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BACKGROUND: Gain in mean survival time from new cancer treatments is a core component of cost-effectiveness analyses frequently used by payers for reimbursement decisions. Due to limited follow-up time, clinical trials rarely report this measure, whereas they often report hazard ratios comparing treatment groups.AIM: We aimed to explore the empirical relationship between gain in mean survival time and the hazard ratio for cancer patients.METHODS: We included all patients in Norway diagnosed from 1965 through 2004 with late-stage cancer at the point of diagnosis and with one of the following cancers: stomach, colon, rectal, pancreas, lung and trachea, kidney excluding renal pelvis, and metastasized breast and prostate. Patients were followed until emigration, death, or June 30, 2016, whichever came first. Observed mean survival times and hazard ratios were obtained in subcohorts defined by patients' sex, age, cancer type, and time period of diagnosis, which had nearly complete follow-up. Based on theoretical considerations, we fitted a linear relationship between observed differences in mean survival and logarithmic hazard ratios. For validation, we estimated differences in mean survival from hazard ratios of bootstrap samples with artificially induced censoring and compared with fitting a Weibull distribution.RESULTS: The relationship between differences in mean survival time and corresponding logarithmic hazard ratios was linear for each of the included cancers. The predicted differences in mean survival of the empirical approach generally had smaller bias than the Weibull approach.CONCLUSION: For cancer diagnoses with poor prognosis, differences in mean survival times could be predicted from corresponding hazard ratios. This hazard ratio-based approach outperforms or is similar to fitting Weibull models to data with incomplete follow-up, while making fewer assumptions.

AIMS: The standardized mortality ratio (SMR) is a widely used measure. A recent methodological study provided an accurate approximate relationship between an SMR and difference in lifetime expectancies. This study examines the usefulness of the theoretical relationship, when comparing historic mortality data in four Scandinavian populations.METHODS: For Denmark, Finland, Norway and Sweden, data on mortality every fifth year in the period 1950 to 2010 were obtained. Using 1980 as the reference year, SMRs and difference in life expectancy were calculated. The assumptions behind the theoretical relationship were examined graphically. The theoretical relationship predicts a linear association with a slope, [Formula: see text], between log(SMR) and difference in life expectancies, and the theoretical prediction and calculated differences in lifetime expectancies were compared. We examined the linear association both for life expectancy at birth and at age 30. All analyses were done for females, males and the total population.RESULTS: The approximate relationship provided accurate predictions of actual differences in lifetime expectancies. The accuracy of the predictions was better when age was restricted to above 30, and improved if the changes in mortality rate were close to a proportional change. Slopes of the linear relationship were generally around 9 for females and 10 for males.CONCLUSIONS: The theoretically derived relationship between SMR and difference in life expectancies provides an accurate prediction for comparing populations with approximately proportional differences in mortality, and was relatively robust. The relationship may provide a useful prediction of differences in lifetime expectancies, which can be more readily communicated and understood.

Background Poor cardiorespiratory fitness (CRF) increases morbidity and mortality risks. Routine CRF assessment in clinical practice has thus been advocated, but little is known about the effect. In this study, we investigated the effect of CRF assessment on CRF in a preventive health check programme. Methods We used a randomised design, in which we invited 4153 middle-aged adults and included 2201 participants who received a preventive health check with CRF assessment (intervention) or without CRF assessment (control). After 1 year, participants were examined. The primary outcomes were adjusted absolute (l/min), relative (ml/kg/min), and poor (%) CRF assessed by the Astrand-Ryhming test. We adjusted for baseline physical activity and intra-cluster correlation within general practices. Results A total of 901 attended the 1-year follow-up. In the intervention group, absolute CRF, relative CRF, and poor CRF were 2.7 l/min (95% confidence interval [CI]: 2.6; 2.8), 34.5 ml/kg/min (95% CI: 33.5; 35.4), and 31.0% (95% CI: 26.8; 35.2). In the control group, the corresponding figures were 2.8 l/min (95% CI: 2.7; 2.9), 35.2 ml/kg/min (95% CI: 34.2; 36.1), and 25.9% (95% CI: 21.8; 30.0). Adjusted absolute CRF was lower in the intervention group (-0.1 l/min [95% CI: -0.2; -0.01]). Adjusted relative CRF (-0.7 ml/kg/min [95% CI: -2.0; 0.6]) and poor CRF (5.0% [95% CI: -0.002; 10.1]) did not differ between groups. No differences were found when adjusting for potential confounding factors. Conclusion Preventive health checks with CRF assessment did not provide higher CRF levels at 1-year follow-up than preventive health checks without CRF assessment.

Background: Demographers and epidemiologists have investigated the dependence of life expectancy on proportional changes in the age-specific mortality. Objective: To develop an approach that allows estimation of change in life expectancy from proportional changes in age-specific mortality and to identify aspects of the death rate that influence the accuracy of the estimation. Results: We obtain an exact expression for the first derivative of the life expectancy with respect to the proportional change in age-specific mortality when the age-specific death rate is log-linear in age. We use the result to establish bounds for the change in life expectancy following a proportional change of the mortality. The result shows that the change in life expectancy is approximately linear in the logarithm of the proportional change of the mortality. In populations with low infant mortality, the slope of this linear relationship is essentially equal to minus the inverse of the slope of the log-linear age dependence of the death rate. Contribution: In a wide range of mortality scenarios, the relationship between change in life expectancy and the logarithm of the proportional change of the mortality allows accurate approximation of a difference in life expectancy from a ratio of death rates.

Background. Alcohol misuse is a global public health priority, with a variation in prevalence and impact between countries. Alcohol misuse in adolescence is associated with adverse psychological, social and physical health. Adolescents in Denmark have higher alcohol consumption and problematic alcohol use than adolescents in other European countries. Associations between social determinants of health (SDH), psycho-social factors and alcohol consumption are complex and influenced by national context and cultures. This study explored these associations in Danish adolescents. Method. The European School Survey Project on Alcohol and Other Drugs (ESPAD) survey collects data on alcohol and substance use among 15–16-year-old European students. Data contributed by Danish students to the 2011 survey were analyzed. The outcomes of interest were alcohol consumption (any, intoxication and problematic). Health literacy was not directly measured, so self-described educational performance and knowledge about alcohol were used as proxies for health literacy. Exploratory factors thus included socio-demographic, health literacy-related (knowledge about alcohol, educational performance) and psycho-social factors, as well as expectancies of the effect of alcohol (both positive and negative) and self-reported health. Univariate and multivariate logistic regression analyses were undertaken. Results. Of the 2768 adolescents who participated in the survey, 2026 (80%) consumed alcohol during the last 30 days, 978 (38%) were intoxicated at least once during the last 30 days, and 1050 (41%) experienced at least one problem because of alcohol use during the last 12 months. Multivariable analysis showed that the factors associated with higher alcohol intake were gender, poor relationships with parents, expectancies of the impact of alcohol (both positive and negative), and the influence of peers and their alcohol use. Higher school performance was related to lower alcohol consumption. Low socio-demographic status was not associated with higher alcohol consumption. Conclusions. This study confirmed the high levels of alcohol intake, intoxication, and problem drinking amongst the Danish students in the survey and the complexity of the socio-demographic, psychosocial, health literacy-related, and environmental factors associated with alcohol behaviours. Approaches to addressing the issue of alcohol use in Danish adolescents will need to be multi-factorial, including supporting students to develop alcohol-related health literacy skills to enable them to make informed choices.

Introduction: Intervening effectively to prevent students' harmful use of alcohol remains a challenge. Harmful alcohol use has been noted as the most dominant public health problem facing universities today. This study sought to investigate the diversity in staff and student perceptions of the contribution alcohol makes to student life in a Danish university setting. Increasing understanding of staff and students' perceptions of how alcohol fits into student life is required to amend future public health intervention for this population. Materials and methods: This Q methodology study included 38 staff members and 105 students from Aarhus University, Denmark. Participants used online Q sorting software, to rank 40 statements about the contribution alcohol makes to the university student experience from strongly agree to disagree. To support the interpretation of the factors, self-reported alcohol consumption and demographic data were collected. In addition qualitative data was collected on the participant's reasons for the ranking of the items they most strongly agreed or disagreed with. Results and discussion: Using principal components analysis, five statistically independent viewpoints for students and four for staff were identified. The findings provide evidence to inform approaches to prevent harmful alcohol use. Some viewpoints suggest a need for tailored secondary and tertiary prevention and intervention that focusses on individuals and/or sub-groups who are at risk of consuming alcohol at harmful levels. Other viewpoints suggest the need for primary universal prevention to support the maintenance of healthy norms which can prevent harmful alcohol behaviour. Public health campaigns need to ensure that interventions targeting harmful alcohol use at universities challenge problematic perceptions and attitudes while also bolstering exposure to positive norms.

The authors have discovered a coding error in the statistical analysis syntax file used for the mixed-effect model analyses in this paper. The error has led to differences (first decimal) in the estimates for the main results.

Studiet undersøger, om socioøkonomisk position (SEP) har betydning for opnåelse af behandlingsmål blandt personer fundet med type 2 diabetes gennem screening i almen praksis i 5.9 års follow-up.Studiet viste generelt forbedring i HbA1c, kolesterol og blodtryk fra baseline til follow-up. Dette blev fundet uanset uddannelsesniveau, indkomstniveau, beskæftigelse eller samlivsstatus. Studiet viste også at evnen til at opnå behandlingsmål for metaboliske risikofaktorer ikke blev modificeret af SEP. Imidlertid indløste personer med lavt uddannelses- og lavt indkomstniveau i intensiv behandling recept på antihypertensiv medicin i højere grad end personer med højere uddannelse og indkomst. Studiet bygger på data fra 1533 personer i alderen 40-69 år, som fik konstateret type 2-diabetes ved screening i almen praksis, 2001-2006. Undersøgelsen udgør en del af ADDITION-studie, der er et samarbejde mellem Storbritannien, Holland og Danmark med fokus på diabetes i almen praksis. Disse fund indikerer, at tidlig opsporing af type 2-diabetes og tidlig igangsættelse af behandling ikke introducerede social ulighed i opnåelse af behandlingsmål for metaboliske risikofaktorer. 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.

$\textbf{Introduction}$ Very few studies have examined the potential spill-over effect of a trial intervention in general practice. We investigated whether training and support of general practitioners in the intensive treatment of people with screen-detected diabetes improved rates of redeemed medication, morbidity and mortality in people with clinically-diagnosed diabetes. $\textbf{Methods}$ This is a secondary, post-hoc, register-based analysis linked to a cluster randomised trial. In the $\textit{ADDITION-Denmark}$ trial, 175 general practices were cluster randomised (i) to routine care, or (ii) to receive training and support in intensive multifactorial treatment of individuals with screen-detected diabetes (2001 to 2009). Using national registers we identified all individuals who were diagnosed with clinically incident diabetes in the same practices over the same time period. (Patients participating in the ADDITION trial were excluded). We compared rates of redeemed medication, a cardiovascular composite endpoint, and all-cause mortality between the routine care and intensive treatment groups. $\textbf{Results}$ In total, 4,107 individuals were diagnosed with clinically incident diabetes in $\textit{ADDITION-Denmark}$ practices between 2001 and 2009 (2,051 in the routine care group and 2,056 in the intensive treatment group). There were large and significant increases in the proportion of patients redeeming cardio-protective medication in both treatment groups during follow- up. After a median of seven years of follow-up, there was no difference in the incidence of a composite cardiovascular endpoint (HR 1.15, 95% CI 0.95 to 1.38) or all-cause mortality between the two groups (HR 1.08, 95% CI 0.94 to 1.23). $\textbf{Discussion}$ There was no evidence of a spill-over effect from an intervention promoting intensive treatment of people with screen-detected diabetes to those with clinically-diagnosed diabetes. Overall, the proportion of patients redeeming cardio-protective medication during follow-up was similar in both groups. $\textbf{Trial Registration}$ ClinicalTrials.gov NCT00237549

Aim/hypothesis: Our aim was to investigate the association between the macrophage-activation marker soluble CD163 (sCD163), adiponectin, C-reactive protein (CRP) and changes in glycaemia, insulin resistance and insulin secretion in individuals at high risk of type 2 diabetes mellitus. Methods: This prospective study included 1014 individuals at high risk of type 2 diabetes mellitus participating in the Danish arm of the Anglo-Danish-Dutch study of Intensive Treatment In PeOple with ScreeN-detected Diabetes in Primary Care (ADDITION-Europe trial) baseline examination in 2001–2006 and follow-up examination (ADDITION-Progression [ADDITION-PRO]) in 2009–2011. Baseline serum samples were analysed for sCD163, adiponectin and CRP. The associations between sCD163, adiponectin and CRP per doubling of concentration, and changes per year in HbA1c, fasting plasma glucose, 2 h glucose, fasting insulin, HOMA-IR and HOMA-β were assessed using a mixed-effects model. Results: A doubling of sCD163 concentration was positively associated with changes in HOMA-β (β = 1.160 per year, 95% CI 0.345, 1.975) as well as a doubling of CRP concentration (β = 0.410 per year, 95% CI 0.051, 0.769) after adjustment for age and sex. A doubling of adiponectin was inversely associated with changes in 2 h glucose (β =−0.063 per year, 95% CI −0.111, −0.014), HOMA-IR (β =−0.038 per year, 95% CI −0.060, −0.015) and HOMA-β (β =−1.028 per year, 95% CI −1.635, −0.421) after adjustment for age and sex. The associations were robust to adjustment for baseline waist circumference and smoking. Adjustment for CRP did not change the associations for sCD163 or adiponectin. Conclusions/interpretation: Our findings indicate that mechanisms related to inflammation, including macrophage activation and adipocyte metabolism, may play a role in changes in glucose homeostasis in individuals at high risk of type 2 diabetes mellitus. © 2016, Springer-Verlag Berlin Heidelberg. Aim/hypothesis: Our aim was to investigate the association between the macrophage-activation marker soluble CD163 (sCD163), adiponectin, C-reactive protein (CRP) and changes in glycaemia, insulin resistance and insulin secretion in individuals at high risk of type 2 diabetes mellitus. Methods: This prospective study included 1014 individuals at high risk of type 2 diabetes mellitus participating in the Danish arm of the Anglo-Danish-Dutch study of Intensive Treatment In PeOple with ScreeN-detected Diabetes in Primary Care (ADDITION-Europe trial) baseline examination in 2001–2006 and follow-up examination (ADDITION-Progression [ADDITION-PRO]) in 2009–2011. Baseline serum samples were analysed for sCD163, adiponectin and CRP. The associations between sCD163, adiponectin and CRP per doubling of concentration, and changes per year in HbA 1c, fasting plasma glucose, 2 h glucose, fasting insulin, HOMA-IR and HOMA-β were assessed using a mixed-effects model. Results: A doubling of sCD163 concentration was positively associated with changes in HOMA-β (β = 1.160 per year, 95% CI 0.345, 1.975) as well as a doubling of CRP concentration (β = 0.410 per year, 95% CI 0.051, 0.769) after adjustment for age and sex. A doubling of adiponectin was inversely associated with changes in 2 h glucose (β =−0.063 per year, 95% CI −0.111, −0.014), HOMA-IR (β =−0.038 per year, 95% CI −0.060, −0.015) and HOMA-β (β =−1.028 per year, 95% CI −1.635, −0.421) after adjustment for age and sex. The associations were robust to adjustment for baseline waist circumference and smoking. Adjustment for CRP did not change the associations for sCD163 or adiponectin. Conclusions/interpretation: Our findings indicate that mechanisms related to inflammation, including macrophage activation and adipocyte metabolism, may play a role in changes in glucose homeostasis in individuals at high risk of type 2 diabetes mellitus.

Maindal HT, Skriver MV, Kirkevold M, Lauritzen T & Sandbaek A (2011) Journal of Nursing and Healthcare of Chronic Illness3, 293–301 Comorbidity and lack of education countered participation in a diabetes prevention self-management program Aim. To investigate socio-economic and disease-related predictors for non-participation in the ‘Ready to Act’ program offering self-management support to people with screen-detected dysglycaemia. Background. Screening for type 2 diabetes followed by support to people’s self-management strategies is increasingly being offered in primary care. Due to non-participation in self-management programs, healthcare providers often miss the opportunity to provide the basic knowledge and skills resulting in uninformed self-management decisions. Methods. A prospective cohort-study was conducted in 2010 within the framework of the Danish part of the Anglo–Danish–Dutch study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION). A total of 322 43- to 75-year-old screen-detected patients, receiving GP-multi-faceted intensive treatment were invited to an additional interdisciplinary 12-week self-management program ‘Ready to Act’. A comparison between participants and non-participants was conducted according to socio-economic outcomes: age, gender, cohabitant and education and disease-related outcomes: diagnosis (diabetes or prediabetes), duration of diagnosis, comorbidity measured by Charlson’s combined 17 medical conditions measure. Results. The participant rate was 44%. The most pronounced predictor for participation was vocational education. With no vocational education as the reference group, the OR for participation was 1·91 (95% CI 1·06–3·44) for 1–3 years of vocational education and 2·65 (95% CI 1·31–5·39) for more than 3 years of vocational education. Second, having comorbidity (a score of one or more at Charlson’s index) tended to decrease participation (OR 0·6, 95% CI 0·34–1·06). Conclusion. Educational level and comorbidity were the most decisive factors that influenced attendance to a diabetes prevention program. Both factors are available in daily clinical practice for healthcare planning. Relevance to clinical practice. The results incite improved awareness of how to develop different recruitment strategies accounting for educational level and comorbidity, involve the target groups in intervention development, and include individual, contextual and health-system factors when shaping self-management interventions.

Det er velkendt, at personer med type 2-diabetes har højere dødelighed end personer uden, samt at der er overdødelighed blandt personer med lavere uddannelses- og indkomstniveau sammenlignet med personer med højere socioøkonomisk position. Formålet med dette studie var at undersøge sammenhængen mellem de tre faktorer: socioøkonomisk position, diabetes og død. I studiet indgik hele den danske befolkning i alderen 40-69 år i årene 2001-06 (N=2,330,206) uden diabetes ved studiestart. Populationen blev fulgt i op til 11 år, og personer overgik til diabetespopulation, hvis de blev registreret med diabetes i Diabetesregisteret i løbet af perioden. Vi fandt, at dødeligheden steg med faldende socioøkonomisk position både blandt personer med og uden diabetes. Både type 2-diabetes og socioøkonomisk position havde stor indflydelse på dødeligheden og den kombinerede effekt af de to faktorer på dødelighed beskrives bedst som additiv. Studiet indikerer, at diabetesbehandling når personer med lav og høj uddannelses- og indkomstniveau i samme grad. Dette støttes af fund fra et tidligere studie, hvor vi fandt CVD-risikofaktorer kontrolleret i samme grad uanset socioøkonomisk position. BACKGROUND: Both socioeconomic position (SEP) and type 2 diabetes have previously been found to be associated with mortality; however, little is known about the association between SEP, type 2 diabetes and long-term mortality when comorbidity is taken into account.METHODS: We conducted a population-based cohort study of all Danish citizens aged 40-69 years with no history of diabetes during 2001-2006 (N=2,330,206). The cohort was identified using nationwide registers, and it was followed for up to 11 years (mean follow-up was 9.5 years (SD: 2.6)). We estimated the age-standardised mortality rate (MR) and performed Poisson regression to estimate the mortality-rate-ratio (MRR) by educational level, income and cohabiting status among people with and without type 2 diabetes.RESULTS: We followed 2,330,206 people for 22,971,026 person-years at risk and identified 139,681 individuals with type 2 diabetes. In total, 195,661 people died during the study period; 19,959 of these had type 2 diabetes. The age-standardised MR increased with decreasing SEP both for people with and without diabetes. Type 2 diabetes and SEP both had a strong impact on the overall mortality; the combined effect of type 2 diabetes and SEP on mortality was additive rather than multiplicative. Compared to women without diabetes and in the highest income quintile, the MRR's were 2.8 (95%CI 2.6, 3.0) higher for women with type 2 diabetes in the lowest income quintile, while diabetes alone increased the risk of mortality 2.0 (95%CI 1.9, 2.2) times and being in the lowest income quintile without diabetes 1.8 (95%CI 1.7,1.9) times after adjusting for comorbidity. For men, the MRR's were 2.7 (95%CI 2.5,2.9), 1.9 (95%CI 1.8,2.0) and 1.8 (95%CI 1.8,1.9), respectively.CONCLUSION: Both Type 2 diabetes and SEP were associated with the overall mortality. The relation between type 2 diabetes, SEP, and all-cause mortality was only partly explained by comorbidity.

Although venous thromboembolism (VTE) is common in patients with cancer, it is not known if it is associated with risk of a second malignancy. Using the Danish Cancer Registry and National Registry of Patients, we studied a population-based cohort of 6285 patients with cancer who had an episode of VTE. The risk of a second cancer was compared with that among 30 713 cancer patients without VTE, matched for age, sex, cancer site and year of diagnosis. Overall, the relative risk for a second cancer diagnosis was 1.3 (95% confidence interval (CI) 1.1–1.4). However, the excess risk varied with the time from the initial cancer diagnosis to the thrombotic event. If the thrombotic episode occurred within the first year, the relative risk for a second cancer was 1.0 (95% CI 0.9–1.3), but if the VTE occurred more than 1 year after the initial cancer, the overall relative risk for a second cancer was 1.4 (95% CI 1.2–1.7), with strong associations for cancers of the digestive organs, ovary and prostate. The association between VTE and subsequent incident cancer extends to patients who already have had a cancer diagnosis.

Background: The most common complication after coronary angiography (CA) and percutaneous coronary intervention (PCI) is the development of haematoma. Several changes in procedures regarding CA and PCI have been made in our department in recent years. The aim of this audit is to establish how many patients develop haematoma after CA/PCI via the femoral artery and subsequently to find predictors that increase the risk of developing haematoma. Methods: We initially included 474 consecutive patients-322 patients undergoing CA and 141 patients undergoing PCI. Eleven patients were later excluded due to the absence of complete data. Thirty-three variables were registered in order to find predictors, which might increase the haematoma frequency. A univariate as well as a multivariate logistic regression analysis was performed. Results: Of the 463 patients, 6 patients developed a haematoma > 10 cm (1.3%) and 41 patients developed a haematoma > 5 cm (8.9%). The following factors were found to be associated with the generation of haematoma: Women, systolic blood pressure > 160 mm Hg, artery puncture > 1, sheath time > 16 min, ACT ≥ 175 s, Glycoprotein (GP) IIB/IIIa inhibitors, Low Molecular Weight Heparin before procedure, personnel change during compression, and anti-coagulant-treatment before procedure. Conclusions: The frequency of haematoma was 1.3% (> 10 cm) and 8.9% (> 5 cm), which corresponds with reports from similar studies and departments. The factors found to increase the risk of haematoma development can provide background for procedural changes and increase the focus on patients at increased risk in order to minimize the development of haematomas.

The objectives of this study were to estimate the data quality of haematological malignancy diagnoses in a hospital discharge registry, and to quantify the impact of any misclassification of diagnoses on survival estimates. We included all patients > or = 15 years living in North Jutland County, Denmark with a first-time discharge diagnosis of a haematological malignancy registered in the Hospital Discharge Registry and the Danish Cancer Registry, the reference standard, from 1994 to 1999. We estimated completeness and positive predictive value (PPV) of haematological malignancies and specific subcategories, as a measure of data quality, and compared mortality rates based on data from the two registries by Cox regression analysis. Completeness in the Hospital Discharge Registry for all haematological malignancies was 91.5% (95% confidence interval (CI) 89.6-93.1) and PPV was 84.5% (95% CI 82.2-86.5). Reviews of the pathological files showed misclassified cases in both registries and thus indicated that both completeness and PPV of the Hospital Discharge Registry were underestimates. Mortality rate ratio for all haematological malignancies when registered in the Hospital Discharge Registry compared with being registered in the Danish Cancer Registry was 0.98 (95% CI 0.88-1.09). Discharge data had some misclassifications but these had no major impact on survival estimates.

Summary Background : Use of metronidazole has been suggested to be associated with an increased risk of acute pancreatitis in case reports. Aim : To examine this issue within a proper epidemiological design. Methods : We identified 3083 incident cases of acute pancreatitis from Hospital Discharge Registries in three Danish counties and 30 830 matched population controls. From prescription databases, we extracted information on use of metronidazole with or without concomitant use of proton-pump inhibitors and/or amoxicillin, macrolides or tetracycline. Results : Adjusted odds ratios for acute pancreatitis in study subjects who redeemed a prescription for metronidazole within 30, 31–180, or 181–365 days before hospitalization or index date among controls were 3.0 [95% confidence interval (CI): 1.4–6.6], 1.8 (95% CI: 1.2–2.9) and 1.1 (95% CI: 0.6–1.8), respectively. Among subjects with a concomitant prescription for proton-pump inhibitors and/or amoxicillin, macrolides or tetracycline within 30, 31–180, or 181–365 days before hospitalization, or index date among controls, adjusted odds ratios were 8.3 (95% CI: 2.6–26.4), 2.7 (95% CI: 1.4–5.5), and 1.7 (95% CI: 0.6–4.8), respectively. Conclusion : Metronidazole may increase the risk of acute pancreatitis. However, the risk seems mainly to increase when metronidazole is used in combination with other drugs used for Helicobacter pylori eradication.

Aims Amoxicillin is a widely used penicillin, but data on its safety in pregnancy are limited. We examined the association between amoxicillin exposure during pregnancy and birth weight, preterm delivery, congenital malformations, perinatal death, and spontaneous abortion.

Meget lavt konditionsniveau er en selvstændig risikofaktor for tidlig død hos raske personer og særligt hos personer med forhøjet 10-års risiko for at dø af hjertekarsygdom. Dette studie viser, at hver anden mand og hver tredje kvinde har et meget lavt konditionsniveau. Blandt personer med høj 10-års risiko for at dø af hjertekarsygdom har to tredjedele af mændene og næsten halvdelen af kvinderne et meget lavt konditionsniveau. Studiet inkluderer 2.253 personer, som deltog i en forebyggende helbredsundersøgelse som led i projektet ”Tjek dit helbred”, der aktuelt gennemføres i Randers Kommune i samarbejde med kommunens praktiserende læger og Region Midtjylland. Studiets resultater tydeliggør, at der på folkesundhedsområdet er behov for effektive strategier til at forbedre konditionsniveauet i den generelle befolkning og særligt blandt personer med høj risiko for hjertekarsygdom. BACKGROUND: Poor cardiorespiratory fitness (CRF) is an independent predictor of cardiovascular and all-cause mortality. Yet, our knowledge about the prevalence of poor CRF is limited. We investigated the prevalence of poor CRF among middle-aged Danish adults from a community-based health promotion program, including identification of a subgroup with high cardiovascular mortality risk.METHODS: This cross-sectional study included 2,253 middle-aged adults, who completed a preventive health check including CRF testing. CRF (ml O2/min/kg) was assessed using the Astrand-Ryhming cycle ergometer test. High 10-year cardiovascular mortality risk as defined in the Danish 2016 guidelines was assessed using questionnaires, health examinations, and prescription data from the Danish National Prescription Registry.RESULTS: The prevalence of poor CRF was 51.7% (95% confidence interval [CI] 48.7-54.7) among men and 31.3% (95% CI 28.7-34.1) among women. A total of 216 (19.4%) men and 220 (19.3%) women were identified with a high 10-year cardiovascular mortality risk. Among these, 65.0% of men (95% CI 58.2-71.3) and 44.1% of women (95% CI 37.4-50.9) had poor CRF.CONCLUSION: Half of men and one third of women participating in a community-based health promotion program were identified with poor CRF. Among high-risk individuals, two thirds of men and almost every second woman had a poor CRF. Our results emphasise the need for effective public health strategies and interventions to increase CRF in the general population and among high-risk individuals in particular in order to improve public health and reduce mortality.

The aim of this study was to examine the association between psychological distress and the risk of cardiovascular disease (CVD) events and all-cause mortality in patients with screen-detected type 2 diabetes mellitus. In addition, we explored whether or not metabolic control and medication adherence could explain part of this association.A follow-up study was performed including 1,533 patients aged 40-69 years with screen-detected type 2 diabetes mellitus identified in general practice during 2001-2006 in the Denmark arm of the ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care) study. Mental health was measured at baseline with the Mental Health Inventory 5 (MHI-5). Psychological distress was defined as an MHI-5 score of ≤ 68 (18.2% of the population). CVD risk factors were measured at baseline and repeated at the follow-up examination. Information on death, hospital discharge diagnosis, and antihypertensive and lipid-lowering drug treatment was obtained from national registers. Cox proportional regression was used to estimate HRs for the association between psychological distress, CVD events and all-cause mortality. Age- and sex-adjusted risk difference analyses were performed to estimate differences in meeting treatment targets.Patients with psychological distress had a 1.8-fold higher mortality rate (HR 1.76, 95% CI 1.23, 2.53) and a 1.7-fold higher risk of having a CVD event (HR: 1.69, 95% CI 1.05, 2.70) compared with those with an MHI-5 score of68. Overall, psychological distress was not associated with the ability to meet treatment targets for HbA1c levels, cholesterol levels or BP, or to redeem antihypertensive or lipid-lowering drug treatment.In people detected and treated early in the diabetes disease trajectory, those with psychological distress at the time of diagnosis had a higher risk of CVD events and death than those without psychological distress.

We examined the use of antibiotics among 2728 women with a first diagnosis of breast cancer during 1994–2003, and 27 280 population controls in North Jutland County, Denmark, based on hospital discharge diagnoses, prescription use from 1989 to 2002, and population registry data. We found no increased relative risk of breast cancer associated with use compared with nonuse. The odds ratio for breast cancer associated with more than 10 prescriptions for antibiotics was 1.00 (95% CI 0.86 –1.15). Relative risks were similar for different classes of antibiotics. A subanalysis based on cases and controls younger than 70 years of age, with data on first birth and number of children, showed similar risk estimates even after adjustment for age at first birth and parity. In our study, use of antibiotics was not associated with an increased risk of breast cancer.

A case report has suggested that exposure to erythromycin through breast milk might cause infantile hypertrophic pyloric stenosis. This study therefore examined whether macrolides, transmitted via breast milk, increase the risk of infantile hypertrophic pyloric stenosis in neonates. A population-based cohort study was conducted, based on data from a prescription registry, the Danish Birth Registry and North Jutland County's hospital discharge registry, Denmark, and comprising 1166 pregnant women who had been prescribed macrolides from birth to 90 d postnatally, and 34,690-41,778 pregnant women as controls. The odds ratios for infantile hypertrophic pyloric stenosis varied between 2.3 and 3.0 according to different periods of postnatal exposure, and after stratification for gender they were 10.3 [95% confidence interval (95% CI) 1.2-92.3] for girls and 2.0 (95% CI 0.5-8.4) for boys. The use of macrolides during breast-feeding increases the risk of infantile hypertrophic pyloric stenosis.

In a population-based setting, we investigated whether diabetes-related morbidity and all-cause mortality within 2 years of HbA(1c) measurement were associated with that HbA(1c) level in individuals with type 2 diabetes. The main objective was to compare outcomes in those with HbA(1c) ≥ and7% (53 mmol/mol).Individuals with type 2 diabetes from Aarhus County, Denmark, were identified from public data files in a 3 year period (2001-2003). Stratifying the 17,760 individuals by HbA(1c), we estimated HRs for diabetes-related morbidities and all-cause mortality using Cox regression. Results were also stratified by treatment modality.In total, 1,805 individuals experienced at least one diabetes-related morbidity and 1,859 individuals died. In general, the HRs in adjusted analyses of diabetes-related morbidity and mortality were increased for HbA(1c) ≥ 7% (53 mmol/mol): morbidity, HR 1.48 (95% CI 1.34, 1.63); and mortality, HR 1.26 (95% CI 1.15, 1.39). On grouping individuals according to HbA(1c)5% (31 mmol/mol), 5.0-5.9% (31-41 mmol/mol), 6.0-6.9% (42-52 mmol/mol), 7.0-7.9% (53-63 mmol/mol), 8.0-8.9% (64-74 mmol/mol) and ≥ 9% (75 mmol/mol), the HRs for mortality formed a U shape, with HbA(1c) 6.0-6.9% (42-52 mmol/mol) at the lowest point. For diabetes-related morbidity, a dose-response pattern appeared (lowest for HbA(1c)5% [31 mmol/mol]). Patterns of HR differed with treatment modality.An HbA(1c) level ≥ 7% (53 mmol/mol) was associated with increased morbidity and mortality. Both high and very low levels of HbA(1c) were associated with increased mortality. A dose-response pattern appeared for morbidity. The impact of HbA(1c) level on morbidity and mortality depended on treatment modality.

Udgivelsesdato: 2010-Nov AIMS/HYPOTHESIS: Stepwise screening for type 2 diabetes will not only identify people with the disease or some other form of dysglycaemia (impaired fasting glucose or impaired glucose tolerance), but also many individuals who are phenotypically at high risk of developing diabetes, but currently have normal glucose tolerance (NGT). We therefore sought to assess whether HbA(1c) adds prognostic information in relation to all-cause mortality in people who have NGT and a high risk of type 2 diabetes mellitus. METHODS: In a Danish population-based stepwise screening programme for type 2 diabetes mellitus in general practice, we identified 15,634 persons at high risk of type 2 diabetes, who had NGT and a recorded HbA(1c) measurement. As comparison groups, we included 1,401 people identified as having type 2 diabetes mellitus and 8,149 individuals characterised as being at low risk of diabetes. All individuals were followed from time of screening (April 2001 to December 2006) until death or 31 October 2009. Excess mortality was estimated using Cox proportional hazard models with all-cause mortality as the outcome measure. RESULTS: Compared with individuals with NGT and HbA(1c) below 6.0%, adjusted hazard ratios were: 1.21 (95% CI 0.95-1.56) for individuals with NGT and HbA(1c) between 6.0% and 6.5%; 2.48 (95% CI 1.23-4.99) for individuals with NGT and HbA(1c) 6.5% or above (in this group there were eight deaths among 68 individuals); 1.73 (95% CI 1.40-2.13) for individuals with type 2 diabetes mellitus. CONCLUSIONS/INTERPRETATION: HbA(1c) level in people with NGT and at high risk of diabetes was clearly associated with increased all-cause mortality.

The measurement of HbA(1c) is suggested as a diagnostic test for diabetes. Screening for diabetes also identifies individuals with elevated cardiovascular risk but who are free of diabetes. This study aims to assess whether screening by HbA(1c) or glucose measures alone, or in combination with a cardiovascular risk assessment, identifies people who may benefit from preventive interventions, i.e. people with screen detected diabetes and people belonging to groups with excess mortality, during a median follow-up of 7 years.A population-based, stepwise high-risk screening programme was performed in 193 family practices from 2001 to 2006. Individuals aged between 40 and 69 years (N = 163,185) were sent a diabetes risk questionnaire. Of these, 20,916 people at risk of diabetes were stratified by glucose measures (normal glucose tolerance [NGT], impaired fasting glucose [IFG], impaired glucose tolerance [IGT] and diabetes), HbA(1c) (6%; 6.0-6.4%; or ≥ 6.5%) and cardiovascular risk (heart SCORE5 or ≥ 5). People were followed for a median of 7 years or until death. Excess mortality was calculated using the Cox hazard ratio (HR).SCORE ≥ 5 identified 91.7% (95% CI 91.1-92.3%) of those who might benefit from preventive interventions. SCORE ≥ 5 in combination with HbA(1c) ≥ 6.0% identified 96.7% (95% CI 96.3-97.0%), compared with 97.6% (95%CI 97.2-97.9%) in combination with glucose measures. Glucose measures or HbA(1c) alone identified 26.1% (95% CI 25.2-27.0%) and 19.8% (95% CI 19.0-20.6%), respectively.In a population-based high risk screening programme in primary care, HbA(1c) ≥ 6.0% combined with an elevated cardiovascular risk assessment (SCORE ≥ 5) can feasibly be used to identify those who may benefit from preventive lifestyle intervention and/or polypharmacy.ClinicalTrials.gov NCT 00237549.The study received unrestricted grants from Novo Nordisk, Novo Nordisk Scandinavia, Astra Denmark, Pfizer Denmark, GlaxoSmithKline Pharma Denmark, Servier Denmark and HemoCue Denmark.

OBJECTIVE: We assessed the relationship of mortality with glycated hemoglobin (HbA1c) variability and with absolute change in HbA1c.DESIGN: A population-based prospective observational study with a median follow-up time of 6 years.METHODS: Based on a validated algorithm, 11 205 Danish individuals with type 2 diabetes during 2001-2006 were identified from public data files, with at least three HbA1c measurements: one index measure, one closing measure 22-26 months later, and one measurement in-between. Medium index HbA1c was 7.3%, median age was 63.9 years, and 48% were women. HbA1c variability was defined as the mean absolute residual around the line connecting index value with closing value. Cox proportional hazard models with restricted cubic splines were used, with all-cause mortality as the outcome.RESULTS: Variability between 0 and 0.5 HbA1c percentage point was not associated with mortality, but for index HbA1c ≤8% (64 mmol/mol), a variability above 0.5 was associated with increased mortality (HR of 1 HbA1c percentage point variability was 1.3 (95% CI 1.1 to 1.5) for index HbA1c 6.6-7.4%). For index HbA1c≤8%, mortality increased when HbA1c declined, but was stable when HbA1c rose. For index HbA1c>8%, change in HbA1c was associated with mortality, with the lowest mortality for greatest decline (HR=0.9 (95% CI 0.80 to 0.98) for a 2-percentage point decrease).CONCLUSIONS: For individuals with an index HbA1c below 8%, both high HbA1c variability and a decline in HbA1c were associated with increased mortality. For individuals with index HbA1c above 8%, change in HbA1c was associated with mortality, whereas variability was not.

The aim of this study was to examine the risk of hypospadias after reported exposure to loratadine and other antihistamines during pregnancy, based on data from the Danish National Birth Cohort. We examined the risk of hypospadias in a nested case-control design based on women enrolled in the Danish National Birth Cohort from 1998 to 2002 ( approximately 95,000 pregnant women). Data on maternal use of medicine in pregnancy were retrieved from questionnaires and telephone interviews, and data on birth outcomes were obtained from the Hospital Discharge Registry (HDR). Within the Danish National Birth Cohort, we identified cases with a diagnosis of hypospadias and randomly selected 10 controls per case without such a diagnosis (matched by date of birth). We identified 203 cases of hypospadias recorded in the HDR within 1 year postpartum and 2030 controls. One case (0.5%) and 25 (1.2%) controls reported exposure to loratadine in the first trimester or up to 30 days before the time of conception. The adjusted odds ratio (OR) for hypospadias among users of loratadine relative to nonusers was 0.9 (95% CI: 0.1-6.9) and the corresponding OR for other antihistamines was 0.5 (95% CI: 0.1-1.9). These data do not indicate an increased risk of hypospadias associated with maternal exposure to loratadine. In addition, this study does not suggest any risk differential between maternal exposure to loratadine and other antihistamines. However, the statistical precision of the risk estimates was low.

Udgivelsesdato: 2006-Jun OBJECTIVES: Patients with ulcerative colitis (UC) are at increased risk of colorectal cancer (CRC). Little is known about how UC impacts CRC prognosis. In a nationwide population-based study we examined the CRC prognosis in UC patients compared to CRC patients without UC. METHODS: From the Danish Cancer Registry and the Danish Hospital Discharge Registry, we identified all CRC patients and all patients with UC in Denmark from 1977 to 1999. We compared survival in 279 UC patients with CRC to all other 71,259 CRC patients and computed mortality rate ratios (MRR). We also compared stage distribution at time of cancer diagnosis. RESULTS: The mean age at time of CRC diagnosis was 62.6 yr in UC patients and 71.2 yr in patients without UC. Cancer stage distribution for localized cancer, regional spread, and distant metastasis were 46.6%, 30.1%, and 16.5% in UC patients compared to 44.0%, 28.3%, and 19.4% in CRC patients without UC. The overall MRR for UC patients with CRC compared with all other CRC patients were 1.24 (95% CI 1.02-1.51) in the first year and 1.17 (95% CI 1.01-1.36) after 5 yr of follow-up. CONCLUSION: UC patients with CRC have a stage distribution similar to patients with CRC without UC. The prognosis of CRC is poorer for UC patients than for patients without UC.

Udgivelsesdato: 2007-Jan BACKGROUND AND AIMS: Patients with Crohn's disease (CD) are at increased risk of colorectal cancer (CRC), but little is known about the impact of CD on CRC prognosis. Based on nationwide population-based registries, we compared survival among CRC patients with CD and CRC patients without CD. METHODS: We used the Danish Cancer Registry and the Danish Hospital Discharge Registry to identify all patients diagnosed with CRC, with and without CD, in Denmark between 1977 and 1999. We ascertained the stage distribution at the time of CRC diagnosis and 1- and 5-yr survival both for patients with Crohn-associated CRC and patients with non-Crohn CRC. Cox regression was used to compute hazard ratios (HRs), adjusting for gender, age, calendar year, and stage. RESULTS: We identified 100 CRC patients with CD and 71,438 CRC patients without CD. At the time of diagnosis, patients with CD were younger, but stage distributions were similar in the two groups. The overall HR for CRC with CD compared to CRC without CD was 1.82 (95% CI 1.36-2.43) after 1 yr of follow-up, and 1.57 (95% CI 1.24-1.99) after 5 yr of follow-up. Subanalyses showed that the effect of CD on CRC survival was more pronounced in the youngest patients (0-59 yr), in men, and in patients whose tumors had regional spread. CONCLUSIONS: We found that CD worsens the prognosis of CRC, particularly CRC with regional spread.

To examine the risk of hypospadias after exposure to loratadine and other antihistamines during pregnancy, we conducted a population-based case-control study in four Danish counties, which account for 30% of the Danish population (approximately 1.6 M). We obtained data on maternal use of antihistamines from prescription databases, and data on birth outcomes from the Danish Medical Birth Registry (MBR) and the Hospital Discharge Registry (HDR). A total of 65,383 male births with a full prescription history of the mother in the study period from 1989-2002 were available for analysis. Within this cohort, we identified cases with a diagnosis of hypospadias, and 10 selected controls per case without such a diagnosis (matched on birth month, gender and year of birth). We identified 227 cases of hypospadias recorded in the HDR within six months postpartum and 2270 controls. One case (0.4%) and eight (0.4%) controls were exposed to loratadine in the first trimester and up to 30 days before the time of conception. The adjusted odds ratio (OR) for hypospadias among users of loratadine relative to non-users was 1.4 (95% CI: 0.2-11.2) and the corresponding OR for other antihistamines was 1.9 (95% CI: 0.7-5.7). In this study, maternal exposure to loratadine did not appear to be associated with an increased risk of hypospadias when compared with other antihistamines, although it should be noted that the statistical precision of the risk estimates might be limited.

Summary Background Fever of unknown origin is associated with cancer, but the tumour types most commonly involved and the prognostic implications of this relation have not been studied. We aimed to assess the risk of cancer and survival after hospital admission for fever of unknown origin in a nationwide Danish follow-up study. Methods We linked the Danish national registry of patients and the nationwide cancer registry, and assessed cancer risk for 43 205 patients discharged for the first time from Danish hospitals after admission for fever of unknown origin during 1977–97. We compared cancer frequency with that expected on the basis of cancer incidence in the general population, and survival of patients with cancer who had had fever of unknown origin with that of controls (ie, patients with cancer matched for cancer site, age at time of cancer diagnosis, and year of cancer diagnosis). Findings Median follow-up was 6·3 years (IQR 2·7–12·3). During the first year of follow-up, 399 cancers were diagnosed in those who had had fever of unknown origin (standardised incidence ratio 2·3 [95% CI 2·1–2·5]). These individuals had an increased risk of developing cancer—in particular haematological malignant disease; sarcoma; and cancers of the liver, brain, kidney, colon, and pancreas. After 1 year of follow-up, individuals had an increased risk of developing haematological malignant disease and cancers of the liver, brain, and kidney. A slightly higher proportion of people diagnosed with cancer within 1 year of hospital discharge after fever of unknown origin had distant metastases compared with controls (101 [34%] of 294 vs 819 [28%] of 2907; prevalence ratio 1·2 [95% CI 1·0–1·4], and had worse survival than did controls (mortality rate ratio 1·4 [95% CI 1·2–1·6]). Interpretation Hospital admission for fever of unknown origin is a marker of occult cancer and is associated with a poor outlook.

Background Recent studies have shown that women with Chlamydia trachomatis-positive test results worry about their future fertility. Goal The goal of this study was to give women infected with C. trachomatis a fertility prognosis by analyzing ectopic pregnancies and birth rates Study design An historical follow-up study in a cohort of 22,264 women tested for the infection was conducted. Results Cox regression analysis with time-dependent covariates showed that women with at least 1 C. trachomatis-positive test result had a lower incidence rate of ectopic pregnancy than women with negative test results only (adjusted hazard ratio, 0.55; 95% confidence interval [CI], 0.31-0.96). We found comparable birth rates in the 2 groups (adjusted hazard ratio, 0.92; 95% CI, 0.84-1.00). Conclusions Counseling of women with a C. trachomatis-positive test result should emphasize the benefit of detection and treatment of the infection in terms of future morbidity.

Recently published evidence suggests that hyperinsulinemia, insulin-like growth factors, and abnormal glucose intolerance may promote mammary carcinogenesis ([1][1]-[6][2]) and that women with type 2 diabetes are at increased risk for postmenopausal breast cancer ([1][1], [3][3]). Insulin and

Clomifene is widely used for inducing ovulation.1 It is structurally related to diethylstilbestrol, which has been linked to vaginal and cervical clear cell adenocarcinoma in women exposed in utero. The adverse effect is less severe in sons, although links to testicular cancer and urogenital anomalies, such as epididymal cysts, have been reported.2 3 A recent study also found an increased risk of hypospadias in the sons of women exposed to diethylstilbestrol in utero.4 Clomifene has a half life of about five days, but its metabolites have been found in blood samples on day 22 of the menstrual cycle and in faeces up to six weeks after administration.5 The occurrence of hypospadias may be increasing. Little is known about the risk of hypospadias in boys born to women who have used clomifene to induce ovulation. ### Methods and results Our case-control study was done in the Danish counties of North Jutland, Aarhus, Viborg, and …

Udgivelsesdato: 2004-null A previous study unexpectedly showed an increased, statistically imprecise, risk of low Apgar score in children of women redeeming prescriptions for pivmecillinam in late pregnancy. To improve statistical precision we extended the previous dataset with data for 5 more y, and in addition added more neonatal outcomes. We thus examined the risk of adverse birth and neonatal outcomes among pregnant users of pivmecillinam based on population-based registries in North Jutland County, Denmark. We included 63,659 women with a live birth, or stillbirth after the 28th week of gestation. 2031 had redeemed prescriptions for pivmecillinam any time during pregnancy, 559 in the first trimester and 371 within 28 d before delivery. Adjusted odds ratios were: birth defects 0.83 (95% confidence interval (95% CI) 0.53-1.32) for exposure during first trimester, preterm delivery 0.96 (95% CI 0.79-1.18) and low birth weight 0.79 (95% CI 0.52-1.20) for exposure any time during pregnancy, and stillbirth 1.19 (95% CI 0.30-4.80), low Apgar score 1.17 (95% CI 0.37-3.66), hypoglycaemia 1.03 (95% CI 0.53-2.00), and respiratory distress syndrome 0.79 (95% CI 0.38-1.68) for exposure within 28 d before delivery. Use of pivmecillinam during pregnancy did not appear to increase the risk of adverse birth and neonatal outcomes; however, statistical precision is still low.

Amoxicillin is a widely used penicillin, but data on its safety in pregnancy are limited. We examined the association between amoxicillin exposure during pregnancy and birth weight, preterm delivery, congenital malformations, perinatal death, and spontaneous abortion.We identified all primiparous women with a live birth, or a stillbirth after the 28th gestational week, from 1 January 1991-31 December 2000 in the County of North Jutland, Denmark. Data on prescriptions for amoxicillin and outcome were obtained from population-based registries. Using a follow-up and a case-control design, we compared pregnancy outcomes between women who had been prescribed amoxicillin during pregnancy and those who had not, adjusting for available potentially confounding factors.We identified 401 primiparous women who redeemed a prescription for amoxicillin during their pregnancy. The control group consisted of 10 237 primiparous women who did not redeem any prescriptions from 3 months before pregnancy until the end of pregnancy. The adjusted mean birth weight of children born to amoxicillin-exposed mothers was 57 g [95% confidence interval (CI) 9, 105] higher than that of children born to controls. Odds ratios among amoxicillin-exposed relative to controls were: low birth weight 0.63 (95% CI 0.26, 1.53), preterm delivery 0.77 (95% CI 0.49, 1.21), congenital malformation 1.16 (95% CI 0.54, 2.50), and spontaneous abortion 0.89 (95% CI 0.66, 1.18). We did not observe any cases of perinatal death in the amoxicillin-exposed women.We did not find any increased risk of adverse pregnancy outcome associated with amoxicillin exposure during pregnancy, but additional studies are warranted.

This study aimed to examine the risk of adverse pregnancy outcomes in children born to mothers who redeemed a prescription for systemic or topical acyclovir during pregnancy. Data on prescriptions of acyclovir were obtained from the Danish North Jutland Prescription Database and data on pregnancy outcomes from the Danish Medical Birth Registry and the County Hospital Discharge Registry. The risk of malformations, low birth weight, preterm birth and stillbirth in users of acyclovir were compared with non-exposed women using a follow-up design, while the risk of spontaneous abortion was examined using a case-control design. 90 pregnant women had redeemed a prescription for systemic acyclovir, and 995 women for topical acyclovir, during 30 d before conception, or during their pregnancies from 1 January 1990 to 31 December 2001. The odds ratios (95% confidence intervals) of the exposed relative to the non-exposed for the systemic and topical acyclovir were: malformations, 0.69 (0.17-2.82) and 0.84 (0.51, 1.39); low birth weight, 2.03 (0.50-8.35) and 0.48 (0.21-1.07); preterm birth, 1.04 (0.38-2.85) and 0.95 (0.70-1.28); stillbirth (for topical acyclovir), 1.70 (0.80-3.60); and spontaneous abortion, 2.16 (0.60-7.80) and 1.29 (0.80-3.60). There is increasing evidence that the use of systemic acyclovir is not associated with an increased prevalence of malformations at birth and preterm delivery. The data for low birth weight and spontaneous abortion are still inconclusive, although the risk of spontaneous abortion is increased in women exposed to acyclovir during the first month of pregnancy. The use of topical acyclovir does not seem to be associated with any adverse pregnancy outcome, although data on stillbirth are inconclusive.

Objective: To estimate the risk of adverse birth and neonatal outcome, and miscarriage in women who used sulfamethizole during pregnancy. Methods: The association between use of sulfamethizole and adverse birth and neonatal outcome was Investigated in a case-control and a cohort study in Denmark. We used data from the Prescription Database, the Birth Registry and the Hospital Discharge Registry in North Jutland County to study any association between sulfamethizole use and first recorded miscarriage. The cohort analysis included 3484 women who received a prescription for sulfamethizole from 30 days before conception to date of delivery, and 60175 women who did not use a sulphonamide-containing drug during pregnancy or 30 days before conception. The case-control analysis Included 3347 women who had a miscarriage, of whom 90 had taken sulfa-methizole, and 22 599 primiparous controls who had a live birth. Results: Among women who received prescriptions for sulfamethizole, adjusted odds ratios and 95% confidence Intervals for adverse birth outcome were: malformation 1.17 (0.95-1.43); low birth weight 0.69 (0.49-0.98); pre-term birth 1.12 (0.97-1.30); stillbirth 1.02 (0.61-1.68); neonatal jaundice 1.14 (0.38-3.46); and for receiving a prescription for sulfamethizole within 1 week before miscarriage 1.66 (0.92-2.99). Conclusions: We found no Increased risk of congenital malformation, stillbirth or pre-term birth, and no association between use of sulfamethizole late in pregnancy and risk of neonatal jaundice. There was an increased risk of miscarriage after exposure to sulfamethizole during the week before miscarriage, but further studies are needed to evaluate whether this increased risk is causal.

It is still controversial whether aspirin use during pregnancy increases the risk of certain congenital abnormalities (in particular, neural tube defects, gastroschisis, and cleft lip +/- palate). We examined the risk of selected congenital abnormalities in a large case-control dataset from Hungary and found no increased risk of such congenital abnormalities.

We studied the pattern of annual cyclical variation of hypospadia by month of birth for all boys born in Denmark after 1983 and hospitalized with hypospadias. We found little indication of any seasonal pattern, with a peak to low ratio of 1.06 (95% CI: 1.00-1.17).

Few data exist on the risk of miscarriage after exposure to pivmecillinam. We therefore conducted a population-based case-control study in a Danish county with 0.5 million inhabitants during the period 1997-2002. We included 1,599 women with a miscarriage recorded in the Hospital Discharge Registry and selected 10 controls per case among primiparous women who had a live birth during the study period. Controls were selected from the Danish Medical Birth Registry. We obtained data on use of pivmecillinam and sulfamethizole from a prescription database. Five cases (0.30%) and 24 controls (0.15%) were exposed to pivmecillinam in the last week before the miscarriage/index date. After adjustment for maternal age, use of antidiabetics or antiepileptics, the odds ratio for miscarriages among users of pivmecillinam compared with non-users was 2.03 (95% confidence interval: 0.77-5.33) and the corresponding odds ratio for use of sulfamethizole was 1.53 (95% confidence interval: 0.76-3.09). Exposure within 2 to 12 weeks before the miscarriage was not associated with an increased risk. We concluded that use of pivmecillinam was associated with an increased risk of miscarriage, but the risk was not significantly (p=0.64) different from the risk associated with use of sulfamethizole.

Aim. To investigate socio-economic and disease-related predictors for non-participationin the ‘Ready to Act’ program offering self-management support to peoplewith screen-detected dysglycaemia.Background. Screening for type 2 diabetes followed by support to people’s selfmanagementstrategies is increasingly being offered in primary care. Due to nonparticipationin self-management programs, healthcare providers often miss theopportunity to provide the basic knowledge and skills resulting in uninformed selfmanagementdecisions.Methods. A prospective cohort-study was conducted in 2010 within the frameworkof the Danish part of the Anglo–Danish–Dutch study of Intensive Treatment inPeople with Screen-Detected Diabetes in Primary Care (ADDITION). A total of 32243- to 75-year-old screen-detected patients, receiving GP-multi-faceted intensivetreatment were invited to an additional interdisciplinary 12-week self-managementprogram ‘Ready to Act’. A comparison between participants and non-participantswas conducted according to socio-economic outcomes: age, gender, cohabitantand education and disease-related outcomes: diagnosis (diabetes or prediabetes),duration of diagnosis, comorbidity measured by Charlson’s combined 17 medicalconditions measure.

We estimated the accuracy of ICD-10 diagnosis of ovarian cancer in a Danish discharge registry (HDR) by comparing it with Cancer Registry data (DCR).Patients (N=489) living in North Jutland County, Denmark with ovarian cancer or borderline tumour registered in the HDR or the DCR. We estimated the completeness and positive predictive value (PPV) of ovarian cancer discharge diagnosis. Mortality rates were constructed for both registries.The completeness in the HDR for ovarian cancer was 96% (95% confidence interval [CI]: 94%-98%) and PPV was 87% (95% CI: 85%-90%). 87 (18%) of the patients coded with ovarian cancer in the HDR had borderline tumours. When borderline tumours were excluded from the DCR, the PPV declined to 69% and the completeness did not change. The mortality rate ratio for ovarian cancer registered in the HDR compared to the DCR was 1.08 (95% CI: 0.90-1.29).The discharge data (ICD-10) had some misclassification, but can be a valuable tool in assessment of the prognosis of ovarian cancer.