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Scaffolding informed consent
The principle of respecting patient autonomy underpins the concept and practice of informed consent. Yet current approaches to consent often ignore the ways in which the exercise of autonomy is deeply epistemically dependent. In this paper, we draw on philosophical descriptions of autonomy “scaffolding” and apply them to informed consent in medicine. We examine how this relates to other models of the doctor patient relationship and other theories (for example, the notion of relational autonomy). A focus on scaffolding autonomy reframes the justification for existing ways of supporting decisions. In other cases, it suggests a need to rethink how, when and where professionals obtain consent. It may highlight the benefit of technology for supporting decisions. Finally, we consider the implications for some high-stakes decisions where autonomy is thought to be critical, for example termination of pregnancy. We argue that such decisions should not be free from all sources of influence – rather that they should be protected from undesired influence.
Head circumference and intelligence, schooling, employment, and income: a systematic review.
BACKGROUND: No consensus exists about the role of head circumference in identifying children at risk of suboptimal development. The objective of this study was to evaluate the association between head circumference and intelligence, schooling, employment, and income. The review 1) summarizes the overall evidence and 2) restricts the evidence to a subset of articles that met minimum quality criteria. METHODS: PubMed, Web of Science, PsycINFO, LILACS, CINAHL, WHO Institutional Repository for Information Sharing and UNICEF Innocenti were searched to identify published studies. Cohort, case-control or cross-sectional studies which evaluated the associations of interest in the general population, premature babies, babies with low birth weight or small for gestational age were included; head circumference must have been measured before the age of 20 years. Two reviewers independently performed study selection, data extraction and quality assessments. RESULTS: Of 2521 records identified, 115 were included and 21 met the minimum quality criteria. Ninety studies investigated if early measures of head circumference predict later outcomes and 25 studies measured head circumference and the outcome at the same timepoint; 78 studies adjusted the head circumference for age and sex. We identified large heterogeneity and inconsistency in the effect measures and data reported across studies. Despite the relatively large number of included articles, more than 80% presented serious limitations such as lack of adjustment for confounding and severe selection bias. Considering the subset of articles which met the minimum quality criteria, 12 of 16 articles showed positive association between head circumference and intelligence in the general population. However, in premature babies, 2 of 3 articles showed no clear effect. Head circumference was positively associated with academic performance in all investigated samples (5 of 5 articles). No article which evaluated educational attainment and employment met the minimum quality criteria, but the association between head circumference and these outcomes seems to be positive. CONCLUSIONS: Larger head circumferences are positively associated with higher levels of intelligence and academic performance in the general population, but there is evidence of non-linearity in those associations. Identifying a group of children in higher risk for worse outcomes by a simple and inexpensive tool could provide an opportunity to mitigate these negative effects. Further research is needed for a deeper understanding of the whole distribution of head circumference and its effect in premature babies. Authors should consider the non-linearity of the association in the data analysis. TRIAL REGISTRATION: Association between head circumference and intelligence, educational attainment, employment, and income: A systematic review, CRD42021289998 .
Statistical analysis plan for the Petal trial: the effects of parental touch on relieving acute procedural pain in neonates
Background Infants undergo multiple clinically-required painful procedures during their time in hospital, and there is an increasing desire from both parents and clinical staff to have parents directly involved in their newborn’s pain relief. To avoid biases due to selective analysis and reporting, a clinical trial’s statistical analysis plan (SAP) should be finalised and registered prior to dataset lock and unblinding. Here, we outline the SAP for the Petal trial, which was registered on the ISRCTN registry prior to dataset lock and unblinding. Methods The Petal trial is a multicentre, individually randomised, parallel-group interventional superiority trial. The study involves in-patient neonates born at or after 35+0 weeks gestation with a postnatal age of ≤7 days, in two hospital research sites (John Radcliffe Hospital, Oxford, UK; Royal Devon and Exeter Hospital, Exeter, UK). The primary objective is to investigate the potential efficacy of a non-pharmacological parent-led stroking intervention on reducing the magnitude of neonates’ noxious stimulus-evoked brain activity. The primary outcome is the neonate’s brain activity recorded using electroencephalography (EEG) in response to a heel lance blood sampling procedure. Secondary outcomes include neonatal clinical pain scores and tachycardia, and parental anxiety. The study hypothesis is neonates’ pain responses and parents’ anxiety scores are lower in the intervention group. Randomisation will be via a minimisation algorithm to maintain balance in five prognostic factors. Conclusions Paediatric pain trials have been highlighted by regulatory bodies as an important and challenging topic, with interest increasing in brain imaging outcomes. The Petal trial, to which this SAP relates, is part of a larger effort of establishing a brain-based EEG outcome measure of infant pain for use in clinical trials. This SAP is thus likely to be of interest to those in academia, pharmaceutical companies, and regulatory bodies. Trial registration ClinicalTrials.gov: NCT04901611, 25/05/2021; ISRCTN: ISRCTN14135962, 23/08/2021).
Premedication for less invasive surfactant administration: a narrative review.
Less invasive surfactant administration (LISA) is an increasingly popular technique to deliver surfactant to spontaneously breathing preterm infants with respiratory distress syndrome. The optimal method of alleviating the pain and discomfort associated with LISA, either pharmacological or non-pharmacological, while maintaining spontaneous respiration remains unclear. There is limited evidence to guide clinicians, resulting in wide variations in practice. The aim of this article is to summarise the current knowledge and evidence gaps regarding the use of premedication prior to LISA.
The association between ibuprofen administration in children and the risk of developing or exacerbating asthma: a systematic review and meta-analysis.
BACKGROUND: Ibuprofen is one of the most commonly used analgesic and antipyretic drugs in children. However, its potential causal role in childhood asthma pathogenesis remains uncertain. In this systematic review, we assessed the association between ibuprofen administration in children and the risk of developing or exacerbating asthma. METHODS: We searched MEDLINE, Embase, Cochrane Library, CINAHL, Web of Science, and Scopus from inception to May 2022, with no language limits; searched relevant reviews; and performed citation searching. We included studies of any design that were primary empirical peer-reviewed publications, where ibuprofen use in children 0-18 years was reported. Screening was performed in duplicate by blinded review. In total, 24 studies met our criteria. Data were extracted according to PRISMA guidelines, and the risk of bias was assessed using RoB2 and NOS tools. Quantitative data were pooled using fixed effect models, and qualitative data were pooled using narrative synthesis. Primary outcomes were asthma or asthma-like symptoms. The results were grouped according to population (general, asthmatic, and ibuprofen-hypersensitive), comparator type (active and non-active) and follow-up duration (short- and long-term). RESULTS: Comparing ibuprofen with active comparators, there was no evidence of a higher risk associated with ibuprofen over both the short and long term in either the general or asthmatic population. Comparing ibuprofen use with no active alternative over a short-term follow-up, ibuprofen may provide protection against asthma-like symptoms in the general population when used to ease symptoms of fever or bronchiolitis. In contrast, it may cause asthma exacerbation for those with pre-existing asthma. However, in both populations, there were no clear long-term follow-up effects. CONCLUSIONS: Ibuprofen use in children had no elevated risk relative to active comparators. However, use in children with asthma may lead to asthma exacerbation. The results are driven by a very small number of influential studies, and research in several key clinical contexts is limited to single studies. Both clinical trials and observational studies are needed to understand the potential role of ibuprofen in childhood asthma pathogenesis.
Parents in Neonatal Pain Management-An International Survey of Parent-Delivered Interventions and Parental Pain Assessment.
BACKGROUND: While parent-delivered pain management has been demonstrated to effectively reduce neonatal procedural pain responses, little is known about to what extent it is utilized. Our aim was to explore the utilization of parents in neonatal pain management and investigate whether local guidelines promote parent-delivered interventions. METHODS: A web-based survey was distributed to neonatal units worldwide. RESULTS: The majority of the 303 responding neonatal intensive care units (NICUs) from 44 countries were situated in high-income countries from Europe and Central Asia. Of the responding units, 67% had local guidelines about neonatal pain management, and of these, 40% answered that parental involvement was recommended, 27% answered that the role of parents in pain management was mentioned as optional, and 32% responded that it was not mentioned in the guidelines. According to the free-text responses, parent-delivered interventions of skin-to-skin contact, breastfeeding, and parental live singing were the most frequently performed in the NICUs. Of the responding units, 65% answered that parents performed some form of pain management regularly or always. CONCLUSIONS: There appears to be some practice uptake of parent-delivered pain management to reduce neonatal pain in high-income countries. Additional incorporation of these interventions into NICU pain guidelines is needed, as well as a better understanding of the use of parent-delivered pain management in low- and middle-income countries.
Effects of timing parameter changes on the gait of functional electrical stimulation users with drop foot
Introduction Functional electrical stimulation uses clinician-set parameters to modify stimulation. This study aimed to investigate whether timing parameters in the ODFS Pace functional electrical stimulation device have an effect on the gait of the general population of functional electrical stimulation users who have a foot drop. Methods Twelve functional electrical stimulation users with foot drop resulting from upper motor neurone disorders were recruited from the functional electrical stimulation Service in Leeds, UK. A crossover trial design was used, comparing adjusted values of rising ramp, delay and extension. Instrumented gait analysis was carried out to measure ankle dorsiflexion during the swing phase of gait, foot clearance from the ground, and speed of ankle plantarflexion at initial contact. The effect of timing parameters on gait kinematics was studied. Results No statistically significant effects on the measured parts of gait were found for any of the timing parameters. Trends were identified in average mid-swing ground clearance and dorsiflexion associated with the delay and rising ramp timing parameters. Conclusions Further work in this area should use larger numbers of participants. Based on these results, the effects of ramping and delay would be of particular interest for further study.