Continuous intraperitoneal insulin infusion (CIPII), a last-resort type 1 diabetes mellitus (T1DM) treatment, has only been investigated in small or controlled studies. We aimed to investigate ...glycaemia and quality of life (QoL) with CIPII versus subcutaneous (SC) insulin therapy during usual T1DM care.
A prospective, observational case-control study. CIPII-treated cases were matched to SC controls. The primary endpoint was a non-inferiority assessment (pre-defined margin of -5.5 mmol÷mol) of the baseline adjusted difference in HbA1c between groups during a 26-week follow-up. Secondary outcomes included QoL, clinical and biochemical measurements.
In total, 183 patients were analysed (CIPII n = 39 and SC n = 144). The HbA1c difference between treatment groups was -3.0 mmol÷mol (95% CI -5.0, -1.0), being lower in the SC group. Patients using SC insulin therapy spent less percentage of time in hyperglycaemia (-9.3% (95% CI -15.8, -2.8)) and more in euglycaemia (6.9% (95% CI 1.2, 12.5) as compared with CIPII-treated patients. Besides a 3.6 U÷l (95% CI 1.2, 6.0) lower concentration of alanine aminotransferase with CIPII, no biochemical and clinical differences were present. Most QoL scores were lower at baseline among CIPII-treated patients. However, besides lower health status, there were no differences in the baseline-adjusted general and diabetes-specific QoL and treatment satisfaction.
Although patients using CIPII had a higher glycaemic profile compared with patients using SC insulin therapy, the HbA1c difference was non-inferior. Overall, health status was lower among CIPII-treated patients, although diabetes-specific QoL and treatment satisfaction was similar to subcutaneously treated patients.
Patients' adherence to guidelines regarding self-monitoring of blood glucose (SMBG) is limited. However, there are no previous reports about the recommendations that are given in clinical practice ...concerning SMBG. The aim of this study was to investigate what healthcare providers recommend to insulin-treated patients with diabetes regarding frequency and timing of SMBG.
In this cross-sectional descriptive study, primary care assistants, diabetes specialised nurses and doctors in the Netherlands were invited via e-mail to complete an internet survey.
A total of 980 (14%) professionals returned the questionnaire. Insulin pump users and patients with type 1 diabetes (T1DM) on 4 injections a day were advised to perform SMBG daily by 96% and 63% of the professionals, respectively. The majority of the professionals advised these patients to perform 3-4 measurements per day. There was less agreement on the timing (pre- and÷or postprandial). Patients with type 2 diabetes (T2DM) on four injections were advised to perform SMBG less frequently. There was a wide variation in recommendations that were given to patients with T2DM on less intensive insulin regimens.
This study investigated SMBG from a professional's perspective. A considerable and relevant variation in the recommendations about the number and timing of SMBG was observed. The most striking differences were found in patients with T2DM on less intensive insulin regimes, also with respect to the frequency of SMBG. Well-designed studies are necessary in order to give a more evidence-based advice on the basic frequency and timing of SMBG.
Whether self-monitoring of blood glucose (SMBG) improves glycaemic control in patients with type 2 diabetes mellitus (T2DM) not using insulin is questionable. Our aim was to investigate the effects ...of SMBG in patients with T2DM who were in persistent moderate glycaemic control whilst not using insulin.
Patients were eligible when between 18 and 70 years of age, with an HbA1c between 7 and 8.5%, using one or two oral blood glucose lowering agents. Forty-one of the anticipated 52 patients were randomly assigned to receive either SMBG added to usual care, or to continue with usual care for one year. A fasting glucose value and three postprandial glucose values were measured twice weekly (including a Saturday or a Sunday). The primary efficacy parameter was HbA1c. Furthermore, health-related quality of life and treatment satisfaction were assessed using the Short-form 36 Health Survey Questionnaire (SF-36), the Type 2 Diabetes Symptom Checklist (DSC-r), the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the WHO -Wellbeing Index (WHO-5).
Change in HbA1c between groups was -0.05% (95% CI: -0.51, 0.41; p=0.507). Also, there were no significant changes between groups on the DTSQ , DSC type 2, WHO-5 or SF -36, except for the SF -36 dimension 'health change' which was lower in the SBMG group (mean difference: -12 (95% CI: -20.9, -3.1).
On top of the absence of a clinical benefit, tablet-treated T2DM patients experienced some worsening of their health perception. We therefore argue that the use of SMBG in this patient group is questionable, and its unlimited use and promotion should be reconsidered.
Between 1998 and 2000 an Expert Panel convened by the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) reviewed information related to the ...developmental and reproductive toxicity of seven phthalate esters; DBP, BBP, DnHP, DEHP, DnOP, DINP, and DIDP. Information on exposures was also considered. The objectives were to determine whether any of these phthalates posed potential human reproductive risks, and if so, to define the circumstances. The Expert Panel also identified some areas of uncertainty. These assessments, ultimately published in 2002, concluded that reproductive risks were minimal to negligible in most cases although some specific uses were considered potentially more problematic. Since the evaluations were completed, numerous studies dealing with both hazard characterization and underlying mechanism have been carried out. Additionally, exposures of the general population have been much better characterized through the use of urinary measurements developed by the Centers for Disease Control (CDC).
This additional information makes several important points. First, calculations based on the urinary metabolite measurements indicate that exposures within the general population are at levels similar to or lower than the estimates used by the NTP-CERHR. The demonstration that exposures were not underestimated by the CERHR has removed a substantial portion of the uncertainty. Second, new hazard characterization studies on several phthalates have established NOAELs similar to or higher than those used by the Expert Panel. Thus, these data demonstrate that, to the extent that the rodent data are useful for human health risk assessment, the no effect levels and dose–response relationships are now more precisely defined. In some cases, the no effect levels may be substantially higher than those estimated by the Expert Panel. Third, studies of underlying mechanism and/or hazard characterization studies in other species suggest that primates may be less sensitive than rodents to the reproductive effects of certain phthalates. Finally, the two specific situations that the CERHR identified as potentially problematic, the exposure of young children to DINP through the use of toys or to DEHP from medical devices, have been assessed by the responsible regulatory authorities. The Consumer Product Safety Commission concluded that exposure to DINP from toys was well below effect levels in animals, and, therefore, there was no risk. The Food and Drug Administration estimates of exposures from medical devices indicated that for some limited, intensive medical procedures, DEHP exposures could be similar to or greater than the NOAELs selected by the NTP-CERHR. However, the FDA also acknowledged that more recent information indicates that the NOAELs identified in rodent studies may be substantially higher than values previously proposed by the NTP-CERHR. In summary, much of the uncertainty identified by the CERHR has now been addressed, and the overall conclusions that levels of concern are minimal to negligible in most situations are much better established. The overall objective of this report is to summarize this new research and comment on its relevance to the NTP-CERHR assessments.
Intravenous thrombolysis (IVT) with (recombinant) tissue plasminogen activator is an effective treatment in acute ischemic stroke. However, IVT is contraindicated when blood pressure is above 185/110 ...mmHg, because of an increased risk on symptomatic intracranial hemorrhage. In current Dutch clinical practice, two distinct strategies are used in this situation. The active strategy comprises lowering blood pressure with antihypertensive agents below these thresholds to allow start of IVT. In the conservative strategy, IVT is administered only when blood pressure drops spontaneously below protocolled thresholds. A retrospective analysis in two recent stroke trials showed a non-significant signal towards better functional outcome in the active group; robust evidence for either strategy, however, is lacking. We hypothesize that (I) the active strategy leads to a better functional outcome three months after acute ischemic stroke. Secondary hypotheses are that this effect occurs despite (II) increasing the number of symptomatic intracranial hemorrhages, and could be attributable to (III) a higher rate of IVT treatments and (IV) a shorter door-to-needle time.
The TRUTH is a prospective, observational, cluster-based, parallel group follow-up study; in which participating centers continue their current local treatment guidelines. Outcomes of patients admitted to centers with an active will be compared to those admitted to centers with a conservative strategy. The primary outcome is functional outcome on the modified Rankin Scale at three months. Secondary outcomes are symptomatic intracranial hemorrhage, IVT treatment and door-to-needle time. We based our sample size estimate on an ordinal analysis of the mRS with the "proportional odds" model. With the aforementioned signal observed in a recent retrospective study in these patients as an estimate of the effect size and with alpha 0 · 05, this analysis would have an 80 % power with a total number of 600 patients. Corrections for expected imbalance in group size and clustering effects resulted in a sample size of 1235 patients.
The TRUTH is the first large prospective study specifically studying IVT-candidates with elevated blood pressure, and has the potential to change clinical practice and optimize acute stroke care in these patients.
This article begins with a brief section updating my 1979 Ethnic and Racial Studies article 'Symbolic ethnicity: the future of ethnic groups and cultures in America'. However, its main aim is to ...describe and develop the somewhat parallel concept of symbolic religiosity, which I conceive as the consumption of religious symbols apart from regular participation in a religious culture or in religious organizations, for the purpose of expressing feelings of religiosity and religious identification. Since I assume that symbolic religiosity develops mainly among the acculturating descendants of immigrants, I also explore the possibility of separating and then comparing ethnic and religious acculturation. I assume further that among religio-ethnic groups like the Jews, and ethno-religious groups such as Russian, Greek and other Orthodox Catholics, ethnic and religious acculturation proceed in divergent ways. This raises a number of interesting empirical questions about the differences between and similarities of ethnicity and religion among these groups and in general. The article concludes with speculations about what might happen to ethnicity and religiosity in the future. Most of my illustrative data in this article are drawn from studies and observations about American Jewry.
Relative mortality differences between educational level in mortality have been reported among diabetic as well as among non-diabetic subjects in Europe, but data on absolute differences are lacking. ...We studied the effect of educational disparities on mortality in a Dutch prospective cohort of type 2 diabetes mellitus (T2DM) patients.
This study was part of the ZODIAC study, a prospective observational study of patients with T2DM. Data on educational level were first collected on 19 May 1998, and from this date on, 858 patients were included in 1998; educational level was known for 656 patients. Vital status was assessed in 2009. The relationship between mortality and educational level was studied using a Cox proportional hazard model, the relative index of inequality (RII), slope index of inequality (SII) and the population attributable risk (PAR). Educational level was divided into four categories; the highest educational level was used as reference.
After a median follow-up time of 9.7 years, 365 out of 858 patients had died. The hazard ratio of primary education for total mortality was 3.02 (95% CI 1.44-6.34). The RII was 2.85 (95% CI 1.21-6.67), the absolute difference in the risk for mortality (SII) was 384 deaths (95% CI 49-719) per 10,000 follow-up years. PAR for patients with the lowest level of education was 51.4%.
A low educational level had a higher impact on mortality than having a macrovascular complication. Given the substantial differences in mortality between educational levels in T2DM, more understanding of underlying (modifiable) mechanisms is necessary.
Abstract The 2015 VESPA voyage (Volcanic Evolution of South Pacific Arcs) was a seismic and rock dredging expedition to the Loyalty and Three Kings Ridges and South Fiji Basin. In this paper we ...present 33 40 Ar/ 39 Ar, 22 micropaleontological, and two U/Pb ages for igneous and sedimentary rocks from 33 dredge sites in this little‐studied part of the southwest Pacific Ocean. Igneous rocks include basalts, dolerites, basaltic andesites, trachyandesites, and a granite. Successful Ar/Ar dating of altered and/or low‐K basalts was achieved through careful sample selection and processing, detailed petrographic and element mapping of groundmass, and incremental heating experiments on both phenocryst and groundmass separates to interpret the complex spectra produced by samples having multiple K reservoirs. The 40 Ar/ 39 Ar ages of most of the sampled lavas, irrespective of composition, are latest Oligocene to earliest Miocene (25–22 Ma); two are Eocene (39–36 Ma). The granite has a U/Pb zircon age of 23.6 ± 0.3 Ma. 40 Ar/ 39 Ar lava ages are corroborated by microfossil ages from associated sedimentary rocks. The VESPA lavas are part of a >3,000 km long disrupted belt of Eocene to Miocene subduction‐related volcanic rocks. The belt includes arc rocks in Northland New Zealand, Northland Plateau, Three Kings Ridge, and Loyalty Ridge and, speculatively, D’Entrecasteaux Ridge. This belt is the product of superimposed Eocene and Oligocene‐Miocene remnant volcanic arcs that were stranded along and near the edge of Zealandia while still‐active arc belts migrated east with the Pacific trench.
Plain Language Summary Samples of lava from the seabed between New Zealand and New Caledonia have been dated using atomic clocks and fossils. Most lavas erupted in a big pulse of volcanic activity between 25 and 22 million years ago. They are part of a belt of now‐extinct undersea volcanoes that stretches for more than 3,000 km between New Zealand and the Solomon Islands. These volcanoes were formed by subduction of the Pacific Plate under the Australian Plate.
Key Points A major pulse of 25–22 Ma volcanism is documented on the Loyalty and Three Kings Ridges, southwest Pacific Ocean The ridges are part of a more than 3,000 km long belt of Eocene to Miocene remnant volcanic arcs, stranded along the edge of Zealandia With care in sample selection, and petrological work, meaningful Ar/Ar ages can be obtained from altered and/or very low‐K submarine basalts
Introduction
Intraosseous access is recommended in vitally compromised patients if an intravenous access cannot be easily obtained. Intraosseous infusion can be initiated by various healthcare ...providers. Currently, there are two mechanical intraosseous devices approved by the U.S. Food and Drug Administration (FDA) for use in adults and children. A comparison is made in this study of the theoretical and practical performance by anesthesiologists and registered nurses of anesthesia (RNAs) in the use of the battery-powered device (device A) versus the spring-loaded needle device (device B). This study entailed a 12-month follow-up of knowledge, skill retention, and self-efficacy measured by standardized testing.
Methods
A prospective randomized trial was performed, initially comparing 15 anesthesiologists and 15 RNAs, both on using the two types of intraosseous devices. A structured lecture and skill station was given with the educational aids provided by the respective manufacturers. Individual knowledge and practical skills were tested at 0, 3, and 12 months after the initial course.
Results
There was no statistical significant difference in the retention of theoretical knowledge between RNAs and anesthesiologists on all testing occasions. However, the self-efficacy of the anesthesiologists is significantly higher (
p
< 0.01) than the self-efficacy of the RNAs for both devices, on any testing occasion. Insufficient skills were local disinfection (both groups, both devices) and attachment of the needle to the intravenous line (RNAs with both devices). In 33 % of all device B handlings, unsafe practice occurred.
Conclusion
The use of device A is safer in handling in comparison to device B at 12 months follow-up. The hypothesis that doctors are more qualified in obtaining intraosseous access has been disproven, as anesthesiologists were as successful as RNAs. However, the low self-efficacy of RNAs in the use of intraosseous devices could diminish the chance of them actually using one.