A pipeline for harmonising NHS Scotland laboratory data to enable national-level analyses.

Objective: Medical laboratory data together with prescribing and hospitalisation records are three of the most used electronic health records (EHRs) for data-driven health research. In Scotland, hospitalisation, prescribing and the death register data are available nationally whereas laboratory data is captured, stored and reported from local health board systems with significant heterogeneity. For researchers or other users of this regionally curated data, working on laboratory datasets across regional cohorts requires effort and time.

A National Network of Safe Havens: Scottish Perspective.

For over a decade, Scotland has implemented and operationalized a system of Safe Havens, which provides secure analytics platforms for researchers to access linked, deidentified electronic health records (EHRs) while managing the risk of unauthorized reidentification. In this paper, a perspective is provided on the state-of-the-art Scottish Safe Haven network, including its evolution, to define the key activities required to scale the Scottish Safe Haven network's capability to facilitate research and health care improvement initiatives. A set of processes related to EHR data and their delivery in Scotland have been discussed.

Serum sodium level variability as a prognosticator in older adults.

Our aim was to explore biological variation of serum sodium levels as a method of quantifying health risk in older adults. We investigated whether dynamic changes in serum sodium levels could provide additional prognostic information to standard predictors of mortality in older people. Analysis of routinely collected clinical datasets containing information on demographics, hospitalisation, biochemistry, haematology and physical function for Dundee in-patient rehabilitation services, between 1999 and 2011.

Possible Sources of Bias in Primary Care Electronic Health Record Data Use and Reuse.

Background: Enormous amounts of data are recorded routinely in health care as part of the care process, primarily for managing individual patient care. There are significant opportunities to use these data for other purposes, many of which would contribute to establishing a learning health system. This is particularly true for data recorded in primary care settings, as in many countries, these are the first place patients turn to for most health problems.

The TRANSFoRm project: Experience and lessons learned regarding functional and interoperability requirements to support primary care.

Introduction: The current model of medical knowledge production, transfer, and application suffers from serious shortcomings. Learning health systems (LHS) have recently emerged as a potential solution-systems in which health information generated from patients is continuously analyzed to improve knowledge that will be transferred to patient care.

Method: Various approaches of data integration already exist and could be considered for the implementation of a LHS.

eSource for clinical trials: Implementation and evaluation of a standards-based approach in a real world trial.

Objective: The Learning Health System (LHS) requires integration of research into routine practice. 'eSource' or embedding clinical trial functionalities into routine electronic health record (EHR) systems has long been put forward as a solution to the rising costs of research. We aimed to create and validate an eSource solution that would be readily extensible as part of a LHS.

Association between bisphosphonate therapy and outcomes from rehabilitation in older people.

Background: Bisphosphonate therapy may have actions beyond bone, including effects on cardiovascular, immune and muscle function. We tested whether bisphosphonate treatment is associated with improved outcomes in older people undergoing inpatient rehabilitation.

Methods: Analysis of prospectively collected, linked routine clinical datasets.

Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting.

Background: Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems.

Cross border semantic interoperability for clinical research: the EHR4CR semantic resources and services.

With the development of platforms enabling the use of routinely collected clinical data in the context of international clinical research, scalable solutions for cross border semantic interoperability need to be developed. Within the context of the IMI EHR4CR project, we first defined the requirements and evaluation criteria of the EHR4CR semantic interoperability platform and then developed the semantic resources and supportive services and tooling to assist hospital sites in standardizing their data for allowing the execution of the project use cases. The experience gained from the evaluation of the EHR4CR platform accessing to semantically equivalent data elements across 11 European participating EHR systems from 5 countries demonstrated how far the mediation model and mapping efforts met the expected requirements of the project.

Slower Decline in C-Reactive Protein after an Inflammatory Insult Is Associated with Longer Survival in Older Hospitalised Patients.

Background: Enhancing biological resilience may offer a novel way to prevent and ameliorate disease in older patients. We investigated whether changes in C-reactive protein (CRP), as a dynamic marker of the acute inflammatory response to diverse stressors, may provide a way to operationalize the concept of resilience in older adults. We tested this hypothesis by examining whether such changes could predict prognosis by identifying which individuals are at greater risk of 6-month mortality.

Association between allopurinol use and hip fracture in older patients.

Background: Allopurinol reduces oxidative stress and interacts with purinergic signalling systems important in bone metabolism and muscle function. We assessed whether allopurinol use was associated with a reduced incidence of hip fracture in older people.

Methods: Analysis of prospective, routinely-collected health and social care data on patients undergoing health and social work assessment in a single geographical area over a 12year period.

Feasibility and acceptability of TRANSFoRm to improve clinical trial recruitment in primary care.

Background: Recruitment of study participants is a challenging process for health professionals and patients. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) clinical trial tools enable automated identification, recruitment and follow-up in clinical trials, potentially saving time, effort and costs for all parties involved.

Objectives: This study evaluates the acceptability and feasibility of TRANSFoRm to improve clinical trial recruitment in primary care.

Translational Medicine and Patient Safety in Europe: TRANSFoRm--Architecture for the Learning Health System in Europe.

Unlabelled: The Learning Health System (LHS) describes linking routine healthcare systems directly with both research translation and knowledge translation as an extension of the evidence-based medicine paradigm, taking advantage of the ubiquitous use of electronic health record (EHR) systems. TRANSFoRm is an EU FP7 project that seeks to develop an infrastructure for the LHS in European primary care.

Methods: The project is based on three clinical use cases, a genotype-phenotype study in diabetes, a randomised controlled trial with gastroesophageal reflux disease, and a diagnostic decision support system for chest pain, abdominal pain, and shortness of breath.

Association between kidney function, rehabilitation outcome, and survival in older patients discharged from inpatient rehabilitation.

Background: Chronic kidney disease (CKD) is common in older people, but it is unclear if it affects survival and rehabilitation outcomes independent of comorbid conditions and physical function in this population.

Study Design: Cohort analysis of prospective, routinely collected, linked clinical data sets.

Setting & Participants: Patients discharged from a single inpatient geriatric rehabilitation center over a 12-year period.

An approach for utilizing clinical statements in HL7 RIM to evaluate eligibility criteria.

The HL7 RIM (Reference Information Model) is a commonly used standard for the exchange of clinical data and can be employed for integrating the patient care and clinical research domains. Yet it is not sufficiently well specified to ensure a canonical representation of structured clinical data when used for the automated evaluation of eligibility criteria from a clinical trial protocol. We present an approach to further constrain the RIM to create a common information model to hold clinical data.

Construction of a linked health and social care database resource--lessons on process, content and culture.

Background: Combining routinely collected health and social care data on older people is essential to advance both service delivery and research for this client group. Little data is available on how to combine health and social care data; this article provides an overview of a successful data linkage process and discusses potential barriers to executing such projects.

Methods And Results: We successfully obtained and linked data on older people within Dundee from three sources: Dundee Social Work Department database (30,000 individuals aged 65 years and over), healthcare data held on NHS Tayside patients by the Health Informatics Centre (400,000 individuals), Dundee, and the Dundee of Medicine for the Elderly rehabilitation database (4300 individuals).

Detailed clinical modelling approach to data extraction from heterogeneous data sources for clinical research.

The reuse of routinely collected clinical data for clinical research is being explored as part of the drive to reduce duplicate data entry and to start making full use of the big data potential in the healthcare domain. Clinical researchers often need to extract data from patient registries and other patient record datasets for data analysis as part of clinical studies. In the TRANSFoRm project, researchers define their study requirements via a Query Formulation Workbench.

Cardiovascular risk factors associated with the metabolic syndrome are more prevalent in people reporting chronic pain: results from a cross-sectional general population study.

To explore whether chronic pain is associated with cardiovascular risk factors and identify whether increased distribution or intensity of pain is associated with cardiovascular risk, participants in Generation Scotland: The Scottish Family Health study completed pain questionnaires recording the following: presence of chronic pain, distribution of pain, and intensity of chronic pain. Blood pressure, lipids, blood glucose, smoking history, waist-hip ratio, and body mass index were recorded; Framingham 10-year coronary heart disease (CHD) risk scores were calculated and a diagnosis of metabolic syndrome derived. Associations between chronic pain and cardiovascular risk were explored.

A unified structural/terminological interoperability framework based on LexEVS: application to TRANSFoRm.

Objective: Biomedical research increasingly relies on the integration of information from multiple heterogeneous data sources. Despite the fact that structural and terminological aspects of interoperability are interdependent and rely on a common set of requirements, current efforts typically address them in isolation. We propose a unified ontology-based knowledge framework to facilitate interoperability between heterogeneous sources, and investigate if using the LexEVS terminology server is a viable implementation method.

Cohort Profile: Generation Scotland: Scottish Family Health Study (GS:SFHS). The study, its participants and their potential for genetic research on health and illness.

GS:SFHS is a family-based genetic epidemiology study with DNA and socio-demographic and clinical data from about 24 000 volunteers across Scotland aged 18-98 years, from February 2006 to March 2011. Biological samples and anonymized data form a resource for research on the genetics of health, disease and quantitative traits of current and projected public health importance. Specific and important features of GS:SFHS include the family-based recruitment, with the intent of obtaining family groups; the breadth and depth of phenotype information, including detailed data on cognitive function, personality traits and mental health; consent and mechanisms for linkage of all data to comprehensive routine health-care records; and 'broad' consent from participants to use their data and samples for a wide range of medical research, including commercial research, and for re-contact for the potential collection of other data or samples, or for participation in related studies and the design and review of the protocol in parallel with in-depth sociological research on (potential) participants and users of the research outcomes.

Developing a survey instrument to assess the readiness of primary care data, genetic and disease registries to conduct linked research: TRANSFoRm International Research Readiness (TIRRE) survey instrument.

Background: Clinical data are collected for routine care in family practice; there are also a growing number of genetic and cancer registry data repositories. The Translational Research and Patient Safety in Europe (TRANSFoRm) project seeks to facilitate research using linked data from more than one source. We performed a requirements analysis which identified a wide range of data and business process requirements that need to be met before linking primary care and either genetic or disease registry data.

Sero-prevalence and incidence of A/H1N1 2009 influenza infection in Scotland in winter 2009-2010.

Background: Sero-prevalence is a valuable indicator of prevalence and incidence of A/H1N1 2009 infection. However, raw sero-prevalence data must be corrected for background levels of cross-reactivity (i.e.

Assuring the confidentiality of shared electronic health records.

Sharing data between multiple institutions offers better regulation and public protection

Data integration in eHealth: a domain/disease specific roadmap.

The paper documents a series of data integration workshops held in 2006 at the UK National e-Science Centre, summarizing a range of the problem/solution scenarios in multi-site and multi-scale data integration with six HealthGrid projects using schizophrenia as a domain-specific test case. It outlines emerging strategies, recommendations and objectives for collaboration on shared ontology-building and harmonization of data for multi-site trials in this domain.

Generation Scotland: the Scottish Family Health Study; a new resource for researching genes and heritability.

Background: Generation Scotland: the Scottish Family Health Study aims to identify genetic variants accounting for variation in levels of quantitative traits underlying the major common complex diseases (such as cardiovascular disease, cognitive decline, mental illness) in Scotland.

Methods/design: Generation Scotland will recruit a family-based cohort of up to 50,000 individuals (comprising siblings and parent-offspring groups) across Scotland. It will be a six-year programme, beginning in Glasgow and Tayside in the first two years (Phase 1) before extending to other parts of Scotland in the remaining four years (Phase 2).