bluuebunny/crossref_metadata_2025_split huggingface dataset:
ACE inhibitor use and risk of cataract: a case–control analysis
Authors: Becker Claudia , Jick Susan S , Meier Christoph R 
Published: February 2019

Background/AimUse of ACE inhibitors (ACEIs) has been associated with an increased risk of cataract in a previous observational study in humans. In contrast, ACEIs were associated with beneficial effects on cataract development in experimental studies. We assessed the risk of cataract in relation to exposure to ACEI and other antihypertensive drugs.MethodsThis is a case-control study based on data from the UK-based Clinical Practice Research Datalink (CPRD). We included first-time cataract patients aged ≥40 years between 1995 and 2015 and an equal number of cataract-free controls. We matched the controls to cases on age, sex, general practice, date of first cataract (ie, index date) and years of history in the CPRD prior to the index date. We assessed the number of prescriptions for ACEI and other antihypertensive drugs in detail and explored the use of single ACEI substances. We performed conditional logistic regression and conducted various sensitivity analyses to test the robustness of our findings. We calculated the risk of cataract associated with previous exposure to ACEI, measured as OR with 95% CIs, and adjusted the multivariable model for body mass index, smoking, diabetes, hypertension, prescriptions of systemic corticosteroids and other antihypertensive drugs.ResultsWe identified 206 931 cataract cases and the same number of matched controls. Use of ACEI was not associated with a materially altered risk of cataract compared with non-use of ACEI, neither in the main analysis (OR 1.06, 95% CI 1.04 to 1.08) nor in any of the sensitivity or stratified analyses.ConclusionIn our large observational study, use of ACEI was not associated with an altered risk of cataract.
Higher circulating adiponectin and lower orosomucoid were associated with postload glucose ≤70 mg/dL, a possible inverse marker for dysglycemia, in young Japanese women
Authors: Tsuboi Ayaka , Minato Satomi , Yano Megumu , Takeuchi Mika , Kitaoka Kaori , Kurata Miki , Yoshino Gen , Wu Bin , Kazumi Tsutomu , Fukuo Keisuke 
Published: February 2019

ObjectiveTo examine whether serum adiponectin and orosomucoid were associated with postload glucose ≤70 mg/dL during an oral glucose tolerance test (OGTT), termed as postload low glycemia, a possible inverse marker for dysglycemia.Research design and methods75 g OGTTs were performed with multiple postload glucose and insulin measurements over a 30–120 min period in 168 normal-weight Japanese women (18–24 years). Insulin resistance (IR) and β-cell function inferred from serum insulin kinetics during OGTT, fat mass and distribution by dual-energy X-ray absorptiometry (DXA), serum adiponectin and inflammatory markers were compared cross-sectionally between 39 women with and 129 women without postload low glycemia.ResultsOf 168 women, 161 had normal glucose tolerance. Women with as compared with those without postload low glycemia had lower fasting and postload glycemia despite similar fasting and postload insulinemia. They had higher insulinogenic index (p=0.03) and lower adipose IR (a product of fasting free fatty acid and insulin, p=0.01), although DXA-derived general and central adiposity, the Matsuda Index and homeostasis model assessment-IR did not differ. In addition, they had higher adiponectin and lower orosomucoid (both p<0.001). Multivariate logistic regression analyses revealed that adiponectin (OR: 1.14, 95% CI 1.03 to 1.26, p=0.009) and orosomucoid (0.96, 0.93 to 0.97, p=0.008) were associated with postload low glycemia independently of adipose IR and insulinogenic index.ConclusionsHigher adiponectin and lower orosomucoid were associated with 70 or lower mg/dL of postload glucose, a possible inverse marker for dysglycemia, in young women independently of DXA-derived fat mass and distribution, insulin secretion and IR.
Comparison of two malnutrition risk screening tools with nutritional biochemical parameters, BMI and length of stay in Chinese geriatric inpatients: a multicenter, cross-sectional study
Authors: Miao Jian-Ping , Quan Xiao-Qing , Zhang Cun-Tai , Zhu Hong , Ye Mei , Shen Li-Ya , Guo Qiu-Hui , Zhu Gang-Yan , Mei Qi-Jian , Wu Yan-Xia , Li Shu-Guo , Zhou Hong-Lian 
Published: February 2019

ObjectivesThe aims of this study were to assess malnutrition risk in Chinese geriatric inpatients using Nutritional Risk Screening 2002 (NRS2002) and Mini-Nutritional Assessment (MNA), and to identify the most appropriate nutritional screening tool for these patients.DesignCross-sectional study.SettingEight medical centres in Hubei Province, China.ParticipantsA total of 425 inpatients aged ≥70 years were consecutively recruited between December 2014 and May 2016.Primary and secondary outcome measuresNutritional risk was assessed using NRS2002, MNA, anthropometric measurements and biochemical parameters within 24 hours of admission. Comorbidities and length of hospitalisation were recorded. Nutritional parameters, body mass index (BMI) and length of hospital stay (LOS) were employed to compare MNA and NRS2002. Kappa analysis was used to evaluate the consistency of the two tools.ResultsThe average age was 81.2±5.9 years (range, 70–98). The prevalence of undernutrition classified by NRS2002 and MNA was 40.9% and 58.6%, respectively. Patients undergoing malnutrition had lower BMI, haemoglobin, albumin and prealbumin (p<0.05), and longer LOS (p<0.05). The NRS2002 showed moderate agreement (κ=0.521, p<0.001) with MNA. Both tools presented significant correlation with age, BMI and laboratory parameters (p<0.001). In addition, a significant association between both tools and LOS was found (p<0.05). In addition, the NRS2002 was not different from MNA in predicting nutritional risk in terms of the area under the receiver operating characteristic curve (p>0.05).ConclusionsThe results show a relatively high prevalence of malnutrition risk in our sample cohort. We found that NRS2002 and MNA were both suitable in screening malnutrition risk among Chinese geriatric inpatients.
Effects of maternal B12 supplementation on neurophysiological outcomes in children: a study protocol for an extended follow-up from a placebo randomised control trial in Bangalore, India
Authors: Anand Shilpa , Thomas Susan , Jayachandra Mahesh , Thomas Tinku , Strand Tor Arne , Kurpad Anura V , Duggan Christopher P , Srinivasan Krishnamachari 
Published: February 2019

IntroductionVitamin B12 deficiency is highly prevalent in pregnant Indian women. Neuropsychological tests have shown an association between low maternal vitamin B12 status and poorer cognitive performances in the offspring, although findings from these studies have been inconsistent. Vitamin B12 has an important role in the formation of myelin which is important for the transmission speed of neural impulses and myelination in the central nervous system has been linked to cognition. Assessing neurophysiological measures using event-related potentials (ERPs) in children may provide additional information on the effect of maternal vitamin B12 supplementation on offspring brain function. The study examines the effects of oral vitamin B12 daily supplements (50 µg) to pregnant Indian women on child neurophysiological function at 72 months.Methods and analysisWe previously conducted a double-blind, placebo-controlled study to examine the effects of maternal vitamin B12 supplementation on cognitive outcomes in their offspring using the Bayley scales of infant development, third edition. In this extended follow-up of the same cohort of mother-child dyad, we propose to use ERP to study the long-term impact of maternal B12 supplementation on brain function in children at 72 months of age. We intend to use P300 and mismatch negativity (MMN) as measures of neurophysiological outcomes. The primary outcome of this study will be child neurophysiological measures (as measured by amplitude and latency of P300 and MMN) assessed at 72 months of age in children whose mothers received vitamin B12 compared with neurophysiological status of children whose mothers received placebo.Ethics and disseminationThe study was approved by the Institutional Ethical Board of St. John’s Medical College and the Harvard School of Public Health Human Subjects Committee. Results obtained will be presented at national and international research meetings and published in peer-reviewed scientific journals.Trial registration numberNCT00641862.
Qualitative study to identify ethnicity-specific perceptions of and barriers to asthma management in South Asian and White British children with asthma
Authors: Lakhanpaul Monica , Culley Lorraine , Huq Tausif , Bird Deborah , Hudson Nicky , Robertson Noelle , McFeeters Melanie , Manikam Logan , Johal Narynder , Hamlyn-Williams Charlotte , Johnson Mark R D 
Published: February 2019

ObjectiveThis paper draws on the data from the Management and Interventions for Asthma (MIA) study to explore the perceptions and experiences of asthma in British South Asian children using semi-structured interviews. A comparable cohort of White British children was recruited to identify whether any emerging themes were subject to variation between the two groups so that generic and ethnicity-specific themes could be identified for future tailored intervention programmes for South Asian children with asthma.SettingSouth Asian and White British children with asthma took part in semi-structured interviews in Leicester, UK.ParticipantsThirty three South Asian and 14 White British children with asthma and aged 5–12 years were interviewed.ResultsBoth similar and contrasting themes emerged from the semi-structured interviews. Interviews revealed considerable similarities in the experience of asthma between the South Asian and White British children, including the lack of understanding of asthma (often confusing trigger with cause), lack of holistic discussions with healthcare professionals (HCPs), an overall neutral or positive experience of interactions with HCPs, the role of the family in children’s self-management and the positive role of school and friends. Issues pertinent to South Asian children related to a higher likelihood of feeling embarrassed and attributing physical activity to being a trigger for asthma symptoms.ConclusionsThe two ethnicity-specific factors revealed by the interviews are significant in children’s self-management of asthma and therefore, indicate the need for a tailored intervention in South Asian children.
Changes in the type and amount of spending disclosed by Australian pharmaceutical companies: an observational study
Authors: Parker Lisa , Karanges Emily A , Bero Lisa 
Published: February 2019

ObjectivesTo describe and quantify disclosed payments from the pharmaceutical industry to the healthcare sector, and to examine the impact of the 2015 changes to Australia’s self-regulated system of transparency.DesignObservational database study.SettingAustralia.ParticipantsPublicly available reports submitted by members of Australian pharmaceutical industry trade organisations, Medicines Australia and the Generic and Biosimilar Medicines Association (GBMA) (October 2011–December 2017).ExposureChanges to transparency reporting requirements with the updates of pharmaceutical industry Codes of Conduct in 2015.Main outcome measuresElements of healthcare sector spending that members of industry organisations are required to publicly disclose; cumulative amount of disclosed spending (monthly average) in the year prior to and following the revision.ResultsThere was a 34.1% reduction in disclosed spending from Medicines Australia member companies in the year after the 2015 changes to the Code of Conduct were introduced ($A89 658 566 in the preceding year, October 2014–September 2015; $A59 052 551 in the following year). The new Code allowed for reduced reporting of spending on food and beverages at events and for sponsored healthcare professionals. However, there was enhanced transparency around identification of individual health professionals receiving payments. GBMA member reporting totalled $A2 580 402 in the year prior to the revision, then ceased.ConclusionsThis study shows the limitations of a self-regulatory system around industry disclosure of spending. We advocate for robust regulatory systems, such as legislation, to promote mandatory long-lasting public transparency.
Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol
Authors: Clarke Paul , Craig Jean V , Wain John , Tremlett Catherine , Linsell Louise , Bowler Ursula , Juszczak Ed , Heath Paul T 
Published: February 2019

IntroductionCatheter-related sepsis is one of the most dangerous complications of neonatal intensive care and is associated with significant morbidity and mortality. Use of catheter-care ‘bundles’ has reduced the incidence of catheter-related sepsis, although individual components have not been well studied. Better evidence is needed to guide selection of the most appropriate antiseptic solution for skin disinfection in preterm neonates. This study will inform the feasibility and design of the first randomised controlled trial to examine the safety and efficacy of alcohol-based versus aqueous-based chlorhexidine antiseptic formulations for skin disinfection prior to percutaneous central venous catheterisation in preterm neonates. The antiseptics to be compared are 2% chlorhexidine gluconate (CHG) aqueous and 2% CHG in 70% isopropyl alcohol.Methods and analysisThe Antiseptic Randomised Controlled Trial for Insertion of Catheters (ARCTIC) is a two-centre randomised-controlled feasibility trial. At least 100 preterm infants born at <34 weeks’ gestation and due to undergo percutaneous insertion of a central venous catheter will be randomly allocated to receive prior skin disinfection with one of the two antiseptic solutions. Outcomes include: i) recruitment and retention rates; ii) completeness of data collection; iii) numbers of enrolled infants meeting case definitions for definite catheter-related sepsis, catheter-associated sepsis and catheter colonisation and iv) safety outcomes of skin morbidity scores recorded daily from catheter insertion until 48 hours post removal. The key feasibility metrics will be reported as proportions with 95% CIs. Estimated prevalence of catheter colonisation will allow calculation of sample size for the large-scale trial. The data will inform whether it will be feasible to progress to a large-scale trial.Ethics and disseminationARCTIC has been approved by the National Health Service Health Research Authority National Research Ethics Service Committee East of England (Cambridge South) (IRAS ID 163868), was adopted onto the National Institute of Health Research Clinical Research Network portfolio (CPMS ID 19899) and is registered with an International Standard Randomised Control Trials Number (ISRCTN: 82571474; Pre-results) and European Clinical Trials Database number 2015-000874-36. Dissemination plans include presentations at scientific conferences, scientific publications and sharing of the findings with parents via the support of Bliss baby charity.Trial registration numberISRCTN82571474; Pre-results.
Short Graphic Values History Tool for decision making during serious illness
Authors: You John J , Allatt Peter , Howard Michelle , Robinson Carole A , Simon Jessica , Sudore Rebecca , Tan Amy , Bernard Carrie , Swinton Marilyn , Jiang Xuran , Klein Doug , McKenzie Michael , Fyles Gillian , Heyland Daren Keith 
Published: February 2019

ObjectivesTo develop and validate a values clarification tool, the Short Graphic Values History Tool (GVHT), designed to support person-centred decision making during serious illness.MethodsThe development phase included input from experts and laypersons and assessed acceptability with patients/family members. In the validation phase, we recruited additional participants into a before–after study. Our primary validation hypothesis was that the tool would reduce scores on the Decisional Conflict Scale (DCS) at 1–2 weeks of follow-up. Our secondary validation hypotheses were that the tool would improve values clarity (reduce scores) more than other DCS subscales and increase engagement in advance care planning (ACP) processes related to identification and discussion of one’s values.ResultsIn the development phase, the tool received positive overall ratings from 22 patients/family members in hospital (mean score 4.3; 1=very poor; 5=very good) and family practice (mean score 4.5) settings. In the validation phase, we enrolled 157 patients (mean age 71.8 years) from family practice, cancer clinic and hospital settings. After tool completion, decisional conflict decreased (−6.7 points, 95% CI −11.1 to −2.3, p=0.003; 0–100 scale; N=100), with the most improvement seen in the values clarity subscale (−10.0 points, 95% CI −17.3 to −2.7, p=0.008; N=100), and the ACP-Values process score increased (+0.4 points, 95% CI 0.2 to 0.6, p=0.001; 1–5 scale; N=61).ConclusionsThe Short GVHT is acceptable to end users and has some measure of validity. Further study to evaluate its impact on decision making during serious illness is warranted.
Advance care plans in dementia: user-centred design
Authors: Harrison Dening Karen , Castle Emma , Scates Caroline , De Vries Kay 
Published: February 2019

ObjectivesHistorically, dementia has not been recognised as a life-limiting condition or one that may benefit from a palliative approach to its care. There are many challenges in providing palliative and end-of-life care to this group of people, some of which may be reduced through advance care planning (ACP) to support people with dementia to have a greater influence on their care at end of life. ACP has been defined as a process of discussing and recording of wishes, values and preferences for future care and treatment held between an individual, family members and their care provider(s) that takes effect when the person loses capacity. The objective of this project was to involve people with dementia and their family carers in co-design of ACP guide and template to prepare for further study related to communication processes in ACP.MethodsA user-centred design process cycle of development and review was undertaken by Dementia UK which involved people with dementia, family carers, Admiral Nurses and other key stakeholders in developing an ACP guide and template.ResultsNine cyclical stages were undertaken to achieve the outcome of an ACP guide and template.ConclusionCo-production using a user-centred design approach offers a structured and inclusive approach to developing ACP materials.Authors:
Validation of the revised classification of cognitive and behavioural impairment in ALS
Authors: Iazzolino Barbara , Pain Debora , Peotta Laura , Calvo Andrea , Moglia Cristina , Canosa Antonio , Manera Umberto , Ilardi Antonio , Bombaci Alessandro , Zucchetti Jean Pierre , Mora Gabriele , Chio Adriano 
Published: February 2019

ObjectiveIn 2017, the diagnostic criteria for cognitive and behavioural impairment in amyotrophic lateral sclerosis (ALS) with frontotemporal dementia (ALSFTD-1) have been modified (ALSFTD-2) with the inclusion of a novel category (ALS with combined cognitive and behavioural impairment, ALScbi) and with changes of operational criteria of the other categories (ALS with cognitive impairment (ALSci), ALS with behavioural impairment (ALSbi) and ALS with frontotemporal dementia (ALS-FTD)). We compared the two sets of criteria to assess the effect of the revised criteria on the cognitive classification of patients with ALS.MethodsTwo cohorts of patients with ALS were included in this study: a population-based cohort including patients identified through the Piemonte/Valle d’Aosta register for ALS in the 2014–2017 period (n=321), and a referral cohort recruited at the Turin ALS centre and at the ALS centre of the Maugeri Institute in Milan in the same period (n=205). Cognitive function was classified in blind by two neuropsychologists expert in ALS.ResultsALSFTD-2 criteria determined a shift of about 15% of patients from their original category to a new one. In both cohorts, about 9% of patients were reclassified to the novel category ALScbi. Among patients previously classified as cognitively normal, 14 (4.3%, population-based cohort) and 19 (9.3%, referral cohort) were reclassified as ALSbi or ALSci. The median survival of the different categories was significantly different with both with sets of criteria.ConclusionsThe new ALSFTD-2 criteria, compared with the old ones, have positive effects on the clinical practice being more sensitive to the early cognitive impairment and having a better prognostic yield.
Re-treatment with abatacept plus methotrexate for disease flare after complete treatment withdrawal in patients with early rheumatoid arthritis: 2-year results from the AVERT study
Authors: Emery Paul , Burmester Gerd R , Bykerk Vivian P , Combe Bernard G , Furst Daniel E , Maldonado Michael A , Huizinga Tom WJ 
Published: February 2019

ObjectivesTo complete reporting of outcomes after total withdrawal of all rheumatoid arthritis (RA) therapy and re-treatment after flare in Assessing﻿Very Early Rheumatoid arthritis Treatment study (NCT01142726).MethodsPatients with early RA were initially randomised to double-blind, weekly subcutaneous abatacept plus methotrexate, or abatacept or methotrexate monotherapy. At month 12, patients with Disease Activity Score (DAS)28 C reactive protein (CRP) <3.2 had all RA treatments rapidly withdrawn and were observed for ≤12 months or until flare. After ≥3 months’ withdrawal, patients with protocol-defined RA flare received open-label abatacept plus methotrexate for 6 months (re-treatment).Results Proportion of patients in DAS28-CRP–defined remission remained numerically higher in original abatacept plus methotrexate and abatacept arms versus methotrexate arm up to day 253 of withdrawal. At the end of the withdrawal period, few patients remained in remission across all arms: 9/73 (12.3%), 7/50 (14.0%) and 6/53 (11.3%), respectively. For patients entering re-treatment, after 6 months’ re-treatment, 95/124 (76.6%) and 78/124 (62.9%) patients achieved DAS28-CRP <3.2 and <2.6, respectively; mean changes in DAS28-CRP and Health Assessment Questionnaire–Disability Index scores from re-treatment baseline were –2.87 and 0.76, respectively. Re-treatment was well tolerated; exposure-adjusted infection rates per 100 patient-years were lower with abatacept plus methotrexate during withdrawal (7.2) and re-treatment (17.2) versus initial treatment periods of months 0–6 (116.6) and 6–12 (64.6).ConclusionsMost patients flared within 6 months of therapy withdrawal and few sustained major responses for 1 year. Re-treatment with abatacept plus methotrexate was effective and well tolerated in this controlled setting.