Showing papers by "Diederick E. Grobbee published in 2015"

Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults

Abstract: BackgroundPneumococcal polysaccharide conjugate vaccines prevent pneumococcal disease in infants, but their efficacy against pneumococcal community-acquired pneumonia in adults 65 years of age or older is unknown. MethodsIn a randomized, double-blind, placebo-controlled trial involving 84,496 adults 65 years of age or older, we evaluated the efficacy of 13-valent polysaccharide conjugate vaccine (PCV13) in preventing first episodes of vaccine-type strains of pneumococcal community-acquired pneumonia, nonbacteremic and noninvasive pneumococcal community-acquired pneumonia, and invasive pneumococcal disease. Standard laboratory methods and a serotype-specific urinary antigen detection assay were used to identify community-acquired pneumonia and invasive pneumococcal disease. ResultsIn the per-protocol analysis of first episodes of infections due to vaccine-type strains, community-acquired pneumonia occurred in 49 persons in the PCV13 group and 90 persons in the placebo group (vaccine efficacy, 45.6%; 95.2% ...

Race/Ethnic Differences in the Associations of the Framingham Risk Factors with Carotid IMT and Cardiovascular Events.

Abstract: Clinical manifestations and outcomes of atherosclerotic disease differ between ethnic groups. In addition, the prevalence of risk factors is substantially different. Primary prevention programs are based on data derived from almost exclusively White people. We investigated how race/ethnic differences modify the associations of established risk factors with atherosclerosis and cardiovascular events.

Cost-effectiveness of adult pneumococcal conjugate vaccination in the Netherlands.

Abstract: The Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) demonstrated the efficacy of 13-valent pneumococcal conjugate vaccine (PCV13) in preventing vaccine-type community-acquired pneumonia and vaccine-type invasive pneumococcal disease in elderly subjects. We examined the cost-effectiveness of PCV13 vaccination in the Netherlands. Using a Markov-type model, incremental cost-effectiveness ratios (ICER) of PCV13 vaccination in different age- and risk-groups for pneumococcal disease were evaluated using a societal perspective. Estimates of quality-adjusted life-years (QALYs), costs, vaccine efficacy and epidemiological data were based on the CAPiTA study and other prospective studies. The base-case was PCV13 vaccination of adults aged 65-74 years compared to no vaccination, assuming no net indirect effects in base-case due to paediatric 10-valent pneumococcal conjugate vaccine use. Analyses for age- and risk-group specific vaccination strategies and for different levels of hypothetical herd effects from a paediatric PCV programme were also conducted. The ICER for base-case was €8650 per QALY (95% CI 5750-17,100). Vaccination of high-risk individuals aged 65-74 years was cost-saving and extension to medium-risk individuals aged 65-74 years yielded an ICER of €2900. Further extension to include medium- and high-risk individuals aged ≥18 years yielded an ICER of €3100.PCV13 vaccination is highly cost-effective in the Netherlands. The transferability of our results to other countries depends upon vaccination strategies already implemented in those countries.

The Impact of Age on the Efficacy of 13-valent Pneumococcal Conjugate Vaccine in Elderly

Abstract: In a post hoc analysis of the Community-Acquired Pneumonia (CAP) immunization Trial in Adults the model-predicted 13-valent pneumococcal conjugate vaccine efficacy for preventing vaccine-type specific CAP and Invasive Pneumococcal Disease declined from 65% to 40% for subjects being 65 and 75 year olds at the time of vaccination, respectively.

Common Carotid Intima-Media Thickness Relates to Cardiovascular Events in Adults Aged <45 Years

Abstract: Although atherosclerosis starts in early life, evidence on risk factors and atherosclerosis in individuals aged <45 years is scarce. Therefore, we studied the relationship between risk factors, common carotid intima-media thickness (CIMT), and first-time cardiovascular events in adults aged <45 years. Our study population consisted of 3067 adults aged <45 years free from symptomatic cardiovascular disease at baseline, derived from 6 cohorts that are part of the USE-IMT initiative, an individual participant data meta-analysis of general-population-based cohort studies evaluating CIMT measurements. Information on risk factors, CIMT measurements, and follow-up of the combined end point (first-time myocardial infarction or stroke) was obtained. We assessed the relationship between risk factors and CIMT and the relationship between CIMT and first-time myocardial infarction or stroke using a multivariable linear mixed-effects model and a Cox proportional-hazards model, respectively. During a follow-up of 16.3 years, 55 first-time myocardial infarctions or strokes occurred. Median CIMT was 0.63 mm. Of the risk factors under study, age, sex, diastolic blood pressure, body mass index, total cholesterol, and high-density lipoprotein cholesterol related to CIMT. Furthermore, CIMT related to first-time myocardial infarction or stroke with a hazard ratio of 1.40 per SD increase in CIMT, independent of risk factors (95% confidence interval, 1.11-1.76). CIMT may be a valuable marker for cardiovascular risk in adults aged <45 years who are not yet eligible for standard cardiovascular risk screening. This is especially relevant in those with an increased, unfavorable risk factor burden.

Predictors of skilled attendance at delivery among antenatal clinic attendants in Ghana: a cross-sectional study of population data

Abstract: Objective To identify demographic, maternal and community predictors of skilled attendance at delivery among women who attend antenatal clinic at least once during their pregnancy in Ghana. Design A cross-sectional study using the 2008 Ghana Demographic and Health Survey (DHS) data. We used frequencies for descriptive analysis, χ2 test for associations and logistic regression to identify significant predictors. Predictive models were built with estimation of area under the receiver operating characteristic curves (AUC). Setting Ghana. Participants A total of 2041 women who had a live birth in the 5 years preceding the survey, and attended an antenatal clinic having a skilled provider, at least once, during the pregnancy. Outcome Skilled attendance at delivery. Results Overall, 60.5% (1235/2041) of women in our study sample reported skilled attendance at delivery. Significant positive associations existed between skilled attendance at delivery and the variables such as maternal educational level, wealth status class, ever use of contraception, previous pregnancy complications and health insurance coverage (p Conclusions Women less likely to have skilled attendance at delivery can be identified during antenatal care by using data on wealth status class, health insurance coverage, residence, history of previous birth complications and religion, and targeted with interventions to improve skilled attendance at delivery.

Completeness and accuracy of data transfer of routine maternal health services data in the greater Accra region

Abstract: High quality routine health system data is essential for tracking progress towards attainment of the Millennium Development Goals 4 & 5. This study aimed to determine the completeness and accuracy of transfer of routine maternal health service data at health facility, district and regional levels of the Greater Accra Region of Ghana. A cross sectional study was conducted using secondary data comprised of routine health information data collected at facility level for the first quarter of 2012. Twelve health facilities were selected using a multistage sampling method. Data relating to antenatal care and delivery were assessed for completeness and accuracy of data transfer. Primary source data from health facility level (registers and record notebooks where health information data are initially entered) , used as the reference data, were counted, collated, and compared with aggregate data on aggregate forms compiled from these sources by health facility staff. The primary source data was also compared with data in the district health information management system (DHIMS–II), a web-based data collation and reporting system. Percentage completeness and percentage error in data transfer were estimated. Data for all 5,537 antenatal registrants and 3, 466 deliveries recorded into the primary source for the first quarter of 2012 were assessed. Completeness was best for age data, followed by data on parity and hemoglobin at registration. Mean completeness of the facility level aggregate data for the data sampled, was 94.3% (95% CI = 90.6% – 98.0%) and 100.0% respectively for the aggregate form and DHIMS-II database. Mean error in data transfer was 1.0% (95% CI = 0.8% - 1.2%). Percentage error comparing aggregate form data and DHIMS-II data respectively to the primary source data ranged from 0.0% to 4.9% respectively, while percentage error comparing the DHIMS-II data to aggregate form data, was generally very low or 0.0%. Routine maternal health services data in the Greater Accra region, available at the district level through the DHIMS-II system is complete when compared to facility level primary source data and reliable for use.

Clinical Manifestation of Depression after Stroke: Is It Different from Depression in Other Patient Populations?

Abstract: Background Despite ample research on depression after stroke, the debate continues regarding whether symptoms such as sleep disturbances, loss of energy, changes in appetite and diminished concentration should be considered to be consequences of stroke or general symptoms of depression. By comparing symptoms in depressed and non-depressed stroke patients with patients in general practice and patients with symptomatic atherosclerotic diseases, we aim to further clarify similarities and distinctions of depression after stroke and depression in other patient populations. Based on this, it is possible to determine if somatic symptoms should be evaluated in stroke patients in diagnosing depression after stroke. Methods An observational multicenter study is conducted in three hospitals and seven general practices including 382 stroke patients admitted to hospital with a clinical diagnosis of intracerebral hemorrhage or ischemic infarction, 1160 patients in general practice (PREDICT-NL), and 530 patients with symptomatic atherosclerotic diseases (SMART-Medea). Results The prevalence of major depressive disorder according to DSM-IV criteria was 14.1% (95% CI 11.0%-18.0%) in the stroke cohort, 5.4% (95% CI 3.8%-7.9%) in the symptomatic atherosclerotic diseases cohort and 12.9% (95% CI 11.1%-15.0%) in the general practice cohorts. Comparing depressed patients of the three cohorts demonstrated broadly similar symptom profiles, as well as comparable levels of individual symptom prevalence. However, the stroke patients suffered more severely from these symptoms than patients in the other populations. Conclusions The findings suggest that depression after stroke is not a different type of depression. This finding indicates that all depressive symptoms should be evaluated in stroke patients, including somatic symptoms.

Effect of physical activity on vascular characteristics in young children

Abstract: Background:Physical activity has long been proposed as an important modifiable cardiovascular risk factor in adults. We assessed whether physical activity already has an effect on childhood vasculature.Methods:In the Wheezing-Illnesses-Study-in-Leidsche-Rijn birth cohort, we performed vascular ultrasound to measure carotid intima–media thickness (cIMT) and functional properties (distensibility, elastic modulus) at 5 and 8 years of age. Child typical physical activities were inquired using a questionnaire completed by parents. Linear regression was used with physical activity level, expressed as a standardized value of time-weighted metabolic equivalent (MET) as the independent variable and vascular properties as dependent variables with further confounder adjustment and evaluation for possible body mass index and sex effect modifications.Results:In 595 5-year-old children and in 237 of those who had reached the age of 8 years, we did not find statistically significant associations between total time-weigh...

Criteria-based audit of quality of care to women with severe pre-eclampsia and eclampsia in a referral hospital in Accra, Ghana.

Abstract: Objectives Severe pre-eclampsia and eclampsia are one of the major causes of maternal mortality globally. Reducing maternal morbidity and mortality demands optimizing quality of care. Criteria-based audits are a tool to define, assess and improve quality of care. The aim of this study was to determine applicability of a criteria-based audit to assess quality of care delivered to women with severe hypertensive disorders in pregnancy, and to assess adherence to protocols and quality of care provided at a regional hospital in Accra, Ghana. Methods Checklists for management of severe preeclampsia, hypertensive emergency and eclampsia were developed in an audit cycle based on nine existing key clinical care protocols. Fifty cases were audited to assess quality of care, defined as adherence to protocols. Analysis was stratified for complicated cases, defined as (imminent) eclampsia, perinatal mortality and/or one or more WHO maternal near miss C-criteria. Results Mean adherence to the nine protocols ranged from 15-85%. Protocols for 'plan for delivery' and 'magnesium sulphate administration' were best adhered to (85%), followed by adherence to protocols for 'eclampsia' (64%), 'severe pre-eclampsia at admission' (60%), 'severe pre-eclampsia ward follow-up' (53%) and 'hypertensive emergency' (53%). Protocols for monitoring were least adhered to (15%). No difference was observed for severe disease. Increased awareness, protocol-based training of staff, and clear task assignment were identified as contributors to better adherence. Conclusion A criteria-based audit is an effective tool to determine quality of care, identify gaps in standard of care, and allow for monitoring and evaluation in a health facility, ultimately resulting in improved quality of care provided and reduced maternal morbidity and mortality. In our audit, good adherence was observed for plan for delivery and treatment with magnesium sulphate. Substandard adherence to a number of protocols was identified, and points towards opportunities for targeted improvement strategies.

Cardiovascular manifestations of HIV infection in children.

Abstract: BACKGROUND: HIV infection in children is now considered as a chronic condition, in which various non-infectious complications may occur, including those affecting the developing cardiovascular system. As children are expected to survive well into adulthood, understanding childhood as well as potential future cardiovascular complications is of major importance. METHODS AND RESULTS: We reviewed published literature on childhood cardiac manifestations and longer term effects of pediatric HIV infection on the cardiovascular system. Evidence gaps that should be prioritized in research are highlighted. Through poorly understood mechanisms, HIV infection may cause various cardiac complications already manifesting in childhood, such as structural and functional myocardial derangements, pulmonary hypertension, pericardial effusion and possibly endocarditis. Evidence indicates that HIV infection in children also has unfavorable effects on the vasculature and cardiovascular biomarkers, such as increased intima-media thickness and decreased flow-mediated dilation, a marker of endothelial function. However, studies are small and predominantly include antiretroviral therapy-treated children, so that it is difficult to differentiate between effects of HIV infection per se and antiretroviral therapy treatment, reported in adults to have cardiovascular side effects. CONCLUSIONS: HIV infection in children may greatly impact the cardiovascular system, including effects on the heart, which tend to manifest early in childhood, and on the vasculature. The underlying mechanisms, essential for targeted prevention, are poorly understood. Current evidence largely stems from research in adults. However, as modes of infection, immune maturity, growth and development, and treatment are markedly different in children, specific pediatric research, accounting for the complex interplay of normal growth and development, HIV infection and treatment, is clearly warranted.

Allergies are associated with arterial changes in young children.

Abstract: BACKGROUND: Inflammation is important in atherosclerosis development. Whether common causes of inflammation, such as allergies and infections, already exert this influence in early childhood is unknown. The objective of this study was to investigate the association between both allergies and infections with children's vasculature. DESIGN: This was a longitudinal study in a general population cohort. METHODS: In 390 five-year-olds of the WHISTLER (Wheezing-Illnesses-Study-LEidsche-Rijn) birth cohort, carotid intima-media thickness (CIMT) and arterial stiffness were obtained ultrasonographically. Physician-diagnosed allergies and infections and recent prescriptions of systemic antihistamines and antibiotics were obtained, as well as parental history of allergies. General linear regression was performed with vascular characteristics as dependent variables and measures of inflammation as independent variables. RESULTS: Having both a positive parental history of allergy and an allergy diagnosis showed 15.0 µm (95% confidence interval (CI): 2.3-27.8, p = 0.02) larger CIMT than not having such history and diagnosis. Having a positive parental history of allergy only showed 11.9 µm (0.87-23.0, p = 0.04) larger CIMT. Recent use of antihistamines and antibiotics showed 18.8 µm (1.6-35.9, p = 0.03) and 16.1 µm (4.5-27.7, p = 0.01) larger CIMT, respectively. Childhood infections were not clearly related to vascular parameters. Neither allergy nor infections were associated with arterial stiffness. CONCLUSION: An allergic predisposition is already associated with thicker arterial walls in early childhood.

Life-course of cardio-respiratory associations.

Abstract: BACKGROUND: Several studies have shown that raised cardiovascular risk factors are associated with an impaired lung function in adulthood. Whether this association also exists in the young is unknown. Our aim was to study the relation between blood pressure and lung function from neonatal to elderly age. STUDY DESIGN: This was a cross-sectional study in a general population cohort. METHODS: Within the Utrecht Health Project (UHP) 6673 adults (aged 18-91 years) had spirometry and blood pressure measurements taken. In the WHeezing Illnesses STudy LEidsche Rijn (WHISTLER) study, a satellite birth cohort of the UHP, blood pressure and respiratory mechanics were measured using the single occlusion technique in 755 newborns and spirometry in 382 5-year-old participants. Linear regression analyses were performed with lung function as an independent variable and blood pressure as a dependent variable in different age groups. The analyses were adjusted for age, sex, weight and height. RESULTS: In infancy a more favorable lung function (higher compliance and lower resistance) was associated with higher blood pressure. In 5-year-old children and young adults higher forced expiratory volume in 1 second (FEV1) was associated with higher systolic blood pressure (p-values < 0.05). At the age of 5 the adjusted regression coefficient for systolic blood pressure was 4.8 mmHg/L (95% confidence interval (95% CI) -0.3-9.98). The association decreased with increasing age and reversed in the age groups above 40 years to -7.3 mmHg/L (95% CI -15.5-0.9) in those aged over 70 years of age. The association with pulse pressure showed a similar pattern. CONCLUSIONS: A positive association between the mechanical properties of the respiratory system and blood pressure in childhood and young adulthood reverses in later adulthood.

The complexity after simplicity: how to proceed with renal denervation in hypertension?

Abstract: Recently the results of the Symplicity HTN-3 trial were presented and simultaneously published. In this study, patients with so called resistant hypertension were randomized to either catheter based renal denervation or a sham procedure. The main results showed no statistically significant difference in the effect of renal denervation on office blood pressure at 6 months follow up (primary efficacy endpoint) between the two arms. Clearly, based on the results of Symplicity HTN-1 and HTN-2 a different outcome of Symplicity HTN-3 was expected. So, it seems appropriate to discuss possible explanations.

Uterine Tonus Assessment by Midwives versus Patient self-assessment in the active management of the third stage of labor (UTAMP): study protocol for a randomized controlled trial

Abstract: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide and accounts for one third of maternal deaths in low-income and middle-income countries. PPH can be prevented by active management of the third stage of labor (AMTSL), a series of steps recommended by the World Health Organization to be performed by skilled birth attendants (SBAs). Task shifting in the AMTSL step of uterotonic drugs administration to community health workers, traditional birth attendants and self-administration has been investigated as a strategy to increase access to quality obstetric care considering persistent SBA and facility-based delivery shortages. The aim of this study is to assess task shifting in the final step of AMTSL and compare uterine tonus assessment by a SBA to self-assessment. The study is an individual-level two-arm non-inferiority randomized controlled trial (RCT). A total of 800 women will be recruited in Korle Bu Teaching Hospital in Accra, Ghana. Adult women in labor at term with an expected vaginal delivery who received antenatal instructions for self-assessment of uterine tonus will be eligible for inclusion. Women with an increased risk for PPH will be excluded. Women will be randomized to uterine tone assessment by a skilled birth attendant (midwife) or uterine tone self-assessment (with the safety back-up of a midwife present in case of PPH or uterine atony). Postpartum blood loss will be measured through weighing of disposable mats. The main study endpoints are PPH (≥500 ml blood loss), severe PPH (≥1000 ml blood loss), mean blood loss, and routine maternal and neonatal outcomes. Participants and caregivers will not be blinded given the nature of the intervention. A reduction of PPH-related maternal mortality requires full implementation of AMTSL. Task shifting of uterine tone assessment may contribute to increased AMTSL implementation in (clinical) settings where SBAs capacity is constrained. Clinicaltrials.gov: NCT02223806 , registration August 2014. PACTR: PACTR201402000736158 , registration July 2014. University of Ghana, Medical School Ethical and Protocol Review Committee: MS-Et/M.8–P4.1/2014-2015

A prognostic model for the thirty-day mortality risk after adult heart transplantation

Abstract: Objective: To develop a prognostic model for the thirty-day mortality risk after adult heart transplantation. Methods: In this report we developed a prediction model for the 30-day mortality risk after adult heart transplantation. Logistic regression analysis was used to develop the model in 1,262 adult patients undergoing primary heart transplantation. We evaluated the accuracy of the prediction model; the agreement between the predicted probability and the observed mortality (calibration); and the ability of the model to correctly discriminate between the discordant survival pairs (discrimination). The internal validity of the prediction model was evaluated using the bootstrapping procedures. Results: Recipients’ age and sex, pre-transplant diagnosis, transplant status, waiting time, cardiopulmonary bypass time, donors’ age and sex, donor-recipient mismatch for BMI and blood type were independent predictors for 30-day mortality risk after adult heart transplantation. The model showed a good calibration and reasonable discrimination (the corrected area under the receiver operating characteristic curve was 0.71). The internal validity of the prediction model was acceptable. For practical use, we converted the prediction model to score chart. Conclusion: The accuracy and the validity of the prediction model were acceptable. This easy-to-use instrument for predicting the 30-day mortality risk after adult heart transplantation would benefit decision-making by classifying recipients according to their mortality risk and allowing optimal allocation of a donor to a recipient for heart transplantation.