Minimal Important Difference Research Articles

Histopathologic degenerative score as a predictor of minimal clinically important difference in pain and functionality following surgical treatment for disc herniation.

Lumbar disc herniation (LDH) often results in significant pain and disability, and histopathologic evaluation of intervertebral discs offers critical insights into treatment outcomes. This prospective observational study explores histopathologic (HP) changes in intervertebral discs (IVD) and their association with clinical outcomes following surgical treatment for lumbar disc herniation (LDH). A cohort of 141 patients undergoing magnetic resonance imaging (MRI)-confirmed LDH surgery underwent HP evaluation using a semi-quantitative Histopathologic Degeneration Score (HDS). Preoperatively and at a six-month follow-up, comprehensive clinical assessment included the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS), with a minimal clinically important difference (MCID) calculated from ODI and VAS. Results indicated significant associations between higher HDS and adverse clinical outcomes, including persistent pain and greater disability post-surgery. Specifically, HDS ≥ 7 was predictive (OR = 6.25, 95%CI: 2.56-15.23) of disability outcomes measured with MCID-ODI (AUC: 0.692, 95%CI: 0.609-0.767, P < 0.001), and HDS ≥ 8 was predictive (OR = 1.72, 95%CI: 1.04-2.77) of persistent pain measured with MCID-VAS (AUC: 0.628, 95%CI: 0.598-0.737, P = 0.008), highlighting the diagnostic potential of HDS in assessing postoperative recovery. This study underscores the potential of HP evaluation using HDS to provide valuable insights into disease progression and outcomes in LDH patients, complementing conventional radiologic methods. The findings support the application of personalized treatment strategies based on HP findings while acknowledging challenges in interpretation and clinical implementation.

Scapula position test reliability and comparisons of scapula position and shoulder function among individuals with and without adolescent idiopathic scoliosis.

An evaluation of scapula position is important to predict spine curvature and shoulder function in patients with adolescent idiopathic scoliosis (AIS). Therefore, a reliable scapula position is required to assess posture in patients with AIS. This study investigated the reliabilities of scapula position tests and differences in scapula position and shoulder function between individuals with and without AIS. The study compared 18 patients with AIS and 18 healthy controls to identify differences in scapula position and shoulder function. The acromion-table distance, lateral displacement of the scapula, acromion depression, winged scapula, upward rotation of the scapula, and anterior tilt of the scapula were measured. Scapula position test reliabilities were assessed using the intraclass correlation coefficient (ICC), standard error of measurement (SEM), and minimum clinically important difference (MCID). Shoulder function was measured using the Shoulder Pain and Disability Index. The reliabilities of scapula position tests (ICC 0.85-0.93, SEM 0.1-1.2, and MCID 0.2-2.5) were good. There were significant differences in scapula position and shoulder function between patients with AIS and healthy controls (p< 0.05). Scapula position tests were highly reliable in patients with AIS; they can be used to evaluate scapula position during clinical assessment of posture in patients with AIS.

Systemic Immunomodulatory Treatments for Atopic Dermatitis

There are multiple approved systemic treatments for atopic dermatitis. Lebrikizumab is a newly licensed biologic medication that has been compared to placebo in clinical trials but not to other systemic treatments. To compare reported measures of efficacy and safety of lebrikizumab to other systemic treatments for atopic dermatitis in a living systematic review and network meta-analysis. The Cochrane Central Register of Controlled Trials, MEDLINE, Embase, the Latin American and Caribbean Health Science Information database, the Global Resource of Eczema Trials database, and trial registries were searched from inception through November 3, 2023. Randomized clinical trials evaluating 8 or more weeks of treatment with systemic immunomodulatory medications for moderate to severe atopic dermatitis. Titles, abstracts, and full texts were screened in duplicate. Data were abstracted in duplicate and random-effects bayesian network meta-analyses were performed. Minimal important differences were used to define important differences between medications. Certainty of evidence was assessed using the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation). The updated analysis was completed from December 13, 2023, to February 20, 2024. Efficacy outcomes were the Eczema Area and Severity Index (EASI), the Patient Oriented Eczema Measure (POEM) Dermatology Life Quality Index (DLQI), and Peak Pruritus Numeric Rating Scales (PP-NRS) and were compared using mean difference (MD) with 95% credible intervals (CrI). Safety outcomes were serious adverse events and withdrawal due to adverse events. Other outcomes included the proportion of participants with 50%, 75%, and 90% improvement in EASI (EASI-50, -75, -90) and the proportion with success on the Investigator Global Assessment compared using odds ratios with 95% CrI. The study sample included 97 eligible trials, with a total of 24 679 patients. Lebrikizumab was associated with no important difference in change in EASI (MD, -2.0; 95% CrI, -4.5 to 0.3; moderate certainty), POEM (MD, -1.1; 95% CrI -2.5 to 0.2; moderate certainty), DLQI (MD, -0.2; 95% CrI -2.1 to 1.6; moderate certainty), or PP-NRS (MD, 0.1; 95% CrI -0.4, 0.6; high certainty) compared to dupilumab among adults with atopic dermatitis who were treated for up to 16 weeks. Dupilumab was associated with higher odds of efficacy in binary outcomes compared with lebrikizumab. The relative efficacy of other approved systemic medications was similar to that found by previous updates of this living study, with high-dose upadacitinib and abrocitinib demonstrating numerically highest relative efficacy. For safety outcomes, low event rates limited useful comparisons. In this living systematic review and network meta-analysis, lebrikizumab was similarly effective to dupilumab for the short-term treatment of atopic dermatitis in adults. Clinicians and patients can use these comparative data to inform treatment decisions.

Social Vulnerability Index Provides Greater Granularity Compared With the Area Deprivation Index When Assessing Outcomes Following Elective Lumbar Fusion.

Retrospective review of a single institution cohort. To determine whether area deprivation index (ADI) or social vulnerability index (SVI) is more suitable for evaluating minimum clinically important difference (MCID) achievement following elective lumbar fusion as captured by the Patient-Reported Outcomes Measurement Information System (PROMIS). A total of 182 patients who underwent elective one-level to two-level posterior lumbar fusion between January 2015 and September 2021. ADI and SVI values were calculated from patient-supplied addresses. Patients were grouped into quartiles based on values; higher quartiles represented greater disadvantage. MCID thresholds for Pain Interference (PI) and Physical Function (PF) were determined through a distribution-based method. Multivariable logistic regression was performed to identify factors impacting MCID attainment. Univariate logistic regression was performed to determine which themes comprising SVI values affected MCID achievement. Statistical significance was set at P <0.05. Multivariable logistic regression demonstrated that ADI and SVI quartile assignment significantly impacted achievement of MCID for PI ( P =0.04 and 0.01, respectively) and PF ( P =0.03 and 0.02, respectively). Specifically, assignment to the third ADI and SVI quartiles were significant for PI (OR: 0.39 and 0.23, respectively), and PF (OR: 0.24 and 0.22, respectively). Race was not a significant predictor of MCID for either PI or PF. Univariate logistic regression demonstrated that among SVI themes, the socioeconomic status theme significantly affected achievement of MCID for PI ( P =0.01), while the housing type and transportation theme significantly affected achievement of MCID for PF ( P =0.01). ADI and SVI quartile assignment were predictors of MCID achievement. While ADI and SVI may both identify patients at risk for adverse outcomes following lumbar fusion, SVI offers greater granularity in terms of isolating themes of disadvantage impacting MCID achievement.

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

BackgroundFunctional 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. MethodsData 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. ResultsAfter 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 %]). LimitationsShort-term studies. ConclusionsThese 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 %.

Establishing minimal clinically important differences forthe Pemphigus Disease Area Index.

Pemphigus is a rare autoimmune blistering disease with potentially life-threatening consequences. Establishing minimal clinically important differences (MCIDs) for disease severity scores like the Pemphigus Disease Area Index (PDAI) is crucial for assessing treatment efficacy. To calculate MCIDs for both improvement and deterioration in PDAI scores in patients with pemphigus vulgaris (PV) and pemphigus foliaceus (PF), using the anchor-based method. A total of 41 patients with pemphigus were recruited, with 35 meeting the MCID analysis criteria. The anchor-based method was used to calculate MCIDs for PDAI scores against the 15-point Likert scale and the Physician Global Assessment visual analogue scale (PGA-VAS) anchors. Receiver operating characteristic curves were employed to determine optimal MCID cutpoints with the highest Youden Index (J). The 15-point Likert scale scores the change in disease severity spanning from -7 to +7, designed to quantify the extent of disease improvement/deterioration since the preceding visit. The MCID for improvement in PDAI activity scores was 2.65 points using the 15-point Likert scale (78.7% correct classification; sensitivity 75.9%; specificity 73.5%) and 2.5 points using the PGA-VAS as the anchor (78.0% correct classification; sensitivity 84.4%; specificity 68.2%). Given the slightly higher correct classification rate using the 15-point Likert scale anchor, the MCID of 2.65 points was selected for PDAI activity score improvement. In contrast, the MCID for deterioration consistently remained at 2.5 points for the 15-point Likert scale anchor (81.0% correct classification; sensitivity 72.7%; specificity 81.0%) and 2.5 points for the PGA-VAS anchor (70.9% correct classification; sensitivity 69.6%; specificity 76.9%). This study marks the inaugural attempt at MCID determination for PDAI scores in pemphigus, filling a critical knowledge gap. The study's calculated MCIDs provide essential benchmarks for clinical trials, treatment evaluation and research design optimization. Future studies should explore international collaborations, to examine potential cross-cultural variations in MCIDs.

Combined Anterolateral Ligament Reconstruction Results in Better Knee Stability and More Satisfactory Subjective Outcomes in Non-Athlete Patients Undergoing Revision Anterior Cruciate Ligament Reconstruction.

Background: Consensus has not yet been reached regarding combined anterior cruciate ligament reconstruction (ALLR) with revisional anterior cruciate ligament reconstruction (RACLR). We aimed to compare the clinical outcomes between patients who underwent isolated RACLR and those who underwent RACLR combined with ALLR. Methods: Between June 2010 and June 2021, 49 patients who underwent RACLR were retrospectively reviewed over a 24-month follow-up. Patients were categorized into the isolated RACLR (n = 37, group 1) or combined ALLR group (n = 12, group 2). Clinical outcomes were evaluated with several patient-reported outcome measures (PROMs) and minimal clinically important differences (MCIDs) for each PROM. The side-to-side difference (SSD) of the anterior instability was measured. The pivot-shift test was performed. Results: Baseline characteristics showed no differences between the groups. PROMs showed no significant differences between the groups at the 2-year follow-up. Group 2 was superior to group 1 in the MCID achievement rate for Lysholm knee and International Knee Documentation Committee (IKDC) subjective scores at 24 months postoperatively. At the final follow-up, the proportion of IKDC grade A in SSD for anterior laxity was higher in group 2 than in group 1 (58.3% versus [vs.] 18.3%, p = 0.009), and the proportion of pivot-shift grade 0 was also higher in group 2 (66.7% vs. 27.0%, p = 0.013). The "near return to activity" rate was also higher in group 2 than in group 1 (83.3% vs. 45.9%, p = 0.043). Conclusions: Combining ALLR with RACLR in non-athletes results in a higher proportion of patients with less mechanical graft failure and satisfactory clinical outcomes.

Interpretation of elevated baseline concentrations and serial changes of high-sensitivity cardiac troponin T in confirmed muscular dystrophies.

Concentrations of high-sensitivity cardiac troponin T (hs-cTnT) are frequently elevated in stable patients with confirmed muscle dystrophies. However, sparse information is available on the interpretation of serial concentration changes. Hs-cTnT was collected in 35 stable outpatients with confirmed skeletal muscle dystrophies at 0 and 1h and after 6-12months during scheduled outpatient visits. We simulated the effectiveness of the European Society of Cardiology (ESC) 0/1h algorithm and assessed biological variation at 6-12months using two established methods: reference change value (RCV) and minimal important difference (MID). Median baseline hs-cTnT concentrations were 34.4ng/L [inter-quartile range (IQR): 17.5-46.2], and values > 99th percentile upper limit of normal were present in 34 of 35 patients. All patients were stable without cardiovascular adverse events during a follow-up of 6.6months (IQR: 6-7). Median concentration change was 1.9ng/L (IQR: 0.7-3.2) and 0.8ng/L (IQR: 0-7.0) at 60min and 6-9months, respectively. Applying the criteria of the ESC 0/1h algorithm for triage of suspected acute coronary syndrome (ACS) showed poor overall effectiveness of baseline hs-cTnT values. No patient would qualify for rule-out based on hs-cTnT less than the limit of detection, whereas five cases would qualify for rule-in based on hs-cTnT≥52ng/L. Biological variabilities at 6-12months per MID and RCV were 1.2ng/L [95% confidence interval (CI): 0.7-2.1] and 28.6% (95% CI: 27.9-29.6), respectively. A total of 8 (22.9%) and 25 (71.4%) cases exceeded the biological variation range, suggesting some additional myocardial damage. The high prevalence of elevated hs-cTnT could negatively impact the effectiveness of rule-out and rule-in strategies based on a single hs-cTnT value. Knowledge of the physiological and biological variation of hs-cTnT after 6-12months is helpful to detect the progression of cardiac involvement or to search for cardiac complications including but not limited to arrhythmias that may trigger acute or chronic myocardial damage.

Effects of a physical therapist-driven individualized hybrid model of the exercise component of cardiac rehabilitation on patient outcomes: a prospective single group, time-series design

Purpose The aim of this prospective single group, time-series study was to determine the feasibility, adherence, and effectiveness of an individualized physical therapist (PT)-driven hybrid model of the exercise component of cardiac rehabilitation (CR) that uses a novel intensity-recovery progression protocol (IRPP) and cardiac testing template (CTT) to assess achieved heart rate (HR) intensity, HR recovery, and intensity-recovery total to guide treatment. Methods Assessment of a questionnaire, treadmill 6-min walk (6MW), 1-min sit-to-stand (1STS), 1-min step, and 1-min agility square tests were assessed on 100 participants. Compared to traditional CR the 36-visit 1:1 hybrid model was individualized using the IRPP program and CTT. Results Adherence was 35% (timely) and 44% (overall) completion. The per-protocol analysis (PPA) and intent-to-treat (ITT) analysis suggest significant improvement in objective assessments baseline to visit 15 (PPA = 11 of 14) (ITT = 13 of 14), baseline to visit 30 (PPA = 12 of 14) (ITT = 12 of 14) and visit 15 to visit 30 (PPA = 9 of 14) (ITT = 10 of 14). Improvement beyond the minimal clinically important difference (MCID) was 94.3% in the 6MW and 91.4% in the 1STS. Conclusions The PT-driven IRPP program was feasible in terms of adherence and safety, showing significant improvement in a majority of assessments. Analysis of HR using the CTT may help clinical decision making for progression in CR. Implications for rehabilitation Cardiac rehabilitation (CR) is an underutilized means of improving health for people recovering from cardiac surgery. People recovering from cardiac surgery have complex reasons for why they choose to enroll in, drop out from, or complete a CR program. Reporting of outcomes in CR and progression in intensity is not often individualized. An individualized physical therapist driven CR program using both subjective and objective assessments may be successful at improving adherence and effectiveness in this cohort.

Meaningful changes in motor function in Duchenne muscular dystrophy (DMD): A multi-center study.

Evaluations of treatment efficacy in Duchenne muscular dystrophy (DMD), a rare genetic disease that results in progressive muscle wasting, require an understanding of the 'meaningfulness' of changes in functional measures. We estimated the minimal detectable change (MDC) for selected motor function measures in ambulatory DMD, i.e., the minimal degree of measured change needed to be confident that true underlying change has occurred rather than transient variation or measurement error. MDC estimates were compared across multiple data sources, representing >1000 DMD patients in clinical trials and real-world clinical practice settings. Included patients were ambulatory, aged ≥4 to <18 years and receiving steroids. Minimal clinically important differences (MCIDs) for worsening were also estimated. Estimated MDC thresholds for >80% confidence in true change were 2.8 units for the North Star Ambulatory Assessment (NSAA) total score, 1.3 seconds for the 4-stair climb (4SC) completion time, 0.36 stairs/second for 4SC velocity and 36.3 meters for the 6-minute walk distance (6MWD). MDC estimates were similar across clinical trial and real-world data sources, and tended to be slightly larger than MCIDs for these measures. The identified thresholds can be used to inform endpoint definitions, or as benchmarks for monitoring individual changes in motor function in ambulatory DMD.

Retrospective Evaluation of Cryopreserved Human Umbilical Cord Tissue Allografts in the Supplementation of Cartilage Defects Associated with Hip Osteoarthritis.

Background: Osteoarthritis is a chronic disorder that affects the synovial joints by the progressive loss of articular cartilage. In the hip, the largest weight-bearing joint, the deterioration of articular cartilage and acetabular labrum can cause pain, diminishing the quality of life for patients. This study presents changes in reported pain scales from patients who received Wharton's jelly applications to cartilage deterioration in the hip from the observational retrospective repository at Regenative Labs. Methods: Sixty-nine patients were selected based on inclusion criteria with patient-reported pain scales, including the Numeric Pain Rating Scale and the Western Ontario and McMaster University Osteoarthritis Index, collected at the initial application, 30, and 90-day follow-up visits. Thirteen patients received a second allograft application and had additional follow-up visits at 120 and 180 days. Results: Five of the six scales used showed a statistically significant improvement in average scores across the cohort. The greatest improvements were observed in the NPRS with a 31.36% improvement after 90 days and a 44.64% improvement for patients with two applications after 180 days. The minimal clinically important difference (MCID) was also calculated to determine the perceived value of care for each patient with 44.9% of patients exceeding the MCID and 78.3% reporting at least one level of improvement. Conclusions: The positive outcomes for the patients in this cohort suggest WJ to be a promising alternative care option for patients with structural tissue degeneration in the hip refractory to the current standard of care.

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

IntroductionBirmingham 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.MethodsProspectively 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.ResultsMCID 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.ConclusionsMCID 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.

Mini-Open Technique for Gluteus Medius Tendon Repairs Is Associated With Low Complication Rates and Sustained Improvement in Patient Reported Outcomes at 2-Year Follow-Up

To evaluate the efficacy of the senior author's hybrid "mini-open" technique for abductor tendon repair at 2-year follow-up. After institutional review board approval, we performed a retrospective review of prospectively collected data for all patients undergoing isolated mini-open gluteus medius tendon repairs from January2018 to January 2022. Inclusion criteria included ongoing abductor pain refractory to nonoperative management, magnetic resonance imaging demonstrating gluteus medius/minimus tear, completion of preoperative patient-reported outcome measures (PROMs) including Modified Harris Hip Score (mHHS), Hip Outcome Score for Activities of Daily Living (HOS-ADL), Hip Outcome Score for Sports-Related Activities (HOS-SS), and visual analog scale (VAS) for pain and minimum 2-year follow-up. PROMs were assessed at preoperative, 6-month, 1-year, and 2-year postoperative intervals. Paired-sample t tests were used to compare the change in each outcome measure. The minimal clinically important difference (MCID) was calculated, and complications were recorded. Sixty-one patients (59 female, 96.7%) with an average age of 61.4 ± 1.3 years were included. The mean follow-up was 25.9 ± 1.13 months. mHHS improved from a mean of 47.2 preoperatively to 68.9 at 2 years (P < 0.001), HOS-ADL from 54 to 78.9 (P< 0.001), HOS-SS from 37 to 66.5 (P= 0.015), and VAS from 13.3 to 7.4 (P= 0.001). The MCIDs for mHHS, HOS-ADL, HOS-SS, and VAS were 11.1 (60%achievement), 6.1 (78.6% achievement), 9.7 (80.3% achievement), and 14.5 (75.4%achievement), respectively. Two patients experienced retears (3.2%), with no other complications reported. The mini-open techniquefor abductor tendon repair provides sustained improvement in both pain and function-related PROMs at 2-year follow-up with comparable complication rates to endoscopic and open techniques in 1 surgeon's practice. Level IV, therapeutic retrospective case series.

Multimodal Deep Learning-based Radiomics Approach for Predicting Surgical Outcomes in Patients with Cervical Ossification of the Posterior Longitudinal Ligament.

A retrospective analysis. This research sought to develop a predictive model for surgical outcomes in patients with cervical ossification of the posterior longitudinal ligament (OPLL) using deep learning and machine learning (ML) techniques. Determining surgical outcomes assists surgeons in communicating prognosis to patients and setting their expectations. Deep learning and ML are computational models that identify patterns from large datasets and make predictions. Of the 482 patients, 288 patients were included in the analysis. A minimal clinically important difference (MCID) was defined as gain in Japanese Orthopaedic Association (JOA) score of 2.5 points or more. The predictive model for MCID achievement at 1 year post-surgery was constructed using patient background, clinical symptoms, and preoperative imaging features (x-ray, CT, MRI) analyzed via LightGBM and deep learning with RadImagenet. The median preoperative JOA score was 11.0 (IQR: 9.0-12.0), which significantly improved to 14.0 (IQR: 12.0-15.0) at 1 year after surgery (P < 0.001, Wilcoxon signed-rank test). The average improvement rate of the JOA score was 44.7%, and 60.1% of patients achieved the MCID. Our model exhibited an area under the receiver operating characteristic curve of 0.81 and the accuracy of 71.9% in predicting MCID at 1 year. Preoperative JOA score and certain preoperative imaging features were identified as the most significant factors in the predictive models. A predictive ML and deep learning model for surgical outcomes in OPLL patients is feasible, suggesting promising applications in spinal surgery. 4.

Ablative Radiation Therapy for Unfavorable Prostate Tumors (ABRUPT): Preliminary Analysis of Toxicity and Quality of Life from a Prospective Study

To assess late gastrointestinal (GI) and genitourinary (GU) side effects in patients with organ-confined unfavorable prostate cancer (PCa) treated with single-dose ablative radiation therapy (SDRT). Thirty patients enrolled in a single-arm prospective trial received 24 Gy SDRT to the whole prostate with urethra-sparing and organ motion control delivered on a Linac platform with a 10 MV flattening filter-free single partial arc. Androgen deprivation therapy was prescribed as per standard of care. Treatment-related acute and late GU and GI toxicities (Common Terminology Criteria for Adverse Events_v5 scale) and quality of life (QoL) outcomes (European Organisation for Research and Treatment of Cancer [EORTC] QLQ-PR25/C30, International Prostate Symptom Score [IPSS]) were assessed at different time points. Minimal important difference (MID) was established as a change of >0.5 pooled standard deviations from baseline. Statistical analysis included analysis of variance and logistic regression. Median follow-up was 18 months (range, 6-31 months), with no ≥G3 late side effects observed. G2 late GI and G2 late GU toxicities occurred in 1 and 2 patients, respectively. GI toxicity of any grade correlated with maximum rectal dose (P = .021). Lower baseline QoL score (P = .025), higher baseline IPSS score (P = .049), acute GU toxicity (P = .029), and acute urinary domain MID (P = .045) predicted GU toxicity of any grade. In multivariate analysis (MVA), only baseline QoL score (odds ratio [OR], 0.95, P = .031) and acute GU toxicity (OR, 8.4, P = .041) remained significant. Significant QoL change was observed only in the urinary domain (P = .005), with a median increase from 8 to 17. Late urinary MID correlated with acute urinary MID (P = .003), acute QoL MID (P = .029), acute GU toxicity (P = .030), and lower baseline urinary score (P = .033). In MVA, only acute urinary MID predicted late urinary MID (OR, 9.7, P = .035). Our findings provide promising data on the feasibility and safety of 24 Gy whole-gland SDRT with urethra-sparing and organ motion control, in association with androgen deprivation therapy and an adequate prophylactic medication, in organ-confined unfavorable PCa. Long-term follow-up is needed to confirm these results.

Minimal Clinically Important Difference (MCID) for the Short Musculoskeletal Function Assessment (SMFA) in Severe Lower Extremity Trauma: Pooled Data from 7 Multicenter, Prospective Clinical Trials.

The Short Musculoskeletal Function Assessment (SMFA) is a well validated, widely used patient-reported outcome (PRO) measure for orthopaedic patients. Despite its widespread use and acceptance, this measure does not have an agreed upon minimal clinically important difference (MCID). The purpose of the present study was to create distributional MCIDs with use of a large cohort of research participants with severe lower extremity fractures. Three distributional approaches were used to calculate MCIDs for the Dysfunction and Bother Indices of the SMFA as well as all its domains: (1) half of the standard deviation (one-half SD), (2) twice the standard error of measurement (2SEM), and (3) minimal detectable change (MDC). In addition to evaluating by patient characteristics and the timing of assessment, we reviewed these calculations across several injury groups likely to affect functional outcomes. A total of 4,298 SMFA assessments were collected from 3,185 patients who had undergone surgical treatment of traumatic injuries of the lower extremity at 60 Level-I trauma centers across 7 multicenter, prospective clinical studies. Depending on the statistical approach used, the MCID associated with the overall sample ranged from 7.7 to 10.7 for the SMFA Dysfunction Index and from 11.0 to 16.8 for the SMFA Bother Index. For the Dysfunction Index, the variability across the scores was small (<5%) within the sex and age subgroups but was modest (12% to 18%) across subgroups related to assessment timing. A defensible MCID can be found between 7 and 11 points for the Dysfunction Index and between 11 and 17 points for the Bother Index. The precise choice of MCID may depend on the preferred statistical approach and the population under study. While differences exist between MCID values based on the calculation method, values were consistent across the categories of the various subgroups presented. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Determining the Minimal Clinically Important Difference (MCID) and Responsiveness of the Chinese Version of Zurich Chronic Middle Ear Inventory (ZCMEI-21-Chn): A Prospective Multicenter Study.

This study aimed to establish the minimal clinically important difference (MCID) and assess the responsiveness of the Chinese version of Zurich Chronic Middle Ear Inventory (ZCMEI-21-Chn). Prospective multicenter study. Four Chinese tertiary referral centers admitting patients nationwide. 230 adult patients with chronic otitis media (COM) undergoing tympanoplasty. Patients were required to complete the ZCMEI-21-Chn to measure health-related quality of life both preoperatively and postoperatively. An anchor-based method was used to determine the MCID of the derivative cohort by including the Global Rating of Change Questionnaire as an anchor. The generalizability and consistency with functional outcomes of the MCID estimates were externally examined in a validation cohort using a receiver operating characteristic curve analysis. A total of 161 and 69 patients were included in the derivative and validation cohort. The mean preoperative and postoperative ZCMEI-21-Chn total scores were 28.4 (standard deviation [SD] 14.5) and 17.5 (SD 12.6). The mean change in ZCMEI-21-Chn score was 10.9 (SD 14.3, p < 0.001). The MCIDs of the ZCMEI-21-Chn for improvement and deterioration were estimated at 13 (SD 13.0) and -7 (SD 12.9), accordingly. For patients who have reported an improved health-related quality of life, a cutoff value of 15.6 dB HL for elevation of the air-conducted hearing threshold was noticed. However, change of clinical importance judged according to MCID and Japan Otological Society criteria disagreed with each other, notably with a Cohen's kappa ( κ ) of 0.14 ( p = 0.21) in the validation cohort. This study is the first to establish the MCID of a COM-specific questionnaire in Chinese. For the COM population undergoing surgical intervention, MCID values of 13 for improvement and -7 for deterioration are recommended. The results were externally validated to be generalizable to nationwide usage, yet distinguishable from the audiological criteria. The availability of the MCID greatly adds to the clinical utility of the ZCMEI-21-Chn by enabling a clinically meaningful interpretation of its score changes.

Poster 161: Rotator Cuff Repair and Minimum Clinically Important Difference: Does Number of Tendons Involved Affect the Minimum Clinically Important Difference Value?

Objectives: The minimum clinically important difference (MCID) is a commonly used measure to aid in determining significant improvements for patient-reported outcomes (PROs). As MCID and PROs continue to be implemented in shoulder procedures, MCID can greatly differ depending upon the specific patient population, follow-up time, and methodology. In the setting of rotator cuff repair (RCR), there are few studies that discuss the effect of tendon involvement on MCID achievement. Other orthopaedic conditions have calculated separate MCIDs depending on the severity of the fracture or pathology. The purpose of this study was to calculate an MCID for one-, two-, and three-tendon RCR. They hypothesis was that MICD values would be lower for larger repairs compared to smaller repairs. The primary outcome was the American Shoulder and Elbow Surgeons (ASES) score. Secondary outcomes included evaluating what patient and surgical characteristics affect MCID achievement for each MCID. Methods: A prospectively collected PRO database was queried for patients who underwent primary RCR from 2018 to 2022. Revision procedures, patients with a history of prior shoulder surgery, or patients lacking PROs at any time point were excluded. Demographic and surgery characteristics were extracted through chart review. The primary outcome was the ASES score. ASES is a validated instrument scored on a 100-point scale with 0 indicating the” worst outcome” and 100 being the “best outcome.” MCID was calculated using the anchor-based method as has been done in previous works. The anchor question from PROMIS-10 asks, “In general, how would you rate your physical health?” scored on a 5-point Likert scale. An increase of one point was deemed to be a significant improvement in the anchor to calculate the MCID. An MCID was calculated for the three sizes of RCRs in this sample. Statistical analysis included descriptive statistics, as well as independent sample t-tests, chi-square tests, and fisher exact tests. Results: A total of 799 patients met inclusion criteria. Most patients were male (n=474, 59.3%) and were 61.2 years old. There were 61.5% of patients who had their dominant shoulder treated with RCR. Patients typically presented with at least one tendon that had a full thickness tear (n=643, 80.5%). Many underwent various concomitant procedures including subacromial decompression (83.9%), biceps tendon procedures (tenotomy or tenodesis) (59.0%), distal clavicle excision (24.2%), and arthroscopic debridement (24.0%). The average case length was 130.1 minutes. There were 36 symptomatic retears (4.5%), 10 revisions (1.3%), and 14 other reoperations (1.8%) within one year. ASES scores at baseline and one-year were 48.1 and 84.6, respectively, with an average one-year change of +36.6. MCIDs by number of tendons involved were 40.5, 36.3, and 39.3 for single-, two-, and three-tendon repairs. The number of patients that achieved MCID by tendon size did not statistically differ between groups (Single: 51.0%; Two: 53.0%; Three: 50.0%, p&gt;0.610, respectively). MCID achievement and biceps tendon procedures trended towards significance for the single-tendon cohort (p=0.085), while patient sex trended towards significance in the two-tendon cohort (p=0.055). More acute tears compared to chronic tears met MCID in the three-tendon cohort although this only trended towards significance (p=0.074). MCID achievement was affected by symptomatic retears in the two-tendon RCR group (p&lt;0.001). While reoperation trended towards significance in the single-tendon RCR group (p=0.058). Conclusions: This study found that MCID value varied by the number of tendons involved in RCR, with two-tendon repairs having the lowest MCID (36.3). The number of patients that met MCID in each cohort was similar. Single-tendon tears appear to be more affected by biceps tendon procedures and reoperations, although both of these findings only trended towards significance. Patients with two-tendon tears were shown to be affected by symptomatic retear (p&lt;0.001), and patient sex, although the later finding was not statistically significant (p=0.055). MCID achievement in three-tendon RCRs appear to be influenced by tear chronicity with those with an acute tear being more likely to attain MCID, although this finding was not significant (p=0.074). Surgeons should consider the size of a cuff repair and what corresponding surgical and patient factors may be more pertinent to each patient to help maximize patient outcomes.

Poster 306: Establishing the Minimum Clinically Important Difference Two Years Following Medial Patellofemoral Ligament Reconstruction

Objectives: Medial patellofemoral ligament (MPFL) reconstruction is used to address cases of recurrent patellar instability. Minimal clinically important difference (MCID) is an important marker that relays the smallest clinical improvement in which patients feel a significant change after surgery. MCID has been previously established for MPFL reconstruction after 6 months and 1 year. To date, no study has established MCID for patient reported outcomes 2 years after MPFL reconstruction. The purpose of this study is to define the MCID for the Kujala, International Knee Documentation Committee (IKDC), and Knee Injury and Osteoarthritis Outcome Score for Joint Reconstruction (KOOS JR) at minimum two-year follow-ups after isolated MPFL reconstruction. Methods: All patients undergoing isolated MPFL reconstruction for recurrent patellar instability at a single institution between December 2015-June 2021 were included. Patients with concomitant osseous procedures beyond chondroplasty and any ligamentous procedure were excluded. A distribution-based approach was used to calculate the MCID. This was performed by determining the standard deviation (SD) of the delta two-year patient reported outcome scores (PROS) and then multiplying the SD by 0.5. The number of patients achieving MCID were then presented as a percentage. Results: Eighty-six of 117 patients who underwent isolated MPFL reconstruction completed preoperative and a two-year follow-up PRO survey (59 female, 27 male; age 21.1 ± 8.7 years). For Kujala, the preoperative mean was 59.3 ± 17.1, two-year follow-up mean was 87.6 ± 13.6, and MCID was 9.2 with 88% of the cohort achieving MCID. For IKDC, preoperative mean was 50.2 ± 17.2, two-year mean was 80.5 ± 18.6, and MCID was 12.4 with 80% of patients achieving MCID. KOOS JR had a preoperative man of 66.0 ± 14.6, two-year follow-up mean of 88.8 ± 11.9, and MCID of 8.5 with 72% of patients meeting this MCID (Figure 1). Conclusions: At two years following MPFL reconstruction, the MCID’s for clinically relevant subjective PROS were 9.2 (Kujala), 12.5 (IKDC), and 8.5 (KOOS JR). MCID’s for MPFL reconstruction are already established for 6-month and 1-year time points, and this was the first presentation of two-year MCID values. Establishing the 2-year MCID for MPFL reconstruction gives surgeons another tool to use in the diagnoses of patellar instability patients who may be struggling post-operatively.

Poster 234: Establishing the Minimal Clinically Important Difference and Patient Acceptable Symptomatic State After Isolated Arthroscopic Posterior Medial Meniscal Root Repair

Objectives: Root tears encompass avulsion injuries affecting the bony or soft tissue root attachments of the meniscus, as well as radial tears occurring within 1 cm of these attachment points. Meniscal root tears have been increasingly recognized as contributors to early onset osteoarthritis and disrupted joint kinematics and insights from animal, cadaveric, and clinical studies have resulted in a paradigm shift from meniscectomy towards repair. The purpose of this study is to define the minimal clinically important difference (MCID) and patient-acceptable symptomatic state (PASS) for patient-reported outcome measures (PROMs) following isolated posterior medial meniscal root repair (PMMR) and to investigate the role of preoperative, demographic, and intraoperative variables for predicting achievement of these thresholds. We hypothesized that patients have a greater likelihood of achieving MCID with lower preoperative outcome scores and a greater likelihood to achieve PASS with higher preoperative outcome scores. Furthermore, certain preoperative and intraoperative factors are likely to influence achievement of MCID and PASS following PMMR. Methods: This is an IRB approved retrospective study of prospectively collected data from a single, high-volume institution. Inclusion criteria were patients who underwent arthroscopic PMMR performed by one of three fellowship-trained attending surgeons with a minimum of two year postoperative follow up. Exclusion criteria consisted of patient with KL grade &gt;3 osteoarthritis and concomitant ligamentous procedures. Patients who had ipsilateral knee surgery within 2 years of undergoing meniscal root repair were also excluded. PROMs were collected from January 2017 to September 2023 and an electronic medical record was reviewed for demographic variables, intraoperative details, and postoperative complications. PROMs analyzed in this study include the International Knee Documentation Committee Score (IKDC), the Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) and the Veterans Rand 12 Physical Function (VR12 P). MCID was determined to be one-half the standard deviation of the difference from baseline in PROM scores at minimum two-year follow-up. PASS thresholds were calculated using an anchor-based approach. Receiver operating characteristic (ROC) analysis for the calculation of PASS was conducted and optimal thresholds were calculated using the Youden Index to maximize the sensitivity and specificity of threshold values. Multivariate logistic regression analyses were conducted to identify patient-related factors at baseline and intraoperative variables associated with the attainment of MCID and PASS. Results: Seventy patients were included in the final analysis. The demographics of included patients is listed in Table 1. The mean preoperative score, mean postoperative score, MCID threshold, MCID achievement rate, PASS threshold, and PASS achievement rate for IKDC, KOOS Jr., and VR12 physical are listed within Table 2. The predictive value for all PASS thresholds was good to excellent, with AUC values for IKDC, KOOS Jr., and VR12 Physical being 0.858, 0.864, and 0.755, respectively (Figure 1). For IKDC, lower BMI (OR 0.73, p = 0.03) and lower preoperative score (OR 0.94, p = 0.02) were predictive of MCID achievement, whereas lower BMI (OR 0.87, p &lt; 0.01) and greater preoperative score (OR 1.04, p = 0.04) were predictive of PASS achievement. For KOOS Jr., use of two sutures (OR 6.98, p &lt; 0.01) was predictive of MCID achievement, whereas use of two sutures (OR 6.91, p &lt; 0.01) and lower BMI (OR 0.81, p &lt; 0.01) were predictive of PASS achievement. For VR12 Physical scores, younger age (OR 0.92, p = 0.04), lower BMI (OR 0.84, p = 0.01), and lower preoperative score (OR 0.89, p &lt; 0.01) were predictive of MCID achievement, whereas use of two sutures (OR 7.24, p = 0.02), lower BMI (OR 0.92, p &lt; 0.01), and greater preoperative score (OR 1.19, p = 0.02) were predictive of PASS achievement. Conclusions: This study defines the thresholds for MCID and PASS achievement at minimum two-year follow-up for IKDC, KOOS Jr., and VR12 Physical scores in a large cohort of patients undergoing isolated posterior-medial meniscal root repair at a single, high-volume institution. More patients achieved MCID than PASS. Lower BMI, use of fewer sutures, and preoperative scores were the most common predictors of MCID and PASS achievement. Additionally, younger age was an independent predictor of MCID achievement for VR-12 Physical Function.