bluuebunny/crossref_metadata_2025_split huggingface dataset:
Bone healing: Advances in biology and technology
Authors: Mullis Brian H. , Gudeman Andrew S. , Borrelli Joseph , Crist Brett D. , Lee Mark A. , Evans Andrew R. 
Published: April 2021

Abstract
Fracture healing is a complex cascade of cellular and molecular processes. These processes require the appropriate cellular and molecular environment to ensure the restoration of skeletal stability and resolution of inflammation. In order for fracture healing to occur, the necessary building blocks for bone metabolism and synthesis must be supplied through proper nutrition. Pharmacologic therapies aimed at modulating the inflammatory response to fractures have the potential to interfere with the synthesis of molecules needed for the production of bone. Infection can interfere with, and even prevent normal fracture healing from occurring. Cellular and genetic treatment strategies are actively being developed to target deficiencies, and bridge gaps that can influence how fractures heal. Evolving technologies, including nutritional supplementation, pharmacotherapies, antibiotics, surgical techniques, as well as genetic and cellular therapies, have the potential to enhance, optimize, and even revolutionize the process of fracture healing.
Regulation of orthopaedic devices: Future implications for research and innovation
Authors: Donnelley Claire A. , Devlin Vincent J. , Harris Mitchel B. , Poggie Robert A. , Sanders Roy W. , Morshed Saam 
Published: April 2021

Abstract
The conception-to-market development of orthopaedic devices occurs across the total product life cycle including device design and preclinical testing, clinical investigations to support marketing applications, and monitoring of device performance after market introduction. This process involves industry, regulatory agencies, health care providers, engineers, scientists, and patients. The Food and Drug Administration (FDA) is responsible for regulating medical devices in the United States, and uses a 3-tier classification system based on the level of control necessary to provide reasonable assurance of safety and effectiveness. Classification directs the required regulatory pathway and premarket submission type. Variations in global regulations, particularly between the United States, European Economic Area (EEA), and the United Kingdom (UK), may impact industry response to orthopaedic device development. Changing device innovation and reimbursement models have led to the consolidation of market share among larger companies. Although larger companies are better able to cope with more rigorous regulatory requirements, this leads to decreased competition and increased upward price pressure. To assist with the complex regulatory processes, the FDA offers pre-submission assistance as an opportunity for early collaboration and discussion about the medical device or device-led combination product submissions. Orthopaedic organizations, such as the Orthopaedic Trauma Association (OTA), may assist in postmarket device surveillance through the coordinated development and maintenance of clinical data registries. Such registries can longitudinally follow patients with a specific orthopaedic pathology or device usage, and monitor outcomes towards improvements in next-generation device development. As technology evolves, the nexus of regulation, industry, and patient outcome monitoring will continue to support safe and effective device innovation.
Patient-reported benefits of bone-anchored transfemoral prostheses as assessed by MedTech20: A general outcome measure for medical products
Authors: Hagberg Kerstin , Brodtkorb Thor-Henrik 
Published: April 2021

Background:
The medical community demands evidence for the benefits of medical devices such as bone-anchored prostheses (BAPs). MedTech20  is a novel instrument aiming to address general benefits of medical devices.

Objective:
To describe general patient-reported benefits of BAPs measured with MedTech20.

Study Design:
This is a cross-sectional descriptive survey.

Methods:
Patients treated in Sweden who had used a BAP for >1 year were mailed the MedTech20  Questionnaire. Responses to each attribute were described, and the MedTech20   Index (0-1), in which a higher figure represents larger benefits from the product, was calculated. Index values were compared based on demographic variables (sex, unilateral or bilateral transfemoral amputation (TFA), and those having experienced any complication of implant parts or the prosthetic connection device).

Results:
The response rate was 72%. The 62 participants (41 men and 21 women; mean age 57 years) had 11 ± 6.9 mean years of BAP experience. Single attributes stated as highly relevant and with high benefit for BAPs included perceived reliability, perceived safety, sense of control of the disability, facilitation of movement outside home, no discomfort at use, and ease of use. Attributes with less relevance included aid to remember tasks, reduction of barriers to a good sleep, and reduced sense of compromised integrity. The MedTech20  Index was 0.655 ± 0.188 and was not statistically significantly different based on any of the demographic variables.

Conclusions:
By using a general measure on attributes of medical devices, this study provides new insights strengthening the evidence regarding the benefits that BAPs provide for patients with TFA who had difficulties with socket-suspended prostheses.
Are Cannabis, Cannabis-Derived Products, and Synthetic Cannabinoids a Therapeutic Tool for Rheumatoid Arthritis? A Friendly Summary of the Body of Evidence
Authors: Schulze-Schiappacasse Clara , Durán Josefina , Bravo-Jeria Rocío , Verdugo-Paiva Francisca , Morel Macarena , Rada Gabriel 
Published: April 2021

Background
Symptom management in rheumatoid arthritis (RA) remains a complex challenge. Widespread use of cannabis-based medicines for a myriad of symptoms has fostered rheumatology patients' interest. However, their safety and efficacy in RA remain unclear.

Objective
The aim of this study was to perform a structured summary of the body of evidence in order to determine whether cannabis, cannabis-derived products, and synthetic cannabinoids are an effective treatment for rheumatoid arthritis.

Methods
An electronic search in Epistemonikos database was performed to identify systematic reviews and their primary studies that addressed our clinical question. The body of evidence was collected in a pivot table in Epistemonikos. Information and data from the primary studies were extracted from the identified reviews. Finally, extracted data were reanalyzed, and a summary of findings table was generated using the Grading of Recommendations Assessment, Development and Evaluation approach.

Results
Twenty-six systematic reviews were identified which included in total only 1 randomized trial assessing our clinical question.

Conclusions
Cannabis, cannabis-derived products and synthetic cannabinoids may slightly reduce disease activity in patients with RA. Its use may result in little to no difference in pain reduction and may slightly increase nervous system adverse events. The evidence is very uncertain about the effect of cannabis, cannabis-derived products, and synthetic cannabinoids on serious adverse events risk.
Reconstruction of Large Tissue Defects After the Resection of Brain Tumors Using a Skin Flap With Vascular Pedicle
Authors: Bai Jie , Fu Jiayue , Xiao Xinru 
Published: April 2021

Abstract
The reconstruction of large tissue defects after the resection of brain tumors is challenging for every neurosurgeon. The authors describe the benefits of a skin flap with vascular pedicle in the reconstruction of large tissue defects after the resection of brain tumors. In this retrospective analysis, a skin flap with vascular pedicle reconstruction was used in 5 patients who underwent intracranial tumor resection, accompanied by tissue defects, cerebrospinal fluid leakage and scalp infection. The surgical techniques are described, and the outcomes were discussed. The harvested flaps showed well-vascularized healing of the transplanted skin without partial necrosis in all 5 patients. One patient had cerebrospinal rhinorrhea, which was successfully treated by endoscopic repair. Another patient had cerebrospinal fluid leakage, which was successfully treated by continuous lumbar drainage. A skin flap with vascular pedicle is an effective choice for the reconstruction of large tissue defects after the resection of brain tumors.
Chimeric Latissimus Dorsi Flap in One-Stage Reconstruction of Depressor Muscle Dysfunction and Depression Deformity in the Perimandibular Area
Authors: Ogawa Kazuya , Okazaki Mutsumi , Tanaka Kentaro , Uemura Noriko , Homma Tsutomu 
Published: April 2021

Background:
Depression deformity and paralysis of depressor muscles (DMs) may occur following tumor resection in the perimandibular region. Obtaining satisfactory results is challenging. The authors report 3 cases of 1-stage reconstruction by transferring neurovascular chimeric latissimus dorsi (LD) musculo-adipose flaps, with satisfactory results.

Methods:
Three patients with depression deformity and DMs dysfunction after tumor resection in the perimandibular region underwent chimeric LD flap transfer. The flap comprised 1 portion with adipose tissue for augmentation, and the other contained muscle bellies with 1 or 2 neural pedicle (s) for DM reanimation. In case 1, the neural pedicle was sutured to the contralateral marginal mandibular branch. In case 2, the neural pedicle was sutured to the ipsilateral marginal mandibular branch. In case 3, the neural pedicle was sutured to both branches of the facial nerve.

Results:
All patients were satisfied with the deformity corrections. However, contractions of the transferred muscles varied. Case 1 showed insufficient contraction. Case 2 had excessive muscle contraction. In case 3, the muscle had double innervation, and well-balanced contraction was maintained for 3 years.

Conclusions:
Neurovascular chimeric LD flaps are versatile and useful for secondary reconstruction after tumor resection for functional loss of mimetic muscles. The ipsilateral facial nerve may be an effective motor source.
Use of Serial Flap Transfer Technique in En Bloc Reconstruction of Extensive Soft Tissue Defects in the Head and Neck
Authors: Zang Mengqing , Zhu Shan , Chen Bo , Li Shanshan , Han Tinglu , Liu Yuanbo 
Published: April 2021

Abstract
En bloc reconstruction of extensive head and neck defects is feasible with matched tissue from the medial arm or chest. Nevertheless, the donor site faces significant morbidity following massive cutaneous flap harvesting. The serial flap transfer technique can increase the reconstructive ability of these flaps and minimize the donor site morbidity. A retrospective review was conducted from 2016 to 2020 on all patients who had undergone extensive head and neck reconstruction with the serial flap transfer technique. En bloc reconstruction of defects in the head and neck was performed using expanded perforator-plus flaps from the medial arm or chest; various flaps from the back were used to close the donor-site defects. Flap type, flap survival, complications, and revision procedures were assessed. This case series included 16 patients. The donor site of the chest or medial arm was successfully closed with the assistance of the thoracodorsal artery perforator flap, the latissimus dorsi myocutaneous flap, ortheparascapular flap. A medial arm flap with a width of 15 cm and a chest flap with a 16 cm width could be transferred with the primary closure of the donor sites. All flaps survived, except 1 had marginal necrosis. Complications occurred in 2 patients and were successfully managed nonsurgically. Both the recipient and donor sites were restored with good aesthetic results. Application of the serial flap transfer technique in extensive head and neck reconstruction decreases the donor site morbidity to a minimum and improves the overall outcomes.
Optimizing Trauma Systems
Authors: Ben Beck  , Tack Guido , Cameron Peter , Smith Karen , Gabbe Belinda 
Published: April 2021

Objective:
The aim of this study was to develop a data-driven approach to assessing the influence of trauma system parameters and optimizing the configuration of the Victorian State Trauma System (VSTS).

Summary Background Data:
Regionalized trauma systems have been shown to reduce the risk of mortality and improve patient function and health-related quality of life. However, major trauma case numbers are rapidly increasing and there is a need to evolve the configuration of trauma systems.

Methods:
A retrospective review of major trauma patients from 2016 to 2018 in Victoria, Australia. Drive times and flight times were calculated for transport to each of 138 trauma receiving hospitals. Changes to the configuration of the VSTS were modeled using a Mixed Integer Linear Programming algorithm across 156 simulations.

Results:
There were 8327 patients included in the study, of which 58% were transported directly to a major trauma service (MTS). For adult patients, the proportion of patients transported directly to an MTS increased with higher transport time limit, greater probability of helicopter emergency medical service utilization, and lower hospital patient threshold numbers. The proportion of adult patients transported directly to an MTS varied from 66% to 90% across simulations. Across all simulations for pediatric patients, only 1 pediatric MTS was assigned.

Conclusions:
We have developed a robust and data-driven approach to optimizing trauma systems. Through the use of geospatial and mathematical models, we have modeled how potential future changes to trauma system characteristics may impact on the optimal configuration of the system, which will enable policy makers to make informed decisions about health service planning into the future.
IDEAL-D Framework for Device Innovation
Authors: Marcus Hani J. , Bennett Amy , Chari Aswin , Day Toni , Hirst Allison , Hughes-Hallett Archie , Kolias Angelos , Kwasnicki Richard M. , Martin Janet , Rovers Maroeska , Squire Sarah E. , McCulloch Peter 
Published: April 2021

Objective:
To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0).

Background:
In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety.

Methods:
Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects, and minimization of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted.

Results:
In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness before progression to clinical studies (stage 1).

Conclusions:
The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice.
Coaching in Surgical Education
Authors: Louridas Marisa , Sachdeva Ajit K. , Yuen Andrew , Blair Patrice , MacRae Helen 
Published: April 2021

Objective:
The objectives of this study were to review the coaching literature to (1) characterize the criteria integral to the coaching process, specifically in surgery, and (2) describe how these criteria have been variably implemented in published studies.

Background:
Coaching is a distinct educational intervention, but within surgery the term is frequently used interchangeably with other more established terms such as teaching and mentoring.

Methods:
A systematic search was performed of the MEDLINE and Cochrane databases to identify studies that used coach/coaching as an intervention for surgeons for either technical or nontechnical skills. Study quality was evaluated using the Medical Education Research Study Quality Instrument (MERSQI).

Results:
A total of 2280 articles were identified and after screening by title, abstract and full text, 35 remained. Thirteen coaching criteria (a–m) were identified in 4 general categories: 1. overarching goal (a. refine performance of an existing skill set), 2. the coach (b. trusting partnership, c. avoids assessment, d. 2-way communication), the coachee (e. voluntary participation, f. self-reflection, g. goal setting, h. action plan, i. outcome evaluation), and the coach-coachee rapport (j. coaching training, k. structured coaching model, l. non-directive, m. open ended questions). Adherence to these criteria ranged from as high of 73% of studies (voluntary participation of coach and coachee) to as low as 7% (use of open-ended questions).

Conclusions:
Coaching is being used inconsistently within the surgical education literature. Our hope is that with establishing criteria for coaching, future studies will implement this intervention more consistently and allow for better comparison and generalization of results.
The impact of COVID-19 on gambling and gambling disorder: emerging data
Authors: Hodgins David C. , Stevens Rhys M.G. 
Published: April 2021

Purpose of review
The lockdown response to the COVID-19 pandemic has significantly impacted commercial gambling in many jurisdictions around the world. The goal of this review is to systematically identify and describe the survey data and findings to date examining the effect on individual gambling and gambling disorder.

Recent findings
Of the 17 publications meeting inclusion criteria, the majority reported cross-sectional assessments (n = 11, 65%) and remainder were longitudinal in that they had earlier gambling data for participants (n = 6, 35%). Not surprisingly given the closure of land-based gambling, an overall reduction in gambling frequency and expenditure was reported in all studies. The estimate of the proportion of participants in both the general population and the population that gambles who increased overall gambling or online gambling was variable. The most consistent correlates of increased gambling during the lockdown were increased problem gambling severity, younger age groups, and being male.

Summary
These results suggest that the impacts of the COVID-19 pandemic on gambling and problematic gambling are diverse – possibly causing a reduction in current or future problems in some, but also promoting increased problematic gambling in others. The longer-term implications of both the reduction in overall gambling, and the increase in some vulnerable groups are unclear, and requires assessment in subsequent follow-up studies. However, in the short term, individuals with existing gambling problems should be recognized as a vulnerable group.
Small RNAs and chromatin in the multigenerational epigenetic landscape ofCaenorhabditis elegans
Authors: Frolows Natalya , Ashe Alyson 
Published: April 2021

For decades, it was thought that the only heritable information transmitted from one individual to another was that encoded in the DNA sequence. However, it has become increasingly clear that this is not the case and that the transmission of molecules from within the cytoplasm of the gamete also plays a significant role in heritability. The roundworm,Caenorhabditis elegans,has emerged as one of the leading model organisms in which to study the mechanisms of transgenerational epigenetic inheritance (TEI). Collaborative efforts over the past few years have revealed that RNA molecules play a critical role in transmitting transgenerational responses, but precisely how they do so is as yet uncertain. In addition, the role of histone modifications in epigenetic inheritance is increasingly apparent, and RNA and histones interact in a way that we do not yet fully understand. Furthermore, both exogenous and endogenous RNA molecules, as well as other environmental triggers, are able to induce heritable epigenetic changes that affect transcription across the genome. In most cases, these epigenetic changes last only for a handful of generations, but occasionally can be maintained much longer: perhaps indefinitely. In this review, we discuss the current understanding of the role of RNA and histones in TEI, as well as making clear the gaps in our knowledge. We also speculate on the evolutionary implications of epigenetic inheritance, particularly in the context of a short-lived, clonally propagating species.This article is part of the theme issue ‘How does epigenetics influence the course of evolution?’
Evaluation of the SARS-CoV-2 inactivation efficacy associated with buffers from three kits used on high-throughput RNA extraction platforms
Authors: Thom Ruth E. , Eastaugh Lin S. , O’Brien Lyn M. , Ulaeto David O. , Findlay James S. , Smither Sophie J. , Phelps Amanda L. , Stapleton Helen L. , Hamblin Karleigh A. , Weller Simon A. 
Published: April 2021

ABSTRACTRapid and demonstrable inactivation of SARS-CoV-2 is crucial to ensure operator safety during high-throughput testing of clinical samples. The inactivation efficacy of SARS-CoV-2 was evaluated using commercially available lysis buffers from three viral RNA extraction kits used on two high-throughput (96-well) RNA extraction platforms (Qiagen QiaCube HT and the ThermoFisher Kingfisher Flex) in combination with thermal treatment. Buffer volumes and sample ratios were chosen for their optimised suitability for RNA extraction rather than inactivation efficacy and tested against a representative sample type; SARS-CoV-2 spiked into viral transport medium (VTM). A lysis buffer from the MagMax Pathogen RNA/DNA kit (ThermoFisher), used on the Kingfisher Flex, which included guanidinium isothiocycnate (GITC), a detergent, and isopropanol demonstrated a minimum inactivation efficacy of 1 x 105TCID50/ml. An alternative lysis buffer from the MagMax Viral/Pathogen Nucleic Acid kit (Thermofisher) also used on the Kingfisher Flex and the lysis buffer from QIAamp 96 Virus QIAcube HT Kit (Qiagen) used on the QiaCube HT (both of which contained GITC and a detergent) reduced titres by 1 x 104TCID50/ml but did not completely inactivate the virus. Heat treatment alone (15 minutes, 68 °C) did not completely inactivate the virus, demonstrating a reduction of 1 x 103TCID50/ml. When inactivation methods included both heat treatment and addition of lysis buffer, all methods were shown to completely inactivate SARS-CoV-2 inactivation against the viral titres tested. Results are discussed in the context of the operation of a high-throughput diagnostic laboratory.