Validation of diagnosis of acute myocardial infarction and stroke in electronic medical records: a primary care cross-sectional study in Madrid, Spain (the e-MADVEVA Study).

OBJECTIVES: To validate the diagnoses of acute myocardial infarction (AMI) and stroke recorded in electronic medical records (EMR) and to estimate the population prevalence of both diseases in people aged ≥18 years. DESIGN: Cross-sectional validation study. SETTING: 45 primary care centres. PARTICIPANTS: Simple random sampling of diagnoses of AMI and stroke (International Classification of Primary Care-2 codes K75 and K90, respectively) registered by 55 physicians and random age-matched and sex-matched sampling of the records that included in primary care EMRs in Madrid (Spain). PRIMARY AND SECONDARY OUTCOME MEASURES: Sensitivity, specificity, positive and negative predictive values and overall agreement were calculated using the kappa statistic. Applied gold standards were ECGs, brain imaging studies, hospital discharge reports, cardiology reports and neurology reports. In the case of AMI, the ESC/ACCF/AHA/WHF Expert Consensus Document was also used. Secondary outcomes were the estimated prevalence of both diseases considering the sensitivity and specificity obtained (true prevalence). RESULTS: The sensitivity of a diagnosis of AMI was 98.11% (95% CI, 96.29 to 99.03), and the specificity was 97.42% (95% CI, 95.44 to 98.55). The sensitivity of a diagnosis of stroke was 97.56% (95% CI, 95.56 to 98.68), and the specificity was 94.51% (95% CI, 91.96 to 96.28). No differences in the results were found after stratification by age and sex (both diseases). The prevalence of AMI and stroke was 1.38% and 1.27%, respectively. CONCLUSION: The validation results show that diagnoses of AMI and stroke in primary care EMRs constitute a helpful tool in epidemiological studies. The prevalence of AMI and stroke was lower than 2% in the population aged over 18 years.

Effect of depression on mortality and cardiovascular morbidity in type 2 diabetes mellitus after 3 years follow up. The DIADEMA study protocol.

BACKGROUND: Type 2 diabetes mellitus and depression are highly prevalent diseases that are associated with an increased risk of cardiovascular disease and mortality. There is evidence about a bidirectional association between depressive symptoms and type 2 diabetes mellitus. However, prognostic implications of the joint effects of these two diseases on cardiovascular morbidity and mortality are not well-known. METHOD/DESIGN: A three-year, observational, prospective, cohort study, carried out in Primary Health Care Centres in Madrid (Spain). The project aims to analyze the effect of depression on cardiovascular events, all-cause and cardiovascular mortality in patients with type 2 diabetes mellitus, and to estimate a clinical predictive model of depression in these patients.The number of patients required is 3255, all them with type 2 diabetes mellitus, older than 18 years, who regularly visit their Primary Health Care Centres and agree to participate. They are chosen by simple random sampling from the list of patients with type 2 diabetes mellitus of each general practitioner.The main outcome measures are all-cause and cardiovascular mortality and cardiovascular morbidity; and exposure variable is the major depressive disorder.There will be a comparison between depressed and not depressed patients in all-cause mortality, cardiovascular mortality, coronary artery disease and stroke using the Chi-squared test. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors that might alter the effect recorded will be taken into account in this analysis. To assess the effect of depression on the mortality, a survival analysis will be used comparing the two groups using the log-rank test. The control of potential confounding variables will be performed by the construction of a Cox regression model. DISCUSSION: Our study's main contribution is to evaluate the increase in the risk of cardiovascular morbidity and mortality, in depressed Spanish adults with type 2 diabetes mellitus attended in Primary Health Care Setting. It would also be useful to identify subgroups of patients for which the interventions could be more beneficial.

Validation of diabetes mellitus and hypertension diagnosis in computerized medical records in primary health care.

BACKGROUND: Computerized Clinical Records, which are incorporated in primary health care practice, have great potential for research. In order to use this information, data quality and reliability must be assessed to prevent compromising the validity of the results.The aim of this study is to validate the diagnosis of hypertension and diabetes mellitus in the computerized clinical records of primary health care, taking the diagnosis criteria established in the most prominently used clinical guidelines as the gold standard against which what measure the sensitivity, specificity, and determine the predictive values.The gold standard for diabetes mellitus was the diagnostic criteria established in 2003 American Diabetes Association Consensus Statement for diabetic subjects. The gold standard for hypertension was the diagnostic criteria established in the Joint National Committee published in 2003. METHODS: A cross-sectional multicentre validation study of diabetes mellitus and hypertension diagnoses in computerized clinical records of primary health care was carried out. Diagnostic criteria from the most prominently clinical practice guidelines were considered for standard reference.Sensitivity, specificity, positive and negative predictive values, and global agreement (with kappa index), were calculated. Results were shown overall and stratified by sex and age groups. RESULTS: The agreement for diabetes mellitus with the reference standard as determined by the guideline was almost perfect (κ=0.990), with a sensitivity of 99.53%, a specificity of 99.49%, a positive predictive value of 91.23% and a negative predictive value of 99.98%.Hypertension diagnosis showed substantial agreement with the reference standard as determined by the guideline (κ=0.778), the sensitivity was 85.22%, the specificity 96.95%, the positive predictive value 85.24%, and the negative predictive value was 96.95%. Sensitivity results were worse in patients who also had diabetes and in those aged 70 years or over. CONCLUSIONS: Our results substantiate the validity of using diagnoses of diabetes and hypertension found within the computerized clinical records for epidemiologic studies.