Shifting from glucose diagnosis to the new HbA1c diagnosis reduces the capability of the Finnish Diabetes Risk Score (FINDRISC) to screen for glucose abnormalities within a real-life primary healthcare preventive strategy.

BACKGROUND: To investigate differences in the performance of the Finnish Diabetes Risk Score (FINDRISC) as a screening tool for glucose abnormalities after shifting from glucose-based diagnostic criteria to the proposed new hemoglobin (Hb)A1c-based criteria. METHODS: A cross-sectional primary-care study was conducted as the first part of an active real-life lifestyle intervention to prevent type 2 diabetes within a high-risk Spanish Mediterranean population. Individuals without diabetes aged 45-75 years (n = 3,120) were screened using the FINDRISC. Where feasible, a subsequent 2-hour oral glucose tolerance test and HbA1c test were also carried out (n = 1,712). The performance of the risk score was calculated by applying the area under the curve (AUC) for the receiver operating characteristic, using three sets of criteria (2-hour glucose, fasting glucose, HbA1c) and three diagnostic categories (normal, pre-diabetes, diabetes). RESULTS: Defining diabetes by a single HbA1c measurement resulted in a significantly lower diabetes prevalence (3.6%) compared with diabetes defined by 2-hour plasma glucose (9.2%), but was not significantly lower than that obtained using fasting plasma glucose (3.1%). The FINDRISC at a cut-off of 14 had a reasonably high ability to predict diabetes using the diagnostic criteria of 2-hour or fasting glucose (AUC = 0.71) or all glucose abnormalities (AUC = 0.67 and 0.69, respectively). When HbA1c was used as the primary diagnostic criterion, the AUC for diabetes detection dropped to 0.67 (5.6% reduction in comparison with either 2-hour or fasting glucose) and fell to 0.55 for detection of all glucose abnormalities (17.9% and 20.3% reduction, respectively), with a relevant decrease in sensitivity of the risk score. CONCLUSIONS: A shift from glucose-based diagnosis to HbA1c-based diagnosis substantially reduces the ability of the FINDRISC to screen for glucose abnormalities when applied in this real-life primary-care preventive strategy.

Rationale and design of the PREDICE project: cost-effectiveness of type 2 diabetes prevention among high-risk Spanish individuals following lifestyle intervention in real-life primary care setting.

BACKGROUND: Type 2 diabetes is an important preventable disease and a growing public health problem. Based on information provided by clinical trials, we know that Type 2 diabetes can be prevented or delayed by lifestyle intervention. In view of translating the findings of diabetes prevention research into real-life it is necessary to carry out community-based evaluations so as to learn about the feasibility and effectiveness of locally designed and implemented programmes. The aim of this project was to assess the effectiveness of an active real-life primary care strategy in high-risk individuals for developing diabetes, and then evaluate its efficiency. METHODS/DESIGN: Cost-Effectiveness analysis of the DE-PLAN (Diabetes in Europe - Prevention using Lifestyle, physical Activity and Nutritional intervention) project when applied to a Mediterranean population in Catalonia (DE-PLAN-CAT). Multicenter, longitudinal cohort assessment (4 years) conducted in 18 primary health-care centres (Catalan Health Institute). Individuals without diabetes aged 45-75 years were screened using the Finnish Diabetes Risk Score - FINDRISC - questionnaire and a 2-h oral glucose tolerance test. All high risk tested individuals were invited to participate in either a usual care intervention (information on diet and cardiovascular health without individualized programme), or the intensive DE-PLAN educational program (individualized or group) periodically reinforced. Oral glucose tolerance test was repeated yearly to determine diabetes incidence. Besides measuring the accumulated incidence of diabetes, information was collected on economic impact of the interventions in both cohorts (using direct and indirect cost questionnaires) and information on utility measures (Quality Adjusted Life Years). A cost-utility and a cost-effectiveness analysis will be performed and data will be modelled to predict long-term cost-effectiveness. DISCUSSION: The project was intended to evidence that a substantial reduction in Type 2 diabetes incidence can be obtained at a reasonable cost-effectiveness ratio in real-life primary health care setting by an intensive lifestyle intervention. As far as we know, the DE-PLAN-CAT/PREDICE project represents the first assessment of long-term effectiveness and cost-effectiveness of a public healthcare strategy to prevent diabetes within a European primary care setting.

Metabolic syndrome as a cardiovascular disease risk factor: patients evaluated in primary care.

To estimate the prevalence of metabolic syndrome (MS) in a population receiving attention in primary care centers (PCC) we selected a random cohort of ostensibly normal subjects from the registers of 5 basic-health area (BHA) PCC. Diagnosis of MS was with the WHO, NCEP and IDF criteria. Variables recorded were: socio-demographic data, CVD risk factors including lipids, obesity, diabetes, blood pressure and smoking habit and a glucose tolerance test outcome. Of the 720 individuals selected (age 60.3 +/- 11.5 years), 431 were female, 352 hypertensive, 142 diabetic, 233 pre-diabetic, 285 obese, 209 dyslipemic and 106 smokers. CVD risk according to the Framingham and REGICOR calculation was 13.8 +/- 10% and 8.8 +/- 9.8%, respectively. Using the WHO, NCEP and IDF criteria, MS was diagnosed in 166, 210 and 252 subjects, respectively and the relative risk of CVD complications in MS subjects was 2.56. Logistic regression analysis indicated that the MS components (WHO set), the MS components (IDF set) and the female gender had an increased odds ratio for CVD of 3.48 (95CI%: 2.26-5.37), 2.28 (95%CI: 1.84-4.90) and 2.26 (95%CI: 1.48-3.47), respectively. We conclude that MS and concomitant CVD risk is high in ostensibly normal population attending primary care clinics, and this would necessarily impinge on resource allocation in primary care.

Impact of depression and/or anxiety on the presentation of cardiovascular events in a cohort with metabolic syndrome. StreX project: Five years of follow-up.

OBJECTIVES: To determine the role of anxiety and depression on the incidence of cardiovascular events (CVE) in a Catalonian population with metabolic syndrome (MetS) over a five-year follow-up according to the number/type of MetS criteria. METHODS: Prospective study to determine the incidence of CVE according to the presence of anxiety and depression disorders among individuals with different combinations of clinical traits of the MetS. SETTING: Primary Care, Catalonia (Spain). SUBJECTS: 35-75 years old fulfilling MetS criteria without CVE at the initiation of follow-up (2009). We studied 16 MetS phenotypes [NCEP-ATPIII criteria] based on the presence of depression/anxiety. The primary endpoint was the incidence of CVE at five years. RESULTS: We analyzed 401,743 people with MetS (17.2% of the population); 8.7% had depression, 16.0% anxiety and 3.8% both. 14.5% consumed antidepressants and 20.8% tranquilizers. At the 5-year follow-up, the incidence of CVE was 5.5%, being 6.4% in men and 4.4% in women. On comparing individuals with and without depression the incidence of CVE was 6.7% vs. 5.3%, respectively (p<0.01), being 5.5% in both groups in relation to anxiety. CONCLUSION: Depression and anxiety play a role in the poor prognosis of patients with MetS. In Catalonia, the two predominant MetS phenotypes do not include obesity as a criterion.

Depression and physical comorbidity in primary care.

OBJECTIVE: To analyse how clinical characteristics in depressed patients, as well as the management of their depression, are related to the presence of significant physical comorbidity. METHODS: This is a two-phase cross-sectional study that took place in 10 primary care centres in Tarragona (Spain). A total of 906 consecutive patients were screened for depression with a self-rating questionnaire and 306 were subject to a structured interview that contained the diagnoses of major depression and dysthymia (DSM-IV), and the severity of the physical comorbidity (Duke Severity of Illness Scale: DUSOI). The association of several clinical variables with the presence of physical comorbidity was evaluated. RESULTS: The comorbidity was of moderate to extreme severity (DUSOI >50) in 31.7% of cases. The patients with comorbidity visited the physician more often. There were no differences in the consumption of antidepressants, reason for the consultation (psychological/somatic), or the probability of being detected as depressed. Neither were there any differences in the severity or disability between both groups. CONCLUSION: Physical comorbidity is frequent in primary care depressed patients. In general, the characteristics of depression and the handling by the doctor are similar in patients with and without comorbidity.

Generalizing molecular results arising from incomplete biological samples: expected bias and unexpected findings.

PURPOSE: In molecular epidemiology, obtaining biological samples for all subjects targeted for study is frequently hampered by ethical, clinical, and logistic factors. The extent to which the incompleteness of biological samples could cause bias is rarely analyzed in depth. Here we report some expected bias and some unexpected findings during a study on mutations in the K-ras gene in exocrine pancreatic cancer (EPC). METHODS: In this case-case study, all patients registered with EPC between 1980 and 1990 at two general hospitals were retrospectively identified from the hospital tumor registries. Their clinical records were abstracted and paraffin-embedded samples retrieved from pathology records. DNA was amplified, and mutations in codon 12 of the K-ras gene were detected using the artificial RFLP technique. RESULTS: Results on the mutations (RM) were obtained for 51 of the 149 cases of EPC (34.2%). There were no significant differences on the availability of RM by age, gender, and tumor stage at diagnosis, but RM were over five times more likely to be available from one of the hospitals. Subjects with RM were more likely to have received a treatment with curative intent (OR = 11.56, 95% CL: 2.88-46.36). The existence of RM was positively associated with the availability of information on alcohol use and family history of cancer. Subjects with RM tended to belong to higher occupational groups and to smoke less than subjects without RM. Unexpectedly--given that in EPC K-ras mutations have consistently been found unrelated to age, gender, tumor stage, and other clinical factors-, cases with a K-ras mutation were more likely than wild-type cases to have information on tobacco and alcohol use (OR = 3.29, p = .21), medical history (OR = 4.46, p = .41), and family history of cancer (OR = 4.80, p = .01). The relationship between completeness of clinical records and K-ras mutations among cases with RM could not be accounted by age, gender, and occupational group. CONCLUSIONS: Simple tests of age and gender distributions among subjects with and without available clinical information and molecular results may not rule out selection and information bias. Studies using biologic specimens are even more in need than classic studies to explain clearly the process followed to include and exclude subjects. Additional caution is needed when generalizing molecular results arising from incomplete biological specimens.