670 research outputs found
A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO)
Rationale Mandibular advancement devices (MADs)
are used to treat obstructive sleep apnoea-hypopnoea
syndrome (OSAHS) but evidence is lacking regarding
their clinical and cost-effectiveness in less severe disease.
Objectives To compare clinical- and cost-effectiveness
of a range of MADs against no treatment in mild to
moderate OSAHS.
Measurements and methods This open-label,
randomised, controlled, crossover trial was undertaken at
a UK sleep centre. Adults with Apnoea-Hypopnoea Index
(AHI) 5â<30/h and Epworth Sleepiness Scale (ESS) score
â„9 underwent 6 weeks of treatment with three nonadjustable
MADs: self-moulded (SleepPro 1; SP1);
semi-bespoke (SleepPro 2; SP2); fully-bespoke MAD
(bMAD); and 4 weeks no treatment. Primary outcome
was AHI scored by a polysomnographer blinded to
treatment. Secondary outcomes included ESS, quality of
life, resource use and cost.
Main results 90 patients were randomised and 83
were analysed. All devices reduced AHI compared with
no treatment by 26% (95% CI 11% to 38%, p=0.001)
for SP1, 33% (95% CI 24% to 41%) for SP2 and 36%
(95% CI 24% to 45%, p<0.001) for bMAD. ESS was
1.51 (95% CI 0.73 to 2.29, p<0.001, SP1) to 2.37
(95% CI 1.53 to 3.22, p<0.001, bMAD) lower than no
treatment (p<0.001 for all). Compliance was lower for
SP1, which was the least preferred treatment at trial exit.
All devices were cost-effective compared with no
treatment at a ÂŁ20 000/quality-adjusted life year (QALY)
threshold. SP2 was the most cost-effective up to
ÂŁ39 800/QALY.
Conclusions Non-adjustable MADs achieve clinically
important improvements in mild to moderate OSAHS and
are cost-effective
The American Association for the Surgery of Trauma renal injury grading scale: Implications of the 2018 revisions for injury reclassification and predicting bleeding interventions.
BackgroundIn 2018, the American Association for the Surgery of Trauma (AAST) published revisions to the renal injury grading system to reflect the increased reliance on computed tomography scans and non-operative management of high-grade renal trauma (HGRT). We aimed to evaluate how these revisions will change the grading of HGRT and if it outperforms the original 1989 grading in predicting bleeding control interventions.MethodsData on HGRT were collected from 14 Level-1 trauma centers from 2014 to 2017. Patients with initial computed tomography scans were included. Two radiologists reviewed the scans to regrade the injuries according to the 1989 and 2018 AAST grading systems. Descriptive statistics were used to assess grade reclassifications. Mixed-effect multivariable logistic regression was used to measure the predictive ability of each grading system. The areas under the curves were compared.ResultsOf the 322 injuries included, 27.0% were upgraded, 3.4% were downgraded, and 69.5% remained unchanged. Of the injuries graded as III or lower using the 1989 AAST, 33.5% were upgraded to grade IV using the 2018 AAST. Of the grade V injuries, 58.8% were downgraded using the 2018 AAST. There was no statistically significant difference in the overall areas under the curves between the 2018 and 1989 AAST grading system for predicting bleeding interventions (0.72 vs. 0.68, p = 0.34).ConclusionAbout one third of the injuries previously classified as grade III will be upgraded to grade IV using the 2018 AAST, which adds to the heterogeneity of grade IV injuries. Although the 2018 AAST grading provides more anatomic details on injury patterns and includes important radiologic findings, it did not outperform the 1989 AAST grading in predicting bleeding interventions.Level of evidencePrognostic and Epidemiological Study, level III
Rotation of planet-harbouring stars
The rotation rate of a star has important implications for the detectability,
characterisation and stability of any planets that may be orbiting it. This
chapter gives a brief overview of stellar rotation before describing the
methods used to measure the rotation periods of planet host stars, the factors
affecting the evolution of a star's rotation rate, stellar age estimates based
on rotation, and an overview of the observed trends in the rotation properties
of stars with planets.Comment: 16 pages, 4 figures: Invited review to appear in 'Handbook of
Exoplanets', Springer Reference Works, edited by Hans J. Deeg and Juan
Antonio Belmont
Using a private 5G network to support the international broadcast of the coronation of HM King Charles III
Wireless cameras for news contribution feeds regularly use âbonded-cellularâ devices, which connect to and split the encoded video across multiple public mobile network SIMs. However, in high demand density environments with large crowds, the public networks can quickly become saturated and unable to sustain the necessary bitrates to support high-definition video. To overcome this and provide uncontested wireless connectivity, the largest pop-up 5G standalone non-public (private) network of its type was deployed outside Buckingham Palace and along The Mall to Admiralty Arch to support news contributions for domestic and foreign broadcasters at the Coronation of HM King Charles III, without changing the contribution workflow. (This paper first appeared in the Proceedings of the 2024 NAB Broadcast Engineering and Information Technology Conference, and is reprinted with permission. https://nabpilot.org/beitc-proceedings/
The Astropy Problem
The Astropy Project (http://astropy.org) is, in its own words, "a community
effort to develop a single core package for Astronomy in Python and foster
interoperability between Python astronomy packages." For five years this
project has been managed, written, and operated as a grassroots,
self-organized, almost entirely volunteer effort while the software is used by
the majority of the astronomical community. Despite this, the project has
always been and remains to this day effectively unfunded. Further, contributors
receive little or no formal recognition for creating and supporting what is now
critical software. This paper explores the problem in detail, outlines possible
solutions to correct this, and presents a few suggestions on how to address the
sustainability of general purpose astronomical software
Pop-up 5G standalone non-public networks (SNPNs) for live broadcast production
A portable, pop-up private standalone 5G network has been developed and deployed around the world in a series of successful proof-of-concepts for outside broadcast production in remote locations. The flexible software-defined radio (SDR) allows us to rapidly customise the network to the environment and requirements, with low-latency configurations and heavy uplink biasing in the bi-directional RF channel to support multiple wireless camera feeds. We used shared spectrum available in the n78 and upper n77 bands (3.3â4.2 GHz) in UK, Ireland, Kenya and New Zealand to deliver live-to-air footage. We explored the use of bonding multiple low Earth orbit (LEO) satellites and cellular backhaul, which allowed us to broadcast the Pitlochry Highland Games live from rural Scotland into the IBC 2022 show in Amsterdam. This paper will discuss the critical technical capabilities of the pop-up private 5G network and how broadcasters have rapidly deployed the technology to support historic and sporting events, including the final journey from Scotland of Queen Elizabeth II and the Danish parliamentary elections. We will also explore how to configure connectivity for optimum performance
MammostratÂź as a tool to stratify breast cancer patients at risk of recurrence during endocrine therapy
Contemporary Photographic Practices on the British Fairground
The fairground is a somewhat magical and uncharted realm of illusion, deception, thrill and adventure. It offers a glimpse of the improbable and impossible, and a taste or touch of the unattainable. This article looks at the crossover of photography and the British fairground following the gradual take-up of photography in the post-war period. It briefly covers early traditions concomitant with the specialised practice of photography, then it identifies photographic practices on the fairground through distinct communities of engagement including professional and amateur photographers attracted to the spectacle of the fair, ethnographic explorers, dedicated enthusiasts, showpeople and the general public of âpuntersâ. In each case photographs from these communities are presented as well as a selection of photographs depicting these communities of photographers in action. The article concludes with the current situation of camera phone technology, social media and digitally manipulated photographic art as a new aesthetic of the fairground
Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)
BACKGROUND: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration\u27s (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine.
OBJECTIVES: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around minimal manipulation and homologous use within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine.
METHODS: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. âą The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. âą Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. âą Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980\u27s and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA\u27s intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs.
CONCLUSIONS: Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use.
KEY WORDS: Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption
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