bluuebunny/crossref_metadata_2025_split huggingface dataset:
Quality control concerns in relation to lamotrigine and their impact
Authors: Parker Gordon , Jenner Andrew 
Published: February 2022

Objective To pursue explanations for compromised efficacy and induction of side-effects in some generic brands of lamotrigine distributed in Australia. Method Bioassays of the non-generic and five generic lamotrigine tablets were undertaken (also after exposure to heat and cold), as well as assays of two generic drugs generating concerning side-effects in two patients, while enquiries were made of manufacturing companies. Results Mass spectrometry of the six tested products showed comparable properties and no compromising when those tablets were heated and cooled, while analyses of the products taken by the two patients reporting significant side-effects showed an increase in the peak area lamotrigine concentration. Conclusions We failed to identify any intrinsically compromised product in our comparison analyses of the six preparations. We consider alternate explanations for an issue leading to widespread international reporting of distinct side-effects and deaths following brand switching, with analyses of the two problematic preparations supporting a ‘faulty’ batch explanation.
The single-item Self-Rated Mental Health Question in women with gestational diabetes mellitus
Authors: Maguire Paul A , Reay Rebecca E , Nolan Christopher J , Looi Jeffrey CL 
Published: February 2022

Objective This study aims to explore whether the single-item Self-Rated Mental Health Question (SRMHQ) may be an indicator of the need for further mental health assessment and investigation in women with gestational diabetes mellitus (GDM). Method Women with GDM ( n = 159) were recruited from outpatient clinics in the Australian Capital Territory prior to a GDM information session (mean gestational age = 26, SD = 4.5). Participants were aged 20–45 (mean = 33, SD = 4.2) and completed a single-item Self-Rated Health Question (SRHQ), single-item Self-Rated Mental Health Question (SRMHQ), Kessler 10-item Psychological Distress Scale (K-10), and Edinburgh Depression Scale (EDS), as well as demographic, psychiatric, and general health items. Multiple regression was used to explore whether there was an association between SRMHQ responses and K-10 or EDS total scores. Results Regression analysis revealed that the SRMHQ was a statistically significant predictor of K-10 and EDS total scores, while controlling for key potential confounders. When mental health was rated as “poor” compared to “excellent,” this was associated with an additional 12 and 9 points on K-10 and EDS total scores, respectively. Conclusion The SRMHQ may have a role as an indicator of the need for further mental health assessment and investigation in women with gestational diabetes mellitus.
Socioeconomic Disparities in Cleft Lip Care
Authors: Kalmar Christopher L. , Malphrus Elizabeth L. , Kosyk Mychajlo S. , Zapatero Zachary D. , Taylor Jesse A. 
Published: February 2022

Objective The purpose of this study was to utilize a multicenter dataset to elucidate whether socioeconomic factors were associated with access to cleft lip surgery, treatment by higher-volume providers, and family choice for higher-volume centers. Design Retrospective cohort study. Setting Hospitals participating in the Pediatric Health Information System. Patients Primary cleft lip repair performed in the United States between 2010 and 2020. Outcomes Travel distance, hospital volume, hospital choice. Results During the study interval, 8954 patients underwent unilateral (78.4%, n  =  7021) or bilateral (21.6%, n  =  1933) primary cleft lip repair. Patients with unilateral cleft lip were repaired significantly earlier if they were White ( P < .001) and significantly later if they lived in an urban community ( P  =  .043). Similarly, patients with bilateral cleft lip were repaired significantly earlier if they were White ( P < .001). Patients from above-median income households ( P  =  .011) and living in urban communities ( P < .001) were significantly more likely to be treated at high-volume hospitals, whereas those living in underserved communities ( P < .001) were significantly less likely to be treated at high-volume hospitals. White patients were significantly more likely to be treated by high-volume surgeons ( P < .001). Patients with White race were significantly more likely to choose a higher-volume hospital than the one most locally available ( P < .001). Conclusions Patients with White race are more likely to travel farther and be treated by high-volume surgeons although at smaller hospitals. Patients from underserved areas travel significantly farther for cleft care and are treated at lower-volume hospitals. Patients in urban communities have shorter travel distances and are treated at higher-volume hospitals.
Use of a cyclical hypofractionated radiotherapy regime (‘QUAD shot’) for the treatment of feline sinonasal carcinomas
Authors: Frezoulis Petros S , Harper Aaron , Mason Sarah L 
Published: February 2022

Objectives Radiation therapy is the treatment of choice for cats with sinonasal carcinomas. Different protocols have been described in the literature, though a clear consensus regarding the optimal protocol is lacking. The aim of the study was to describe the tolerability, efficacy and outcome of cats treated with a cyclical hypofractionated protocol. Methods Cats with histologically diagnosed sinonasal carcinomas in a single institution were retrospectively included. All patients were treated with a cyclical hypofractionated protocol (‘QUAD shot’ regime). Cats were treated with 4 Gray (Gy) delivered in four fractions within 48 h, with a minimum of 6 h between two treatments, and repeated every 3–4 weeks for a total dose of 48 Gy in three cycles. Results Seven cats met the inclusion criteria. Nasal discharge and sneezing were the most common presenting complaints. All cats presented with advanced stage of disease with CT examination (three with modified Adams stage 3 and four with stage 4). Clinical improvement was seen in six cats. Five cats had a follow-up CT; one had a complete response, two had partial responses, one had stable disease and one had progressive disease. Two cats were still alive at the time of writing while four were euthanased owing to tumour-related causes. The median overall survival time was 460 days. The 1-year survival time was 80% and the 2-year survival time was 0%. Severe acute or late toxicity was not reported. Conclusions and relevance This is the first report of a cyclical hypofractionated protocol in the veterinary literature that can provide prolonged survival in cats with advanced stage sinonasal carcinoma. Its use should be considered in patients when prolonged hospitalisation can be detrimental to quality of life, while still delivering a therapeutic total dose of radiation therapy.
Analysis of tear film in cystinosis patients treated with topical viscous cysteamine hydrochloride (Cystadrops®)
Authors: Sergio Petroni , Giancarlo Iarossi , Matteo Federici , Maria De Sanctis Carlo , Gianni Petrocelli , Parrilla Rosa , Valente Paola , Luca Buzzonetti 
Published: February 2022

Purpose The aim of this study was to evaluate in vivo the tear film in infantile nephropathic cystinosis patients with corneal crystals treated with topical viscous cysteamine hydrochloride (Cystadrops®). Methods Ten eyes of five patients with nephropathic cystinosis aged from 10 to 35 years were included in this study. The patients were under treatment with viscous cysteamine hydrochloride formulation containing 3.8 mg/mL cysteamine (vCH 0.55%, equivalent to 0.55% CH; Cystadrops®; Recordati rare Diseases, Puteaux, France) to reduce corneal crystal density. Five age and sex matched individuals were randomly selected as control group. Tear osmolarity testing (TearLabTM) was performed to assess the in vivo osmolarity of patients under treatment and compared to control group values. Tear film break-up time (TBUT) and basic tear secretion (Schirmer test) were also assessed. Results Mean tear osmolarity was 294.8 mOsms/L (±10.4), with a mean absolute difference of 1.85 mOsms/L (±2.13) between the eyes. There was no statistically significant difference between the osmolarity readings of cystinosis and the control group (294.8 ± 10.4 vs 299.4 ± 6.2mOsm/L, respectively; p = 0.39). The mean TBUT was 10.2 ± 0.83 s in the study group versus 10 ± 0.7 s in controls (p = 0.62). The mean Schirmer test score was 9.2 ± 0.83 mm in the patients versus 10.2 ± 0.83 mm in the controls (p = 0.14). Conclusions The TearLabTM osmolarity system test showed good reliability and precision in repeated measurements. This is the first report using the TearLab osmolarity system to assess tear film in patients with cystinosis treated with vCH 0.55%. TearLabTM examination showed that the use of vCH 0.55% drops does not determine alterations of the tear film quality.
Acute Effects of Coffee on Peripapillary and Subfoveal Choroidal Parameters in Young Healthy Subjects
Authors: Koçak Nurullah , Beldağlı Cihangir , Yeter Volkan 
Published: February 2022

Purpose To evaluate the acute effects of coffee on peripapillary and subfoveal choroidal structures using spectral-domain optical coherence tomography (SD-OCT). Materials and Methods A total of 28 healthy individuals (study group) and 28 healthy controls were enrolled in this study. The peripapillary and subfoveal choroidal thickness (SFCT) was measured at baseline, 30 min, 1 h, 2 h, and 4 h, following coffee (75 mg caffeine/200 ml) intake in the study group and the same amount of water in the control group. Choroidal images were binarized to the luminal area (LA), stromal area (SA), and total choroidal area (TCA) using ImageJ software. Similar to the CT, the peripapillary and subfoveal choroidal vascularity indices (CVIs) were calculated at the same time points in both groups. Results CT and CVI measurements of four peripapillary quadrants displayed no significant difference at baseline and all-time points in both groups ( p > 0.05). In the study group, SFCT was found to be significantly lower (at 30 min, 1 h, 2 h, and 4 h) than the baseline measurement ( p < 0.05). Additionally, subfoveal LA, TCA, and CVI decreased in all-time points compared with baseline measurements ( p < 0.05, for all). This was not true for the subfoveal SA ( p > 0.05). No significant difference was found between the respective SFCT and subfoveal CVI measurements in the control group ( p > 0.05, for all). Conclusion Our study revealed that peripapillary choroidal thickness and CVI did not change following a cup of coffee intake, while subfoveal CT, LA, TCA, and CVI significantly decreased for at least 4 h.
One-Year First-in-Human Success for VenoValve in Treating Patients With Severe Deep Venous Insufficiency
Authors: Ulloa Jorge H. , Glickman Marc 
Published: February 2022

Objective The clinical outcomes of this first-in-human (FIH) study provide safety and performance results 1 year after implantation of the VenoValve. Background Chronic venous insufficiency (CVI) is most often caused by valve failure in the venous system, which circulates blood from the lower limbs back to the heart and lungs. Severe diseases significantly influence quality of life, and current treatment options are limited. This study provides 1-year patient outcomes from 11 patients implanted with the VenoValve for treatment of severe deep venous CVI in C5 and C6 patients. Earlier results from 6-month follow-ups were previously published. Methods This prospective FIH study assessed the safety and performance of the VenoValve surgically implanted in 11 patients with C5 and C6 disease. All patients were followed up for at least 1 year. Assessments for adverse events, reflux time, disease severity, pain scores, and quality of life were reported. Results Implantation of VenoValve into the deep femoral vein was successful in all patients. Adverse events included 1 hematoma, 3 superficial wound infections, and 1 bleeding complication due to over-anticoagulation. One VenoValve became occluded due to patient non-compliance with anticoagulation medication. One-year clinical outcomes included significant decreases in mean reflux times (54%), and significant improvements in mean disease severity revised venous clinical severity score (56%), mean visual analog scale pain scores (76%), and Venous Insufficiency Epidemiologic and Economic Study QOL/sym scores. Conclusions The promising results from this FIH study demonstrate sustained safety and effectiveness of the VenoValve at 1 year post-implantation, and support further study for its use as a novel treatment for severe, deep venous CVI caused by valvular incompetence. A pivotal, prospective, non-blinded, single-arm, multi-center study in the United States with seventy-five (75) patients is in progress to assess the safety and effectiveness of VenoValve in these patients through 30 days and 6 months. The clinical trial is registered on ClinicalTrials.gov under identifier: NCT04943172 ( https://clinicaltrials.gov/ct2/show/NCT04943172?term=hancock+jaffe&draw=2&rank=1 ).
Developing and validating a new scale to measure the acceptability of health apps among adolescents
Authors: Chen Elizabeth , Moracco Kathryn E. , Kainz Kirsten , Muessig Kathryn E. , Tate Deborah F. 
Published: February 2022

BackgroundThe acceptability of health interventions is centrally important to achieving their desired health outcomes. The construct of acceptability of mobile health interventions among adolescents is neither well-defined nor consistently operationalized.ObjectivesBuilding on the theoretical framework of acceptability, these two studies developed and assessed the reliability and validity of a new scale to measure the acceptability of mobile health applications (“apps”) among adolescents.MethodsWe followed a structured scale development process including exploratory factor analyses (EFAs), confirmatory factor analyses (CFAs), and employed structural equation modeling (SEM) to assess the relationship between the scale and app usage. Adolescent participants used the Fooducate healthy eating app and completed the acceptability scale at baseline and one-week follow-up.ResultsEFA ( n = 182) determined that the acceptability of health apps was a multidimensional construct with six latent factors: affective attitude, burden, ethicality, intervention coherence, perceived effectiveness, and self-efficacy. CFA ( n = 161) from the second sample affirmed the six-factor structure and the unidimensional structures for each of the six subscales. However, CFA did not confirm the higher-order latent factor model suggesting that the six subscales reflect unique aspects of acceptability. SEM indicated that two of the subscales—ethicality and self-efficacy—were predictive of health app usage at one-week follow-up.ConclusionsThese results highlight the importance of ethicality and self-efficacy for health app acceptability. Future research testing and adapting this new acceptability scale will enhance measurement tools in the fields of mobile health and adolescent health.
Rise of teledermatology in the COVID-19 era: A pan-world perspective
Authors: Naik Piyu Parth 
Published: February 2022

Objective During the coronavirus disease pandemic, enforced restrictions prevented face-to-face consultations for patients requiring non-emergency medical treatment. In response, there was a rise in telemedical practices, such as teledermatology. This study aimed at understanding the pan-world experiences of patients and healthcare staff who adapted to teledermatology in the coronavirus disease era. Methods This study made use of an online survey presented to dermatology professionals using social media and WhatsApp groups. Professionals who applied teledermatology between March and June 2020 were targeted. The survey was designed to identify respondent demographics and the preferred platforms for digital consultations. The most common diagnoses and rates of referral for further evaluation were recorded. Lastly, a platform was provided for practitioners to report their own and their patient's perspectives on the advantages and operational challenges of teledermatology. Data were collated and analyzed in Microsoft Excel. Results In total, 653 stakeholders participated, representing countries worldwide. Facebook and WhatsApp services were the most popular mediums of digital consultation. Diagnoses of ailments, such as acne and eczema, as well as skin-related infections, were most common. Of the cases referred for biopsy, 10 patients were subsequently diagnosed with cutaneous malignancies. Practitioners and patients not only reported personal benefit from adopting teledermatology, but also reported concerns regarding data privacy and the levels of technological literacy required. Conclusions Teledermatology proved an innovative clinical response to unprecedented challenges. However, further policy development and technological advancement aimed at increasing the diagnostic power of digital consultations are needed to support the continuation of teledermatology in the post-pandemic world.
A Randomised Controlled Study on Epidural Morphine and Bupivacaine for Post-Operative Analgesia After Transforaminal Lumbar Interbody Fusion
Authors: Kanna Dr Rishi , Jakkepally Dr Sridhar , Shetty Dr Ajoy P. , Rajasekaran Dr Shanmuganathan 
Published: February 2022

Study design Randomised control study. Objective Different parenteral analgesics are used to alleviate post-operative pain after transforaminal lumbar interbody fusion (TLIF) but limited by their efficacy and side effects. We performed a RCT to evaluate the safety and efficacy of epidural Morphine-Bupivacaine on post-operative pain management after TLIF. Methods Consecutive patients (n=100) of TLIF were divided randomly into study (SG) and control groups (CG). At the end of procedure, SG (n=50) received epidural instillation of morphine 5 mg and bupivacaine .25% - 2 mL, along with 6 mL of .25% bupivacaine infiltration in the deep fascia before wound closure. The functional outcomes were assessed at regular intervals (4, 8, 12, 24, 36, 48, 72, 96 hours) with VAS, nausea and vomiting scale, Ramsay sedation scale and breakthrough analgesia needed, time to ambulation and other complications. Results The mean VAS score at 4 hours in SG was significantly less (1.16 ± .88) than the CG (3.32 ± 1.0) ( P = .000). This significant difference was maintained at each time point during the first 48 hours ( P < .004). Similarly, the mean NRS score in SG at 4 hours was 1.02 ± .89, and in CG 3.3 ± .69 ( P = .0000) which was maintained at all intervals of assessment till 48 hours ( P = .0137). The mean time to first ambulation was significantly less in the SG (4.46 ± 1.04 hours) than CG (11.64 ± 2.3 hours) ( P < .001). There were no drug-related complications. Conclusion Epidural instillation of bupivacaine and morphine is safe and enables better pain relief in the initial 48 hours which helps in early mobilisation, and enhanced functional recovery.
High School Athletes’ Health-Related Quality of Life Across Recovery After Sport-Related Concussion or Acute Ankle Injury: A Report From the Athletic Training Practice-Based Research Network
Authors: DiSanti Justin S. , Marshall Ashley N. , Valier Alison R. Snyder , McLeod Tamara C. Valovich 
Published: February 2022

Background: Evaluating adolescent athletes’ perceived health status after a sport-related injury can provide important direction for health promotion strategies and preparation for a successful return to play. Furthermore, comparing specific injury types regarding their impact on athletes' perspectives of their global and domain-specific health perceptions allows for a more detailed understanding of an athlete's experience while also providing avenues for targeted treatment strategies. Purpose: To compare health-related quality of life (HRQOL) between high school athletes who had sustained either a concussion or an acute ankle injury and compare how these injury types related to their global and domain-specific HRQOL across recovery. Study Design: Cohort study; Level of evidence, 3. Methods: Electronic medical records created by athletic trainers working in 32 high school facilities were examined, and records from 1749 patients who sustained either a sport-related concussion (n = 862) or ankle sprain (n = 887) were screened for inclusion. HRQOL was assessed by self-reported scores on the Pediatric Quality of Life Inventory (PedsQL) at 2 time points after injury (T1 = 0-2 days; T2 = 11-29 days). A 2-way group by time analysis of variance was conducted to examine differences in trajectories and disrupted areas of HRQOL. Results: Overall, 85 patient cases (46 concussion, 39 ankle sprain) fit the inclusion criteria. Each injury group exhibited improved global and domain-specific PedsQL scores between their 2 measured time points ( P < .05), indicating recovery. However, domain-specific comparisons revealed that at T2, patients who had sustained an ankle sprain reported significantly lower PedsQL physical functioning scores (78.3 ± 19.3 vs 86.2 ± 15.7 for concussion; P = .005), whereas patients who had sustained a concussion reported lower scores related to their school functioning (80.0 ± 20.0 vs 90.8 ± 12.7 for ankle sprain; P = .006). Conclusion: The study results indicated that in high school athletes, the trajectories and disrupted areas of HRQOL stemming from a sport-related injury may be influenced differentially when comparing concussions with ankle sprains.
Evaluation of Differences Between Non-Hispanic White and African American Patients With Sports Medicine–Related Hip Disabilities
Authors: Brown Marsalis , Udawatta Thiran , Flesch Lance , Strnad Gregory J. , Briskin Isaac , Jones Morgan , Kaar Scott , Rosneck James T. , Farrow Lutul D. 
Published: February 2022

Background: Racial disparities within the field of orthopaedics are well-documented in the spinal surgery, knee arthroplasty, and hip arthroplasty literature. Not much is known about racial differences in patients with sports medicine–related hip disabilities. Purpose: To investigate whether differences exist between African American and non-Hispanic White (White) patients evaluated for hip disabilities. Study Design: Cross-sectional study; Level of evidence, 3. Methods: We performed a multicenter retrospective cohort study of 905 patients who were evaluated over a 1-year period for hip-related orthopaedic concerns. Patient demographic data, disability characteristics, and hip radiographic findings were obtained from electronic medical records. We also obtained data on whether patients were offered physical therapy, magnetic resonance imaging (MRI), and/or surgery. Comparisons by race and insurance status were evaluated using univariate and multivariate analyses. Results: African Americans comprised a significantly lower proportion of the patients evaluated for hip-related disabilities compared with Whites (6.5% vs 93.5%; P < .001). A significantly smaller proportion of African Americans with hip disabilities was recommended for surgery than White patients (35.6% vs 54.6%; P = .007). Cam deformities were more common in White vs African American patients (39.7% vs 23.7%; P = .021), as were labral tears (54.1% vs 35.6%; P = .009). Logistic regression demonstrated that neither race nor insurance status were significant determinants in surgery recommendations. Conversely, race was a determinant of whether an MRI was performed, as White patients were 2.74 times more likely to have this procedure. There were no differences with respect to obtaining an MRI between private and Medicaid insurance. Conclusion: Compared with White patients, there were differences in both the proportion of African Americans evaluated for hip-related disabilities and the proportion receiving a surgery recommendation. African Americans with sports medicine–related hip issues were also less likely to obtain an MRI. With regard to observed pathology, African American patients were less likely to have cam deformities and labral tears than White patients.