Real world data in primary care: validation of diagnosis of atrial fibrillation in primary care electronic medical records and estimated prevalence among consulting patients

Primary care electronic medical records contain clinical-administrative information on a high percentage of the population. Before this information can be used for epidemiological purposes, its quality must be verified. This study aims to validate diagnoses of atrial fibrillation (AF) recorded in primary care electronic medical records and to estimate the prevalence of AF in the population attending primary care consultations. Methods: We performed a cross-sectional validation study of all diagnoses of AF recorded in primary care electronic medical records in Madrid (Spain). We also performed simple random sampling of diagnoses of AF (ICPC-2 code K78) registered by 55 physicians and random age- and sex-matched sampling of the records that included a diagnosis of AF. Electrocardiograms, echocardiograms, and hospital discharge or cardiology clinic reports were matched. Sensitivity, specificity, positive and negative predictive values (PPV and NPV), and overall agreement were calculated using the kappa statistic (κ). The prevalence of AF in the community of Madrid was estimated considering the sensitivity and specificity obtained in the validation. All calculations were performed overall and by sex and age groups. Results: The degree of agreement was very high (κ = 0.952), with a sensitivity of 97.84%, specificity of 97.39%, PPV of 97.37%, and NPV of 97.85%. The prevalence of AF in the population aged over 18 years was 2.41% (95%CI 2.39–2.42% [2.25% in women and 2.58% in men]). This increased progressively with age, reaching 16.95% in those over 80 years of age (15.5% in women and 19.44% in men). Conclusions: The validation results obtained enable diagnosis of AF recorded in primary care to be used as a tool for epidemiological studies. A high prevalence of AF was found, especially in older patientsThis study forms part of research funded by the FIS (Fondo de Investigaciones Sanitarias—Health Research Fund, Instituto de Salud Carlos III) grants no. PI13/00632, and co-funded by the European Union through the Fondo Europeo de Desarrollo Regional (FEDER, “A way of shaping Europe”. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript

Self-Reported Health Status in Primary Health Care: The Influence of Immigration and Other Associated Factors

OBJECTIVE: The aims of this study are to compare self-reported health status between Spanish-born and Latin American-born Spanish residents, adjusted by length of residence in the host country; and additionally, to analyse sociodemographic and psychosocial variables associated with a better health status. DESIGN: This is a cross-sectional population based study of Latin American-born (n = 691) and Spanish-born (n = 903) in 15 urban primary health care centres in Madrid (Spain), carried out between 2007 and 2009. The participants provided information, through an interview, about self-reported health status, socioeconomic characteristics, psychosocial factors and migration conditions. Descriptive and multiple logistic regression analyses were conducted. RESULTS: The Spanish-born participants reported a better health status than the Latin America-born participants (79.8% versus 69.3%, p<0.001). Different patterns of self-reported health status were observed depending on the length of residence in the host country. The proportion of immigrants with a better health status is greater in those who have been in Spain for less than five years compared to those who have stayed longer. Better health status is significantly associated with being men, under 34 years old, being Spanish-born, having a monthly incomes of over 1000 euros, and having considerable social support and low stress. CONCLUSIONS: Better self-reported health status is associated with being Spanish-born, men, under 34 years old, having an uppermiddle-socioeconomic status, adequate social support, and low stress. Additionally, length of residence in the host country is seen as a related factor in the self-reported health status of immigrants

Effectiveness of PRECEDE model for health education on changes and level of control of HbA1c, blood pressure, lipids, and body mass index in patients with type 2 diabetes mellitus

<p>Abstract</p> <p>Background</p> <p>Individual health education is considered to be essential in the overall care of patients with type 2 diabetes (DM2), although there is some uncertainty regarding its metabolic control benefits. There have been very few randomized studies on the effects of individual education on normal care in DM2 patients with a control group, and none of these have assessed the long-term results. Therefore, this study aims to use this design to assess the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational Diagnosis, and Evaluation) education model in the metabolic control and the reduction of cardiovascular risk factors, in patients with type 2 diabetes.</p> <p>Methods</p> <p>An open community effectiveness study was carried out in 8 urban community health centers in the North-East Madrid Urban Area (Spain). Six hundred patients with DM2 were randomized in two groups: PRECEDE or conventional model for health promotion education. The main outcome measures were glycated hemoglobin A1c, body mass index (BMI), blood pressure, lipids and control criteria during the 2-year follow-up period.</p> <p>Results</p> <p>Glycated hemoglobin A1c and systolic blood pressure (SBP) levels decreased significantly in the PRECEDE group (multivariate analysis of covariance, with baseline glycated hemoglobin A1c, SBP, and variables showing statistically significant differences between groups at baseline visits). The decrease levels in diastolic blood pressure (DBP), triglycerides and LDL cholesterol were nonsignificant. PRECEDE increased compliance in all control criteria, except for LDL cholesterol. BMI did not change during the study in either of the two models analyzed.</p> <p>Conclusions</p> <p>PRECEDE health education model is a useful method in the overall treatment in patients with type 2 diabetes, which contributes to decrease glycated hemoglobin A1c and SBP levels and increase the compliance in all the control criteria, except for LDL cholesterol.</p> <p>Trial registration number</p> <p>ClinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT01316367">NCT01316367</a></p

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>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.</p> <p>Results</p> <p>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%.</p> <p>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.</p> <p>Conclusions</p> <p>Our results substantiate the validity of using diagnoses of diabetes and hypertension found within the computerized clinical records for epidemiologic studies.</p

Effectiveness of a strategy that uses educational games to implement clinical practice guidelines among Spanish residents of family and community medicine (e-EDUCAGUIA project):A clinical trial by clusters

This study was funded by the Fondo de Investigaciones Sanitarias FIS Grant Number PI11/0477 ISCIII.-REDISSEC Proyecto RD12/0001/0012 AND FEDER Funding.Background: Clinical practice guidelines (CPGs) have been developed with the aim of helping health professionals, patients, and caregivers make decisions about their health care, using the best available evidence. In many cases, incorporation of these recommendations into clinical practice also implies a need for changes in routine clinical practice. Using educational games as a strategy for implementing recommendations among health professionals has been demonstrated to be effective in some studies; however, evidence is still scarce. The primary objective of this study is to assess the effectiveness of a teaching strategy for the implementation of CPGs using educational games (e-learning EDUCAGUIA) to improve knowledge and skills related to clinical decision-making by residents in family medicine. The primary objective will be evaluated at 1 and 6months after the intervention. The secondary objectives are to identify barriers and facilitators for the use of guidelines by residents of family medicine and to describe the educational strategies used by Spanish teaching units of family and community medicine to encourage implementation of CPGs. Methods/design: We propose a multicenter clinical trial with randomized allocation by clusters of family and community medicine teaching units in Spain. The sample size will be 394 residents (197 in each group), with the teaching units as the randomization unit and the residents comprising the analysis unit. For the intervention, both groups will receive an initial 1-h session on clinical practice guideline use and the usual dissemination strategy by e-mail. The intervention group (e-learning EDUCAGUIA) strategy will consist of educational games with hypothetical clinical scenarios in a virtual environment. The primary outcome will be the score obtained by the residents on evaluation questionnaires for each clinical practice guideline. Other included variables will be the sociodemographic and training variables of the residents and the teaching unit characteristics. The statistical analysis will consist of a descriptive analysis of variables and a baseline comparison of both groups. For the primary outcome analysis, an average score comparison of hypothetical scenario questionnaires between the EDUCAGUIA intervention group and the control group will be performed at 1 and 6months post-intervention, using 95% confidence intervals. A linear multilevel regression will be used to adjust the model. Discussion: The identification of effective teaching strategies will facilitate the incorporation of available knowledge into clinical practice that could eventually improve patient outcomes. The inclusion of information technologies as teaching tools permits greater learning autonomy and allows deeper instructor participation in the monitoring and supervision of residents. The long-term impact of this strategy is unknown; however, because it is aimed at professionals undergoing training and it addresses prevalent health problems, a small effect can be of great relevance. Trial registration: ClinicalTrials.gov: NCT02210442.Publisher PDFPeer reviewe

Five-year incidence of chronic kidney disease (stage 3-5) and associated risk factors in a Spanish cohort: the MADIABETES Study.

OBJECTIVE:To evaluate the incidence rate of Chronic Kidney Disease (CKD) stage 3-5 (persistent decreased kidney function under 60 mL/min per 1.73 m2) among patients with type 2 diabetes over five years, to identify the risk factors associated with CKD, and develop a risk table to predict five-year CKD stage 3-5 risk stratification for clinical use. DESIGN:The MADIABETES Study is a prospective cohort study of 3,443 outpatients with type 2 diabetes mellitus, sampled from 56 primary health care centers (131 general practitioners) in Madrid (Spain). RESULTS:The cumulative incidence of CKD stage 3-5 at five-years was 10.23% (95% CI = 9.12-11.44) and the incidence density was 2.07 (95% CI = 1.83-2.33) cases per 1,000 patient-months or 2.48 (95% CI = 2.19-2.79) cases per 100 patient-years. The highest hazard ratio (HR) for developing CKD stage 3-5 was albuminuria ≥ 300 mg/g (HR = 4.57; 95% CI= 2.46-8.48). Furthermore, other variables with a high HR were age over 74 years (HR = 3.20; 95% CI = 2.13-4.81), a history of Hypertension (HR = 2.02; 95% CI = 1.42-2.89), Myocardial Infarction (HR= 1.72; 95% IC= 1.25-2.37), Dyslipidemia (HR = 1.68; 95% CI 1.30-2.17), duration of diabetes mellitus ≥ 10 years (HR = 1.46; 95% CI = 1.14-1.88) and Systolic Blood Pressure >149 mmHg (HR = 1.52; 95% CI = 1.02-2.24). CONCLUSIONS:After a five-year follow-up, the cumulative incidence of CKD is concordant with rates described in Spain and other countries. Albuminuria ≥ 300 mg/g and age over 74 years were the risk factors more strongly associated with developing CKD (Stage 3-5). Blood Pressure, lipid and albuminuria control could reduce CKD incidence of CKD in patients with T2DM

Associated Risk Factors for Incident CKD (Stage 3–5) (n = 268) after five-year follow-up of 2,620 patients (Multivariable Cox Regression).

<p>aHR: Adjusted Hazard Ratio; CI: Confidence Interval; CKD: Chronic Kidney Disease; SBP: Systolic Blood Pressure.</p><p>Associated Risk Factors for Incident CKD (Stage 3–5) (n = 268) after five-year follow-up of 2,620 patients (Multivariable Cox Regression).</p

Comparison of characteristics according to the presence of CKD (Stage 3–5).

<p>¹. Stage 3–5 of K/DOQI</p><p>². Albumin excretion rate > 30 mg/g</p><p>SD: Standard Deviation; IQR: Interquartile range; BMI: Body mass index; SBP: Systolic Blood Pressure; DBP: Dyastolic Blood Pressure; FPG: Fasting plasma glucose; HbA1c: Glycated haemoglobin; LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol.</p><p>* Pearson’s chi-square method was applied for categorical variables, and Student’s t-test for continuous variables. Mann-Whitney U-test was applied to compare medians of duration of DM2.</p><p>Comparison of characteristics according to the presence of CKD (Stage 3–5).</p

Flow diagram of participants.

<p>Flow diagram of participants.</p

Glycemic variability and all-cause mortality in a large prospective southern European cohort of patients with differences in glycemic status

Background Few studies have analyzed the relationship between glucose variability (GV) and adverse health outcomes in patients with differences in glycemic status. The present study tests the hypothesis that GV predicts all-cause mortality regardless of glycemic status after simple adjustment (age and sex) and full adjustment (age, sex, cardiovascular disease, hypertension, use of aspirin, statins, GLP-1 receptor agonists, SGLT-2 inhibitors and DPP-4 inhibitors, baseline FPG and average HbA1c). Methods Prospective cohort study with 795 normoglycemic patients, 233 patients with prediabetes, and 4,102 patients with type 2 diabetes. GV was measured using the coefficient of variation of fasting plasma glucose (CV-FPG) over 12 years of follow-up. The outcome measure was all-cause mortality. Results A total of 1,223 patients (657 men, 566 women) died after a median of 9.8 years of follow-up, with an all-cause mortality rate of 23.35/1,000 person-years. In prediabetes or T2DM patients, the fourth quartile of CV-FPG exerted a significant effect on all-cause mortality after simple and full adjustment. A sensitivity analysis excluding participants who died during the first year of follow-up revealed the following results for the highest quartile in the fully adjusted model: overall, HR (95%CI) = 1.54 (1.26–1.89); dysglycemia (prediabetes and T2DM), HR = 1.41 (1.15–1.73); T2DM, HR = 1.36 (1.10–1.67). Conclusion We found CV-FPG to be useful for measurement of GV. It could also be used for the prognostic stratification of patients with dysglycemia