Isabel del Cura-González

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

BackgroundComputerized 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.MethodsA 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.ResultsThe 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.ConclusionsOur results substantiate the validity of using diagnoses of diabetes and hypertension found within the computerized clinical records for epidemiologic studies.

Trends in Hypertension Prevalence, Awareness, Treatment and Control in an Adult Type 2 Diabetes Spanish Population between 2003 and 2009

In patients with type 2 diabetes, the prevalence of hypertension is higher than in non-diabetic subjects. Despite the high cardiovascular risk involving hypertension in these patients, its prevalence and control are not well known. The aims of this study were: to estimate the hypertension prevalence, awareness, treatment and control in Spanish adults with type 2 diabetes attended in Primary Care; and to analyse its time trend from 2003 to 2009. A serial cross-sectional study from 2003 to 2009 was performed in 21 Primary Care Centres in Madrid. The study population comprised all patients with diagnosed type 2 diabetes in their computerised medical history. Overall annual prevalence during the period 2003–2009 was calculated from and according to sex and age groups. Linear trend tests, regression lines and coefficients of determination were used. In 2003 89.78% (CI 87.92–91.64) of patients with type 2 diabetes suffered hypertension and 94.76% (CI: 92.85–96.67) in 2009. This percentage was greater for women and for patients over 65 years old. 30% of patients suffered previously undiagnosed hypertension in 2003 and 23.1% in 2009. 97% of diagnosed patients received pharmacological treatment and 28.79% reached the blood pressure objective in 2009. The average number of antihypertensive drugs taken was 2.72 in 2003 and 3.27 in 2009. Only 5.2% of patients with type 2 diabetes show blood pressure levels below 130/80 mmHg. Although significant improvements have been achieved in the diagnosis and control of hypertension in people with type 2 diabetes, these continue to remain far from optimum.

Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12).

BackgroundThe oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency.Methods/designThe proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited.Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3–8,and 1 mg/month in weeks 9–52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses.DiscussionThe results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment.Trial registrationThis trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

Delayed diagnosis of hypertension in diabetic patients monitored in primary care.

INTRODUCTION AND OBJECTIVES Delayed diagnosis of hypertension may result in inadequate blood pressure control and increased cardiovascular risk. The aim of this study was to estimate the delay in hypertension diagnosis in patients with type 2 diabetes and the likelihood of a diagnosis within a suitable period (first 6 months), and to analyze the patient and physician characteristics associated with delayed diagnosis. METHODS Retrospective dynamic cohort study, with a 7-year follow-up in primary care, of 8074 adult patients with diabetes who met the diagnostic criteria for hypertension. Two thresholds were considered: 140/90mmHg and 130/80mmHg. The time elapsed between meeting these criteria and recording the diagnosis was estimated; the time course of the likelihood of a missed diagnosis and the variables associated with correct diagnosis were assessed by Kaplan-Meier survival analysis and logistic regression analysis, respectively. RESULTS The mean diagnostic delay was 8.9 (15.4) months in patients with blood pressure≥140/90mmHg compared to 15.2 (19.6) months for those with <140/90mmHg (P<.001). The main variables associated with correct diagnosis were baseline blood pressure≥140/90mmHg (odds ratio=2.77; 95% confidence interval, 2.44-3.15), no history of acute myocardial infarction (odds ratio=2.23; 95% confidence interval, 1.67-2.99), obesity (odds ratio=1.70; 95% confidence interval, 1.44-1.99), absence of depression (odds ratio=1.63; 95% confidence interval, 1.27-2.08), female sex (odds ratio=1.29; 95% confidence interval, 1.14-1.46), older age, and taking more intensive antidiabetic therapy. There was an inverse relationship with the age of physicians and a direct relationship with their professional stability. CONCLUSIONS The mean diagnostic delay in hypertension among diabetic patients was greater than 6 months and varied according to the diagnostic threshold used. Patients with baseline blood pressure≥140/90mmHg were more likely to receive a timely diagnosis.

Effectiveness of a clinical practice guideline implementation strategy for patients with anxiety disorders in primary care: cluster randomized trial

BackgroundAnxiety is a common mental health problem seen in primary care. However, its management in clinical practice varies greatly. Clinical practice guidelines (CPGs) have the potential to reduce variations and improve the care received by patients by promoting interventions of proven benefit. However, uptake and adherence to their recommendations can be low.Method/designThis study involves a community based on cluster randomized trial in primary healthcare centres in the Madrid Region (Spain). The project aims to determine whether the use of implementation strategy (including training session, information, opinion leader, reminders, audit, and feed-back) of CPG for patients with anxiety disorders in primary care is more effective than usual diffusion.The number of patients required is 296 (148 in each arm), all older than 18 years and diagnosed with generalized anxiety disorder, panic disorder, and panic attacks by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV). They are chosen by consecutive sampling.The main outcome variable is the change in two or more points into Goldberg anxiety scale at six and twelve months. Secondary outcome variables include quality of life (EuroQol 5D), and degree of compliance with the CPG recommendations on treatment, information, and referrals to mental health services. Main effectiveness will be analyzed by comparing the patients percentage improvement on the Goldberg scale between the intervention group and the control group. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.DiscussionThere is a need to identify effective implementation strategies for CPG for the management of anxiety disorders present in primary care. Ensuring the appropriate uptake of guideline recommendations can reduce clinical variation and improve the care patients receive.Trial registrationISRCTN: ISRCTN83365316

EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting

BackgroundHigh blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD). European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of a cardiovascular risk visual learning method - the EDUCORE method - is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD;Methods/DesignThis work describes a protocol for a clinical trial, randomised by clusters and involving 22 primary healthcare clinics, to test the effectiveness of the EDUCORE method. The number of patients required was 736, all between 40 and 65 years of age (n = 368 in the EDUCORE and control groups), all of whom had been diagnosed with HBP at least one year ago, and all of whom had poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic ≥ 90 mmHg). All personnel taking part were explained the trial and trained in its methodology. The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action, plus the receipt of a pamphlet explaining how to better maintain cardiac health. The main outcome variable was the control of blood pressure; secondary outcome variables included the SCORE score, therapeutic compliance, quality of life, and total cholesterol level. All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months. Information on sex, age, educational level, physical activity, body mass index, consumption of medications, change of treatment and blood analysis results was also recorded;DiscussionThe EDUCORE method could provide a simple, inexpensive means of improving blood pressure control, and perhaps other health problems, in the primary healthcare setting;Trial registrationThe trial was registered with ClinicalTrials.gov, number NCT01155973 [http://ClinicalTrials.gov].

Explaining differences in perceived health-related quality of life: a study within the Spanish population

OBJECTIVE To assess the burden of several determinants on health-related quality of life (HRQOL) and to study its heterogeneity among the different Spanish regions. METHOD Cross-sectional study. Data were obtained from the Spanish National Health Survey (2012), and HRQOL was measured using the EQ-5D-5L questionnaire (utility and visual analogue scale -VAS- scores). Demographic variables, physical health condition, social variables, mental health status, and lifestyle were also analysed. Tobit regression models were employed to study the relationships between expressed HRQOL and personal characteristics. RESULTS A total of 20,979 surveys were obtained. Of them, 62.4% expressed a utility score of 1, corresponding to perfect health (95%CI: 61.8%-63.2%), and 54.2% showed VAS scores ≥80 (95%CI: 53.5%-54.9%). HRQOL was mainly described as a function of age, chronic limitation in daily activities, and mental health status. Belonging to a higher-class strata and physical activity were related to better self-perceived HRQOL. Ageing worsened perceived HRQOL, but did not influence its determinants, and differences in HRQOL by regions were also not significant after model adjustment. CONCLUSION HRQOL perception in the Spanish population varied slightly depending on the measure used (utilities index or VAS). Age, chronic limitations in daily life, and mental health status best explained the variability in perception, and no meaningful differences in HRQOL perception among regions were found after adjustment.

La glucemia mantenida entre 110-125 mg/dl ¿es un factor de riesgo de desarrollo de diabetes?

La prediabetes es una situación clínica que hace referencia a pacientes con cifras elevadas de glucemia (entre 110-125 mg/dl para la OMS y entre 100-125 mg/dl para la ADA). Se trata de un concepto no ajeno a la controversia pero que puede tener un sentido práctico para recordar el efecto nocivo de la glucosa y el riesgo de desarrollar diabetes tipo 2, así como la necesidad de actuar con el fin de evitar y/o retrasar su aparición. Según el estudio Di@abet.es, la prevalencia en España de prediabetes sería del 14,8% en población adulta. Aunque estudios previos han identificado que la incidencia de diabetes en España en población general estaría entre 7,2-7,9 casos/10.000 habitantes, se desconoce la incidencia de diabetes en pacientes con prediabetes. El objetivo de este trabajo es