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Johnson M.,Cegedim Strategic Data Medical Research Ltd | Anderson P.,University of Swansea | Lockhart I.,Pfizer
BMC Family Practice | Year: 2014

Background: Guidance in England and Wales recommends that nicotine replacement therapies (NRTs), varenicline or bupropion should be offered for smoking cessation support. Research on general practitioner (GP) NRT prescribing patterns for smoking cessation is lacking in the published literature. Methods. UK primary care electronic health records were retrospectively analysed to identify the most common GP initiated NRT prescribing patterns, characterise people who receive NRT and determine whether NRTs given in a first quit attempt are different from subsequent attempts. Results: The study population comprised 38,954 individuals in UK primary care data with a first ever NRT patch smoking cessation attempt for the period January 2008-December 2011. The majority (64.3%) received NRT patch monotherapy at first smoking cessation attempt, and the most common NRT was 21 mg/24 hours patch monotherapy (15.2%). Of the 35.7% first smoking cessation attempts which were NRT combination therapy, the most common combination was patch + inhalator (56.2%). The proportion of people who started a smoking cessation attempt with combination therapy increased from 25.7% in 2008 to 44.8% in 2011. The majority of the population had one recorded smoking cessation attempt but a significant minority (20.2% N = 7,868) started a second smoking cessation attempt. Second and third attempts, while predominantly patch monotherapy, also demonstrated an increasing use of NRT combinations over the study period (2ndepisode: 20.6%-38.2%; 3 rdepisode: 20.0%-36.8%). However, a minority received only non-patch NRT during second and third NRT episodes. Taking into account the 39,068 people prescribed NRT patch during the study period with a history of NRT at baseline (excluded from the analysis), the total proportion of people prescribed NRT patch between 2008-2011 who had more than one NRT episode was 48.4% (46,936/96,986) and of 128,115 NRT users, only 14.7% (N = 18,838) were prescribed bupropion or varenicline prior to NRT use. Conclusions: The study findings represent new data describing GP NRT prescription patterns in the UK. Given the predominance of NRT patch monotherapy observed, health policy makers and service commissioners should ensure that GPs provide equality of access to all recommended smoking cessation pharmacotherapies. © 2014 Johnson et al.; licensee BioMed Central Ltd.

Blak B.T.,Cegedim Strategic Data Medical Research Ltd. | Smith H.T.,Lilly UK | Hards M.,Cegedim Strategic Data Medical Research Ltd. | Curtis B.H.,Lilly United States | Ivanyi T.,Lilly Hungary
Diabetic Medicine | Year: 2012

Aims To describe patients with Type 2 diabetes mellitus treated with basal insulin, with or without oral antidiabetics in UK primary care, and evaluate insulin treatment patterns and factors explaining changes in therapy. Methods Retrospective analysis of patients with Type 2 diabetes within The Health Improvement Network UK primary care database. Patients receiving basal insulin between January and June 2006 were followed until July 2009. Results Analysis included 3185 patients, mean age 65.6years [standard deviation (SD) 12.4], 50.9% men, median diabetes duration 9.6years, median basal insulin use 1.3years, 86.5% had received oral antidiabetics in the previous 12months. Mean follow-up was 2.9years (SD 1.0), 59.8% patients maintained basal insulin throughout follow-up with a mean HbA1C of 69mmol/mol (SD 19; 8.4%, SD 1.7) at baseline and 65mmol/mol (SD 17; 8.1%, SD 1.6) during follow-up. During follow-up, 6.9% of patients discontinued, 19.3% intensified with and 14.1% switched to prandial or premixed insulin. Patients who intensified (prandial) had a mean HbA1c of 77mmol/mol (SD 18; 9.2%, SD 1.6) before change and a mean HbA1c of 71mmol/mol (SD 21; 8.6%, SD 2.0) at the end of the study. Those switching to premixed insulin had a mean HbA1c of 80mmol/mol (SD 18; 9.5%, SD 1.7) before change and a mean HbA1c of 69mmol/mol (SD 17; 8.5%, SD 1.5) at the end of the study. Increasing HbA1c and longer diabetes duration explained intensification and switch. Conclusions The majority of patients had HbA1c above the 53mmol/mol (<7%) target at baseline and post-intensification/switch. The HbA1c levels were reduced by intensification/switch suggesting that insulin changes did have some impact. Most patients did not change insulin treatment despite having higher than recommended HbA1c levels. Reasons for not changing treatment in face of unsatisfactory clinical outcomes are unclear. Further research is warranted to explore barriers towards therapy change. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.4.2-2 | Award Amount: 4.07M | Year: 2011

Background: The efficacy of long-acting -agonists (LABAs) in asthma has been demonstrated but their safety remains an issue, particularly in children. Co-therapy with inhaled corticosteroids (ICs) is recommended in persistent asthma. However, drug-use studies suggest frequently inadequate IC adherence, possibly explaining the occurrence of exacerbations. There is a need for detailed analyses of patterns of use of LABAs and ICs to describe asthma outcomes related to LABAs in monotherapy and at different levels of concomitant ICs, to explore the role of adherence in LABA safety, and to identify populations possibly at risk of adverse LABA-related asthma outcomes. Methods: Summarise available evidence on the risks of LABAs in asthma; develop questionnaires and instruments for the study; identify, in the UK and France, paediatric (6-15) and adult (16-40) patients with persistent asthma treated by LABAs; and link distinct datasets for this group using past and ongoing prescriptions provided by GPs and identified from electronic health records, dispensed therapy identified from claims data, information collected from prescribers, and details on exposures and outcomes collected by computer-assisted telephone interviews with patients over a prospective 24-month period. Analyze the linked datasets to characterise individual asthma care in detail and with high validity, describe patterns of use of LABAs and ICs, and relate these patterns to asthma outcomes. Disseminate results to the scientific community, patients associations, physicians associations, and regulators. Deliverables: Ranking of observed patterns of LABA and IC use according to risk of adverse outcomes due to LABAs. Identification from prescriber and patient data of predictors of patterns of use which put patients at risk. Results for regulators to use regarding recommendations to prescribers and patients on the use of LABAs. Assessment of the potential impact of these recommendations on public health.

PubMed | University of Aarhus, IT Arsenal, Regional Agency for Healthcare Services of Tuscany, Janssen Research & Development and 9 more.
Type: Journal Article | Journal: PloS one | Year: 2016

Due to the heterogeneity of existing European sources of observational healthcare data, data source-tailored choices are needed to execute multi-data source, multi-national epidemiological studies. This makes transparent documentation paramount. In this proof-of-concept study, a novel standard data derivation procedure was tested in a set of heterogeneous data sources. Identification of subjects with type 2 diabetes (T2DM) was the test case. We included three primary care data sources (PCDs), three record linkage of administrative and/or registry data sources (RLDs), one hospital and one biobank. Overall, data from 12 million subjects from six European countries were extracted. Based on a shared event definition, sixteeen standard algorithms (components) useful to identify T2DM cases were generated through a top-down/bottom-up iterative approach. Each component was based on one single data domain among diagnoses, drugs, diagnostic test utilization and laboratory results. Diagnoses-based components were subclassified considering the healthcare setting (primary, secondary, inpatient care). The Unified Medical Language System was used for semantic harmonization within data domains. Individual components were extracted and proportion of population identified was compared across data sources. Drug-based components performed similarly in RLDs and PCDs, unlike diagnoses-based components. Using components as building blocks, logical combinations with AND, OR, AND NOT were tested and local experts recommended their preferred data source-tailored combination. The population identified per data sources by resulting algorithms varied from 3.5% to 15.7%, however, age-specific results were fairly comparable. The impact of individual components was assessed: diagnoses-based components identified the majority of cases in PCDs (93-100%), while drug-based components were the main contributors in RLDs (81-100%). The proposed data derivation procedure allowed the generation of data source-tailored case-finding algorithms in a standardized fashion, facilitated transparent documentation of the process and benchmarking of data sources, and provided bases for interpretation of possible inter-data source inconsistency of findings in future studies.

Kinra S.,London School of Hygiene and Tropical Medicine | Rameshwar Sarma K.V.,National Institute of Nutrition | Hards M.,Cegedim Strategic Data Medical Research Ltd | Smith G.D.,Translational Center | Ben-Shlomo Y.,University of Bristol
International Journal of Epidemiology | Year: 2011

Background: Relative leg length is frequently used as a biomarker of childhood nutrition in epidemiological studies, but evidence is lacking. We examined the association between supplemental nutrition in pregnancy and childhood and relative proportions of components of height in adolescence. Methods: In a community trial of nutritional supplementation, villages from adjacent administrative areas were selected to serve as intervention (n=15) and control (n=14) arms. In the intervention villages, balanced protein-calorie supplementation (2.51 MJ, 20 g protein) was offered daily to pregnant women and their offspring until the age of 6 years. Children born in the trial were re-examined 15 years later to assess components of height. Results: A total of 1165 adolescents (intervention: 654, 49% of trial participants; control: 511, 41% of trial participants) aged 13-18 years were examined. Supplemented children were 10mm taller [95% confidence interval (CI): 1.4 to 18.7 mm], but almost all of the increase was in trunk length (9 mm, 95% CI: 2.6 to 15.4 mm). The age- and gender-adjusted β-coefficients for the association of nutritional supplementation with relative trunk, leg and lower leg lengths (expressed as standard deviation scores) were 0.26 (95% CI: 0.11 to 0.42), 0.08 (95% CI: -0.03 to 0.19) and 0.03 (95% CI: -0.08 to 0.15) respectively, thereby unsupportive of cephalocaudal gradient in growth. Conclusions: In this nutritional supplementation trial in an undernourished population, we were unable to confirm relative leg length as a biomarker of childhood nutrition. Alternative explanations may underlie the reported associations between childhood conditions and relative leg length. Published by Oxford University Press on behalf of the International Epidemiological Association © The Author 2011; all rights reserved.

Hakimi Z.,Astellas Pharma Global Development | Johnson M.,Cegedim Strategic Data Medical Research Ltd | Nazir J.,Astellas Pharma Europe Ltd | Blak B.,Cegedim Strategic Data Medical Research Ltd | Odeyemi I.A.O.,Astellas Pharma Europe Ltd
Current Medical Research and Opinion | Year: 2015

Background: Real-world data on the pharmacological management of men who have lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) are limited.Objective: To characterize men with LUTS/BPH who had both storage and voiding symptoms and to evaluate treatment patterns in UK primary care.Design, setting and participants: This was an observational study of men aged ≥45 years with a diagnosis, symptoms or therapies indicative of LUTS/BPH with both storage and voiding components. These men were identified from the large Health Improvement Network (THIN) database between 1 January 2004 and 30 September 2011.Outcome measurements and statistical analysis: Drug prescriptions and switching/discontinuation patterns for α1-blockers and antimuscarinics.Results and limitations: We identified 8694 men with a median age of 66.0 (interquartile range [IQR], 59.0-74.0) years. Most (7850; 90.3%) received an α1-blocker, and 2167 (24.9%) received antimuscarinic therapy over a median of 2.1 years. The most commonly prescribed α1-blocker was tamsulosin (81.8%); most frequent antimuscarinics were tolterodine (41.0%), oxybutynin (37.2%) and solifenacin (35.7%). Concomitant prescription of α1-blocker and antimuscarinic therapy (within 30 days of each other) was received by 1160 men (14.8% of α1-blocker-treated men). Of α1-blocker recipients, 3024 (38.5%) discontinued during follow-up, while 1149 (53.0%) discontinued antimuscarinic therapy. Of 2167 men who received an antimuscarinic, 476 (22.0%) switched to another antimuscarinic. Of the three most commonly prescribed antimuscarinics, solifenacin had the lowest proportions of discontinuations (43.0%) and switches (15.3%), and the longest median duration of therapy (90 days, IQR 30-300). General practice consultations accounted for most resource use (5307.9 per 1000 patient-years).Conclusions: This study presents real-world management of men with LUTS/BPH who have both storage and voiding symptoms. The low proportion of men who received concomitant α1-blocker and antimuscarinic therapy suggests that some patients are sub-optimally treated in routine clinical practice. © 2015 Informa UK Ltd.

Hall G.C.,Grimsdyke House | Hill F.,Cegedim Strategic Data Medical Research Ltd
Pharmacoepidemiology and Drug Safety | Year: 2014

Background: The UK primary care databases are used in pharmacoepidemiology studies of vaccination type. We investigated vaccine recording and whether, and how, exposure to specific brands and batches can be identified. Methods: Details of influenza vaccinations given in the 2010-2011 or 2011-2012 seasons were identified from coded and text fields in The Health Information Network UK primary care database. The proportion of people over 64years of age vaccinated against influenza was compared with published regional rates. Searches for Fluvirin (Novartis Vaccines and Diagnostics GmbH, Marburg, Germany) batch numbers and name identified exposure to this specific vaccine. The recording of any brand name and batch number was described for a sample of 1000 vaccinations across 472 practices. Results: A total of 767904 influenza vaccinations were identified during the 2010-2011 season and 784518 in 2011-2012. Vaccination rates for people aged over 64years were 75.6%, 80.9%, 78.4% and 71.9% in England, Northern Ireland, Scotland and Wales, respectively (2011-2012 season), compared with published figures of 74.0%, 77.0%, 76.2% and 67.7%. Rates were slightly lower in 2010-2011 in both data sources. A Fluvirin brand was identified for 3.6% of all UK vaccinations but 26.2% of those in Scottish practices. Vaccination brand could be identified for 94.3% of the sample, 93.6% with a batch number. Batch number (98.5%) and brand name (50.3%) were most frequently recorded in an immunisation 'batch' text field. Conclusion: Patients exposed to an influenza vaccine in primary care can be identified from The Health Information Network. Identification of brand or batch number requires a text search. Regional variation in brand of vaccine should be considered when estimating sample size. © 2013 John Wiley & Sons, Ltd.

Zhou X.,Pfizer | Murugesan S.,Pfizer | Bhullar H.,Cegedim Strategic Data Medical Research Ltd | Liu Q.,Pfizer | And 5 more authors.
Drug Safety | Year: 2013

Background: There has been increased interest in using multiple observational databases to understand the safety profile of medical products during the postmarketing period. However, it is challenging to perform analyses across these heterogeneous data sources. The Observational Medical Outcome Partnership (OMOP) provides a Common Data Model (CDM) for organizing and standardizing databases. OMOP's work with the CDM has primarily focused on US databases. As a participant in the OMOP Extended Consortium, we implemented the OMOP CDM on the UK Electronic Healthcare Record database - The Health Improvement Network (THIN). Objective: The aim of the study was to evaluate the implementation of the THIN database in the OMOP CDM and explore its use for active drug safety surveillance. Methods: Following the OMOP CDM specification, the raw THIN database was mapped into a CDM THIN database. Ten Drugs of Interest (DOI) and nine Health Outcomes of Interest (HOI), defined and focused by the OMOP, were created using the CDM THIN database. Quantitative comparison of raw THIN to CDM THIN was performed by execution and analysis of OMOP standardized reports and additional analyses. The practical value of CDM THIN for drug safety and pharmacoepidemiological research was assessed by implementing three analysis methods: Proportional Reporting Ratio (PRR), Univariate Self-Case Control Series (USCCS) and High-Dimensional Propensity Score (HDPS). A published study using raw THIN data was selected to examine the external validity of CDM THIN. Results: Overall demographic characteristics were the same in both databases. Mapping medical and drug codes into the OMOP terminology dictionary was incomplete: 25 % medical codes and 55 % drug codes in raw THIN were not listed in the OMOP terminology dictionary, representing 6 % condition occurrence counts, 4 % procedure occurrence counts and 7 % drug exposure counts in raw THIN. Seven DOIs had <0.3 % and three DOIs had 1 % of unmapped drug exposure counts; each HOI had at least one definition with no or minimal (≤0.2 %) issues with unmapped condition occurrence counts, except for the upper gastrointestinal (UGI) ulcer hospitalization cohort. The application of PRR, USCCS and HDPS found, respectively, a sensitivity of 67, 78 and 50 %, and a specificity of 68, 59 and 76 %, suggesting that safety issues defined as known by the OMOP could be identified in CDM THIN, with imperfect performance. Similar PRR scores were produced using both CDM THIN and raw THIN, while the execution time was twice as fast on CDM THIN. There was close replication of demographic distribution, death rate and prescription pattern and trend in the published study population and the cohort of CDM THIN. Conclusions: This research demonstrated that information loss due to incomplete mapping of medical and drug codes as well as data structure in the current CDM THIN limits its use for all possible epidemiological evaluation studies. Current HOIs and DOIs predefined by the OMOP were constructed with minimal loss of information and can be used for active surveillance methodological research. The OMOP CDM THIN can be a valuable tool for multiple aspects of pharmacoepidemiological research when the unique features of UK Electronic Health Records are incorporated in the OMOP library. © 2012 Springer International Publishing Switzerland.

Blak B.T.,Cegedim Strategic Data Medical Research Ltd | Thompson M.,Cegedim Strategic Data Medical Research Ltd | Dattani H.,Cegedim Strategic Data Medical Research Ltd | Bourke A.,Cegedim Strategic Data Medical Research Ltd
Informatics in Primary Care | Year: 2011

Introduction The degree of generalisability of patient databases to the general population is important for interpreting database research. This report describes the representativeness of The Health Improvement Network (THIN), a UK primary care database, of the UK population. Methods Demographics, deprivation (Townsend), Quality and Outcomes Framework (QOF) condition prevalence and deaths from THIN were compared with national statistical and QOF 2006/ 2007 data. Results Demographics were similar although THIN contained fewer people aged under 25 years. Condition prevalence was comparable, e.g. 3.5% diabetes prevalence in THIN, 3.7% nationally. More THIN patients lived in the most affluent areas (23.5% in THIN, 20% nationally). Between 1990 and 2009, standardised mortality ratio ranged from 0.81 (95% CI: 0.39-1.49; 1990) to 0.93 (95% CI: 0.48-1.64; 1995). Adjusting for demographics/ deprivation, the 2006 THIN death rate was 9.08/ 1000 population close to the national death rate of 9.4/1000 population. Conclusion THIN is generalisable to the UK for demographics, major condition prevalence and death rates adjusted for demographics and deprivation. © 2011 PHCSG, British Computer Society.

Blak B.T.,Cegedim Strategic Data Medical Research Ltd. | Smith H.T.,Lilly UK | Hards M.,Cegedim Strategic Data Medical Research Ltd. | Maguire A.,United Biosource Corporation | Gimeno V.,Lundbeck
Diabetic Medicine | Year: 2012

Diabet. Med. 29, e191-e198 (2012) Aims This study characterized UK primary care patients with Type 2 diabetes who initiated insulin treatment, and described the initial insulin regimens used, overall metabolic changes and health-care resource usage. Methods A retrospective cohort study was performed using quality-checked patient data from The Health Improvement Network database. Eligible patients who initiated insulin for the first time between 2004 and 2006 were grouped into four cohorts according to the type of insulin regimen initiated. Data on patient characteristics, metabolic and clinical outcomes and health-care resource use were collected at baseline and during 6months of follow-up. Results In total, 4045 eligible adults [2269 male, 1776 female; mean age 62.6±13.3years; mean baseline HbA 1c 82±22mmol/mol (9.6%±2.0%)] initiated insulin. Approximately half (52.4%) initiated insulin as basal insulin only, 41.6% as premixed only, 4.0% as basal-bolus and 2.1% as prandial insulin only. Among patients with ≥180days follow-up (n=3815), the initial insulin regimen was not changed during follow-up in 75.1% of patients, while 13.7% discontinued, 7.0% switched and 4.7% intensified insulin therapy. The mean change in HbA 1c was -14mmol/mol (-1.3%, n=2881), with 17.3% of patients achieving an HbA 1c of <53mmol/mol (7%, n=3024). The mean weight change was +0.9kg (n=2345). Conclusions Basal and premixed insulin were the most common types of insulin initiated and in most patients no changes were made to the initial regimen over 6months. However, few patients achieved glycemic control targets. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

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