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      Cohort study investigating the relationship between cholesterol, cardiovascular risk score and the prescribing of statins in UK primary care: study protocol

      protocol
      , ,
      BMJ Open
      BMJ Publishing Group
      PREVENTIVE MEDICINE, PRIMARY CARE, THERAPEUTICS

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          Abstract

          Introduction

          Risk scoring is an integral part of the prevention of cardiovascular disease (CVD) and should form the basis for the decision to offer medication to reduce cholesterol (statins). However, there is a suggestion in the literature that many patients are still initiated on statins based on raised cholesterol rather than a raised CVD risk. It is important, therefore, to investigate the role that lipid levels and CVD risks have in the decision to prescribe. This research will establish how cholesterol levels and CVD risk independently influence the prescribing of statins for the primary prevention of CVD in primary care.

          Methods and analysis

          The Health Improvement Network (THIN) is a database of coded primary care electronic patient records from over 500 UK general practices. From this resource, a historical cohort will be created of patients without a diagnosis of CVD, not currently receiving a prescription for statins and who had a lipid profile measured. A post hoc QRISK2 score will be calculated for these patients and they will be followed up for 60 days to establish whether they were subsequently prescribed a statin. Primary analysis will consist of predictive modelling using multivariate logistic regression with potential predictors including cholesterol level, calculated QRISK2 score, sociodemographic characteristic and comorbidities. Descriptive statistics will be used to identify trends in prescribing and further secondary analysis will explore what other factors may have influenced the prescribing of statins and the degree of interprescriber variability.

          Ethics and dissemination

          The THIN Data Collection Scheme was approved by the South-East Multicentre Research Ethics Committee in 2003. Individual studies using THIN require Scientific Review Committee approval. The original protocol for this study and a subsequent amendment have been approved (16THIN009A1). The results will be published in a peer review journal and presented at national and international conferences.

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          Most cited references18

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          Simple scoring scheme for calculating the risk of acute coronary events based on the 10-year follow-up of the prospective cardiovascular Münster (PROCAM) study.

          The absolute risk of an acute coronary event depends on the totality of risk factors exhibited by an individual, the so-called global risk profile. Although several scoring schemes have been suggested to calculate this profile, many omit information on important variables such as family history of coronary heart disease or LDL cholesterol. Based on 325 acute coronary events occurring within 10 years of follow-up among 5389 men 35 to 65 years of age at recruitment into the Prospective Cardiovascular Münster (PROCAM) study, we developed a Cox proportional hazards model using the following 8 independent risk variables, ranked in order of importance: age, LDL cholesterol, smoking, HDL cholesterol, systolic blood pressure, family history of premature myocardial infarction, diabetes mellitus, and triglycerides. We then derived a simple point scoring system based on the beta-coefficients of this model. The accuracy of this point scoring scheme was comparable to coronary event prediction when the continuous variables themselves were used. The scoring system accurately predicted observed coronary events with an area under the receiver-operating characteristics curve of 82.4% compared with 82.9% for the Cox model with continuous variables. Our scoring system is a simple and accurate way of predicting global risk of myocardial infarction in clinical practice and will therefore allow more accurate targeting of preventive therapy.
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            Generalisability of The Health Improvement Network (THIN) database: demographics, chronic disease prevalence and mortality rates.

            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. Demographics, deprivation (Townsend), Quality and Outcomes Framework (QOF) condition prevalence and deaths from THIN were compared with national statistical and QOF 2006/2007 data. 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. THIN is generalisable to the UK for demographics, major condition prevalence and death rates adjusted for demographics and deprivation.
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              The effect of giving global coronary risk information to adults: a systematic review.

              Global coronary heart disease (CHD) risk estimation (ie, a quantitative estimate of a patient's chances of CHD calculated by combining risk factors in an empirical equation) is recommended as a starting point for primary prevention efforts in all US adults. Whether it improves outcomes is currently unknown. To assess the effect of providing global CHD risk information to adults, we performed a systematic evidence review. We searched MEDLINE for the years 1980 to 2008, Psych Info, CINAHL, and the Cochrane Database and included English-language articles that met prespecified inclusion criteria. Two reviewers independently reviewed titles, abstracts, and articles for inclusion and assessed study quality. We identified 20 articles, reporting on 18 unique fair or good quality studies (including 14 randomized controlled studies). These showed that global CHD risk information alone or with accompanying education increased the accuracy of perceived risk and probably increased intent to start therapy. Studies with repeated risk information or risk information and repeated doses of counseling showed small significant reductions in predicted CHD risk (absolute differences, -0.2% to -2% over 10 years in studies using risk estimates derived from Framingham equations). Studies providing global risk information at only 1 point in time seemed ineffective. Global CHD risk information seems to improve the accuracy of risk perception and may increase intent to initiate CHD prevention among individuals at moderate to high risk. The effect of global risk presentation on more distal outcomes is less clear and seems to be related to the intensity of accompanying interventions.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2016
                17 November 2016
                : 6
                : 11
                : e013120
                Affiliations
                Institute of Applied Health Research, University of Birmingham , Birmingham, UK
                Author notes
                [Correspondence to ] Dr Samuel Finnikin; finniksj@ 123456bham.ac.uk
                Article
                bmjopen-2016-013120
                10.1136/bmjopen-2016-013120
                5128938
                27856481
                7eacfc17-e8b2-41d9-b4ca-4c45ebabddd0
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                History
                : 18 July 2016
                : 6 October 2016
                : 19 October 2016
                Funding
                Funded by: National Institute for Health Research, http://dx.doi.org/10.13039/501100000272;
                Award ID: NIHR-IPF-2015-09-04
                Categories
                General practice / Family practice
                Protocol
                1506
                1696
                1683
                1724

                Medicine
                preventive medicine,primary care,therapeutics
                Medicine
                preventive medicine, primary care, therapeutics

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