Biomedical subjects

D E Grobbee

Publications and source records attributed to D E Grobbee.

At least 127 records · Page 7Linked to original sources

PubMed2001

[Limited effect of Health Council guideline on outpatient preoperative evaluation clinics in the Netherlands: an inventory].

OBJECTIVE: To investigate the current status of preoperative evaluation in the Netherlands and the implementation of the Health Council recommendations. DESIGN: Cross-sectional study. METHOD: All Dutch anaesthesiologic partnerships and their hospital managers in February 2000 received a structured questionnaire about the existence of an outpatient evaluation clinic, possible problems in creating such a clinic and the contents of preoperative evaluation. RESULTS: We received responses of 101 (80%) and 111 (87%) from anaesthesiologists and managers, respectively. From 119 hospitals (94%) we received at least one useful questionnaire. On January 1, 2000, 24 (20%) hospitals had a complete and 36 (30%) a partial outpatient clinic. Within one year, 44% of the hospitals without a preoperative outpatient clinic expected to create one. The most common problem concerned financing this clinic. In hospitals with a complete clinic, anaesthesiologists were more often in employment (odds ratio (OR): 2.5; 95% confidence interval (95% CI): 1.0-10.0) and a routinely performed physical examination by the anaesthesiologist (or under his or her responsibility) was also conducted more often (OR: 5.0; 95% CI: 1.6-15.0). Not every patient saw an anaesthesiologist before entering the operating room in 70% of all hospitals. In hospitals without outpatient clinic, 57% of the day-surgery patients contacted the anaesthesiologist in the operating room. CONCLUSION: The recommendations of the Health Council of the Netherlands with respect to contents and organisation of the preoperative evaluation had, 3 years after being published, limited effect.

Adult↗

PubMed2001

Neural network-based screening (NNS) in cervical cytology: no need for the light microscope?

Neural network-based screening (NNS) of cervical smears can be performed as a so-called "hybrid screening method," in which parts of the cases are additionally studied by light microscope, and it can also be used as "pure" NNS, in which the cytological diagnosis is based only on the digital images, generated by the NNS system. A random enriched sample of 985 cases, in a previous study diagnosed by hybrid NNS, was drawn to be screened by pure NNS. This study population comprised 192 women with (pre)neoplasia of the cervix, and 793 negative cases. With pure NNS, more cases were recognized as severely abnormal; with hybrid NNS, more cases were cytologically diagnosed as low-grade. For a threshold value > or = HSIL (high-grade squamous intraepithelial lesions), the areas under the receiver operating characteristic (ROC) curves (AUC) were 81% (95% CI, 75-88%) for pure NNS vs. 78% (95% CI, 75-81%) for hybrid NNS. For low-grade squamous intraepithelial lesions (LSIL), the AUC was significantly higher for hybrid NNS (81%; 95% CI, 77-85%) than for pure NNS (75%; 95% CI, 70-80%). Pure NNS provides optimized prediction of HSIL cases or negative outcome. For the detection of LSIL, light microscopy has additional value.

Cervix Uteri↗

PubMed2001

The effect of hormone replacement therapy on serum homocysteine levels in perimenopausal women: a randomized controlled trial.

Serum homocysteine levels may be lowered by hormone replacement therapy, but randomized controlled trial data are scarce. We performed a single center randomized placebo-controlled trial to assess the 6 months effect of hormone replacement therapy compared with placebo on fasting serum homocysteine levels in 121 perimenopausal women free of cardiovascular disease, and recruited from the general population. The trial was double-blind with respect to a sequential combined regimen of oral 17 beta-estradiol and desogestrel (17 beta E(2)-D) and the placebo group and open with respect to a combination of conjugated equine estrogens and norgestrel (CEE-N). At baseline and after 6 months, fasting serum homocysteine levels were measured. Differences in 6 months serum homocysteine levels from baseline between treatment and placebo groups were calculated, and expressed as a percentage of the 6 months placebo level. After 6 months, the difference in serum homocysteine levels between women receiving 17 beta E(2)-D and placebo was -6.3% (95% CI, -12.4%; 0.0%, P=0.06). The difference between women receiving CEE-N and placebo was -10.1% (95% CI, -16.7%; -2.9%, P<0.01). The difference between the combined group of both types of hormone replacement therapy users and placebo was -7.8% (95% CI, -13.2%; -2.0%, P=0.01). No significant difference was observed between the two active regimens. Our results indicate that hormone replacement therapy decreases homocysteine levels in perimenopausal women.

Adult↗

PubMed2001

Hormone replacement therapy and endothelial function. Results of a randomized controlled trial in healthy postmenopausal women.

OBJECTIVE: To compare the effects of 3 months treatment with tibolone (a single entity synthetic steroid hormone with estrogenic, progestanic and androgenic activities), or continuous combined conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA), with placebo, on endothelial function. DESIGN: A single center, randomized, double-blind, placebo-controlled study. SETTING: Research center as part of the University Medical Center Utrecht. SUBJECTS: One hundred and five healthy postmenopausal women, sampled from the general population. INTERVENTIONS: Three months treatment with tibolone or CEE+MPA or placebo. MAIN OUTCOME MEASURE: At baseline and after 3 months, endothelial function was assessed non-invasively by measuring percent lumen diameter change in the brachial artery after reactive hyperemia and sublingual nitroglycerine spray. RESULTS: Results are presented as mean differences between treatment groups of endothelium dependent flow mediated dilatation (fmd) and endothelium independent nitroglycerine induced dilatation with 95% confidence intervals (95% CI). After treatment, there was a significant difference in mean fmd between the CEE+MPA group and the placebo group of 2.5% (95% CI: 0.3-4.6) while the tibolone group and the placebo group did not differ significantly (0.6%; 95% CI: 1.6-2.8). Nitroglycerine induced dilatation did not differ significantly between the groups. CONCLUSIONS: Hormone replacement therapy with CEE+MPA for 3 months increases endothelium dependent fmd of the brachial artery in healthy postmenopausal women. Tibolone did not alter fmd. The clinical significance of this improvement in fmd for cardiovascular disease risk needs to be established.

Aged↗

PubMed2001

Low prevalence of GAD and IA2 antibodies in schoolchildren from a village in the southwestern section of the Netherlands.

Glutamic acid decarboxylase (GAD) and insulinoma antigen 2 (IA2) antibodies are increasingly used as a tool to predict type I diabetes in children and as a differential diagnostic tool to distinguish type I and type II diabetes in adults. However, the background frequency of these antibodies in the general population has not been extensively studied and may differ between countries. The current study aims to establish the frequency of GAD and IA2 antibodies in an unselected population of schoolchildren and confirm the previously reported low prevalence of islet cell antibodies (ICA) in the general Dutch population. The study population consisted of 1403 unselected schoolchildren. All children were tested for GAD antibodies, and 1085 children were analyzed for IA2 antibodies by radiobinding assay. Development of diabetes was recorded during a 7-year follow-up. Five children (0.4%) were positive for GAD antibodies, one child (0.1%) was positive for IA2 antibodies. Two children developed diabetes during follow-up, one was positive for GAD antibodies only, the second was positive for both GAD and IA2 antibodies. The frequency of GAD and IA2 antibodies in the southwestern part of The Netherlands is low. This observation is in concordance with earlier studies on ICA in Dutch schoolchildren. For future diabetes prediction and intervention trials it is important to establish the background frequencies and predictive power of antibody screening in different populations.

Autoantibodies↗

PubMed2001

Clinical and quantitative coronary angiographic predictors of coronary restenosis: a comparative analysis from the balloon-to-stent era.

OBJECTIVES: We sought to assess whether coronary stents have modified the predictive value of demographic, clinical and quantitative coronary angiographic (QCA) predictors of coronary restenosis. BACKGROUND: A systematic analysis in a large cohort of registries and randomized trials of the percutaneous transluminal coronary angioplasty (PTCA) and stent era has never been performed. METHODS: A total of 9,120 treated lesions in 8,156 patients included in nine randomized trials and 10 registries, with baseline, post-procedural and six-month follow-up QCA analyses, were included in this study. Predictors of restenosis were identified with univariate and multivariate logistic regression analyses. Interaction terms were introduced in the regression equation to evaluate whether the predictors of restenosis were common to both eras or specific for either one of the revascularization techniques. RESULTS: The restenosis rate was 35% after PTCA and 19% after angioplasty with additional stenting. In the univariate analysis, favorable predictors were previous coronary artery bypass graft surgery (CABG), stent use, stent length and a large pre-procedural minimal lumen diameter (pre-MLD); unfavorable predictors were weight, body mass index, diabetes mellitus, multi-vessel disease, lesion length and a high residual post-procedural diameter stenosis (post-DS). Predictors specific for the PTCA population were a large post-procedural MLD (post-MLD) as favorable and a severe pre-procedural DS (pre-DS) as unfavorable. Favorable predictors specific for the stent population were a large post-MLD and a large pre-procedural reference diameter (pre-RD). In the multivariate analysis, the best model included the following favorable predictors: stent use, a large post-MLD, previous CABG and the interaction term between stent use and a large post-MLD; unfavorable predictors were lesion length and diabetes mellitus. CONCLUSIONS: There are no major differences in demographic and clinical predictors of coronary restenosis between PTCA and stent populations. In the modern (stent) era, a severe pre-DS is no longer an unfavorable predictor of restenosis. Still important, but more so in the stent population, is a large post-MLD (optimal result). Finally, a larger pre-RD became a favorable predictor with the advent of stenting.

Aged↗

PubMed2001

Psychometric properties of Aquarel. a disease-specific quality of life questionnaire for pacemaker patients.

In cardiac pacing current clinical practice permits the use of ventricular or atrioventricular-synchronous pacemakers. However, it is not known which type of pacemaker results in superior clinical and patient outcomes. To date, there is no feasible and validated disease-specific questionnaire for pacemaker patients to assess quality of life (QoL) available. The Aquarel questionnaire was developed as a disease-specific extension to the Short-Form-36 (SF-36). A cross-sectional study was carried out in 74 pacemaker patients to evaluate validity and reliability of this instrument. Items were selected and scales constructed based on factorial analysis. Internal consistency, content validity and test-retest reliability were moderate to excellent. Correlations with the SF-36 scales, pacing mode and functional tests were as hypothesized, demonstrating the individual value and distinctiveness of the Aquarel subscales. The results support the feasibility and usefulness of evaluating QoL in pacemaker patients when using Aquarel as an extension to the SF-36.

Activities of Daily Living↗

PubMed2001

Prognostic factors for influenza-associated hospitalization and death during an epidemic.

To predict which patients with current high-risk disease in the community may benefit most from additional preventive or therapeutic measures for influenza, we determined prognostic factors for influenza-associated hospitalization and death in a general practice-based case-control study among this segment of the vaccine target population with high influenza vaccination rates. In 103 general practices followed during the 1996/7 influenza epidemic, cases were either hospitalized, or died due to influenza, bronchitis, pneumonia, diabetes, heart failure or myocardial infarction. Age- and gender-matched controls were randomly sampled from the remaining cohort. Information was collected by review of patient records. In total, 119 cases and 196 matched controls were included. Of the cases, 34, 25 and 4% were hospitalized for acute pulmonary and cardiac disease and diabetes, respectively, and 37% died. Multivariate conditional logistic regression analysis revealed that presence of chronic obstructive pulmonary disease, heart failure, previous hospitalization, high GP visiting rate and polypharmacy were independent prognostic factors. Several non-modifiable determinants can be used to ensure targeting additional preventive or therapeutic measures at the most vulnerable segment of the vaccine target group.

Adult↗

PubMed2001

Determinants of circulating insulin-like growth factor (IGF)-I and IGF binding proteins 1-3 in premenopausal women: physical activity and anthropometry (Netherlands).

OBJECTIVE: Epidemiologic studies suggest that subjects with elevated plasma concentrations of insulin-like growth factor (IGF)-I are at increased risk of developing cancer. The objective of our study was to assess whether cancer risk factors such as lack of physical activity, obesity, and central body fat distribution are associated with plasma levels of IGF-I and related proteins (i.e. IGF binding proteins 1-3 and C-peptide). METHODS: A cross-sectional study was conducted in a population of 225 premenopausal women, aged 49-57, participating in the Prospect-EPIC study in the Netherlands. Plasma concentrations of IGF-I, IGFBP-1, IGFBP-2, IGFBP-3, and C-peptide were determined. On the day of blood collection height, weight, and waist and hip circumference were measured. Habitual physical activity was assessed using a validated self-administered questionnaire. RESULTS: Mean concentrations of plasma IGF-I, IGFBP-1, IGFBP-2, IGFBP-3, and C-peptide were 156.1, 14.3, 434.4, 3062, and 2.86 ng/ml, respectively. Women in the highest tertile for physical activity had lower plasma concentrations of IGF-I, IGFBP-3, and C-peptide, and higher concentrations of IGFBP-1 and IGFBP-2, as compared to women in the lowest tertile. However, these differences were not statistically significant. BMI and related measures were significantly inversely associated with IGFBP-1 and IGFBP-2, and positively with IGFBP-3 and C-peptide. Linear regression analyses showed that the non-significant association of physical activity with components of the plasma IGF system was further attenuated by adjusting for obesity and central body fat distribution. CONCLUSIONS: Our data suggest that an active lifestyle is not independently associated with the plasma IGF system. We did confirm that a lean body shape is associated with higher concentrations of IGFBP-1 and IGFBP-2, and possibly also with lower concentrations of IGF-I and IGFBP-3.

Aged↗

PubMed2001

Persistent impaired emotional functioning in survivors of a myocardial infarction?

The quality of life (QoL) of survivors of a myocardial infarction (MI) remains lower than that of their peers long after the acute event. Previous research on this subject has indicated, however, that this difference might lessen somewhat over time for the dimension 'emotional functioning' (as measured by the sickness impact profile (SIP): a generic instrument for QoL). The present study explores this phenomenon further using two instruments that specifically measure emotional functioning i.e. the hospital anxiety and depression scale (HAD) and the heart patients psychological questionnaire (HPPQ). Ninety-nine participants of a large population-based cohort (the Rotterdam study), who had been admitted to the hospital because of an MI in the previous 6-60 months, and 101 reference subjects, without a history of infarction of heart or brain, from the same age and gender-groups, were interviewed twice (at 1- to 3-year time intervals). The results of the present study confirm earlier findings that the emotional functioning (in terms of 'anxiety', 'depression', 'well-being', 'feeling disabled', and 'displeasure') of MI survivors is impaired when compared to their unaffected peers. Moreover, they did not show any improvement in 'anxiety', 'depression', 'well-being' and 'displeasure' over time in the MI survivors. The results did, however, show that the difference between MI survivors and referents became less in time in the dimension 'feeling disabled'. This decrease was partly because MI survivors improved and partly because referents felt more disabled over time. One explanation for this might be that referents (51% aged 70 years and over) had difficulties in adapting emotionally to decreasing levels of physical functioning with increasing age, while the MI survivors tended to adjust to and accept the impairments they had contracted several years earlier.

Aged↗

PubMed2001

Prospect-EPIC Utrecht: study design and characteristics of the cohort population. European Prospective Investigation into Cancer and Nutrition.

The European Prospective Investigation into Cancer and Nutrition (EPIC), which has been established in order to investigate the relations between nutrition and cancer, was initiated in 1990 and involves 10 European countries with heterogeneous dietary patterns and differing cancer incidence rates. This manuscript presents the design, recruitment and baseline characteristics of the Prospect-EPIC cohort co-ordinated in Utrecht, The Netherlands. The cohort is based on volunteers recruited among women participating in a regional breast cancer screening program. It comprises of 17,357 subjects aged 50-69 years at enrolment from Utrecht and vicinity, who have consented to participate in the study and its follow-up. Each participant filled out a general questionnaire and a food frequency questionnaire. Participants were also physically examined and have donated a blood sample. Participation rate was 34.5%. Blood samples were donated by most participants (97.5%) and detailed informed consents were obtained from 87.4% of participants. Mean age at enrolment was 57 years. Anthropometric, lifestyle and morbidity characteristics of the cohort population did not differ largely from those of similar study populations in The Netherlands. Based on the Prospect-EPIC population, we intend to conduct prospective total cohort, nested case-control or case-cohort studies, in order to investigate relations between consumption of certain food groups or nutrients and chronic diseases, including hormone dependant cancers such as breast, colon, endometrial and ovary cancers.

Aged↗

PubMed2001

Validity and reproducibility of ultrasonography for the measurement of intra-abdominal adipose tissue.

OBJECTIVE: We studied the validity and reproducibility of a new abdominal ultrasound protocol for the assessment of intra-abdominal adipose tissue. MEASUREMENTS: Intra-abdominal adipose tissue was assessed by CT, MRI, anthropometry and ultrasonography on a single day. By ultrasonography the distance between peritoneum and lumbar spine was measured using a strict protocol, including the location of the measurements, pressure on the transducer and respiration. All measurements were repeated after 3 months. RESULTS: The study population consisted of 19 overweight patients with a body mass index (BMI) of 32.9 kg/m(2) (s.d. 3.7), intra-abdominal adipose tissue on CT 140.1 cm(2) (s.d. 55.9), and a mean ultrasound distance of 9.8 cm (s.d. 2.5). There was a strong association between the CT and ultrasonographic measures: Pearson correlation coefficient was 0.81 (P<0.001). The correlation between ultrasound and waist circumference was 0.74 (P<0.001), the correlation between CT and waist circumference was 0.57 (P=0.01). Ultrasound appeared a good method to diagnose intra-abdominal obesity: the area under the ROC curve was 0.98. During the follow-up period of 3 months, the patients lost on average almost 3 kg of body weight. The correlation coefficient between changes in intra-abdominal adipose tissue assessed by CT and ultrasound was 0.74 (P<0.001). The correlation coefficient of the mean ultrasound distance assessed by two different sonographers at baseline was 0.94 (P<0.001), the mean difference 0.4 cm (s.d. 0.9), and the coefficient of variation 5.4%, indicating good reproducibility of the ultrasound measurements. CONCLUSIONS: The results of this validation study show that abdominal ultrasound, using a strict protocol, is a reliable and reproducible method to assess the amount of intra-abdominal adipose tissue and to diagnose intra-abdominal obesity.

Abdomen↗

PubMed2001

Mortality associated with anaesthesia: a qualitative analysis to identify risk factors.

From a prospectively defined cohort of patients who underwent either general, regional or combined anaesthesia from 1 January 1995 to 1 January 1997 (n = 869 483), all consecutive patients (n = 811) who died within 24 h or remained unintentionally comatose 24 h after anaesthesia were classified to determine a relationship with anaesthesia. These deaths (n = 119; 15%) were further analysed to identify contributing aspects of the anaesthetic management, other factors and the appropriateness of care. The incidence of 24-h peri-operative death per 10 000 anaesthetics was 8.8 (95% CI 8.2-9.5), of peri-operative coma was 0.5 (0.3-0.6) and of anaesthesia-related death 1.4 (1.1-1.6). Of the 119 anaesthesia-related deaths, 62 (52%) were associated with cardiovascular management, 57 (48%) with other anaesthetic management, 12 (10%) with ventilatory management and 12 (10%) with patient monitoring. Inadequate preparation of the patient contributed to 30 (25%) of the anaesthesia-related deaths. During induction of anaesthesia, choice of anaesthetic technique (n = 18 (15%)) and performance of the anaesthesiologist (n = 8 (7%)) were most commonly associated with death. During maintenance, the most common factors were cardiovascular management (n = 43 (36%)), ventilatory management (n = 12 (10%)) and patient monitoring (n = 12 (10%)). In both the recovery and the postoperative phases, patient monitoring was the most common factor (n = 12 (10%) for both). For cardiovascular, ventilatory and other anaesthetic management, human failure contributed to 89 (75%) deaths and organisational factors to 12 (10%). For inadequate patient monitoring, human factors contributed to 71 (60%) deaths and organisational factors to 48 (40%). Other contributing factors were inadequate communication (30 deaths (25%) for all four aspects of the anaesthetic management) and lack of supervision (particularly for ventilatory management). Inadequate care was delivered in 19 (16%) of the anaesthesia-related deaths with respect to cardiovascular management, in 20 (17%) with respect to ventilatory management, in 18 (15%) with respect to patient monitoring and in 23 (19%) with respect to other anaesthetic management.

Anesthesia↗

PubMed2001

Changes in treatment strategies for severe haemophilia over the last 3 decades: effects on clotting factor consumption and arthropathy.

A cohort study was performed among 214 patients with severe haemophilia, born 1944-1994, to describe changes in treatment over the last 3 decades and its effects on clotting factor consumption and haemophilic arthropathy. Data on treatment strategy, clotting factor consumption, and outcome were collected for 3567 patient years (from 1972 to 1998), and 493 Pettersson scores were analysed. Median follow up was 17 years (range 6-27 years), and median age in 1998 was 27.6 years. Since 1965, replacement therapy, prophylaxis, and home treatment have been used and treatment intensified. Over the last 3 decades, annual clotting factor consumption increased by 260%, for both prophylactic and on-demand treatment. Annual clotting factor consumption kg-1 increased during childhood and appeared to stabilize in early adulthood for patients born 1965-79, who were treated with early replacement therapy or early prophylaxis. In contrast, clotting factor consumption increased continuously for patients born before 1965, who had had no access to replacement therapy during the early years of their life. The annual number of joint bleeds decreased over the years. Arthropathy as measured by the Pettersson score generally became apparent around the age of 15 years and was lowest in patients treated with primary prophylaxis. In conclusion, clotting factor consumption has increased and haemophilic arthropathy has decreased due to the intensification of treatment for severe haemophilia over the last 3 decades. Annual clotting factor consumption stabilizes in adulthood for patients who receive early intensive treatment.

Adolescent↗

PubMed2001

Discontinuation of prophylactic therapy in severe haemophilia: incidence and effects on outcome.

A cohort study was performed to assess adherence to early prophylactic therapy and its effects on outcome in 49 patients with severe haemophilia born 1970-1980. Median age at start of prophylaxis was 5.5 years. The majority (69%) of patients interrupted prophylactic treatment one or more times of their own accord (median total interruption 2.2 years). Patients who discontinued prophylaxis at any point tended to have more arthropathy as measured by the Pettersson scale (median 8 points versus 4 points). One-third of these patients interrupted prophylaxis for longer periods and had permanently stopped taking prophylaxis at a mean age of 20.1 years (mean +/- SD duration 4.1 +/- 4 years) and consequently experienced 5.4 +/- 3.4) joint bleeds per year. This subgroup could be identified by a predictive score based on age at start of prophylaxis, weekly dose of prophylaxis, and joint bleed frequency on prophylaxis. In conclusion, while on prophylaxis, more than two-thirds of patients with severe haemophilia try to discontinue treatment, resulting in slightly more arthropathy. One-third of these patients permanently discontinue prophylaxis in adulthood, while maintaining a low number of joint bleeds.

Blood Coagulation Factors↗

PubMed2001

Microalbuminuria is common, also in a nondiabetic, nonhypertensive population, and an independent indicator of cardiovascular risk factors and cardiovascular morbidity.

OBJECTIVES: To assess the prevalence of microalbuminuria in the general population, especially in nondiabetic and nonhypertensive subjects, and its association with known cardiovascular risk factors and cardiovascular morbidity. DESIGN: Cross-sectional cohort study. SETTING: Inhabitants of the city of Groningen, the Netherlands. SUBJECTS: All inhabitants, aged between 28 and 75 years, were send a postal questionnaire and a vial to collect an early morning urine sample (n = 85 421). Of these 40 856 subjects (47.8%) responded. Cardiovascular risk factors and morbidity were validated in a well defined nondiabetic and nonhypertensive group of 5241 subjects. MAIN OUTCOME MEASURES: Microalbuminuria, self-reported cardiovascular risk and cardiovascular morbidity in the total study cohort, and additionally more detailed measurements in a subset of the total population. RESULTS: Microalbuminuria (20-200 mg L-1) was present in 7.2% of the subjects and independently associated with age, gender, hypertension, diabetes, smoking, previous myocardial infarction and stroke. Some of these associations were already observed at albuminuria levels of 10-20 mg L-1. After exclusion of the diabetic and hypertensive subjects, microalbuminuria was still prevalent in 6.6% of the subjects. CONCLUSIONS: Microalbuminuria appears to be common not only in the general population but also in a nondiabetic, nonhypertensive population and is independently associated with increased cardiovascular risk factors and cardio-vascular morbidity. Importantly, some of these associations are present at urinary albumin levels currently considered to be normal. These findings suggest that urinary albumin measurements may be useful in early risk profiling and prevention of cardiovascular disease in the population at large.

Adult↗

PubMed2001

Effect of second and third generation oral contraceptives on lipid metabolism in the absence or presence of the factor V Leiden mutation.

OBJECTIVES: The effect of a second and third generation oral contraceptive and of the progestagens used in these pills on lipid metabolism was studied in the absence or presence of the factor V Leiden mutation. DESIGN: A single centre, double blind randomized trial. SETTING: University Medical Centre. SUBJECTS: A total of 51 women without and 35 women with the factor V Leiden mutation. INTERVENTIONS: A second generation (30 microg ethinylestradiol/150 microg levonorgestrel) or a third generation (30 microg ethinylestradiol/l 50 microg desogestrel) oral contraceptive. After two cycles of use and a wash-out period of two cycles, the participants received the corresponding progestagen-only preparation containing 150 microg levonorgestrel or 150 microg desogestrel. MAIN OUTCOME MEASURES: Mean difference in changes between the treatment groups on total cholesterol, HDL, LDL, triglycerides and total/HDL cholesterol ratio. RESULTS: Compared with levonorgestrel, desogestrel-containing oral contraceptives caused in women without the factor V Leiden mutation significant changes in HDL (0.43; 95% confidence interval [CI] 0.25-0.61), LDL (-0.55; 95% CI -0.90 to -0.20), triglycerides (0.19; 95% CI 0.06-0.32) and total/ HDL cholesterol ratio (-0.87; 95% CI -1.21 to -0.53). When the progestagen-only preparations were used, differential changes were found for HDL (0.16; 95% CI 0.03-0.29), LDL (-0.31; 95% CI - 0.56 to -0.05) and total/HDL cholesterol ratio (-0.55; 95% CI -0.84 to -0.26). Desogestrel-only caused changes opposite to those of desogestrel-containing oral contraceptives. For cholesterol and triglycerides, this effect was also found for levonorgestrel-only in comparison with levonorgestrel-combined oral contraceptives. Levonorgestrel appeared to induce the effect on HDL. Almost all results were similar for women with the factor V Leiden mutation. CONCLUSION: It appears that desogestrel counteracts the effects of oestrogens to a lesser extent than levonorgestrel. Desogestrel-containing oral contraceptives have therefore a more favourable influence on cholesterol metabolism in comparison with levonorgestrel-containing oral contraceptives.

Adolescent↗

PubMed2001

Changes in quality-of-life after pacemaker implantation: responsiveness of the Aquarel questionnaire.

Before being introduced for widespread use, health status instruments should be evaluated for reliability, validity, and responsiveness to relevant clinical changes. In a previous study the validity and reliability of Aquarel, a disease-specific quality-of-life (QOL) questionnaire for pacemaker patients, were tested and found satisfactory. The purpose of this study was to assess the sensitivity to change in health of Aquarel. A cohort of 51 patients was assessed at baseline and at 4-6 weeks after pacemaker implantation. We compared the sensitivity to change over time on the Aquarel scores to the scores on the SF-36 using various techniques (t-test value, effect size, standard error of measurement). Using the 1-standard error of measurement (SEM) criterion for clinically relevant change, Aquarel seemed to provide better classification of patients compared to the SF-36 alone. This study supports the value of Aquarel as a disease-specific measure of QOL in pacemaker patients.

Aged↗