Proposed Core Outcomes After Neonatal Sepsis: A Consensus Statement.

Importance: Sepsis is one of the leading causes of neonatal mortality. There is heterogeneity in the outcomes measured and reported in studies of neonatal sepsis. To address this challenge, a core outcome set (COS) for research on neonatal sepsis was needed.

Factors that influence recruitment to COVID-19 vaccine trials: a qualitative evidence synthesis.

Background: The COVID-19 pandemic marked a unique period characterised by an extraordinary global virus spread. The collective effort to halt the transmission of the virus led to various public health initiatives, including a variety of COVID-19 vaccine trials. Many of these trials used adaptive methods to address the pandemic's challenges, such as the need for rapid recruitment.

The impact of midwife/nurse-led psychosocial interventions on parents experiencing perinatal bereavement: An integrative review.

Background: Perinatal loss is a traumatic event associated with a high risk of parents experiencing negative psychological outcomes. Despite most parents being in regular contact with midwives and nurses during the perinatal period, there is a lack of evidence which hampers these professionals from using effective psychosocial interventions with parents.

Aim: This study aims to synthesise the existing evidence on the types of psychosocial interventions delivered by midwives/nurses for parents with perinatal bereavement, their impacts on bereaved parents' mental health and the experiences of midwives and nurses in delivering psychosocial interventions for parents experiencing perinatal loss.

IPV Routine Enquiry in Antenatal Care: Perspectives of Women and Healthcare Professionals-A Qualitative Study.

Despite one in three women experiencing abuse by an intimate partner in their lifetime, intimate partner violence (IPV) is under-reported. Globally, IPV routine enquiry is used as part of healthcare response to addressing IPV. This paper presents the views of pregnant women (= 40) and providers (= 30) of IPV routine enquiry as part of antenatal care policy in Ireland.

COHESION: a core outcome set for the treatment of neonatal encephalopathy.

Background: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis.

Factors that impact on recruitment to vaccine trials in the context of a pandemic or epidemic: a qualitative evidence synthesis.

Background: The World Health Organization declared the COVID-19 pandemic on 11 March 2020. Vaccine development and deployment were swiftly prioritised as a method to manage and control disease spread. The development of an effective vaccine relies on people's participation in randomised trials.

Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial.

Background: Delphi surveys are commonly used to prioritise critical outcomes in core outcome set (COS) development. This trial aims to compare a three-round (Multi-Round) Delphi (MRD) with a Real-Time Delphi (RTD) in the prioritisation of outcomes for inclusion in a COS for neonatal encephalopathy treatments and explore whether 'feedback', 'iteration', and 'initial condition' effects may occur in the two survey methods.

Methods: We recruited 269 participants (parents/caregivers, healthcare providers and researchers/academics) of which 222 were randomised to either the MRD or the RTD.

Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.

: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to sharing quantitative data remain, there are additional challenges for sharing qualitative data in trials.

VBAC or elective CS? An exploration of decision-making process employed by women on their mode of birth following a previous lower segment caesarean section.

Background: Part of the caseload of an Advanced Midwife Practitioner (AMP) service in a Northwest of Ireland maternity unit includes vaginal birth after caesarean section (VBAC) women. Despite evidence about VBAC being a safe option for women, the numbers attempting a VBAC remain small. This research was undertaken to give an insight into how VBAC eligible women opt for an elective repeat CS (ERCS) or VBAC birth.

Sharing space at the research table: exploring public and patient involvement in a methodology priority setting partnership.

Background: Public and patient involvement aims to improve research quality, relevance, and appropriateness. Despite an increasing evidence base on the influence of public involvement in health research, the role of involvement in methodology research (i.e.

Development of a co-designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity care.

Background: The evidence on what strategies can improve recruitment to clinical trials in maternity care is lacking. As trial recruiters, maternity healthcare professionals (MHCPs) perform behaviours (e.g.

Core outcomes in neonatal encephalopathy: a qualitative study with parents.

Objective: To identify the outcomes considered important to parents or caregivers of infants diagnosed with neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia in high-income and low- to middle-income countries (LMiCs), as part of the outcome-identification process in developing a core outcome set (COS) for the treatment of neonatal encephalopathy.

Design: A qualitative study involving 25 semistructured interviews with parents or other family members (caregivers) of infants who were diagnosed with, and treated for, neonatal encephalopathy, hypoxic ischaemic encephalopathy or birth asphyxia.

Setting: Interviews were conducted in high-income countries (HiCs) (n=11) by Zoom video conferencing software and in LMiCs (n=14) by phone or face to face.

Quality of patient-reported outcome reporting in trials of diabetes in pregnancy: A systematic review.

Aims: Patient-reported outcomes (PROs) are reports of the patient's health status that come directly from the patient without interpretation by the clinician or anyone else. They are increasingly used in randomised controlled trials (RCTs). In this systematic review we identified RCTs conducted in women with diabetes in pregnancy which included PROs in their primary or secondary outcomes.

The People's Trial: supporting the public's understanding of randomised trials.

Background: Randomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are and why they are important. This limits the overall acceptance of and public participation in clinical trials.

Theory-guided interviews identified behavioral barriers and enablers to healthcare professionals recruiting participants to maternity trials.

Objective: To conduct a behavioral investigation, using the Theoretical Domains Framework (TDF), to identify barriers and enablers to maternity healthcare professionals (HCP) inviting all eligible women to participate in a maternity care trial.

Study Design And Setting: We invited HCP recruiters from maternity care trials in high priority research areas including, diabetes, preeclampsia and breastfeeding, from across Ireland and the UK, to take part in a semi-structured interview. Data collection was informed by the TDF, followed by inductive thematic analysis and deductive mapping to the TDF.

Does reading a book in bed make a difference to sleep in comparison to not reading a book in bed? The People's Trial-an online, pragmatic, randomised trial.

Background: The best way of comparing healthcare treatments is through a randomised trial. In a randomised trial, we compare something (a treatment or intervention) to something else, often another treatment. Who gets what is decided at random, meaning everyone has an equal chance of getting any of the treatments.

Patient-reported outcomes (PROs) in randomised controlled trials in diabetes and pregnancy: protocol for a systematic review.

Introduction: Diabetes mellitus is the most common metabolic complication of pregnancy and its prevalence worldwide is rising. The number of randomised controlled trials (RCTs) being conducted in people with diabetes is also increasing. Many studies preferentially publish findings on clinical endpoints and do not report patient-reported outcomes (PROs).

A systematic review on outcome reporting in randomised controlled trials assessing treatment interventions in pregnant women with pregestational diabetes.

Background: Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes. Studies assessing interventions to improve maternal and infant outcomes have increased exponentially over recent years. Several outcomes in this field of maternal diabetes are rare, making it difficult to synthesise evidence.

A study protocol of qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.

: Data sharing enables researchers to conduct novel research with previously collected data sets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing anonymised data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to data sharing remain, there are additional challenges for qualitative data.

A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study.

Objective: To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM).

Design: A consensus developmental study.

Setting: International.

Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial.

Background: The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants' survey responses in between rounds. By informing participants about how others answer a question or prioritise specific topics, it allows for diverse opinions to inform the consensus process.