Minimal Important Difference Research Articles

Impact of preoperative age-adjusted sagittal imbalance on radiographic and clinical outcomes following 1-level minimally invasive transforaminal lumbar interbody fusion for degenerative spondylolisthesis.

Prior studies investigating the use of minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) for treatment of degenerative lumbar conditions and concomitant sagittal deformity have not stratified patients by preoperative pelvic incidence (PI)-lumbar lordosis (LL) mismatch, which is the earliest parameter to deteriorate in mild sagittal deformity. Thus, the aim of the present study was to determine the impact of preoperative PI-LL mismatch on clinical outcomes and sagittal balance restoration among patients undergoing MI-TLIF for degenerative spondylolisthesis (DS). Consecutive adult patients undergoing primary 1-level MI-TLIF between April 2017 and April 2022 for DS with ≥ 6 months radiographic follow-up were included. Patient-reported outcome measures (PROMs) included the Oswestry Disability Index, visual analog scale (VAS), 12-Item Short-Form Health Survey (SF-12), and Patient-Reported Outcomes Measurement Information System at preoperative, early postoperative (< 6 months), and late postoperative (≥ 6 months) time points. The minimal clinically important difference (MCID) for PROMs was also evaluated. Radiographic parameters included PI, LL, pelvic tilt (PT), and sagittal vertical axis (SVA). Patients were categorized into balanced and unbalanced groups based on preoperative PI-LL mismatch according to age-adjusted alignment goals. Changes in radiographic parameters and PROMs were evaluated. Eighty patients were included (L4-5 82.5%, grade I spondylolisthesis 82.5%, unbalanced 58.8%). Mean clinical and radiographic follow-up were 17.0 and 8.3 months, respectively. The average preoperative PI-LL was 18.8° in the unbalanced group and -3.3° in the balanced group. Patients with preoperative PI-LL mismatch had significantly worse preoperative PT (26.2° vs 16.4°, p < 0.001) and SVA (53.2 vs 9.0 mm, p = 0.001) compared with balanced patients. Patients with preoperative PI-LL mismatch also showed significantly worse PI-LL (16.0° vs 0.54°, p < 0.001), PT (25.9° vs 18.7°, p < 0.001), and SVA (49.4 vs 22.8 mm, p = 0.013) at long-term follow-up. No significant radiographic improvement was observed among unbalanced patients. All patients demonstrated significant improvements in all PROMs (p < 0.05) except for SF-12 mental component score. Achievement of MCID for VAS back score was significantly greater among patients with preoperative PI-LL mismatch (85.7% vs 65.5%, p = 0.045). Although 1-level MI-TLIF did not restore sagittal alignment in patients with preoperative PI-LL mismatch, patients presenting with DS can expect significant improvement in PROMs following 1-level MI-TLIF regardless of preoperative alignment or extent of correction. Thus, attaining good clinical outcomes in patients with mild sagittal imbalance may not require addressing imbalance directly.

Twelve-Month Health Status Response Following Peripheral Vascular Intervention for Femoropopliteal Lesions Using Zilver PTX Databases Focusing on the Role of Preprocedural Health Status, Comorbid Risks, and Global Setting

Tailoring resources of peripheral vascular interventions (PVIs) to those who stand to gain the most would allow for more equitable and value-based care. One way of evaluating the benefit of PVIs in patients with symptomatic peripheral artery disease is evaluating their health status and identifying predictors of health status response 12months after the intervention. Patients who underwent femoropopliteal PVI between March 2005 and August 2008 from the Zilver PTX randomized trial and single-arm study were combined into a single cohort for secondary data analysis. The preprocedural and 12-month health status was assessed by the EuroQol-5D-3L (EQ-5D). First, we evaluated the 12-month EQ-5D Index (per 1-unit increase), adjusted for treatment condition and patient characteristics using a linear regression. Second, using the minimally clinically important difference threshold for the EQ-5D Index, we identified 12-month nonresponders (worsened or no change) vs responders (improved) and conducted an adjusted logistic regression model. A total of 513 patients were included (mean age: 67.8± 9.2years; 25.1% female), with 17.8% U.S. and 82.2% non-U.S. global enrollment sites. The minimally clinically important difference for the EQ-5D was 0.058. For 12-month health status after PVI, a total of 57.9% improved, 31.4% experienced no change, and 10.7% worsened, relative to their preprocedural health status. Patients who were more likely to be nonresponders were more likely to have a history of carotid artery disease or were located at a U.S. enrolling center. The majority of patients reported improved or stable health status after femoral-popliteal PVI. Approximately 4 in 10 patients were nonresponders, with the highest risk for nonresponse including individuals with existing carotid disease or those undergoing PVIs in the U.S. vs non-U.S.

Miniplates versus Headless Screws for Fixation of Displaced Radial Head Fractures: A Randomized Controlled Trial

BackgroundFixation of displaced radial head fractures using miniplates is technically challenging and has some drawbacks like hardware prominence and limitation of forearm rotation. Fixation by headless compression screws has emerged as a less invasive alternative to miniplates. This study compares the radiological and functional outcomes of both methods of fixation. MethodsThis single-center, prospective, randomized controlled trial was conducted at an academic level 1 trauma center. Sixty patients with displaced isolated radial head fractures were randomized to treatment using either headless compression screws or miniplates in 2 parallel groups. At the final follow-up of 18 months, patients were evaluated radiologically for union and clinically using the Mayo Elbow Performance Score (MEPS), elbow range of motion, grip strength, the visual analogue scale (VAS) for pain, and the Disabilities of the Shoulder, Arm, and Hand (DASH) score. ResultsUnion was achieved after 8±1.7 weeks in the screw group and after 8.5±2.7 weeks in the plate group. The MEPS was significantly better in the screw group (87.7±10.7) than in the plate group (80.5±13.9). However, this difference is below the minimum clinically important difference (MCID) for the MEPS and as such may not be clinically meaningful. No significant differences were observed between both groups regarding flexion, extension ranges, VAS, grip strength, or the DASH score. However, supination and pronation were significantly better in the screw group. The rate of complications was higher in the plate group (26.7%) than in the screw group (3.3%). ConclusionBoth techniques yielded comparable outcomes with better forearm rotation, a lower complication rate, and a lower hardware removal rate in the screw group.

Comparable Pain Levels and Functional Outcomes With and Without the Use of Dermal Allograft Augmentation in Endoscopic Gluteus Medius Repair

PurposeTo retrospectively compare the clinical outcomes of patients undergoing endoscopic gluteal tendon repair with and without the use of dermal allograft augmentation. MethodsA retrospective review of prospectively collected data, single-surgeon cohort study was performed on all patients undergoing endoscopic gluteus medius repair (GMR) and gluteus medius repair with augmentation (GMR-A) between April 2017 and April 2022. Dermal allograft augmentation was utilized in cases where intraoperative gluteus tissue quality was poor. An electronic survey of patient-reported outcome measures (PROMs) was completed at a minimum of 1 year postoperatively. PROMs included a Visual Analogue Scale (VAS) for pain; University of California, Los Angeles (UCLA) Activity Scale; modified Harris Hip Score (mHHS); Hip Outcome Score-Sport-Specific Subscale (HOS-SSS); and a Single Assessment Numeric Evaluation (SANE). The proportion of patients achieving the minimal clinically important difference (MCID), patient acceptable symptom state (PASS), and substantial clinical benefit (SCB) for each PROM were compared between groups. ResultsSixty-four patients were reached for follow-up (26 GMR, 38 GMR-A). No differences were found between the groups in terms of demographics. There was a significantly longer time to follow-up in the GMR group (39.4±26.9 vs 24.2±11.7 months, p=0.003). There were no differences between the GMR and GMR-A groups in terms of postoperative PROMs including VAS (3.3±2.6 vs 3.3±2.8, p=0.99), UCLA (5.8±2.1 vs 5.1±2.0, p=0.17), mHHS (70.1±18.1 vs 68.9±17.8, p=0.80), HOS-SSS (67.7±28.9 vs 62.5±30.2, p=0.50), and SANE (71.7±27.9 vs 71.3±22.8, p=0.95). A significantly greater proportion of patients in the GMR group achieved a PASS for UCLA (64% vs. 34%, p=0.02). One patient each in the GMR (3.8%) and GMR-A (2.6%) groups underwent revision gluteus medius repair with dermal allograft augmentation at the final follow-up. ConclusionsOur study demonstrates comparable clinical outcomes with and without the use of dermal allograft augmentation in endoscopic gluteus medius repairs. Level of EvidenceIII, retrospective comparative series

High Survival Rate and Satisfaction at More Than 11-Year Follow-Up After Hip Arthroscopy for Femoroacetabular Impingement Syndrome: Impact of Preoperative Functional Scores, Osteoarthritis, and Chondrolabral Junction Damage on Failure

The purpose of the study was to investigate the survival and durability of clinical improvements following hip arthoscopy (HA) for femoroacetabular impingement syndrome (FAIS) at a minimum of 10-year follow-up. The primary objective was to determine the long-term survival, defined as: lack of conversion to total hip replacement (THR) or subsequent hip joint preservation surgery (HJPS). The secondary objective was to determine which preoperative factors were predictive of failure. Data from patients who underwent HA for FAIS between March 2003 and May 2012 were collected and retrospectively reviewed. Patients who underwent evaluation at a minimum 10-year follow-up, assessed according to hip outcome score - activities of daily living (HOS-ADL) and sport-specific subscale (HOS-SSS), and non-arthritic hip score (NAHS) were included. Satisfaction ratings were collected. Statistical analysis assessed within-group differences and survival. 95 patients with an average follow-up of 11.8 years were included. Mean age was 39.5 ± 11.0 years. Overall THR conversion rate was 24.2%, with a mean time of 3.4 ± 3.2 years. 3.2% required HJPS revision at a mean 3.2 ± 3 years. Survivorship was 72.6% at ten years. 28 patients (73.6% and 75.6%) achieved the minimal clinically important difference (MCID) for HOS-ADL and HOS-SSS, while 33 (84.6%) for NAHS. Patient Acceptable Symptom State (PASS) was achieved by 42 (61.7%), 43 (65.1%) and 44 (64.7%) patients respectively. Comparative analysis between patients who preserved their hip and those who underwent HJPS revision or THR highlighted that Tönnis ≥ 2, chondrolabral junction damage, and lower preoperative scores are associated with failure. HA for FAIS demonstrated durable results, with an accepatable THR conversion rate and sustained clinical benefits. 91.3% of the patients who preserved their hip were satisfied. Tönnis 2, MRA signs of chondrolabral junction damage and lower preoperative functional status are strongly associated with failure.

Patient-reported Physical and Mental Health Outcomes Following Lumbar Spinal Fusion versus Total Hip and Total Knee Replacement

BackgroundTotal hip and knee arthroplasty (THA/TKA) are reliable surgical procedures for alleviating pain and optimizing function. Spinal fusion has also been shown to be beneficial, however the comparative benefit of THA/TKA to lumbar spinal fusion is incompletely understood. MethodsThis study analyzed a single-center database of patients who underwent primary lumbar spinal fusion, elective primary TKA, or THA. PROMs included Veterans-Rand (VR12) Physical and mental component score (PCS/MCS) for TKA/THA and PROMIS (Patient-Reported Outcomes Measurement Information System) global mental and physical health (GPH/GMH) for spinal fusion. Results356 patients who underwent TKA, 290 underwent THA, and 125 underwent spinal fusion were included. Joint replacement patients were older, with higher body mass index in the TKA group. Spine patients had a lower improvement in physical health than the joint patients (TKA: 9.4 ± 11.2, THA: 15.2 ± 11.2, Spine: 6.2 ± 8.7, p<.001) and a lower proportion of patients reaching the minimal clinically important difference (MCID). Spine patients had higher GMH improvements compared to TKA patients (TKA: -1.1 ± 10.7, THA: 1.1 ± 11.9, Spine: 1.8 ± 8.4, p=.009) and the highest proportion of patients reaching the MCID. ConclusionSpinal fusion, total knee arthroplasty, and total hip arthroplasty all significantly improved PROMs at 1-year follow-up. At baseline, spinal fusion patients had better physical function scores and worse mental health scores compared to joint arthroplasty patients, while spinal fusion resulted in mean smaller gains in patient reported physical function and higher gains in patient reported mental health function compared to arthroplasty.

Mesenchymal Stem Cells Injection Is More Effective Than Hyaluronic Acid Injection in the Treatment of Knee Osteoarthritis With Similar Safety: A Systematic Review and Meta-Analysis

PurposeTo evaluate the Efficacy and safety of intra-articular injection of mesenchymal stem cells (MSCs) versus Hyaluronic acid (HA) in the treatment of knee osteoarthritis (KOA). MethodsEligible randomized controlled trials (RCTs) were identified through a search of Pubmed, Embase, the Cochrane Library, Web of science, SinoMed and CNKI databases from inception to March 2024. For meta-analysis, data on clinical outcomes were measured using a visual analog scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and data on cartilage repair were measured using the Whole-Organ Magnetic Resonance Imaging Score (WORMS); data on safety was evaluated by the incidence of adverse events. Two researchers independently read the included literatures, extracted data and evaluated the quality, and used Cochrane risk bias assessment tool for bias risk assessment, and RevMan5.3 software for Meta-analysis. Result：Ten RCTs involving 818 patients with KOA ranging from I-Ⅲ Kellgren – Lawrence grading scale were included in this meta-analysis. Meta results showed that compared with the HA control group, at 12months, the WOMAC total score [MD=-10.22, 95% CI (-14.86∼-5.59), P<0.0001, Z=4.32];VAS score[MD=-1.31, 95% CI (-1.90∼-0.73), P<0.0001, Z=4.40]; WORMS score [MD=-26.01,95% CI (-31.88∼-20.14),P<0.001,Z=8.69]of MSCs group all decreased significantly (P<0.05), and reached the minimum clinically important differences (MCID). Furthermore, there was no significant difference in the incidence of adverse events (RR=1.54, 95% CI= 0.85 ∼ 2.79, P=0.16, I2=0) between the two groups (P >0.05). ConclusionCompared to HA, intra-articular injection of MSCs therapy appears to effectively alleviate joint pain, improve clinical function of KOA patients. These benefits are observed to last for at least 12 months without an increase in adverse events. Due to limited, varied, and lacking MCID results in existing literature, further research is needed. Level of EvidenceLevel I, Meta-analysis of Level I studies.

Postoperative Effusion-Synovitis Is Associated With Poor Clinical Outcomes in Patients With Femoroacetabular Impingement Syndrome

Purpose(1) to investigate the consecutive changes in effusion-synovitis following primary arthroscopic treatment for patients with femoroacetabular impingement syndrome (FAIS), and (2) to determine the effect of postoperative effusion-synovitis on clinical outcomes. MethodsData between March 2021 and January 2022 was reviewed. Patients diagnosed with FAIS and undergoing hip arthroscopic treatment were included. Exclusion criteria were incomplete magnetic resonance imaging (MRI) data, prior history of hip surgery, labral reconstruction, and concomitant hip conditions. MRI (non-contrast 3.0 T) was performed preoperatively and 3, 6, 12-month postoperatively, and the measurement of the largest femoral neck fluid thickness (FTM) and cross-sectional area (CSA) of the effusion-synovitis were collected. Preoperative and a minimum of 2-year postoperative patient-reported outcome (PRO) scores including Visual Analog pain Scale (VAS), modified Harris Hip Score (mHHS), and international Hip Outcome Tool, 12-component form (iHOT-12) were collected and compared. Postoperative Tegner activity scale was also collected. The PROs and achievements of minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) were compared between patients with and without postoperative effusion-synovitis. Multivariate linear regression analysis was performed to determine the effect of the effusion-synovitis size on PROs. ResultsA total of 61 patients (61 hips) were included in the study. The 3-month postoperative FTM, CSA and grade of effusion-synovitis presented a significant increase compared to the preoperative values (all with P < .05). No significant differences were observed in the 6-month postoperative measurements compared to the preoperative values (all with P > .05). At the 12-month follow-up, although there was a significant decrease in all measurements compared to the preoperative values (all with P < .001), 39 patients (63.9%) still presented effusion-synovitis. Compared to the other 22 patients (36.1%) without effusion-synovitis, these patients presented inferior mHHS, iHOT-12 (all with P < .05), as well as lower achievement of PASS of mHHS (82.1% vs 100%, P = .035) and iHOT-12 (38.5% vs 81.8%, P = .001). The achievement of MCID of mHHS (79.5% vs 77.3%, P = .839) and iHOT-12 (89.7% vs 95.5%, P = .839) were comparable between patients with and without effusion-synovitis. The postoperative sagittal CSA (Beta = -.302, P = .039) were negatively related to mHHS in the regression analysis. ConclusionAfter arthroscopic treatment for FAIS, the level of effusion-synovitis presented an initial increase, then followed by a subsequent decrease. Effusion-synovitis was significantly alleviated at 12 months compared to the preoperative level. Patients with postoperative effusion-synovitis had inferior clinical outcomes and lower achievement of PASS compared to those without. Level of EvidenceLevel IV; retrospective case series.

Long-term patient-reported outcomes of open subpectoral biceps tenodesis with cortical button fixation.

Open subpectoral biceps tenodesis (OSBT) with cortical button fixation has been shown to deliver acceptable results in the short and intermediate term for long head of the biceps (LHB) pathology with the benefit of smaller bone tunnel diameter and a reduced risk of postoperative humeral shaft fracture. The primary purpose of this study was to determine whether OSBT with cortical button fixation results in significant improvements in patient reported outcomes (PROs) from pre-operative to long-term final follow-up. A retrospective analysis of patients who underwent OSBT with cortical button fixation at a single institution between the years of 2012 and 2014 was conducted and PROs were collected in the intermediate (> 2years follow-up) and long term (> 9years follow-up). PROs were measured pre-operatively, at intermediate follow-up, and at long-term follow-up using three validated questionnaires: American Shoulder and Elbow Surgeons (ASES) score, Disabilities of the Arm, Shoulder, and Hand (DASH) score, and Oxford Shoulder Score (OSS). Patients were additionally asked at final follow-up if they would undergo the same procedure again if they needed it. Twenty-nine (29) patients with a mean age of 51.16 ± 9.06years at the time of surgery were included in the study at final follow-up. Mean final follow-up time was 10.2 ± 0.5years (range: 9.2-11.1years). All PROs (ASES, OSS, and DASH) demonstrated statistically significant improvements from pre-operative to final follow-up with p < 0.01 for each. The proportions of patients exceeding established values for minimum clinically important difference (MCID) were 96.55%, 93.10%, and 75.86% for ASES, OSS, and DASH respectively. Only one patient had required re-operation as of final follow-up. None experienced humeral fractures post-operatively. A significant majority (89.66%; p < 0.01) of patients reported that they would undergo the same procedure again if they needed it. Fifty-three (53) patients were included in the study at intermediate follow-up with a mean follow-up time of 3.5 ± 1.4years (range: 2-5.3years). There were no statistically significant differences in any of the PRO measures from intermediate to long-term follow-up. This study reported a minimum 9-year follow-up of patients undergoing OSBT with cortical button fixation for the management of LHBT pathology in the setting of concomitant shoulder procedures. All patients had significantly improved functional outcomes assessed with ASES, OSS, and DASH and no obvious differences in median group scores were found between patients assessed at intermediate (mean 3.5years) and final (mean 10.2years) follow-up. No infections, fractures, or fixation failures were reported.

Arthroscopic Autologous Iliac Crest Grafting with an Adjustable Loop Suspensory Device Yields Favorable Outcomes for Anterior Shoulder Instability with Glenoid Defects.

This study aims to evaluate the clinical and radiological outcomes of the arthroscopic autologous iliac crest grafting (AICG) procedure with an adjustable-loop suspensory fixation device in the treatment of anterior shoulder instability (ASI) with glenoid bone defects. A retrospective review was conducted on the patients who underwent arthroscopic AICG with an adjustable-loop suspensory fixation device from January 2017 to December 2020. Patients with traumatic ASI, significant glenoid bone defects, and a minimum follow-up of 24 months were included. Patient-reported outcomes (PROs), including the Oxford Shoulder Instability Score (OSIS), the Rowe score, the Walch-Duplay score, the Constant score, and the Visual Analogue Score (VAS), were compared preoperatively and postoperatively. Radiological assessments using computed tomography (CT) were performed before and after the procedure. Additional data on active range of motion, recurrence events, and complications were recorded. A total of 42 patients were included in the study, with a mean follow-up time of 35.2 months ranging from 25.1 to 55.9 months. Mean preoperative OSIS, Rowe score, Walch-Duplay score, and Constant score significantly improved from 24.4±7.2, 25.0±9.0, 25.2±9.8, 87.5±7.1 to 42.4±4.9, 92.4±8.1, 87.9±8.3, 93.6±4.5 at the last follow-up, respectively. All patients exceeded the minimal clinically important difference (MCID) for OSIS, Rowe, and Walch-Duplay scores. The graft union rate was 100%, and the glenoid area increased significantly from 82.5% preoperatively to 100.1% at the final follow-up. No patient experienced a recurrence of instability. Two recorded complications included one case of dysesthesia around the donor site and one case of postoperative shoulder stiffness. The outcomes of the arthroscopic AICG procedure, which utilizes an adjustable-loop suspensory fixation device, demonstrated stable bone graft fixation, high rates of graft integration, favorable clinical results, and a low incidence of complications. Moreover, the remodeling of the graft during the follow-up period significantly restored the width and concavity of the inferior glenoid, contributing to the overall recovery. Level IV, retrospective case series.

Initial Outcomes of Single versus Multiple-Plug Osteochondral Allograft Transplantation for Osteochondral Defects of the Knee: A Matched Cohort Analysis.

Although several prior studies have described the outcomes of osteochondral allograft (OCA) transplantation for single osteochondral lesions, there is a paucity of comparative data on outcomes of single versus multiple OCA transplants. We aimed to describe the initial outcomes of single-plug versus multiple-plug knee OCA transplants at a minimum of 1 year of follow-up. We hypothesized that there would be no difference in patient-reported outcome measures (PROMs) between patients undergoing single-plug and multiple-plug OCA transplants at a minimum of 1 year of follow-up. We retrospectively reviewed the prospectively collected data of patients undergoing OCA transplantation for large (>2 cm2) osteochondral defects of the knee. Thirty patients who underwent multiple-plug (2 + ) OCA transplants (either single surface using the snowman technique or multi-surface) were 1:1 age, sex, and body mass index (BMI) matched with 30 patients who underwent single-plug OCA transplants. PROMs, including the International Knee Documentation Committee (IKDC) and Knee Injury and Osteoarthritis Outcome Score (KOOS) subscores, were obtained both preoperatively and at a minimum of 1 year postoperatively. Failure was defined as a revision OCA or conversion to unicompartmental knee arthroplasty (UKA) or total knee arthroplasty (TKA). The cohort comprised 30 females (31 affected left knees), with an average age of 37 ± 10.3 years and median follow-up of 2.0 years (interquartile range: 1.7-2.5 years). There was a significant increase in PROMs from the preoperative to the postoperative period for the entire cohort and the single-plug versus multiple-plug subgroups (p < 0.01). There was no difference between the groups with respect to the percentage of patients who achieved the minimal clinically important difference (MCID) for each PROM (p > 0.05). There were two failures, both in the single-plug group, with a mean time to failure of 3.5 years. There was no difference in the initial outcomes between patients undergoing single-plug versus multiple-plug OCA transplant at the short-term follow-up. LEVEL OF EVIDENCE:: Level IV, case series.

Systematic review reveals that EQ-5D minimally important differences vary with treatment type and may decrease with increasing baseline score

ObjectivesTo provide an updated summary of published anchor-based Minimally Important Difference (MID) estimates for the EQ-5D index and EQ visual analog scale (EQ VAS) scores and identify factors influencing those estimates. Study Design and SettingWe systematically searched eight electronic databases from January 1990 to March 2023. We examined the association of baseline score, type of score change (improvement/worsening), data source, value set, disease/condition, treatment type (surgical/non-surgical), and type of anchor (clinical vs. self-rated) with MID estimates for the EQ-5D-3L and EQ-5D-5L indices, and EQ VAS. Significant variables were used to develop prediction formulas for MID by testing both linear and nonlinear regression models. ResultsOf 6786 records reviewed, 47 articles were included for analysis. MID ranges for improved scores were −0.13 to 0.68 (EQ-5D-3L), 0.01–0.41 (EQ-5D-5L), and 0.42–23.0 (EQ VAS). Surgical intervention and lower baseline scores were associated with higher MIDs for both the EQ indices but not for EQ VAS. The nonlinear polynomial model outperformed the linear model in predicting the MIDs. MIDs based on deteriorated scores were insufficient for quantitative synthesis (mean: −0.02 for EQ-5D-3L; −0.04 for EQ-5D-5L; and −6.5 for EQ VAS). ConclusionThis review revealed that the MID of EQ-5D index scores varies with baseline score and treatment type, indicating that use of a uniform MID may not be appropriate. We recommend using baseline score-adjusted and treatment type-specific EQ-5D MIDs, and call for more MID research, particularly in the context of assessing deterioration in health using this widely used generic health-status instrument.

Comparison of Time and Rate of Achieving Minimal Clinically Important Difference: Robotic Versus Manual Unicompartmental Knee Arthroplasty.

Robotics in unicompartmental knee arthroplasty (UKA) continues to increase with the ever-growing demand to use technology in the surgical setting. However, no studies have used minimal clinically important difference (MCID) to compare patient-reported outcome measures (PROMs) between robotic UKA (rUKA) and manual UKA (mUKA). This study aimed to compare the rate of achieving MCID for improvement (MCID-I) and worsening (MCID-W) and the time to achieving MCID. We conducted a retrospective analysis of robotic and manual UKAs performed between 2016 and 2022. Preoperative and postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical, PROMIS Physical Function Short-Form 10a (PF-10a), and Knee Injury and Osteoarthritis Outcome Score-Physical Function Short-Form (KOOS-PS) scores were collected. Patients were stratified on reaching MCID-I, MCID-W, or "no notable change" (score between MCID-W and MCID-I). Survival curves with and without interval censoring were used to assess the time to achieving the MCID. Log-rank and weighted log-rank tests were used to compare groups. A total of 256 UKAs (64 robotic and 192 manual) were analyzed. No differences were observed in the proportion of patients achieving MCID-I or MCID-W across all three PROMs. Similarly, median time to achieving MCID showed no significant differences between rUKA and mUKA for PROMIS Global Physical (3.3 versus 4.9 months, P = 0.44), PROMIS PF-10a (7.7 versus 8.3 months, P = 0.93), and KOOS-PS (3.0 versus 6.0 months, P = 0.055) scores, both with and without interval censoring. This study indicates that rUKA and mUKA exhibit comparable rates of achieving MCID-I and MCID-W, along with similar median time to reach MCID. These findings offer valuable patient-centric insights into the effectiveness of rUKA. Additional studies evaluating the long-term outcomes of rUKA are needed to determine its long-term advantages. Level III, retrospective comparative study.

Does preoperative forward elevation weakness affect clinical outcomes in anatomic or reverse total shoulder arthroplasty patients with glenohumeral osteoarthritis and intact rotator cuff?

This study sought to determine if preoperative forward elevation (FE) weakness affects outcomes of anatomic (aTSA) and reverse total shoulder arthroplasty (rTSA) for patients with rotator cuff-intact glenohumeral osteoarthritis (RCI-GHOA). A retrospective review of a single institution's prospectively collected shoulder arthroplasty database was performed between 2007 and 2020, including 333 aTSAs and 155 rTSAs for primary RCI-GHOA with a minimum 2-year follow-up. Defining preoperative weakness as FE strength ≤4.9 lb (2.2 kg), three cohorts were matched 1:1:1 by age, sex, and follow-up: weak (n=82) to normal aTSAs, weak (n=44) to normal rTSAs, and weak aTSAs (n=61) to weak rTSAs. Compared outcomes included range of motion, outcome scores, and complication and revision rates at latest follow-up. Weak aTSAs and weak rTSAs achieved similar postoperative outcome measures to normal aTSAs and normal rTSAs, respectively (P>0.05). Compared to weak rTSAs, weak aTSAs achieved superior postoperative passive (P=0.006) and active external rotation (ER) (P=0.014) but less favorable postoperative Shoulder Pain and Disability Index (P=0.032), American Shoulder and Elbow Surgeons (P=0.024), and University of California, Los Angeles scores (P=0.008). Weak aTSAs achieved the minimal clinically important difference and substantial clinical benefit at a lower rate for abduction (P=0.045 and P=0.003) and FE (P=0.011 and P=0.001). Weak aTSAs had a higher revision rate (P=0.025) but a similar complication rate (P=0.291) compared to weak rTSAs. Patients with RCI-GHOA and preoperative FE weakness obtain postoperative outcomes similar to patients with normal preoperative strength after either aTSA or rTSA. Preoperatively, weak aTSAs achieved greater ER but lower rates of clinically relevant improvement in overhead motion compared to weak rTSAs. Level of evidence: III.

Surgical hip dislocation technique through the femoral head fovea fenestration and impaction bone grafting for the treatment of non-traumatic osteonecrosis of the femoral head: a retrospective study

BackgroundOsteonecrosis of the femoral head (ONFH) often leads to the collapse of the femoral head, ultimately resulting in patients undergoing premature total hip arthroplasty (THA). The surgical hip dislocation (SHD) technique is a type of hip-preserving surgery aimed at delaying or avoiding THA. This study aims to evaluate the clinical efficacy of SHD techniques through femoral head fovea fenestration and impaction bone grafting for the treatment of non-traumatic ONFH.MethodsA retrospective analysis was conducted on the clinical data of 39 patients (39 hips) with non-traumatic ONFH who underwent SHD for treatment from 2016 to 2017. The Harris hip score (HHS) and the minimum clinically important difference (MCID) are used to evaluate clinical outcomes, while radiographic evaluations are conducted using X-rays. Kaplan-Meier survival analysis defined clinical failure as further THA, and conducted univariate survival analysis and Cox regression analysis. Any complications were recorded.ResultsAll patients were followed up for 24–72 months, with an average of (60 ± 13.0) months. At the last follow-up, based on the HHS, 25 patients (64.1%) reported excellent and good clinical outcomes. 29 patients (74.3%) achieved MCID. Imaging evaluation of the postoperative femoral head status showed that 6 cases improved, 20 cases remained stable, and 13 cases showed progressed. Out of 39 hips, 12 hips had postoperative clinical failure, resulting in a clinical success rate of 69.2%. Association Research Circulation Osseous (ARCO) stage, China-Japan Friendship Hospital (CJFH) classification, and postoperative crutch-bearing time are risk factors for clinical failure. Postoperative crutch-bearing time of less than 3 months is an independent risk factor for clinical failure. After surgery, there was one case of sciatic nerve injury and one case of heterotopic ossification. There were no infections or non-union of the greater trochanter osteotomy.ConclusionThe SHD technique through the femoral head fovea fenestration and impaction bone grafting provides a safe and effective method for treating non-traumatic ONFH, with good mid-term clinical outcomes. ARCO staging, CJFH classification, and postoperative crutch-bearing time are risk factors that affect clinical outcomes after surgery and lead to further THA. Insufficient postoperative crutch-bearing time is an independent risk factor for clinical failure.

Impact of High Risk of Obstructive Sleep Apnea on Health-Related Quality of Life: The Korean National Health and Nutrition Survey 2019-2021.

Background/Objectives: Obstructive sleep apnea (OSA) impairs quality of life (QoL). However, its disease burden in the general population remains unknown. We aimed to investigate the association between OSA and health-related QoL in the general Korean population. Methods: This study analyzed cross-sectional datasets of adults (≥40 years) in the Korean National Health and Nutrition Examination Survey 2019-2021. QoL was assessed using the 3-level EuroQoL 5-dimension component (EQ-5D-3L). The high risk of OSA was determined using the STOP-Bang questionnaire (score ≥ 3). Demographic and clinical factors were included in linear regression analyses to identify the factors associated with EQ-5D-3L. Results: Of the 8966 total participants, 6792 (75.8%) and 2174 (24.2%) were classified as having a low risk and high risk of OSA, respectively. The high risk OSA group showed significantly lower QoL scores when compared with the low risk OSA group (0.939 ± 0.003 vs. 0.951 ± 0.002, p < 0.001). However, the mean difference was within the minimal clinically important difference (MCID) of EQ-5D-3L. Only females exceeded the MCID for the EQ-5D-3L. Elderly females with a high risk of OSA showed the lowest QoL. The regression coefficient of high risk OSA in the multivariate model was -0.018 (95% CI: -0.025--0.01, p < 0.001). Patient demographics and comorbidities also showed significant associations with the EQ-5D-3L. Their regression coefficient was higher than that of high risk OSA. Conclusions: The impact of high risk OSA on QoL manifested differently according to age and sex. The impact of comorbidities on QoL was greater than that of high risk OSA, highlighting the important role of comorbidities and the need for their adjustment in the assessment of QoL.

The timed 100 mL water swallow test for patients with head and neck cancer: What constitutes a clinically significant difference?

Swallowing function in patients with head and neck cancer (HNC) is often assessed pre-treatment, during and at intervals post-treatment to identify those with dysphagia as early as possible. This study aims to investigate the minimal clinical important difference (MCID) for the 100 mL water swallow test (100 mL WST) to increase its utility in clinical practice and in clinical trials. Data from 211 HNC patients, treated byeither single or combined modality were included. Patients completed both the 100 mL WST and M.D. Anderson Dysphagia Inventory (MDADI) at baseline (i.e., prior to treatment) and 12 months post-treatment. The MCID for the 100 mL WST was calculated using two approaches of the anchor-based method (using the MDADI), including mean change, and ROC curve. Additionally, the distribution-based method was used utilizing the half standard deviation approach. In the anchor-based method, a 4 mL/s in the 100 mL WST was defined as an MCID for deterioration, with a sensitivity of 75% and a 1-specificity of 46%. In contrast, a change of 5 mL/s was deemed as an MCID for improvement, based on the distribution-based method. The findings showed that deterioration of 4 mL, or an increase of 5 mL from baseline to 12 months post-HNC treatment equates to an MCID from the patients' perspective. Based on these findings, it may be beneficial to increase the utilization of the 100 mL WST in clinical practice to observe the changes, and in clinical trials to interpret and compare different study arms.

Estimating minimal clinically important difference (MCID) for gastrointestinal symptoms in cystic fibrosis

BackgroundMinimal clinically important difference (MCID) is important to establish as a meaningful outcome in research when using patient reported outcome measures (PROMs). We determined the MCID using the distribution-based approach for three measurements used as part of the GALAXY study, which is an observational prospective study on gastrointestinal (GI) symptoms in cystic fibrosis (CF). MethodsFour hundred and two persons with cystic fibrosis (PwCF) participated in the GALAXY study, all with baseline values available for all questionnaires. Mean age was 20.9 years (2.1- 61.1) with 75 females and 94 males under the age of 18 (42.04 %) and 118 females and 115 males aged 18 or older (57.99 %). MCID was measured for Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Upper Gastrointestinal Symptoms (PAGI-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL) and their subscales. Two distribution-based approaches, defined as multiplications of the standard deviation (SD) or standard error of the mean (SEM), were used to approximate the MCID. ResultsThe two distribution-based approaches for determining the MCID estimates produced comparable results in trends in MCIDs across the subscales and total scores. In general, MCID estimates of subscales for all three measurements were higher than their total score MCIDs. The one-half SD- and SEM-based MCID estimates for total scores of each questionnaire are as follows: PAC-SYM: 0.26 and 0.14; PAGI-SYM: 0.32 and 0.15; PAC-QOL: 0.27 and 0.18, respectively. ConclusionThis paper establishes initial MCIDs estimated by the distribution-based approach for the PAC-SYM, PAGI-SYM and PAC-QOL that can now be used to evaluate interventional studies that may impact gastrointestinal symptoms in PwCF.

Improving the Impact of BODY-Q Scores Through Minimal Important Differences in Body Contouring Surgery: An International Prospective Cohort Study.

The BODY-Q is a widely used patient-reported outcome measure for comprehensive assessment of treatment outcomes specific to patients undergoing body contouring surgery (BCS). However, for BODY-Q to be meaningfully interpreted and used in clinical practice, minimal important difference (MID) scores are needed. A MID is defined as the smallest change in outcome measure score that patients perceive important. The aim of this study was to determine BODY-Q MID estimates for patients undergoing BCS to enhance the interpretability of the BODY-Q. Data from an international, prospective cohort from Denmark, Finland, Germany, Italy, the Netherlands, and Poland were included. Two distribution-based methods were used to estimate MID: 0.2 standard deviations of mean baseline scores and the mean standardized response change of BODY-Q scores from baseline to 3 years postoperatively. A total of 12,554 assessments from 3,237 participants (mean age; 42.5±9.3 years; body mass index; 28.9±4.9 kg/m2) were included. Baseline MID scores ranged from 1 to 5 in the health-related quality of life (HRQL) scales and 3 to 6 in the appearance scales. The estimated MID scores from baseline to 3 years follow-up ranged from 4 to 5 in HRQL and from 4 to 8 in the appearance scales. The BODY-Q MID estimates from before BCS to 3 years postoperatively ranged from 4 to 8 and are recommended for use to interpret patients' BODY-Q scores, evaluate treatment effects of different BCS procedures, and for calculating sample size for future studies.

Prolonged Fatigue and Mental Health Challenges in Critical COVID-19 Survivors.

Background: The aim of this study was to investigate the development of fatigue and mental illness between 3 and 12 months after critical COVID-19 and explore risk factors for long-lasting symptoms. Study Design and Methods: A prospective, multicenter COVID-19 study in southern Sweden, including adult patients (≥18 years) with rtPCR-confirmed COVID-19 requiring intensive care. Survivors were invited to a follow-up at 3 and 12 months, where patient-reported symptoms were assessed using the Modified Fatigue Impact Scale (MFIS), the Hospital Anxiety and Depression Scale (HADS) and the Posttraumatic Stress Disorder Checklist version 5 (PCL-5). The development between 3 and 12 months was described by changes in relation to statistical significance and suggested values for a minimally important difference (MID). Potential risk factors for long-lasting symptoms were analyzed by multivariable logistic regression. Results: At the 3-month follow-up, 262 survivors (87%) participated, 215 (72%) returned at 12 months. Fatigue was reported by 50% versus 40%, with a significant improvement at 12 months (MFIS; median 38 vs. 33, P < .001, MID ≥4). There were no significant differences in symptoms of mental illness between 3 and 12 months, with anxiety present in 33% versus 28%, depression in 30% versus 22%, and posttraumatic stress disorder in 17% versus 13%. A worse functional outcome and less sleep compared to before COVID-19 were risk factors for fatigue and mental illness at 12 months. Conclusions: Fatigue improved between 3 and 12 months but was still common. Symptoms of mental illness remained unchanged with anxiety being the most reported. A worse functional outcome and less sleep compared to before COVID-19 were identified as risk factors for reporting long-lasting symptoms.