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  • Outcome of Critically ill Patients Undergoing Mandatory Insulin Therapy Compared to Usual Care Insulin Therapy: Protocol for a Pilot Randomized Controlled Trial.

    3 July 2018

    BACKGROUND: Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advantage or reduces complication rates. Policies of "tight" glycaemic control were rapidly adopted by many general intensive care units (ICUs) worldwide in the mid 00's, even though the results of the studies were not generalizable to mixed medical/surgical ICUs with different intravenous feeding policies. OBJECTIVE: The primary objective of the study is to assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting. METHODS: This protocol summarizes the rationale and design of a randomized, controlled, single-center trial investigating the effect of mandatory insulin therapy versus usual care insulin therapy for those patients admitted for a stay of longer than 48 hours. In total, 109 critically ill adults predicted to stay in intensive care for longer than 48 hours consented. The primary outcome is to determine the safety of mandatory insulin therapy in critically ill patients using the number of episodes of hypoglycaemia and hypokalaemia per unit length of stay in intensive care. Secondary outcomes include the duration of mechanical ventilation, duration of ICU and hospital stay, hospital mortality, and measures of renal, hepatic, and haematological dysfunction. RESULTS: The project was funded in 2005 and enrolment was completed 2007. Data analysis is currently underway and the first results are expected to be submitted for publication in 2018. CONCLUSIONS: This protocol for a randomized controlled trial investigating the effect of mandatory insulin therapy should provide an answer to a key question for the management of patients in the ICU and ultimately improving outcome. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number ISRCTN00550641; http://www.isrctn.com/ISRCTN00550641 (Archived at WebCite: http://www.webcitation.org/6xk8NXxNv).

  • Does bone mineral density improve the predictive accuracy of fracture risk assessment? A prospective cohort study in Northern Denmark.

    27 June 2018

    OBJECTIVE: To evaluate the added predictive accuracy of bone mineral density (BMD) to fracture risk assessment. DESIGN: Prospective cohort study using data between 01 January 2010 and 31 December 2012. SETTING: North Denmark Osteoporosis Clinic of referred patients presenting with at least one fracture risk factor to the referring doctor. PARTICIPANTS: Patients aged 40-90 years; had BMD T-score recorded at the hip and not taking osteoporotic preventing drugs for more than 1 year prior to baseline. MAIN OUTCOME MEASURES: Incident diagnoses of osteoporotic fractures (hip, spine, forearm, humerus and pelvis) were identified using the National Patient Registry of Denmark during 01 January 2012-01 January 2014. Cox regression was used to develop a fracture model based on predictors in the Fracture Risk Assessment Tool (FRAX®), with and without, binary and continuous BMD. Change in Harrell's C-Index and Reclassification tables were used to describe the added statistical value of BMD. RESULTS: Adjusting for predictors included in FRAX®, patients with osteoporosis (T-score ≤-2.5) had 75% higher hazard of a fracture compared with patients with higher BMD (HR: 1.75 (95% CI 1.28 to 2.38)). Forty per cent lower hazard was found per unit increase in continuous BMD T-score (HR: 0.60 (95% CI 0.52 to 0.69)).Accuracy improved marginally, and Harrell's C-Index increased by 1.2% when adding continuous BMD (0.76 to 0.77). Reclassification tables showed continuous BMD shifted 529 patients into different risk categories; 292 of these were reclassified correctly (57%; 95% CI 55% to 64%). Adding binary BMD however no improvement: Harrell's C-Index decreased by 0.6%. CONCLUSIONS: Continuous BMD marginally improves fracture risk assessment. Importantly, this was only found when using continuous BMD measurement for osteoporosis. It is suggested that future focus should be on evaluation of this risk factor using routinely collected data and on the development of more clinically relevant methodology to assess the added value of a new risk factor.

  • Population trends in the incidence and initial management of osteoarthritis: age-period-cohort analysis of the Clinical Practice Research Datalink, 1992-2013.

    27 June 2018

    Objective: To determine recent trends in the rate and management of new cases of OA presenting to primary healthcare using UK nationally representative data. Methods: Using the Clinical Practice Research Datalink we identified new cases of diagnosed OA and clinical OA (including OA-relevant peripheral joint pain in those aged over 45 years) using established code lists. For both definitions we estimated annual incidence density using exact person-time, and undertook descriptive analysis and age-period-cohort modelling. Demographic characteristics and management were described for incident cases in each calendar year. Sensitivity analyses explored the robustness of the findings to key assumptions. Results: Between 1992 and 2013 the annual age-sex standardized incidence rate for clinical OA increased from 29.2 to 40.5/1000 person-years. After controlling for period effects, the consultation incidence of clinical OA was higher for successive cohorts born after the mid-1950s, particularly women. In contrast, with the exception of hand OA, we observed no increase in the incidence of diagnosed OA: 8.6/1000 person-years in 2004 down to 6.3 in 2013. In 2013, 16.4% of clinical OA cases had an X-ray referral. While NSAID prescriptions fell from 2004, the proportion prescribed opioid analgesia rose markedly (0.1% of diagnosed OA in 1992 to 1.9% in 2013). Conclusion: Rising rates of clinical OA, continued use of plain radiography and a shift towards opioid analgesic prescription are concerning. Our findings support the search for policies to tackle this common problem that promote joint pain prevention while avoiding excessive and inappropriate health care.

  • Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals.

    3 July 2018

    BACKGROUND: Large-scale and contemporary population-based studies of heart failure incidence are needed to inform resource planning and research prioritisation but current evidence is scarce. We aimed to assess temporal trends in incidence and prevalence of heart failure in a large general population cohort from the UK, between 2002 and 2014. METHODS: For this population-based study, we used linked primary and secondary electronic health records of 4 million individuals from the Clinical Practice Research Datalink (CPRD), a cohort that is representative of the UK population in terms of age and sex. Eligible patients were aged 16 years and older, had contributed data between Jan 1, 2002, and Dec 31, 2014, had an acceptable record according to CPRD quality control, were approved for CPRD and Hospital Episodes Statistics linkage, and were registered with their general practice for at least 12 months. For patients with incident heart failure, we extracted the most recent measurement of baseline characteristics (within 2 years of diagnosis) from electronic health records, as well as information about comorbidities, socioeconomic status, ethnicity, and region. We calculated standardised rates by applying direct age and sex standardisation to the 2013 European Standard Population, and we inferred crude rates by applying year-specific, age-specific, and sex-specific incidence to UK census mid-year population estimates. We assumed no heart failure for patients aged 15 years or younger and report total incidence and prevalence for all ages (>0 years). FINDINGS: From 2002 to 2014, heart failure incidence (standardised by age and sex) decreased, similarly for men and women, by 7% (from 358 to 332 per 100 000 person-years; adjusted incidence ratio 0·93, 95% CI 0·91-0·94). However, the estimated absolute number of individuals with newly diagnosed heart failure in the UK increased by 12% (from 170 727 in 2002 to 190 798 in 2014), largely due to an increase in population size and age. The estimated absolute number of prevalent heart failure cases in the UK increased even more, by 23% (from 750 127 to 920 616). Over the study period, patient age and multi-morbidity at first presentation of heart failure increased (mean age 76·5 years [SD 12·0] to 77·0 years [12·9], adjusted difference 0·79 years, 95% CI 0·37-1·20; mean number of comorbidities 3·4 [SD 1·9] vs 5·4 [2·5]; adjusted difference 2·0, 95% CI 1·9-2·1). Socioeconomically deprived individuals were more likely to develop heart failure than were affluent individuals (incidence rate ratio 1·61, 95% CI 1·58-1·64), and did so earlier in life than those from the most affluent group (adjusted difference -3·51 years, 95% CI -3·77 to -3·25). From 2002 to 2014, the socioeconomic gradient in age at first presentation with heart failure widened. Socioeconomically deprived individuals also had more comorbidities, despite their younger age. INTERPRETATION: Despite a moderate decline in standardised incidence of heart failure, the burden of heart failure in the UK is increasing, and is now similar to the four most common causes of cancer combined. The observed socioeconomic disparities in disease incidence and age at onset within the same nation point to a potentially preventable nature of heart failure that still needs to be tackled. FUNDING: British Heart Foundation and National Institute for Health Research.