Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial.

BACKGROUND: Previous studies have investigated the protective effect of vitamin D serum levels, at diagnosis and during the follow-up period after treatment, on melanoma outcome. In the present study we assess whether vitamin D supplementation, in the follow-up period after diagnosis and surgical resection of the primary tumor, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and Vitamin D Receptor immunoreactivity in the primary tumor. METHODS/DESIGN: This study is a multicenter randomized double blind placebo- controlled phase III trial. Patients between the age of 18 and 80 years diagnosed and treated surgically for a melanoma stage IB-III are eligible for randomization in a 1:1 ratio to active treatment or placebo. The study drug is taken each month and consists of either 100,000 International Unit cholecalciferol or arachidis oleum raffinatum used as a placebo. The primary endpoint is relapse free survival. The secondary endpoints are 25 hydroxyvitamin D3 serum levels at diagnosis and at 6 month intervals, melanoma subtype, melanoma site and stage of melanoma at diagnosis according to the 2009 American Joint Committee on Cancer melanoma staging and classification. At randomization a bloodsample is taken for DNA analysis. The study is approved by the local Ethics Committees. DISCUSSION: If we can confirm our hypothesis that vitamin D supplementation after removal of the tumor has a protective effect on relapse of cutaneous malignant melanoma we may reduce the burden of CMM at several levels. Patients, diagnosed with melanoma may have a better clinical outcome and improved quality of life. There will be a decrease in health care costs related to treatment of metastatic disease and there will be a decrease in loss of professional years, which will markedly reduce the economic burden of the disease. TRIAL REGISTRATION: Clinical Trial.gov, NCT01748448 , 05/12/2012.

Determination of residual dimethylsulfoxide in cryopreserved cardiovascular allografts.

Dimethylsulfoxide (DMSO) is a solvent which protects the structure of allografts during the cryopreservation and thawing process. However, several toxic effects of DMSO in patients after transplantation of cryopreserved allografts have been described. The aim of this study is to determine the residual DMSO in the cardiovascular allografts after thawing and preparation of cryopreserved allografts for clinical application following guidelines of the European Pharmacopoeia for DMSO detection. Four types of EHB allografts (aortic valve-AV, pulmonary valve-PV, descending thoracic aorta-DA, and femoral artery-FA) are cryopreserved using as cryoprotecting solution a 10% of DMSO in medium 199. Sampling is carried out after thawing, after DMSO dilution and after delay of 30 min from final dilution (estimated delay until allograft implantation). After progressive thawing in sterile water bath at 37-42 °C (duration of about 20 min), DMSO dilution is carried out by adding consecutively 33, 66 and 200 mL of saline. Finally, tissues are transferred into 200 mL of a new physiologic solution. Allograft samples are analysed for determination of the residual DSMO concentration using a validated Gas Chromatography analysis. Femoral arteries showed the most important DMSO reduction after the estimated delay: 92.97% of decrease in the cryoprotectant final amount while a final reduction of 72.30, 72.04 and 76.29% in DMSO content for AV, PV and DA, was found, respectively. The residual DMSO in the allografts at the moment of implantation represents a final dose of 1.95, 1.06, 1.74 and 0.26 mg kg-1 in AV, PV, DA and FA, respectively, for men, and 2.43, 1.33, 2.17 and 0.33 mg kg-1 for same tissues for women (average weight of 75 kg in men, and 60 kg in women). These results are seriously below the maximum recommended dose of 1 g DMSO kg-1 (Regan et al. in Transfusion 50:2670-2675, 2010) of weight of the patient guaranteeing the safety and quality of allografts.

Comparison of diagnostic accuracy of (111)In-pentetreotide SPECT and (68)Ga-DOTATOC PET/CT: A lesion-by-lesion analysis in patients with metastatic neuroendocrine tumours.

OBJECTIVES: To compare the diagnostic accuracy of (111)In-pentetreotide-scintigraphy with (68)Ga-DOTATOC-positron emission tomography (PET)/computed tomography (CT) in patients with metastatic-neuroendocrine tumour (NET) scheduled for peptide receptor radionuclide therapy (PRRT). Incremental lesions (ILs) were defined as lesions observed on only one modality. METHODS: Fifty-three metastatic-NET-patients underwent (111)In-pentetreotide-scintigraphy (24 h post-injection; planar+single-photon emission CT (SPECT) abdomen) and whole-body (68)Ga-DOTATOC-PET/CT. SPECT and PET were compared in a lesion-by-lesion and organ-by-organ analysis, determining the total lesions and ILs for both modalities. RESULTS: Significantly more lesions were detected on (68)Ga-DOTATOC-PET/CT versus (111)In-pentetreotide-scintigraphy. More specifically, we observed 1,098 lesions on PET/CT (range: 1-105; median: 15) versus 660 on SPECT (range: 0-73, median: 9) (p<0.0001), with 439 PET-ILs (42/53 patients) and one SPECT-IL (1/53 patients). The sensitivity for PET/CT was 99.9 % (95 % CI, 99.3-100.0), for SPECT 60.0 % (95 % CI, 48.5-70.2). The organ-by-organ analysis showed that the PET-ILs were most frequently visualized in liver and skeleton. CONCLUSION: Ga-DOTATOC-PET/CT is superior for the detection of NET-metastases compared to (111)In-pentetreotide SPECT. KEY POINTS: Somatostatin receptor PET is superior to SPECT in detecting NET metastases. PET is the scintigraphic method for accurate depiction of NET tumour burden. The sensitivity of PET is twofold higher than the sensitivity of SPECT.

Bacteriology testing of cardiovascular tissues: comparison of transport solution versus tissue testing.

Bacteriology testing is mandatory for quality control of recovered cardiovascular allografts (CVA). In this paper, two different bacteriology examinations (A tests) performed before tissue antibiotic decontamination were compared: transport solution filtration analysis (A1) and tissue fragment direct incubation (A2). For this purpose, 521 CVA (326 heart and 195 artery tissues) from 280 donors were collected and analyzed by the European Homograft Bank (EHB). Transport solution (A1) tested positive in 43.25 % of hearts and in 48.21 % of arteries, whereas the tissue samples (A2) tested positive in 38.34 % of hearts and 33.85 % of arteries. The main species identified in both A1 and A2 were Staphylococcus spp. in 55 and 26 % of cases, and Propionibacterium spp. in 8 and 19 %, respectively. Mismatches in bacteriology results between both initial tests A1 and A2 were found. 18.40 % of the heart valves were identified as positive by A1 whilst 13.50 % were considered positive by A2. For arteries, 20.51 % of cases were positive in A1 and negative in A2, and just 6.15 % of artery allografts presented contamination in the A2 test but were considered negative for the A1 test. Comparison between each A test with the B and C tests after antibiotic treatment of the allograft was also performed. A total decontamination rate of 70.8 % of initial positive A tests was obtained. Due to the described mismatches and different bacteria identification percentage, utilization of both A tests should be implemented in tissue banks in order to avoid false negatives.

How do cumulative live birth rates and cumulative multiple live birth rates over complete courses of assisted reproductive technology treatment per woman compare among registries?

STUDY QUESTION: How do the national cumulative (multiple) live birth rates over complete assisted reproduction technology (ART) courses of treatment per woman in Belgium compare to those in other registries? SUMMARY ANSWER: Cumulative live birth rates (CLBRs) remain high with a low cumulative multiple live birth rate when compared with other registries and publications. WHAT IS KNOWN ALREADY: In ART, a reduction in the multiple live birth rate could be achieved by reducing the number of embryos transferred. It has been shown that by doing so, live birth rates per cycle were maintained, particularly when the augmentation effect of attached frozen-thawed cycles was considered. STUDY DESIGN, SIZE, DURATION: A retrospective cohort study included all patients with a Belgian national insurance number who were registered in the national ART registry (Belrap) and who started a first fresh ART cycle between 1 July 2009 until 31 December 2011 with follow up until 31 December 2012. We analysed 12 869 patients and 38 008 cycles (both fresh and attached frozen cycles). PARTICIPANTS, MATERIALS, SETTINGS, METHODS: CLBRs per patient who started a first ART cycle including fresh and consecutive frozen cycles leading to a live birth. Conservative estimates of cumulative live birth assumed that patients who did not return for treatment had no chance of achieving an ART-related live birth, whereas optimal estimates assumed that women discontinuing treatment would have the same chance of achieving a live birth as those continuing treatment. A maximum of six fresh ART cycles with corresponding frozen cycles was investigated and compared with other registries and publications. MAIN RESULTS AND ROLE OF CHANCE: The CLBR was age dependent and declined from 62.9% for women <35 years, to 51.4% for women 35-37 years, to 34.1% for women 38-40 years and 17.7% for women 41-42 years in the conservative analysis after six cycles. In the optimal estimate, the CLBR declined from 85.9% for women <35 years, to 72.0% for women 35-37 years, to 50.4% for women 38-40 years and 36.4% for women 41-42 years. The cumulative multiple live birth rates for the whole population were 5.1 and 8.6% for the conservative and optimal estimate, respectively. LIMITATIONS, REASONS FOR CAUTION: Conservative and optimal estimates use assumptions for the whole ART population and do not take the individual patient into account. WIDER IMPLICATIONS OF THE FINDINGS: These data reinforce the validity of the Belgian model of coupling reimbursement of ART costs to a restriction in the number of embryos transferred. Our data can improve decision-making in medical ART practice both on the patient level and for society at large and could provide health care takers and insurance companies with a valid model. STUDY FUNDING COMPETING INTERESTS: none.

Curing kinetics and morphology of a nanovesicular epoxy/stearyl-block-poly(ethylene oxide) surfactant system.

Brittle epoxy based thermosets can be made tougher by introducing structural inhomogeneities at the micro- or nanoscale. In that respect, nano vesicles and worm-like micelles from self-assembling blockcopolymers have been shown to be very effective. This paper describes the curing kinetics and morphology of an epoxy composed of diglycidyl ether of bisphenol A (DGEBA) and 4,4'-methylenedianiline (MDA), modified by 20% of the surfactant stearyl-block-poly(ethylene oxide). Time resolved, synchrotron small-angle X-ray scattering demonstrates that at any time during the epoxy curing process, the surfactant predominantly adopts a bilayer vesicular nano-morphology. Transmission electron microscopy on fully cured systems reveals the coexistence of spherical and worm-like micelles. Differential scanning calorimetry experiments prove that the presence of surfactant reduces the epoxy curing rate but that ultimately full curing is accomplished. The material glass transition temperature falls below that of the pure resin due to plasticization. It is suggested that favorable secondary interactions between the PEO segments and the epoxy resin are responsible for the observed phenomena.

Evaluation of 6 years of confidential unit exclusion at the Belgian Red Cross Flanders Blood Service.

BACKGROUND AND OBJECTIVES: The effectiveness of the confidential unit exclusion (CUE) as a safety measure to the blood supply is debated. We therefore investigated the usefulness of CUE in our donor population. METHODS: Data of CUE use, donor deferrals due to different degrees of sexual or blood exposure and data of confirmed positive transfusion-transmissible infection (TTI) markers were analyzed for the study period January 1, 2004 to December 31, 2009. RESULTS: The CUE user tended to be of young age, male and first time donor whereas the CUE non-responder was more likely to be older, first time donor without a clear sex predilection. CUE had low sensitivity (0·33%) and low positive predictive value (0·02%) in detecting TTI marker positive donations. Of 46 incident cases, one donor designated his pre-conversion donation as CUE positive. 29·6% of the donors deferred due to reported sex or intravenous drug related risk factors on the donor history questionnaire had ticked 'I do practice risk behavior' on the CUE form. Deferrals for all sexual or blood-blood contact related risk factors were 19·2 times higher among CUE positive donors than among CUE negative donors (95% CI, 18·5-19·9). CONCLUSION: Although CUE use is associated with higher rates of TTI risk, CUE has low efficiency to detect window period donations. Moreover, misuse results in a significant loss of units. Our data indicate a low risk perception among donors, hence efforts should focus on improving donor knowledge of and on donor's responsibility to disclose TTI risk.

The history of Belgian assisted reproduction technology cycle registration and control: a case study in reducing the incidence of multiple pregnancy.

STUDY QUESTION: What is the effect of a legal limitation of the number of embryos that can be transferred in an assisted reproductive technology (ART) cycle on the multiple delivery rate? SUMMARY ANSWER: The Belgian national register shows that the introduction of reimbursement of ART laboratory costs in July 2003, and the imposition of a legal limitation of the number of embryos transferred in the same year, were associated with a >50% reduction of the multiple pregnancy rate from 27 to 11% between 2003 and the last assessment in 2010, without any reduction of the pregnancy rate per cycle. WHAT IS KNOWN ALREADY: Individual Belgian IVF centres have published their results since the implementation of the law, and these show a decrease in the multiple pregnancy rate on a centre by centre basis. However, the overall national picture remains unpublished. STUDY DESIGN, SIZE, DURATION: Cohort study from 1990 to 2010 of all ART cycles in Belgium (2685 cycles in 1990 evolving to 19 110 cycles in 2010), with a retrospective analysis from 1990 to 2000 and prospective online data collection since 2001. PARTICIPANTS/MATERIALS, SETTING, METHODS: Registration evolved from paper written reports per centre to a compulsory online registration of all ART cycles. From 2001 up to mid-2009, data were collected from Excel spread sheets or MS Access files into an MS Access database. Since mid-2009, data collection is done via a remote and secured web-based system (www.belrap.be) where centres can upload their data and get immediate feedback about missing data, errors and inconsistencies. MAIN RESULTS AND THE ROLE OF CHANCE: National Belgian registration data show that reimbursement of IVF laboratory costs in July 2003, coupled to a legal limitation in the number of embryos transferred in utero, were associated with a 50% reduction of the multiple pregnancy rate from 27 to 11% without reduction of the pregnancy rate per cycle, and with an increase in the number of fresh and frozen ART cycles due to improved access to treatment. LIMITATIONS, REASONS FOR CAUTION: There is potential underreporting of complications of ART treatment, pregnancy outcome and neonatal health. WIDER IMPLICATIONS OF THE FINDINGS: Over the 20 years of registration, the pregnancy rate has remained constant, despite the reduction in the number of embryos transferred, optimization of laboratory procedures and stimulation protocols, introduction of quality systems and implementation of the EU Tissue Directive over the period 2004-2010. STUDY FUNDING/COMPETING INTEREST(S): No external funding was sought for this study. None of the authors has any conflict of interest to declare.

Effect of caries experience in primary molars on cavity formation in the adjacent permanent first molar.

This study sought to address the influence of a sound versus affected first and/or second deciduous molar on the incidence of visible caries experience in the adjacent permanent first molar. Clinical and questionnaire data were obtained from a 6-year prospective oral health screening project in Flanders, Belgium (Signal-Tandmobiel project), where 4,468 children (born in 1989) were examined annually during their primary school time. A multiple survival model allowing for dependent data with possible censoring was applied. The impact of timing of tooth emergence (determining the period at risk), gender, presence of sealants and reported oral hygiene habits was also considered. Cavity formation in permanent first molars was clearly influenced by the status of the adjacent primary molars;the effect of the second deciduous molar was most pronounced. Moreover, if both deciduous molars experienced caries and the child presented with poor oral hygiene, a peak in cavity formation of the permanent first molar 1-2 years after emergence was noticed. On the other hand, if a child presented with good oral hygiene, no peak was observed; caries risk increased slightly over time. No significant benefit from restoring primary molars could be demonstrated, possibly because of methodological limitations.

Prevalence and determinants of enamel fluorosis in Flemish schoolchildren.

As part of an epidemiological study on the oral health of Flemish schoolchildren, fluoride use was studied together with risk factors (medical history, tap water fluoride concentration, use of fluoride supplements, toothpaste and brushing habits). Fluorosis was scored according to the Thylstrup-Fejerskov index (TFI) in children aged 11 years (4,128 children examined). Explanatory variables were recorded yearly, starting at the age of 7. Earliest toothpaste use was reported at the age of 1. By age 7, 99.7% of the children reported the use of toothpaste (90% fluoride-containing), but only 13.9% reported using a pea-sized amount. At age 7, 66% of the children had received systemic fluoride supplements during at least part of their childhood. At 11 years, 92% of the children used a fluoride-containing toothpaste and 6% still received systemic fluoride supplements. Fluorosis was present in about 10% of all the children examined, mainly TFI score 1 (7.3% in upper central incisors). Logistic regression established tooth brushing frequency and fluoride supplement use, in addition to tap water fluoride concentrations above 0.7 mg/l, as significant risk factors when the presence of fluorosis on at least one tooth was used as outcome variable. Children having fluorosis had a lower risk of caries, both in the primary (median dmft 1, range 0-10 vs. 2, range 0-12) and permanent dentition (median DMFT 0, range 0-5 vs. 0, range 0-11).

Efficacy and safety of tenecteplase in combination with the low-molecular-weight heparin enoxaparin or unfractionated heparin in the prehospital setting: the Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 PLUS randomized trial in acute myocardial infarction.

BACKGROUND: The combination of a single-bolus fibrinolytic and a low-molecular-weight heparin may facilitate prehospital reperfusion and further improve clinical outcome in patients with ST-elevation myocardial infarction. METHODS AND RESULTS: In the prehospital setting, 1639 patients with ST-elevation myocardial infarction were randomly assigned to treatment with tenecteplase and either (1) intravenous bolus of 30 mg enoxaparin (ENOX) followed by 1 mg/kg subcutaneously BID for a maximum of 7 days or (2) weight-adjusted unfractionated heparin (UFH) for 48 hours. The median treatment delay was 115 minutes after symptom onset (53% within 2 hours). ENOX tended to reduce the composite of 30-day mortality or in-hospital reinfarction, or in-hospital refractory ischemia to 14.2% versus 17.4% for UFH (P=0.080), although there was no difference for this composite end point plus in-hospital intracranial hemorrhage or major bleeding (18.3% versus 20.3%, P=0.30). Correspondingly, there were reductions in in-hospital reinfarction (3.5% versus 5.8%, P=0.028) and refractory ischemia (4.4% versus 6.5%, P=0.067) but increases in total stroke (2.9% versus 1.3%, P=0.026) and intracranial hemorrhage (2.20% versus 0.97%, P=0.047). The increase in intracranial hemorrhage was seen in patients >75 years of age. CONCLUSIONS: Prehospital fibrinolysis allows 53% of patients to receive reperfusion treatment within 2 hours after symptom onset. The combination of tenecteplase with ENOX reduces early ischemic events, but lower doses of ENOX need to be tested in elderly patients. At present, therefore, tenecteplase and UFH are recommended as the routine pharmacological reperfusion treatment in the prehospital setting.

Modelling tooth emergence data based on multivariate interval-censored data.

Studies on emergence of (permanent) teeth are published regularly in the dental literature. Besides descriptive statistics (mean or median values) on emergence times, comparisons between boys and girls are of interest. Gender comparisons are intersubject analyses, but also intrasubject questions, like 'Is there a left-right symmetry with respect to the mean (median) emergence times?' are of interest. Studies on emergence times most often are faced with interval-censored data. We will extend a GEE-type test proposed by Huster et al. for bivariate right-censored data to the multivariate setting with interval-censored data. Central to our paper is to provide appropriate statistical models to resolve some dental questions on emergence. The analyses are based on data from the longitudinal Signal-Tandmobiel study.

Long-term fluctuations of pressure pain thresholds in healthy men, normally menstruating women and oral contraceptive users.

The aim of this investigation was to evaluate whether the pressure pain threshold (PPT) in masticatory muscles of symptom-free subjects was influenced by fluctuations of the sex hormones. The PPT was measured with an electronic algometer for at least 10 consecutive menstrual cycles in 10 women using oral contraceptives and 10 women not using oral contraceptives, with a regular menstrual cycle (26-31 days). In addition, 10 men were measured in a regular pattern over a period of 1 year. All subjects were symptom-free with an age range between 18 and 39 years. Measurement sessions were held during three different cycle phases (follicular, luteal, perimenstrual) and each session consisted of four consecutive PPT measurements. By means of a linear mixed model (SAS), the PPTs of the masster, temporalis and thumb muscles were compared between: (1) groups, (2) sex-hormonal phases, (3) the four consecutive measurements of each muscle per session and (4) time. The PPTs of the masseter (p = 0.8419) and temporalis muscles (p = 0.2786) did not change significantly over time. There was no significant difference in variance for the masseter (p = 0.6250), temporalis (p = 0.9705) and thumb (p = 0.7446) between the three groups. The PPTs of all muscles were significantly lower during the perimenstrual phases in the two female groups. The present data showed similar patterns of PPTs for the three muscle groups. Moreover, the results have shown a very good consistency of the PPTs over a long time period, both in males and females.

Circulating oxidized LDL is a useful marker for identifying patients with coronary artery disease.

Our aim was to determine the usefulness of circulating oxidized low density lipoprotein (LDL) in the identification of patients with coronary artery disease (CAD). A total of 304 subjects were studied: 178 patients with angiographically proven CAD and 126 age-matched subjects without clinical evidence of cardiovascular disease. The Global Risk Assessment Score (GRAS) was calculated on the basis of age, total and high density lipoprotein cholesterol, blood pressure, diabetes mellitus, and smoking. Levels of circulating oxidized LDL were measured in a monoclonal antibody 4E6-based competition ELISA. Compared with control subjects, CAD patients had higher levels of circulating oxidized LDL (P<0.001) and a higher GRAS (P<0.001). The sensitivity for CAD was 76% for circulating oxidized LDL (55% for men and 81% for women) compared with 20% (24% for men and 12% for women) for GRAS, with a specificity of 90%. Logistic regression analysis revealed that the predictive value of oxidized LDL was additive to that of GRAS (P<0.001). Ninety-four percent of the subjects with high (exceeding the 90th percentile of distribution in control subjects) circulating oxidized LDL and high GRAS had CAD (94% of the men and 100% of the women). Thus, circulating oxidized LDL is a sensitive marker of CAD. Addition of oxidized LDL to the established risk factors may improve cardiovascular risk prediction.

Treatment of reinfarction after thrombolytic therapy for acute myocardial infarction: an analysis of outcome and treatment choices in the global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (gusto I) and assessment of the safety of a new thrombolytic (assent 2) studies.

BACKGROUND: Early reinfarction after thrombolytic therapy is associated with adverse outcomes and increased mortality. Among patients with reinfarction in the 1992 Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO I) and the 1998 Assessment of the Safety of a New Thrombolytic (ASSENT 2) trials, we investigated temporal and regional differences in the use of repeat thrombolysis, revascularization (angioplasty and/or bypass surgery), or conservative measures and the outcomes of each management strategy. METHODS AND RESULTS: Data from the 4% of patients (n=2301) who experienced reinfarction after thrombolytic therapy were studied. Baseline characteristics, 30-day mortality, and incidence of total and hemorrhagic strokes were compared among the 3 treatment groups. The 30-day mortality did not differ between the repeat thrombolysis and revascularization groups (P=0.72), and it was significantly lower among patients treated by these 2 strategies than in those treated conservatively (11% and 11% versus 28%, respectively; P<0.001). Stroke rates did not differ significantly between the 3 treatment strategies (P=0.49). From 1992 to 1998, the percentage of reinfarction patients treated with repeat thrombolysis decreased from 29.3% to 18.5% in US centers and from 51.4% to 41.9% in all other centers (P<0.001). In contrast, use of revascularization procedures increased from 33.5% to 47.9% in US centers and from 8.1% to 23.0% in all other centers (P<0.001). CONCLUSIONS: Repeat thrombolysis and revascularization are associated with significantly lower mortality among reinfarction patients. Randomized trials are necessary to assess the exact risks and benefits of rethrombolysis versus interventional revascularization in this subset of high-risk patients presenting with reinfarction after thrombolytic therapy.

The value of a baseline caries risk assessment model in the primary dentition for the prediction of caries incidence in the permanent dentition.

To establish a reliable screening method for caries prediction and to identify predominant risk factors, this study tested whether a cross-sectional caries risk model assessed at age 7 could be used to predict future caries onset in the permanent first molars at age 10 in 3,303 children born in 1989. As prediction variables, assessing the believed risk, baseline data at age 7 on oral health status, oral hygiene level, oral health behaviour and sociodemographic factors were used. The real risk, based on data collected for the first permanent molars during the follow-up, was assessed by different approaches. Cumulative incidence during the 3-year observation period was 31.6%, ranging from 22.4% in the believed low-risk group to 43.2% in the believed high-risk group. A stepwise logistic regression analysis was performed with net caries increment as outcome measure, adjusted for the real time at risk, using eruption times. Baseline dmfs and occlusal and buccal plaque indices were highly significant for having a high caries increment in permanent first molars with respective odds ratios of 1.07, 1.43 and 1.35. Brushing less than once a day and the daily use of sugar-containing drinks between meals were confirmed as risk factors (OR 2.43 and 1.25, respectively). The logistic regression analysis provided a sensitivity of 59-66% and a specificity of 65.7-72.8%, which indicates that the risk marker did not have an important predictive power. None of the socio-demographic and behavioural variables had enough predictive power at community level to be useful for identifying caries susceptible children. Even the power of dmfs at baseline must be considered modest.

Assessing risk indicators for dental caries in the primary dentition.

The aim of the present study was to assess indicators shown to be associated with the prevalence of caries in the primary dentition of 7-year-old Flemish schoolchildren. Cross-sectional first year data of the longitudinal Signal-Tandmobiel survey were analysed (n=4468). Gender, age, oral hygiene habits, use of fluorides, dietary habits, geographical factors and parental modelling were the considered predictors. From the multiple logistic regression analysis, including schools as a random effect, and after adjusting for the confounding variables-educational system and province (stratification variables), gender and age-it became clear that the following risk indicators remained significant (at 5% level) for the presence of caries: frequency of toothbrushing (P=0.05) with an OR 1.24 for brushing less than once a day, age at start of brushing (P<0.001) with an OR=1.22 for a delay of 1 year, regular use of fluoride supplements (P<0.001) with an OR=1.54 for no use, daily use of sugar-containing drinks between meals (P<0.001) with an OR=1.38, and number of between-meals snacks (P=0.012) with an OR=1.22 for using more than 2 between-meal snacks. There was a significant difference (P<0.05) in caries experience determined by the geographical spread, with an explicit trend of caries declining from the east to the west. In a model with an ordinal response outcome, the daily use of sugar-containing drinks between meals had a more pronounced effect when caries levels were high. From this study it became obvious that, in Flemish children, an early start of brushing and a brushing frequency of at least once a day need to be encouraged, while the use of sugar-containing drinks and snacks between meals needs to be restricted to a maximum of 2 per day. Geographical differences need to be investigated in more detail.

Development of an activity scale for individuals with advanced Parkinson disease: reliability and "on-off" variability.

BACKGROUND AND PURPOSE: Functional mobility in people with advanced Parkinson disease, some of whom have a variable response to drug treatment, is often difficult to evaluate. The objectives of this study were to investigate the interrater reliability of measurements obtained with a scale designed to measure mobility and to determine the impact of self-rated dyskinesias and fluctuations on the measure. SSUBJECTS: Twenty-nine people with Parkinson disease and with disability and considerable disease duration (mean=11.7 years, SD=4.9, range=6-22) took part in the study. METHODS: The subjects' performance on a 10-item scale was videotaped. The videotapes were then scored by 2 independent raters, and the scores were used to determine interrater reliability. The stability of 6 repeated measurements was examined in the home situation, taking into account self-rated fluctuations of motor performance. RESULTS: Weighted Kappa values of agreement (.86-.98) confirmed the reliability between testers. Measurement during the "on" phase (when medication was working optimally) and the "off" phase (when the action of medication was strongly decreased or absent) led to different measurements. Measuring frequently within "on" and "off" phases gave relatively stable measurements for total function, bed transfers, and gait akinesia, the latter during the "off" phase only (intraclass correlation coefficients [ICCs]=.70-.93). However, more modest repeatability applied to transfers from a chair (ICC=.65-.67). CONCLUSION AND DISCUSSION: To ensure valid results in future effect studies, clinical differentiation between "on" and "off" phase measurements is proposed on the basis of patients' own perception of their medication status.

Mechanical support with microaxial blood pumps for postcardiotomy left ventricular failure: can outcome be predicted?

OBJECTIVE: We sought to identify the indications of mechanical support in postcardiotomy left ventricular failure in patients who are unable to undergo transplantation. METHODS: From 1989 through 1997, 61 patients with postcardiotomy left ventricular failure beyond intra-aortic balloon pumping were assisted with the Hemopump cardiac assist system (Medtronic, Minneapolis, Minn). Their mean age was 64 +/- 8 years. Comorbidity was prevalent; 47% underwent cardiac massage before pump support, and evolving myocardial infarction was diagnosed in 43% before surgery. Multivariable logistic regression of data known at the moment of pump insertion was performed to identify the risk factors for mortality. RESULTS: Sixty-five percent of the patients were weaned from the device, but only 30% were discharged home. Cardiac index evolution during the first hours after pump insertion (P <.001) is the only independent predictor for possibility to wean from the device in the multivariable analysis. Acute renal failure is the only variable retained in the model for 90-day mortality. Device-related complications were far more frequent with the femoral (54%) than with the transthoracic (6%) cannula. Only 13% of the patients had bleeding complications. CONCLUSIONS: One third of the patients with postcardiotomy heart failure refractory to use of the intra-aortic balloon pump can be saved with the use of an endovascular axial flow pump. It is impossible to predict lethal outcome on preoperative data alone. The early hemodynamic response to support seems to be related to functional recovery of the heart and subsequent weaning from the device.