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The concept of precision medicine aims to tailor treatment based on data unique to the patient. An example is the use of genetic data from malignant tumours to select the most appropriate oncological treatment. The competing interests of utilitarianism and egoism create dilemmas for decisions regarding investment in precision medicine. The need to balance the perceived rights and needs of individuals against those of society as a whole is an on-going challenge in the distribution of limited health service resources. There is need for proper planning, organisation and investment into precision medicine to cope with the consequences of both direct-to-consumer and healthcare-directed genetic testing for genetic counselling, therapeutics and diagnostic networks. Consideration needs to be given to providing adequate time and training to allow for meaningful shared decision-making with patients and there is a strong case in support of a hub-and-spoke model to provide rapid, solid tumour genetic mutational analysis to prevent patients missing out on beneficial treatments. [ABSTRACT FROM AUTHOR]

Introduction: It is widely acknowledged that breaches and misuses of health-related data can have serious implications and consequently they often carry penalties. However, harm due to the omission of health data usage, or data non-use, is a subject that lacks attention. A better understanding of this 'other side of the coin' is required before it can be addressed effectively.Approach: This article uses an international case study approach to explore why data non-use is difficult to ascertain, the sources and types of health-related data non-use, its implications for citizens and society and some of the reasons it occurs. It does this by focussing on issues with clinical care records, research data and governance frameworks and associated examples of non-use.Results and Discussion: The non-use of health-related data is a complex issue with multiple explanations. Individual instances of data non-use can be associated with harm, but taken together, they can describe a trail of data non-use that may complicate and compound its impacts. There is ample indirect evidence that health data non-use is implicated in the deaths of many thousands of people and potentially £billions in financial burdens to societies.Conclusions: Harm due to the non-use of health data is difficult to attribute unequivocally and actual proven evidence is sparse. Although it can be elusive, it is nevertheless a real problem with widespread and serious, if largely unquantifiable, consequences. The most effective initiatives to address specific contexts of data non-use will be those that: firstly, understand the pertinent sources, types and reasons for data non-use in a given domain in order to meet the challenges and create appropriate incentives and repercussions; and secondly, are cognisant of the multiple aspects to this complex issue in other domains to keep benefits and limitations in perspective, to move steadily towards socially responsible reuse of data becoming the norm to save lives and resources. [ABSTRACT FROM AUTHOR]

Introduction: People with Multiple Sclerosis are known to have a relatively high prevalence of both anxiety and depression. Studies of the relationship between physical disability and mental health in people with MS have reported mixed results, showing the need for further work. Methods: Between May 2011 and April 2012, 4516 people completed the MSIS-29 (v.1) and HADS scales via the dedicated internet site of the UK MS Register within a 7 day time window. These responses were linked with basic demographic and descriptive data and analysed in SPSS (v.20). Results: The proportions of people experiencing anxiety or depression increased with physical disability such that 38.0% of respondents with low, and 66.7% with high disability reported at least mild anxiety, and 17.1% of people with low, and 71.7% with high disability experienced at least mild depression. The multiple regression model explained 18.4% of the variance in anxiety with MSIS-29-PHYS score being the strongest predictor of anxiety. The model for depression explained 37.8% of the variance with MSIS-29-PHYS score being the strongest predictor. Some of the other variables included showed negative associations with anxiety and depression, indicating that the influence of physical disability on mental wellbeing could be underestimated. Conclusions: This study indicates that there is a positive relationship between physical disability and anxiety and depression, that physical disability impacts on anxiety and depression to differing extents, and that the effects vary with gender, age, disease course and disease duration. We have shown that physical disability is a predictor of anxiety and depression, and that other factors may mask the extent of this effect. Whether the causes of anxiety and depression are reactive, organic or a combination, it is essential that mental wellbeing is given due attention in caring for people with MS so that all their health needs can be met. [ABSTRACT FROM AUTHOR]

OBJECTIVES:To examine the incidence of Campylobacter and Salmonella infection in patients prescribed proton pump inhibitors (PPIs) compared with controls.METHODS:Retrospective cohort study using anonymous general practitioner (GP) data. Anonymised individual-level records from the Secure Anonymised Information Linkage (SAIL) system between 1990 and 2010 in Wales were selected. Data were available from 1,913,925 individuals including 358,938 prescribed a PPI. The main outcome measures examined included incidence of Campylobacter or Salmonella infection following a prescription for PPI.RESULTS:The rate of Campylobacter and Salmonella infections was already at 3.1-6.9 times that of non-PPI patients even before PPI prescription. The PPI group had an increased hazard rate of infection (after prescription for PPI) of 1.46 for Campylobacter and 1.2 for Salmonella, compared with baseline. However, the non-PPI patients also had an increased hazard ratio with time. In fact, the ratio of events in the PPI group compared with the non-PPI group using the prior event rate ratio was 1.17 (95% CI 0.74-1.61) for Campylobacter and 1.00 (0.5-1.5) for Salmonella.CONCLUSIONS:People who go on to be prescribed PPIs have a greater underlying risk of gastrointestinal (GI) infection beforehand and they have a higher prevalence of risk factors before PPI prescription. The rate of diagnosis of infection is increasing with time regardless of PPI use, and there is no evidence that PPI is associated with an increase in diagnosed GI infection. It is likely that factors associated with the demographic profile of the patient are the main contributors to increased rate of GI infection for patients prescribed PPIs. [ABSTRACT FROM AUTHOR]

Introduction: The EQ-5D is a widely-used, standardised, quality of life measure producing health profiles, indices and states. The aims of this study were to assess the role of various factors in how people with Multiple Sclerosis rate their quality of life, based on responses to the EQ-5D received via the web portal of the UK MS Register. Methods: The 4516 responses to the EQ-5D (between May 2011 and April 2012) were collated with basic demographic and descriptive MS data and the resulting dataset was analysed in SPSS (v.20). Results: The mean health state for people with MS was 59.73 (SD 22.4, median 61), compared to the UK population mean of 82.48 (which is approximately 1SD above the cohort mean). The characteristics of respondents with high health states (at or above +1SD) were: better health profiles (most predictive dimension: Usual Activities), higher health indices, younger age, shorter durations of MS, female gender, relapsing-remitting MS, higher educational attainment and being in paid employment (all p-values<0.001). Conversely, the characteristics of respondents with low health states (at or below -1SD) were: poorer health profiles (most predictive dimension: Mobility), lower health indices, older age, longer durations of MS, male gender, progressive MS, lower educational attainment and having an employment status of sick/disabled (p = 0.0014 for age, all other p-values<0.001). Particular living arrangements were not associated with either the high or low health status groups. Conclusions: This large-scale study has enabled in-depth analyses on how people with MS rate their quality of life, and it provides new knowledge on the various factors that contribute to their self-assessed health status. These findings demonstrate the impact of MS on quality of life, and they can be used to inform care provision and further research, to work towards enhancing the quality of life of people with MS. [ABSTRACT FROM AUTHOR]

Introduction:The MSIS-29 was developed to assess the physical and psychological impact of MS. The aims of this study were to use the responses to the MSIS-29 via the web portal of the UK MS Register to: examine the internal properties of the scale delivered via the internet, profile the cohort, and assess how well the scale measures impact of disability on the potential workforce. Methods: Between May 2011 and April 2012, 4558 people with MS completed the MSIS-29(v.1). The responses were collated with basic demographic and descriptive MS data and the resulting dataset was analysed in SPSS(v.20). Results: Internal consistency was high (Cronbach's alpha 0.97 MSIS-29-PHYS, 0.92 MSIS-29-PSYCH). The mean MSIS-29-PHYS score was 60.5 (50.6%) with a median of 62 and the mean MSIS-29-PSYCH score was 24.8 (43.8%) with a median of 24. Physical scores increased with age and disease duration (p<0.001, p<0.001), but there was a weak negative relationship between psychological scores and age (p<0.001). The odds of people having an employment status of sick/disabled were 7.2 (CI 5.5, 9.4, p<0.001) for people with a moderate physical score, and 22.3 (CI 17.0, 29.3, p<0.001) for people with a high physical score (relative to having a low physical score). Conclusions: This largest known study of its kind has demonstrated how the MSIS-29 can be administered via the internet to characterise a cohort, and to predict the likely impact of disability on taking an active part in the workforce, as a reasonable proxy for the effects of MS on general activities. The findings examining MSIS-29-PHYS and MSIS-29-PSYCH scores against age support the use of two sub-scales, not a combined score. These results underline the importance of using a scale such as this to monitor disability levels regularly in guiding MS care to enable people to be as active as possible. [ABSTRACT FROM AUTHOR]

Introduction: Studies have found that people with Multiple Sclerosis experience relatively high rates of anxiety and depression. Although methodologically robust, many of these studies had access to only modest sample sizes (N<200). The aims of this study were to use responses gained via the web portal of the UK MS Register (N>4000) to: describe the depression and anxiety profiles of people with MS; to determine if anxiety and depression are related to age or disease duration; and to assess whether the levels of anxiety and depression differ between genders and types of MS. Methods: From its launch in May 2011 to the end of December 2011, 7786 adults with MS enrolled to take part in the UK MS Register via the web portal. The responses to the Hospital Anxiety and Depression Scale (HADS) were collated with basic demographic and descriptive MS data provided at registration and the resulting dataset was analysed in SPSS (v.16). Results: The mean HADS score among the 4178 respondents was 15.7 (SE 0.117, SD 7.55) with a median of 15.0 (IQR 11). Anxiety and depression rates were notably high, with over half (54.1%) scoring ≥8 for anxiety and 46.9% scoring ≥8 for depression. Women with relapsing-remitting MS were more anxious than men with this type (p<0.001), and than women with other types of MS (p = 0.017). Within each gender, men and women with secondary progressive MS were more depressed than men or women with other types of MS (p<0.001, p<0.001). Conclusions: This largest known study of its kind has shown that anxiety and depression are highly prevalent in people with MS, indicating that their mental health needs could be better addressed. These findings support service planning and further research to provide the best care for people with MS to help alleviate these debilitating conditions. [ABSTRACT FROM AUTHOR]

Background: A UK Register of people with Multiple Sclerosis has been developed to address the need for an increased knowledge-base about MS. The Register is being populated via: a web-based portal; NHS neurology clinical systems; and administrative data sources. The data are de-identified and linked at the individual level. At the outset, it was not known whether people with MS would wish to participate in the UK MS Register by personally contributing their data to the Register via a web-based system. Therefore, the research aim of this work was to build an internet-mounted recruitment and consenting technology for people with Multiple Sclerosis, and to assess its feasibility as a questionnaire delivery platform to contribute data to the UK MS Register, by determining whether the information provided could be used to describe a cohort of people with MS. Methods: The web portal was developed using VB.net and JQuery with a Microsoft SQL 2008 database. UK adults with MS can self-register and enter data about themselves by completing validated questionnaires. Descriptive statistics were used to characterise the respondents. Results: The web portal was launched in May 2011, and in first three months 7,279 individuals registered on the portal. The ratio of men to women was 1:2.4 (n = 5,899), the mean self-reported age at first symptoms was 33.8 (SD 10.5) years, and at diagnosis 39.6 (SD 10.3) years (n = 4,401). The reported types of MS were: 15% primary progressive, 63% relapsing-remitting, 8% secondary progressive, and 14% unknown (n = 5,400). These characteristics are similar to those of the prevalent MS population. Employment rates, sickness/disability rates, ethnicity and educational qualifications were compared with the general UK population. Information about the respondents' experience of early symptoms and the process of diagnosis, plus living arrangements are also reported. Conclusions: These initial findings from the MS Register portal demonstrate the feasibility of collecting data about people with MS via a web platform, and show that sufficient information can be gathered to characterise a cohort of people with MS. The innovative design of the UK MS register, bringing together three disparate sources of data, is creating a rich resource for research into this condition. [ABSTRACT FROM AUTHOR]

Background: Vast amounts of data are collected about patients and service users in the course of health and social care service delivery. Electronic data systems for patient records have the potential to revolutionise service delivery and research. But in order to achieve this, it is essential that the ability to link the data at the individual record level be retained whilst adhering to the principles of information governance. The SAIL (Secure Anonymised Information Linkage) databank has been established using disparate datasets, and over 500 million records from multiple health and social care service providers have been loaded to date, with further growth in progress. Methods: Having established the infrastructure of the databank, the aim of this work was to develop and implement an accurate matching process to enable the assignment of a unique Anonymous Linking Field (ALF) to person-based records to make the databank ready for recordlinkage research studies. An SQL-based matching algorithm (MACRAL, Matching Algorithm for Consistent Results in Anonymised Linkage) was developed for this purpose. Firstly the suitability of using a valid NHS number as the basis of a unique identifier was assessed using MACRAL. Secondly, MACRAL was applied in turn to match primary care, secondary care and social services datasets to the NHS Administrative Register (NHSAR), to assess the efficacy of this process, and the optimum matching technique. Results: The validation of using the NHS number yielded specificity values > 99.8% and sensitivity values > 94.6% using probabilistic record linkage (PRL) at the 50% threshold, and error rates were < 0.2%. A range of techniques for matching datasets to the NHSAR were applied and the optimum technique resulted in sensitivity values of: 99.9% for a GP dataset from primary care, 99.3% for a PEDW dataset from secondary care and 95.2% for the PARIS database from social care. Conclusion: With the infrastructure that has been put in place, the reliable matching process that has been developed enables an ALF to be consistently allocated to records in the databank. The SAIL databank represents a research-ready platform for record-linkage studies. [ABSTRACT FROM AUTHOR]

Objective: This study was undertaken to develop a novel pathway linking genetic data with routinely collected data for people with epilepsy, and to analyze the influence of rare, deleterious genetic variants on epilepsy outcomes. Methods: We linked whole‐exome sequencing (WES) data with routinely collected primary and secondary care data and natural language processing (NLP)‐derived seizure frequency information for people with epilepsy within the Secure Anonymised Information Linkage Databank. The study participants were adults who had consented to participate in the Swansea Neurology Biobank, Wales, between 2016 and 2018. DNA sequencing was carried out as part of the Epi25 collaboration. For each individual, we calculated the total number and cumulative burden of rare and predicted deleterious genetic variants and the total of rare and deleterious variants in epilepsy and drug metabolism genes. We compared these measures with the following outcomes: (1) no unscheduled hospital admissions versus unscheduled admissions for epilepsy, (2) antiseizure medication (ASM) monotherapy versus polytherapy, and (3) at least 1 year of seizure freedom versus <1 year of seizure freedom. Results: We linked genetic data for 107 individuals with epilepsy (52% female) to electronic health records. Twenty‐six percent had unscheduled hospital admissions, and 70% were prescribed ASM polytherapy. Seizure frequency information was linked for 100 individuals, and 10 were seizure‐free. There was no significant difference between the outcome groups in terms of the exome‐wide and gene‐based burden of rare and deleterious genetic variants. Significance: We successfully uploaded, annotated, and linked genetic sequence data and NLP‐derived seizure frequency data to anonymized health care records in this proof‐of‐concept study. We did not detect a genetic influence on real‐world epilepsy outcomes, but our study was limited by a small sample size. Future studies will require larger (WES) data to establish genetic variant contribution to epilepsy outcomes. [ABSTRACT FROM AUTHOR]

The value of using population data to answer important questions for individual and societal benefit has never been greater. Governments and research funders world-wide are recognizing this potential and making major investments in data-intensive initiatives. However, there are challenges to overcome so that safe, socially-acceptable data sharing can be achieved. This paper outlines the field of population data science, the International Population Data Linkage Network (IPDLN), and their roles in advancing data-intensive research. We provide an overview of core concepts and major challenges for data-intensive research, with a particular focus on ethical, legal, and societal implications (ELSI). Using international case studies, we show how challenges can be addressed and lessons learned in advancing the safe, socially-acceptable use of population data for public benefit. Based on the case studies, we discuss the common ELSI principles in operation, we illustrate examples of a data scrutiny panel and a consumer panel, and we propose a set of ELSI-based recommendations to inform new and developing data-intensive initiatives.We conclude that although there are many ELSI issues to be overcome, there has never been a better time or more potential to leverage the benefits of population data for public benefit. A variety of initiatives, with different operating models, have pioneered the way in addressing many challenges. However, the work is not static, as the ELSI environment is constantly evolving, thus requiring continual mutual learning and improvement via the IPDLN and beyond. [ABSTRACT FROM AUTHOR]

A response from the author of an article, which discusses the association between campylobacter infections and the use of proton pump inhibitors (PPIs) in the previous issue is presented.

Highlights: [•] A qualitative dimension to understanding users’ desires regarding, and expectations of, health registers. [•] That there is a difference between what users think health registers would be used for, and how they want them to be used. [•] Users wish for social contact, exchange, and networking functions, from a health register. [ABSTRACT FROM AUTHOR]

Quality deliberation is essential for societies to address the challenges presented by the coronavirus pandemic effectively and legitimately. Critics of deliberative and participatory democracy are highly skeptical that most citizens can engage with such complex issues in good circumstances and these are far from ideal circumstances. The need for rapid action and decision-making is a challenge for inclusivity and quality of deliberation. Additionally, policy responses to the virus need to be even more co-ordinated than usual, which intensifies their complexity. The digitalisation of the public sphere may be seen as a further challenge to deliberating. Furthermore, these are stressful and emotional times, making a considered judgement on these issues potentially challenging. We employ a modified version of the Discourse Quality Index to assess the deliberative quality in two facilitated synchronous digital platforms to consider aspects of data use in light of COVID 19. Our study is the first to perform a comprehensive, systematic and in-depth analysis of the deliberative capacity of citizens in a pandemic. Our evidence indicates that deliberation can be resilient in a crisis. The findings will have relevance to those interested in pandemic democracy, deliberative democracy in a crisis, data use and digital public spheres. [ABSTRACT FROM AUTHOR]

This article outlines the value of administrative data for family justice research. Although socio-legal scholars have extended their research beyond purely theoretical or doctrinal analyses, studies using large-scale digital datasets remain few in number. As new opportunities arise to link large-scale administrative datasets across health, education, welfare and justice, it is vital that the community of family justice researchers and analysts are supported to deliver research based on entire service or family court populations. In this context, this article provides a definition of administrative data, before outlining the potential of single, linked or blended administrative data sets for family justice research. The remaining sections of the article speak to questions that are pertinent to this particular academic community, including the distinctive contribution of the socio-legal scholar to interdisciplinary teams and the place of data providers in collaborative research. Drawing on the sociological concept of 'publics', the final section considers the multiple interest groups whose social licence must be secured, when personal records are used to understand the relationship between law and family life. [ABSTRACT FROM AUTHOR]

In order to fully understand and explore the effectiveness of any intervention for the management of multiple sclerosis (MS), it is important to have robust, valid, reliable, and universally applied measures. The recent article, ‘Disability outcome measures in multiple sclerosis clinical trials’ by Cohen, Reingold, Polman and Wolinsky (2012), explores this issue in regards to the effective measurement of MS-related disability, and the utilisation of patient-reported outcome measures, whilst highlighting the need for collaboration between the academic and clinical communities. Although it is important to examine disability measures, it is also equally important to recognise that physical function is only one aspect of a person’s experience; for example, quality of life and psychological well-being are also important aspects to assess. The application of e-health technologies and patient registers could be a useful method of gaining additional information, using patient-reported outcomes. This commentary explores these issues in relation to points raised by the Cohen et al. paper. [ABSTRACT FROM AUTHOR]

Although inequalities in health and socioeconomic status have an important influence on childhood educational performance, the interactions between these multiple factors relating to variation in educational outcomes at micro-level is unknown, and how to evaluate the many possible interactions of these factors is not well established. This paper aims to examine multi-dimensional deprivation factors and their impact on childhood educational outcomes at micro-level, focusing on geographic areas having widely different disparity patterns, in which each area is characterised by six deprivation domains (Income, Health, Geographical Access to Services, Housing, Physical Environment, and Community Safety). Traditional health statistical studies tend to use one global model to describe the whole population for macro-analysis. In this paper, we combine linked educational and deprivation data across small areas (median population of 1500), then use a local modelling technique, the Takagi-Sugeno fuzzy system, to predict area educational outcomes at ages 7 and 11. We define two new metrics, “Micro-impact of Domain” and “Contribution of Domain”, to quantify the variations of local impacts of multidimensional factors on educational outcomes across small areas. The two metrics highlight differing priorities. Our study reveals complex multi-way interactions between the deprivation domains, which could not be provided by traditional health statistical methods based on single global model. We demonstrate that although Income has an expected central role, all domains contribute, and in some areas Health, Environment, Access to Services, Housing and Community Safety each could be the dominant factor. Thus the relative importance of health and socioeconomic factors varies considerably for different areas, depending on the levels of each of the other factors, and therefore each component of deprivation must be considered as part of a wider system. Childhood educational achievement could benefit from policies and intervention strategies that are tailored to the local geographic areas' profiles. [ABSTRACT FROM AUTHOR]

Background: Fitness and physical activity are important for cardiovascular and mental health but activity and fitness levels are declining especially in adolescents and among girls. This study examines clustering of factors associated with low fitness in adolescents in order to best target public health interventions for young people. Methods: 1147 children were assessed for fitness, had blood samples, anthropometric measures and all data were linked with routine electronic data to examine educational achievement, deprivation and health service usage. Factors associated with fitness were examined using logistic regression, conditional trees and data mining cluster analysis. Focus groups were conducted with children in a deprived school to examine barriers and facilitators to activity for children in a deprived community. Results: Unfit adolescents are more likely to be deprived, female, have obesity in the family and not achieve in education. There were 3 main clusters for risk of future heart disease/diabetes (high cholesterol/insulin); children at low risk (not obese, fit, achieving in education), children ‘visibly at risk’ (overweight, unfit, many hospital/GP visits) and ‘invisibly at risk’ (unfit but not overweight, failing in academic achievement). Qualitative findings show barriers to physical activity include cost, poor access to activity, lack of core physical literacy skills and limited family support. Conclusions: Low fitness in the non-obese child can reveal a hidden group who have high risk factors for heart disease and diabetes but may not be identified as they are normal weight. In deprived communities low fitness is associated with non-achievement in education but in non-deprived communities low fitness is associated with female gender. Interventions need to target deprived families and schools in deprived areas with community wide campaigns. [ABSTRACT FROM AUTHOR]

A cohort comprising residents of a housing regeneration and health programme was created from routinely collected data using a system which allows us to anonymously link housing data to individuals and their health. The regeneration programme incorporating four rolling work packages runs from 2009 to 2014. The main intervention cohort we describe here contains the 18 312 residents of 9051 residences at baseline. The cohort will be followed continuously through routine health data (demographics, mortality, hospital admissions and general practitioner records including prescriptions) with periodic updates of housing regeneration intervention data. Here, we describe the baseline data for the primary health outcomes of emergency hospital admissions for cardiovascular and respiratory conditions and injuries for those aged &geq;60 years. We will compare the health of residents within the homes before and after the housing regeneration work has taken place, and we will calculate the change in health service costs with use of hospital and General Practitioners (GP) services. We will also use a difference in differences approach to assess changes in comparison with comparator cohorts. These data will be accessible at the end of the study period in 2016. Further information about this study can be obtained from Ronan Lyons; r.a.lyons@swansea.ac.uk [ABSTRACT FROM PUBLISHER]

Background: This review determined the most commonly used, and reliable, measures for assessing clinical outcomes for multiple sclerosis (MS). Objectives: It was anticipated that this would facilitate the development of a common set of metrics, and aid reaching a consensus regarding the outcome measures that are typically used in the field of MS clinical research. Major findings: A thorough literature review of clinical outcome measures for MS produced 166 measures that have been used in this context. This list was then refined by discussion with a panel of consultant neurologists, which reduced the list to 23 commonly employed tools. This shortlist was then further refined through surveying 41 centres for MS treatment, which reduced the shortlist to 16 measures. The properties of these scales, in terms of their symptom/function domains, their specificity for MS, their administration characteristics, and their reliability and validity for MS, are all discussed. Conclusions: Conclusions regarding the development of potential sets of assessment measures for MS, which encompass broad symptom/function domains, and which are sensitive to the practical requirements of administration within clinical contexts, are explored. [ABSTRACT FROM AUTHOR]

Background: Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods: Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results: The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions: We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. [ABSTRACT FROM AUTHOR]

Background: To develop a population-based cohort of people with ankylosing spondylitis (AS) in Wales using (1) secondary care clinical datasets, (2) patient-derived questionnaire data and (3) routinely-collected information in order to examine disease history and the health economic cost of AS. Methods: This data model will include and link (1) secondary care clinician datasets (i.e. electronic patient notes from the rheumatologist) (2) patient completed questionnaires (giving information on disease activity, medication, function, quality of life, work limitations and health service utilisation) and (3) a broad range of routinely collected data (including; GP records, in-patient hospital admission data, emergency department data, laboratory/pathology data and social services databases). The protocol involves the use of a unique and powerful data linkage system which allows datasets to be interlinked and to complement each other. Discussion: This cohort can integrate patient supplied, primary and secondary care data into a unified data model. This can be used to study a range of issues such as; the true economic costs to the health care system and the patient, factors associated with the development of severe disease, long term adverse events of new and existing medication and to understand the disease history of this condition. It will benefit patients, clinicians and health care managers. This study forms a pilot project for the use of routine data/patient data linked cohorts for other chronic conditions. [ABSTRACT FROM AUTHOR]

Background: Fitness and physical activity are important for cardiovascular and mental health but activity and fitness levels are declining especially in adolescents and among girls. This study examines clustering of factors associated with low fitness in adolescents in order to best target public health interventions for young people.Methods: 1147 children were assessed for fitness, had blood samples, anthropometric measures and all data were linked with routine electronic data to examine educational achievement, deprivation and health service usage. Factors associated with fitness were examined using logistic regression, conditional trees and data mining cluster analysis. Focus groups were conducted with children in a deprived school to examine barriers and facilitators to activity for children in a deprived community.Results: Unfit adolescents are more likely to be deprived, female, have obesity in the family and not achieve in education. There were 3 main clusters for risk of future heart disease/diabetes (high cholesterol/insulin); children at low risk (not obese, fit, achieving in education), children 'visibly at risk' (overweight, unfit, many hospital/GP visits) and 'invisibly at risk' (unfit but not overweight, failing in academic achievement). Qualitative findings show barriers to physical activity include cost, poor access to activity, lack of core physical literacy skills and limited family support.Conclusions: Low fitness in the non-obese child can reveal a hidden group who have high risk factors for heart disease and diabetes but may not be identified as they are normal weight. In deprived communities low fitness is associated with non-achievement in education but in non-deprived communities low fitness is associated with female gender. Interventions need to target deprived families and schools in deprived areas with community wide campaigns. [ABSTRACT FROM AUTHOR]

Background: Vast quantities of electronic data are collected about patients and service users as they pass through health service and other public sector organisations, and these data present enormous potential for research and policy evaluation. The Health Information Research Unit (HIRU) aims to realise the potential of electronically-held, person-based, routinely-collected data to conduct and support health-related studies. However, there are considerable challenges that must be addressed before such data can be used for these purposes, to ensure compliance with the legislation and guidelines generally known as Information Governance.Methods: A set of objectives was identified to address the challenges and establish the Secure Anonymised Information Linkage (SAIL) system in accordance with Information Governance. These were to: 1) ensure data transportation is secure; 2) operate a reliable record matching technique to enable accurate record linkage across datasets; 3) anonymise and encrypt the data to prevent re-identification of individuals; 4) apply measures to address disclosure risk in data views created for researchers; 5) ensure data access is controlled and authorised; 6) establish methods for scrutinising proposals for data utilisation and approving output; and 7) gain external verification of compliance with Information Governance.Results: The SAIL databank has been established and it operates on a DB2 platform (Data Warehouse Edition on AIX) running on an IBM 'P' series Supercomputer: Blue-C. The findings of an independent internal audit were favourable and concluded that the systems in place provide adequate assurance of compliance with Information Governance. This expanding databank already holds over 500 million anonymised and encrypted individual-level records from a range of sources relevant to health and well-being. This includes national datasets covering the whole of Wales (approximately 3 million population) and local provider-level datasets, with further growth in progress. The utility of the databank is demonstrated by increasing engagement in high quality research studies.Conclusion: Through the pragmatic approach that has been adopted, we have been able to address the key challenges in establishing a national databank of anonymised person-based records, so that the data are available for research and evaluation whilst meeting the requirements of Information Governance. [ABSTRACT FROM AUTHOR]