Commentary on 'Case for BJOG compliance with prospective trial registration

Prospective registration of clinical trials before enrolment of the first participant is an ethical and scientific. Registering clinical trials reduces duplication of research and aids better identification of gaps in our knowledge, as when all research on a topic can be identified it is easier to know when a new study is not needed, as the question has already been answered; and if all research is identified it becomes easier to see where there are gaps, and so where new studies are needed. Prospective registration of clinical trials reduces publication bias and bias due to selective reporting of studies with equivocal or ‘negative’ results, since studies are identified and registered before their results are known, and there is less likelihood that our understanding of research evidence is distorted by studies that have disappeared without a trace, or are slow to appear. Prospective registration of trials additionally reduces bias due to selective reporting of outcomes that are ‘positive’ as outcomes are disclosed at registration and can be compared with published reports. Prospective registration thus contributes to less scientific misconduct, as failure to report research findings accurately and make them publicly available, is a betrayal of trust of the people who participated in that research, and can lead to harm in patient care. Prospective registration also makes it harder to fabricate research results, and can result in less scientific frau

Commentary on 'Case for BJOG compliance with prospective trial registration

Prospective registration of clinical trials before enrolment of the first participant is an ethical and scientific. Registering clinical trials reduces duplication of research and aids better identification of gaps in our knowledge, as when all research on a topic can be identified it is easier to know when a new study is not needed, as the question has already been answered; and if all research is identified it becomes easier to see where there are gaps, and so where new studies are needed. Prospective registration of clinical trials reduces publication bias and bias due to selective reporting of studies with equivocal or ‘negative’ results, since studies are identified and registered before their results are known, and there is less likelihood that our understanding of research evidence is distorted by studies that have disappeared without a trace, or are slow to appear. Prospective registration of trials additionally reduces bias due to selective reporting of outcomes that are ‘positive’ as outcomes are disclosed at registration and can be compared with published reports. Prospective registration thus contributes to less scientific misconduct, as failure to report research findings accurately and make them publicly available, is a betrayal of trust of the people who participated in that research, and can lead to harm in patient care. Prospective registration also makes it harder to fabricate research results, and can result in less scientific frau

"A roller coaster of emotions": a qualitative study of parents very first experiences with their preterm baby

Objectives: To assess parents 19 first experiences of their very preterm babies and the neonatal intensive care unit (NICU). Design: Qualitative study using semistructured interviews. Participants: 32 mothers and 7 fathers of very preterm babies (<32 weeks gestation). Setting: Three neonatal units in tertiary care hospitals in South East England. Results: Five themes were identified. The first describes parents 19 blurred recall of the birth. The second shows the anticipation of seeing and touching their baby for the first time was characterised by contrasting emotions, with some parents feeling scared and others excited about the event. The third theme describes parents 19 first sight and touch of their babies and their 18rollercoaster 19 of emotions during this time. It also highlights the importance of touch to trigger and strengthen the parent 13baby bond. However, some parents were worried that touching or holding the baby might transmit infection or interfere with care. The fourth theme captures parents 19 impressions of NICU and how overwhelming this was particularly for parents who had not toured NICU beforehand or whose first sight of their baby was on NICU. The final theme captures unique experiences of fathers, in particular that many felt excluded and confused about their role. Conclusions: This study informs family-centred care by providing insight into the experiences of parents of very preterm infants at a time when they are most in need of support. Clinical implications include the importance of offering parents preparatory tours of the NICU and including fathers

1q12 chromosome translocations form aberrant heterochromatic foci associated with changes in nuclear architecture and gene expression in B cell lymphoma.

International audienceEpigenetic perturbations are increasingly described in cancer cells where they are thought to contribute to deregulated gene expression and genome instability. Here, we report the first evidence that a distinct category of chromosomal translocations observed in human tumours--those targeting 1q12 satellite DNA--can directly mediate such perturbations by promoting the formation of aberrant heterochromatic foci (aHCF). By detailed investigations of a 1q12 translocation to chromosome 2p, in a case of human B cell lymphoma, aberrant aHCF were shown to be localized to the nuclear periphery and to arise as a consequence of long range 'pairing' between the translocated 1q12 and chromosome 2 centromeric regions. Remarkably, adjacent 2p sequences showed increased levels of repressive histone modifications, including H4K20me3 and H3K9me3, and were bound by HP1. aHCF were associated to aberrant spatial localization and deregulated expression of a novel 2p gene (GMCL1) that was found to have prognostic impact in diffuse large B cell lymphoma. Thus constitutive heterochromatin rearrangements can contribute to tumourigenesis by perturbing gene expression via long range epigenetic mechanisms

Performance of the Safer Nursing Care Tool to measure nurse staffing requirements in acute hospitals: a multi-centre observational study

Objectives: To determine the precision of nurse staffing establishments estimated using the SNCT patient classification system, and to assess whether the recommended staff levels correspond with professional judgements of adequate staffing. Setting / population 81 medical/surgical units in 4 acute care hospitals. Methods: Nurses assessed patients using the SNCT and reported on the adequacy of staffing at least daily for one year. Bootstrap samples of varying sizes were used to estimate the precision of the tool’s recommendations for the number of nurses to employ on each unit. Multi-level regression models were used to assess the association between shortfalls from the measured staffing requirement and nurses’ assessments of adequate staffing. Results: The recommended minimum sample of 20 days allowed the required number to employ to be estimated with a mean precision of 4.1%. For most units, much larger samples were required to estimate establishments within +/- 1 whole time staff member. Every registered nurse hour per patient day shortfall in staffing was associated with an 11% decrease in the odds of nurses reporting that there were enough staff to provide quality care and a 14% increase in the odds of reporting that necessary nursing care was left undone. No threshold indicating an optimal staffing level was observed. Surgical specialty, patient turnover and more single bedded rooms were associated with lower odds of staffing adequacy. Conclusions: The SNCT can provide reliable estimates of the number of nurses to employ on a unit, but larger samples than the recommended minimum are usually required. The SNCT provides a measure of nursing workload that correlates with professional judgements, but the recommended staffing levels may not be optimal. Some sources of systematic variations in staffing requirements for some units are not accounted for. SNCT measurements are a potentially useful adjunct to professional judgement, but cannot replace it.Peer reviewe

Risk factors for maternal death in patients with severe preeclampsia and eclampsia Fatores de risco para morte materna em pacientes com pré-eclâmpsia grave/ eclâmpsia

OBJECTIVES: to determine the principal death causes in patients with severe preeclampsia/eclampsia and identify related risk factors. METHODS: a case-control study was performed comprising all cases of maternal death (n = 20) in patients with severe preeclampsia or eclampsia (n = 2.541). 80 controls (survivors) were randomly selected. The odds ratio and an estimate of maternal death relative risk were determined, and a multiple logistic regression analysis performed to determine the adjusted odds ratio. RESULTS: the basic causes for death were: acute pulmonary edema, disseminated intravascular coagulopathy, hemorrhagic shock, pulmonary embolism, acute renal failure, sepsis and three cases of undetermined causes of death. The principal risk factors were: age > 25 years old, multiparity, gestational age < 32 weeks, lack of prenatal care, diastolic pressure > 110mmHg, convulsions, chronic systemic arterial hypertension, HELLP syndrome, pulmonary edema, normally inserted abruptio placenta, disseminated intravascular coagulation, acute renal failure. Variables persistently related to maternal death were: HELLP syndrome, eclampsia, acute pulmonary edema, eclampsia, chronic hypertension and lack of prenatal care. CONCLUSIONS: the principal risk factors for death in women with preeclampsia/eclampsia are the lack of prenatal care, associated to chronic hypertension, HELLP syndrome, eclampsia and acute pulmonary edema.<br>OBJETIVOS: determinar as principais causas de óbito em pacientes com pré-eclâmpsia grave/eclâmpsia e identificar os fatores de risco associados. MÉTODOS: realizou-se um estudo de caso-controle, com todos os casos de morte materna (n = 20) em pacientes com pré-eclâmpsia grave ou eclâmpsia (n = 2.541). Selecionaram-se aleatoriamente 80 controles (sobreviventes). Determinou-se o odds ratio como estimativa do risco relativo de morte materna, realizando-se análise de regressão logística múltipla para determinação do odds ratio ajustado. RESULTADOS: as causas básicas de óbito foram: edema agudo de pulmão, coagulopatia intravascular disseminada, choque hemorrágico, embolia pulmonar, insuficiência renal aguda, e septicemia e três casos por causas indeterminadas. Os principais fatores de risco foram: idade > 25 anos, multiparidade, idade gestacional < 32 semanas, falta de pré-natal, pressão diastólica > 110mmHg, convulsões, hipertensão arterial sistêmica crônica, síndrome HELLP, edema agudo de pulmão, descolamento prematuro de placenta, coagulopatia intravascular disseminada e insuficiência renal aguda. As variáveis que persistiram associadas com morte materna foram: síndrome HELLP, eclâmpsia, edema agudo de pulmão, hipertensão crônica e falta de pré-natal. CONCLUSÕES: os principais fatores de risco para morte em mulheres com pré-eclâmpsia/eclâmpsia são falta de pré-natal associados com hipertensão crônica e complicações como síndrome HELLP, eclâmpsia e edema agudo de pulmão