bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cost-effectiveness of enfortumab vedotin in previously treated advanced urothelial carcinoma
Authors: Wu Qiuji , Qin Yi , Liao Weiting , Zhang Mengxi , Yang Yang , Zhang Pengfei , Li Qiu 
Published: January 2022

Background: Antibody-drug conjugates have recently been introduced as a treatment for advanced urothelial carcinoma. The EV-301 study demonstrated that enfortumab vedotin (EV) improved overall survival compared with conventional chemotherapy. To assess the cost-effectiveness of EV for the treatment of advanced urothelial carcinoma (UC) from a payer perspective in middle- and high-income countries. Methods: A decision analysis model was developed to assess the efficacy and economic viability of EV as a subsequent-line treatment following disease progression in patients with advanced urothelial carcinoma already treated with PD-1 or PD-L1 inhibitors. Clinical and utility values were obtained from the published literature and available databases. Cost data were obtained from payer perspectives in the United States, United Kingdom, and China. Quality-adjusted life-years (QALYs) were used to measure health outcomes, and incremental cost-effectiveness ratios (ICERs) used to evaluate cost-effectiveness in comparison to willingness-to-pay in the United States, United Kingdom, and China. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the robustness of the model. Results: Compared with chemotherapy, EV increased the benefit by 0.16-0.17 QALYs, resulting in ICERs of $2,168,746.71, $2,164,494.38, and $1,775,576.56 per QALY in the United States, United Kingdom, and China, respectively. One-way sensitivity analysis indicated that the largest effect on outcome was the utility value for progression-free survival. Probabilistic sensitivity analysis demonstrated that the probability of EV being cost-effective was 0%. Conclusions: EV provides an additional health benefit over chemotherapy for patients with advanced urothelial carcinoma but is not cost-effective from a payer perspective in the United States, United Kingdom, or China.
Predictive Risk Models to Identify Patients at High-Risk for Severe Clinical Outcomes With Chronic Kidney Disease and Type 2 Diabetes
Authors: Sheer Richard , Nair Radhika , Pasquale Margaret K. , Evers Thomas , Cockrell Meghan , Gay Alain , Singh Rakesh , Schmedt Niklas 
Published: January 2022

Introduction/Objective: Predictive risk models identifying patients at high risk for specific outcomes may provide valuable insights to providers and payers regarding points of intervention and modifiable factors. The goal of our study was to build predictive risk models to identify patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) at high risk for progression to end stage kidney disease (ESKD), mortality, and hospitalization for cardiovascular disease (CVD), cerebrovascular disease (CeVD), and heart failure (HF). Methods: This was a retrospective observational cohort study utilizing administrative claims data in patients with CKD (stage 3-4) and T2D aged 65 to 89 years enrolled in a Medicare Advantage Drug Prescription plan offered by Humana Inc. between 1/1/2012 and 12/31/2017. Patients were enrolled ≥1 year pre-index and followed for outcomes, including hospitalization for CVD, CeVD and HF, ESKD, and mortality, 2 years post-index. Pre-index characteristics comprising demographic, comorbidities, laboratory values, and treatment (T2D and cardiovascular) were evaluated and included in the models. LASSO technique was used to identify predictors to be retained in the final models followed by logistic regression to generate parameter estimates and model performance statistics. Inverse probability censoring weighting was used to account for varying follow-up time. Results: We identified 169 876 patients for inclusion. Declining estimated glomerular filtration rate (eGFR) increased the risk of hospitalization for CVD (38.6%-61.8%) and HF (2-3 times) for patients with eGFR 15 to 29 mL/min/1.73 m2 compared to patients with eGFR 50 to 59 mL/min/1.73 m2. Patients with urine albumin-to-creatinine ratio (UACR) ≥300 mg/g had greater chance for hospitalization for CVD (2.0 times) and HF (4.9 times), progression to ESKD (2.9 times) and all-cause mortality (2.4 times) than patients with UACR <30 mg/g. Elevated hemoglobin A1c (≥8%) increased the chances for hospitalization for CVD (21.3%), CeVD (45.4%), and death (20.6%). Among comorbidities, history of HF increased the risk for ESKD, mortality, and hospitalization for CVD, CeVD, and HF. Conclusions: The predictive models developed in this study could potentially be used as decision support tools for physicians and payers, and the risk scores from these models can be applied to future outcomes studies focused on patients with T2D and CKD.
Risk for Subsequent SARS-CoV-2 Infection and Severe COVID-19 Among Community-Dwellers With Pre-Existing Cervicocephalic Atherosclerosis: A Population-Based Study
Authors: Del Brutto Oscar H. , Mera Robertino M. , Del Brutto Victor J. , Recalde Bettsy Y. , Rumbea Denisse A. , Costa Aldo F. , Sedler Mark J. 
Published: January 2022

Background: COVID-19 patients may develop atherosclerosis-related complications. Whether a proportion of these patients already had asymptomatic cervicocephalic atherosclerosis before SARS-CoV-2 infection is not known. This study assessed whether pre-existing cervicocephalic atherosclerosis increased the susceptibility to SARS-CoV-2 infection or resulted in more severe or fatal COVID-19. Methods: Individuals enrolled in the Atahualpa Project cohort who received head CT (for assessing carotid siphon calcifications) and B-mode ultrasounds (for measurement of the carotid intima-media thickness) prior to the pandemic were eligible for this study. Among this cohort, those who also received serological tests for detection of SARS-CoV-2 antibodies and clinical evaluations for assessment of COVID-19 severity were enrolled. Multivariate logistic regression and exposure-effect models were fitted to assess the association between pre-existing atherosclerosis biomarkers, and SARS-CoV-2 seropositivity and COVID-19 severity. Results: Overall, 154 of 519 study participants (30%) had evidence of cervicocephalic atherosclerosis. A total of 325 (63%) individuals became SARS-CoV-2 positive, and 65 (23.5%) of seropositive individuals had severe or fatal COVID-19. The risk of SARS-CoV-2 seropositive status did not differ across individuals with and without atherosclerosis biomarkers ( P = .360). Likewise, seropositive individuals with pre-existing atherosclerosis were not more prone to develop severe or fatal COVID-19 than those without evidence of atherosclerosis ( P = .274). Average estimated exposure effects of pre-existing cervicocephalic atherosclerosis versus no atherosclerosis over SARS-CoV-2 seropositivity and COVID-19 severity were not significant. Conclusions: Pre-existing cervicocephalic atherosclerosis does not increase the risk of acquiring SARS-CoV-2 infection nor the severity of COVID-19 among seropositive individuals.
Reconstructive Surgical Management of Charcot Neuropathy of the Foot and Ankle: A Retrospective Study
Authors: Pattisapu Naveen , Bettin Clayton C. , Yeoh Jane C. , Sarfani Shumaila 
Published: January 2022

Category: Diabetes Introduction/Purpose: Treatment of Charcot neuropathy (CN) of the foot and ankle remains a challenge for both patient and surgeon. Non-operative treatment with immobilization in a cast/orthosis has long been the mainstay of treatment, but more recently surgical intervention-with attention to internal fixation-has gained interest because of the poor long-term outcomes with non-operative care. Methods: To assess long-term outcomes between CN patients managed with reconstructive surgeries at a tertiary referral center; a retrospective chart review analyzed comorbidities, demographics, and complications (ulceration, infection, and below the knee amputation). Results: Over the last 16 years, 31 patients with CN were treated with internal fixation (midfoot fusion, open reduction, or hindfoot fusion nail). Average BMI was 33.5, average number of comorbidities was 2.93, and the percentage of patients with a vascular deficit was 19.3%. The rate of infection and ulceration prior to surgery was 19.4% (6/31 patients) and 45.2% (14/31 patients) respectively. After surgery, the rate of new infections was 38.7% (12/31 patients). The rate of new ulcerations was 41.9% (13/31 patients). The rates of below the knee amputation was 19.4% (6/31 patients). Conclusion: A 16-year retrospective review of operative management of Charcot neuropathy in 31 patients at a tertiary referral center found high rates of ulceration, infection, and amputation in patients treated with internal fixation. This study could prove valuable in counseling CN patients regarding reconstructive surgery.
Association of Length of Stay and COVID-19 in Rotational Ankle Fracture Surgery in the National COVID Cohort Collaborative (N3C)
Authors: Pitts Charles C. , Levitt Eli , Patch David A. , Terrero Alfredo , Butler Reed , Ponce Brent A. , Theiss Steven M. , Spitler Clay A. , Johnson Michael D. 
Published: January 2022

Category: Ankle; Trauma Introduction/Purpose: Coronavirus (COVID-19) is an emerging, rapidly evolving situation. The National COVID Cohort Collaborative (N3C) is an innovative approach to integrate real-world clinical observations into a harmonized database. To investigate the outcomes of adults with ankle fracture surgery during the (COVID-19) pandemic, we had the following research question: What are the outcomes of ankle fracture patients with COVID-19 (invasive ventilation, length of stay, death)? The purpose of this abstract is to introduce the largest cohort of ankle fracture patients to date with a comparison between lab- confirmed COVID-19-positive and COVID-19-negative. Methods: A retrospective cohort of adults with ankle fracture surgery in the N3C Data Enclave. The N3C Data Enclave is an NIH-funded, secure platform through which the harmonized clinical data from electronic health records is stored ( https://covid.cd2h.org/ ). COVID-19 status was determined using a set of 55 SARS-CoV-2 polymerase chain reaction and antigen lab tests. Ankle fracture surgery was defined using SNOMED codes for 'fracture of bone' and one of the following CPT codes '27766, 27769, 27792, 27814, 27822, 27823, 27829' for 'ankle fracture surgery.' Results: A total population of 3.4 million patient records was queried in the National COVID Cohort, identifying 2,032 participants with ankle fracture surgery. The age range of the overall group was 18-98 years. Comparing COVID-19-positive to COVID-19-negative, the age (48.9 years vs 47.7 years) and gender (66.7% female vs 55.1% female) distribution of each group were comparable (both p>0.05). COVID-19-positive comprised 2.4% of the group (n=48). The length of stay was 4.7 days longer in the COVID-19-positive group (8.7 days vs 4.0 days, p<0.001). Higher proportions of COVID-19-positive patients who required invasive ventilation (12.5% vs 3.2%, p<0.002). The number of outcomes for mortality was too few to report. Conclusion: Based on the initial results, rotational ankle fractures requiring surgery necessitated longer hospitalizations in COVID-19-positive patients during the COVID-19 pandemic than in patients without the virus. The average increased length in hospitalization was, on average, about 6 days. When treated in isolation, ankle fractures can often be treated on an outpatient basis, and a multiple-day increase in average hospital stay is substantial. Though the overall complication profiles (with the exception of pulmonary disease) were similar, lengthy hospital stays could lead to delays in the recovery and rehabilitative process, and functional outcomes could not be determined in our study.
Revision First Metatarsophalangeal Joint Fusion for Non-Union, Implant Failures, and Failed Hallux Valgus Correction: Does the Indication Matter?
Authors: Prat Dan , Haghverdian Brandon A. , Pridgen Eric , Lee Wonyong , Wapner Keith L. , Chao Wen , Farber Daniel C. 
Published: January 2022

Category: Midfoot/Forefoot; Bunion Introduction/Purpose: The most common indications for revision of 1st Metatarsophalangeal (MTP) joint surgery are symptomatic failures of prior fusion, failed hallux valgus correction, and failed MTP arthroplasty implants. The outcome of revision 1st MTP fusion has rarely been studied. The purpose of this study was to compare the clinical, radiographic, and patient-reported outcomes of revision MTP fusion for different indications. Methods: A retrospective chart review was performed for patients who underwent revision 1st MTP fusion between January 2015 and December 2019 in a single-center, by 4 fellowship-trained foot and ankle surgeons. The complication, revision, and non- union rates as well as VAS and PROMIS scores and pre-operative and post-operative radiographs were analyzed and compared between the different indication groups. Univariate and multivariate analysis and logistic regression models were used to obtain odds ratio of the explanatory variables for outcome measures. Results: A total of 79 cases of revision MTP fusion were included. Thirty-eight cases of hallux valgus corrections salvage, 22 failed MTP arthroplasty implants, 6 failed polyvinyl alcohol hydrogel implants, 13 prior MTP fusion non-unions. The mean follow-up time was 350 days (Median 226, SD 306). Seven cases (8.9%) required structural iliac-crest bone graft during the revision. Seven cases (8.9%) required allograft augmentation. The overall complication rate was 40.7%. Fifteen patients (18.5%) were classified as Clavien-Dindo grade 3, which represents a complication that may require a revision surgery (i.e. non-union, deep infection, loss of correction). Eventually, 7 cases (8.9%) underwent further revision surgery. The logistic regression model demonstrated that indication for revision was not significantly related to union rate (p=0.280). Visual-Analogue-Scale significantly improved at 6 weeks, 3 months, and at last follow-up in all indications for revision (p=0.001). PROMIS-10 Physical and PROMIS-10 Mental did not change significantly during follow-up (p=0.860, p=0.589). Conclusion: Treatment of 1st MTP joint surgery failures is a clinical challenge in orthopaedic surgery. In our study, revision of 1st MTP joint surgery with MTP fusion had higher non-union rates and higher overall complication rates compared to primary 1st MTP fusion. Nevertheless, revision rates remained comparable to primary 1st MTP fusion. Complication rates and patient- reported outcomes were similar between the different indications for revision groups. Visual-analogue-scale improved significantly during follow-up in all groups. Diabetes mellitus had a significant impact on non-union rates and overall complication rates.
Differences in the 30 Days vs One-Year Complications and Reoperations after Total Ankle Replacement and Ankle Arthrodesis: A Large Database Study
Authors: Riepen Dietrich , Sambandam Senthil , Mounasamy Varatharaj , Wukich Dane K. 
Published: January 2022

Category: Ankle; Ankle Arthritis Introduction/Purpose: Total ankle replacement (TAR) and Ankle arthrodesis (AA) are two commonly performed procedures for end stage arthritis of ankle joint. Aim of this study was to analyze the characteristics of the complications and reoperations at 30 days and 1 year in a matched sample of TAR and AA in a large database population Methods: Commercially available patient database record (PearlDiver) was used for this study. Patient undergoing TAR and AA were identified using CPT code. After matching two groups for diabetes, smoking, obesity and comorbidities scores, the differences in the risk of complications at 30 days and 1 year and the risk of reoperation at 1 year were noted in both groups. Results: There were 1287 patients in each matched group. Four hundred and thirty patients were diabetic, 102 patients were smokers and 543 patients were obese. The risk of surgical site infection and wound dehiscence were higher at 30 days in the AA group. Vast majority of observed complications (More than 50% of complications) happened after 30 days. AA group showed higher risk of SSI, wound dehiscence, mechanical complications and pneumonia at 1 year. The risk of reoperation was also higher in the AA group at 1 year. Conclusion: Ankle arthrodesis is associated with higher risk of local and systemic complications at 30 days and 1 years and higher reoperation rate at 1 year. Most complications happened after 30 days which highlights the fact that studies reporting 30 days complications after AA and TAR may underestimate the complications.
Incidence of (Osteo)Chondral Lesions Concomitant to Chronic Lateral Ankle Instability: Systematic Review and Meta-Analysis
Authors: Rikken Quinten , Wijnhoud Emma , Dahmen Jari , Sierevelt Inger , Stufkens Sjoerd A. , Kerkhoffs Gino 
Published: January 2022

Category: Ankle Introduction/Purpose: To determine the incidence of (osteo)chondral lesions ((O)CLs) in patients with chronic lateral ankle instability (CLAI). Methods: A literature search was conducted in PubMed (MEDLINE), EMBASE (Ovid), and the Cochrane Library databases for articles published from January 2000 until December 2020. Two authors independently screened the search results and conducted the quality assessment using the MINORS criteria. Clinical studies that reported findings on (O)CLs of the ankle as per preoperative or intraoperative diagnostic measures in patients with CLAI (> 6 months of symptoms) were included. Chondral and osteochondral lesions were analyzed altogether for the primary outcome, namely, the incidence of (O)CLs in ankles with CLAI. Additionally, a subgroup analysis for the incidence of (O)CLs located on the talus. Secondary outcomes included the study-, patient, and lesion characteristics. Lesions characteristics included lesion localization and chondral- or osteochondral involvement. A random-effects model with 95% confidence intervals (95% CI) was used to analyze the primary outcome and subgroup analysis. Secondary outcomes were pooled using a simplified pooling method. Results: 12 studies with a total of 2145 patients with 2170 ankles with CLAI were included. The overall pooled incidence of (O)CLs in ankles with CLAI was 32.2% (95% CI 22.7 - 41.7). The pooled incidence of talar (O)CLs was 26.5% (95% CI 19.0 - 34.0). Overall the most common location of OCLs in patients with CLAI is the talus with 85%, of which 68% of (O)CLs are located on the medial talus and 32% are located laterally. 43% of lesions were chondral lesions and 57% of lesions were osteochondral in nature. Conclusion: (O)CLs were found in up to 32% of ankles with CLAI. Furthermore, most lesions are located on the medial talar dome. These findings will aid physicians in the early recognition and treatment of ankle (O)CLs in the context of CLAI.
The INBONE-2 Total Ankle Prosthesis: Outcomes At 5 to 9 Years Follow-Up
Authors: Rushing Calvin J. , Malloy McCoy Antonio M. , Berlet Gregory C. , Hyer Christopher F. 
Published: January 2022

Category: Ankle; Hindfoot; Other Introduction/Purpose: Short and medium term outcomes of the INBONE I and INBONE II tibial stems have been favorable. The INBONE-2 talus has been shown to have lower reoperation and failure rates compared to its predecessor, INBONE-1 at short term follow-up. The purpose of the present study was to assess mid-term outcomes for the INBONE-2 prosthesis at 5 to 9 years follow-up considering both the tibial and talar components. Methods: All patients who underwent primary total ankle arthroplasty (TAA) with INBONE-2 between July 2010 and July 2014 at a single institution and who were at least 5 years postoperative were included. A total of 15 ankles with a mean follow up 85 (range, 61-113) months met the criteria. Radiographs were assessed using coronal and sagittal alignment parameters preoperatively, at 6 weeks postoperative, and at the most recent follow-up. Medical records were reviewed and revisions, reoperations, and complications were classified according to the criteria established by Vander Griend et al. and Glazebrook at el., respectively. Results: Survivorship for the INBONE-2 at a mean of 85 months was 93.7%. Coronal and sagittal tibiotalar alignment improved after surgery (p=0.081, p=0.15), and was maintained at the most recent follow-up (p=0.684, p=0.837). One ankle (6.7%) required early component revision; while 4 (26.7%) required a non-implant related revision. Six complications (2 high grade, 1 intermediate, and 3 low) in 5 ankles (33.3%) were recorded according to the Glazebrook classification system. Conclusion: The present study is the first to report midterm follow-up after TAA with the INBONE-2. High survivorship, maintenance of correction, and a low incidence of major complications was observed. The most common complication overall was lateral gutter impingement, which accounted for the majority of the non-revisional reoperations.
Surgical Intervention for 5th Metatarsal Fracture in the Athlete: A Systematic Review
Authors: Samsonov Alan , Diamond Julia L. , Randall Grace , Mercer Nathaniel P. , Ubillus Hugo , Hurley Eoghan T. , Kennedy John G. 
Published: January 2022

Category: Midfoot/Forefoot; Sports Introduction/Purpose: To provide an overview and evaluation of the available evidence on surgical intervention for 5th metatarsal fractures in the athletic population. Methods: PubMed, Cochrane, and Embase databases were systematically reviewed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The level and quality of evidence (LOE and QoE) were recorded and assessed. Return to sport/play (RTS/RTP), radiographic outcomes, complications, reoperations, and revisions were also evaluated. Results: Twenty-eight studies were included in this review spanning a total of 761 patients and 765 fractures. The weighted mean age of the study population was 24 years, and the mean follow-up was 33.8 months. Surgical techniques and fracture types varied across the studies, but the majority (18) used internal fixation. Nonunion occurred in 5.8% (11/190) of patients who received a surgical treatment other than internal fixation, but only in 2.3% (11/480) of patients who received surgical treatment with internal fixation. Patients presenting with acute 5th MTP fractures returned to play significantly faster than those with delayed union 5th MTP fractures (7.6 weeks vs. 11.2 weeks) (p<.001). However, reoperation/revision rates were highest in patients who received surgery for acute 5th MTP fracture, of which 8.3% (16/192) of patients with acute fracture underwent reoperation or revision after surgical management. Conclusion: The current systematic review showed favorable outcomes for the surgical treatment of 5th MTP fractures in the athletic population. Athletes who underwent surgical treatment for an acute 5th MTP fracture returned to play at a faster rate compared to other fracture types but were associated with a high complication rate and a higher reoperation and revision rate.