Drug safety and the impact of drug warnings: An interrupted time series analysis of diabetes drug prescriptions in Germany and Denmark.

OBJECTIVE: To analyse the impact of drug safety warnings from the European Medicines Agency (EMA) on drug utilisation and their interaction with information released through national reimbursement bodies. METHODS: Insurance claims data on anti-diabetic drug prescriptions in primary care in Germany and Denmark were analysed using interrupted time series analysis, with EMA drug warnings for thiazolidinediones (TZDs) in 2007 and 2011 as the intervention. Monthly drug utilisation data per substance in defined daily dosages (DDD) consumed per 1000 insurees were retrieved from the Danish national drug prescriptions register and one large statutory sickness fund in Germany. RESULTS: TZDs were generally reimbursed in Germany but restricted to individual reimbursement in Denmark. Consequently, utilisation of TZDs was much higher in Germany in 2007 compared with Denmark. For rosiglitazone, the drug warning had a significant impact on utilisation, reducing the number of DDD per 1000 insurees per day by -0.0105 in Denmark and -0.0312 in Germany (p-values<0.05). For pioglitazone, neither of the drug warnings had a significant effect on utilisation. CONCLUSION: The impact of EMA drug warnings differed across countries and might be mediated by information released through national reimbursement bodies and physician associations. Increasing complexity of new drugs and modified approval procedures require a strengthening of information exchange between drug regulation bodies and physicians to ensure patient safety.

A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study.

BACKGROUND: Intensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain. OBJECTIVE: To quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes. DESIGN: Pragmatic, multicentre, cluster-randomised, parallel-group trial. SETTING: Three hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK. PARTICIPANTS: Individuals aged 40-69 years with screen-detected diabetes. INTERVENTIONS: Screening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol. MAIN OUTCOME MEASURES: The primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3; (©) Isis Innovation Ltd 2010; see www.dtu.ox.ac.uk/outcomesmodel (accessed 27 January 2016)]. RESULTS: We included 3055 (RC, n = 1377; IT, n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient. CONCLUSIONS: Compared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT00237549. FUNDING DETAILS: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

Socioeconomic position and cardiovascular risk factors among people with screen-detected Type 2 DM: six-year follow-up of the ADDITION-Denmark trial.

AIMS: To examine whether socioeconomic position (SEP) was associated with change in cardiovascular risk factors and meeting treatment targets for cardiovascular risk factors among individuals with screen-detected Type 2 DM at six-year follow-up. METHODS: The study population was 1533 people with Type 2 DM identified from at stepwise diabetes screening programme in general practice during 2001-2006 in the ADDITION-Denmark study. The ADDITION-study was performed as a randomised trial but the two randomisation groups were analysed as one cohort in this study. Cardiovascular risk factors were measured at baseline and repeated at follow-up (mean: 5.9 [1.4] years). Information on SEP, redeemed antihypertensive and lipid-lowering treatment were obtained from Danish registers. Multivariate analyses were performed to estimate change in cardiovascular risk factors and difference in meeting treatment targets. RESULTS: The change in HbA1c, cholesterol, blood pressure and BMI were virtually the same across educational level, income level, occupational status or cohabiting status. Overall, the ability to meet treatment targets for HbA1c, cholesterol and blood pressure was not modified by SEP-group. A higher proportion of people with lower educational level or lower income level in the intensive care redeemed anti-hypertensive treatment compared to people with higher educational or income levels. CONCLUSION: Screen-detection and early treatment onset did not introduce socioeconomic inequality in metabolic control in people with screen-detected Type 2 DM at six-year follow-up.

Effect of early intensive multifactorial therapy compared with routine care on self-reported health status, general well-being, diabetes-specific quality of life and treatment satisfaction in screen-detected type 2 diabetes mellitus patients (ADDITION-Europe): a cluster-randomised trial.

AIMS/HYPOTHESIS: The study aimed to examine the effects of intensive treatment (IT) vs routine care (RC) on patient-reported outcomes after 5 years in screen-detected diabetic patients. METHODS: In a pragmatic, cluster-randomised, parallel-group trial, 343 general practices in Denmark, Cambridge and Leicester (UK) and the Netherlands were randomised to screening for type 2 diabetes mellitus plus IT of multiple risk factors in people 40-69 years without known diabetes (n = 1,678 patients) or screening plus RC (n = 1,379 patients). Practices were randomised in a 1:1 ratio according to a computer-generated list. Diabetes mellitus was diagnosed according to WHO criteria. Exclusions were: life expectancy <1 year, housebound, pregnant or lactating, or psychological or psychiatric problems. Treatment targets for IT were: HbA1c <7.0% (53 mmol/mol), BP ≤135/85 mmHg, cholesterol <5 mmol/l in the absence of a history of coronary heart disease and <4.5 mmol/l in patients with cardiovascular (CV) disease; prescription of aspirin to people taking antihypertensive medication and, in cases of CV disease or BP >120/80 mmHg, ACE inhibitors were recommended. After 2003, the treatment algorithm recommended statins to all patients with cholesterol of ≥3.5 mmol/l. Outcome measures were: health status (Euroqol 5 Dimensions [EQ-5D]) at baseline and at follow-up; and health status (36-item Short Form Health Survey [SF-36] and Euroquol Visual Analogue Scale [EQ-VAS]), well-being (12-item Short Form of the Well-Being Questionnaire), diabetes-specific quality of life (Audit of Diabetes-Dependent Quality of Life) and satisfaction with diabetes treatment (Diabetes Treatment Satisfaction Questionnaire) at follow-up. At baseline, standardised self-report questionnaires were used to collect information. Questionnaires were completed at the same health assessment visit as the anthropometric and biochemical measurements. The patients and the staff assessing the outcomes were unaware of the group assignments. Participants were followed for a mean of 5.7 years. Outcome data were available for 1,250 participants in the intensive treatment group (74%) and 967 participants in the routine care group (70%). The estimated differences in means from the four centres were pooled using random effects meta-analysis. Baseline EQ-5D level was used as a covariate in all analyses. RESULTS: EQ-5D values did not change between diagnosis and follow-up, with a median (interquartile range) of 0.85 (0.73-1.00) at baseline and 0.85 (0.73-1.00) at 5 year follow-up. Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the intensive treatment and routine care groups. There was some heterogeneity between centres (I 2 being between 13% [SF-36 physical functioning] and 73% [EQ-VAS]). CONCLUSIONS/INTERPRETATION: There were no differences in health status, well-being, quality of life and treatment satisfaction between screen-detected type 2 diabetes mellitus patients receiving intensive treatment and those receiving routine care. These results suggest that intensive treatment does not adversely affect patient-reported outcomes. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT00237549 FUNDING: ADDITION-Denmark was supported by the National Health Services, the Danish Council for Strategic Research, the Danish Research Foundation for General Practice, Novo Nordisk Foundation, the Danish Centre for Evaluation and Health Technology Assessment, the Diabetes Fund of the National Board of Health, the Danish Medical Research Council and the Aarhus University Research Foundation. In addition, unrestricted grants from pharmaceutical companies were received. ADDITION-Cambridge was supported by the Wellcome Trust, the Medical Research Council, the NIHR Health Technology Assessment Programme, National Health Service R&D support funding and the National Institute for Health Research. SJG received support from the Department of Health NIHR grant funding scheme. ADDITION-Leicester was supported by Department of Health, the NIHR Health Technology Assessment Programme, National Health Service R&D support funding and the National Institute for Health Research. ADDITION-Netherlands was supported by unrestricted grants from Novo Nordisk, Glaxo Smith Kline and Merck, and by the Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht.

Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial.

BACKGROUND: Intensive treatment of multiple cardiovascular risk factors can halve mortality among people with established type 2 diabetes. We investigated the effect of early multifactorial treatment after diagnosis by screening. METHODS: In a pragmatic, cluster-randomised, parallel-group trial done in Denmark, the Netherlands, and the UK, 343 general practices were randomly assigned screening of registered patients aged 40-69 years without known diabetes followed by routine care of diabetes or screening followed by intensive treatment of multiple risk factors. The primary endpoint was first cardiovascular event, including cardiovascular mortality and morbidity, revascularisation, and non-traumatic amputation within 5 years. Patients and staff assessing outcomes were unaware of the practice's study group assignment. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00237549. FINDINGS: Primary endpoint data were available for 3055 (99·9%) of 3057 screen-detected patients. The mean age was 60·3 (SD 6·9) years and the mean duration of follow-up was 5·3 (SD 1·6) years. Improvements in cardiovascular risk factors (HbA(1c) and cholesterol concentrations and blood pressure) were slightly but significantly better in the intensive treatment group. The incidence of first cardiovascular event was 7·2% (13·5 per 1000 person-years) in the intensive treatment group and 8·5% (15·9 per 1000 person-years) in the routine care group (hazard ratio 0·83, 95% CI 0·65-1·05), and of all-cause mortality 6·2% (11·6 per 1000 person-years) and 6·7% (12·5 per 1000 person-years; 0·91, 0·69-1·21), respectively. INTERPRETATION: An intervention to promote early intensive management of patients with type 2 diabetes was associated with a small, non-significant reduction in the incidence of cardiovascular events and death. FUNDING: National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Wellcome Trust, UK Medical Research Council, UK NIHR Health Technology Assessment Programme, UK National Health Service R&D, UK National Institute for Health Research, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Novo Nordisk, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Merck.

Dietary patterns, food and macronutrient intakes among adults in three ethnic groups in rural Kenya.

OBJECTIVE: To compare dietary patterns and food and macronutrient intakes among adults in three ethnic groups in rural Kenya. DESIGN: In the present cross-sectional study, dietary intake was estimated in adult volunteers using two non-consecutive interactive 24 h recalls. Dietary patterns were assessed from the number of meals and snacks per day and from the food items and major food groups registered, and their contribution to energy intake (EI) was calculated. Anthropometric values were measured and sociodemographic data obtained using a questionnaire. SETTING: A cross-sectional study was conducted in the Bondo, Kitui and Transmara districts of rural Kenya. A high prevalence of food insecurity in Kenya underlines the importance of describing the dietary patterns and intakes in different Kenyan ethnic groups. SUBJECTS: A total of 1163 (61 % women) adult Luo, Kamba and Maasai, with a mean age of 38·6 (range: 18-68) years, volunteered to participate. RESULTS: Dietary patterns and food groups contributing to EI differed significantly among the ethnic groups. Mean EI ranged from 5·8 to 8·6 MJ/d among women and from 7·2 to 10·5 MJ/d among men, with carbohydrates contributing between 55·7 % and 74·2 % and fat contributing between 14·5 % and 30·2 % of total EI. Mean protein intake ranged from 0·72 to 1·3 g/kg per d, and EI:BMR ratio ranged between 1·1 and 1·6 in both sexes, and was highest among the Luo. Prevalence of underweight (BMI < 18·5 kg/m2) was 13·7 %, 20·5 % and 24·2 % in the Luo, Kamba and Maasai, respectively. CONCLUSIONS: The degree of food insecurity measured as a degree of undernutrition and as dietary patterns differed considerably among the ethnic groups. The Maasai and Kamba in particular were exposed to food insecurity.

Comparison of different stepwise screening strategies for type 2 diabetes: Finding from Danish general practice, Addition-DK.

AIM: To examine attendance, number of people with T2DM and costs of three different stepwise screening strategies for T2DM in general practice (GP). METHODS: Diabetes risk questionnaires were mailed to individuals aged 40-69 years from 45 general practices in 2001-2002 and individuals at high risk for T2DM, were asked to contact their GP to arrange a screening test. In 2005-2006, 26 general practices were randomised into two different opportunistic screening programmes (OP-direct and OP-subsequent) and risk questionnaires were distributed to individuals aged 40-69 years during GP consultations. In the OP-direct approach, high-risk individuals were offered to start the screening during the actual consultation while high-risk individuals in the OP-subsequent approach, were invited to a screening test at a later date. We report attendance, number of people with T2DM and costs of each screening approach. RESULTS: The mail-distributed approach identified 0.8% of the target population with T2DM, the OP-direct approach and the OP-subsequent approach, 0.9% and 0.5% respectively. Cost per person with T2DM was in the mail-distributed approach: € 1058, OP-direct approach: € 707 and the OP-subsequent approach: € 727. CONCLUSION: This study indicates that opportunistic screening identifies the same level of unknown diabetes as a mail-distributed approach but with lower costs.

Age at initiation and frequency of screening to detect type 2 diabetes: a cost-effectiveness analysis.

BACKGROUND: No clinical trials have assessed the effects or cost-effectiveness of sequential screening strategies to detect new cases of type 2 diabetes. We used a mathematical model to estimate the cost-effectiveness of several screening strategies. METHODS: We used person-specific data from a representative sample of the US population to create a simulated population of 325,000 people aged 30 years without diabetes. We used the Archimedes model to compare eight simulated screening strategies for type 2 diabetes with a no-screening control strategy. Strategies differed in terms of age at initiation and frequency of screening. Once diagnosed, diabetes treatment was simulated in a standard manner. We calculated the effects of each strategy on the incidence of type 2 diabetes, myocardial infarction, stroke, and microvascular complications in addition to quality of life, costs, and cost per quality-adjusted life-year (QALY). FINDINGS: Compared with no screening, all simulated screening strategies reduced the incidence of myocardial infarction (3-9 events prevented per 1000 people screened) and diabetes-related microvascular complications (3-9 events prevented per 1000 people), and increased the number of QALYs (93-194 undiscounted QALYs) added over 50 years. Most strategies prevented a significant number of simulated deaths (2-5 events per 1000 people). There was little or no effect of screening on incidence of stroke (0-1 event prevented per 1000 people). Five screening strategies had costs per QALY of about US$10,500 or less, whereas costs were much higher for screening started at 45 years of age and repeated every year ($15,509), screening started at 60 years of age and repeated every 3 years ($25,738), or a maximum screening strategy (screening started at 30 years of age and repeated every 6 months; $40,778). Several strategies differed substantially in the number of QALYs gained. Costs per QALY were sensitive to the disutility assigned to the state of having diabetes diagnosed with or without symptoms. INTERPRETATION: In the US population, screening for type 2 diabetes is cost effective when started between the ages of 30 years and 45 years, with screening repeated every 3-5 years. FUNDING: Novo Nordisk, Bayer HealthCare, [corrected] and Pfizer.

The metabolic syndrome in a global perspective. The public health impact--secondary publication.

The term "metabolic syndrome" refers to the clustering of a number of cardiovascular risk factors (obesity, hypertension, dyslipidemia and hyperglycaemia) believed to be related to insulin resistance. The prevalence of each of these diseases as well as the metabolic syndrome is increasing world wide. Obesity, hypertension, dyslipidemia and diabetes are no longer diseases of the wealthy. By 2025, three out of four people with diabetes will be living in third world countries, and similar trends are likely for the other components of the syndrome. Preventive action is urgently needed, and studies in China and India have proven to be effective.

Is prevention of Type-2 diabetes feasible and efficient in primary care? A systematic PubMed review.

AIM: To answer: (1) Do we have effective treatments to improve prognosis for those identified at risk of Type-2 diabetes? (2) Will prevention be cost-effective? METHODS: A systematic search was done in PubMed using the following search strategy: "diabetes AND prevention AND (IFG OR IGT)". Restrictions were: "English, Meta-Analysis, Randomized Controlled Trial, Review, Humans". RESULTS: Few randomised controlled preventive trials were found. Almost all were done in research settings in people with high risk of developing Type-2 diabetes. It seems possible to either delay or prevent Type-2 diabetes through lifestyle interventions and medication. Cost-utility analyses are few in number and come to very different conclusions as to whether health policy should promote prevention of Type-2 diabetes. CONCLUSION: Intervention studies using lifestyle counselling and drug therapy in research settings illustrate promising results with lowering of the incidence of Type-2 diabetes, meaning that Type-2 diabetes can be delayed or prevented. It is, however, questionable whether these interventions are cost-effective. We need studies in routine clinical settings evaluating morbidity, mortality and cost-effectiveness as primary outcomes. While waiting for these studies to prove cost-effective, patients with pre-diabetes should be treated according to their 10-year risk of cardiovascular disease following present guidelines.

Representativeness in population-based studies: a detailed description of non-response in a Danish cohort study.

BACKGROUND: Decreasing rates of participation in population-based studies increasingly challenge the interpretation of study results, in both analytic and descriptive epidemiology. Consequently, estimates of possible differences between participants and non-participants are increasingly important for the interpretation of study results and generalization to the background population. METHODS: An age-specific, population-based cohort of 1,198 individuals was examined at age 40, 45, 51, and 60. Participants were compared with non-participants and when possible also with the background population using a wide range of detailed information on somatic and mental health collected at each examination, including data from a clinical examination, biochemical measurements, questionnaires, interviews, and public registers. RESULTS: Participation rates were higher than 80% at examinations at age 40, 45, and 51, but decreased to 65% at age 60. At the baseline investigation at age 40, analyses indicated that participants were representative of the cohort as well as the background population. However, the mortality rate was higher among non-participants in the succeeding 20 years. Among living cohort members at the 60-year examination, non-participants had lower socioeconomic status, higher hospitalization rate, and a worse overall health profile than participants. CONCLUSIONS: The detailed data presented reinforce the contention that the health profile of non-participants is typically worse than that of participants. The results also indicate that while data from public registers give easily accessible information about non-participants, these crude proxy measures of health may not be enough to document representativeness.

A multinational assessment of complications in type 1 diabetes: the DiaMond substudy of complications (DiaComp) Level 1.

The objectives of this study were to describe the global geographic variation of microvascular and macrovascular complications in childhood onset type 1 diabetes (T1D) and to relate any such variation to diabetes care activities such as self blood glucose monitoring and intensive insulin therapy. The DiaComp study is a multinational (17 countries) cross-sectional study of complications in T1D (n=2,657). All participants were diagnosed at < 15 years of age and had a diabetes duration of 524 years when surveyed. Complications were assessed by self-report of physician diagnosis. Twenty-two centres in 17 countries achieved at least a 67% response rate and are included in the analyses. Central European centres exhibited high rates of retinopathy (Lithuania=31.6%, Romania=24.2%), laser treatment (Lithuania=25.4%) and neuropathy (Lithuania=29.9%, Romania=12.4%) in those with short duration of diabetes (515 years), as did Cuba for neuropathy (15.4%). For retinopathy the geographic variation in the short-duration group was also pronounced, ranging from 1.6% in Italy to 41.6% in Lithuania, and from 0% in Brazil, Italy and Australia, to 29.9% in Lithuania for laser treatment. Variation was less dramatic for the prevalence of complications in the long-duration group (1525 years). Hypertension and duration were strong consistent predictors of all complications, while women had higher prevalence for half the complications (retinopathy, laser treatment and renal disease). Intensive insulin therapy and self-monitoring of blood glucose showed little association with prevalence of complications. In conclusion, this first population-based account of the geographic variation of T1D complications has demonstrated substantial variation. However, the healthcare practice variables that were measured contributed little toward explaining this variation.

A multinational assessment of complications in type 1 diabetes: the DiaMond substudy of complications (DiaComp) level 1.

The objectives of this study were to describe the global geographic variation of microvascular and macrovascular complications in childhood onset type 1 diabetes (T1D) and to relate any such variation to diabetes care activities such as self blood glucose monitoring and intensive insulin therapy. The DiaComp study is a multinational (17 countries) cross-sectional study of complications in T1D (n=2,657). All participants were diagnosed at < 15 years of age and had a diabetes duration of 5-24 years when surveyed. Complications were assessed by self-report of physician diagnosis. Twenty-two centres in 17 countries achieved at least a 67% response rate and are included in the analyses. Central European centres exhibited high rates of retinopathy (Lithuania=31.6%, Romania=24.2%), laser treatment (Lithuania=25.4%) and neuropathy (Lithuania=29.9%, Romania=12.4%) in those with short duration of diabetes (5-15 years), as did Cuba for neuropathy (15.4%). For retinopathy the geographic variation in the short-duration group was also pronounced, ranging from 1.6% in Italy to 41.6% in Lithuania, and from 0% in Brazil, Italy and Australia, to 29.9% in Lithuania for laser treatment. Variation was less dramatic for the prevalence of complications in the long-duration group (15-25 years). Hypertension and duration were strong consistent predictors of all complications, while women had higher prevalence for half the complications (retinopathy, laser treatment and renal disease). Intensive insulin therapy and self-monitoring of blood glucose showed little association with prevalence of complications. In conclusion, this first population-based account of the geographic variation of T1D complications has demonstrated substantial variation. However, the healthcare practice variables that were measured contributed little toward explaining this variation.

The socioeconomic correlates of global complication prevalence in type 1 diabetes (T1D): a multinational comparison.

We sought to determine the extent to which the geographic variation in the complications of type 1 diabetes (T1D) may reflect the socioeconomic status (SES) conditions and health care performance (HCP) of countries around the world. The World Health Organization (WHO) DiaMond complications study (DiaComp) is a multinational, cross-sectional study of complications in T1D. Information on complications was identified for 892 subjects from 14 clinical centers in 12 countries. All participants were diagnosed with diabetes in childhood (<15 years of age) and had disease duration of 5-24 years. Complications were assessed by self-report, and by clinical exam, with microalbuminuria identified by Micral II dipstick, neuropathy by the Michigan Neuropathy Screening Instrument exam and hypertension using the HDFP protocol. These data were linked to center-specific information on the local social and economic landscape, health care access and diabetes management practices and health care costs. Country-specific indicators of social and economic development were also linked to the complications data. Both diabetes complications and economic and health care factors vary widely across the DiaComp centers. Health system performance, as measured by disability adjusted life expectancy (DALE), gross national investment (GNI) per capita and purchasing power all showed strong consistent correlations with complications, and significant independent associations with complication prevalence after controlling for HbA1c and hypertension. In conclusion, health system performance, social distribution of wealth and purchasing power may play important roles in explaining the geographic variation of diabetes complications.

Acceptance of the smoking cessation intervention in a large population-based study: the Inter99 study.

AIMS: Potential exists for improving the impact of quit-smoking programmes, by recruiting smokers in early motivational stages, by using active recruitment strategies, and by offering professional assistance to quit. METHODS: This was a randomized population-based intervention study, in Copenhagen, Denmark. A total of 2,408 daily smokers in all motivational stages were included. All participants completed a questionnaire, and underwent a health examination and a lifestyle consultation. Smokers in the high-intensity intervention were offered assistance to quit smoking in smoking cessation groups. RESULTS: Before the lifestyle consultation only 11% of the smokers stated that they planned to quit within one month. After the lifestyle consultation 27% accepted smoking cessation in groups and an additional 12% planned to quit without assistance. Of the smokers who accepted smoking cessation groups 23% had not been planning to quit before the lifestyle consultation. Being a woman, having high tobacco consumption, having a long smoking history, having tried to quit within the previous year, and having a higher motivation to quit predicted participation in smoking cessation groups. CONCLUSIONS: It was possible to recruit a large number of smokers in early motivational stages by using active recruitment strategies and by offering assistance to quit. Lifestyle consultations markedly increased the number of smokers willing to try to quit. Smokers preferred assistance to quit in a smoking cessation group to quitting on their own; therefore, it is important to improve recruitment strategies for smoking cessation programmes.

Smoking cessation intervention in a large randomised population-based study. The Inter99 study.

BACKGROUND: Several large and well-conducted community interventions have failed to detect an effect on prevalence of smoking. METHODS: Two thousand four hundred eight daily smokers in all motivational stages were actively recruited and included in a randomised population-based intervention study in Copenhagen, Denmark. All smokers completed a questionnaire and underwent a health examination and a lifestyle consultation. Daily smokers in the high intensity intervention group were offered assistance to quit in smoking cessation groups. RESULTS: The validated abstinence rate at 1-year follow-up was 16.3% in the high intensity group and 12.7% in the low intensity group compared with a self-reported abstinence rate of 7.3% in the background population. The adjusted odds ratio of abstinence in the high intervention group was significantly higher, OR = 2.2 (1.6-3.0) than in the background population, also in the 'intention-to-treat' analyses, OR = 1.5 (1.1-2.0). Higher socioeconomic status, higher age at onset of daily smoking, and a higher wish to quit were predictors of success. CONCLUSION: In a population-based setting, using active recruitment and offering assistance to quit, it was possible to include many smokers and to achieve a significantly higher validated abstinence in the high intensity intervention than in the background population, even when using 'intention-to-treat' analyses.

A multinational comparison of complications assessment in type 1 diabetes: the DiaMond substudy of complications (DiaComp) level 2.

OBJECTIVE: To describe the global geographic variation of micro- and macrovascular complications in childhood-onset type 1 diabetes assessed by both reported and measured disease and risk factors and relate any such variation to diabetes control and health care activities. RESEARCH DESIGN AND METHODS: The DiaComp study is a multinational (17 countries) cross-sectional study of complications in type 1 diabetes and is comprised of two levels (level 1 includes survey only and level 2 includes survey plus examination). This report concerns level 2, representing 12 countries (n = 892). All participants were diagnosed at <15 years of age and had a diabetes duration of 5-24 years when surveyed. All complications were assessed by self-report and for microalbuminuria by Micral II dipstick, neuropathy by the Michigan Neuropathy Screening Instrument exam, and hypertension using the Hypertension Detection and Follow-up Program (HDFP) protocol. HbA(1c) was determined by using the DCA analyzer. RESULTS: A wide variation in neuropathy, reported renal disease/proteinuria, and hypertension among those of short diabetes duration was noted, with central Europe (Romania and Lithuania) standing out for both self-reported renal disease and measured microalbuminuria and for both self-reported and examined neuropathy. The Caribbean (Puerto Rico) also had high rates of microalbuminuria and examined neuropathy. For those of long duration, variation was more moderate. We found generally good agreement between the reported and clinically determined measures for neuropathy (r = 0.5, P = 0.01) and hypertension (r = 0.61, P = 0.001) as demonstrated by the high overall correlation between examination and self-report for these two complications. However, the agreement between examination and self-report for renal disease/proteinuria was less, with low overall correlation (r = -0.05, P = 0.86) and incongruous centers (Slovakia and Finland). Geographic variation in prevalence was not consistently explained for all complications, even with strong independent prediction by systolic blood pressure, although the variation in microalbuminuria was largely accounted for by self-monitored blood glucose, which was significantly protective. CONCLUSIONS: This report has identified wide variation and geographic patterns in complication prevalence, with a further indication that self-report is generally in agreement with examined prevalence, though less for renal disease/proteinuria. However, this level of DiaComp, with more complete assessment of risk factors and health care practice, was still not able to completely explain the variation in complication prevalence, except for microalbuminuria.

[Screening and intervention. A strategy in type 2 diabetes?]. / Screening og intervention. En strategi ved type 2-diabetes?

Before the introduction of screening for type 2 diabetes, it is necessary to evaluate not only the technology, but also the patient perspective, the economical consequences, and the organising aspects. A review of the relevant literature shows that type 2 diabetes is a rapidly increasing, serious disease. However, there is no documentation that systematic screening will have a positive effect on morbidity and mortality, owing to the lack of randomised clinical trials. The methods for screening could be optimised, and there is a lack of literature on patient perspective. Economical models indicate that opportunistic screening is more cost-effective than is systematic screening, but the lack of randomised trials makes the conclusion dubious. A decision to introduce systematic screening for type 2 diabetes should await the results of ongoing randomised clinical trials. In the meantime, efforts should be spent on improving the level of care for those already diagnosed with diabetes.