An investigation into the factors that attract young students to the Open University and support their studies to module completion

The research investigates the reasons why students aged 18-24 come to the Open University and the factors that influence their decision. It also examines their learning experience and the key factors that lead to successful study. The research population comprised new Open University students with no previous higher education qualification, studying one of four introductory level modules in the Faculties of Arts, Social Sciences, Health and Social Care or Science. Data were compared by module and from students aged 18-20 (Group 1) and 21-24 (Group 2). An online survey was administered to 827 students and yielded 231 responses. In addition, 40 students volunteered to participate in semi-structured email interviews. The discussion of the data was focused on the three theoretical concepts of transitions, networks of intimacy and cultural capital. The findings indicate that students' decisions about higher education study were mainly influenced by family members and friends. They were studying principally to improve their job or career prospects although many were seeking to redress negative educational experiences in the past and to prove to themselves and others that they could study successfully at higher education level. They were attracted to the Open University by its flexibility, cost-effectiveness and open access policy. Respondents' study experience was largely very positive but students in Group 1 in particular missed face -to-face tutor contact and social integration with other students. The majority of respondents in both groups expressed confidence about their progress on the module although women in particular had underlying doubts about their academic ability. Successful students had developed a number of coping strategies for managing the conflicting demands of work, study and family

On the Evolution of the Velocity-Mass-Size Relations of Disk-Dominated Galaxies over the Past 10 Billion Years

We study the evolution of the scaling relations between maximum circular velocity, stellar mass and optical half-light radius of star-forming disk-dominated galaxies in the context of LCDM-based galaxy formation models. Using data from the literature combined with new data from the DEEP2 and AEGIS surveys we show that there is a consistent observational and theoretical picture for the evolution of these scaling relations from z\sim 2 to z=0. The evolution of the observed stellar scaling relations is weaker than that of the virial scaling relations of dark matter haloes, which can be reproduced, both qualitatively and quantitatively, with a simple, cosmologically-motivated model for disk evolution inside growing NFW dark matter haloes. In this model optical half-light radii are smaller, both at fixed stellar mass and maximum circular velocity, at higher redshifts. This model also predicts that the scaling relations between baryonic quantities evolve even more weakly than the corresponding stellar relations. We emphasize, though, that this weak evolution does not imply that individual galaxies evolve weakly. On the contrary, individual galaxies grow strongly in mass, size and velocity, but in such a way that they move largely along the scaling relations. Finally, recent observations have claimed surprisingly large sizes for a number of star-forming disk galaxies at z \sim 2, which has caused some authors to suggest that high redshift disk galaxies have abnormally high spin parameters. However, we argue that the disk scale lengths in question have been systematically overestimated by a factor \sim 2, and that there is an offset of a factor \sim 1.4 between H\alpha sizes and optical sizes. Taking these effects into account, there is no indication that star forming galaxies at high redshifts (z\sim 2) have abnormally high spin parameters.Comment: 19 pages, 10 figures, accepted to MNRAS, minor changes to previous versio

EnROL: A multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme

BACKGROUND: During the last two decades the use of laparoscopic resection and a multimodal approach known as an enhanced recovery programme, have been major changes in colorectal perioperative care. Clinical outcome improves using laparoscopic surgery to resect colorectal cancer but until recently no multicentre trial evidence had been reported regarding whether the benefits of laparoscopy still exist when open surgery is optimized within an enhanced recovery programme. The EnROL trial (Enhanced Recovery Open versus Laparoscopic) examines the hypothesis that laparoscopic surgery within an enhanced recovery programme will provide superior postoperative outcomes when compared to conventional open resection of colorectal cancer within the same programme. METHODS/DESIGN: EnROL is a phase III, multicentre, randomised trial of laparoscopic versus open resection of colon and rectal cancer with blinding of patients and outcome observers to the treatment allocation for the first 7 days post-operatively, or until discharge if earlier. 202 patients will be recruited at approximately 12 UK hospitals and randomised using minimization at a central computer system in a 1:1 ratio. Recruiting surgeons will previously have performed >100 laparoscopic colorectal resections and >50 open total mesorectal excisions to minimize conversion. Eligible patients are those suitable for elective resection using either technique. Excluded patients include: those with acute intestinal obstruction and patients in whom conversion from laparoscopic to open procedure is likely. The primary outcome is physical fatigue as measured by the physical fatigue domain of the multidimensional fatigue inventory 20 (MFI-20) with secondary outcomes including postoperative hospital stay; complications; reoperation and readmission; quality of life indicators; cosmetic assessments; standardized performance indicators; health economic analysis; the other four domains of the MFI-20. Pathological assessment of surgical quality will also be undertaken and compliance with the enhanced recovery programme will be recorded for all patients. DISCUSSION: Should this trial demonstrate that laparoscopic surgery confers a significant clinical and/or health economic benefit this will further support the transition to this type of surgery, with implications for the training of surgeons and resource allocation. TRIAL REGISTRATION: ISRCTN48516968

A phase II clinical trial of 6-mercaptopurine (6MP) and methotrexate in patients with BRCA defective tumours: a study protocol

BACKGROUND: BRCA1 and BRCA2 genes are critical in homologous recombination DNA repair and have been implicated in familial breast and ovarian cancer tumorigenesis. Tumour cells with these mutations demonstrate increased sensitivity to cisplatin and poly (ADP-ribose) polymerase (PARP) inhibitors. 6MP was identified in a screen for novel drugs and found to selectively kill BRCA-defective cells in a xenograft model as effectively as the PARP inhibitor AGO14699, even after these cells had acquired resistance to a PARP inhibitor or cisplatin. Exploiting the genetic basis of these tumours enables us to develop a more tailored approach to therapy for patients with BRCA mutated cancers.METHODS: This multi-centre phase II single arm trial was designed to investigate the activity and safety of 6-mercaptopurine (6MP) 55 mg/m² per day, and methotrexate 15 mg/m² per week in patients with advanced breast or ovarian cancer, ECOG PS 0-2, progressing after ≥ one prior regimen and known to bear a BRCA1/2 germ line mutation. Accrual was planned in two stages, with treatment continuing until progression or unacceptable toxicity; in the first, if less than 3/30 evaluable patients respond at 8 weeks after commencing treatment, the trial will be stopped for futility; if not, then accrual would proceed to a second stage, in which if more than 9/65 evaluable patients are found to respond at 8 weeks, the treatment will be regarded as potentially effective and a phase III trial considered subject to satisfactory safety and tolerability. The primary outcome is objective response at 8 weeks, defined by RECISTS v1.1 as complete response, partial response or stable disease. Secondary outcomes include safety, progression- free and overall survival, and quality of life.DISCUSSION: This study aims to investigate whether 6MP might be an effective treatment for BRCA deficient tumours even after the development of resistance to PARP inhibitors or platinum drugs. The study has surpassed the first stage analysis criteria of more than 3 out of 30 evaluable patients responding at 8 weeks, and is currently in the second stage of recruitment.TRIAL REGISTRATION: NCT01432145 http://www.ClinicalTrials.gov.</p

Multivariate analysis of paired data: a review of methods for paired organ systems

Tests for paired data have been used extensively for assessing the treatment effect in studies involving paired organ systems (e.g. kidneys, eyes). However, there is considerable uncertainty when it comes to choose an appropriate multivariate regression model that would take into account the "within subject" clustering nature of these data. Robust sandwich estimate of the covariance matrix[1], generalized linear model[2] and use of mixed models and random effects[3] are some of the methods that have been proposed and used to deal with the correlation/clustering of these data. Still, a number of studies involving paired organ systems data either do not report or do not use methods to account for this effect. This review will identify and examine the different analysis approaches that have been previously used in studies involving paired organ systems and will discuss the potential benefits and limitations of the most common approaches. Relevant analysis techniques will be identified by searching the MEDLINE and EMBASE databases to find published papers in the English language which report the statistical methods used to analyse paired organ systems data in a multivariate framework. A search will also be undertaken on the Transplant Library Database. The findings from this review will help other researchers to select the most appropriate model when analysing paired organ systems data. 1. Khalil, A.K., et al., Retransplants compared to Primary Kidney Transplants Recipients: A Mate Kidney Paired analysis of the OPTN/UNOS database. Clin Transplant, 2016. 2. Robert, R., et al., A pair analysis of the delayed graft function in kidney recipient: the critical role of the donor. J Crit Care, 2010. 25(4): p. 58290. 3. Cook, R.J., et al., A conditional Markov model for clustered progressive multistate processes under incomplete observation. Biometrics, 2004. 60(2): p. 43643

Cast versus functional brace in the rehabilitation of patients with a rupture of the Achilles tendon: statistical analysis plan for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised controlled trial

Background The incidence of Achilles tendon rupture in the UK is increasing and the best rehabilitation strategy for patients treated non-operatively remains unclear. We describe a statistical analysis plan (SAP) for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised trial. Methods/designUK STAR is a 1:1, multi-centre, parallel, two-arm, superiority randomised controlled trial. This study aims to evaluate the use of functional bracing compared to plaster cast for the management of acute Achilles tendon rupture in adult patients treated non-operatively. The primary outcome is the Achilles Tendon Rupture Score measured at 9 months after injury and will be estimated based on a linear mixed effects regression model adjusted for the stratification factor (centre) and other key prognostic variables. Secondary outcomes include complications, quality of life and resource use evaluated at 8 weeks and at 3, 6 and 9 months after the injury. Missing data will be summarised and reported by treatment arm. Full details of the planned analysis methods are described in this paper. Further study design details are published in the UK STAR protocol. DiscussionThe planned statistical analyses for UK STAR aim to reduce the risk of outcome reporting bias arising from prior data knowledge. Any changes or deviations from the current SAP will be described and justified in the final study report

Determining external randomised pilot trial feasibility in preparation for a definitive trial: a web-based survey of corresponding authors of external pilot trial publications

Background External randomised pilot trials aim to determine whether a future definitive randomised controlled trial (RCT) should be conducted, and if so, how. However, not every pilot trial that suggests that a definitive trial will be feasible will progress to a definitive study. In this study, we surveyed corresponding authors of external randomised pilot trial publications to assess pilot trial outcomes in terms of feasibility and progression. Methods Web-based surveys were sent to corresponding authors of external randomised pilot trial publications, open for four weeks between January and February 2022. Four surveys were produced depending on whether the corresponding author had published a trial protocol or results publication, and whether progression criteria were reported. Surveys asked whether a future RCT was considered feasible, whether progression criteria were met (if applicable), what other factors informed the assessment of pilot trial feasibility, and whether the pilot trial has progressed to further research. Data was analysed using descriptive statistics and conventional content analysis. Results 98 of 276 corresponding authors completed the survey (average response rate of 36% across all surveys). Of these, 89 respondents indicated that their trial had completed. Ninety per cent of respondents who were corresponding authors of completed pilot trials stated that their pilot trial was either feasible (42/89, 47%) or feasible with changes to the trial design (38/89, 43%), yet only 66% (59/89) reported the intention to conduct a future definitive trial. Availability of funding for a future definitive trial and changing priorities of the Chief Investigator were the most common barriers to progression identified. Qualitative research findings was the most frequent factor considered both by corresponding authors who reported and who did not report progression criteria when determining trial feasibility. Conclusions Just under one quarter (21/89, 24%) of respondents who considered their external randomised pilot trial to be feasible, or feasible with changes, did not intend to conduct a definitive trial highlighting research inefficiency and waste. Trial registration Open Science Framework osf.io/d28hr [20 December 2021

Changing from a Western to a Mediterranean-style diet does not affect iron or selenium status:Results of the New Dietary Strategies Addressing the Specific Needs of the Elderly Population for Healthy Aging in Europe (NU-AGE) 1-year randomized clinical trial in elderly Europeans

Background: Mediterranean diets limit red meat consumption and increase intakes of high-phytate foods, a combination that could reduce iron status. Conversely, higher intakes of fish, a good source of selenium, could increase selenium status. Objectives: A 1-y randomized controlled trial [New Dietary Strategies Addressing the Specific Needs of the Elderly Population for Healthy Aging in Europe (NU-AGE)] was carried out in older Europeans to investigate the effects of consuming a Mediterraneanstyle diet on indices of inflammation and changes in nutritional status. Methods: Selenium and iron intakes and status biomarkers were measured at baseline and after 1 y in 1294 people aged 65–79 y from 5 European countries (France, Italy, the Netherlands, Poland, and the United Kingdom) who had been randomly allocated either to a Mediterranean-style diet or to remain on their habitual, Western diet. Results: Estimated selenium intakes increased significantly with the intervention group (P < 0.01), but were not accompanied by changes in serum selenium concentrations. Iron intakes also increased (P < 0.001), but there was no change in iron status. However, when stratified by study center, there were positive effects of the intervention on iron status for serum ferritin for participants in Italy (P = 0.04) and France (P = 0.04) and on soluble transferrin receptor (sTfR) for participants in Poland (P < 0.01). Meat intake decreased and fish intake increased to a greater degree in the intervention group, relative to the controls (P < 0.01 for both), but the overall effects of the intervention on meat and fish intakes were mainly driven by data from Poland and France. Changes in serum selenium in the intervention group were associated with greater changes in serum ferritin (P = 0.01) and body iron (P = 0.01), but not sTfR (P = 0.73); there were no study center × selenium status interactions for the iron biomarkers. Conclusions: Consuming a Mediterranean-style diet for 1 y had no overall effect on iron or selenium status, although there were positive effects on biomarkers of iron status in some countries. The NU-AGE trial was registered at clinicaltrials.gov as NCT01754012. Am J Clin Nutr 2019;00:1–12