bluuebunny/crossref_metadata_2025_split huggingface dataset:
Synthetic Cast Material Versus Plaster of Paris for the Treatment of Idiopathic Clubfoot by the Ponseti Protocol: A Comparative Analysis of 136 Feet
Authors: Monforte Sergio , Alberghina Flavia , Paonessa Matteo , Canavese Federico , Andreacchio Antonio 
Published: March 2021

Background:
Synthetic casting materials have been used as alternatives to plaster of Paris (POP) in the treatment of clubfoot using the Ponseti method. The aim of this study was to evaluate the clinical outcome of children with idiopathic clubfoot managed by the Ponseti method using POP versus semirigid fiberglass (SRF).

Methods:
Medical records were retrospectively reviewed for all newborns with idiopathic clubfoot who underwent manipulation and casting by the Ponseti technique between January 2013 and December 2016 at 2 different institutions. In all, 136 consecutive clubfeet were included, of which 68 underwent casting with POP (Group A), and 68 were casted using SRF (Group B). Statistical analysis was performed using the Fisher exact test for categorical variables, and the unpaired t test for quantitative parameters.

Results:
Mean age at time of first cast was 10 days (range, 3 to 21 d). Mean Pirani score at start of treatment was 4.6 and 4.5 in Groups A and B, respectively. Mean number of casts for each patient in Group A was 5.2 against 4.2 in patients in Group B. Mean follow-up was 63.8 months (range, 42 to 88 mo). In each group, 4 cases of relapse were reported (2.9%). No complications related to cast phase or brace phase were recorded. Shorter duration of cast treatment was recorded in Group B.

Conclusions:
Despite its higher cost and slightly lower moldability, the use of SRF in experienced hands showed comparable results in idiopathic clubfeet treated by the Ponseti technique.

Level of Evidence:
Level III.
Research Participant Recruitment Strategies Among Individuals with Acute Spinal Cord Injury and Their Caregivers
Authors: Watson Jack D. , Perrin Paul B. , McDonald Scott D. , Tyler Carmen M. , Burke Julian , Pierce Bradford S. , Hugeback Hannah , Mickens Melody N. 
Published: March 2021

Study Design.
Pre-post study.

Objective.
To evaluate the efficiency of a series of recruitment strategies in a longitudinal study of individuals with SCI and their informal caregivers. Primary strategies included (a) rapport building in advance, (b) warm handoffs from another healthcare provider who already had a relationship with the potential participant, (c) ensuring the potential participant had information about the study prior to the initial contact by the research coordinator (RC), (d) attempting informed consent only when both the patient and informal caregiver were present, and (e) ensuring the RC had at least 30 minutes to explain the study when attempting recruitment.

Summary of Background Data.
While a fairly large body of research has been conducted on general recruitment strategies for clinical trials, very little has examined the efficacy of these strategies within neurological conditions and almost none within SCI.

Methods.
Individuals with an acute SCI and their informal caregivers were recruited from acute spinal cord rehabilitation units with a Veteran's Affairs medical center and an academic medical center in the same urban area. Of 49 eligible dyads, 41 were approached for consent, with 27 consenting to join the study (9 from the academic medical center; 18 from the VA).

Results.
There was a significant difference in enrollment rates after implementing the recruitment strategies, χ
2(1) = 7.572, P = 0.006, with the per month participant enrollment rate nearly doubling after implementation.

Conclusion.
Using a multiteam and multidisciplinary approach to recruitment may increase the likelihood that individuals with an acute SCI and their caregivers enroll in research.

Level of Evidence: 3
Structural Iliac Crest Autograft for Segmental Reconstruction After Metastatic Renal Cell Tumor Resection of the Radial Shaft
Authors: Ola David , Perez Diandra , Damron Timothy A. 
Published: March 2021

Introduction:
Metastatic bone lesions are sometimes managed with en bloc resection that creates defects often requiring reconstruction. Reconstructive options for intercalary segmental bone defects are dependent on defect site and size. The radius is a rare site of metastatic disease and even rarer to require resection. While vascularized or nonvascularized fibular autografts have been used in this setting, there is no prior report detailing the use of a large autogenous iliac crest bone graft. We report structural iliac crest autograft reconstruction in a surgically resected radial diaphyseal solitary renal cell carcinoma metastasis.

Case Report:
A 62-year-old man presented with a solitary osseous metastatic bone lesion to the radial shaft. After nephrectomy, resection of the bone lesion followed by reconstruction with autogenous iliac crest bone graft was accomplished. Postoperative plain radiographs a year later showed integration at both graft-host junctions without hardware failure. The Musculoskeletal Tumor Society (MSTS)/Enneking score at 1 year was 22/30 points.

Discussion:
This article presents a case illustrating unique use of structural iliac crest autograft in segmental diaphyseal reconstruction of the radial shaft following metastatic renal cell carcinoma bone resection. This technique has the advantage of potentially increasing rate and decreasing time of healing when compared with allograft techniques and avoids increased operative time and potential donor site morbidity of vascularized fibular grafts.
Stereotactic Body Radiotherapy for Palliation of Hematuria Arising From Urothelial Carcinoma of the Kidney in Unfavorable Surgical Candidates
Authors: Aronowitz Jesse , Ding Linda , Yates Jennifer , Zong Yang , Zheng Larry , Jiang Zhong , Yancey Jessica , Mittal Kriti , Fitzgerald Thomas J. 
Published: March 2021

Introduction:
Hematuria can be a distressing and debilitating complication of urothelial carcinoma (UC) of the kidney for patients who are not candidates for surgery or ureteroscopic ablation. We retrospectively assessed the efficacy, tolerability, and safety of stereotactic body radiotherapy (SBRT) for controlling gross hematuria in this patient population.

Materials and Methods:
Institutional Review Board (IRB)-approved review of the records, laboratory values, pathology, and imaging of 8 consecutive patients treated with SBRT over a 5-year period for uncontrolled gross hematuria caused by UC of the renal pelvis or calyces.

Results:
Therapy was delivered in 3 to 5 treatments over 1 to weeks. Individual treatments lasted an average of 17.2 minutes. No patient experienced treatment-related pain, vomiting, or diarrhea. All enjoyed cessation of bleeding within a week of completing therapy. Hematuria recurred in 2 patients in 4 and 22 months. Of the patients who have not re-bled, 3 expired of metastatic disease or co-morbidities, and 3 remain alive up to 6 years posttreatment. Of patients who have survived longer than a year, creatinine has changed by −0.05 to +0.35, and estimated glomerular filtration rate has fallen by an average of 22%. No patient has required dialysis.

Conclusions:
SBRT appears to be an effective and well-tolerated means of palliating gross hematuria secondary to UC of the renal pelvis or calyces in patients who are unfavorable candidates for nephrectomy or ureteroscopic ablation. Treatment was associated with a moderate decline in renal function.
Surveillance Only for High-risk FIGO Stage IA/IB Malignant Ovarian Germ Cell Tumors
Authors: Nasioudis Dimitrios , Frey Melissa K. , Chapman-Davis Eloise , Caputo Thomas A. , Holcomb Kevin M. 
Published: March 2021

Objectives:
Investigate the use and outcomes of a surveillance only strategy for patients with high-risk stage I malignant ovarian germ cell tumors.

Methods:
Patients with International Federation of Gynecology and Obstetrics stage IA/IB grade 2 or 3 immature teratoma, yolk sac, or mixed germ cell tumor diagnosed between 2004 and 2014 who had at least 1 month of follow-up were drawn from the National Cancer Database. Overall survival (OS) was evaluated for each histologic subtype using Kaplan-Meier curves, and compared with the log-rank test.

Results:
A total of 497 patients were identified; 115 (23.1%) with grade 2 immature teratoma, 157 (31.6%) with grade 3 immature teratoma, 101 (20.3%) with yolk sac tumor, 124 (25%) with mixed germ cell tumor. Rate of adjuvant chemotherapy was 68.2% (655 patients), while rate of lymph node biopsy/dissection was 55.2%. A total of 19 (3.8%) deaths were observed at a median of 29.8 months. There was no difference in OS between patients who did and did not receive adjuvant chemotherapy with grade 2 (P=0.35) and grade 3 immature teratoma (P=0.47) or mixed germ cell tumors (P=0.55). Patients with yolk sac tumors those who received chemotherapy had better OS compared with those who did not, P=0.019; 5-year OS rates were 92.7% and 79.6%, respectively.

Conclusions:
A surveillance only strategy for patients with stage I malignant ovarian germ cell tumors is associated with excellent survival outcomes for patients with grade 2 or 3 immature teratoma or mixed germ cell tumors.
Pancreatic Cancer Clinical Treatment Trials Accrual
Authors: Guerra Carmen E. , Kelly Sheila , Redlinger Colleen , Hernández Patricia , Glanz Karen 
Published: March 2021

Objectives:
Low rates of participation in cancer clinical trials are commonly reported, raising concerns about missed opportunities to engage patients in treatment trials. We reviewed eligibility for and enrollment in pancreatic cancer clinical trials for patients seen at a National Cancer Institute (NCI)-designated cancer center during 1 year, to calculate participation rates with detailed information to determine the best-case participation rate.

Materials and Methods:
This retrospective cohort study used the Abramson Cancer Center Cancer Registry, clinical trial protocols, and electronic medical records (EMRs) to determine eligibility for all available pancreatic cancer clinical trials. Patient characteristics and reasons for ineligibility were abstracted from EMRs. We then computed participation rates based on enrollment in trials using EMR and clinical trials monitoring data.

Results:
Of 233 new pancreatic cancer patients in 2014, 47 or 20% enrolled in a clinical trial (enrollment fraction). According to the EMR, of the 66 patients who were eligible for a trial, 54 (82% of eligible) accepted and 47 (71% of eligible) ultimately enrolled in a trial, 8 (12% of eligible) declined, and 4 (6% of eligible) had no record of patient decision. Enrollment in a trial by both the EMR and clinical trials database was confirmed for 71% of eligible patients.

Conclusions:
This study reveals that 71% of newly diagnosed pancreatic cancer patients who were eligible for a trial were enrolled in a treatment trial. We contend that in-depth analysis, rather than enrollment fraction, should be used to inform the gap between actual participation and optimal clinical trial participation for cancer patients.
Trends and Factors Associated With Receipt of Upfront Surgery for Stage II to III Rectal Adenocarcinoma in the United States, 2006 to 2016
Authors: Hein David M. , Ahn Chul , Aguilera Todd A. , Folkert Michael R. , Sanford Nina N. 
Published: March 2021

Introduction:
The German rectal study published in 2004 established neoadjuvant chemoradiation as a standard of care for locally advanced rectal cancer and current National Comprehensive Cancer Network guidelines endorse several preoperative regimens. Upfront surgery, however, is considered substandard care. In the era of evolving treatment paradigms for locally advanced rectal cancer, we sought to assess trends and predictors of receipt of upfront surgery for stage II to III rectal cancer.

Methods:
The National Cancer Database was used to identify patients diagnosed with clinical stage II to III rectal adenocarcinoma between 2006 and 2016. Multivariable logistic regression defined adjusted odds ratios and associated 95% confidence intervals of receipt of upfront definitive surgery. The timing of upfront surgery relative to day of diagnosis and rate of receipt of adjuvant therapy were also estimated.

Results:
Among 51,562 patients, 6411 (12.4%) were treated with upfront surgery, which decreased from 16.7% in 2006 to 7.1% in 2016 (P<0.001). The majority of patients (5737 [89.5%]) had definitive surgery after initial diagnostic biopsy. Variables associated with receipt of upfront surgery included female sex, older age, higher comorbidity score, and treatment at a community cancer center (P<0.001). Among those receiving upfront surgery, 2904 (45.3%) received adjuvant radiation therapy, 3218 (50.2%) received adjuvant chemotherapy, and 2559 (39.9%) received no further treatment.

Conclusions:
The proportion of patients with clinical stage II to III rectal cancer treated with upfront surgery has steadily declined since 2006, however, certain subgroups appear to remain at greater risk. Further research is needed to better elucidate patient and systems-level factors contributing to these disparities in care.
Personalized Therapy for Mycophenolate: Consensus Report by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology
Authors: Bergan Stein , Brunet Mercè , Hesselink Dennis A. , Johnson-Davis Kamisha L. , Kunicki Paweł K. , Lemaitre Florian , Marquet Pierre , Molinaro Mariadelfina , Noceti Ofelia , Pattanaik Smita , Pawinski Tomasz , Seger Christoph , Shipkova Maria , Swen Jesse J. , van Gelder Teun , Venkataramanan Raman , Wieland Eberhard , Woillard Jean-Baptiste , Zwart Tom C. , Barten Markus J. , Budde Klemens , Dieterlen Maja-Theresa , Elens Laure , Haufroid Vincent , Masuda Satohiro , Millan Olga , Mizuno Tomoyuki , Moes Dirk J. A. R. , Oellerich Michael , Picard Nicolas , Salzmann Linda , Tönshoff Burkhard , van Schaik Ron H. N. , Vethe Nils Tore , Vinks Alexander A. , Wallemacq Pierre , Åsberg Anders , Langman Loralie J. 
Published: March 2021

Abstract:
When mycophenolic acid (MPA) was originally marketed for immunosuppressive therapy, fixed doses were recommended by the manufacturer. Awareness of the potential for a more personalized dosing has led to development of methods to estimate MPA area under the curve based on the measurement of drug concentrations in only a few samples. This approach is feasible in the clinical routine and has proven successful in terms of correlation with outcome. However, the search for superior correlates has continued, and numerous studies in search of biomarkers that could better predict the perfect dosage for the individual patient have been published. As it was considered timely for an updated and comprehensive presentation of consensus on the status for personalized treatment with MPA, this report was prepared following an initiative from members of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT). Topics included are the criteria for analytics, methods to estimate exposure including pharmacometrics, the potential influence of pharmacogenetics, development of biomarkers, and the practical aspects of implementation of target concentration intervention. For selected topics with sufficient evidence, such as the application of limited sampling strategies for MPA area under the curve, graded recommendations on target ranges are presented. To provide a comprehensive review, this report also includes updates on the status of potential biomarkers including those which may be promising but with a low level of evidence. In view of the fact that there are very few new immunosuppressive drugs under development for the transplant field, it is likely that MPA will continue to be prescribed on a large scale in the upcoming years. Discontinuation of therapy due to adverse effects is relatively common, increasing the risk for late rejections, which may contribute to graft loss. Therefore, the continued search for innovative methods to better personalize MPA dosage is warranted.
Multimodal imaging in infectious and noninfectious intermediate, posterior and panuveitis
Authors: Thomas Akshay S. , Lin Phoebe 
Published: March 2021

Purpose of review
Given the heterogeneity of uveitis, markers of inflammation vary from patient to patient. Multimodal imaging has proven itself to be critical for accurate evaluation for disease activity and treatment response in uveitis.

Recent findings
Ultra-widefield (UWF) fluorescein angiography and autofluorescence (AF) as well as optical coherence tomography angiography (OCTA) have provided insights into disease pathogenesis and monitoring not previously appreciated. In addition to structural retinal imaging, OCT can be used to assess the choroid, the posterior cortical vitreous and the retinal vasculature in eyes with uveitis.

Summary
Multimodal ocular imaging in eyes with uveitis is critical for disease diagnosis and assessing response to treatment. UWF fluorescein angiography can detect retinal vasculitis even in the absence of overt vascular sheathing. UWF AF can help detect more chorioretinal lesions than clinically visible. OCT can be used to assess the posterior cortical vitreous, retina, large retinal vessels and choroid in uveitis. The use of multimodal imaging will likely be needed to determine clinical trial endpoints in studies evaluating therapeutics for uveitis.
Detection of Primary Angle Closure Glaucoma Progression by Optical Coherence Tomography
Authors: Kurysheva Natalia I. , Lepeshkina Lyudmila V. 
Published: March 2021

Purpose:
To compare the role of spectral-domain optical coherence tomography (SD-OCT) in regard to retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) assessment in the detection of primary angle-closure glaucoma (PACG) and primary open-angle glaucoma (POAG) progression.

Materials and Methods:
In the prospective study, 131 subjects with PACG and POAG were examined during 72 months with follow-up visits every 6 months. Visual field (VF) progression was detected using the Guided Progression Analysis (GPA) of the Humphrey visual field analyzer and structural change using SD-OCT while a significant negative trend for the RNFL and GCC was gauged. The diagnostic accuracy of RNFL and GCC thinning in the detection of glaucoma progression was compared between PACG and POAG eyes using the Kaplan-Meier method with the calculation of the log-rank test.

Results:
Progression was detected in 57% of eyes with POAG and 59% of eyes with PACG. The rate of thinning of RNFL (−2.95±1.85 μm/y) and GCC (−3.22±2.96 μm/y) was significantly higher in PACG progression eyes compared with POAG [−1.64±2.00 μm/y (P=0.018) and −1.74±2.05 μm/y (P=0.046), respectively]. The progression was associated with initial pattern standard deviation in both glaucoma subtypes, while only in PACG—with long-term intraocular pressure fluctuations (cutoff >5.2 mm Hg) and lens thickness (cutoff >4.92 mm), and only in POAG—with initial focal loss volume of GCC (cutoff >1.5%).
In PACG, the rate of the visual function deterioration correlated with GCC thinning rate (r=0.330, P=0.027), but not with the RNFL thinning rate (r=−0.010, P=0.79), while in POAG, it was significant for both RNFL thinning (r=0.296, P=0.039) and GCC thinning (r=0.359, P=0.011). In PACG patients with progressive GCC thinning, functional progression was detected earlier (log-rank test P≤0.001) than in patients with progressive RNFL thinning (log-rank test P=0.457), while for POAG, these results were P=0.012 and ≤0.001 for GCC and RNFL thinning, respectively.

Conclusions:
SD-OCT plays an important role in detecting PACG progression. In contrast to POAG, GCC thinning predicted functional loss better than RNFL thinning in PACG.
Carcinoma Expleomorphic Adenoma of the Lacrimal Gland
Authors: Vahdani Kaveh , Rose Geoffrey E. 
Published: March 2021

Aims:
To report the characteristics and long-term outcomes of patients presenting with carcinoma ex-pleomorphic adenoma (CXPA) or malignant mixed tumor of the lacrimal gland.

Methods:
A retrospective case-note review for patients with CXPA, seen at Moorfields Eye Hospital between 1985 and 2018, was performed for demographics, presentation, imaging, histopathology, management, and outcome.

Results:
Twenty-six patients (11 male; 42%) presented at a mean age of 46 years (median 46.4; range 24–81), with average symptom(s) duration of 67 months (median 24 months; range 6 weeks–53 years). The commonest symptoms were proptosis (13 patients; 50%), orbital ache or pain (11/26, 42%), having noted a lump in the upper eyelid (8/26, 31%), and diplopia (7/26, 27%). About 90% of patients had nonaxial globe displacement, over a half had a palpable mass and 3-quarters had reduced motility. Adenocarcinoma was the commonest malignant component of the tumor, occurring in 16 (62%) of the patients, followed by adenoid cystic carcinoma in 5 patients (19%); 10/26 (28%) tumors showed significant invasion on histological examination. A quarter of the patients had tumor-related death at an average of 2.8 years after diagnosis (median 2.5; range 1.5–4.4 years), and the overall probability of survival for the whole cohort was 63% at both 5 years and 10 years after treatment. The prognosis for CXPA was significantly worse with a history of prior incompletely excised pleomorphic adenoma (p < 0.001), a markedly invasive malignant component (p = 0.001), evidence of perineural invasion (p = 0.042), and an American Joint Committee on Cancer tumor size of T3 or greater (p = 0.024).

Conclusion:
Intact excision of CXPAs that do not display histological evidence of extension beyond the tumor pseudocapsule have a good outcome, similar to that for intact excision of benign pleomorphic adenomas. In contrast, our patients with markedly invasive CXPA had a tendency to local recurrence or distant metastasis, and tumor-related death occurred in about two-thirds.
Early Experience With the Clinical Use of Teprotumumab in a Heterogenous Thyroid Eye Disease Population
Authors: Diniz Stefania B. , Cohen Liza M. , Roelofs Kelsey A. , Rootman Daniel B. 
Published: March 2021

Purpose:
To describe the clinical course in a heterogeneous series of subjects with thyroid eye disease (TED) treated with teprotumumab.

Methods:
Cross-sectional cohort study including patients with clinical diagnosis of TED who was treated with teprotumumab. The entire cohort was analyzed together and subsequently in clinical subgroups based on stage and grade of disease. Primary outcome measure was change in proptosis ≥2 mm. Secondary outcome measures included change in clinical activity score (CAS), ductions, strabismic deviation, MRD1, and MRD2. Bivariate and multivariate statistics were performed.

Results:
The study included 21 patients. Mean ± SD age was 61.5 ± 12.6 years and 71.4% were female. Reduction in proptosis ≥2 mm was achieved in 71.4% of the sample. Stage and grade were not significant predictors of outcome. Treatment with teprotumumab resulted in a 2.5 ± 1.8 mm reduction of proptosis (P < 0.001), 2.2 ± 1.4 reduction in CAS (P < 0.001), and 16.9 ± 19.3 degree improvement in extraocular motility (P < 0.001). There were no significant differences for change in CAS, proptosis, ductions, or MRD2 between different grades and stages of disease. Total strabismus and MRD1 improvement were greater in the active stage of disease (P < 0.05). Three cases of dysthyroid optic neuropathy, refractory to methylprednisolone therapy improved after initiation of teprotumumab.

Conclusions:
Treatment of TED with teprotumumab in a heterogeneous patient population is associated with improvement in proptosis, extraocular motility, and CAS. Patients beyond those defined in the clinical trials, including those affected by stable stage, milder grade, and vision-threatening TED may benefit from this therapy. There are, however, limits on the overall efficacy of this medication in the management of certain physical characteristics in TED including eyelid position and strabismus.