Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

BACKGROUND: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). METHODS: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. RESULTS: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. CONCLUSIONS: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Establishing how much improvement in lung function and distance walked is clinically important for adult patients with Pompe disease.

BACKGROUND AND PURPOSE: Pompe disease is a rare, inheritable, progressive metabolic myopathy. This study aimed to estimate the minimal clinically important difference (MCID) for an improvement in forced vital capacity in the upright seated position (FVCup) and the 6-min walk test (6MWT) after a year of treatment with enzyme replacement therapy. METHODS: Data were obtained from two prospective follow-up studies. Between-group and within-group MCIDs were estimated using anchor-based methods. Additionally, a distribution-based method was used to generate supportive evidence. As anchors, self-reported change in health and in physical functioning, shortness of breath and a categorization of the Short-Form 36 Physical Component Summary score were used. Anchor appropriateness was assessed using Spearman correlations (absolute values ≥0.29) and a sufficient number of observations in each category. RESULTS: In all, 102 patients had at least one FVCup or 6MWT measurement during enzyme replacement therapy. Based on the anchors assessed as appropriate, the between-group MCID for an improvement in FVCup ranged from 2.47% to 4.83% points. For the 6MWT, it ranged from 0.35% to 7.47% points which is equivalent to a distance of 2.18-46.61 m and 1.97-42.13 m for, respectively, a man and a woman of age 50, height 1.75 m and weight 80 kg. The results of the distribution-based method were within these ranges when applied to change in the outcome values. CONCLUSION: The MCIDs for FVCup and 6MWT derived in this study can be used to interpret differences between and within groups of patients with Pompe disease in clinical trials and cohort studies.

The minimal important difference of patient-reported outcome measures related to female urinary incontinence: a systematic review.

BACKGROUND: The minimal important difference is a valuable metric in ascertaining the clinical relevance of a treatment, offering valuable guidance in patient management. There is a lack of available evidence concerning this metric in the context of outcomes related to female urinary incontinence, which might negatively impact clinical decision-making. OBJECTIVES: To summarize the minimal important difference of patient-reported outcome measures associated with urinary incontinence, calculated according to both distribution- and anchor-based methods. METHODS: This is a systematic review conducted according to the PRISMA guidelines. The search strategy including the main terms for urinary incontinence and minimal important difference were used in five different databases (Medline, Embase, CINAHL, Web of Science, and Scopus) in 09 June 2021 and were updated in January 09, 2024 with no limits for date, language or publication status. Studies that provided minimal important difference (distribution- or anchor-based methods) for patient-reported outcome measures related to female urinary incontinence outcomes were included. The study selection and data extraction were performed independently by two different researchers. Only studies that reported the minimal important difference according to anchor-based methods were assessed by credibility and certainty of the evidence. When possible, absolute minimal important differences were calculated for each study separately according to the mean change of the group of participants that slightly improved. RESULTS: Twelve studies were included. Thirteen questionnaires with their respective minimal important differences reported according to distribution (effect size, standard error of measurement, standardized response mean) and anchor-based methods were found. Most of the measures for anchor methods did not consider the smallest difference identified by the participants to calculate the minimal important difference. All reports related to anchor-based methods presented low credibility and very low certainty of the evidence. We pooled 20 different estimates of minimal important differences using data from primary studies, considering different anchors and questionnaires. CONCLUSIONS: There is a high variability around the minimal important difference related to patient-reported outcome measures for urinary incontinence outcomes according to the method of analysis, questionnaires, and anchors used, however, the credibility and certainty of the evidence to support these is still limited.

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.

Minimal clinically important differences in health-related quality of life after treatment with direct-acting antivirals for chronic hepatitis C: ANRS CO22 HEPATHER cohort (PROQOL-HCV).

PURPOSE: Patient Reported Outcomes Quality of Life survey for HCV (PROQOL-HCV) is a specific tool developed to assess health-related quality of life (HRQoL) in patients with chronic hepatitis C receiving direct-acting antivirals (DAA). Thresholds for clinically meaningful changes in PROQOL-HCV scores should be documented to improve the tool's use in clinical practice. This study aimed to estimate the minimal clinically important differences (MCIDs) in PROQOL-HCV scores before and after HCV cure by DAA among participants in the prospective cohort ANRS-CO22 HEPATHER. METHODS: Data from 460 chronic HCV patients were collected at DAA initiation (baseline) and 24 weeks after treatment end. MCIDs were estimated for the six HRQoL dimensions (Physical Health (PH), Emotional Health (EH), Future Uncertainty (FU), Intimate Relationships (IR), Social Health (SH), and Cognitive Functioning (CF)) using two approaches: anchor-based and score distribution-based. Each MCID was estimated for improvement/deterioration both globally and separately for patients with a baseline PRQoL-HCV score ≤ 50 (group1) and patients with a baseline PRQoL-HCV score > 50 (group2). RESULTS: The pooled MCIDs for improvement/deterioration globally, in group1, and in group2, respectively, were as follows: 8.8/- 7.6, 9.7/- 9.5, and 6.0/- 6.9 for PH; 7.1/- 4.6, 7.7/- 9.6, and 6.6/- 6.7 for EH; 6.7/- 6.7, 8.2/- 8.2, and 6.0/- 6.0 for FU; 7.0/- 7.0, 5.4/- 5.4, and 6.2/- 6.2 for IR; 7.7/- 7.7, 8.6/- 8.6, and 6.5/- 6.5 for SH; 7.3/- 5.6, 9.1/- 8.0, and 6.5/- 6.3 for CF. CONCLUSIONS: The overall MCID for the PROQOL-HCV scores ranged from 6.7 to 8.8 for improvement and from - 7.7 to - 4.6 for deterioration. The effect of DAA on PROQOL-HCV scores seemed particularly beneficial for patients with lower baseline scores. This subgroup could be motivated to take DAA if they are informed of the benefits for their HRQoL.

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

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

Clinical importance in Alzheimer's disease: effects of anchor agreement and disease severity.

OBJECTIVES: Methods of evaluating clinically meaningful decline are critical in research on Alzheimer's disease. A common method of quantifying clinically meaningful change is to calculate an anchor-based minimal clinically important difference (MCID) score. In this approach, individuals who report a meaningful change serve as the "anchors", and the mean level of change for this group serves as the MCID. In research on Alzheimer's disease, there are several possible anchors, including patients, knowledgeable observers (e.g., a family member), and clinicians. The goal of this study was to examine the extent to which agreement among anchors impacts MCID estimation and whether this relationship is moderated by cognitive severity status. METHODS: Analyses were completed on a longitudinal sample of 2247 adults, aged 50-103, from the Uniform Data Set. Outcome measures included the Montreal Cognitive Assessment, Clinical Dementia Rating-Sum of Boxes, and Functional Activities Questionnaire. RESULTS: For all of the outcomes, the MCID estimate was significantly higher when meaningful decline was endorsed by all of the anchors compared to when there was disagreement among the anchors. In addition, the MCID estimate was higher with increasing severity of cognitive impairment. Finally, cognitive severity status moderated the influence of agreement among anchors on MCID estimation; as disease severity increased, anchor agreement demonstrated less influence on the MCID. CONCLUSIONS: MCID estimates based on one anchor may underestimate meaningful change, and researchers should consider the viewpoints of multiple anchors in constructing MCIDs, particularly in the early stages of cognitive decline.

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.

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.

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.

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.

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.

Preoperative patient factors that predict achieving the minimal clinically important difference following arthroscopic treatment of snapping scapula syndrome.

BACKGROUND: The aim of this study was to define the minimal clinically important difference (MCID) values for patient-reported outcomes (PROs) after arthroscopic treatment of snapping scapula syndrome (SSS) using a distribution-based method, and to identify demographic, clinical, and intraoperative factors significantly associated with the achievement of MCID. It was hypothesized that subjective satisfaction scores after the procedure would be strongly associated with the achievement of MCID thresholds for the PROs and that pain, preoperative response to injection, and a scapulectomy in addition to bursal resection would be predictive of clinically relevant improvement. METHODS: Patients who underwent arthroscopic treatment of SSS between October 2005 and September 2020 with a minimum of 2-year short-term postoperative follow-up were enrolled in this retrospective single-center study. The MCID was calculated using a distribution-based approach for the following PROs: 12-Item Short Form Health Survey (SF-12), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH), Single Assessment Numeric Evaluation (SANE), and visual analog scale (VAS) pain "today" and "at worst." The association between achievement of the MCID and postoperative subjective satisfaction was investigated, and factors associated with achievement of MCID were determined using bivariate analysis. RESULTS: Of a total of 190 patients assessed for eligibility, 77 patients (38.1 ± 14.3 years; 36 females) were included. Within the study population, statistically significant improvements in postoperative SF-12 physical component summary (PCS) (P < .001) and mental component summary (MCS) (P < 0.034), ASES (P < .001), QuickDASH (P < .001), SANE (P < .001), and VAS pain (P < .001) scores were observed at the minimum 2-year follow-up. The calculated MCID threshold values based on the study population were 5.0 for SF-12 PCS, 5.8 for SF-12 MCS, 11.3 for ASES, -10.5 for QuickDASH, 14.7 for SANE, 1.5 for VAS pain, and 1.7 for VAS pain at worst. Reaching the MCID was strongly associated with postoperative satisfaction (rated on a scale of 1-10). Across the PROs, younger age, favorable preoperative response to injection, partial scapuloplasty or scapulectomy, no prior surgery, and pain and function at baseline were significantly associated with attaining MCID. CONCLUSIONS: Patients who underwent arthroscopic treatment for SSS experienced clinically significant improvements in functional scores, pain, and quality of life. This study demonstrated predictive roles for certain patient-specific factors and diagnostic variables for achieving MCID in PROs, which may help surgeons preoperatively assess the probability of success and manage patient expectations.

Minimal Important Clinical Difference Values Are Not Uniformly Valid in the Active Duty Military Population Recovering from Shoulder Surgery.

BACKGROUND: There are multiple methods for calculating the minimal clinically important difference (MCID) threshold, and previous reports highlight heterogeneity and limitations of anchor-based and distribution-based analyses. The Warfighter Readiness Survey assesses the perception of a military population's fitness to deploy and may be used as a functional index in anchor-based MCID calculations. The purpose of the current study in a physically demanding population undergoing shoulder surgery was to compare the yields of two different anchor-based methods of calculating MCID for a battery of PROMs, a standard receiver operator curve (ROC) -based MCIDs and baseline-adjusted ROC MCIDs. METHODS: All service members enrolled prospectively in a multicenter database with prior shoulder surgery that completed pre- and postoperative PROMs at a minimum of 12 months were included. The PROMs battery included Single Assessment Numeric Evaluation (SANE), American Shoulder and Elbow Surgeons score (ASES), Patient Reported Outcome Management Information System (PROMIS) Physical Function (PF), PROMIS Pain Interference (PI), and the Warfighter Readiness survey. Standard anchor-based and baseline-adjusted ROC MCIDs were employed to determine if the calculated MCIDs were both statistically and theoretically valid (95% confidence interval either completely negative or positive). RESULTS: There were 117 patients (136 operations) identified, comprised of 83% males with a mean age of 35.7 ± 10.4 years and 47% arthroscopic labral repair/capsulorrhaphy. Using the standard, anchor-based ROC MCID calculation, the area under the curve (AUC) for SANE, ASES, PROMIS PF, and PROMIS PI were greater than 0.5 (statistically valid). For ASES, PROMIS PF, and PROMIS PI, the calculated MCID 95% CI all crossed 0 (theoretically invalid). Using the baseline-adjusted ROC MCID calculation, the MCID estimates for SANE, ASES, and PROMIS PI were both statistically and theoretically valid if the baseline score was less than 70.5, 69, and 65.7. CONCLUSION: When MCIDs were calculated and anchored to the results of standard, anchor-based MCID, a standard ROC analysis did not yield statistically or theoretically valid results across a battery of PROMs commonly used to assess outcomes after shoulder surgery in the active duty military population. Conversely, a baseline-adjusted ROC method was more effective at discerning changes across a battery of PROMs among the same cohort.

What Are the Diagnosis-Specific Thresholds of Minimal Clinically Important Difference and Patient Acceptable Symptom State in Hip Disability and Osteoarthritis Outcome Score After Primary Total Hip Arthroplasty?

BACKGROUND: This study aimed to determine the minimal clinically important difference (MCID) and Patient Acceptable Symptom State (PASS) thresholds for Hip Disability and Osteoarthritis Outcome Score (HOOS) pain, physical short form (PS), and joint replacement (JR) 1 year after primary total hip arthroplasty stratified by preoperative diagnosis of osteoarthritis (OA) versus non-OA. METHODS: A prospective institutional cohort of 5,887 patients who underwent primary total hip arthroplasty (January 2016 to December 2018) was included. There were 4,184 patients (77.0%) who completed a one-year follow-up. Demographics, comorbidities, and baseline and one-year HOOS pain, PS, and JR scores were recorded. Patients were stratified by preoperative diagnosis: OA or non-OA. Minimal detectable change (MDC) and MCIDs were estimated using a distribution-based approach. The PASS values were estimated using an anchor-based approach, which corresponded to a response to a satisfaction question at one year post surgery. RESULTS: The MCID thresholds were slightly higher in the non-OA cohort versus OA patients. (HOOS-Pain: OA: 8.35 versus non-OA: 8.85 points; HOOS-PS: OA: 9.47 versus non-OA: 9.90 points; and HOOS-JR: OA: 7.76 versus non-OA: 8.46 points). Similarly, all MDC thresholds were consistently higher in the non-OA cohort compared to OA patients. The OA cohort exhibited similar or higher PASS thresholds compared to the non-OA cohort for HOOS-Pain (OA: ≥80.6 versus non-OA: ≥77.5 points), HOOS-PS (OA: ≥83.6 versus non-OA: ≥83.6 points), and HOOS-JR (OA: ≥76.8 versus non-OA: ≥73.5 points). A similar percentage of patients achieved MCID and PASS thresholds regardless of preoperative diagnosis. CONCLUSIONS: While MCID and MDC thresholds for all HOOS subdomains were slightly higher among non-OA than OA patients, PASS thresholds for HOOS pain and JR were slightly higher in the OA group. The absolute magnitude of the difference in these thresholds may not be sufficient to cause major clinical differences. However, these subtle differences may have a significant impact when used as indicators of operative success in a population setting.

Mental Robustness May Be Associated With Improved Physical Function in Bilateral Total Knee Arthroplasty Patients.

BACKGROUND: In accordance with the high incidence of bilateral knee osteoarthritis, many patients have undergone bilateral total knee arthroplasty (BTKA). Whether patients undergo bilateral procedures in a staged or simultaneous fashion, the physical and mental burden of undergoing 2 major orthopedic procedures is considerable. The aims of this study were to (1) investigate differences between minimal clinically important difference (MCID) achievement between staged versus simultaneous BTKA, and (2) identify the patient variables, specifically mental scores, that were associated with MCID achievement in patients undergoing BTKA. METHODS: Simultaneous and staged BTKA patients within a single health care network from 2016 to 2021 were retrospectively reviewed. Patient demographics, surgery details, and Patient-Reported Outcome Measurement Information System Physical Function Short Forms 10a (PROMIS PF10a), PROMIS Mental scores, and Knee Disability Osteoarthritis Outcome Scores (KOOS) were reviewed. Preoperative and postoperative patient-reported outcome measures were collected before the first total knee arthroplasty (TKA) and after the second TKA, respectively, in staged BTKA patients. The final cohort consisted of 249 patients, with an average age of 66 years (range, 21 to 87), 63% women, and an average body mass index of 32 (range, 20 to 52), at a mean follow-up of 1.1 years (range, 0.5 to 2.4). Multivariate regressions were performed on MCID PF10a and KOOS achievement, as well as whether the BTKA was performed simultaneously versus staged. RESULTS: A preoperative PROMIS Mental score in the upper 2 quartiles was associated with MCID PF10a achievement in BTKA. Men and surgeries performed at an Academic Medical Center were negatively associated with the achievement of MCID KOOS. Interestingly, those who underwent simultaneous BTKA were less likely to achieve MCID KOOS than those who underwent a staged BTKA. CONCLUSIONS: Preoperative mental robustness may be positively associated with improved physical function outcome in BTKA patients.

Does Your Patient Need to Lose Weight? Weight Change Before and After Total Hip Arthroplasty Does Not Affect Health Care Utilization and Achievement of the Minimal Clinically Important Difference.

BACKGROUND: Despite the potential negative impact of preoperative obesity on total hip arthroplasty (THA) outcomes, the association between preoperative and postoperative weight change and outcomes is much less understood. Therefore, this study aimed to determine the impact of preoperative and postoperative weight change and preoperative body mass index (BMI) on health care utilization, satisfaction, and achievement of minimal clinically important difference (MCID) for Hip Disability and Osteoarthritis Outcome Score Physical Function Short-Form (HOOS PS) and HOOS Pain. METHODS: Patients who underwent primary elective unilateral THA between January 2016 and December 2019 were included (N = 2,868). Multivariable logistic regression assessed the association between BMI and preoperative and postoperative weight change on outcomes while controlling for demographic characteristics. RESULTS: There was no association between preoperative weight change and prolonged length of stay (> 3 days), 90-day readmission, nonhome discharge, patient dissatisfaction at 1 year, or achievement of HOOS Pain or HOOS PS MCID. Postoperative weight loss was an independent risk factor for patient dissatisfaction at 1 year but was not associated with achievement of either HOOS Pain or HOOS PS MCID at 1-year postoperative. Preoperative obesity classes I to III were independent risk factors for nonhome discharge. Nevertheless, preoperative obesity class I and class II were associated with an increased probability of reaching HOOS Pain MCID. Preoperative BMI was not associated with an increased risk of patient dissatisfaction. CONCLUSIONS: Preoperative weight change does not appear to influence health care utilization, satisfaction, or achievement of MCID in pain and function following THA. Postoperative weight loss may play a role as a risk factor for dissatisfaction following THA. Additionally, patients who had a higher baseline BMI may be more likely to see improvement in pain following THA. Therefore, when counseling obese patients for THA, surgeons must balance the risk of perioperative complications with the expectation of greater improvements in pain.

Despite Greater Improvement in Pain and Function Among Obese Patients Shortly After Total Knee Arthroplasty, There is No Difference in Patient-Reported Outcomes and Satisfaction Between Body Mass Index Classes at 1 Year Postoperatively.

BACKGROUND: Although obesity may be associated with an increased risk of perioperative and postoperative complications after total knee arthroplasty (TKA), body mass index (BMI) cutoffs for TKA patient selection remain a controversial topic. This study aimed to investigate patient-reported outcomes, satisfaction, and pain among BMI classes at 3 months and 1 year following TKA. METHODS: A total of 2,365 patients were categorized into Centers for Disease Control BMI classes according to preoperative values. The BMI distribution over the cohort demonstrated 7 underweight, 340 healthy weight, 731 overweight, 666 Class I, 391 Class II, and 230 Class III obesity. Preoperative and postoperative Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), satisfaction, and pain scores were compared by BMI class by Analysis of Variance with pairwise comparisons. RESULTS: Preoperative KOOS JR scores and satisfaction scores were both significantly greater for healthy weight patients compared to Class III patients (P < .0001). However, KOOS JR, satisfaction, and pain did not vary by BMI class postoperatively. Changes in scores from baseline suggest larger improvements with increasing BMI class, where Class III patients reported the greatest improvements in KOOS JR (23.24 ± 15.67, P < .0001) and pain scores (-3.56 ± 2.65, P < .0001) at 90 days. Significantly greater improvement with increasing BMI was also present at 1-year postoperatively for KOOS JR scores. A total of 85.8% of Class III patients reached the Minimal Clinically Important Difference for KOOS JR at 90 days compared to 76.8% of the healthy weight group (P = .03). Differences between BMI groups in the proportion reaching Minimal Clinically Important Difference at 1 year were not significant. CONCLUSIONS: Patients of higher BMI reported greater and earlier improvements in satisfaction, knee function, and pain following TKA. Shared decision-making remains paramount to preoperative surgical evaluation. However, rationing of this surgical intervention based on BMI alone may not be warranted.

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.

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.