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  This is an Open Access Journal Open Access journal
ISSN (Online) 2589-5370
Published by Elsevier Homepage  [3161 journals]
  • Are Neuroanatomical Abnormalities Underlying Hallucinations

    • Abstract: Publication date: Available online 2 February 2019Source: EClinicalMedicineAuthor(s): Judith M. Ford, Holly K. Hamilton
  • Cell and Gene Therapy Trials: Are We Facing an ‘Evidence

    • Abstract: Publication date: Available online 2 February 2019Source: EClinicalMedicineAuthor(s): Mohamed Abou-El-Enein, Spencer Phillips Hey
  • Sugary t(h)reats: our gut microbiome and diet

    • Abstract: Publication date: December 2018Source: EClinicalMedicine, Volume 6Author(s):
  • β-Blocker Therapy and Risk of Chronic Obstructive Pulmonary Disease – A
           Danish Nationwide Study of 1·3 Million Individuals

    • Abstract: Publication date: Available online 29 January 2019Source: EClinicalMedicineAuthor(s): Anne Orholm Nielsen, Lars Pedersen, Birgitte Fischer Sode, Morten Dahl BackgroundThe possible association between β-adrenoceptor antagonists (β-blockers) and risk of COPD is controversial. The objective of the present study was to test whether β-blocker use is associated with susceptibility to the disease.MethodsA total of 301,542 new users of β-blockers and 1,000,633 new users of any other antihypertensive drugs aged 30–90 years without any history of COPD hospitalizations were included in the present study and followed in the Danish National Patient Registry for incident admissions for COPD and COPD death between 1995 and 2015. Multiple adjusted cox regression models were used to examine the association between use of β-blockers and COPD hospitalization. Additionally, subgroup analyses based on underlying diseases at baseline or duration of treatment were performed.FindingsPeople treated with β-blockers continuously for more than 6 months had a lower risk of COPD hospitalization during follow-up compared to people treated with any other antihypertensive drugs (adjusted hazard ratio [HRadjusted] 0·80, 95% CI 0·79–0·82). Risk of COPD hospitalization was lowered in the groups treated with β-blockers among patients with ischemic heart disease (0·72, 0·69–0·75), cardiac arrhythmias (0·76, 0·72–0·80), asthma (0·69, 0·61–0·79), hypertension (0·91, 0·86–0·96), and diseases of the pulmonary circulation (pulmonary embolism and cor pulmonale) (0·72, 0·59–0·87). All-cause mortality as well as risk of COPD death during follow-up was lower in the group treated with β-blockers compared to the group treated with any other antihypertensive drugs (0·56, 0·53–0·59).InterpretationTreatment with β-blockers seems to reduce risk of COPD hospitalization and mortality compared to treatment with any other antihypertensive drugs.FundingThe Danish Council for Independent Research in Denmark (grant no. 4183-00569B), The Research Foundation of Health Science in Region Zealand (grant no. RSSF2017000661 and no. 15-000342), The Research Foundation of Medical Science (A.P. Møller Foundation, grant no. 16-68), The Research Foundation in memory of King Christian 10th (grant no. 142/2017), Aase & Ejnar Danielsen's Research Foundation (grant no. 10-001946), and Lundbeck Foundation (grant no. R252-2017-1690).
  • Who's Afraid of the Big Bad Wolf' Safety of Beta-Blockers in COPD

    • Abstract: Publication date: Available online 29 January 2019Source: EClinicalMedicineAuthor(s): Giuseppe Ambrosio, Sergio Harari, Iosief Abraha
  • Sustained Effect of Immunotherapy for Food Allergy: Breaking Up is Hard to

    • Abstract: Publication date: Available online 29 January 2019Source: EClinicalMedicineAuthor(s): Lars K. Poulsen
  • Effect of Marijuana Smoking on Pulmonary Disease in HIV-Infected and
           Uninfected Men: A Longitudinal Cohort Study

    • Abstract: Publication date: Available online 24 January 2019Source: EClinicalMedicineAuthor(s): David R. Lorenz, Hajime Uno, Steven M. Wolinsky, Dana GabuzdaSummaryBackgroundLung disease is a common comorbidity in people with HIV/AIDS, independent of smoking status. The effects of marijuana smoking on risk of lung disease in HIV-infected individuals are unclear.MethodsIn this prospective cohort study, we quantified lung disease risk among men enrolled in the Multicenter AIDS Cohort Study (MACS), a long-term observational cohort of HIV-infected and uninfected men who have sex with men. Eligible participants were aged ≥ 30 years with self-reported marijuana and tobacco smoking data from biannual study visits between 1996 and 2014. Pulmonary diagnoses were obtained from self-report and medical records. Analyses were performed using Cox models and Generalized Estimating Equations adjusted for tobacco smoking, CD4 T cell count, and other risk factors.Findings1630 incident pulmonary diagnoses were reported among 1352 HIV-seropositive and 1352 HIV-seronegative eligible participants matched for race and baseline age (53,794 total person-visits, median follow-up 10.5 years). 27% of HIV-infected participants reported daily or weekly marijuana smoking for one or more years in follow-up, compared to 18% of uninfected participants (median 4·0 and 4·5 years daily/weekly use, respectively). HIV-infected participants had an increased likelihood of infectious or non-infectious pulmonary diagnoses compared to uninfected participants (33·2% vs. 21·5%, and 20·6% vs. 17·2%, respectively). Among HIV-infected participants, recent marijuana smoking was associated with increased risk of infectious pulmonary diagnoses and chronic bronchitis independent of tobacco smoking and other risk factors for lung disease (hazard ratio [95% confidence interval] 1·43 [1·09–1·86], and 1·54 [1·11–2·13], respectively); these risks were additive in participants smoking both substances. There was no association between marijuana smoking and pulmonary diagnoses in HIV-uninfected participants.InterpretationIn this longitudinal study, long-term marijuana smoking was associated with lung disease independent of tobacco smoking and other risk factors in HIV-infected individuals. These findings could be used to reduce modifiable risks of lung disease in high-risk populations.FundingU.S. National Institutes of Health.
  • Better Data Enables Better Intervention

    • Abstract: Publication date: Available online 24 January 2019Source: EClinicalMedicineAuthor(s): Malcolm Battin
  • Individual Patient-specific Planning of Minimally Invasive Transcatheter
           Intervention for Heart Valve Disease

    • Abstract: Publication date: Available online 23 January 2019Source: EClinicalMedicineAuthor(s): A. De Vecchi, S. Niederer, R. Rajani, S. Redwood, B. Prendergast
  • A Phase 2 Randomized Controlled Multisite Study Using
           Omalizumab-facilitated Rapid Desensitization to Test Continued vs
           Discontinued Dosing in Multifood Allergic Individuals

    • Abstract: Publication date: Available online 21 January 2019Source: EClinicalMedicineAuthor(s): Sandra Andorf, Natasha Purington, Divya Kumar, Andrew Long, Katherine L. O'Laughlin, Scott Sicherer, Hugh Sampson, Antonella Cianferoni, Terri Brown Whitehorn, Daniel Petroni, Melanie Makhija, Rachel G. Robison, Michelle Lierl, Stephanie Logsdon, Manisha Desai, Stephen J. Galli, Efren Rael, Amal Assa'ad, Sharon Chinthrajah, Jacqueline Pongracic BackgroundAs there is limited data on the sustainability of desensitization of multifood-oral immunotherapy (multifood-OIT), we conducted a multisite multifood-OIT study to compare the efficacy of successful desensitization with sustained dosing vs discontinued dosing after multifood-OIT.MethodsWe enrolled 70 participants, aged 5–22 years with multiple food allergies confirmed by double-blind placebo-controlled food challenges (DBPCFCs). In the open-label phase of the study, all participants received omalizumab (weeks 1–16) and multi-OIT (2–5 allergens; weeks 8–30) and eligible participants (on maintenance dose of each allergen by weeks 28–29) were randomized 1:1:1 to 1 g, 300 mg, or 0 mg arms (blinded, weeks 30–36) and then tested by food challenge at week 36. Success was defined as passing 2 g food challenge to at least 2 foods in week 36.FindingsMost participants were able to reach a dose of 2 g or higher of each of 2, 3, 4, and 5 food allergens (as applicable to the participant's food allergens in OIT) in week 36 food challenges. Using an intent-to-treat analysis, we did not find evidence that a 300 mg dose was effectively different than a 1 g dose in maintaining desensitization, and both together were more effective than OIT discontinuation (0 mg dose) (85% vs 55%, P = 0.03). Fifty-five percent of the intent-to-treat participants and 69% of per protocol participants randomized to the 0 mg arm showed no objective reactivity after 6 weeks of discontinuation. Cross-desensitization was found between cashew/pistachio and walnut/pecan when only one of the foods was part of OIT. No statistically significant safety differences were found between the three arms.InterpretationThese results suggest that sustained desensitization after omalizumab-facilitated multi-OIT best occurs through continued maintenance OIT dosing of either 300 mg or 1 g of each food allergen as opposed to discontinuation of multi-OIT.FundingSean N. Parker Center for Allergy and Asthma Research at Stanford University, Jeff and MacKenzie Bezos, NIAID AADCRC U19AI104209.Trial Registration number, NCT02626611.
  • Early Essential Newborn Care Is Associated With Reduced Adverse Neonatal
           Outcomes in a Tertiary Hospital in Da Nang, Viet Nam: A Pre- Post-
           Intervention Study

    • Abstract: Publication date: Available online 14 January 2019Source: EClinicalMedicineAuthor(s): Hoang Thi Tran, Priya Mannava, John C.S. Murray, Phuong Thi Thu Nguyen, Le Thi Mong Tuyen, Tuan Hoang Anh, Thi Quynh Nga Pham, Vinh Nguyen Duc, Howard L. Sobel BackgroundTo accelerate reductions in neonatal mortality, Viet Nam rolled out early essential newborn care (EENC) using clinical coaching, quality improvement assessments in hospitals, and updated protocols. Da Nang Hospital for Women and Children, a tertiary referral hospital in central Viet Nam, compared outcomes pre- and post-EENC introduction.MethodsRecords of live births and NICU admissions were reviewed pre- (November 2013–October 2014) and post- (November 2014–October 2015) EENC implementation. Delivery room practices, NICU admissions and adverse outcomes on NICU admission were compared using descriptive statistics.FindingsA total of 13,201 live births were delivered pre- and 14,180 live births post-EENC introduction. Post-EENC, delivery practice scores, rates of early and prolonged skin-to-skin contact and early breastfeeding rose significantly. There was a significant reduction in risk of NICU admissions (relative risk [RR] 0.68; 95% confidence interval [CI] 0.64–0.71; p 
  • Patient-centered Care and Treatment in HIV Infection

    • Abstract: Publication date: Available online 10 January 2019Source: EClinicalMedicineAuthor(s): Massimiliano Lanzafame, Sandro Vento
  • Effectiveness of 23-Valent Polysaccharide Pneumococcal Vaccine and Changes
           in Invasive Pneumococcal Disease Incidence from 2000 to 2017 in Those Aged
           65 and Over in England and Wales

    • Abstract: Publication date: Available online 2 January 2019Source: EClinicalMedicineAuthor(s): Abdelmajid Djennad, Mary E. Ramsay, Richard Pebody, Norman K. Fry, Carmen Sheppard, Shamez N. Ladhani, Nick J. Andrews BackgroundInvasive Pneumococcal Disease (IPD) is a major public health concern. The effectiveness of 23-valent polysaccharide pneumococcal vaccine (PPV23) against IPD in older age-groups is not fully understood. We measured PPV23 effectiveness against IPD and interpreted changes in IPD incidence between 2000 and 2017.MethodsPublic Health England conducts enhanced national IPD surveillance in England and Wales. The indirect cohort method was used to estimate PPV23 effectiveness against IPD in individuals aged ≥ 65 years eligible for PPV23 vaccination during 2012–2016. IPD incidence in 2016/17 was compared to rates during 2000–2003, when neither PPV23 nor pneumococcal conjugate vaccines (PCVs) were routinely used in England and Wales.FindingsPPV23 effectiveness, irrespective of time since vaccination, was 27% (95% CI, 17–35) after adjusting for age, co-morbidity and year of infection. Vaccine effectiveness reduced non-significantly (p = 0.13) with time since vaccination, from 41% (95% CI, 23–54) for those vaccinated within two years, to 34% (95% CI, 16–48) for those vaccinated 2–4 years previously, and 23% (95% CI, 12–32) for those vaccinated ≥ 5 years previously. Vaccine effectiveness did not vary significantly by age but was highest in previously healthy individuals (45%; 95%CI, 27–59). IPD incidence for PPV23 serotypes not included in the PCVs did not decrease after routine PPV23 use but increased significantly since PCV introduction in 2006.InterpretationPPV23 offers moderate short-term protection against IPD in older adults. PPV23 serotypes comprise an increasing proportion of IPD cases in older adults because of serotype replacement following routine PCV use in children.FundingEuropean Union's Horizon 2020.
  • Identifying English Practices that Are High Antibiotic Prescribers
           Accounting for Comorbidities and Other Legitimate Medical Reasons for

    • Abstract: Publication date: Available online 12 December 2018Source: EClinicalMedicineAuthor(s): Emma C. Hope, Ron E. Crump, T. Deirdre Hollingsworth, Timo Smieszek, Julie V. Robotham, Koen B. Pouwels BackgroundSeeing one's practice as a high antibiotic prescriber compared to general practices with similar patient populations can be one of the best motivators for change. Current comparisons are based on age-sex weighting of the practice population for expected prescribing rates (STAR-PU). Here, we investigate whether there is a need to additionally account for further potentially legitimate medical reasons for higher antibiotic prescribing.MethodsPublicly available data from 7376 general practices in England between April 2014 and March 2015 were used. We built two different negative binomial regression models to compare observed versus expected antibiotic dispensing levels per practice: one including comorbidities as covariates and another with the addition of smoking prevalence and deprivation. We compared the ranking of practices in terms of items prescribed per STAR-PU according to i) conventional STAR-PU methodology, ii) observed vs expected prescribing levels using the comorbidity model, and iii) observed vs expected prescribing levels using the full model.FindingsThe median number of antibiotic items prescribed per practice per STAR-PU was 1.09 (25th–75th percentile, 0.92–1.25). 1133 practices (76.8% of 1476) were consistently identified as being in the top 20% of high antibiotic prescribers. However, some practices that would be classified as high prescribers using the current STAR-PU methodology would not be classified as high prescribers if comorbidity was accounted for (n = 269, 18.2%) and if additionally smoking prevalence and deprivation were accounted for (n = 312, 21.1%).InterpretationCurrent age-sex weighted comparisons of antibiotic prescribing rates in England are fair for many, but not all practices. This new metric that accounts for legitimate medical reasons for higher antibiotic prescribing may have more credibility among general practitioners and, thus, more likely to be acted upon.Outstanding QuestionsFindings of this study indicate that the antibiotic prescribing metric by which practices are measured (and need to implement interventions determined) may be inadequate, and therefore raises the question of how they should be measured. Substantial variation between practices remains after accounting for comorbidities, deprivation and smoking. There is a need for a better understanding of why such variation remains and, more importantly, what can be done to reduce it. While antibiotics are more frequently indicated in patients with comorbidities, it is unclear to what extent antibiotic prescribing can be lowered among that patient population and how this could be achieved.
  • Systematic De-escalation of Successful Triple Antiretroviral Therapy to
           Dual Therapy with Dolutegravir plus Emtricitabine or Lamivudine in Swiss
           HIV-positive Persons

    • Abstract: Publication date: Available online 6 December 2018Source: EClinicalMedicineAuthor(s): Natascha D. Diaco, Claudio Strickler, Stéphanie Giezendanner, Sebastian A. Wirz, Philip E. Tarr BackgroundStudies increasingly suggest that the efficacy of certain dual antiretroviral therapy (ART) combinations is equal to triple ART. Increasing concerns among HIV-positive patients and physicians in Switzerland include ART cost and long-term ART safety and toxicity, i.e. taking only as many ART agents as necessary. The aims of this retrospective analysis are to report on the de-escalation of our entire clinic population of eligible patients with well-controlled HIV-infection to dolutegravir-containing dual ART.MethodsStarting in March 2015, we systematically considered the de-escalation of eligible patients to either dolutegravir/emtricitabine or dolutegravir/lamivudine, by discontinuing tenofovir disoproxil fumarate or abacavir. We report on the virological efficacy, tolerability and patient satisfaction ≥ 48 weeks after de-escalation.FindingsOf 106 HIV-positive patients followed in our clinic, 70 patients were de-escalated. Three returned to triple ART (insomnia after dolutegravir start, n = 2; new wish for single tablet regimen, n = 1). All de-escalated patients and all who continued triple ART had suppressed HIV viremia at last follow-up and were satisfied with their ART regimen, except for one patient who had virological failure after ART discontinuation in the setting of major depression. The most common reasons to not de-escalate included hepatitis B co-infection (n = 6), physician's concern about ART adherence (n = 6), patient reluctance to switch from a single tablet to a 2-tablet regimen (n = 7), patient satisfied with current ART (n = 5) and others (n = 12).InterpretationART de-escalation to dolutegravir/FTC or dolutegravir/3TC is possible in the majority of patients virologically suppressed on triple ART, and may effectively address patient and physician concerns about long-term safety and cost of ART.
  • Emerging Carriage of NDM-5 and MCR-1 in Escherichia coli From Healthy
           People in Multiple Regions in China: A Cross Sectional Observational Study

    • Abstract: Publication date: Available online 4 December 2018Source: EClinicalMedicineAuthor(s): Zhangqi Shen, Yanyan Hu, Qiaoling Sun, Fupin Hu, Hongwei Zhou, Lingbin Shu, Tengfei Ma, Yingbo Shen, Yang Wang, Juan Li, Timothy R. Walsh, Rong Zhang, Shaolin Wang BackgroundCarriage of carbapenem-resistant Enterobacteriaceae (CRE) in humans may contribute to the dissemination of CRE and impact on communities and healthcare facilities. Carbapenem-resistant Escherichia coli (CREC) is one of the major type of CRE in the human gut. Here, we describe a cross-sectional study to investigate the prevalence of CREC, and in particular the mcr-1 carrying CREC, in health volunteers in China.MethodsDuring September to December 2016, 3859 non-duplicated stool specimens were collected from healthy volunteers who received regular physical examinees in healthcare centers located in 19 provinces across China. Enrichment culture supplemented meropenem was used to isolate CREC. Carbapenemase producing determinants and the mcr-1 gene were determined by PCR amplification and sequencing. Isolates were further analyzed by antibiotic susceptibility test, genotyping, and whole genome analysis.FindingsA total of 92 non-duplicated CREC were isolated from 3859 stool specimens, among which 43 CREC are carbapenemase positive. In addition, the co-existence of blaNDM and mcr-1 was found in 14 CREC, which also showed resistance to the majority of all antimicrobial agents analyzed. The genetic background of these CREC isolates are highly diversified based on molecular typing. Furthermore, whole genome sequence indicated that NDM-5 is the predominant determinant conferring carbapenem resistance in CREC, and that NDM-5 carrying plasmids (IncX3) are very similar.InterpretationThe incidence of CREC carriage in healthy people in China was small; however, the co-existence of CREC with mcr-1 is disconcerting. Therefore, pre-screening prior to admission and monitoring of patients on high-dependency wards is highly recommended to control and prevent the dissemination of CRE in hospitals.Outstanding QuestionThe high prevalence of CREC in the healthy people should not be underestimated, as it may increase the risk of infection. This knowledge could have impact on the pre-screening and monitoring of CRE before patient administration.
  • Predicting STI Diagnoses Amongst MSM and Young People Attending Sexual
           Health Clinics in England: Triage Algorithm Development and Validation
           Using Routine Clinical Data

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Carina King, Gwenda Hughes, Martina Furegato, Hamish Mohammed, John Were, Andrew Copas, Richard Gilson, Maryam Shahmanesh, Catherine H Mercer BackgroundSexual health (SH) services increasingly need to prioritise those at greatest risk of sexually transmitted infections (STIs). We used SH surveillance data to develop algorithms to triage individuals attending SH services within two high-risk populations: men who have sex with men (MSM) and young people (YP).MethodsSeparate multivariable logistic regression models for MSM and YP were developed using surveillance data on demographics, recent sexual history, prior STI diagnoses and drug/alcohol use from five clinics in 2015–2016 to identify factors associated with new STI diagnoses. The models were prospectively applied in one SH clinic in May 2017 as an external validation.Findings9530 YP and 1448 MSM SH episodes informed model development. For YP, factors associated with new STI diagnosis (overall prevalence: 10.6%) were being of black or mixed white/black ethnicity; history of chlamydia diagnosis (previous year); and multiple partners/new partner (previous 3-months). The YPs model had reasonable performance (c-statistic: 0.703), but poor discrimination when externally validated (c-statistic: 0.539). For MSM, being of South Asian ethnicity; being born in Europe (excluding the UK); and condomless anal sex or drug use (both in previous 3-months) were associated with STI diagnosis (overall prevalence: 22.0%). The MSM model had a c-statistic of 0.676, reducing to 0.579 on validation.InterpretationSH surveillance data, including limited behavioural data, enabled triage algorithms to be developed, but its implementation may be problematic due to poor external performance. This approach may be more suitable to self-triage, including online, ensuring patients are directed towards appropriate services.FundingNIHR HTA programme (12/191/05).
  • Comparison of Selection and Long-term Clinical Outcomes Between
           Chemotherapy and Radiotherapy as Primary Therapeutic Modality for Ocular
           Adnexal MALT Lymphoma

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Young-Woo Jeon, Hee-Jung Yang, Byung-Ock Choi, Seung-Eun Jung, Kyung-Sin Park, Joo-Hyun O, Suk-Woo Yang, Seok-Goo Cho BackgroundThe choice of a primary treatment for ocular adnexal mucosa-associated lymphoid tissue lymphoma (OAML) depends on the extent of tumor spread. However, radiotherapy is commonly used as a first-line therapy despite ophthalmic complications, because most OAMLs are in a limited stage of progression. However, the initial therapeutic modality, including chemotherapy and treatment of the advanced stage, has not been fully established for OAML. Therefore, we evaluated the optimal therapeutic options and survival outcome-related parameters for patients with primary OAML.MethodsWe evaluated 208 consecutive patients with primary OAML who were diagnosed at the Catholic University Lymphoma Group between January 2004 and April 2015.FindingsDuring a median follow-up of 70.0 months (range, 3.2–182.0 months) in 208 patients with primary OAML, most patients were female and the median age was 46 years old. Overall survival (OS) and progression-free survival (PFS) at 13 years were excellent (92.7% and 69.7%, respectively). Of the 117 patients who received the first-line radiotherapy, 92% achieved complete remission (CR), usually by being treated with less than 30 Gy. Radiation-related ophthalmic complications including dry eye syndrome (59%) and cataract (22%) caused a decline in the quality of life (QoL). Chemotherapy alone was used to treat 86 OAML patients, with 84.9% achieving CR and 12.8% achieving partial remission with tolerable toxicities. There were no differences in survival outcomes between patients treated with radiotherapy versus those treated with rituximab-containing chemotherapy, although the latter group had more advanced stages of OAML (OS, p = 0.057; PFS, p = 0.075).InterpretationOAML patients were predominantly female and relatively young, and radiotherapy as a primary therapeutic option was more likely to lead to radiation-related complications, resulting in lower QoL. On the other hand, frontline chemotherapy showed consistent therapeutic outcomes with tolerable toxicities compared to radiotherapy, and there were no long-term or delayed adverse events. Therefore, when considering therapeutic efficacy and therapy-related QoL, chemotherapy is recommended for younger patients, and radiotherapy is recommended for older and chemotherapy-ineligible patients.FundingA National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIP) (No. NRF-2016R1A2B4007282).
  • Equivalent Long-term Transplantation Outcomes for Kidneys Donated After
           Brain Death and Cardiac Death: Conclusions From a Nationwide Evaluation

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Alexander Schaapherder, Leonie G.M. Wijermars, Dorottya K. de Vries, Aiko P.J. de Vries, Frederike J. Bemelman, Jacqueline van de Wetering, Arjan D. van Zuilen, Maarten H.L. Christiaans, Luuk H. Hilbrands, Marije C. Baas, Azam S. Nurmohamed, Stefan P. Berger, Ian P. Alwayn, Esther Bastiaannet, Jan H.N. Lindeman BackgroundDespite growing waiting lists for renal transplants, hesitations persist with regard to the use of deceased after cardiac death (DCD) renal grafts. We evaluated the outcomes of DCD donations in The Netherlands, the country with the highest proportion of DCD procedures (42.9%) to test whether these hesitations are justified.MethodsThis study included all procedures with grafts donated after brain death (DBD) (n = 3611) and cardiac death (n = 2711) performed between 2000 and 2017. Transplant outcomes were compared by Kaplan Meier and Cox regression analysis, and factors associated with short (within 90 days of transplantation) and long-term graft loss evaluated in multi-variable analyses.FindingsDespite higher incidences of early graft loss (+ 50%) and delayed graft function (+ 250%) in DCD grafts, 10-year graft and recipient survival were similar for the two graft types (Combined 10-year graft survival: 73.9% (95% CI: 72.5–75.2), combined recipient survival: 64.5% (95 CI: 63.0–66.0%)). Long-term outcome equivalence was explained by a reduced impact of delayed graft function on DCD graft survival (RR: 0.69 (95% CI: 0.55–0.87), p 
  • Cutaneous Leishmaniasis Due to Leishmania aethiopica

    • Abstract: Publication date: Available online 8 January 2019Source: EClinicalMedicineAuthor(s): Saskia van Henten, Wim Adriaensen, Helina Fikre, Hannah Akuffo, Ermias Diro, Asrat Hailu, Gert Van der Auwera, Johan van Griensven Leishmania aethiopica is the main causative species for cutaneous leishmaniasis (CL) in Ethiopia. Despite its considerable burden, L. aethiopica has been one of the most neglected Leishmania species. In this review, published evidence on L. aethiopica history, geography, vector, reservoir, epidemiology, parasitology, and immunology is discussed and knowledge gaps are outlined. L. aethiopica endemic regions are limited to the highland areas, although nationwide studies on CL prevalence are lacking. Phlebotomus pedifer and P. longipes are the sandfly vectors and hyraxes are considered to be the main reservoir, but the role of other sandfly species and other potential reservoirs requires further investigation. Where and how transmission occurs exactly are also still unknown. Most CL patients in Ethiopia are children and young adults. Lesions are most commonly on the face, in contrast to CL caused by other Leishmania species which may more frequently affect other body parts. CL lesions caused by L. aethiopica seem atypical and more severe in their presentation as compared to other Leishmania species. Mucocutaneous leishmaniasis and diffuse cutaneous leishmaniasis are relatively common, and healing of lesions caused by L. aethiopica seems to take longer than that of other species. A thorough documentation of the natural evolution of L. aethiopica as well as in depth studies into the immunological and parasitological characteristics that underpin the atypical and severe clinical presentation are needed. Better understanding of CL caused by this parasite species will contribute to interventions related to transmission, prevention, and treatment.
  • Control of Carbapenemase-producing Enterobacteriaceae: Beyond the Hospital

    • Abstract: Publication date: Available online 7 January 2019Source: EClinicalMedicineAuthor(s): Vincent C.C. Cheng, Shuk-Ching Wong, Sally C.Y. Wong, Pak-Leung Ho, Kwok-Yung Yuen
  • Social Media Use and Adolescent Mental Health: Findings From the UK
           Millennium Cohort Study

    • Abstract: Publication date: Available online 4 January 2019Source: EClinicalMedicineAuthor(s): Yvonne Kelly, Afshin Zilanawala, Cara Booker, Amanda Sacker BackgroundEvidence suggests social media use is associated with mental health in young people but underlying processes are not well understood. This paper i) assesses whether social media use is associated with adolescents' depressive symptoms, and ii) investigates multiple potential explanatory pathways via online harassment, sleep, self-esteem and body image.MethodsWe used population based data from the UK Millennium Cohort Study on 10,904 14 year olds. Multivariate regression and path models were used to examine associations between social media use and depressive symptoms.FindingsThe magnitude of association between social media use and depressive symptoms was larger for girls than for boys. Compared with 1–3 h of daily use: 3 to
  • Early Childhood Outcomes After Neonatal Encephalopathy in Uganda: A Cohort

    • Abstract: Publication date: Available online 20 December 2018Source: EClinicalMedicineAuthor(s): Cally J. Tann, Emily L. Webb, Rachel Lassman, Julius Ssekyewa, Margaret Sewegaba, Margaret Musoke, Kathy Burgoine, Cornelia Hagmann, Eleanor Deane-Bowers, Kerstin Norman, Jack Milln, Jennifer J. Kurinczuk, Alison M. Elliott, Miriam Martinez-Biarge, Margaret Nakakeeto, Nicola J. Robertson, Frances M. Cowan BackgroundNeonatal encephalopathy (NE) is a leading cause of global child mortality. Survivor outcomes in low-resource settings are poorly described. We present early childhood outcomes after NE in Uganda.MethodsWe conducted a prospective cohort study of term-born infants with NE (n = 210) and a comparison group of term non-encephalopathic (non-NE) infants (n = 409), assessing neurodevelopmental impairment (NDI) and growth at 27–30 months. Relationships between early clinical parameters and later outcomes were summarised using risk ratios (RR).FindingsMortality by 27–30 months was 40·3% after NE and 3·8% in non-NE infants. Impairment-free survival occurred in 41·6% after NE and 98·7% of non-NE infants. Amongst NE survivors, 29·3% had NDI including 19·0% with cerebral palsy (CP), commonly bilateral spastic CP (64%); 10·3% had global developmental delay (GDD) without CP. CP was frequently associated with childhood seizures, vision and hearing loss and mortality. NDI was commonly associated with undernutrition (44·1% Z-score 
  • No increased sensitization from early vaccination of infants: a
           prospective study of infant vaccination in anthroposophical families

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Lennart J. Nilsson
  • Tackling Cardiovascular Risk in Type 2 Diabetes: Does Baseline Glucose
           Control Matter'

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Stephen J. Nicholls, Alex Brown
  • Time to Cast the Prejudices Towards Transplantation of Kidneys Donated
           After Cardiac Death'

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Elisabet Van Loon, Line Heylen, Maarten Naesens
  • Changing the System — Major Trauma Patients and Their Outcomes in the
           NHS (England) 2008–17

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): S. Michael Crawford
  • Only collective action can fight off winter influenza outbreaks

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s):
  • Prophylactic Intravenous Hydration to Protect Renal Function From
           Intravascular Iodinated Contrast Material (AMACING): Long-term Results of
           a Prospective, Randomised, Controlled Trial

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Estelle C. Nijssen, Patty J. Nelemans, Roger J. Rennenberg, Vincent van Ommen, Joachim E. Wildberger BackgroundThe aim of A MAastricht Contrast-Induced Nephropathy Guideline (AMACING) trial was to evaluate non-inferiority of no prophylaxis compared to guideline-recommended prophylaxis in preventing contrast induced nephropathy (CIN), and to explore the effect on long-term post-contrast adverse outcomes. The current paper presents the long-term results.MethodsAMACING is a single-centre, randomised, parallel-group, open-label, phase 3, non-inferiority trial in patients with estimated glomerular filtration rate [eGFR] 30–59 mL/min/1.73 m2 combined with risk factors, undergoing elective procedures requiring intravenous or intra-arterial iodinated contrast material. Exclusion criteria were eGFR
  • Vaccination and Allergic Sensitization in Early Childhood – The
           ALADDIN Birth Cohort

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Jackie Swartz, Bernice Aronsson, Frank Lindblad, Hans Järnbert-Pettersson, Annika Scheynius, Göran Pershagen, Johan Alm BackgroundThe increasing incidence of allergic diseases highlights the importance of finding underlying mechanisms. Early vaccination has been suggested as one influential factor. However, it is difficult to find a study group with a large variation between subjects concerning compliance to the official vaccination program. The anthroposophic lifestyle is of interest in this context. Moreover, cohort studies show that children of families with this lifestyle run a lower risk of allergic sensitization and allergy-related disease.MethodsFrom the prospective birth cohort ALADDIN we included one group from the anthroposophic community, with restrictive attitudes concerning vaccinations, and two other groups of age-matched children with more conventional parental lifestyles. In all, 466 children were followed from birth to five years of age. Detailed vaccination data and blood samples were collected at six months, one, two, and five years. Information was also obtained on risk factors for allergy. The outcome variable, allergic sensitization was defined as allergen-specific serum IgE levels ≥ 0.35 kUA/L.FindingsIn a logistic regression model adjusted for socio-demographics and established allergy risk factors, vaccination at later age or having a lower number of injections or vaccines were associated with low OR for allergic sensitization during the first year of life. However, after adjustment for anthroposophic lifestyle, no statistically significant associations remained. The adjusted OR for sensitization at five years of age in children not receiving any vaccinations (n = 54) was 0.98 [95% CI 0.38–2.57].InterpretationWe found no support for an association between early childhood vaccination and subsequent allergic sensitization. Our findings do not support scepticism towards early childhood vaccination motivated by allergy risk.
  • What Works in Youth Suicide Prevention' A Systematic Review and

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Jo Robinson, Eleanor Bailey, Katrina Witt, Nina Stefanac, Allison Milner, Dianne Currier, Jane Pirkis, Patrick Condron, Sarah HetrickSummaryBackgroundYoung people require specific attention when it comes to suicide prevention, however efforts need to be based on robust evidence.MethodsWe conducted a systematic review and meta-analysis of all studies examining the impact of interventions that were specifically designed to reduce suicide-related behavior in young people.FindingsNinety-nine studies were identified, of which 52 were conducted in clinical settings, 31 in educational or workplace settings, and 15 in community settings. Around half were randomized controlled trials. Large scale interventions delivered in both clinical and educational settings appear to reduce self-harm and suicidal ideation post-intervention, and to a lesser extent at follow-up. In community settings, multi-faceted, place-based approaches seem to have an impact. Study quality was limited.InterpretationOverall whilst the number and range of studies is encouraging, gaps exist. Few studies were conducted in low-middle income countries or with demographic populations known to be at increased risk. Similarly, there was a lack of studies conducted in primary care, universities and workplaces. However, we identified that specific youth suicide-prevention interventions can reduce self-harm and suicidal ideation; these types of intervention need testing in high-quality studies.
  • Syndemic Characterization of HCV, HBV, and HIV Co-infections in a Large
           Population Based Cohort Study

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Geoffrey McKee, Zahid A. Butt, Stanley Wong, Travis Salway, Mark Gilbert, Jason Wong, Maria Alvarez, Nuria Chapinal, Maryam Darvishian, Mark W. Tyndall, Mel Krajden, Naveed Z. Janjua, BC Hepatitis Testers Cohort BackgroundLimited data are available on HBV, HCV, and HIV co-infections and triple infection. We characterized co-occurrence of HIV, HBV, and HCV infections at the population level in British Columbia (BC) to identify patterns of predisposing factors unique to co-infection subgroups.MethodsWe analyzed data from the BC Hepatitis Testers Cohort, which includes all individuals tested for HCV or HIV in BC between 1992 and 2013, or included in provincial public health registries of HIV, HCV, HBV, and active tuberculosis. Individuals were classified as negative, mono-, and co-infection groups based on HIV, HBV, and HCV status. We evaluated associations between risk factors (injection drug use, sexual orientation etc.) and co-infection groups using multivariate multinomial logistic regression.FindingsOf a total of 1,376,989 individuals included in the analysis, 1,276,290 were negative and 100,699 were positive for HIV, HBV, and/or HCV. Most cases (91,399, 90.8%) were mono-infected, while 3991 (4.0%) had HBV/HCV, 670 HBV/HIV (0.7%), 3459 HCV/HIV (3.4%), and 1180 HBV/HCV/HIV (1.2%) co-infection. Risk factor and demographic distribution varied across co-infection categories. MSM classification was associated with higher odds of all HIV co-infection groups, particularly HBV/HIV (OR 6.8; 95% CI: 5.6, 8.27), while injection drug use was most strongly associated with triple infection (OR 64.19; 95% CI: 55.11, 74.77) and HIV/HCV (OR 23.23; 95% CI: 21.32, 25.31).InterpretationSyndemics of substance use, sexual practices, mental illness, socioeconomic marginalization, and co-infections differ among population groups, highlighting avenues for optimal composition and context for health services to meet each population's unique needs.FundingBC Centre for Disease Control and Canadian Institutes of Health Research.
  • Cardiovascular Outcomes in Patients With Previous Myocardial Infarction
           and Mild Diabetes Mellitus Following Treatment With Pioglitazone: Reports
           of a Randomised Trial From The Japan Working Group for the Assessment
           Whether Pioglitazone Protects DM Patients Against Re-Infarction (PPAR

    • Abstract: Publication date: October–November 2018Source: EClinicalMedicine, Volumes 4–5Author(s): Masanori Asakura, Jiyoong Kim, Hiroshi Asanuma, Yasuharu Nakama, Kengo Tsukahara, Yorihiko Higashino, Tetsuya Ishikawa, Shinji Koba, Mitsuru Tsujimoto, Hideo Himeno, Yasuyuki Maruyama, Takanori Ookusa, Shunichi Yoda, Hiroshi Suzuki, Shinji Okubo, Makoto Shimizu, Yuji Hashimoto, Kazuo Satake, Susumu Fujino, Hiroyasu Uzui BackgroundSecondary prevention in patients with myocardial infarction (MI) is critically important to prevent ischaemic heart failure and reduce social burden. Pioglitazone improves vascular dysfunction and prevents coronary atherosclerosis, mainly via anti-inflammatory and antiatherogenic effects by enhancing adiponectin production in addition to antihyperglycemic effects, thus suggesting that pioglitazone attenuates cardiovascular events in patients with mild (HbA1c levels 
School of Mathematical and Computer Sciences
Heriot-Watt University
Edinburgh, EH14 4AS, UK
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Fax: +00 44 (0)131 4513327
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