hip preservation surgery grows, large high-quality registries represent a foundational study design for establishing whether hip arthroscopy is effective for patients with femoroacetabular impingement syndrome (FAIS). Original research publications from experienced high-volume surgeons tell us "Can it work". A registry tells us "Does it work?". The ability of preservation to truly preserve the joint, delay the arthritis process, and reduce the risk of arthroplasty requires long-term follow-up. A geographic registry can follow this. The registry represents the "real world", a heterogeneous set of variables pertaining to the doctor, patient, intervention, and outcome. The vast array of factors that can be analyzed before, during, and after surgery makes machine learning an ideal technique for analysis of large quantities of data. A global hip preservation surgery registry is a desirable and achievable goal. In order to optimally predict outcome of hip arthroscopy, given the known large number of patient- and hip-specific factors that influence outcomes, a deep learning model with tens of thousands of subjects for this medium-scale task would be needed. Measures of clinical relevance need to include more than just MCID (minimal clinically important difference), which is the lowest bar minimal threshold. Patient expectations often far exceed MCID-requiring other metrics like SCB (substantial clinical benefit), PASS (patient acceptable symptom state), and MOI (maximal outcome improvement). Registries should include validated, reliable, and responsive patient-reported outcome scores (e.g., International Hip Outcome Tool [iHOT-12]) with measures of clinical relevance and expectations assessed routinely. The United Kingdom's NAHR (Non-Arthroplasty Hip Registry) and Denmark's DHAR (Danish Hip Arthroscopy Registry) are the two largest geography-based registries in current hip preservation research both with 11 years of patient enrollment.