50 research outputs found
Assessment of Long-term Follow-up of Randomized Trial Participants by Linkage to Routinely Collected Data: A Scoping Review and Analysis: A Scoping Review and Analysis
TB167: Management and Winter Hardiness of Hairy Vetch in Maine
The research presented here describes a set of three different experiments that sought to establish appropriate management practices for hairy vetch in Maine, and to determine whether variability for winter hardiness exists among germplasm available commercially or from gene banks. Specific objectives of the first experiment were to evaluate effects of planting date and companion crop on crop and weed dry weight and total above-ground N content, at two sites differing in drainage. In a second experiment, the winter hardiness of hairy vetch from six commercial sources and the effect of a rye companion crop on hardiness were evaluated. In a third experiment, 69 V. villosa accessions from three gene banks were evaluated for winter hardiness, vigor, flowering date, and seed production.https://digitalcommons.library.umaine.edu/aes_techbulletin/1043/thumbnail.jp
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Personalized versus standardized dosing strategies for the treatment of childhood amblyopia: study protocol for a randomized controlled trial
Background: Amblyopia is the commonest visual disorder of childhood in Western societies, affecting, predominantly,
spatial visual function. Treatment typically requires a period of refractive correction (âoptical treatmentâ) followed by occlusion: covering the nonamblyopic eye with a fabric patch for varying daily durations. Recent studies have provided insight into the optimal amount of patching (âdoseâ), leading to the adoption of standardized dosing strategies, which, though an advance on previous ad-hoc regimens, take little account of individual patient characteristics. This trial compares the effectiveness of a standardized dosing strategy (that is, a fixed daily occlusion dose based on disease severity) with a personalized dosing strategy (derived from known treatment dose-response functions), in which an initially prescribed occlusion dose is modulated, in a systematic manner, dependent on treatment compliance.
Methods/design: A total of 120 children aged between 3 and 8 years of age diagnosed with amblyopia in association with either anisometropia or strabismus, or both, will be randomized to receive either a standardized or a personalized occlusion dose regimen. To avoid confounding by the known benefits of refractive correction, participants will not be randomized until they have completed an optical treatment phase. The primary study objective is to determine whether, at trial endpoint, participants receiving a personalized dosing strategy require fewer hours of occlusion than those in receipt of a standardized dosing strategy. Secondary objectives are to quantify the relationship between
observed changes in visual acuity (logMAR, logarithm of the Minimum Angle of Resolution) with age, amblyopia type, and severity of amblyopic visual acuity deficit.
Discussion: This is the first randomized controlled trial of occlusion therapy for amblyopia to compare a treatment arm representative of current best practice with an arm representative of an entirely novel treatment regimen based on statistical modelling of previous trial outcome data. Should the personalized dosing strategy demonstrate superiority over the standardized dosing strategy, then its adoption into routine practice could bring practical benefits in reducing the duration of treatment needed to achieve an optimal outcome
Long non-coding antisense RNA controls Uchl1 translation through an embedded SINEB2 repeat.
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The ethics of âTrials within Cohortsâ (TwiCs): 2nd international symposium - London, UK. 7-8 November 2016
On 7-8
th
November 2016, 60 people with an interest in the
â
Trials
within Cohorts
â
(TwiCs) approach for randomised controlled trial design
met in London. The purpose of this 2
nd
TwiCs international symposium
was to share perspectives and experiences on ethical aspects of the
TwiCs design, discuss how TwiCs relate to the current ethical frame-
work, provide a forum in which to discuss and debate ethical issues
and identify future directions for conceptual and empirical research.
The symposium was supported by the Wellcome Trust and the NIHR
CLAHRC Yorkshire and Humber and organised by members of the
TwiCs network led by Clare Relton and attended by people from the
UK, the Netherlands, Norway, Canada and USA. The two-day sympo-
sium enabled an international group to meet and share experiences
of the TwiCs design (also known as the
â
cohort multiple RCT design
â
),
and to discuss plans for future research. Over the two days, invited
plenary talks were interspersed by discussions, posters and mini pre-
sentations from bioethicists, triallists and health research regulators.
Key findings of the symposium were: (1) It is possible to make a
compelling case to ethics committees that TwiCs designs are ap-
propriate and ethical; (2) The importance of wider considerations
around the ethics of inefficient trial designs; and (3) some questions
about the ethical requirements for content and timing of informed
consent for a study using the TwiCs design need to be decided on
a case-by-case basis
Evaluating the Effects of SARS-CoV-2 Spike Mutation D614G on Transmissibility and Pathogenicity.
Global dispersal and increasing frequency of the SARS-CoV-2 spike protein variant D614G are suggestive of a selective advantage but may also be due to a random founder effect. We investigate the hypothesis for positive selection of spike D614G in the United Kingdom using more than 25,000 whole genome SARS-CoV-2 sequences. Despite the availability of a large dataset, well represented by both spike 614 variants, not all approaches showed a conclusive signal of positive selection. Population genetic analysis indicates that 614G increases in frequency relative to 614D in a manner consistent with a selective advantage. We do not find any indication that patients infected with the spike 614G variant have higher COVID-19 mortality or clinical severity, but 614G is associated with higher viral load and younger age of patients. Significant differences in growth and size of 614G phylogenetic clusters indicate a need for continued study of this variant