Can HbA1c detect undiagnosed diabetes in acute medical hospital admissions?

Objective: to study hyperglycaemia in acute medical admissions to Irish regional hospital.Research design and methods: from 2005 to 2007, 2061 white Caucasians, aged &gt;18 years, were admitted by 1/7 physicians. Those with diabetes symptoms/complications but no previous record of hyperglycaemia (n = 390), underwent OGTT with concurrent HbA1c in representative subgroup (n = 148). Comparable data were obtained for 108 primary care patients at risk of diabetes.Results: diabetes was diagnosed immediately by routine practice in 1% (22/2061) [aged 36 (26–61) years (median IQ range)/55% (12/22) male] with pre-existing diabetes/dysglycaemia present in 19% (390/2061) [69 (58–80) years/60% (235/390) male].Possible diabetes symptoms/complications were identified in 19% [70 (59–79) years/57% (223/390) male] with their HbA1c similar to primary care patients [54 (46–61) years], 5.7 (5.3–6.0)%/39 (34–42) mmol/mol (n = 148) vs 5.7 (5.4–6.1)%/39 (36–43) mmol/mol, p = 0.35, but lower than those diagnosed on admission, 10.2 (7.4–13.3)%/88 (57–122) mmol/mol, p &lt; 0.001. Their fasting plasma glucose (FPG) was similar to primary care patients, 5.2 (4.8–5.7) vs 5.2 (4.8–5.9) mmol/L, p = 0.65, but 2hPG higher, 9.0 (7.3–11.4) vs 5.5 (4.4–7.5), p &lt; 0.001.HbA1c identified diabetes in 10% (15/148) with 14 confirmed on OGTT but overall 32% (48/148) were in diabetic range on OGTT. The specificity of HbA1c in 2061 admissions was similar to primary care, 99% vs 96%, p = 0.20, but sensitivity lower, 38% vs 93%, p &lt; 0.001 (63% on FPG/23% on 2hPG, p = 0.037, in those with possible symptoms/complications).Conclusion: HbA1c can play a diagnostic role in acute medicine as it diagnosed another 2% of admissions with diabetes but the discrepancy in sensitivity shows that it does not reflect transient/acute hyperglycaemia resulting from the acute medical event.</p

A novel preference-informed complementary trial (PICT) design for clinical trial research influenced by strong patient preferences

Background: Patients and their families often have preferences for medical care that relate to wider considerations beyond the clinical effectiveness of the proposed interventions. Traditionally, these preferences have not been adequately considered in research. Research questions where patients and families have strong preferences may not be appropriate for traditional randomized controlled trials (RCTs) due to threats to internal and external validity, as there may be high levels of drop-out and non-adherence or recruitment of a sample that is not representative of the treatment population. Several preference-informed designs have been developed to address problems with traditional RCTs, but these designs have their own limitations and may not be suitable for many research questions where strong preferences and opinions are present. Methods: In this paper, we propose a novel and innovative preference-informed complementary trial (PICT) design which addresses key weaknesses with both traditional RCTs and available preference-informed designs. In the PICT design, complementary trials would be operated within a single study, and patients and/or families would be given the opportunity to choose between a trial with all treatment options available and a trial with treatment options that exclude the option which is subject to strong preferences. This approach would allow those with strong preferences to take part in research and would improve external validity through recruiting more representative populations and internal validity. Here we discuss the strengths and limitations of the PICT design and considerations for analysis and present a motivating example for the design based on the use of opioids for pain management for children with musculoskeletal injuries. Conclusions: PICTs provide a novel and innovative design for clinical trials with more than two arms, which can address problems with existing preference-informed trial designs and enhance the ability of researchers to reflect shared decision-making in research as well as improving the validity of trials of topics with strong preferences

Impact of discussion on preferences elicited in a group setting

BACKGROUND: The completeness of preferences is assumed as one of the axioms of expected utility theory but has been subject to little empirical study. METHODS: Fifteen non-health professionals was recruited and familiarised with the standard gamble technique. The group then met five times over six months and preferences were elicited independently on 41 scenarios. After individual valuation, the group discussed the scenarios, following which preferences could be changed. Changes made were described and summary measures (mean and median) before and after discussion compared using paired t test and Wilcoxon Signed Rank Test. Semi-structured telephone interviews were carried out to explore attitudes to discussing preferences. These were transcribed, read by two investigators and emergent themes described. RESULTS: Sixteen changes (3.6%) were made to preferences by seven (47%) of the fifteen members. The difference between individual preference values before and after discussion ranged from -0.025 to 0.45. The average effect on the group mean was 0.0053. No differences before and after discussion were statistically significant. The group valued discussion highly and suggested it brought four main benefits: reassurance; improved procedural performance; increased group cohesion; satisfying curiosity. CONCLUSION: The hypothesis that preferences are incomplete cannot be rejected for a proportion of respondents. However, brief discussion did not result in substantial number of changes to preferences and these did not have significant impact on summary values for the group, suggesting that incompleteness, if present, may not have an important effect on cost-utility analyses

Cost Effectiveness of Imatinib Compared with Interferon-alpha or Hydroxycarbamide for First-Line Treatment of Chronic Myeloid Leukaemia

Objective: To evaluate the cost utility of imatinib compared with interferon (IFN)-alpha or hydroxycarbamide (hydroxyurea) for first-line treatment of chronic myeloid leukaemia. Design and Setting: A cost-utility (Markov) model within the setting of the UK NHS and viewed from a health system perspective was adopted. Transition probabilities and relative risks were estimated from published literature. Costs of drug treatment, outpatient care, bone marrow biopsies, radiography, blood transfusions and inpatient care were obtained from the British National Formulary and local hospital databases. Costs (Lstg , year 2001-03 values) were discounted at 6%. Quality-of-life (QOL) data were obtained from the published literature and discounted at 1.5%. The main outcome measure was cost per QALY gained. Extensive one-way sensitivity analyses were performed along with probabilistic (stochastic) analysis. Results: The incremental cost-effectiveness ratio (ICER) of imatinib, compared with IFNalpha, was Lstg 26_180 per QALY gained (one-way sensitivity analyses ranged from Lstg 19_449 to Lstg 51_870) and compared with hydroxycarbamide was Lstg 86_934 per QALY (one-way sensitivity analyses ranged from Lstg 69_701 to Lstg 147_095) [Lstg 1 = $US1.691 = _1.535 as at 31 December 2002]. Based on the probabilistic sensitivity analysis, 50% of the ICERs for imatinib, compared with IFNalpha, fell below a threshold of approximately Lstg 31_000 per QALY gained. Fifty percent of ICERs for imatinib, compared with hydroxycarbamide, fell below approximately Lstg 95_000 per QALY gained. Conclusions: This model suggests, given its underlying data and assumptions, that imatinib may be moderately cost effective when compared with IFNalpha but considerably less cost effective when compared with hydroxycarbamide. There are, however, many uncertainties due to the lack of long-term data.Antineoplastics, Chronic-myeloid-leukaemia, Cost-utility, Hydroxycarbamide, Imatinib, Interferon-alpha

What Value Health?: A Review of Health State Values Used in Early Technology Assessments for NICE

The objective of this article was to review the methods used to obtain quality-of-life (utility) weights reported in assessments carried out for the National Institute for Health and Clinical Excellence (NICE). The design of the review was a cross-sectional survey. Health technology assessment (HTA) reports published on the NICE website up to May 2003 were reviewed. Data were extracted on the following: the approach to utility estimation (direct or indirect), how health states were described for indirect estimation, valuation techniques used (standard gamble [SG], time trade-off [TTO], visual analogue scale [VAS], etc.), whether uncertainty in utility estimates was explored in cost-utility analyses, and whether utility values were identified as a priority for further research by assessment authors. Fifty-six assessments were reviewed, of which 28 reported 45 cost-utility analyses. There was striking variation in the values used to describe different health states. Data from patients were used in 15 (33%) analyses, from the general public in 10 (22%) and from clinicians in 4 (9%). In 16 (36%) cases, the source for utility estimates was unclear. Health states were described using a range of generic and disease-specific measures, although the EQ-5D was used most frequently. In 25 analyses (56%), the valuation technique used was not reported. TTO was used in 11 (24%), SG in 3 (7%), magnitude estimation in 5 (11%) and VAS in 1 (2%). Sensitivity analyses based on utility values were reported in 25 cases (56%), more commonly in reports of analyses carried out by independent teams than technology sponsors although this may be subject to reporting bias. Further research into quality of life was recommended in 17 (61%) of the 28 assessment reports that contained at least one cost-utility analysis. Greater transparency and consistency are required in reporting the methods used to obtain quality-of-life weights in cost-utility analyses, and better sources of data are required. Methodological variation results in important differences in values. Therefore, caution must be exercised when comparing the results of different cost-utility analyses.Health-status, Quality-of-life

The effect of silica desiccation under different storage conditions on filter-immobilized environmental DNA

Abstract Objective Silica gel beads have promise as a non-toxic, cost-effective, portable method for storing environmental DNA (eDNA) immobilized on filter membranes. Consequently, many ecological surveys are turning to silica bead filter desiccation rather than ethanol preservation. However, no systematic evaluation of silica bead storage conditions or duration past 1 week has been published. The present study evaluates the quality of filter-immobilized eDNA desiccated with silica gel under different storage conditions for over a year using targeted quantitative real-time polymerase chain reaction (qPCR)-based assays. Results While the detection of relatively abundant eDNA target was stable over 15 months from either ethanol- or silica gel-preserved filters at − 20 and 4 °C, silica gel out-performed ethanol preservation at 23 °C by preventing a progressive decrease in eDNA sample quality. Silica gel filter desiccation preserved low abundance eDNA equally well up to 1 month regardless of storage temperature (18, 4, or − 20 °C). However only storage at − 20 °C prevented a noticeable decrease in detectability at 5 and 12 months. The results indicate that brief storage of eDNA filters with silica gel beads up to 1 month can be successfully accomplished at a range of temperatures. However, longer-term storage should be at − 20 °C to maximize sample integrity