Long term extension of a randomised controlled trial of probiotics using electronic health records.

Most randomised controlled trials (RCTs) are relatively short term and, due to costs and available resources, have limited opportunity to be re-visited or extended. There is no guarantee that effects of treatments remain unchanged beyond the study. Here, we illustrate the feasibility, benefits and cost-effectiveness of enriching standard trial design with electronic follow up.

The use of secure anonymised data linkage to determine changes in healthcare utilisation following severe open tibial fractures.

Severe open fractures of the lower limbs are complex injuries requiring expert multidisciplinary management in appropriate orthoplastic centres. This study aimed to assess the impact of open fractures on healthcare utilisation and test the null hypotheses that there is no difference in healthcare utilisation between the year before and year after injury, and that there is no difference in healthcare utilisation in the year post-injury between patients admitted directly to an orthoplastic centre in keeping with the joint BOA/BAPRAS standards and those having initial surgery elsewhere. This retrospective cohort study utilising secure anonymised information linkage (SAIL), a novel databank of anonymised nationally pooled health records, recruited patients over 18 years of age sustaining severe open lower limb fractures managed primarily or secondarily at our centre and who had data available in the SAIL databank.

Healthcare databases in Europe for studying medicine use and safety during pregnancy.

Purpose: The aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy.

Methods: A sample of electronic healthcare databases that captured pregnancies and prescription data was selected on the basis of contacts within the EUROCAT network. For each participating database, a database inventory was completed.

A case study of the Secure Anonymous Information Linkage (SAIL) Gateway: a privacy-protecting remote access system for health-related research and evaluation.

With the current expansion of data linkage research, the challenge is to find the balance between preserving the privacy of person-level data whilst making these data accessible for use to their full potential. We describe a privacy-protecting safe haven and secure remote access system, referred to as the Secure Anonymised Information Linkage (SAIL) Gateway. The Gateway provides data users with a familiar Windows interface and their usual toolsets to access approved anonymously-linked datasets for research and evaluation.

Volunteer bias in recruitment, retention, and blood sample donation in a randomised controlled trial involving mothers and their children at six months and two years: a longitudinal analysis.

Background: The vulnerability of clinical trials to volunteer bias is under-reported. Volunteer bias is systematic error due to differences between those who choose to participate in studies and those who do not.

Methods And Results: This paper extends the applications of the concept of volunteer bias by using data from a trial of probiotic supplementation for childhood atopy in healthy dyads to explore 1) differences between a) trial participants and aggregated data from publicly available databases b) participants and non-participants as the trial progressed 2) impact on trial findings of weighting data according to deprivation (Townsend) fifths in the sample and target populations.

Toxic marine microalgae and shellfish poisoning in the British isles: history, review of epidemiology, and future implications.

The relationship between toxic marine microalgae species and climate change has become a high profile and well discussed topic in recent years, with research focusing on the possible future impacts of changing hydrological conditions on Harmful Algal Bloom (HAB) species around the world. However, there is very little literature concerning the epidemiology of these species on marine organisms and human health. Here, we examine the current state of toxic microalgae species around the UK, in two ways: first we describe the key toxic syndromes and gather together the disparate reported data on their epidemiology from UK records and monitoring procedures.

The prescribed duration algorithm: utilising 'free text' from multiple primary care electronic systems.

Purpose: To develop and test an algorithm that translates total dose and daily regimen, inputted as 'free text' on a prescription, into numerical values to calculate the prescribed treatment duration.

Method: The algorithm was developed using antibiotic prescriptions (n = 711,714) from multiple primary care computer systems. For validation, the prescribed treatment duration of an independent sample of antibiotic scripts was calculated in two ways: (a) computer algorithm, (b) manually reviewed by a researcher blinded to the results of (a).

Frequency and characteristics of disease flares in ankylosing spondylitis.

Objective: To examine the characteristics and frequency of disease flares in a cohort of people with AS.

Methods: A prospective data set from a randomized controlled trial (RCT) of a probiotic treatment/placebo was utilized to examine disease flares in 134 people with AS. Disease flares were defined as either minor/localized flares (pain/swelling localized to one area with fatigue and stiffness) or major/generalized flares (generalized pain, hot burning joints, muscle spasm, fever, sweating, extreme fatigue and stiffness).

The SAIL Databank: building a national architecture for e-health research and evaluation.

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.

Are blood pressure levels taken during a secondary care diabetic clinic likely to be higher than when measured in primary care?

Blood pressure management guidelines are widely available. Our aim was to examine differences in blood pressure on the same subjects in primary and secondary care. We identified 661 diabetic subjects with measurements with the aid of the SAIL databank.

Residential Anonymous Linking Fields (RALFs): a novel information infrastructure to study the interaction between the environment and individuals' health.

Background: The necessity of aggregating health data over areas can impede our understanding of health determinants.

Methods: We demonstrate the possibility of creating anonymous links between individual residences and the local environment using digital map data and a data linkage system.

Results: Digital map data were used successfully to anonymously link 1.

The SAIL databank: linking multiple health and social care datasets.

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.