The importance of core outcome sets and developing one for neonatal care

It has been estimated that 85% of all clinical research is wasted. Suboptimal outcome selection is an important cause of waste because it leads to research that cannot be compared and may not be clinically relevant. A solution to this problem is the use of a core outcome set, a standardised set of outcomes recorded whenever research in a specific field is carried out. The methodology behind developing a core outcome set and how this is being applied in the Core Outcomes in Neonatology (COIN) project is described

Outcomes following early parenteral nutrition use in preterm neonates: Protocol for an observational study

Introduction Preterm babies are among the highest users of parenteral nutrition (PN) of any patient group, but there is wide variation in commencement, duration, and composition of PN and uncertainty around which groups will benefit from early introduction. Recent studies in critically unwell adults and children suggest that harms, specifically increased rates of nosocomial infection, outweigh the benefits of early administration of PN. In this study, we will describe early PN use in neonatal units in England, Wales and Scotland. We will also evaluate if this is associated with differences in important neonatal outcomes in neonates born between 30+0 and 32+6 weeks+days gestation. Methods and analysis We will use routinely collected data from all neonatal units in England, Wales and Scotland, available in the National Neonatal Research Database (NNRD). We will describe clinical practice in relation to any use of PN during the first 7 postnatal days among neonates admitted to neonatal care between 1 January 2012 and 31 December 2017. We will compare outcomes in neonates born between 30+0 and 32+6 weeks+days gestation who did or did not receive PN in the first week after birth using a propensity score-matched approach. The primary outcome will be survival to discharge home. Secondary outcomes will include components of the neonatal core outcome set: outcomes identified as important by former patients, parents, clinicians and researchers. Ethics and dissemination We have obtained UK National Research Ethics Committee approval for this study (Ref: 18/NI/0214). The results of this study will be presented at academic conferences; the UK charity Bliss will aid dissemination to former patients and parents

What topics should we teach the parents of admitted neonates in the newborn care unit in the resource-limited setting - a Delphi study

BACKGROUND: In resource-limited settings, such as Rwanda, health care profession (HCP) to neonate ratios are low, and therefore caregivers play a significant role in providing care for their admitted neonates. To provide such Family Integrated Care, caregivers need knowledge, skills, and confidence. The objective of this study was to identify consensus from key stakeholders regarding the priority topics for a "parental neonatal curriculum." METHODS: A three-round Delphi-study was conducted. During Round-1, face-to-face interviews were undertaken and responses coded and categorized into themes. In Round-2, participants were presented with Round-1 feedback and asked to provide additional topics in respective themes. In Round-3, respondents were asked to rank the importance of these items using a 9-point Likert scale. RESULTS: Ten, 36 and 40 stakeholders participated in Rounds-1, - 2 and - 3 respectively, including parents, midwives, nurses and physicians. Twenty and 37 education topics were identified in Rounds-1 and -2 respectively. In Round-3 47 of the 57 presented outcomes met pre-defined criteria for inclusion in the "parental neonatal curriculum." CONCLUSION: We describe a "parental neonatal curriculum," formed using robust consensus methods, describing the core topics required to educate parents of neonates admitted to a newborn care unit. The curriculum has been developed in Rwanda and is relevant to other resource-limited settings

Epidemiological Interactions between Urogenital and Intestinal Human Schistosomiasis in the Context of Praziquantel Treatment across Three West African Countries

© 2015 Knowles et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. The attached file is the published version of the article

Calculations of net present value for a small modular fusion power plant under a range of scenarios

If, as suggested by proponents, fusion small modular reactors (SMRs) can be developed faster than envisaged by the multi-national ITER/DEMO programme, the question remains as to whether such reactors will be a viable commercial proposition. Such viability will depend on a range of factors, including capital costs, income from the sale of electricity and the cost of capital. To investigate these effects, Net Present Values (NPVs) were calculated for a range of scenarios for both First of a Kind (FOAK) and Nth of a Kind (NOAK) plants supplying electricity to the United Kingdom grid commencing in 2040. Calculations have also been carried out to delineate the “space” in which positive NPVs would be obtained. These calculations show that there are combinations of capital costs, electricity prices and costs of capital in which a fusion SMR plant would be financially viable. These calculations, being based on uncertain costs and incomes, are necessarily uncertain. The calculations show that minimisation of capital costs must be a key goal for those seeking to develop a fusion SMR as a commercial proposition

Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks gestation: a propensity score matched observational study

Objective To evaluate whether in preterm neonates parenteral nutrition use in the first seven postnatal days, compared with no parenteral nutrition use, is associated with differences in survival and other important morbidities. Randomised trials in critically ill older children show that harms, such as nosocomial infection, outweigh benefits of early parenteral nutrition administration; there is a paucity of similar data in neonates. Design Retrospective cohort study using propensity matching including 35 maternal, infant and organisational factors to minimise bias and confounding. Setting National, population-level clinical data obtained for all National Health Service neonatal units in England and Wales. Patients Preterm neonates born between 30+0 and 32+6 weeks+days . Interventions The exposure was parenteral nutrition administered in the first seven days of postnatal life; the comparator was no parenteral nutrition. Main outcome measures The primary outcome was survival to discharge from neonatal care. Secondary outcomes comprised the neonatal core outcome set. Results 16,292 neonates were compared in propensity score matched analyses. Compared with matched neonates not given parenteral nutrition in the first postnatal week, neonates who received parenteral nutrition had higher survival at discharge (absolute rate increase 0.91%; 95% CI 0.53% to 1.30%), but higher rates of necrotising enterocolitis (absolute rate increase 4.6%), bronchopulmonary dysplasia (absolute rate increase 3.9%), late-onset sepsis (absolute rate increase 1.5%) and need for surgical procedures (absolute rate increase 0.92%). Conclusions In neonates born between 30+0 and 32+6 weeks gestation, those given parenteral nutrition in the first postnatal week had a higher rate of survival but higher rates of important neonatal morbidities. Clinician equipoise in this area should be resolved by prospective, randomised trials

Estimation of changes in the force of infection for intestinal and urogenital schistosomiasis in countries with Schistosomiasis Control Initiative-assisted programmes

The last decade has seen an expansion of national schistosomiasis control programmes in Africa based on large-scale preventative chemotherapy. In many areas this has resulted in considerable reductions in infection and morbidity levels in treated individuals. In this paper, we quantify changes in the force of infection (FOI), defined here as the per (human) host parasite establishment rate, to ascertain the impact on transmission of some of these programmes under the umbrella of the Schistosomiasis Control Initiative (SCI)

Anti-tumour activity of bisphosphonates in preclinical models of breast cancer

There is increasing evidence of anti-tumour effects of bisphosphonates from pre-clinical studies, supporting a role for these drugs beyond their traditional use in treatment of cancer-induced bone disease. A range of model systems have been used to investigate the effects of different bisphosphonates on tumour growth, both in bone and at peripheral sites. Most of these studies conclude that bisphosphonates cause a reduction in tumour burden, but that early intervention and the use of high and/or repeated dosing is required. Successful eradication of cancer may only be achievable by targeting the tumour cells directly whilst also modifying the tumour microenvironment. In line with this, bisphosphonates are demonstrated to be particularly effective at reducing breast tumour growth when used in combination with agents that directly target cancer cells. Recent studies have shown that the effects of bisphosphonates on breast tumours are not limited to bone, and that prolonged anti-tumour effects may be achieved following their inclusion in combination therapy. This has opened the field to a new strand of bisphosphonate research, focussed on elucidating their effects on cells and components of the local, regional and distal tumour microenvironment. This review highlights the recent developments in relation to proposed anti-tumour effects of bisphosphonates reported from in vitro and in vivo models, and summarises the data from key breast cancer studies. Evidence for effects on different processes and cell types involved in cancer development and progression is discussed, and the main outstanding issues identified

Study protocol: developing, disseminating, and implementing a core outcome set for selective fetal growth restriction in monochorionic twin pregnancies.

BACKGROUND: Selective fetal growth restriction in monochorionic twin pregnancies is associated with an increased risk of perinatal mortality and morbidity and represents a clinical dilemma. Interventions include expectant management with early preterm delivery if there are signs of fetal compromise, selective termination of the compromised twin, fetoscopic laser coagulation of the communicating placental vessels or termination of the whole pregnancy. Previous studies evaluating interventions have reported many different outcomes and outcome measures. Such variation makes comparing, contrasting, and combining results challenging, limiting ongoing research on this uncommon condition to inform clinical practice. We aim to produce, disseminate, and implement a core outcome set for selective fetal growth restriction research in monochorionic twin pregnancies. METHODS: An international steering group, including professionals, researchers, and lay experts, has been established to oversee the development of this core outcome set. The methods have been guided by the Core Outcome Measures in Effectiveness Trials Initiative Handbook. Potential core outcomes will be developed by undertaking a systematic review of studies evaluating interventions for selective fetal growth restriction in monochorionic twin pregnancies. Potential core outcomes will be entered into a three-round Delphi survey and key stakeholders including clinical professionals, researchers, and lay experts will be invited to participate. Repeated reflection and rescoring of individual outcomes should encourage group and individual stakeholder convergence towards consensus outcomes which will be entered into a modified Nominal Group Technique to finalize the core outcome set. Once core outcomes have been agreed, we will establish standardized definitions and recommend high-quality measurement instruments for each outcome. DISCUSSION: The development, dissemination, and implementation of a core outcome set for selective fetal growth restriction should ensure that future research protocols select, collect, and report outcomes and outcome measures in a standardized manner. Data synthesis will be possible on a broad level and rigorous implementation should advance the quality of research studies and their effective use in order to guide clinical practice, improve patient care, maternal, short-term perinatal outcomes, and long-term neurodevelopmental outcomes. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) registration number: 998. International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42018092697 . 18th April 2018

Malaria and Helminth Co-infections in School and Preschool Children: A Cross-sectional Study in Magu district, north-Western Tanzania.

Malaria, schistosomiasis and soil transmitted helminth infections (STH) are important parasitic infections in Sub-Saharan Africa where a significant proportion of people are exposed to co-infections of more than one parasite. In Tanzania, these infections are a major public health problem particularly in school and pre-school children. The current study investigated malaria and helminth co-infections and anaemia in school and pre-school children in Magu district, Tanzania. School and pre-school children were enrolled in a cross-sectional study. Stool samples were examined for Schistosoma mansoni and STH infections using Kato Katz technique. Urine samples were examined for Schistosoma haematobium using the urine filtration method. Blood samples were examined for malaria parasites and haemoglobin concentrations using the Giemsa stain and Haemoque methods, respectively. Out of 1,546 children examined, 1,079 (69.8%) were infected with one or more parasites. Malaria-helminth co-infections were observed in 276 children (60% of all children with P. falciparum infection). Malaria parasites were significantly more prevalent in hookworm infected children than in hookworm free children (p = 0.046). However, this association was non-significant on multivariate logistic regression analysis (OR = 1.320, p = 0.064). Malaria parasite density decreased with increasing infection intensity of S. mansoni and with increasing number of co-infecting helminth species. Anaemia prevalence was 34.4% and was significantly associated with malaria infection, S. haematobium infection and with multiple parasite infections. Whereas S. mansoni infection was a significant predictor of malaria parasite density, P. falciparum and S. haematobium infections were significant predictors of anaemia. These findings suggest that multiple parasite infections are common in school and pre-school children in Magu district. Concurrent P. falciparum, S. mansoni and S. haematobium infections increase the risk of lower Hb levels and anaemia, which in turn calls for integrated disease control interventions. The associations between malaria and helminth infections detected in this study need further investigation