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.

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.

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.

Estimation of minimal clinically important difference for 6-minute walking distance in patients with acute stroke using anchor-based methods and credibility instruments.

BACKGROUND AND PURPOSE: Stroke impairs a patient's ability to walk. In patients with acute stroke, a 6-min walking distance (6MWD) is recommended to assess walking function. Minimal clinically important difference (MCID) is used to determine the effectiveness of rehabilitation; however, the MCID for 6MWD has not been adequately validated. This study aimed to estimate the MCID of 6MWD, a measure of walking endurance, in patients with acute stroke using anchor-based methods. METHODS: Based on the change in 6MWD from baseline to the follow-up measurement 2 weeks later, the MCID was estimated using anchor-based methods (receiver operator operating characteristic curves, predictive and adjustment models) with a patient- and therapist-rated global rating of change scale (p-GRC, t-GRC) as external anchors. The accuracy of "meaningful change" was estimated from the area under the curve. Using MCID's credibility instruments, the credibility of each anchor was evaluated. Using the credibility instrument, high credibility was defined as satisfying 3/5 of the Core criteria and 6/9 of all criteria. RESULTS: The analysis included 58 patients. The MCID for each anchor was 78.7-100.0 m for p-GRC, and 95.2-99.5 m for t-GRC. The p-GRC demonstrated excellent accuracy (area under the curve >0.8). With p-GRC as anchors, over 50% of patients showed improvement. The p-GRC satisfied the core criterion of 3/5 and all criteria of 6/9 on the reliability instrument. The t-GRC demonstrated low reliability and satisfied the core criterion of 2/5 and all criteria of 3/9. DISCUSSION: Since the percentage of improved groups exceeded 50%, the adjusted model was useful in the anchor-based method. Therapists may not accurately capture patient fatigue and subjective symptoms, potentially affecting the correlation between the 6MWD change score and the t-GRC and, consequently, the reliability instrument. The p-GRC showed high accuracy and reliability; therefore, the MCID was estimated to be 78.7 m.

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.

Minimal and robust clinically important differences for patient-reported outcome measures of fatigue in chronic stroke survivors after fatigue rehabilitation.

PURPOSE: The minimal and robust clinically important difference (MCID and/or RCID) are essential in assessing the clinical significance of multidimensional fatigue inventory-20 and checklist of individual strength-fatigue subscale questionnaires changes scores. This is the first study to determine the MCID and RCID of these questionnaires in chronic stroke survivors. MATERIALS AND METHODS: A total of 125 participants in an observational cohort study completed MFI-20 and CIS-fs before and after receiving multidisciplinary rehabilitation (cognitive behavioral therapy, graded exercise and adaptive pacing therapy). Anchor-based MCIDs and RCIDs were calculated using the mean change, the mean difference and the receiver operating characteristics methods. To evaluate the accordance between of distribution-based MCIDs (1 SD, ½ SD, SEM, 1.96 SEM and MDC values) with anchored values, the accuracy, sensitivity, specificity and Youden's index were calculated. RESULTS: The anchored MCIDs were between -5 to -7.33 for MFI-20 and -4.87 to -5.40 for CIS-fs. The anchored RCIDs ranged from -5 to -13.88 and -6 to -9.88 for MFI-20 and CIS-fs, respectively. The values of ½ SD and SEM for CIS-fs were consistent with anchored RCIDs. CONCLUSIONS: The estimated MCIDs and RCIDs of MFI-20 and CIS-fs can help researchers and clinicians interpret their chronic stroke patient data.

The Multidimensional Fatigue Inventory-20 (MFI-20) And Checklist Individual Strength-20 (CIS-20) Measures Are Two Important And Valid Instruments For Measuring Fatigue In Patients With Chronic Stroke.The Identified Minimal Clinically Important Differences (MCID) And Robust Clinically Important Difference In The Current Study Can Assist Clinicians In The Clinical Interpretation Of Fatigue Changes Observed In MFI-20 And CIS-20 Scores.The MCID Obtained In This Study Can Be Useful In Determining The Proportion Of Patients Who Benefit From Fatigue Treatment In Stroke Rehabilitation.

The Functioning Assessment Short Test (FAST): Clinically meaningful response threshold in patients with major depressive disorder receiving antidepressant treatment.

BACKGROUND: Functional impairment is common in patients with major depressive disorder (MDD). The Functioning Assessment Short Test (FAST) provides a detailed clinician-rated assessment of functioning across multiple aspects of daily life. This study aimed to establish clinically relevant response thresholds for the FAST in patients with MDD receiving antidepressant treatment. METHODS: Data were derived from three 8-week clinical trials of antidepressant therapy in patients with MDD that included assessment of functioning using the FAST as a pre-specified endpoint. The minimal clinically important difference (MCID) and threshold for response in terms of change in FAST total score were determined using anchor-based methods. RESULTS: After 8 weeks of antidepressant treatment, the mean reduction in FAST total score in patients considered clinically minimally improved (Clinical Global Impression-Improvement [CGI-I] score of 3) was 7-9 points (~20 % reduction). The threshold for functional response (reduction in FAST total score from baseline in patients with a CGI-I score of ≤2 at week 8) was 16-19 points (~50 % reduction). The threshold for functional response was higher in patients with MDD and comorbid generalized anxiety disorder than in those with MDD alone (mean reduction in FAST total score at 8 weeks: 26 points [63 %]). LIMITATIONS: Short-term studies. CONCLUSIONS: These results provide further validation of the FAST for assessing functioning in patients with MDD. In patients with MDD, the suggested MCID for FAST total score is 7-9 points and the proposed threshold for response is a reduction from baseline of approximately 50 %.

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.

Optimal dose and type of non-pharmacological treatments to improve cognitive function in people with Alzheimer's disease: a systematic review and network meta-analysis.

OBJECTIVES: To evaluate and rank the effectiveness of specific non-pharmacological treatments (NPTs) in improving the global cognitive function in individuals with Alzheimer's disease (AD) and to examine the dose-response relationship. METHOD: We conducted a systematic search in PubMed, MEDLINE, Embase, PsycINFO, CENTRAL, WOS, and CNKI from their inception to 15 February 2023. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for outcomes using random effects models. RESULTS: We included 68 studies involving 5053 participants in this meta-analysis. The treatments with the highest cumulative probabilities for improving global cognitive function were transcranial direct current stimulation (tDCS), followed by physical exercise (PE), and repetitive transcranial magnetic stimulation (rTMS). Additionally, cognitive stimulation (CS), cognitive training CT), multidisciplinary program (MD), and reminiscence treatment (RT) also significantly improve the global cognitive function of people with AD. A non-linear dose-response association was observed for tDCS, PE, rTMS, CS, and CT with global cognitive improvement. Notably, no minimal threshold was identified for the beneficial effects of PE on cognition. The estimated minimal doses for clinically relevant changes in cognition were 33 min per week for tDCS, 330 MET-min per week for PE, and 8000 pulses per week for rTMS. CONCLUSION: tDCS, PE, and rTMS are the better effective NPTs for enhancing global cognitive function in individuals with AD. Properly dosing these treatments can yield significant clinical benefits. Our findings support the clinical utility of low-dose exercise in improving cognition in people with AD.

Establishing minimal clinically important differences and patient acceptable symptom state thresholds following birmingham hip resurfacing.

INTRODUCTION: Birmingham Hip Resurfacing (BHR) has emerged as a compelling and innovative alternative to total hip arthroplasty (THA), especially among young, active patients. However, the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptom State (PASS) thresholds have not yet been determined for patients undergoing BHR. Therefore, the current study aimed to (1) determine the MCID and PASS thresholds for both the Hip disability and Osteoarthritis Outcome Score (HOOS)-Pain and HOOS physical function shortform (PS), for patients who underwent BHR; and (2) identify factors influencing the achievement of MCID and PASS for HOOS-Pain and HOOS-PS. METHODS: Prospectively collected data from patients undergoing BHR was analyzed. Patients with osteoarthritis and completed preoperative and 1-year postoperative PROMs were included. Distribution-based and anchored-based approaches were used to estimate MCID and PASS, respectively. The optimal cut-off point for PASS thresholds was calculated using the Youden index. RESULTS: MCID for HOOS-Pain and PS were calculated to be 9.2 and 9.3, respectively. The PASS threshold for HOOS-Pain and PS were ≥ 77.7 and ≥ 87.3, respectively. The current study identified several factors affecting postoperative achievement of thresholds. Baseline Mental Component Summary (MCS) scores were a predictor for achieving MCID for postoperative HOOS-Pain, achieving MCID for postoperative HOOS-PS, achieving PASS for postoperative HOOS-Pain, and achieving PASS for postoperative HOOS-PS. Furthermore, baseline HOOS-Pain was a significant predictor for achieving MCID for postoperative HOOS-PS, achieving PASS for postoperative HOOS-Pain, and achieving PASS for postoperative HOOS-PS. CONCLUSIONS: MCID and PASS thresholds were established for HOOS-Pain and PS domains following BHR with most patients achieving these clinically meaningful benchmarks. Additionally, several factors affecting achievement of MCID and PASS were identified, including modifiable risk factors that may allow clinicians to implement optimization strategies and further improve outcomes.

Alternatives to the P value: connotations of significance.

The statistical significance of a clinical trial analysis result is determined by a mathematical calculation and probability based on null hypothesis significance testing. However, statistical significance does not always align with meaningful clinical effects; thus, assigning clinical relevance to statistical significance is unreasonable. A statistical result incorporating a clinically meaningful difference is a better approach to present statistical significance. Thus, the minimal clinically important difference (MCID), which requires integrating minimum clinically relevant changes from the early stages of research design, has been introduced. As a follow-up to the previous statistical round article on P values, confidence intervals, and effect sizes, in this article, we present hands-on examples of MCID and various effect sizes and discuss the terms statistical significance and clinical relevance, including cautions regarding their use.

Immediate Effects, Detailed Clinical Outcomes, and Prognostic Factors of Chemonucleolysis Using Condoliase for Lumbar Disc Herniation.

Chemonucleolysis utilizing condoliase is a minimally invasive treatment for lumbar disc herniation (LDH) aimed at reducing intervertebral disc pressure and enhancing symptoms. In this study, lower limb pain was measured using the numeric rating scale (NRS) the day after treatment and 1 and 3 months after treatment. Prognostic factors were assessed, categorizing participants into an improvement group (I-group) for NRS lower limb pain scores of ≥3.5 and a non-improvement group (N-group) for scores of <3.5. This study included a total of 225 patients treated between April 2020 and March 2023. The mean age was 46.5 ± 16.5 years, with 151 males. The mean duration of illness was 6.2 ± 8.52 months. As of the day after treatment, 60 cases were classified into the I-group, 118 cases at 1 month after surgery, and 152 cases at 3 months after surgery. The disease duration before treatment was significantly shorter in the I-group at 1 (8.19 ± 8.74 [I-group] vs. 5.17 ± 8.04 [N-group] months) and 3 months (8.51 [I-group] ± 7.35 vs. 5.69 ± 8.87[N-group] months) after treatment. The comparison of baseline leg pain NRS shows a difference in leg pain NRS in the I-group when compared on the day after treatment (6.02 ± 2.64 [I-group] vs. 7.50 ± 1.79 [N-group]), 1 (5.13 ± 2.69 [I-group] vs. 7.58 ± 1.66 [N-group]), and 3 months (4.42 ± 2.70 [I-group] vs. 7.34 ± 1.77 [N-group]). Chemonucleolysis using condoliase for LDH can improve symptoms the day after treatment and can be a minimally invasive treatment to avoid surgery.

Minimum clinically important difference and substantial clinical benefit in patients with chronic temporomandibular disorders.

BACKGROUND: Research on temporomandibular disorder (TMD) responsiveness is scarce and limited regarding patients' representativeness. OBJECTIVE(S): This study aimed to estimate minimum clinically important difference (MCID) and substantial clinical benefit (SCB) among a large and diverse patient population regarding sex and age. METHODS: In this study, 162 patients participated from five hospitals. MCID and SCB in pain, functional disability and quality of life were examined with anchor-based methods. Patients' global impression of change was used as the anchor. Area under the curve (AUC) values were determined for testing accuracy. Changes from baseline and coefficient of variation by responsiveness status were calculated to explain the results of accuracy. RESULTS: SCB was estimated to be 2.18 for the numeric rating scale (NRS) for pain (AUC: 0.80 [95% CI: 0.72-0.88]) in all patients and 2.50 in women (AUC: 0.81 [95% CI: 0.71-0.89]). The estimated SCB of NRS for discomfort (1.50) and Jaw Functional Limitation Scale for mastication (1.35) had wide CIs for AUCs. Likewise, the estimated MCIDs of NRS for pain (0.80) and NRS for discomfort (1.50) had wide CIs for AUCs. Among non-responders who did not achieve the MCID of NRS for pain, the coefficient of variation was very high for all outcomes other than the NRS for pain. CONCLUSION: This study investigated the responsiveness of patients with TMD using a large and diverse patient sample. SCB in pain decrease can be used to assess the responsiveness of patients with TMD. Composite outcomes should be developed to estimate MCID.

Establishing minimal clinically important differences and cut-off values for the lower limb motricity index and trunk control test in older patients with acute stroke: a prospective cohort study.

OBJECTIVE: To establish the Minimal Clinically Important Differences (MCIDs) for lower limb strength measured by the Motricity Index (LLMI) and trunk function assessed by the Trunk Control Test (TCT) in the acute phase of stroke in older patients. Further, the study sought to determine the cutoff values predicting functional prognosis at discharge for both the LLMI and TCT. METHODS: This prospective cohort study was conducted for older patients (≥65 years) admitted for acute stroke, receiving guideline-based stroke care that includes early rehabilitation. The LLMI and TCT were measured within 7 days of admission and at discharge. The MCID was derived from receiving operating characteristic curves, based on a ≥ 1 point shift in the modified Rankin Scale (mRS) from admission to discharge. A good functional prognosis at discharge was defined as an mRS score of ≤ 3. RESULTS: A total of 201 older patients with acute stroke were included. The TCT achieved an MCID of 13 (area under the curve [AUC] = 0.704, 95% confidence interval [CI]: 0.633-0.775), whereas the LLMI lacked the precision to produce a significant MCID. The optimal cutoff points for predicting a good outcome were found to be an LLMI score of 65 (AUC = 0.770, 95% CI: 0.705-0.835) and a TCT score of 25 (AUC = 0.827, 95% CI: 0.768-0.887) upon admission. CONCLUSIONS: This study identified a valid MCID for the TCT, failed to do so for the LLMI, and established cutoff values for both the LLMI and TCT that can predict good outcomes in older patients with acute stroke.

Is the difference real, is the difference relevant: the minimal detectable and clinically important changes in the Montreal Cognitive Assessment.

Background and aims: The Montreal Cognitive Assessment (MoCA) is a widely used instrument for assessing cognitive function in stroke survivors. To interpret changes in MoCA scores accurately, it is crucial to consider the minimal detectable change (MDC) and minimal clinically important difference (MCID). The aim was to establish the MDC and MCID of the MoCA within 6 months after stroke. Methods: This cohort study analysed data from the EFFECTS trial. The MoCA was administered at baseline and at 6-month follow-up. The MDC was calculated as the upper limit of the 95 % confidence interval of the standard error of the MoCA mean. The MCID was determined using anchor-based and distribution methods. The visual analogue recovery scale of the Stroke Impact Scale (SIS [primary anchor]) and Euro Quality of Life-5 Dimensions index (EQ-5D [confirmatory anchor]) were used as anchors. The distribution-based method, the Cohen benchmark effect size was chosen. Results: In total, 1131 (mean age [SD], 71 [10.6] years) participants were included. The mean (SD) MoCA scores at admission and 6-month follow-up were 22 (5.2) and 25 (4.2), respectively. The MDC of the MoCA was 5.1 points. The anchor method yielded the MCIDs 2 and 1.6 points for SIS and EQ-5D, respectively. Using the distribution method, the MCID for the MoCA was 1 point. Conclusions: Even a small change in MoCA scores can be important for stroke survivors; however, larger differences are required to ensure that any difference in MoCA values is a true change and is not related to the inherent variation in the test. Due to small sample sizes, the results of the anchor analysis need to be interpreted with caution.

Surgical factors play a critical role in predicting functional outcomes using machine learning in robotic-assisted total knee arthroplasty.

PURPOSE: Predictive models help determine predictive factors necessary to improve functional outcomes after total knee arthroplasty (TKA). However, no study has assessed predictive models for functional outcomes after TKA based on the new concepts of personalised surgery and new technologies. This study aimed to develop and evaluate predictive modelling approaches to predict the achievement of minimal clinically important difference (MCID) in patient-reported outcome measures (PROMs) 1 year after TKA. METHODS: Four hundred thirty robotic-assisted TKAs were analysed in this retrospective study. The mean age was 67.9 ± 7.9 years; the mean body mass index (BMI) was 32.0 ± 6.8 kg/m2. The following PROMs were collected preoperatively and 1-year postoperatively: knee injury and osteoarthritis outcome score for joint replacement, Western Ontario and McMaster Universities osteoarthritis index (WOMAC) Function, WOMAC Pain. Demographic data, preoperative CT scan, implant size, implant position on the robotic system and characteristics of the joint replacement procedure were selected as predictive variables. Four machine learning algorithms were trained to predict the MCID status at 1-year post-TKA for each PROM survey. 'No MCID' was chosen as the target. Models were evaluated by class discrimination (F1-score) and area under the receiver operating characteristic curve (ROC-AUC). RESULTS: The best-performing model was ridge logistic regression for WOMAC Function (area under the curve [AUC] = 0.80, F1 = 0.48, sensitivity = 0.79, specificity = 0.62). Variables most strongly contributing to not achieving MCID status were preoperative PROMs, high BMI and femoral resection depth (posterior and distal), supporting functional positioning principles. Conversely, variables contributing to a positive outcome (achieving MCID) were medial/lateral alignment of the tibial component, whether the procedure was an outpatient surgery and whether the patient received managed Medicare insurance. CONCLUSION: The most predictive variables included preoperative PROMs, BMI and surgical planning. The surgical predictive variables were valgus femoral alignment and femoral rotation, reflecting the benefits of personalised surgery. Including surgical variables in predictive models for functional outcomes after TKA should guide clinical and surgical decision-making for every patient. LEVEL OF EVIDENCE: Level III.

Measurement Error, Minimal Detectable Change, and Minimal Clinically Important Difference of the Short Form-36 Health Survey, Hospital Anxiety and Depression Scale, and Pain Numeric Rating Scale in Patients With Chronic Pain.

In both pain research and clinical practice, patient-reported outcome measures are used to assess dimensions of health. Interpreting these instruments requires understanding their measurement error and what magnitude of change has subjective importance for patients. This study estimated the standard error of measurement, 1-year minimal detectable change, and 1-year minimal clinically important difference (MCID) for the Short Form-36 Health Survey physical component summary and mental component summary, the Hospital Anxiety and Depression Scale subscales for anxiety symptoms and depression symptoms, and the numeric rating scale for past-week average pain intensity. MCIDs for these instruments have not previously been estimated in a large sample of chronic pain patients participating in interdisciplinary pain rehabilitation. Data were drawn from the Swedish Quality Registry for Pain Rehabilitation (n = 8,854 patients). MCID was estimated as average change and change difference based on 3 different anchors. MCID estimates were 2.62 to 4.69 for Short Form-36 Health Survey physical component summary, 4.46 to 6.79 for Short Form-36 Health Survey mental component summary, .895 to 1.48 for numeric rating scale, 1.17 to 2.13 for anxiety symptoms in the Hospital Anxiety and Depression Scale, and 1.48 to 2.54 for depression symptoms in the Hospital Anxiety and Depression Scale. The common assumption of an identical standard error of measurement for pre- and post-treatment measurements was not always applicable. When estimating MCID, researchers should select an estimation method and anchor aligned with the study's context and objectives. PERSPECTIVE: This article presents estimates of MCID and minimal detectable change for several commonly used patient-reported outcome measures among patients with chronic pain. These estimates can help clinicians and researchers to determine when a measured health improvement is subjectively important to the patient and greater than measurement error.

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.

Predictors of Sinonasal Improvement After Highly Effective Modulator Therapy in Adults with Cystic Fibrosis.

OBJECTIVES: The 22-question SinoNasal Outcome Test (SNOT-22) assesses chronic rhinosinusitis (CRS) severity. We aimed to identify predictors of SNOT-22 score improvement following highly effective modulator therapy (HEMT) initiation and to corroborate the SNOT-22 minimal clinically important difference (MCID) in adults with cystic fibrosis (CF). METHODS: Prospective observational data was pooled from four studies across 10 US centers investigating people with CF (PwCF) and CRS. Three studies evaluated HEMT's impact on CRS. For participants enrolled prior to HEMT initiation, SNOT-22 scores were obtained at baseline and after 3-6 months of HEMT. Multivariate regression identified predictors of improvement. Cronbach's alpha and four distribution-based methods were used to assess internal consistency and calculate the MCID of the SNOT-22. RESULTS: A total of 184 PwCF participated with mean baseline SNOT-22 scores ranging from 18.1 to 56.7. Cronbach's alpha was ≥0.90 across sites. Participants at sites with pre- and post-HEMT data reported improvement in SNOT-22 scores after initiating HEMT (all p < 0.05). Worse baseline SNOT-22 score (odds ratio (OR): 1.05, p < 0.001, 95% CI: 1.02-1.08), F508del homozygosity (OR: 4.30, p = 0.040, 95% CI: 1.14-18.99), and absence of prior modulator therapy (OR: 4.99, p = 0.017, 95% CI: 1.39-20.11) were associated with greater SNOT-22 improvement. The mean MCID calculated via distribution-based methods was 8.5. CONCLUSION: Worse baseline sinonasal symptoms, F508del homozygosity, and absence of prior modulator therapy predicted greater improvement after HEMT initiation. The mean MCID for SNOT-22 in PwCF is 8.5 points, similar to non-CF individuals with CRS, and provides a threshold specifically for PwCF. The SNOT-22 has strong internal consistency in PwCF. LEVEL OF EVIDENCE: 3 Laryngoscope, 134:3965-3973, 2024.