Trusted Research Environment users: Evidence supporting a TRE usability principle

For Trusted Research Environments (TREs) to be safe, secure, and productive, they must also be usable. In turn, a TRE that is useable minimises barriers to use and provides a productive and accessible analysis environment for research. Ensuring TREs are usable is a core concern of the Standard Architecture for Trusted Research Environments (SATRE) specification, a reference TRE architecture and accompanying implementation created using a community driven approach. This report contributes to that project in two ways. First, we provide a rich set of recommendations that builders and operators of TREs can follow to increase TRE usability. We encapsulate these recommendations in a TRE usability principle which is incorporated into SATRE's specification architecture version 1.0. Second, we outline the methods and analytic perspectives we have used to understand users' needs and we recommend a series of future research ideas now required to advance this work

A UK Specification for Trusted Research Environments

ObjectivesThe need for Trusted Research Environments (TREs) is clear. Several influential reports have highlighted that personal or sensitive data which have been collected for operational, commercial or governmental reasons need to be managed securely in an environment that encourages best practices.TREs are designed to enable only authorised projects and researchers access to sensitive data whilst minimising risk of data exposure. Yet the TRE landscape has grown organically over at least the last decade resulting in heterogeneous environments, making it harder for data to be discovered, shared and used for public benefit.A baseline specification for TREs is required

SATRE: Standardised Architecture for Trusted Research Environments

The SATRE DARE UK-funded Driver Project was challenged to create a trusted research environment (TRE) architecture supporting the research community's need to have suitable data analytics and research environments for working with sensitive data. The project developed an inclusive and transparent way of working to ensure that what was created was representative of the TRE community in the UK. We have created, for the first time, an open specification for TRE operators by which to evaluate themselves against a set of capabilities. It is a thorough specification, perhaps definition, for TREs informed not only by the experience of the project team who have been running a TRE and supporting sensitive data projects for a combined 15 years but also the expansive knowledge of the wider UK research community. The public has also been involved throughout the development of the specification to ensure their voices are heard and reflected in the specification. The specification has been informed through one survey completed by 105 individuals representing approximately 60 organisations, 14 Collaboration Cafés with up to 75 participants, 26 individuals contributing directly, 44 issues raised and six public engagement sessions online and in-person. Despite the breadth and diversity of the individuals included, we have been able to create a single specification encompassing four architectural principles, four pillars, 29 capabilities and 160 statements. The 75 mandatory statements are what is considered the minimum required to be a SATRE-compliant TRE. Now, with a stable version 1.0 release, the specification is ready for use by the UK TRE community. We are and will continue to work with all organisations to evaluate themselves against the specification and also identify what works and what doesn't, which will be captured in future versions of the specification. The specification has been developed with the long-term in mind and can be a basis for a common understanding between operators, data controllers, accreditors, researchers, industry and government organisations for how TREs can federate and interoperate better.This work was funded by UK Research & Innovation [Grant Number MC_PC_23008] as part of Phase 1 of the DARE UK (Data and Analytics Research Environments UK) programme, delivered in partnership with Health Data Research UK (HDR UK) and Administrative Data Research UK (ADR UK)

A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial.

BACKGROUND Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment. METHOD The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site. DISCUSSION We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe. TRIAL REGISTRATION ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php -use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC)

miR-337-3p and Its Targets STAT3 and RAP1A Modulate Taxane Sensitivity in Non-Small Cell Lung Cancers

NSCLC (non-small cell lung cancer) often exhibits resistance to paclitaxel treatment. Identifying the elements regulating paclitaxel response will advance efforts to overcome such resistance in NSCLC therapy. Using in vitro approaches, we demonstrated that over-expression of the microRNA miR-337-3p sensitizes NCI-H1155 cells to paclitaxel, and that miR-337-3p mimic has a general effect on paclitaxel response in NSCLC cell lines, which may provide a novel adjuvant strategy to paclitaxel in the treatment of lung cancer. By combining in vitro and in silico approaches, we identified STAT3 and RAP1A as direct targets that mediate the effect of miR-337-3p on paclitaxel sensitivity. Further investigation showed that miR-337-3p mimic also sensitizes cells to docetaxel, another member of the taxane family, and that STAT3 levels are significantly correlated with taxane resistance in lung cancer cell lines, suggesting that endogenous STAT3 expression is a determinant of intrinsic taxane resistance in lung cancer. The identification of a miR-337-3p as a modulator of cellular response to taxanes, and STAT3 and RAP1A as regulatory targets which mediate that response, defines a novel regulatory pathway modulating paclitaxel sensitivity in lung cancer cells, which may provide novel adjuvant strategies along with paclitaxel in the treatment of lung cancer and may also provide biomarkers for predicting paclitaxel response in NSCLC

Occult Metabolic Bone Disease in Chronic Pancreatitis

Background: Chronic pancreatitis (CP) leads to malabsorption and metabolic bone disease (MBD). Alcoholic CP (ACP) and tropical CP (TCP) are the two common types of CP. Objective: We investigated the presence of occult MBD in patients with CP and compared the same between ACP and TCP. Materials and Methods: In this cross‑sectional, observational study, we included serial patients of CP in different stages and are grouped as ACP (Group 1; n = 67) and TCP (Group 2; n = 35). We determined serum calcium, phosphorus, alkaline phosphatase, 25‑hydroxyvitamin D (25OHD), and intact parathyroid hormone (PTH) levels. Bone mineral density (BMD) was measured by dual‑energy X‑ray absorptiometry in the neck of the left femur. MBD was defined by the presence of either low bone mass (Z‑score <−2) or osteomalacia. The results were analyzed using appropriate statistical methods. Results: The study participants (85 males; 17 females) had a mean age of 40.8 ± 12.6 years, CP duration of 3.7 ± 4.7 years, and Body Mass Index of 22.5 ± 3.2 kg/m2. A total of 37 (36%) patients had MBD (osteomalacia in 31 and low bone mass in 6). The frequency of MBD was same in the TCP (16/35) and ACP (21/65) groups (P = 0.1940). Elevated PTH (>70 pg/mL) was seen in 14 patients with 25OHD deficiency and low calcium (<8.5 mg/dL) in 29 patients. BMD did not show a significant correlation with the duration of CP. Conclusion: Occult MBD is seen in a third of patients with CP and is similar irrespective of the etiology. The disease is silent and mandates active screening in all susceptible individuals.Keywords: Chronic pancreatitis, metabolic bone disease, osteomalacia, osteopenia, osteoporosi

Prevalence and characteristics of the metabolic syndrome in patients with chronic pancreatitis

Objective: Chronic pancreatitis (CP) and metabolic syndrome (MS) share a bidirectional cause and effect relation. We investigated the prevalence and characteristics of MS in patients with CP and compared the same between alcoholic CP and tropical CP (TCP).Materials and Methods: In this cross‑sectional, observational study, we included serial patients of CP presented to our hospital. We excluded CP patients with other known systemic disorders, long‑term intake of drugs that could affect the lipids and also excluded patients with features of exocrine deficiency. The study population is grouped as alcoholic CP (Group 1; n = 65) and TCP (Group 2; n = 37). A fasting blood sample was checked for all the biochemical parameters, and MS was defined as per the Asian modification of the National Cholesterol Education Program Adult Treatment Panel III definition. The results were analyzed by appropriate statistical methods.Results: The study participants (85 male and 17 female) had a mean age 40.8 ± 12.6 years, CP duration 3.7 ± 4.7 year, and body mass index of 22.5 ± 3.2 kg/m2. A total of 27 (26%) out of 102 patients had the presence of the MS, which was similar in frequency between both the groups (P = 0.0991). Hyperglycemia and low high‑density lipoprotein cholesterol (HDL‑C) were the common features in alcoholic CP, whereas TCP patents showed hyperglycemia, abdominal obesity, and low HDL‑C. None of the participants had all the five components, and seven patients had no features of the MS.Conclusion: MS is seen in a quarter of patients with CP, and the prevalence is same irrespective of the underlying etiology.Keywords: Alcohol, chronic pancreatitis, diabetes, hypertension, metabolic syndrom

Opening up your communications

<p>This presentation was given by members of The Turing Way project as part of a workshop on 'Opening up your communuications' at the Centre for Doctoral Training (CDT) conference 2023 on 15th November 2023. </p><p>The presentation introduces the idea that all outputs should be opening up, if possible, and this should be done throughour the research lifecycle - not just at the end!<br>To communicate research effecively and accessibly, you should consider the audience for your output and also considered additional ways to make the output accessible to more people such as making the writing less technical for a lay audience such as writing a lay summary, and writing alt text to fully describe figures. </p><p>More information about the CDT Conference can be found on the <a href="https://www.turing.ac.uk/events/cdt-conference-2023">website</a>. </p><p>Find out more about The Turing Way Project by looking at <a href="https://the-turing-way.start.page/">our start page</a> or <a href="https://the-turing-way.netlify.app/index.html">The Turing Way Book</a>. <br> </p&gt