Length Of Follow-up Research Articles

Diagnostic interval of inflammatory bowel disease in Chinese children and its relationship with growth parameters: a retrospective study

BackgroundDelayed diagnosis of inflammatory bowel disease (IBD) is common in Europe and North America, with limited research in Asia. We aimed to investigate factors influencing delayed diagnosis of IBD in Chinese children and the impact of delayed diagnosis on growth.MethodsThis was a retrospective study. Clinical data on children with IBD were collected through electronic medical records. The diagnostic interval includes the time from symptom onset to hospital admission and admission to diagnosis. Diagnostic delay was defined as the upper quartile of the time interval from the first symptom to the diagnosis of IBD. For the effect on growth indicators, the length of follow-up was at least 3 months from diagnosis.ResultsThis study included 222 children with IBD, predominantly with Crohn's disease (86.0%). Approximately one-quarter of children require more than 366 days to be diagnosed with IBD, primarily due to the extended interval between the onset of initial symptoms and hospital admission. Multivariate logistic regression models showed that fever was associated with a prolonged time interval from first symptom onset to admission and the odds ratio (OR) was 0.45 [95% confidence interval (CI) 0.22–0.94]. Age and bloody stools were associated with prolonged intervals from admission to diagnosis, with ORs of 0.84 (95% CI 0.77–0.92) and 0.36 (95% CI 0.14–0.94), respectively. Delayed diagnosis was associated with height at first admission and follow-up. Children with a delayed diagnosis had a 5.87-fold higher chance of growth retardation upon initial admission compared to children without a delayed diagnosis (95% CI 1.59–24.05). After 15.7 months of follow-up, this elevated risk remained (OR 3.28, 95% CI 1.00–10.50).ConclusionDelayed diagnosis is common in Chinese children with IBD and is associated with persistent height impairment.

Ketone Bodies Are Potential Prognostic Biomarkers in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Results from the R2-GDP-GOTEL Trial

Background: Patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are ineligible for high-dose chemotherapy have limited treatment options and poor life expectancy. The purpose of this study is to identify a serum metabolomic profile that may be predictive of outcome in patients with R/R-DLBCL. Methods: This study included 69 R/R DLBCL patients from the R2-GDP-GOTEL trial (EudraCT 2014-001620-299). Serum samples were collected at baseline, and the mean length of follow-up was 41 months. Serum metabolites were analyzed by nuclear magnetic resonance (NMR). Metabolites were correlated with treatment response, progression-free survival (PFS), and overall survival (OS). Results: Serum levels of 3-hydroxybutyrate (3OHB) and acetone were significantly (p < 0.001) associated with PFS (3OHB: hazard ratio [HR] 7.7, 95% confidence interval [CI] 2.5–24.1; acetone: HR 9.32, 95% CI 2.75–31.6) and OS (3OHB: HR 9.32, 95% CI 2.75–31.6; acetone: HR 1.92, 95% CI 1.36–2.69). Serum values of 141 µM for 3OHB and 40 µM for acetone were the optimal cutoffs associated with the survival outcomes. Elevated 3OHB levels (>141 μM) were specific to the ABC subtype of DLBCL, while acetone levels were elevated in both types of DLCBL but more pronounced in ABC cases. In a multivariate survival analysis, including the International Prognostic Index (IPI) score and refractoriness status (R/R), 3OHB and acetone remained significant. To aid oncologists employing the R2-GDP regime, we constructed PFS and OS nomograms for R/R-DLBCL risk stratification, incorporating 3OHB levels or acetone levels, IPI score, and refractoriness status. The nomogram with 3OHB and refractoriness status showed a time-dependent AUC of 0.86 for 6-month PFS and 0.84 for 12-month OS. These nomograms provide a comprehensive tool for individualized risk assessment and treatment optimization. Conclusions: The ketone bodies 3OHB and acetone are potential prognostic biomarkers of poor outcome in R/R DLBCL patients treated with the R2-GDP regimen, independently of IPI score and chemorefractoriness status.

Predictors of mortality in a large cohort of elders with essential tremor.

Prospective data show an increased risk of mortality in essential tremor (ET). Understanding the contributors to this increased mortality is of value. 347 cases enrolled in a prospective study of cognition in elders with ET (M baseline age = 79.6 years, M follow-up length = 2.7 years). At each visit, cases completed clinical assessments, a cognitive test battery and were assigned a Clinical Dementia Rating (CDR). Cox proportional hazards regression equations identified predictors of cases' relative risk of mortality. 41 (11.8%) of 347 cases died during follow-up. Deceased cases were older at baseline, had fewer years of education, used more medication, had more severe tremor, had more gait impairment, and reported more falls, less physical activity, and more depressive symptoms than did living cases. In univariate analyses, a CDR score of 1 or 2 (dementia) was associated with a six-fold increased the risk of mortality (Hazards ratio, HR = 6.33). Moderate rather than milder levels of dementia (CDR 2 rather than 1) were driving this effect, with multivariate models demonstrating HRs in excess of 7.5 (p <0.001). Gait impairment and falls were also associated with significant increased risk of mortality in multivariate models. We identified several factors that may be used to risk-stratify ET patients with respect to mortality. The information from these analyses can be of value in identifying subgroups of ET patients who demonstrate risk for early death; such subgroups can then be targeted for interventions as well as preventive measures.

Effect of Resurfaced Patellar Thickness on Outcomes after Total Knee Arthroplasty: Paper for Salman and Karen to process.

Total knee arthroplasty (TKA) is the gold standard for treatment of end stage knee osteoarthritis. Patellar resurfacing is an optional step in the procedure and remains a controversial topic of discussion. This retrospective study aims to assess the impact of over-resecting and under-resecting the patella during resurfacing on patient reported outcomes (PROMs) and range of motion (ROM) after surgery. 438 (92.2%) of 475 patients who underwent TKA between August 2017 and November 2019 at a single center by a single surgeon were included in the analysis. Patients were split into three study groups based on reconstructed patellar thickness; normal resection (NR) was defined as within 2 mm native thickness, over-resected (OR) was defined as ≤ -2 mm, and under-resected (UR) was defined as ≥ 2 mm. Statistical analyses included chi-squared test, mixed effect models, and cox proportional hazards models. There were 364, 41, 33 patients were in NR, OR, UR group respectively. The cohort mean age at time of surgery was 67.1 ± 9.1 and had mean length of follow-up of 2.1 ± 1.7 years with no difference among cohorts. Significant differences were found in gender (p<0.001) and BMI (p=0.0134) with UR having less males, OR having more males, and OR having lower BMI. At 6 months, the complete cohort ROM improved from 108.7 ± 14.4 degrees to 111 ± 11 degrees, objective Knee Society Score (KSS) increase from 15.4 ± 11.2 to 36.2 ± 12, functional KSS increase from 47.3 ± 18.9 to 65.6 ± 22.2, and knee injury and osteoarthritis outcome score increase from 46.1 ± 15 to 70.7 ± 15 with no significant differences among cohorts. There were no patellofemoral related complications. This study supports that while it is important to restore the anatomy in the anterior compartment of the knee, minor changes in patellar thickness from patellar resurfacing likely have minimal impact on outcomes for patients. Further studies with a larger sample size are necessary to further validate these findings.

National Implementation of a Crisis Resolution Home Treatment (CRHT) Team in Malta: Insights From the First Two Years of Operation.

Crisis Resolution Home Treatment (CRHT) teams have become a widespread alternative to psychiatric hospitalisation. Despite their popularisation, Malta has only recently introduced a CRHT team. The aims of the current study were to investigate (i) patient characteristics, (ii) factors influencing patients' length of follow-up (LoFU) and (iii) predictors of clinical outcomes. Descriptive and quantitative non-identifiable data were collected and analysed for patients utilising the CRHT service within its first 2 years of operation (n = 643). One-way ANOVA tests investigated influencing factors for LoFU, whereas binary logistic regressions deduced predictive factors for clinical outcomes. Patients without acute psychiatric disorders had the shortest LoFU, indicating that the team received inappropriate referrals. Patients were most likely to have extended LoFU if they were diagnosed with OCD & related disorders and were most likely to be diagnosed with an underlying personality disorder if they were diagnosed with anxiety & phobic disorders. Continuity of care facilitates discharge planning. Patients receiving the CRHT service in Malta are most comparable with health systems that prefer to hospitalise patients with a higher risk profile. The high occurrence of personality disorders necessitates staff to have interdisciplinary knowledge and an appropriate skill mix.

Permanent trials for spinal cord stimulation.

Prior to the permanent implant of a spinal cord stimulator, patients typically undergo a screening trial using a percutaneously placed lead to ensure adequate response. However, due to several factors, patients may not be candidates for this screening trial and therefore instead undergo a "permanent trial" where either a percutaneous lead or paddle lead is placed using a tunneled extension for the trial, with the intent of conversion to a permanent system. If these patients proceed with an implant, the epidural space is not re-accessed and only an impulse generator (IPG) is needed. Although this technique is commonly employed, there is a paucity of literature describing outcomes with the "permanent trial" methodology. We present here our clinical experience with this technique. Participants who underwent permanent trials at a single institution between 2014 and 2020 were identified. Charts were reviewed to collect demographic information, numerical rating score (NRS) data, length of follow-up, revisions, complications, and removals. A total of 27 patients who underwent permanent trial placement were identified from a database of 762 patients who underwent SCS placement (3.54%). The permanent placement group included 7 paddle trials, 14 percutaneous trials, and 6 dorsal root ganglion (DRG) trials. The reasons for pursuing a permanent trial included previously aborted percutaneous trial (n = 8), inability to hold anticoagulation for a prolonged period (n = 4), previous thoracic spine surgery or presence of thoracic stenosis on MRI (n = 4), and significant medical comorbidities precluding typical percutaneous trial lead placement at a surgery center (n = 3). 24/27 (88.8%) proceeded to permanent implant, and 16/24 (66.7%) were considered responders (greater than 50% reduction in pain) after 3 months. Over an average follow-up of 28.7 months, complications included 1 peri-operative intracranial hemorrhage delaying IPG placement, 2 lead fractures, 1 lead migration, and 1 CSF leak. Three patients required revision surgery for lead migration, lead fracture, and CSF leak, respectively. One patient had his system explanted 25.9 months after initial placement due to increased pain from stimulation. This study aims to characterize our experience with permanent trials for SCS. Here we demonstrate a higher rate of trial-to-implant conversion than previously documented for traditional percutaneous trials. We show similar rates of revisions and complications, elucidating the important role of permanent SCS trials in high-risk patients.

Synergistic effect of defocus incorporated multiple segment glasses and repeated low level red light therapy against myopia progression

Defocus incorporated multiple segment (DIMS) lenses and repeated low-level red-light (RLRL) are used to retard myopia progression. However, it is currently unknown if there is a synergistic effect of the two interventions. In the current study, 190 school-aged children with myopia (380 eyes) were studied for the change in axial length (AL) over nearly one year of follow-up. Of 380 eyes, 170 eyes wore DIMS lenses, 80 eyes had RLRL therapy, and 130 eyes had both interventions (DIMS_RLRL) for myopia control. AL changes were calculated at each follow-up visit by subtracting the baseline measurements and normalized to yearly changes in mm. AL changes as a primary outcome were analyzed in a generalized linear mixed model to compare effect sizes of myopia control among three interventions while adjusting for age, sex, baseline axial length, and follow-up length. Participants had a mean age of 9.84 ± 2.63 years old, mean AL of 24.49 ± 1.20 mm, mean SER of -2.90 ± 2.08 diopters, and mean follow-up time of 301 ± 91 days. By the end of the study, the adjusted mean yearly axial change with combination therapy was − 0.13 mm, -0.04 mm for the eyes with RLRL alone, and 0.16 mm for the eyes with DIMS lenses alone (p < 0.0001). Combination therapy of DIMS and RLRL has significantly greater effect size in controlling myopia progression than either RLRL alone (p = 0.0009) or DIMS alone (p < 0.0001).

Utility of Ultrasound Surveillance for Thyroid Cancer in Children.

Background: Differentiated thyroid cancer (DTC) is the most common pediatric endocrine malignancy. The utility of ultrasound (US) surveillance after initial treatment has not been clearly delineated. We sought to evaluate the clinical utility of US for the detection of residual or recurrent disease in pediatric patients with thyroid cancer beginning 1 year after initial therapy. Methods: This is a retrospective cohort study of pediatric patients (<19 years) diagnosed with DTC between 1998 and 2022 whose response to therapy (RTT) one year after initial treatment (thyroidectomy ± radioactive iodine) was excellent or indeterminate. We evaluated the association between sonographic and biochemical findings (thyroglobulin [Tg] and Tg antibodies [TgAb]) at one year with the subsequent diagnosis of residual/recurrent structural disease in the neck (SDN). Results: In total, 112 patients had 1-year RTT that was excellent (n = 61, 54.5%) or indeterminate (n = 51, 45.5%). Median length of subsequent follow-up was 6.4 (interquartile range 3.8-8.9) years. Overall, 683 surveillance neck US were performed, with a mean ± standard deviation of 1.0 ± 0.4 US per patient per year. Of 61 patients with excellent RTT, none developed SDN during follow-up. Eighteen patients (29.5%) had a false-positive indeterminate or abnormal US finding. Of 51 patients with indeterminate RTT, 9 (17.6%) developed SDN during follow-up. SDN was detected by US in 7/9 cases (77.8%). SDN was detected by I-123 scan, but not by US, in two cases (22.2%), both with abnormal Tg/TgAb. 7/9 (77.8%) cases of SDN were detectable by Tg/TgAb. Overall, fine-needle aspiration (FNA) was performed in 17/112 (15.2%) patients and diagnosed SDN in six patients. Overall, 11/112 patients (9.8%) underwent FNA but were not diagnosed with SDN. Conclusions: In pediatric DTC patients with excellent response to initial therapy, the utility of serial US surveillance is limited by the low risk of SDN and frequent false-positive US findings. In children with indeterminate RTT, SDN occurs in a significant proportion and may be detected by US or by abnormal Tg/TgAb levels. These patients may benefit from the combination of US and biochemical surveillance.

Do Patients Who Undergo Sleeve Gastrectomy Differ from Those Who Underwent Roux-en-Y Gastric Bypass? A Comparison of Eating Disorders Outcomes

This review compares the incidence of eating disorders (EDs) after sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) and explores the risk factors associated with developing EDs after SG and RYGB and examines the association of EDs after SG and RYGB with weight loss outcomes. Despite the heterogeneity of included studies that differ in assessment tools, study type, and length of follow-up, EDs are prevalent after bariatric surgery. Postoperative risk factors associated with EDs include weight and shape concerns, loss of control of eating, and a history of psychological illness. EDs interfere negatively with weight loss outcomes after SG and RYGB.

Surrogate End Points for Overall Survival in Neoadjuvant Randomized Clinical Trials for Early Breast Cancer.

To assess trial-level surrogacy value for overall survival (OS) of the pathologic complete response (pCR) and invasive disease-free survival (iDFS) in randomized clinical trials (RCTs) for early breast cancer (BC). Individual patient data of neoadjuvant RCTs with available data on pCR, iDFS, and OS were included in the analysis. We used the coefficient of determination R2 from weighted linear regression models to quantify the association between treatment effects on OS and on the surrogate end points. Eleven RCTs, for a total of 15 treatment comparisons and 12,247 patients, were included in the analysis. There was a weak association between hazard ratios (HRs) for OS and odds ratio of pCR overall (R2, 0.07; 95% CI, 0.00 to 0.48), as well as in all the subgroups explored. Overall, the R2 for the association between HR OS and HR iDFS was 0.46 (95% CI, 0.08 to 0.71), which is just below the cutoff of 0.5 for moderate surrogacy. In the majority of subgroups explored, the R2 ranged from 0.5 to <0.7, while in hormone receptor-/human epidermal growth factor receptor 2- subtype, histologic grade 1-2 tumors, and lobular tumors, surrogacy was strong (ie, R2 ≥0.7). The surrogacy value of iDFS for OS was affected by follow-up (FUP) length: R2 substantially increased up to 36 months of FUP, with little further improvement after 48 months of FUP. iDFS with sufficient FUP is an acceptable surrogate end point to confidently anticipate final OS results of neoadjuvant RCTs for early BC. This recommendation holds true across many subgroups, with the notable exception of HR+ disease. There is definite need to reassess whether OS is the optimal end point for treatment efficacy measurement in HR+ early BC.

Autologous Peripheral Blood-Derived Orthobiologics for the Management of Elbow Disorders: A Review of Current Clinical Evidence.

Elbow ailments are common, but conventional treatment modalities have shortcomings, offering only interim pain relief rather than targeting the underlying pathophysiology. The last two decades have seen a marked increase in the use of autologous peripheral blood-derived orthobiologics (APBOs), such as platelet-rich plasma (PRP), to manage elbow disorders. Platelet-rich plasma (PRP) is the most widely used APBO, but its efficacy remains debatable. Consequently, other APBOs, such as platelet lysate (PL), autologous conditioned serum (ACS), gold-induced cytokine (GOLDIC), plasma rich in growth factors (PRGF), autologous protein solution (APS), and hyperacute serum (HS), have been considered. Only a few reviews summarize the results of clinical studies investigating the efficacy of these APBOs in elbow disorders. This review documents the results of clinical studies involving APBOs in managing elbow disorders and summarizes the ongoing clinical studies on different clinical trial protocol repositories comprising these APBOs to manage elbow disorders. This systematic review adhered to the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. In December 2024, PubMed, Embase, and Web of Science were accessed with no additional filters or time constraints. All available clinical studies published in English, French, Spanish, German, or Italian concerning the management of elbow disorders by means of APBOs were considered. Only three clinical studies met our predefined search and inclusion criteria. In particular, two and one studies involving the use of PL and ACS, respectively, were included in this review. Data from 99 patients were obtained. Of them, 57.6% (57 of 99 patients) were women. The mean length of follow-up was 11.9 ± 0.6months, and the mean age was 42.0 ± 3.5years. No complications were reported in any of the studies included. The included studies have low to medium risk of bias, and a very low score on methodological quality. Finally, no clinical studies involving the use of GOLDIC, PRGF, APS or HS were identified, and only one ongoing clinical study involving the use of PL was registered. The current peer-reviewed published studies demonstrated that administering APBOs, including PL and ACS, might be safe and effective in reducing pain and improving function in patients with elbow disorders. Further, high-quality studies are required.

Evaluation of autologous venous allograft for lower limb in the treatment of critical limb ischemia. The REVATEC (REVAscularisation par greffons veineux bioproTEC) study.

Chronic limb-threatening ischemia (CLTI) requires revascularization whenever it is possible. The great saphenous vein represents the surgical conduit of choice. However, it is not always available, in particular in multi-operated patients. In such cases, alternative efficient biological conduits are needed but data remains limited. This study aims at evaluating the performance of cold stored venous allografts provided by Bioprotec® society. Prospective multi-center cohort. The primary endpoint was limb salvage rate at one year following revascularization with cold stored venous allografts. Follow-up based on clinical examination and duplex-scan. Uni- and multivariate analyses were performed to analyze predictive factors of endpoints. Overall, 39 patients (40 limbs) were included between 2018 and 2021. Patients had a median of 2 [0-6] revascularizations prior to inclusion. A total of 97 grafts were used (median of 3 [1-4] grafts per procedure). In the postoperative period (30 days) no death and 4 major amputations were noted. The median length of follow-up was 13.4 [0.7-31.1] months. The six-months, one-year and two-year freedom from major amputation rates were 79% [95% CI: 68-93], 75% [95% CI 62-91] and 68% [95% CI: 51-90], respectively. The six months, one-year and two-year survival rates were 95% [88-100], 83% [95% CI: 71-98] and 79% [95% CI: 65-96], respectively. Primary patency rates were 77% [95% CI: 64-91] at six months, and 47% [95% CI: 32-70] at one and two years. Secondary patency rates were 82% [95% CI: 70-95] at 6 months and 50% [95% CI: 34-73] at one and two years. The analysis identified the number of previous revascularizations as a significant risk factor for graft patency (Hazard Ratio: 1.59; 95% Confidence Interval: 1.13-2.24). Revascularization of CLTI patients with previous failed interventions is highly challenging. The use of cold stored venous allograft showed encouraging limb salvage rate despite modest patency rates and thus may represent an alternative to other substitute in some selected cases. More studies are necessary to identify the potential of CSVA in CLTI patients.

Management of nutritional deficiencies following one anastomosis gastric bypass (OAGB): a single-center experience.

Metabolic/bariatric surgery (MBS) remains the most effective and long-lasting treatment for obesity and its complications. Apart from any surgical complications, the often less obvious but possibly severe side-effects of nutritional deficiencies have become of interest in recent years. OAGB is known to come with the need for thorough supplementation. Retrospective study; university-hospital based. Assessing nutritional issues and their management in a real-life cohort of patients undergoing OAGB. Patients that underwent OABG between 01/2018 and 08/2019 were retrospectively assessed. Laboratory values (gained from electronic patients charts) were analyzed for nutritional issues (parathyroid hormone, vitamin A, E, D, B12, folic acid, albumin, ferritin, iron, and transferrin saturation) as well as postoperative complications and reoperations. Furthermore, weight development, improvement/remission of obesity-related complications, and regular intake of multivitamin supplementation (MVS) were assessed. 120 patients underwent OAGB; 89 were female. A follow-up was available for 101 patients. Mean length of follow-up was 27.8 ± 20.9months. OAGB led to a %TWL of 36.7 ± 9.5% and %EWL of 86.8 ± 25.5%. Preoperative deficiencies were vitamin D (53.3%), followed by folic acid (16.7%) and vitamin A (6.7%). During follow-up, every patient developed at least one deficiency, hypovitaminosis D and A were predominant (74.3% and 41.0%), and 31 suffered from folic acid deficiency (30.7%). Hypovitaminosis B12 and calcium deficiency was observed in three patients (2.9%). Although advised to, only 45.5% opted for the intake of specialized MVS, whereas 10% did not take any MVS at all. More than half of all patients (53.5%) took additional supplements. Nineteen patients underwent reoperations associated with the initial OAGB. Two conclusions can be drawn: First, there is a general need for bypass patients to get assessed for a broad array of deficiencies over time. Second, MVS is essential for patients that had bypass surgery. Additionally, compliance needs to be promoted by educating patients as well as other treating physicians.

Irradiated Homologous Costal Cartilage Grafts in Complex Functional Septorhinoplasty.

Optimal results in complex nasal reconstruction, particularly in the context of post-traumatic and revision septorhinoplasty, often require the use of cartilage grafts to provide additional structural support to the nose. While autologous costal cartilage (ACC) has been traditionally used, this can be limited by donor site morbidity, increased operative time, and in some cases, lack of suitable cartilage for grafting. There has been a trend towards using irradiated homologous costal cartilage (IHCC) as an alternative source of graft material. We review our departmental experience of using IHCC in functional septorhinoplasty surgery. We performed a retrospective review of electronic medical records of all patients who underwent septorhinoplasty using IHCC at a tertiary referral center between May 1, 2022, and April 30, 2024. Demographic data, surgical details, and postoperative outcomes, including rates of infection, resorption, warping, and revision were recorded and analyzed. Fifty-seven patients (34 males, 23 females) with a mean age of 41.0 years (range: 18-65 years) were included. Forty-one were revision septorhinoplasty operations, while 16 were primary cases. Almost all were performed via an open approach (98.2%). Three patients developed postoperative infection (5.3%) while one developed columellar dehiscence needing further revision surgery (1.8%). Functional and aesthetic results were otherwise satisfactory in all patients. We observed no cases of warping, resorption, or extrusion. The median length of follow-up was 279 days (interquartile range: 171-527 days). We present the largest United Kingdom series to date on the use of IHCC in septorhinoplasty surgery. Our findings support its use as a safe and effective graft material and a viable alternative to autologous sources, offering the benefits of a robust reconstructive material and shortened operative time, without the risk of donor site complications. A longer follow-up period is ideally required to evaluate its long-term structural stability.

Longitudinal Improvement of Quality of Life in Children With Legg-Calve-Perthes Disease Treated With Proximal Femoral Varus Osteotomy.

Proximal femoral varus osteotomy (PFVO) is commonly performed to improve femoral head containment and decrease deformity in Legg-Calve-Perthes disease (LCPD). Little is known about how PFVO impacts the quality of life after surgery. The purpose of this study was to determine the longitudinal changes to patient-reported physical, mental, and social health measures after PFVO. This is a retrospective review of prospectively collected Patient-Reported Outcomes Measurement Information System (PROMIS) data from 20 patients with unilateral LCPD treated with a PFVO. We collected seven PROMIS measures (mobility, anxiety, fatigue, depressive symptoms, pain interference, anger, and peer relationships) before and approximately 1, 3, 8, 12, and 18 months after surgery. We compared PROMIS scores across different time points using repeated measures ANOVA and multiple pairwise comparisons with Tukey adjustment. The relationship between presurgery and postsurgery mental health scores was analyzed using a Spearman correlation. The mean age at PFVO was 8.2 ± 1.6 years. The mean length of follow-up was 17.0 ± 2.1 months. There was a significant improvement in the mobility score between preoperation and 12 months (P=0.0031) and 18 months postoperation (P<0.0001). Anxiety scores significantly improved from preoperation and 18 months postoperation (P=0.0014). A significant reduction in the pain interference score between preoperation and 12 and 18 months postoperation (P<0.0001) was observed. Peer relationships significantly improved from one month postoperatively to 18 months postoperation (P=0.0355). Individual variations were also observed with some patients having elevated depressive symptoms and anxiety scores. Moderate correlations between preoperative and postoperative anxiety and depressive symptoms scores were observed. PROMIS mobility, anxiety, pain interference, and peer relationship scores improved significantly after PFVO. While the mean anxiety, depressive symptoms, peer relationships, and anger scores were in normal ranges at each visit, individual variations with elevated anxiety and depressive symptom scores were observed. This new longitudinal PROMIS data will better inform patients and families about the quality of life and recovery experience after PFVO. Level IV-therapeutic study.

The predictive value of prostate spherical volume ratio in lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia: a retrospective cohort study.

To evaluate the predictive value of Prostate Spherical Volume Ratio for Lower urinary tract symptoms and clinical progression of Benign prostatic hyperplasia. And compared with other prostatic anatomical parameters. A total of 154 patients with Benign prostatic hyperplasia who underwent MRI and urodynamics were included in the study, while prostate anatomical parameters such as prostate spherical volume ratio, prostate volume, intravesical prostatic protrusion, prostatic urethral length and presumed circle area ratio were determined based on MRI measurements. Average length of follow-up was 12months. The primary outcome was follow-up for the clinical progression of Benign prostatic hyperplasia, defined as an increase in the International Prostate Symptom Score of at least 4 points, Benign prostatic hyperplasia-related prostatic surgery. Univariate and multivariate linear regression analyses were conducted to identify risk factors for lower urinary tract symptoms. Logistic regression analyses were conducted to identify risk factors for clinical progression of Benign prostatic hyperplasia. Multivariate linear regression highlighted the significant association of prostate spherical volume ratio with lower urinary tract symptoms. In multivariable logistic regression analysis prostate spherical volume ratio is an independent risk factor for the clinical progression of Benign prostatic hyperplasia to an increase in the International Prostate Symptom Score of at least 4 points (OR = 1.53 p = 0.016) and Benign prostatic hyperplasia -related prostatic surgery (OR = 5.15 p = 0.020). Prostate spherical volume ratio has been significantly correlated with Lower urinary tract symptoms, and it was an independent risk factor for the clinical progression of Benign prostatic hyperplasia. THIS TRIAL IS REGISTERED ON CLINICALTRIALS.GOV: NCT06448533.

Feasibility of Simon 2-Stage Futility Trials in Early Parkinson Disease: Analysis of the PRECEPT and DATATOP Trial Datasets.

Disease-modifying treatments (DMTs) are a major unmet need in Parkinson disease (PD). To date, trials investigating DMT candidates in PD most often used a randomized controlled trial (RCT) design. Unfortunately, RCTs to date have not led to a breakthrough, in part because of the large sample sizes and length of follow-up required. In the interest of testing DMT candidates in a more efficient manner, it may be worthwhile to perform futility trials, which are smaller clinical trials that have originally been developed as phase 2 trials in oncology and more recently been used in progressive multiple sclerosis. In this investigation, we used original, patient-level data from DATATOP and PRECEPT, 2 large RCTs in early PD, to explore the feasibility of using the Simon 2-Stage futility trial design in early PD. This is a post hoc analysis of original, patient-level data from the DATATOP and PRECEPT RCTs in early PD. In our analyses, we use descriptive statistics, survival analysis, and binary logistic regression to explore thresholds of change in the Unified Parkinson Disease Rating Scale (UPDRS) motor score as the primary outcome measure, length of follow-up, inclusion and exclusion criteria, and projected sample sizes for Simon 2-Stage futility trials in early PD. We also performed bootstrapping experiments to illustrate the ability of trials using the Simon 2-Stage futility design to identify selegiline as nonfutile and tocopherol as futile. PRECEPT included 806 participants (mean age 59.7 years, SD 10.3, 64.4% male), and DATATOP included 800 participants (mean age 61.1 years, SD 9.5, 64.4% male). Our analyses suggest that futility trials using the Simon 2-Stage methodology are feasible in PD. We propose a 5-point worsening on the UPDRS motor score as the primary outcome measure and a length of follow-up of 12 months. Trial simulations based on these data suggest the required sample size for such clinical trials to be lower than 200 participants. Based on our analysis of DATATOP and PRECEPT, phase 2 clinical trials using the Simon 2-Stage methodology are feasible in PD and may offer an opportunity to expedite the discovery of promising treatments in early PD.

Long-term outcomes of scleral fixated black diaphragm intraocular lens in eyes with combined aphakia and aniridia

Purpose To evaluate long-term anatomical and functional outcomes in eyes undergoing scleral fixation of aniridic black diaphragm intraocular lens (BDIOL). Methods Total 38 eyes that underwent scleral fixation of BDIOL for secondary aniridia following ocular trauma with aphakia with absent posterior capsule or primary congenital aniridia with subluxated lens were retrospectively analyzed. Final visual acuity, early and late complications were examined. Correlation analysis was done. Results The mean follow-up was 28 months (range 6 to 66 months). The mean preoperative visual acuity of 1.82 ± 0.90 logMAR improved to 0.69 ± 0.61 ( p = 0.00). The mean spherical equivalent refractive error of 7.88 ± 4.85 diopters improved to −0.69 ± 1.52( p = 0.00). Complications were seen in 9 eyes (23.6%). Early complications were raised intraocular pressure (IOP) in 2 eyes and one eye with suture site infection which were managed conservatively. Late complications were corneal decompensation 3eyes (7.8%), retinal detachment, hypotonic maculopathy and refractive surprise in 1 eye each (2.6%). None reported IOL tilt or dislocation. The patients noticed a significant reduction in glare disability and photophobia. No significant association was found between pre-operative factors such as prior surgical procedures, history of trauma and length of follow-up with surgical outcomes. Conclusions Scleral fixation of BDIOL is an effective option in eyes with aniridia and aphakia without capsular support that have undergone multiple previous surgeries. Despite severe damage, the BDIOL helps reconstruct the anterior segment and give a good quality of vision with minimal complications rate.

Risk Factors For Increased External Rotation Deficit After Combined Bankart Repair And Remplissage For Recurrent Anterior Shoulder Instability.

External rotation (ER) deficit following Bankart repair and remplissage (BRR) is reported to be a major concern. The purpose of this study was to identify potential risk factors which correlate with increased postoperative ER deficit in a population which underwent BRR for recurrent anterior shoulder instability and glenoid bone loss (<20%). A retrospective analysis of prospectively collected data was performed on 41 patients who underwent BRR for anterior shoulder instability with glenoid bone loss of < 20%. Inclusion criteria were; a minimum of 2-year postoperative follow-up with available pre and postoperative functional scores (ASES and WOSI) and preoperative MRI. Regression analysis was conducted to detect risk factors for postoperative ER deficit, including age, sex, number of dislocations, length of follow-up, Hill-Sachs interval (HSI), Hill-Sachs depth (HSD), sport participation, number of anchors used for remplissage and hand dominance. A sub-analysis was undertaken after dividing patients into 2 groups (deficit < 20% and ≥ 20%). Correlation between postoperative scores and ER deficit was performed. All patients showed marked improvement in postoperative WOSI and ASES compared to preoperative by a mean difference of 46.2 ± 19.9 and 29.6 ± 14.4 respectively. Compared to the opposite side the mean reduction in external rotation at the side (ERs), external rotation in abduction (ERa), forward flexion (FF) and internal rotations in abduction (IRa) were (21.9% ± 15.5), (14.3% ± 9.9), (2.7% ± 1.9) and (10% ± 6.2) respectively. Univariate regression analysis showed that shorter postoperative time, Larger HSI and the use of two anchors were significantly associated with increased limitation of both ERs and ERa. Participation in sports was significantly associated with less ERs limitation. HSD was significantly associated with increased ERa limitation. Multivariate regression analysis revealed that larger HSI was significantly associated with increased both ERs and ERa limitation. Time of final follow-up and number of anchors were significantly associated with ERs and Era limitation respectively. ≥ 20% ER deficit was significantly associated with lower number of preoperative dislocations, shorter time of final follow-up, HSI, and 2 anchors used in remplissage. No correlation exist between functional scores and ER deficit. There were no recurrent dislocations. The results show that postoperative ER deficit improves over time. Risk factors for increased postoperative ER deficit are larger HSI and when more than one anchor is used for capsulotenodesis. There was no correlation between functional scores and ER deficit.

Satisfactory Clinical Outcomes of Revision Anterior Cruciate Ligament Reconstruction Using Quadriceps Tendon-Patellar Bone Allograft.

Allografts are preferred in certain cases of revision anterior cruciate ligament reconstructions to avoid additional graft harvesting and to fill in enlarged tunnels. The clinical outcomes of quadriceps tendon-patellar bone allograft in revision anterior cruciate ligament reconstruction are not well-known. This study was performed to evaluate the clinical outcomes of revision anterior cruciate ligament reconstructions using quadriceps tendon-patellar bone allografts. Patients who underwent revision anterior cruciate ligament reconstructions with quadriceps tendon-patellar bone allografts with a minimum follow-up of 2 years were retrospectively reviewed. Their mean follow-up length was 33.5 ± 19.5 months. Outcomes including clinical scores (Lysholm, International Knee Documentation Committee [IKDC], Tegner scale, and Knee injury and Osteoarthritis Outcome Score [KOOS]), knee stability (physical examinations and knee arthrometer), return to sports, and any associated complications were assessed. Degrees of graft synovialization were also evaluated using arthroscopy. A total of 38 patients were reviewed and their age at the time of surgery and follow-up length were 37.2 ± 12.5 years (range, 17-66 years) and 2.8 ± 1.6 years, respectively. All clinical scores including KOOS, IKDC, Lysholm, and Tegner scale significantly improved at 2 years after surgery and 92.1% of the patients returned to sports. The mean preoperative side-to-side difference in knee arthrometer decreased from 4.5 ± 2.3 mm before surgery to 2.6 ± 1.5 mm after surgery (p < 0.001). Graft synovialization was observed in 13 of 16 patients (81.3%) who underwent second-look arthroscopy. Complication rate was 10.5% (n = 4). All complications were graft re-rupture and occurred at an average of 18 months after revision surgery. Quadriceps tendon-patellar bone allograft showed satisfactory clinical outcomes in revision anterior cruciate ligament reconstruction and thus could be a good alternative when autograft harvesting is not optimal.