Quality indicators for the prevention of type 2 diabetes in Europe--IMAGE.

BACKGROUND: The marked increase of type 2 diabetes necessitates active development and implementation of efficient prevention programs. A European level action has been taken by launching the IMAGE project to unify and improve the various prevention management concepts, which currently exist within the EU. This report describes the background and the methods used in the development of the IMAGE project quality indicators for diabetes primary prevention programs. It is targeted to the persons responsible for diabetes prevention at different levels of the health care systems. METHODS: Development of the quality indicators was conducted by a group of specialists representing different professional groups from several European countries. Indicators and measurement recommendations were produced by the expert group in consensus meetings and further developed by combining evidence and expert opinion. RESULTS: The quality indicators were developed for different prevention strategies: population level prevention strategy, screening for high risk, and high risk prevention strategy. Totally, 22 quality indicators were generated. They constitute the minimum level of quality assurance recommended for diabetes prevention programs. In addition, 20 scientific evaluation indicators with measurement standards were produced. These micro level indicators describe measurements, which should be used if evaluation, reporting, and scientific analysis are planned. CONCLUSIONS: We hope that these quality tools together with the IMAGE guidelines will provide a useful tool for improving the quality of diabetes prevention in Europe and make different prevention approaches comparable.

Take action to prevent diabetes--the IMAGE toolkit for the prevention of type 2 diabetes in Europe.

When we ask people what they value most, health is usually top of the list. While effective care is available for many chronic diseases, the fact remains that for the patient, the tax payer and the whole of society: prevention is better than cure. Diabetes and its complications are a serious threat to the survival and well-being of an increasing number of people. It is predicted that one in ten Europeans aged 20-79 will have developed diabetes by 2030. Once a disease of old age, diabetes is now common among adults of all ages and is beginning to affect adolescents and even children. Diabetes accounts for up to 18 % of total healthcare expenditure in Europe. The good news is that diabetes is preventable. Compelling evidence shows that the onset of diabetes can be prevented or delayed greatly in individuals at high risk (people with impaired glucose regulation). Clinical research has shown a reduction in risk of developing diabetes of over 50 % following relatively modest changes in lifestyle that include adopting a healthy diet, increasing physical activity, and maintaining a healthy body weight. These results have since been reproduced in real-world prevention programmes. Even a delay of a few years in the progression to diabetes is expected to reduce diabetes-related complications, such as heart, kidney and eye disease and, consequently, to reduce the cost to society. A comprehensive approach to diabetes prevention should combine population based primary prevention with programmes targeted at those who are at high risk. This approach should take account of the local circumstances and diversity within modern society (e.g. social inequalities). The challenge goes beyond the healthcare system. We need to encourage collaboration across many different sectors: education providers, non-governmental organisations, the food industry, the media, urban planners and politicians all have a very important role to play. Small changes in lifestyle will bring big changes in health. Through joint efforts, more people will be reached. The time to act is now.

[Incidence of strokes in Spain: the Iberictus study. Data from the pilot study]. / Incidencia de ictus en España: estudio Iberictus. Datos del estudio piloto.

INTRODUCTION: In a population-based study of the incidence of stroke conducted on a broad denominator, it is wise first to carry out a pilot study. AIM: To present the results of the pilot phase of the study on stroke incidence in Spain, entitled Iberictus. PATIENTS AND METHODS: Population of the study: all cases involving the first episode of acute cerebrovascular disease (stroke or transient ischaemic attack) diagnosed among residents over 17 years of age with their habitual place of abode registered in the areas of study between 15th and 31st October 2005 (total denominator: 1,440,997 inhabitants). SOURCE OF DATA: prospective, hospital records (basic minimum data set, discharge abstracts) and casualty department registers. Standardised definitions: diagnostic categorisation and pathological, topographical and aetiological classification. Inter-observer agreement analysis among researchers (kappa). RESULTS: A total of 128 cases were identified. Age range, 37-103 years; mean age, 75.7 +/- 13.4 years; 54% were females. In all, 71.1% of the cases were collected by means of a basic minimum data set. There were 91 ischaemic events (29.7% atherothrombotic and 29.7% cardioembolic). Of the 15 haemorrhagic strokes, 40% due to arterial hypertension, six were lobar hemispheric, six were deep basal ganglia, and there were three cerebellar haemorrhages. The incidence of stroke was seen to increase exponentially with age. Inter-observer agreement was good for the classifications that were employed (range of kappa indices, 0.57-0.78). Several problems were detected and corrected in the fieldwork. CONCLUSIONS: The Iberictus pilot study yielded data that were consistent with the literature and provided us with the opportunity to detect and correct issues that would hinder us from conducting the main study.

[Incidence of strokes in Spain. Methodological foundations of the Iberictus study]. / Incidencia de ictus en España. Bases metodológicas del estudio Iberictus.

INTRODUCTION: Epidemiological data on the incidence of cerebrovascular diseases in our country are scarce. A representative population-based study with a large denominator is required. AIM: To present the design of the study on stroke incidence in Spain, entitled Iberictus. SUBJECTS AND METHODS: We conducted a prospective, population-based study on the incidence of strokes and transient ischemic attacks, in which it is possible to distinguish: 1) population with a steady risk, which was well defined and had a broad denominator. We included all the cases in which the first episode of acute cerebrovascular disease was diagnosed among those over the age of 17 years (with no upper age limit) with their habitual residence in the areas of study between the 1st January and 31st December 2006: Lugo, Segovia, Talavera de la Reina, Mallorca and Almeria (total denominator, 1,440,997 inhabitants; minimum denominator per area, 100,000 inhabitants); 2) source of multiple and complementary data: hospital records (minimum basic data set, discharge abstracts), emergency and primary care records for the area with diagnostic codes 430-39 and 674.0 (International Classification of Diseases-9), population-based mortality records; 3) standardised definitions: diagnostic categorisation (MONICA-World Health Organisation, 1987), pathological classification (ischaemia, haemorrhagic), topography and aetiology; 4) presentation of data in suitable age groups, by sex and overall; 5) pilot study and analysis of inter-observer agreement among researchers. CONCLUSIONS: With this design, the Iberictus study satisfies the methodological criteria as an 'ideal' study of the incidence of acute cerebrovascular diseases proposed by Malgrem, Sudlow and Warlow, and represents a unique opportunity to further our knowledge of the epidemiology of strokes in our country.

[Relationship between pulse pressure and clinical cardiovascular damage in elderly subjects of EPICARDIAN study]. / Relación entre presión de pulso y antecedente de enfermedad cardiovascular en ancianos de dos poblaciones pertenecientes al estudio EPICARDIAN.

INTRODUCTION: Arterial hypertension and aging are the main cardiovascular risk factors (CVRF) in the elderly population. Aging is associated with an increase in systolic blood pressure (SBP) levels and a decrease of diastolic blood pressure (DBP), due to increased large artery stiffness. Several epidemiological studies have demonstrated that pulse pressure (PP) is an independent risk factor, better than SBP, for overall, cardiovascular mortality, coronary heart disease and cerebrovascular, particularly in the elderly. OBJECTIVES: To determine the association of PP with clinical cardiovascular damage, in a population-based sample of Spanish elders subjects. To quantify the association between PP and the background of clinical cardiovascular damage. To determine which PP, SBP, DBP or mean arterial pressure (MAP) are better associated to the history of clinical cardiovascular damage. PATIENTS AND METHODS: The sample analyzed included individuals from the EPICARDIAN study in the areas of Lista district (Madrid) and Arévalo (Avila). The following CVRF of age, gender, hypertension, diabetes, dyslipidemia, obesity, abdominal obesity and smoking were considered. Clinical cardiovascular damage is defined as the personal background of stroke, myocardial infarction, angina pectoris and/or intermittent claudication. RESULTS: The sample included 2665 individuals, 56% women, mean age: 74 year-old; 74.3% were hypertensive, 55.6% had central obesity and 31.9% hypercholesterolemia. In the multivariate analysis, the PP was the BP parameter associated most to stroke, angina pectoris and intermittent claudication: OR, 1.015, (95% CI: 1.001-1.030), 1.029 (95% CI: 1.006-1.052) and 1.012 (95% CI: 1.002-1.023), respectively. CONCLUSIONS: In the elderly population studied, an elevated PP is the component of arterial pressure with the greatest association to the background of cardiovascular damage.

[Effects of NSAID on blood pressure among hypertensive patients with a high cardiovascular risk]. / Efecto del tratamiento con AINE sobre la presión arterial en pacientes hipertensos con riesgo cardiovascular elevado.

BACKGROUND: An elevation in the risk of cardiovascular (CV) events and blood pressure (BP) levels in patients treated with COX-2 inhibitors compared to non selective NSAID has been shown previously. OBJECTIVES: To compare the effects of NSAID (COX-2 inhibitors and non-selective) on BP levels and control of HT. To determine the association between NSAID use and coronary heart disease in HT patients with elevated CV risk. METHODS: Cross sectional epidemiological study in 8126 ambulatory HT patients, older than 40, with a high CV risk. We obtained data on personal variables, CV risk factors, previous CV history, CV medication, analgesic and anti inflammatory drugs (AID). Control of HT was classified: optimal, suboptimal and no control. Absolute CV risk was calculated according to the WHO-ISH score. RESULTS: 44.2% of subjects took ASA and 3.7% another NSAID. SBP was 5.90 mmHg (95%CI: 2.53-9.27 mmHg) higher (p < 0.05) in patients treated with NSAID than in those with no AID medication. Patients having ASA, both SBP and DBP were 5.89 mmHg (p < 0.01) and 2.25 mm Hg (p < 0.05) respectively, lower than in patients with NSAID. However, mean SBP was similar in the ibuprofen group compared to without AID; 11.12 mmHg lower (95%CI: 3.66-18.58) than in the group on NSAID (p < 0.05) and 8.82 mmHg (95%CI: 0.27-17.38) (p < 0.05) lower than in those on COX-2 inhibitors. CONCLUSIONS: Among HT patients, NSAID therapy (selective or not) is associated with a higher level of SBP than in those without such medication. However, patients treated exclusively with Ibuprofen show similar levels of SBP than without NSAID treatment. Frequency of ischemic disease was significantly higher in the group treated with COX-2 inhibitors than in the non-selective NSAID treated group or in patients without NSAID treatment.

[Pain in Spanish rheumatology outpatient offices: EPIDOR epidemiological study]. / El dolor en las consultas de Reumatología españolas: estudio epidemiológico EPIDOR.

OBJECTIVE: To establish the prevalence and characteristics of rheumatologic pain in Spanish adult population cared in specialized rheumatology offices. DESIGN: Cross selection study in a population of patients cared in rheumatology offices of public Spanish hospitals. SUBJECTS: 1,134 patients selected through random sampling based on waiting lists of patients, during a period of 1 week, in rheumatology offices of each participating hospital. MAIN OUTCOMES OF THE STUDY: Reason behind the consultation (a new patient [NP] or a patient for revision [RP]), characteristics of the patient (sex, age, habits [alcohol/tobacco], marital status), location, type, intensity, duration, tolerance and management of pain; treatment (pharmacological or non-pharmacological) carried out; satisfaction with the treatment; and association with fibromyalgia. RESULTS: The prevalence of pain in NP was 98.6% and in RP 95.1%, with a global prevalence of 96%, predominating mainly in adult sedentary women with fibromyalgia. The frequency of acute pain was 20.9% and this of chronic pain 79.1% [corrected] The prevalence of fibromyalgia was 12% (2.2% in men, and 15.5% in women). The most prevalent pattern of current dominant pain was this of the mechanical type. More frequent associated pathologies were: hypertension (21.7%), depression (14.4%), gastrointestinal diseases (13.8%) and anxiety (13.4%). All variables analyzed in the study showed changes according to age, sex, and type of patient (NP or RP). Most used treatment was pharmacological; more than 57.6% of patients were receiving NSAIDs. In NP, medical prescriber of the treatment was first the general practitioner (56.1%) followed by the rheumatologist (14.1%); in PR the first one was the rheumatologist (69.9%) followed by the general practitioner (16.5%). CONCLUSIONS: Our results show that the prevalence of the rheumatologic pain is very high, predominating mainly in adult women with fibromyalgia. Pain location, intensity, and type, associated pathology, and treatment vary according to age, sex, and type of patient. The most commonly used drugs for pain management were NSAIDs (58%); opiodes were only used in 6.4% of patients even though pain was intense in more than two-thirds.

Hormone replacement therapy for preventing cardiovascular disease in post-menopausal women.

BACKGROUND: There is apparently compelling evidence, from observational studies, that hormone replacement therapy (HRT) may have benefits in reducing cardiovascular events in post-menopausal women. However, these observational data are subject to biases and confounding and require support from formally designed randomised controlled trials of the effects of HRT on cardiovascular disease risk. OBJECTIVES: To assess the effects of HRT for the primary and secondary prevention of cardiovascular diseases in post-menopausal women. SEARCH STRATEGY: We searched MEDLINE (1998 to December 2002)), EMBASE (1998 to December 2002), the Cochrane Controlled Trials Register (CCTR) (Issue 4 2002), the National Research Register (1998 to present), Clinical Trials.gov (1998 to present), and the database of Spanish Clinical Trials (1998 to present) and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials comparing HRT with controls (placebo or no treatment) with a minimum follow up of 6 months for treating or preventing cardiovascular disease in postmenopausal women with or without cardiovascular disease. DATA COLLECTION AND ANALYSIS: Three independent reviewers extracted information from the articles, solving discrepancies by consensus. All outcomes studied were dichotomous. Risk ratios and 95% confidence intervals (CI) were calculated for each study and plotted. Random effects meta-analysis was used in efficacy outcomes (cardiovascular events) and fixed-effects meta-analysis in variables regarding side effects (deep venous thrombosis). MAIN RESULTS: No protective effect of HRT was seen for any of the cardiovascular outcomes assessed: all cause mortality, cardiovascular death, non-fatal MI, venous thromboemboli or stroke. Higher risks of venous thromboembolic events (Relative risk (RR) 2.15, 95% CI 1.61 to 2.86), pulmonary embolus (RR 2.15, 95% CI 1.41 to 3.28), and stroke (RR 1.44, 95% CI 1.10 to 1.89) was found in those randomised to HRT compared with placebo. No substantial heterogeneity (p <0.1) was detected in any of the outcomes studied. AUTHORS' CONCLUSIONS: At present, a recommendation for initiating HRT for the reason of preventing cardiovascular events in post-menopausal women (with or without cardiovascular disease) should not be made. Women with other risk factors for venous thromboembolic events should be discouraged from using HRT if the sole goal is to prevent cardiovascular events.

[Pattern of the distribution of total cholesterol and cHDL cholesterol Spanish children and adolescents: RICARDIN Study]. / Patrón de la distribución de colesterol total y cHDL en niños y adolescentes españoles: estudio RICARDIN.

BACKGROUND: The RICARDIN Study multicenter study of cardiovascular risk factors in children and adolescents has described the standards of normality of blood cholesterol levels in the Spanish school population. The objective of the present study was to compare mean values of cholesterol between different regions of Spain, and to compare the global mean with a pool international study. Also, the pattern of total cholesterol and cHDL by age and sex using mathematical model is described, and comparison with two international studies carried out in USA and Japan is performed. SUBJECTS AND METHODS: 10,683 children aged 6 to 18 were selected from 7 different Spanish provinces (Madrid, Vizcaya, Lugo, Badajoz, Murcia, Asturias and Barcelona). Blood samples were obtained by capilar puncture (Reflotron). RESULTS: Mean values of total cholesterol was different among provinces, and globally, were lower than the international pooled population, although the pattern observed in each population was very similar. Total cholesterol curve for Spanish boys showed a curvilinear trend that can be estimated through a cubic function that explains 89% of observed data, while for girls the best estimate was obtained through an inverse function (R2 = 0.40). cHDL for boys showed a cubic function as the best estimate (R2 = 0.90), while for girls the best estimate was obtained through a quadratic function (R2 = 0.59). CONCLUSIONS: There are important physiological variations of total cholesterol level by age and sex in children and adolescents. The pattern of cholesterol does not follow a linear model but a curvilinear one, that need to be considered in clinically assessing individual determinations of cholesterol, since highest percentiles can vary by age and sex.

[Decision making in cardiology: methodology]. / Toma de decisiones en cardiología: metodología.

This article reviews the methods employed in usual clinical thinking for making decisions, the problems and limitations inherent in them and claims that a more frequent utilization of the so called "Evidence Based Medicine" methods is a more valid and efficient alternative for medical decision making. We also describe the theoretical basis and strategies used in the medical decision process; the specific concepts and basic components for building decision trees are also shown. Finally, a real case is presented and approached step by step: the statement of the decision problem, its possible alternatives, the allocation of probabilities to each outcome based on the best available evidence, and the calculations of the expected values (projected usefulness, cost-effectiveness) and sensitivity analysis by means of specific software for making decisions.

[Estimation of initial interobserver variability of forced spirometry in the multicenter epidemiological study IBERPOC. Scientific Committee of the IBERPOC study]. / Estimación de la variabilidad inicial interobservador de la espirometría forzada en el estudio epidemiológico multicéntrico IBERPOC. Comité Científico del Estudio IBERPOC.

To estimate the interobserver variability and degree of agreement for basic spirometric parameters before beginning field work for the IBERPOC Project. Study of agreement between 7 observers (pneumologists) and a gold standard, using a scheme of incomplete balanced and randomized blocks with an equal number of spirometric measurements (n = 3) per patient and an equal number of measurements (n = 9) per observer performed at the same session. The study population consisted of 14 patients with different degrees of air flow obstruction and 7 normal volunteers. Statistically significant differences attributable to subjects (inter-patient variability) were found for the three variables analyzed. Variability attributable to the observer was found for FVC and FEV1 but not for FEV1/FVC. The greatest interobserver differences were found for FEV1, such that 4 of the 7 observers recorded values that were significantly different from the mean (p < 0.05). The differences were less marked for FVC and for the FEV1/FVC ratio, with only 2 observers recording significantly different values for each variable. The high degree of reproducibility as well as the excellent interobserver agreement found in this standardization session provide an a priori guarantee of validity for spirometric measurements and rule out the existence of differential bias in data recorded at the various geographic areas involved in the study.

[Research methods in clinical cardiology (I). Types of basic designs. Observational studies in clinical cardiology (I)]. / Métodos de investigación en cardiología clínica (I). Tipos de diseños básicos. Estudios observacionales en cardiología clínica (I).

Clinical investigation studies can be classified according to their purpose (causality, diagnosis, therapy, etc), by its research strategy (observation or intervention), by the characteristics of its design (descriptive or analytic) or according to the basic axes of the investigation process (directionality and time orientation); and the personal attributes (exposure and disease) of the study population. Among observational designs, the cross-sectional and ecological studies are the main representatives of descriptive research. Their main objectives are the estimation of disease prevalence and risk factor distribution in the population, as well as the comparison of prevalence and risk factor distribution among several populations. On the other hand, the aim of analytical studies is the identification of individual risk factors associated with the disease. The key difference between descriptive and analytical studies is the existence of a comparison group in the latter, which allow hypotheses testing. Examples or analytical studies are the case-control and cohort studies. This paper deal with the principles of basic design and methods of descriptive (cross-sectional and ecological), and case-control studies. Finally we outline the basic concepts and principles of the screening, a frequent objective in many cardiovascular surveys, specifically in primary prevention.

[Drug consumption by people over 60 years of age in a rural area]. / Consumo de fármacos en población mayor de 60 años en una zona rural.

OBJECTIVES: To describe the frequency and distribution of the consumption of medicines in a census-based sample of people of 60 or over. To determine the association between the consumption of medicines and other socio-demographic and clinical (presence of disease) variables. DESIGN: An epidemiological crossover study based in the community. SETTING: Rural population: the Health District of Arévalo in Castilla y León. PARTICIPANTS: 825 subjects (446 women and 379 men) over 60, with an average age of 71,84. MEASUREMENTS: A standard questionnaire was used, containing medicine consumption, prescription, and clinical and demographic features. RESULTS: The consumption of medicines per person per day was 1,92. Therapeutic groups most consumed were, in this order, hypotension drugs, cardiotonics, antirheumatics, peripheral vasodilators, digestive system drugs, neurotropics and analgesics. The number of illnesses suffered by this age-group was 2,19. There is a strong connection between consumption of medicines and age, especially in the over 80's. CONCLUSIONS: 75% of the target population took some medicine each day. Consumption is higher among women than men. Cardiovascular drugs are the most frequently used therapeutic group. Consumption of medicines is directly related to age and the number of illnesses.

What happens to blood pressure when on-call?

This study was designed to compare the 24-h blood pressure profile of young physicians during on-call days with those obtained during a normal day, and to explore the factors related to blood pressure reactivity in a stress situation. The study was a self-comparison study in two environments (on-call and at home). The study population was 100 physicians, staff, and residents working in the emergency room. A previously validated ambulatory, automated, auscultatory blood pressure (BP) monitoring device (A&D Takeda 2420) was used. BP measurements were programmed to be taken every 15 min and three time periods were considered for analysis: the whole day, awake, and sleep periods. Systolic and diastolic BP behavior were described by their average and distributions. Within each considered phase (on-call, at home) the pressor response was defined as the difference in average blood pressure. Being on-call modified both systolic and diastolic ambulatory BP profiles. Both average BP values and BP load were significantly higher when subjects were on-call. Systolic blood pressure increased in 83% of subjects and 40% displayed a significant pressor response of 10 mm Hg or more. For diastolic blood pressure some increase was observed in 93% of subjects, and a significant pressor response of 10 mm Hg or greater in 23% of them. Age, sex, personality, and tobacco consumption were not associated with the pressor response. Familial history of hypertension and professional status were the most important determinants of the pressor response.

Mortality among people affected by toxic oil syndrome.

The authors conducted a mailed questionnaire survey of a 5% sample of the cohort of 20,643 people officially recognized by the Spanish government as having had toxic oil syndrome, a previously undescribed illness that was epidemic in Spain in 1981. After three mailings of a letter and questionnaire, responses for only 66% of the sample had been received. Nevertheless, responses were obtained from virtually all remaining patients (or surrogates for them in the cases of patients that had died) when they were sought by telephone. In 1981, there was clear-cut excess mortality in the cohort (standardized mortality ratio [SMR] 6.51; 95% confidence interval [CI]: 3.92-10.17). During the period January 1982 through 7 March 1988, there was no statistically significant overall mortality excess except during the period 1982-1983 among people aged < 65 years (SMR 2.26; 95% CI: 1.03-4.29). Toxic oil syndrome substantially altered the patterns of mortality among affected people. Analysis of deaths by cause among the TOS cohort will be useful for further evaluation of the long-term impact of the TOS epidemic.

Acute effect of intrapulmonary enalaprilat in ten patients with severe pulmonary hypertension due to toxic oil syndrome.

Ten patients with severe pulmonary hypertension due to Toxic Oil Syndrome underwent cardiac catheterization to analyse the acute effect of intrapulmonary injection of 1.25 mg of enalaprilat. Haemodynamic parameters were obtained at basal state, 15, 30, 45 and 60 minutes after administration of the drug. Enalaprillat did not produce any statistically significant changes in pulmonary pressures and resistances or cardiac output. This lack of response is unknown but may be related to the presence of endothelial damage and fixed pulmonary vascular lesions observed at autopsy in three patients.