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.

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.

Development of a video-based evidence synthesis knowledge translation resource: Drawing on a user-centred design approach.

Objectives: We aimed to develop a video animation knowledge translation (KT) resource to explain the purpose, use and importance of evidence synthesis to the public regarding healthcare decision-making.

Methods: We drew on a user-centred design approach to develop a spoken animated video (SAV) by conducting two cycles of idea generation, prototyping, user testing, analysis, and refinement. Six researchers identified the initial key messages of the SAV and informed the first draft of the storyboard and script.

COSUTI: A Core Outcome Set (COS) for Interventions for the Treatment of Uncomplicated Urinary Tract Infection (UTI) in Adults.

Uncomplicated urinary tract infections (UTIs) are among the most common presentations of bacterial infections in the outpatient setting. The variation of outcomes reported in trials to assess the most effective treatment interventions for uncomplicated UTIs has meant that comparing and synthesising the outcomes across trials is challenging and limits the reliability of evidence which would otherwise inform healthcare decisions. Develop a Core Outcome Set (COS) for interventions for the treatment of uncomplicated UTIs in otherwise healthy adults.

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.

Priority III: top 10 rapid review methodology research priorities identified using a James Lind Alliance Priority Setting Partnership.

Objectives: A rapid review is a form of evidence synthesis considered a resource-efficient alternative to the conventional systematic review. Despite a dramatic rise in the number of rapid reviews commissioned and conducted in response to the coronavirus disease 2019 pandemic, published evidence on the optimal methods of planning, doing, and sharing the results of these reviews is lacking. The Priority III study aimed to identify the top 10 unanswered questions on rapid review methodology to be addressed by future research.

A systematic review of the outcomes reported in the treatment of uncomplicated urinary tract infection clinical trials.

Background: Uncomplicated urinary tract infections (UTIs) are amongst the most frequent infections presenting in the outpatient setting. A growing number of clinical trials are assessing the most effective treatment interventions for uncomplicated UTI. Due to the heterogeneity of the outcomes reported in these trials, however, comparing these outcomes is challenging.

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.

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.

In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety? Protocol for a systematic review.

Intravenous therapy and medicines (IVTM) are the most common invasive interventions in use in healthcare. Prescribed IVTM play an essential role in the treatment of illness, management of chronic conditions and in maintaining health and wellbeing. The intravenous (IV) route is the administration of concentrated medications (diluted or undiluted) directly into peripherally or centrally inserted vascular access devices.

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.

COHESION: core outcomes in neonatal encephalopathy (protocol).

Background: Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or complications later in life, including seizures, movement disorders and cerebral palsy.

OptiBIRTH: a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section.

Background: Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are low in many countries.

Methods: OptiBIRTH investigated the effects of a woman-centred intervention designed to increase VBAC rates through an unblinded cluster randomised trial in 15 maternity units with VBAC rates < 35% in Germany, Ireland and Italy. Sites were matched in pairs or triplets based on annual birth numbers and VBAC rate, and randomised, 1:1 or 2:1, intervention versus control, following trial registration.

Can learning about trials be child's play? A qualitative exploration of the 'Schools Teaching Awareness of Randomised Trials' (START) initiative.

Background: The Health Research Board-Trials Methodology Research Network (HRB-TMRN) celebrates International Clinical Trials Day with the help of the younger members of our community through the Network's 'Schools Teaching Awareness of Randomised Trials (START)' initiative. START seeks to increase public awareness of randomised trials in Ireland. Launched in 2016, it asks children (8-12 years old) to conduct and report their very own fun randomised trial.

Preference of birth mode and postnatal health related quality of life after one previous caesarean section in three European countries.

Objectives: Women who have had a caesarean section may have a preference for birth mode during their subsequent pregnancy, either 'vaginal birth after caesarean' (VBAC) or 'elective repeat caesarean section' (ERCS). A mismatch between the preferred and actual birth mode may result in an impaired postnatal Health Related Quality of Life (HRQoL). This study examined the associations between antenatal birth mode preferences, the actual birth mode and postnatal HRQoL in women with one previous caesarean section in three European countries.

A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study.

Background: Fetal growth restriction refers to a fetus that does not reach its genetically predetermined growth potential. It is well-recognized that growth-restricted fetuses are at increased risk of both short- and long-term adverse outcomes. Systematic evaluation of the evidence from clinical trials of fetal growth restriction is often difficult because of variation in the outcomes that are measured and reported.

Labour characteristics of women achieving successful vaginal birth after caesarean section in three European countries.

Objective: Knowledge about labour characteristics of women achieving successful vaginal birth after caesarean section (VBAC) might be used to improve labour and birth management. This study examined sociodemographic and labour process-related factors regarding a) differences between countries, b) the comparison of successful VBAC with unplanned caesarean section, and c) predictors for the success of planned VBAC in three European countries.

Design: We analysed observational data collected within the OptiBIRTH trial, a cluster-randomised controlled trial.

COSUTI: a protocol for the development of a core outcome set (COS) for interventions for the treatment of uncomplicated urinary tract infection (UTI) in adults.

Background: Urinary tract infections (UTIs) are the second most common infection presenting in the community. Clinical guidelines and decision aids assist health practitioners to treat a UTI; however, treatment practices vary due to patient needs and context of presentation. Numerous trials have evaluated the effectiveness of treatment interventions for UTI; however, it is difficult to compare the results between trials due to inconsistencies between reported outcomes.

Improving trial recruitment processes: how qualitative methodologies can be used to address the top 10 research priorities identified within the PRioRiTy study.

How can we improve recruitment to trials? In their recently published paper, Healy et al. outline the top 10 prioritised questions for trial recruitment research identified by the PRioRiTy study. The challenge now is for researchers to answer these questions; but how best can these be answered? In this commentary, we illustrate how qualitative research can be utilised to generate in-depth insight into trial recruitment issues, either as a stand-alone methodology, or through a mixed-methods approach.

Development of an online resource for recruitment research in clinical trials to organise and map current literature.

Background: Recruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological priority. While there is growing research around recruitment, navigating this literature to support an evidence-based approach remains difficult. The Online resource for Recruitment Research in Clinical triAls project aims to create an online searchable database of recruitment research to improve access to existing evidence and to identify gaps for future research.