bluuebunny/crossref_metadata_2025_split huggingface dataset:
Telephone versus video consultations: A systematic review of comparative effectiveness studies and guidance for choosing the most appropriate modality
Authors: Caffery Liam J , Catapan Soraia De Camargo , Taylor Monica L , Kelly Jaimon T , Haydon Helen M , Smith Anthony C , Snoswell Centaine L 
Published: February 2024

Objective This systematic review compared clinical, service and cost effectiveness of telephone consultations (TC) to video consultations (VC). Methods We searched Embase, CINAHL and MEDLINE for empirical studies that compared TC to VC using clinical, service or economic outcome measures. Clinician or patient preference and satisfaction studies were excluded. Findings were synthesised descriptively. Results A total of 79 articles were included. The most effective modality was found to be VC in 40 studies (50%) and TC in 3 (4%). VC and TC were found to be equivalent in 28 of the included articles (35%). VC were superior or equivalent to TC for all clinical outcomes. When compared to TC, VC were likely to have better patient engagement and retention, to improve transfer decisions, and reduce downstream sub-acute care utilisation. The impact of telehealth modality on consultation time, completion rates, failure-to-attend rates and acute care utilisation was mixed. VC were consistently found to be more cost effective despite having a higher incremental cost than TC. Conclusions Our systematic review demonstrates equal or better, but not inferior clinical and cost outcomes for consultations delivered by VC when compared to TC. VC appear to be more clinically effective when visual information is required, when verbal communication with the patient is impaired and when patient engagement and retention is linked to clinical outcomes. We have provided conditions where VC should be used in preference to TC. These can be used by clinicians to guide the choice of telehealth modality. Cost effectiveness is also important to consider when choosing modality.
Understanding the Injury Mechanism in Hamate Hook Fractures by Investigating Fracture Morphologies: A Case Series Study
Authors: Suzuki Ayumi , Kanda Toshihiro 
Published: February 2024

Background: Many studies have described hamate hook fractures resulting from direct force from sporting tools. However, several authors have reported fractures that did not occur during swing-related activities. This study aimed to understand the injury mechanism of fractures by investigating their morphologies. Methods: We selected patients with hamate hook fractures and collected data on computed tomography scans, injury causes, and how athletes handled sporting tools. Results: We investigated 50 patients, and the study cohort included 32 patients who sustained injuries during sports: 24 during baseball (group A) and 8 during other sports (group B). Sixteen patients sustained injuries from falls (group C), and 2 had their hands crushed while using an industrial press machine (group D). In group A, most patients had a fracture line starting from the middle section of the radial side, accompanied by osteosclerotic changes in their lower hand. In group B, most patients had fracture morphologies similar to those of most patients in group A. The main morphology of fractures in group C was a transverse fracture at the base. Two patients in group D had minimal fragments at the tip of the hooks. Conclusions: Our results question the theory that most hamate hook fractures in athletes are caused by direct force exerted on the palm because the fracture morphology was different from that of patients injured by acute trauma from direct force. Instead, these fractures likely stem from an indirect mechanism involving repetitive force generated by the tendons and muscles acting on the hook.
Simple coiling of middle meningeal artery embolization for chronic subdural hematoma: An inverse probability of treatment weighting matched cohort study
Authors: Perng Pang-Shuo , Chuang Ming-Tsung , Wong Chia-En , Chang Yu , Sun Yuan-Ting , Wang Hao-Kuang , Lee Jung-Shun , Wang Liang-Chao , Huang Chih-Yuan 
Published: February 2024

Background Middle meningeal artery embolization (MMAE) for chronic subdural hematoma (CSDH) has gained much attention in recent years. However, unintended embolization may occur when employing liquid embolic agents or particles. We present our clinical experience in simple coiling of MMAE to manage CSDH. Methods Patients underwent either surgical evacuation or MMAE with simple coiling for CSDH were reviewed. Clinical and radiographic outcomes were assessed at admission, 1-month, and 6-month intervals. Two treatment groups were matched with inverse probability of treatment weighting. Results One hundred twelve patients were included, with 27 patients in MMAE group and 87 patients in surgery group. In MMAE group, significant reductions were observed in hematoma width (admission vs. 1-month, 2.04 [1.44–2.60] cm vs. 0.62 [0.37–0.95] cm, p < 0.001). The adjusted odds ratio (aOR) of surgical rescue rate (0.77 95%CI 0.13–4.47, p = 0.77), hematoma reduction (>50%) (0.21 95%CI 0.04–1.07, p = 0.06), and midline shift improvement rate (3.22, 95%CI 0.84–12.4, p = 0.09) had no substantial disparities between two groups at 1-month follow-up. In addition, no significant difference was noted between two groups in terms of hematoma reduction (>50%) at 6-month follow-up (aOR 1.09 95%CI 0.32–3.70, p = 0.89). No procedure-related complications were found in MMA embolization group. Conclusion Simple coiling for MMA had comparable outcomes with surgical evacuation for CSDH. Our findings suggest that simple coiling can be an alternative choice for liquid agents or particles in MMA embolization for CSDH with acceptable safety.
Assessing the impact of risk-based data monitoring on outcomes for a paediatric multicentre randomised controlled trial
Authors: Le Marsney Renate , Johnson Kerry , Chumbes Flores Jenipher , Coetzer Shelley , Darvas Jennifer , Delzoppo Carmel , Jolly Arielle , Masterson Kate , Sherring Claire , Thomson Hannah , Ergetu Endrias , Gilholm Patricia , Gibbons Kristen S 
Published: February 2024

Background/Aims Regulatory guidelines recommend that sponsors develop a risk-based approach to monitoring clinical trials. However, there is a lack of evidence to guide the effective implementation of monitoring activities encompassed in this approach. The aim of this study was to assess the efficiency and impact of the risk-based monitoring approach used for a multicentre randomised controlled trial comparing treatments in paediatric patients undergoing cardiac bypass surgery. Methods This is a secondary analysis of data from a randomised controlled trial that implemented targeted source data verification as part of the risk-based monitoring approach. Monitoring duration and source to database error rates were calculated across the monitored trial dataset. The monitored and unmonitored trial dataset, and simulated trial datasets with differing degrees of source data verification and cohort sizes were compared for their effect on trial outcomes. Results In total, 106,749 critical data points across 1,282 participants were verified from source data either remotely or on-site during the trial. The total time spent monitoring was 365 hours, with a median (interquartile range) of 10 (7, 16) minutes per participant. An overall source to database error rate of 3.1% was found, and this did not differ between treatment groups. A low rate of error was found for all outcomes undergoing 100% source data verification, with the exception of two secondary outcomes with error rates >10%. Minimal variation in trial outcomes were found between the unmonitored and monitored datasets. Reduced degrees of source data verification and reduced cohort sizes assessed using simulated trial datasets had minimal impact on trial outcomes. Conclusions Targeted source data verification of data critical to trial outcomes, which carried with it a substantial time investment, did not have an impact on study outcomes in this trial. This evaluation of the cost-effectiveness of targeted source data verification contributes to the evidence-base regarding the context where reduced emphasis should be placed on source data verification as the foremost monitoring activity.
Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial
Authors: Shah Viral N. , Al-Karadsheh Amer , Barnes Cathy , Mandry Jose , Nakhle Samer , Wernicke-Panten Karin , Kramer Daniel , Schmider Wolfgang , Pierre Suzanne , Teichert Lenore , Rotthaeuser Baerbel , Mukherjee Bhaswati , Bailey Timothy S. 
Published: February 2024

Background: SAR341402 insulin aspart (SAR-Asp) is a rapid-acting insulin analog developed as an interchangeable biosimilar to the marketed insulin aspart reference product (NovoLog; NN-Asp). GEMELLI X was a randomized controlled trial to assess outcomes with a biosimilar in line with the US Food and Drug Administration requirements for designation as an interchangeable biosimilar. This report assessed whether multiple switches between SAR-Asp and NN-Asp lead to equivalent safety and efficacy compared with continuous use of NN-Asp in adults with type 1 diabetes (T1D) treated with multiple daily injections, using once-daily insulin glargine U100 (Lantus) as the basal insulin. Methods: This open-label randomized (1:1), parallel-group, phase 3 trial compared four × four weeks of alternating use of individually titrated SAR-Asp and NN-Asp (NN-Asp for first four weeks, SAR-Asp in last four weeks; switching group) vs 16 weeks of continuous use of NN-Asp (nonswitching group). End points included pharmacokinetics, immunogenicity, adverse events, hypoglycemia, insulin dose, and change in efficacy parameters. Results: Of the 210 patients randomized, 200 (95.5%) completed the trial. Patients assigned to switching group (n = 104) and nonswitching group (n = 106) showed similar safety and tolerability, including anti-insulin aspart antibody responses, adverse events, and hypoglycemia. At week 16, there was no relevant difference between switching vs nonswitching groups in the change from baseline in glycated hemoglobin (least square [LS] mean difference = 0.05% [95% confidence interval [CI] = −0.13, 0.22]; 0.50 mmol/mol [−1.40, 2.39]), fasting plasma glucose (LS mean difference = 0.23 mmol/L [95% CI = −1.08, 1.53]; 4.12 mg/dL [−19.38, 27.62]), and changes in insulin dosages. Conclusions: Alternating doses of SAR-Asp and NN-Asp compared with continuous use of NN-Asp showed similar safety, immunogenicity, and clinical efficacy in adults with T1D. This study supports interchangeability between SAR-Asp and NN-Asp in T1D management.
Day case Rezum™ water vapour therapy for urinary retention secondary to benign prostatic hyperplasia
Authors: Noureldin Mohamed , Alabed Allat Omar , Elnabarawy Ramzy , Alnoomani Mohamed , Abdelmotagly Yehia , Gehring Tina , Rajkumar Govindaraj N , Emara Amr , Hindley Richard G 
Published: February 2024

Objectives: Rezum (Boston Scientific) water vapour therapy is an effective day case minimally invasive surgical treatment (MIST) for men with troublesome lower urinary tract symptoms (LUTSs) due to benign prostatic obstruction. The potential place for MISTs in the treatment of patients with urinary retention or permanent catheter dependence is currently unclear. Patients and Methods: A total of 48 patients presenting with retention of urine (out of a total of 524 patients) over a 4-year period from 2017 underwent Rezum treatment. All patients were followed up at 3, 6 and 12 months after the procedure. At each visit, flow rate, post void residual urine, and patient reported outcome measures (PROMs) including International Prostate Symptom Score (IPSS) were recorded. Results: A total of 34 patients had an indwelling catheter prior to treatment and 14 were self-catheterising. The mean age was 67 years (standard deviation (SD) = 3) with a mean prostate volume of 56 mL (SD = 6). The average number of injections per case was 8 (SD1), which included median lobe (ML) treatment in one man. 75% of the patients passed their post treatment trial without catheter (TWOC). IPSS improved to 6 ( p = 0.001) in 12 months. Conclusion: The results from this cohort of patients are encouraging. Further evaluation with longer follow-up is required. The addition of MISTs to the portfolio of options for men with retention of urine may offer a streamlined and efficient alternative to the conventional treatments, and help therefore to reduce the national waiting list, and allow men a more rapid solution avoiding prolonged catheterisation. Level of evidence: Not applicable.
Refined image quality assessment for color fundus photography based on deep learning
Authors: Guo Tianjiao , Liu Kun , Zou Haidong , Xu Xun , Yang Jie , Yu Qi 
Published: February 2024

Purpose Color fundus photography is widely used in clinical and screening settings for eye diseases. Poor image quality greatly affects the reliability of further evaluation and diagnosis. In this study, we developed an automated assessment module for color fundus photography image quality assessment using deep learning. Methods A total of 55,931 color fundus photography images from multiple centers in Shanghai and the public database were collected and annotated as training, validation, and testing data sets. The pre-diagnosis image quality assessment module based on the multi-task deep neural network was designed. The detailed criterion of color fundus photography image quality including three subcategories with three levels of grading was applied to improve precision and objectivity. The auxiliary tasks such as the localization of the optic nerve head and macula, the classification of laterality, and the field of view were also included to assist the quality assessment. Finally, we validated our module internally and externally by evaluating the area under the receiver operating characteristic curve, sensitivity, specificity, accuracy, and quadratic weighted Kappa. Results The “Location” subcategory achieved area under the receiver operating characteristic curves of 0.991, 0.920, and 0.946 for the three grades, respectively. The “Clarity” subcategory achieved area under the receiver operating characteristic curves of 0.980, 0.917, and 0.954 for the three grades, respectively. The “Artifact” subcategory achieved area under the receiver operating characteristic curves of 0.976, 0.952, and 0.986 for the three grades, respectively. The accuracy and Kappa of overall quality reach 88.15% and 89.70%, respectively, on the internal set. These two indicators on the external set were 86.63% and 88.55%, respectively, which were very close to that of the internal set. Conclusions This work showed that our deep module was able to evaluate the color fundus photography image quality using more detailed three subcategories with three grade criteria. The promising results on both internal and external validation indicated the strength and generalizability of our module.
Access to MAT: Participants’ Experiences With Transportation, Non-Emergency Transportation, and Telehealth
Authors: Boyd Jennifer , Carter Martha , Baus Adam 
Published: February 2024

Introduction: Access to medication assisted treatment (MAT) for opioid use disorder (OUD) in the United States is a significant challenge for many individuals attempting to recover and improve their lives. Access to treatment is especially challenging in rural areas characterized by lack of programs, few prescribers, and transportation barriers. This study aims to better understand the roles that transportation, Medicaid-funded non-emergency medical transportation (NEMT), and telehealth play in facilitating access to MAT in West Virginia (WV). Methods: We developed this survey using an exploratory sequential mixed methods approach following a review of current peer-reviewed literature plus information gained from 3 semi-structured interviews and follow-up discussions with 5 individuals with lived experience in MAT. Survey results from 225 individuals provided rich context on the influence of transportation in enrolling and remaining in treatment, use of NEMT, and experiences using telehealth. Data were collected from February through August 2021. Results: We found that transportation is a significant factor in entering into and remaining in treatment, with 170 (75.9%) respondents agreeing or strongly agreeing that having transportation was a factor in deciding to go into a MAT program, and 176 (71.1%) agreeing or strongly agreeing that having transportation helps them stay in treatment. NEMT was used by one-quarter (n = 52, 25.7%) of respondents. Only 13 (27.1%) noted that they were picked up on time and only 14 (29.2%) noted that it got them to their appointment on time. Two thirds of respondents (n = 134, 66.3%) had participated in MAT services via telehealth video or telephone visits. More preferred in-person visits to telehealth visits but a substantial number either preferred telehealth or reported no preference. However, 18 (13.6%) reported various challenges in using telehealth. Conclusions: This study confirms that transportation plays a significant role in many people’s decisions to enter and remain in treatment for OUD in WV. Additionally, for those who rely on NEMT, services can be unreliable. Finally, findings demonstrate the need for individualized care and options for accessing treatment for OUD in both in-person and telehealth-based modalities. Programs and payers should examine all possible options to ensure access to care and recovery.
The Use of Osteobiologics in Single versus Multi-Level Anterior Cervical Discectomy and Fusion: A Systematic Review
Authors: Hoffmann Jim , Ricciardi Guillermo A. , Yurac Ratko , Meisel Hans Jörg , Buser Zorica , Qian Bangping , Vergroesen Pieter-Paul A. ,   AO Spine Knowledge Forum Degenerative
Published: February 2024

Study Design Systematic literature review. Objectives In this study we assessed evidence for the use of osteobiologics in single vs multi-level anterior cervical discectomy and fusion (ACDF) in patients with cervical spine degeneration. The primary objective was to compare fusion rates after single and multi-level surgery with different osteobiologics. Secondary objectives were to compare differences in patient reported outcome measures (PROMs) and complications. Methods After a global team of reviewers was selected, a systematic review using different repositories was performed, confirming to PRISMA and GRADE guidelines. In total 1206 articles were identified and after applying inclusion and exclusion criteria, 11 articles were eligible for analysis. Extracted data included fusion rates, definition of fusion, patient reported outcome measures, types of osteobiologics used, complications, adverse events and revisions. Results Fusion rates ranged from 87.7% to 100% for bone morphogenetic protein 2 (BMP-2) and 88.6% to 94.7% for demineralized bone matrix, while fusion rates reported for other osteobiologics were lower. All included studies showed PROMs improved significantly for each osteobiologic. However, no differences were reported when comparing osteobiologics, or when comparing single vs multi-level surgery specifically. Conclusion The highest fusion rates after 2-level ACDF for cervical spine degeneration were reported when BMP-2 was used. However, PROMs did not differ between the different osteobiologics. Further blinded randomized trials should be performed to compare the use of BMP-2 in single vs multi-level ACDF specifically.
Comparative Complications Associated With BMP Use In Patients Undergoing ACDF for Degenerative Spinal Conditions: Systematic Review and Meta-Analysis
Authors: Martin Christopher T. , Holton Kenneth , Broida Samuel E. , Hickmann Anne-Katrin , Bakker Caitlin , Lender Paul A. , Watanabe Kota , Meisel Hans Jörg , Buser Zorica , Presciutti Steven M. , Yoon Sangwook Tim ,   AO Spine Knowledge Forum Degenerative
Published: February 2024

Study Design Systematic Review and Meta-Analysis. Objectives To compare complication incidence in patients with or without the use of recombinant human Bone Morphogenic Protein-2 (BMP2) undergoing anterior cervical discectomy and fusion (ACDF) for degenerative conditions. Methods A systematic search of eight online databases was conducted using PRISMA guidelines. Inclusion criteria included English language studies with a minimum of 10 adult patients undergoing instrumented ACDF surgery for a degenerative spinal condition in which BMP2 was used in all patients or one of the treatment arms. Studies with patients undergoing circumferential fusions, with non-degenerative indications, or which did not report post-operative complication data were excluded. Patients with and without BMP2 were compared in terms of the incidence of dysphagia/dysphonia, anterior soft tissue complications (hematoma, seroma, infection, dysphagia/dysphonia), nonunion, medical complications, and new neurologic deficits. Results Of 1832 preliminary search results, 27 manuscripts were included. Meta-analysis revealed the relative risk of dysphagia or dysphonia (RR = 1.39, CI 95% 1.18 – 1.64, P = <.001), anterior soft tissue complications (RR = 1.43, CI 95% 1.25-1.64, P = <.001), and medical complications (RR = 1.32, CI 95% 1.06-1.66, P = .013) were statistically significant in the BMP2 group while the relative risk of non-union (RR = .5, CI 95% .23 - 1.13, P = .09) trended lower in the BMP2 group. Neurological deficit (RR = 1.06, CI 95% .82-1.37, P = .66), and additional medical complications (RR = 1.53, CI 95% .98-2.38, P = .06) were not found to be statistically different between the groups. Conclusions This meta-analysis identified a high rate of arthrodesis when BMP2 was used in ACDF, but confirmed increased rates of dysphagia and anterior soft tissue complications. Surgeons may consider reserving BMP2 implementation for cases with a high risk of non-union, and should be aware of the risk of airway compromise.
Machine learning based predictive model of Type 2 diabetes complications using Malaysian National Diabetes Registry: A study protocol
Authors: Abas Mohamad Zulfikrie , Li Ken , Hairi Noran Naqiah , Choo Wan Yuen , Wan Kim Sui 
Published: February 2024

Background: The prevalence of diabetes in Malaysia is increasing, and identifying patients with higher risk of complications is crucial for effective management. The use of machine learning (ML) to develop prediction models has been shown to outperform non-ML models. This study aims to develop predictive models for Type 2 Diabetes (T2D) complications in Malaysia using ML techniques. Design and methods: This 10-year retrospective cohort study uses clinical audit datasets from Malaysian National Diabetes Registry from 2011 to 2021. T2D patients who received treatment in public health clinics in the southern region of Malaysia with at least two data points in 10 years are included. Patients with diabetes complications at baseline are excluded to ensure temporality between predictors and the target variable. Appropriate methods are used to address issues related to data cleaning, missing data imputation, data splitting, feature selection, and class imbalance. The study uses 7 ML algorithms, including logistic regression, support vector machine, k-nearest neighbours, decision tree, random forest, extreme gradient boosting, and light gradient boosting machine, to develop predictive models for four target variables: nephropathy, retinopathy, ischaemic heart disease, and stroke. Hyperparameter tuning is performed for each algorithm. The model training is performed using a stratified k-fold cross-validation technique. The best model for each algorithm is evaluated on a hold-out dataset using multiple metrics. Expected impact of the study on public health: The prediction model may be a valuable tool for diabetes management and secondary prevention by enabling earlier interventions and optimal resource allocation, leading to better health outcomes.