Minimal Important Difference Research Articles

Comparative Study on Postoperative Immobilization in Reverse Total Shoulder Arthroplasty: 4 Weeks vs. 6 Weeks of Immobilization Yields Similar Clinical and Functional Outcomes.

Background/Objectives: To investigate clinical and functional outcomes of patients undergoing reverse total shoulder arthroplasty (RTSA) using a rehabilitation protocol of either 4 or 6 weeks of immobilization. Methods: This comparative study analyzed a consecutive patient cohort that underwent RTSA in a single institute from January 2021-February 2023. Patients were assigned to groups according to the duration of postoperative immobilization and were followed up for a minimum of one year. Patient demographics, range of motion (ROM), functional outcomes using the Simple Shoulder Test (SST) and the American Shoulder and Elbow Score (ASES) as well as postoperative complications were recorded. The minimum clinically important difference (MCID) was used to assess whether the differences between the groups in SST, ASES, SWB, and VAS were clinically relevant. Results: Sixty patients met the inclusion criteria (35 patients in the 6-week immobilization group (6 WG) and 25 patients in the 4-week immobilization group (4 WG)) and were available for the total follow-up period. Similar baseline demographics were observed between the groups. Active ROM significantly improved for both groups, with abduction and forward flexion improving the most. In terms of functional outcomes, significant improvement (p < 0.001) was demonstrated for both groups (ASES, SST, VAS, and SWB). However, patients in the 4 WG reached significantly better results in VAS and SWB at 6 weeks and 3 months, as well as in ASES 3 months postoperatively, whereas both groups leveled off at the end of the follow-up period after 1 year. Taking into account the MCID, these differences for ASES at 3 months, as well as VAS and SWB at 6 weeks and 3 months postoperatively, were significant. Surprisingly, there were no differences between the groups over the entire follow-up period in terms of the SST. Conclusions: The author's findings suggest faster clinical recovery at 6 weeks and 3 months in patients undergoing postoperative immobilization of 4 weeks compared to 6 weeks following RTSA. However, clinical and functional outcomes were equal for 4 WG and 6 WG at one year follow up.

Short-term effects on physical activity level with web-based self-management support in people with COPD: a randomised controlled trial

We aimed to evaluate short-term effects of a web-based self-management support on objectively measured physical activity (PA) compared to usual care in people with chronic obstructive pulmonary disease (COPD). We conducted a pragmatic randomised controlled trial including people with stable COPD within primary healthcare. Participants were randomised to intervention group, IG (access to the COPD Web, an interactive website to support self-management with focus on PA), or to control group, CG (usual care). Primary outcome at 3 months was change in accelerometry-measured daily steps analysed with ANCOVA, and secondary outcomes were self-reported PA, disease-related symptoms, and quality of life. Missing data in intention-to-treat (ITT) analyses were multiply imputed. One hundred and forty-six participants (n = 73/group), mean (SD) age 69.5 (6.7) years, FEV1pred 60.7 (19.1)% were included. The ITT analysis showed no significant difference in steps between the groups: 1295 steps (95% CI: [−365, 2955], p = 0.12), while the complete case analysis (n = 98) revealed a significant difference of 1492 steps (95% CI: [374, 2609], p = 0.01) in favour of IG. A significant increase in self-reported PA was seen in IG in both the ITT and complete case analysis. In summary, access to the COPD Web was insufficient to increase short-term PA level compared to usual care. However, among participants with complete step data, a clinically relevant effect on daily steps exceeding the minimal important difference was observed, partly explained by higher baseline PA than among dropouts. This indicates that access to the COPD Web may increase PA levels for some people with COPD.

Unsupervised Clustering of Adult Spinal Deformity Patterns Predicts Surgical and Patient-Reported Outcomes.

Retrospective cohort study. To evaluate whether different radiographic clusters of adult spinal deformity identified using artificial intelligence-based clustering are associated with distinct surgical outcomes. Patients were classified based on the results of a previously conducted analysis that examined clusters of deformity, including Moderate Sagittal (Mod Sag), Severe Sagittal (Sev Sag), Coronal, and Hyper-Thoracic Kyphosis (Hyper-TK). The surgical data, HRQOL, and complication outcomes of these clusters were then compared. The final analysis included 1062 patients. Similar to published results on a different patient sample, Mod Sag and Sev Sag patients were older, more likely to have a history of previous spine surgery, and more disabled. By 2-year, all clusters improved in HRQOL and reached a similar rate of minimal clinically important difference (MCID).The Sev Sag cluster had the highest rate major complications (53% vs 34-40%), and complications leading to reoperation (29% vs 17-23%), implant failures (20% vs 8-11%), and operative complications (27% vs 10-17%). Coronal patients had the highest rate of pulmonary complications (9% vs 3-6%) but the lowest rate of X-ray imbalance (10% vs 19-21%). No significant differences were found in neurological complications, infection rate, gastrointestinal, or cardiac events (all P > .1). Kaplan-Meier survival curves demonstrated a lower time to first complications for the Sev Sag cluster. All clusters of adult spinal deformity benefit similarly from surgery as they all achieved similar rates of MCID. Although the rates of complications varied among the clusters, the types of complications were not significantly different.

Days at Home After Traumatic Brain Injury: Moving Beyond Mortality to Evaluate Patient-Centered Outcomes Using Population Health Data.

Administrative data are invaluable for assessing outcomes at the population level. However, there are few validated patient-centered outcome measures that capture morbidity following traumatic brain injury (TBI) using these data. We sought to characterize and validate days at home (DAH) as a measure to quantify population-level outcomes after moderate to severe TBI. We additionally assessed the earliest feasible outcome assessment period for patients with TBI using this outcome measure. This multicenter retrospective cohort study used linked health administrative data sources to identify adults with moderate to severe TBI presenting to trauma centers in Ontario, Canada, between 2009 and 2021. DAH at 180 days (DAH180 days) reflects the total number of days spent alive and at home excluding the days spent institutionalized across care settings. Construct validity was determined using hierarchical quantile regression to assess the associations between clinical and injury covariates with DAH180 days. Predictive validity was assessed using Spearman rank correlation. We estimated minimally important difference (MID) in DAH180 days to aid with outcome measure interpretability. There were 6,340 patients who met inclusion criteria. Median DAH180 days was 70 days (interquartile range 0-144). Mortality occurred in 2,162 (34.1%) patients within 90 days following injury. Patients in the lower DAH180 days group were more commonly older (absolute standardized difference [ASD] = 0.68) with higher preinjury health resource utilization (ASD = 0.36) and greater injury severity (ASD = 0.81). Increased baseline health resource utilization (-10.1 days, 95% CI -17.4 to -2.8, p = 0.0041), older age (-4.6 days, 95% CI -5.7 to -3.4, p < 0.001), higher cranial injury severity (-84.6 days, 95% CI -98.3 to -71.0, p < 0.001), and major extracranial injuries (-14.2 days, 95% CI -19.5 to -8.93, p < 0.001) were significantly associated with fewer DAH180 days. DAH180 days was positively correlated with DAH at up to 3 years (r = 0.91, 95% CI 0.90-0.92) and negatively correlated with direct health care expenditure (rs = -0.89, 95% CI -0.88 to -0.90). The average MID estimated from anchor-based and distribution-based methods was 18 days. We validate DAH180 days as a potentially useful outcome measure with construct, predictive, and face validity in a population with moderate to severe TBI. Given the intensity of acute care requirements for patients with TBI, our work highlights DAH180 days as a feasible and sufficiently responsive outcome measure.

Clinical and Radiographic Outcomes With Minimum 2-Year Follow-up and Sub-Analysis of Navigation vs Non-Navigation for Hip Resurfacing.

The purpose of this study was to report the short-term clinical outcomes of hip resurfacing with navigation and the impact on accuracy of acetabular implant placement in both the frontal and sagittal planes. Data were retrospectively analyzed for patients who received hip resurfacing between 2010 and 2021. Eligible patients had postoperative radiographs and completed a minimum 2-year follow-up questionnaire for the following patient-reported outcomes: modified Harris Hip Score (mHHS), Harris Hip Score (HHS), Forgotten Joint Score (FJS), visual analog scale (VAS) score, satisfaction, and Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS-JR). Hips were propensity matched in a 1:1 ratio based on the use of navigation, age, and body mass index. The percentage of hips that met the minimal clinically important difference (MCID) for mHHS and VAS score was noted. Component placement analysis was conducted based on the safe zones defined by Lewinnek and Callanan and the Relative Acetabular Inclination Limit. Seventy-six hips were matched, 38 per group. No differences were observed in patient-reported outcomes or the percentage of hips reaching MCID between the groups. The navigation group was 28.8 and 6.8 times more likely to be within the Callanan and Lewinnek safe zones, respectively. Based on the Relative Acetabular Inclination Limit, the navigation group was 3.1 and 6.4 times more likely to be within the 95% and 99% CI safe zones, respectively. Comparable improvements in patient-reported outcomes were observed in the two groups during a minimum 2-year follow-up. Navigation-assisted surgery enhances the accuracy of acetabular component positioning, with a higher likelihood of cup placement within the safe zones. [Orthopedics. 202x;4x(x):xx-xx.].

Uncementing the status quo: systematic review of a loose-fit, polished stem radial head prosthesis shows stable clinical results in complex elbow injuries with a concomitant radial head fracture.

Selecting the optimal radial head prosthesis to treat radial head fractures, especially in the context of complex elbow injuries like terrible triad, Monteggia, and Essex Lopresti, can be challenging, as there is currently no consensus in the field that favors a particular design. This study investigated the safety and performance of a Polished Stem Radial Head Prosthesis (PS RHP) compared to other modern RHP designs. A systematic review was conducted according to PRISMA guidelines to capture data on a Polished Stem Radial Head Prosthesis (PS RHP) and other Radial Head Prostheses (RHPs). Functional scores, range of motion, complications, and revisions were extracted from published literature and analyzed in parallel with the percentage of complex injuries. Comparison of functional outcomes between groups were based on minimum clinically important differences (MCIDs). There were 16 articles reporting on 711 cases of the PS RHP and 23 articles reporting on 605 cases of other RHPs included in the systematic literature review. Functional scores and range of motion were similar amongst the groups. The PS RHP design achieved a comparable revision rate as other RHPs despite a higher number of terrible triad injuries. Notably, the PS RHP group showed a significantly lower rate of instability (1.0%) than other RHPs (3.4%) (p < 0.05). Other complication rates were similar amongst the two groups. The PS RHP group had higher rates of terrible triads at baseline compared to the other RHPs group. Regardless of greater injury complexity, the clinical outcomes of the PS RHP group were favorable and resulted in a significantly lower rate of postoperative instability as compared to other RHPs.

Metabolic Syndrome, Adipokines, and Response to Advanced Therapies in Rheumatoid Arthritis.

We determined if metabolic syndrome, its components, and adipokines (adiponectin, leptin, Fibroblast Growth Factor-21) were associated with response to advanced therapies among patients with rheumatoid arthritis (RA). This study included participants with RA initiating either TNFi or non-TNFi biologic therapies from the Comparative Effectiveness Registry to studyTherapies forArthritis andInflammatory Conditions(CERTAIN) cohort within the CorEvitas registry. Metabolic syndrome was defined according to the National Cholesterol Education Program Adult Treatment Panel III definition. Adipokines were assessed on stored samples from a sub-sample of responders and non-responders (N=200). The primary outcome was the achievement of a change as large as the minimal clinically important difference (MCID) for the Clinical Disease Activity Index (CDAI) at 6 months. Among 2,368 participants, 687 (29%) had metabolic syndrome. Metabolic syndrome was associated with lower odds of achieving CDAI MCID [OR (95% CI): 0.69 (0.56,0.86) p=0.001] with a dose-dependent decrease in response rate according to the number of components present. Model fit was superior for metabolic syndrome compared to BMI. Associations between metabolic syndrome and MCID achievement were similar between patients receiving TNFi [OR (95% CI): 0.65 (0.49,0.87) p=0.003] v. non-TNF therapies [OR (95% CI): 0.76 (0.55,1.04) p=0.08)] (p-for-interaction=0.49). Adipokines were not associated with MCID achievement. Metabolic syndrome is associated with lower response rates with the initiation of an advanced therapy in RA, with similar effects for both TNFi and non-TNFi agents. Adipokines were strongly associated with metabolic syndrome but were not associated with clinical response.

Early Changes in Health-Related Quality of Life as a Biomarker of Survival in African Patients with HIV-Associated Kaposi Sarcoma.

Sub-Saharan Africa bears the largest public health burden of Kaposi sarcoma (KS), a leading cause of cancer mortality. Quality of life (QOL) assessments in cancer patients can provide information on prognosis beyond traditional biomarkers or biological measures. The prognostic value of QOL measures in patients with HIV-KS was evaluated. Prognostic associations of baseline QOL scores (by quartiles or thresholds for clinical importance) and changes in QOL scores (using minimum important difference) over the first 3 months of therapy were evaluated in 112 participants with HIV-KS randomised to receive ART, with or without chemotherapy. Cox's regression analysis assessed the prognostic contribution of QOL scores from the EORTC QLQ-C30 questionnaire. Survival curves were generated using the Kaplan-Meier method. Baseline QOL scores did not predict overall survival. The change in the 3-month QOL scores for the global health scale, fatigue, and pain domains was prognostic; the hazard ratios were 3.88 (95% CI 1.32-11.38, p = 0.01), 3.72 (95% CI 1.61-8.62, p = 0.00) and 5.96 (95% CI 2.46-14.43, p = 0.00), respectively. QOL assessments can provide useful prognostic information in patients with HIV-KS. Patients lacking meaningful improvement early into treatment represent a population at high risk of death.

Predictors of symptomatic relief in water vapor thermal therapy for prostatic hyperplasia: 36-month prospective study.

Existing literature lacks an analysis of factors predicting the achievement of minimum clinically important differences (MCID) after water vapor thermal therapy (WVTT) for prostatic hyperplasia. This study aims to identify these predictors over a 36-month post-WVTT period. This prospective single surgeon case series assessed male patients receiving WVTT. Eligibility criteria included being at least 45 years old, having an estimated prostate volume (EPV) of 30-80cc, an International Prostate Symptom Score (IPSS) of 12 points or more, and a maximum urinary flow rate (Qmax) under 16 mL/sec. MCID, representing the smallest symptomatic improvement perceived by patients, was calculated using the distribution-based method, considering half a standard deviation of baseline IPSS scores. Correlation and linear regression analyses assessed MCID attainment. Multivariable logistic regression evaluated MCID achievement, considering multicollinearity, heteroskedasticity, and normality. Of 206 men with a median 29.1-month follow-up (Range: 24-36), 13.6% didn't achieve MCID for IPSS, and 7.2% for QoL scores. Significant hindrances to MCID attainment for IPSS were a large median lobe (> 10mm protrusion) (OR = 3.01, 95% CI: 2.3-3.72), increased median lobe treatments (OR = 1.73, 95% CI: 1.23-2.35), and high preoperative irritative IPSS scores (OR = 1.25, 95% CI: 1.13-1.38). Factors for QoL MCID non-achievement included age over 75 (OR = 1.25, 95% CI: 1.13-1.38), a large median lobe (OR = 1.87, 95% CI: 1.62-2.01), and EPV over 60cc (OR = 1.55, 95% CI: 1.16-1.97). A 6.3% surgical re-intervention rate was noted. The characteristics of the median lobe as well as the severity of lower urinary tract symptoms are crucial for treatment success. These should be integral to preoperative assessments and patient discussions on treatment options.

Efficacy of Thiocolchicoside for Musculoskeletal Pain Management: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background: Despite the fact that thiocolchicoside has been widely used in the treatment of musculoskeletal pain, its efficacy has never been systematically evaluated. We carried out a systematic review and meta-analysis of randomized clinical trials (RCTs) to appraise the existing evidence on the efficacy of thiocolchicoside for musculoskeletal pain management. Methods: The literature search was performed on multiple databases, extracting reports of RCTs evaluating the efficacy of thiocolchicoside compared to placebo or no exposure. The reduction in pain intensity was evaluated through between-groups mean differences (MDs) in Visual Analogue Scale (VAS) scores after the intervention. The pooled effect estimates were compared to a minimally important difference (MID) of 1 point on a scale from 0 to 10. Results: We retrieved eight RCTs, including a total of 1397 patients. All the included studies were determined as being at high risk of bias. Seven trials evaluated patients with acute low back pain. After 2-3 days of treatment, the pooled MD in VAS score was -0.49 (95%CI = -0.90; -0.09) compared to controls. After 5-7 days of treatment, the summary MD was -0.82 (95%CI = -1.46; -0.18). Conclusions: Although thiocolchicoside was found to significantly reduce patient-reported low back pain, the clinical impact was very small, as the pooled effect estimates were below the MID, and the overall certainty of evidence was very low. In light of the safety concerns raised by the European Medicine Agency, an in-depth analysis on the risk-benefit balance of thiocolchicoside is required.

Demographic Disparities and Outcomes Following Hip Arthroscopy

Background: The purpose of this study was to explore the impact of social deprivation on preoperative characteristics and postoperative outcomes following hip arthroscopy (HA) for femoroacetabular impingement syndrome (FAIS). Methods: Patients undergoing primary HA for FAIS were identified, and their social deprivation index (SDI) score was assigned on the basis of the provided ZIP code. Quartiles (Q1 to Q4) were established using national percentiles, with Q4 representing patients from the areas of greatest deprivation. Patient-reported outcomes (PROs) were collected preoperatively and at a minimum follow-up of 2 years. Achievement rates for clinically meaningful outcomes, including the minimal clinically important difference (MCID), patient acceptable symptom state (PASS), and substantial clinical benefit (SCB), were determined. The incidences of revision HA and conversion to total hip arthroplasty (THA) were recorded. SDI groups were compared with respect to preoperative characteristics and postoperative outcome measures. Predictors of MCID, PASS, and SCB achievement; revision HA; and conversion to THA were identified with use of multivariable logistic regression. Results: In total, 2,060 hips were included, which had the following SDI distribution: Q1 = 955, Q2 = 580, Q3 = 281, and Q4 = 244. The composition of the included patients with respect to race and/or ethnicity was 85.3% Caucasian, 3.8% African American, 3.7% Hispanic, 1.7% Asian, and 5.4% “other.” Patients with more social deprivation presented at a later age and with a higher body mass index (BMI), a longer duration of preoperative hip pain, and greater joint degeneration (p ≤ 0.035 for all). The most socially deprived groups had higher proportions of African American and Hispanic individuals, less participation in physical activity, and greater prevalences of smoking, lower back pain, and Workers’ Compensation (p ≤ 0.018 for all). PRO scores and achievement of the PASS and SCB were worse among patients from areas of greater social deprivation (p ≤ 0.017 for all). Age, BMI, activity status, race and/or ethnicity classified as “other,” SDI quartile, Workers’ Compensation, preoperative back pain, duration of preoperative hip pain, and Tönnis grade were independent predictors of clinically meaningful outcome achievement, revision arthroscopy, and/or THA conversion (p ≤ 0.049 for all). Conclusions: Individuals with more social deprivation demonstrated inferior postoperative outcome measures. This was driven primarily by preoperative characteristics such as SDI, hip pain duration, joint degeneration, and overall health at presentation. Despite differential outcomes, patients still showed clinical improvement regardless of SDI quartile. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Comparison of clinical efficacy between reconstruction of the superior acromioclavicular ligament with acellular dermal allografts and clavicular hook plate in acromioclavicular dislocations

Purposes: We aimed to compare the clinical efficacy of superior acromioclavicular ligament reconstruction (SALR) using acellular dermal allograft with that of clavicular hook plate fixation (HP) in patients with acromioclavicular (AC) dislocations. We hypothesized that the SALR could provide more stability than hook plate. Methods: Twenty-two cases of acute AC joint dislocation between November 2021 to December 2023 were retrospectively reviewed. All patients were divided into 2 groups based on the treatment with SALR (12 cases) or HP (10 cases). Patients were evaluated radiologically and clinically using coracoclavicular distance and ratio, pain visual analogue scale (PVAS), Single Assessment Numerical Evaluation (SANE), and American Shoulder and Elbow Surgeons (ASES) at postoperative 3 months and 1 year. We evaluated whether patient achieve MCID of PVAS at the last visit, based on the minimal clinically important differences (MCIDs) of PVAS. Results: The SALR group showed a lower rate of reduction loss (8.3 % vs. 40.0 %) and similar clinical outcomes compared to the hook plate group. Initial SANE score was statistically significantly lower in SALR group (SANE: SALR, 45.8 ± 20.7; HP, 68.0 ± 15.5, p = 0.009), but there were no significant differences in final clinical outcomes, including PVAS, ASES, and SANE scores. Conclusion: SALR with acellular dermal allograft demonstrates comparable clinical outcomes to hook plate fixation and may offer a viable alternative, especially in complicated cases. Study Design: Case series; Level of evidence, 4.

A majority of the patient achieved both patient-acceptable symptom state and minimal clinically important difference of International Knee Documentation Committee Subjective Knee Form score at one year after anatomical double-bundle anterior cruciate ligament reconstruction

ObjectivesThere is a paucity of data about clinical outcomes after double-bundle anterior cruciate ligament reconstruction (DB-ACLR) using the concepts of patient-acceptable symptom state (PASS) and minimal clinically important difference (MCID). The aim of the present study was to evaluate the one-year clinical outcomes of patients who underwent DB-ACLR using PASS and MCID. MethodsAchievement of PASS and MCID were retrospectively evaluated for 298 (mean age 26.9 years; 145 men/153 women) and 214 patients (mean age 23.9 years; 114 males/100 females), respectively, who underwent primary DB-ACLR using a hamstring autograft. For patients who achieved PASS or MCID, demographics, preoperative and postoperative data were statistically analyzed. ResultsOf 298 patients, 254 (85.2%) achieved International Knee Documentation Committee-Subjective Knee Form (IKDC-SKF) PASS and 191 out of 214 patients (88.8%) achieved MCID. The dichotomous logistic regression analyses to assess the achievement of PASS showed that younger age (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.93–0.99; P ​= ​0.013), male sex (OR, 2.2; 95% CI, 1.08–4.83; P ​= ​0.030) and better one-year quadriceps strength symmetry (OR, 1.05; 95% CI, 1.03–1.07; P ​< ​0.001) were independent predictors of PASS achievement. For MCID, preoperative IKDC-SKF score below the 50th percentile (OR, 14.39; 95% CI, 2.90–71.25; P ​= ​0.001) and better one-year quadriceps strength symmetry (OR, 1.035; 95% CI, 1.007–1.064; P ​= ​0.014) were independent predictors for MCID achievement. ConclusionsMore than 85% of the patients achieved PASS and MCID for the IKDC-SKF score one year after undergoing DB-ACLR with hamstring tendon autograft. Better quadriceps strength symmetry at one year contributed to the achievement of both PASS and MCID. Rehabilitation dedicated to quadriceps strength recovery may be important for achieving good clinical outcomes after DB-ACLR. Level of evidenceIV, retrospective cohort.

Endoscopic and microsurgical decompression for central lumbar spinal stenosis

Objective. To perform comparative analysis of the results of endoscopic and microsurgical decompression for lumbar spinal stenosis.Material and Methods. Design: Retrospective monocentric intra-cohort comparison of two groups of patients. The study included 99 patients aged 51–88 years with clinically significant lumbar spinal stenosis manifested by neurogenic intermittent claudication syndrome. Endoscopic decompression was performed in 51 patients, and microsurgical decompression – in 48 patients. To objectify and standardize clinical symptoms, walking distance in meters, pain syndrome and quality of life were assessed before and after surgery using standard scales and questionnaires (VAS, ODI). On the first day after surgery, back and lower limb pain were assessed, and during the observation period back and lower limb pain, quality of life and walking distance were assessed. Functional lumbar radiography was performed to exclude instability of the spinal motion segment. Using MRI, the cross-sectional area of the dural sac at the level of stenosis was measured before and after surgery. Clinical efficacy was assessed using the MCID (Minimal Clinical Important Difference) criterion. The results of the operation were followed-up for 12 months after the operation.Results. Blood loss in the endoscopic intervention group was less than in the microsurgical group. Pain in the lumbar spine and in the lower extremities decreased, and the cross-sectional area of the dural sac increased. In the first days after surgery, patients after endoscopic decompression had less severe back and lower extremity pain than patients after microsurgical decompression due to less soft tissue trauma. Pain syndrome in back 10–12 months after surgery was without statistically significant difference between the groups. Patients after endoscopic decompression had statistically significantly better quality of life according to ODI, lesser pain in the lower extremities according to VAS and longer walking distance than those in the microsurgical decompression group. Surgical treatment in both groups turned out to be effective, which is confirmed by MCID. The time of endoscopic intervention is significantly longer than that of microsurgical intervention. The length of the incision during endoscopic decompression is shorter than that of microsurgical decompression.Conclusion. A comparative analysis of the results of endoscopic and microsurgical decompression for degenerative central lumbar stenosis showed comparable effectiveness of both methods, including an increase in the spinal canal dimension and ensuring regression of clinical symptoms. The results of the comparison do not allow making a sufficiently substantiated judgment on the advantages of one of the methods, which dictates the need for further research.

Quantitative analysis of effectiveness and associated factors of exercise on symptoms in osteoarthritis: a pharmacodynamic model-based meta-analysis

ObjectiveThis study aims to evaluate the time point and magnitude of peak effectiveness of exercise and the effects of various exercise modalities for osteoarthritis (OA) symptoms and to identify factors...

Reliability, validity, and minimal clinically important differences for the Thai-version of the Aberdeen Varicose Vein Questionnaire (AVVQ-Thai) in patients with chronic venous disease

Background Patient-reported outcome measures (PROMs) are essential for assessing the health of patients with chronic venous disease (CVD). Therefore, we aimed to translate the Aberdeen Varicose Vein Questionnaire into Thai language (AVVQ-Thai) and evaluate its reliability and validity. Minimal clinically important differences (MCID) of the AVVQ-Thai also be estimated. Methods International standards for PROM translation were followed including the forward-backwards translation of the AVVQ. Patients with Clinical-Etiology-Anatomy-Pathophysiology (CEAP) C2-C6 with truncal reflux were prospectively included. Venous interventions were used to treat reflux and varicosities. Patients’ characteristics, venous clinical severity scores (VCSS), EuroQol EQ-5D, and AVVQ-Thai were collected pre- and one-month post-intervention. AVVQ-Thai was also collected one to two weeks after the initial visit by reply-paid postal questionnaire. Results The study included 119 patients (30% C2, 29% C3, 28% C4, 11% C5, and 2% C6). The AVVQ-Thai had good internal consistency with Cronbach’s alpha of 0.783 and moderate reliability with the intraclass correlation coefficient of 0.67 (95%CI: 0.50, 0.79). The AVVQ-Thai was significantly correlated with VCSS and was able to discriminate patients with different levels of health problems as assessed by EQ-5D at both pre-and post-intervention, demonstrating good construct and discriminative validity. The median AVVQ scores improved significantly after intervention from 15.4 (IQR 8.3, 24.2) to 4.2 (IQR 1.3, 8.4) in C2-C3, and 18.9 (IQR 14.1, 25.5) to 7.3 (IQR 4.6, 16.3) in C4-C6. The MCID of the AVVQ was 6.21 on the 0-100 scale, which equates to the level of difference necessary to be clinically meaningful. Conclusions AVVQ-Thai has satisfactory evidence for internal consistency, reliability, validity, and responsiveness to change and is recommended for application in Thailand.

Patient-reported disease burden in the Accelerate Clinical Trials in Charcot-Marie-Tooth Disease Study.

The Charcot-Marie-Tooth Disease Health Index (CMT-HI) is a disease-specific, patient-reported disease burden measure. As part of an international clinical trial readiness study, individuals with CMT1A (ages 18-75 years) underwent clinical outcome assessments (COAs), including the CMT-HI, to capture their longitudinal perspective on the disease burden. Two hundred and fifteen participants underwent serial COAs including the CMT-HI, CMT Functional Outcome Measure (CMT-FOM), CMT Neuropathy Score (CMTNSv2R), and CMT Exam Score (CMTES/CMTES-R). Correlations between the total and subscale scores for the CMT-HI and other COAs were determined. Changes in the CMT-HI scores over 12 months were assessed using paired t-tests. The minimum clinically important difference (MCID) for the CMT-HI and its subscales were calculated by anchoring to a participant global impression of change scale. At baseline, CMT1A participants were 44.5 ± 15 years old (range: 18-75) and 58% were women. The mean CMT-HI was 25.7 ± 18.8 (range: 0-91.9; 100 reflecting maximal disease burden). The CMT-HI correlated with the CMT-FOM (r = .54, p < .0001), CMTNSv2R (r = .48, p < .0001), and CMTES/CMTES-R (r = .52/r = .54, p < .0001). Disease burden was greater in women than in men (CMT-HI 29.1 ± 19.1 vs. 21.2 ± 17.3, p = .001). Over 12 months, there was a nonsignificant mean increase in CMT-HI of 0.40 ± 10.0 (n = 189, p = .89). The MCID for the CMT-HI total score was 3.8 points (95% CI: 1.7-5.9). Patient-reported disease burden in CMT1A as measured by the CMT-HI is associated with measures of neurologic impairment and physical functioning. Women reported a higher disease burden than men. These data will inform the design of clinical trials in CMT1A.

Establishing the minimum clinically important difference of the Quality of Life in Childhood Epilepsy Questionnaire.

To estimate the minimum clinically important difference (MCID) for the parent-reported 55-item Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) and its shortened 16-item version, QOLCE-16. Data came from 74 children with epilepsy (CWE) (ages 4-10, mean age = 8 [SD = 1.8]) enrolled in the Making Mindfulness Matter in Epilepsy (M3-E) trial, a pilot, parallel randomized-controlled trial of a mindfulness-based intervention. Both anchor-based and distribution-based methods were used to estimate MCID values for the QOLCE-55 and QOLCE-16. For the anchor-based approach, the Patient Centered Global Ratings of Change (PCGRC) scale and linear regression analysis were used to estimate the MCID. For the distribution-based approach, .5 SD of the health-related quality of life (HRQOL) change score distribution was used to estimate the MCID. For the QOLCE-55, the MCID obtained using an anchor-based approach was 10 points and using a distribution-based method was 6 points. For the QOLCE-16, the MCID obtained using an anchor-based method was 13 points and using a distribution-based method was 7 points. This is the first study to estimate MCID values for the QOLCE-55 and the QOLCE-16. It has been well documented that CWE are at risk of experiencing psychological, behavioral, and cognitive impairments, which can negatively impact their HRQOL. Reporting MCID values for the QOLCE-55 and QOLCE-16 is important in determining whether changes in HRQOL observed are meaningful to CWE themselves, as a key factor in shaping the nature of epilepsy care delivered.

The european organisation for research and treatment of cancer head and neck cancer module (EORTC QLQ-HN43): Estimates for minimal important difference and minimal important change

IntroductionMinimal important change estimates (MIC) are useful for interpreting results of clinical research with quality of life (QoL) as an endpoint. For the European Organisation for Research and Treatment of Cancer head and neck cancer module, the EORTC QLQ-HN43, no such thresholds are established. MethodsHead and neck cancer patients under active treatment (n = 503) from 15 countries completed the EORTC QLQ-HN43 three times (t1: before treatment, t2: three months after t1, t3: six months after t1). A subgroup completed a Subjective Significance Questionnaire (SSQ), indicating experienced change from the previous time point in four QoL domains. QoL was assumed to deteriorate after t1 and improve again until t3. The MIC was established using the average of mean differences in SSQ groups (MICmean) and estimates based on logistic regressions (MICpredict). Additionally, minimal detectable changes (MDC) were computed using 0.5 standard deviation and standard error of the mean. ResultsFor swallowing, speech, dry mouth, and global QoL, the MIC for deterioration were 13, 14, 26, and 10 respectively. The MIC for improvement were 8 (swallowing), 6 (dry mouth), and 5 (global QoL); no MIC for speech improvement can be presented because of insufficient correlation between change score and anchor. The MDC estimates for deterioration were 15, 14, 15, and 11. For improvement, the MDC estimates were 13, 14, 14, and 11. ConclusionsOur results underline that no single MIC or MDC can be applied to all EORTC QLQ-HN43 scales, and that the MIC for deterioration seems larger than those for improvement.

ChatGPT-4 and wearable device assisted Intelligent Exercise Therapy for co-existing Sarcopenia and Osteoarthritis (GAISO): a feasibility study and design for a randomized controlled PROBE non-inferiority trial.

Sarcopenia and osteoarthritis are prevalent age-related diseases that mutually exacerbate each other, creating a vicious cycle that worsens both conditions. Exercise is key to breaking this detrimental cycle. Facing increasing demand for rehabilitation services within this patient demographic, ChatGPT-4 and wearable device may increase the availability, efficiency and personalization of such health care. To evaluate the clinical efficacy and cost-effectiveness of a rehabilitation system implemented on mobile platforms, utilizing the integration of ChatGPT-4 and wearable devices. The study design is a prospective randomized open blinded end-point (PROBE) non-inferiority trial. 278 patients diagnosed with osteoarthritis and sarcopenia will be recruited and randomly assigned to the intervention group and the control group. In the intervention group patients receive mobile phone-based rehabilitation service where ChatGPT-4 generates personalized exercise therapy, and wearable device guides and monitor the patient to implement the exercise therapy. Traditional clinic based face-to-face exercise therapy will be prescribed and implemented in the control group. All patients will receive three-months exercise therapies following the frequency, intensity, type, time, volume and progression (FITT-VP) principle. The patients will be assessed at baseline, one month, three months, and six months after initiation. Outcome measures will include ROM, gait patterns, Visual Analogue Scale (VAS) for pain assessment, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS) for functional assessment, Short-Form Health Survey 12 (SF-12) for quality of life, Minimal Clinically Important Difference (MCID), Patient Acceptable Symptom State (PASS), and Substantial Clinical Benefit (SCB) for clinically significant measures. A rehabilitation system combining the capabilities of ChatGPT-4 and wearable devices potentially enhance the availability and efficiency of professional rehabilitation services, thus enhancing the therapeutic outcomes for a substantial population concurrently afflicted with sarcopenia and osteoarthritis.