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  • 1
    ISSN: 1365-2214
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine , Psychology
    Notes: Background  This paper recounts the difficulties experienced when the authors sought access to children in hospital for social research interviews. These were part of a 2-year study, funded by the Joseph Rowntree Foundation, aiming to explore the numbers, circumstances and experiences of children who spend prolonged periods in health care settings.Methods  As the intention was to carry out ‘guided conversations’ with 24 young people in various different NHS locations, permission to do so was sought from a multi-site research ethics committee (MREC), and from several local research ethics committees (LRECs). Agreement was then necessary from NHS trusts, which were asked to nominate a liaison person to help identify and recruit children to the study. Consent was also required from individual parents and children. A series of unexpected delays encountered during this process are discussed in some detail. Eventually a sample of 15 children was achieved.Discussion  The second part of the paper locates this experience within a wider context, noting that similar difficulties gaining access to children in NHS settings have recently been reported by other social researchers. Several possible reasons for this trend are identified and discussed. These relate to the role of MRECs and LRECs in screening social research proposals, recently implemented legislation about data protection, heightened concerns within the NHS about confidentiality and consent, and increasing awareness of the risk of child abuse in health care settings.Conclusion  Finally, some suggestions for facilitating the access process are discussed. They include the sensitive and appropriate application of research governance frameworks to social research – including studies within health care settings. Ethical considerations and adequate protection of children are vital but, the authors argue, wherever possible children themselves should be encouraged to decide whether or not to participate in research. In addition, unnecessarily complex access procedures may adversely affect research outcomes.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1365-2036
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Background : It is uncertain whether ursodeoxycholic acid therapy slows down the progression of primary biliary cirrhosis, according to two meta-analyses. However, the randomized trials evaluated had only a median of 24 months of follow-up.Aim : To evaluate long-term ursodeoxycholic acid therapy in primary biliary cirrhosis.Methods : We evaluated 209 consecutive primary biliary cirrhosis patients, 69 compliant with ursodeoxycholic acid and 140 untreated [mean follow-up 5.79 (s.d. = 4.73) and 4.87 (s.d. = 5.21) years, respectively] with onset of all complications documented. Comparison was made following adjustment for baseline differences according to Cox modelling, Mayo and Royal Free prognostic models.Results : Bilirubin and alkaline phosphatase concentrations improved with ursodeoxycholic acid (at 36 months, P = 0.007 and 0.018, respectively). Unadjusted Kaplan–Meier analysis showed benefit (P = 0.028), as 44 (31%) untreated and 15 (22%) ursodeoxycholic acid patients died or had liver transplantation. However, there was no difference when adjusted by Cox modelling (P = 0.267), Mayo (P = 0.698) and Royal Free models (P = 0.559). New pruritus or fatigue or other complications were not different, either before or after adjustment for baseline characteristics.Conclusions : Long-term ursodeoxycholic acid therapy did not alter disease progression in primary biliary cirrhosis patients despite a significant improvement in serum bilirubin and alkaline phosphatase consistent with, and similar to, those seen in ursodeoxycholic acid cohorts in randomized trials.
    Type of Medium: Electronic Resource
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  • 3
    Publication Date: 2018-03-27
    Description: Introduction Chronic obstructive pulmonary disease (COPD) is a progressive disease affecting 3 million people in the UK, in which patients exhibit airflow obstruction that is not fully reversible. COPD treatment guidelines are largely informed by randomised controlled trial results, but it is unclear if these findings apply to large patient populations not studied in trials. Non-interventional studies could be used to study patient groups excluded from trials, but the use of these studies to estimate treatment effectiveness is in its infancy. In this study, we will use individual trial data to validate non-interventional methods for assessing COPD treatment effectiveness, before applying these methods to the analysis of treatment effectiveness within people excluded from, or under-represented in COPD trials. Methods and analysis Using individual patient data from the landmark COPD Towards a Revolution in COPD Health (TORCH) trial and validated methods for detecting COPD and exacerbations in routinely collected primary care data, we will assemble a cohort in the UK Clinical Practice Research Datalink (selecting people between 1 January 2004 and 1 January 2017) with similar characteristics to TORCH participants and test whether non-interventional data can generate comparable results to trials, using cohort methodology with propensity score techniques to adjust for potential confounding. We will then use the methodological template we have developed to determine risks and benefits of COPD treatments in people excluded from TORCH. Outcomes are pneumonia, COPD exacerbation, mortality and time to treatment change. Groups to be studied include the elderly (〉80 years), people with substantial comorbidity, people with and without underlying cardiovascular disease and people with mild COPD. Ethics and dissemination Ethical approval has been granted by the London School of Hygiene & Tropical Medicine Ethics Committee (Ref: 11997). The study has been approved by the Independent Scientific Advisory Committee of the UK Medicines and Healthcare Products Regulatory Agency (protocol no. 17_114R). An application to use the TORCH trial data made to clinicalstudydatarequest.com has been approved. In addition to scientific publications, dissemination methods will be developed based on discussions with patient groups with COPD.
    Keywords: Open access, Epidemiology, Epidemiology
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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