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. Therefore, we aimed to develop a core outcome set for treating NE. METHODS: Outcomes identified from a systematic review of the literature and interviews with parents were prioritised by stakeholders (n = 99 parents/caregivers, n = 101 healthcare providers, and n = 22 researchers/ academics) in online Delphi surveys. Agreement on the outcomes was achieved at online consensus meetings attended by n = 10 parents, n = 18 healthcare providers, and n = 13 researchers/ academics. RESULTS: Seven outcomes were included in the final core outcome set: survival; brain injury on imaging; neurological status at discharge; cerebral palsy; general cognitive ability; quality of life of the child, and adverse events related to treatment. CONCLUSION: We developed a core outcome set for the treatment of NE. This will allow future trials to measure and report the same outcomes and ensure results can be compared. Future work should identify how best to measure the COS. IMPACT: We have identified seven outcomes that should be measured and reported in all studies for the treatment of neonatal encephalopathy. Previously, a core outcome set for neonatal encephalopathy treatments did not exist. This will help to reduce heterogeneity in outcomes reported in clinical trials and other studies, and help researchers identify the best treatments for neonatal encephalopathy.

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. Recruitment to vaccine trials is particularly challenging as it involves healthy volunteers who may have concerns around the potential risks and benefits associated with rapidly developed vaccines. OBJECTIVES: To explore the factors that influence a person's decision to participate in a vaccine trial in the context of a pandemic or epidemic. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was June 2021. SELECTION CRITERIA: We included qualitative studies and mixed-methods studies with an identifiable qualitative component. We included studies that explored the perspectives of adults aged 18 years or older who were invited to take part in vaccine trials in the context of a pandemic or epidemic. DATA COLLECTION AND ANALYSIS: We assessed the title, abstracts and full texts identified by the search. We used a sampling frame to identify data-rich studies that represented a range of diseases and geographical spread. We used QSR NVivo to manage extracted data. We assessed methodological limitations using an adapted version of the Critical Skills Appraisal Programme (CASP) tool for qualitative studies. We used the 'best-fit framework approach' to analyse and synthesise the evidence from our included studies. We then used the Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) assessment to assess our confidence in each finding and develop implications for practice. MAIN RESULTS: We included 34 studies in our review. Most studies related to HIV vaccine trials. The other studies related to Ebola virus, tuberculosis, Zika virus and COVID-19. We developed 20 key findings, under three broad themes (with seven subthemes), that described the factors that people consider when deciding whether to take part in a vaccine trial for a pandemic or epidemic disease. Our GRADE-CERQual confidence was high in nine of the key findings, moderate in 10 key findings and low in one key finding. The main reason for downgrading review findings were concerns regarding the relevance and adequacy of the underlying data. As a result of the over-representation of HIV studies, our GRADE-CERQual assessment of some findings was downgraded in terms of relevance because the views described may not reflect those of people regarding vaccine trials for other pandemic or epidemic diseases. Adequacy relates to the degree of richness and quantity of data supporting a review finding. Moderate concerns about adequacy resulted in a downgrading of some review findings. Some factors were considered to be under the control of the trial team. These included how trial information was communicated and the inclusion of people in the community to help with trial information dissemination. Aspects of trial design were also considered under control of the trial team and included convenience of participation, provision of financial incentives and access to additional support services for those taking part in the trial. Other factors influencing people's decision to take part could be personal, from family, friends or wider society. From a personal perceptive, people had concerns about vaccine side effects, vaccine efficacy and possible impact on their daily lives (carer responsibilities, work, etc.). People were also influenced by their families, and the impact participation may have on relationships. The fear of stigma from society influenced the decision to take part. Also, from a societal perspective, the level of trust in governments' involvement in research and trial may influence a person's decision. Finally, the perceived rewards, both personal and societal, were influencing factors on the decision to participate. Personal rewards included access to a vaccine, improved health and improved disease knowledge, and a return to normality in the context of a pandemic or epidemic. Potential societal rewards included helping the community and contributing to science, often motivated by the memories of family and friends who had died from the disease. AUTHORS' CONCLUSIONS: This review identifies many of the factors that influence a person's decision to take part in a vaccine trial, and these reflect findings from reviews that examine trials more broadly. However, we also recognise some factors that become more important in connection with a vaccine trial in the context of a pandemic or epidemic. These factors include the potential stigma of taking part, the possible adverse effects of a vaccine, the added motivation for helping society, the role of community leaders in trial dissemination, and the level of trust placed in governments and companies developing vaccines. These specific influences need to be considered by trial teams when designing, and communicating about, vaccine trials in the context of a pandemic or epidemic.

A core outcome set for studies of gestational diabetes mellitus prevention and treatment.

AIMS/HYPOTHESIS: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). METHODS: We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. RESULTS: Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). CONCLUSIONS/INTERPRETATION: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. TRIAL REGISTRATION: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/.

Barriers and facilitators to healthcare workers' adherence with infection prevention and control (IPC) guidelines for respiratory infectious diseases: a rapid qualitative evidence synthesis.

BACKGROUND: This review is one of a series of rapid reviews that Cochrane contributors have prepared to inform the 2020 COVID-19 pandemic. When new respiratory infectious diseases become widespread, such as during the COVID-19 pandemic, healthcare workers' adherence to infection prevention and control (IPC) guidelines becomes even more important. Strategies in these guidelines include the use of personal protective equipment (PPE) such as masks, face shields, gloves and gowns; the separation of patients with respiratory infections from others; and stricter cleaning routines. These strategies can be difficult and time-consuming to adhere to in practice. Authorities and healthcare facilities therefore need to consider how best to support healthcare workers to implement them. OBJECTIVES: To identify barriers and facilitators to healthcare workers' adherence to IPC guidelines for respiratory infectious diseases. SEARCH METHODS: We searched OVID MEDLINE on 26 March 2020. As we searched only one database due to time constraints, we also undertook a rigorous and comprehensive scoping exercise and search of the reference lists of key papers. We did not apply any date limit or language limits. SELECTION CRITERIA: We included qualitative and mixed-methods studies (with a distinct qualitative component) that focused on the experiences and perceptions of healthcare workers towards factors that impact on their ability to adhere to IPC guidelines for respiratory infectious diseases. We included studies of any type of healthcare worker with responsibility for patient care. We included studies that focused on IPC guidelines (local, national or international) for respiratory infectious diseases in any healthcare setting. These selection criteria were framed by an understanding of the needs of health workers during the COVID-19 pandemic. DATA COLLECTION AND ANALYSIS: Four review authors independently assessed the titles, abstracts and full texts identified by our search. We used a prespecified sampling frame to sample from the eligible studies, aiming to capture a range of respiratory infectious disease types, geographical spread and data-rich studies. We extracted data using a data extraction form designed for this synthesis. We assessed methodological limitations using an adapted version of the Critical Skills Appraisal Programme (CASP) tool. We used a 'best fit framework approach' to analyse and synthesise the evidence. This provided upfront analytical categories, with scope for further thematic analysis. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. We examined each review finding to identify factors that may influence intervention implementation and developed implications for practice. MAIN RESULTS: We found 36 relevant studies and sampled 20 of these studies for our analysis. Ten of these studies were from Asia, four from Africa, four from Central and North America and two from Australia. The studies explored the views and experiences of nurses, doctors and other healthcare workers when dealing with severe acute respiratory syndrome (SARS), H1N1, MERS (Middle East respiratory syndrome), tuberculosis (TB), or seasonal influenza. Most of these healthcare workers worked in hospitals; others worked in primary and community care settings. Our review points to several barriers and facilitators that influenced healthcare workers' ability to adhere to IPC guidelines. The following factors are based on findings assessed as of moderate to high confidence. Healthcare workers felt unsure as to how to adhere to local guidelines when they were long and ambiguous or did not reflect national or international guidelines. They could feel overwhelmed because local guidelines were constantly changing. They also described how IPC strategies led to increased workloads and fatigue, for instance because they had to use PPE and take on additional cleaning. Healthcare workers described how their responses to IPC guidelines were influenced by the level of support they felt that they received from their management team. Clear communication about IPC guidelines was seen as vital. But healthcare workers pointed to a lack of training about the infection itself and about how to use PPE. They also thought it was a problem when training was not mandatory. Sufficient space to isolate patients was also seen as vital. A lack of isolation rooms, anterooms and shower facilities was a problem. Other important practical measures described by healthcare workers included minimising overcrowding, fast-tracking infected patients, restricting visitors, and providing easy access to handwashing facilities. A lack of PPE, and equipment that was of poor quality, was a serious concern for healthcare workers and managers. They also pointed to the need to adjust the volume of supplies as infection outbreaks continued. Healthcare workers believed that they followed IPC guidance more closely when they saw the value of it. Some healthcare workers felt motivated to follow the guidance because of fear of infecting themselves or their families, or because they felt responsible for their patients. Some healthcare workers found it difficult to use masks and other equipment when it made patients feel isolated, frightened or stigmatised. Healthcare workers also found masks and other equipment uncomfortable to use. The workplace culture could also influence whether healthcare workers followed IPC guidelines or not. Across many of the findings, healthcare workers pointed to the importance of including all staff, including cleaning staff, porters, kitchen staff and other support staff when implementing IPC guidelines. AUTHORS' CONCLUSIONS: Healthcare workers point to several factors that influence their ability and willingness to follow IPC guidelines when managing respiratory infectious diseases. These include factors tied to the guideline itself and how it is communicated, support from managers, workplace culture, training, physical space, access to and trust in personal protective equipment, and a desire to deliver good patient care. The review also highlights the importance of including all facility staff, including support staff, when implementing IPC guidelines.

Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis.

BACKGROUND: Randomised trials (also referred to as 'randomised controlled trials' or 'trials') are the optimal way to minimise bias in evaluating the effects of competing treatments, therapies and innovations in health care. It is important to achieve the required sample size for a trial, otherwise trialists may not be able to draw conclusive results leading to research waste and raising ethical questions about trial participation. The reasons why potential participants may accept or decline participation are multifaceted. Yet, the evidence of effectiveness of interventions to improve recruitment to trials is not substantial and fails to recognise these individual decision-making processes. It is important to synthesise the experiences and perceptions of those invited to participate in randomised trials to better inform recruitment strategies. OBJECTIVES: To explore potential trial participants' views and experiences of the recruitment process for participation. The specific objectives are to describe potential participants' perceptions and experiences of accepting or declining to participate in trials, to explore barriers and facilitators to trial participation, and to explore to what extent barriers and facilitators identified are addressed by strategies to improve recruitment evaluated in previous reviews of the effects of interventions including a Cochrane Methodology Review. SEARCH METHODS: We searched the Cochrane Library, Medline, Embase, CINAHL, Epistemonikos, LILACS, PsycINFO, ORRCA, and grey literature sources. We ran the most recent set of searches for which the results were incorporated into the review in July 2017. SELECTION CRITERIA: We included qualitative and mixed-methods studies (with an identifiable qualitative component) that explored potential trial participants' experiences and perceptions of being invited to participate in a trial. We excluded studies that focused only on recruiters' perspectives, and trials solely involving children under 18 years, or adults who were assessed as having impaired mental capacity. DATA COLLECTION AND ANALYSIS: Five review authors independently assessed the titles, abstracts and full texts identified by the search. We used the CART (completeness, accuracy, relevance, timeliness) criteria to exclude studies that had limited focus on the phenomenon of interest. We used QSR NVivo to extract and manage the data. We assessed methodological limitations using the Critical Skills Appraisal Programme (CASP) tool. We used thematic synthesis to analyse and synthesise the evidence. This provided analytical themes and a conceptual model. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. Our findings were integrated with two previous intervention effectiveness reviews by juxtaposing the quantitative and qualitative findings in a matrix. MAIN RESULTS: We included 29 studies (published in 30 papers) in our synthesis. Twenty-two key findings were produced under three broad themes (with six subthemes) to capture the experience of being invited to participate in a trial and making the decision whether to participate. Most of these findings had moderate to high confidence. We identified factors from the trial itself that influenced participation. These included how trial information was communicated, and elements of the trial such as the time commitment that might be considered burdensome. The second theme related to personal factors such as how other people can influence the individual's decision; and how a personal understanding of potential harms and benefits could impact on the decision. Finally, the potential benefits of participation were found to be key to the decision to participate, namely personal benefits such as access to new treatments, but also the chance to make a difference and help others. The conceptual model we developed presents the decision-making process as a gauge and the factors that influence whether the person will, or will not, take part. AUTHORS' CONCLUSIONS: This qualitative evidence synthesis has provided comprehensive insight into the complexity of factors that influence a person's decision whether to participate in a trial. We developed key questions that trialists can ask when developing their recruitment strategy. In addition, our conceptual model emphasises the need for participant-centred approaches to recruitment. We demonstrated moderate to high level confidence in our findings, which in some way can be attributed to the large volume of highly relevant studies in this field. We recommend that these insights be used to direct or influence or underpin future recruitment strategies that are developed in a participant-driven way that ultimately improves trial conduct and reduces research waste.

Membrane sweeping for induction of labour.

BACKGROUND: Induction of labour involves stimulating uterine contractions artificially to promote the onset of labour. There are several pharmacological, surgical and mechanical methods used to induce labour. Membrane sweeping is a mechanical technique whereby a clinician inserts one or two fingers into the cervix and using a continuous circular sweeping motion detaches the inferior pole of the membranes from the lower uterine segment. This produces hormones that encourage effacement and dilatation potentially promoting labour. This review is an update to a review first published in 2005. OBJECTIVES: To assess the effects and safety of membrane sweeping for induction of labour in women at or near term (≥ 36 weeks' gestation). SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (25 February 2019), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (25 February 2019), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing membrane sweeping used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed on a predefined list of labour induction methods. Cluster-randomised trials were eligible, but none were identified. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, risk of bias and extracted data. Data were checked for accuracy. Disagreements were resolved by discussion, or by including a third review author. The certainty of the evidence was assessed using the GRADE approach. MAIN RESULTS: We included 44 studies (20 new to this update), reporting data for 6940 women and their infants. We used random-effects throughout. Overall, the risk of bias was assessed as low or unclear risk in most domains across studies. Evidence certainty, assessed using GRADE, was found to be generally low, mainly due to study design, inconsistency and imprecision. Six studies (n = 1284) compared membrane sweeping with more than one intervention and were thus included in more than one comparison. No trials reported on the outcomes uterine hyperstimulation with/without fetal heart rate (FHR) change, uterine rupture or neonatal encephalopathy. Forty studies (6548 participants) compared membrane sweeping with no treatment/sham Women randomised to membrane sweeping may be more likely to experience: · spontaneous onset of labour (average risk ratio (aRR) 1.21, 95% confidence interval (CI) 1.08 to 1.34, 17 studies, 3170 participants, low-certainty evidence). but less likely to experience: · induction (aRR 0.73, 95% CI 0.56 to 0.94, 16 studies, 3224 participants, low-certainty evidence); There may be little to no difference between groups for: · caesareans (aRR 0.94, 95% CI 0.85 to 1.04, 32 studies, 5499 participants, moderate-certainty evidence); · spontaneous vaginal birth (aRR 1.03, 95% CI 0.99 to 1.07, 26 studies, 4538 participants, moderate-certainty evidence); · maternal death or serious morbidity (aRR 0.83, 95% CI 0.57 to 1.20, 17 studies, 2749 participants, low-certainty evidence); · neonatal perinatal death or serious morbidity (aRR 0.83, 95% CI 0.59 to 1.17, 18 studies, 3696 participants, low-certainty evidence). Four studies reported data for 480 women comparing membrane sweeping with vaginal/intracervical prostaglandins There may be little to no difference between groups for the outcomes: · spontaneous onset of labour (aRR, 1.24, 95% CI 0.98 to 1.57, 3 studies, 339 participants, low-certainty evidence); · induction (aRR 0.90, 95% CI 0.56 to 1.45, 2 studies, 157 participants, low-certainty evidence); · caesarean (aRR 0.69, 95% CI 0.44 to 1.09, 3 studies, 339 participants, low-certainty evidence); · spontaneous vaginal birth (aRR 1.12, 95% CI 0.95 to 1.32, 2 studies, 252 participants, low-certainty evidence); · maternal death or serious morbidity (aRR 0.93, 95% CI 0.27 to 3.21, 1 study, 87 participants, low-certainty evidence); · neonatal perinatal death or serious morbidity (aRR 0.40, 95% CI 0.12 to 1.33, 2 studies, 269 participants, low-certainty evidence). One study, reported data for 104 women, comparing membrane sweeping with intravenous oxytocin +/- amniotomy There may be little to no difference between groups for: · spontaneous onset of labour (aRR 1.32, 95% CI 88 to 1.96, 1 study, 69 participants, low-certainty evidence); · induction (aRR 0.51, 95% CI 0.05 to 5.42, 1 study, 69 participants, low-certainty evidence); · caesarean (aRR 0.69, 95% CI 0.12 to 3.85, 1 study, 69 participants, low-certainty evidence); · maternal death or serious morbidity was reported on, but there were no events. Two studies providing data for 160 women compared membrane sweeping with vaginal/oral misoprostol There may be little to no difference between groups for: · caesareans (RR 0.82, 95% CI 0.31 to 2.17, 1 study, 96 participants, low-certainty evidence). One study providing data for 355 women which compared once weekly membrane sweep with twice-weekly membrane sweep and a sham procedure There may be little to no difference between groups for: · induction (RR 1.19, 95% CI 0.76 to 1.85, 1 study, 234 participants, low-certainty); · caesareans (RR 0.93, 95% CI 0.60 to 1.46, 1 study, 234 participants, low-certainty evidence); · spontaneous vaginal birth (RR 1.00, 95% CI 0.86 to 1.17, 1 study, 234 participants, moderate-certainty evidence); · maternal death or serious maternal morbidity (RR 0.78, 95% CI 0.30 to 2.02, 1 study, 234 participants, low-certainty evidence); · neonatal death or serious neonatal perinatal morbidity (RR 2.00, 95% CI 0.18 to 21.76, 1 study, 234 participants, low-certainty evidence); We found no studies that compared membrane sweeping with amniotomy only or mechanical methods. Three studies, providing data for 675 women, reported that women indicated favourably on their experience of membrane sweeping with one study reporting that 88% (n = 312) of women questioned in the postnatal period would choose membrane sweeping in the next pregnancy. Two studies reporting data for 290 women reported that membrane sweeping is more cost-effective than using prostaglandins, although more research should be undertaken in this area. AUTHORS' CONCLUSIONS: Membrane sweeping may be effective in achieving a spontaneous onset of labour, but the evidence for this was of low certainty. When compared to expectant management, it potentially reduces the incidence of formal induction of labour. Questions remain as to whether there is an optimal number of membrane sweeps and timings and gestation of these to facilitate induction of labour.

Follow-up at 1 year and beyond of women with gestational diabetes treated with insulin and/or oral glucose-lowering agents: a core outcome set using a Delphi survey.

AIMS/HYPOTHESIS: Gestational diabetes mellitus (GDM) is linked with a higher lifetime risk for the development of impaired fasting glucose, impaired glucose tolerance, type 2 diabetes, the metabolic syndrome, cardiovascular disease, postpartum depression and tumours. Despite this, there is no consistency in the long-term follow-up of women with a previous diagnosis of GDM. Further, the outcomes selected and reported in the research involving this population are heterogeneous and lack standardisation. This amplifies the risk of reporting bias and diminishes the likelihood of significant comparisons between studies. The aim of this study is to develop a core outcome set (COS) for RCTs and other studies evaluating the long-term follow-up at 1 year and beyond of women with previous GDM treated with insulin and/oral glucose-lowering agents. METHODS: The study consisted of three work packages: (1) a systematic review of the outcomes reported in previous RCTs of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral glucose-lowering agents; (2) a three-round online Delphi survey with key stakeholders to prioritise these outcomes; and (3) a consensus meeting where the final COS was decided. RESULTS: Of 3344 abstracts identified and evaluated, 62 papers were retrieved and 25/62 papers were included in this review. A total of 121 outcomes were identified and included in the Delphi survey. Delphi round 1 was emailed to 835 participants and 288 (34.5%) responded. In round 2, 190 of 288 (65.9%) participants responded and in round 3, 165 of 190 (86.8%) participants responded. In total, nine outcomes were selected and agreed for inclusion in the final COS: assessment of glycaemic status; diagnosis of type 2 diabetes since the index pregnancy; number of pregnancies since the index pregnancy; number of pregnancies with a diagnosis of GDM since the index pregnancy; diagnosis of prediabetes since the index pregnancy; BMI; post-pregnancy weight retention; resting blood pressure; and breastfeeding. CONCLUSIONS/INTERPRETATION: This study identified a COS that will help bring consistency and uniformity to outcome selection and reporting in clinical trials and other studies involving the follow-up at 1 year and beyond of women diagnosed with GDM treated with insulin and/or oral glucose-lowering agents during pregnancy.

Active versus expectant management for women in the third stage of labour.

BACKGROUND: Active management of the third stage of labour involves giving a prophylactic uterotonic, early cord clamping and controlled cord traction to deliver the placenta. With expectant management, signs of placental separation are awaited and the placenta is delivered spontaneously. Active management was introduced to try to reduce haemorrhage, a major contributor to maternal mortality in low-income countries. This is an update of a review last published in 2015. OBJECTIVES: To compare the effects of active versus expectant management of the third stage of labour on severe primary postpartum haemorrhage (PPH) and other maternal and infant outcomes.To compare the effects of variations in the packages of active and expectant management of the third stage of labour on severe primary PPH and other maternal and infant outcomes. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the World health Organization International Clinical Trials Registry Platform (ICTRP), on 22 January 2018, and reference lists of retrieved studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing active versus expectant management of the third stage of labour. Cluster-randomised trials were eligible for inclusion, but none were identified. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the studies for inclusion, assessed risk of bias, carried out data extraction and assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: We included eight studies, involving analysis of data from 8892 women. The studies were all undertaken in hospitals, seven in higher-income countries and one in a lower-income country. Four studies compared active versus expectant management, and four compared active versus a mixture of managements. We used a random-effects model in the analyses because of clinical heterogeneity. Of the eight studies included, we considered three studies as having low risk of bias in the main aspects of sequence generation, allocation concealment and completeness of data collection. There was an absence of high-quality evidence according to GRADE assessments for our primary outcomes, which is reflected in the cautious language below.The evidence suggested that, for women at mixed levels of risk of bleeding, it is uncertain whether active management reduces the average risk of maternal severe primary PPH (more than 1000 mL) at time of birth (average risk ratio (RR) 0.34, 95% confidence interval (CI) 0.14 to 0.87, 3 studies, 4636 women, I2 = 60%; GRADE: very low quality). For incidence of maternal haemoglobin (Hb) less than 9 g/dL following birth, active management of the third stage may reduce the number of women with anaemia after birth (average RR 0.50, 95% CI 0.30 to 0.83, 2 studies, 1572 women; GRADE: low quality). We also found that active management of the third stage may make little or no difference to the number of babies admitted to neonatal units (average RR 0.81, 95% CI 0.60 to 1.11, 2 studies, 3207 infants; GRADE: low quality). It is uncertain whether active management of the third stage reduces the number of babies with jaundice requiring treatment (RR 0.96, 95% CI 0.55 to 1.68, 2 studies, 3142 infants, I2 = 66%; GRADE: very low quality). There were no data on our other primary outcomes of very severe PPH at the time of birth (more than 2500 mL), maternal mortality, or neonatal polycythaemia needing treatment.Active management reduces mean maternal blood loss at birth and probably reduces the rate of primary blood loss greater than 500 mL, and the use of therapeutic uterotonics. Active management also probably reduces the mean birthweight of the baby, reflecting the lower blood volume from interference with placental transfusion. In addition, it may reduce the need for maternal blood transfusion. However, active management may increase maternal diastolic blood pressure, vomiting after birth, afterpains, use of analgesia from birth up to discharge from the labour ward, and more women returning to hospital with bleeding (outcome not pre-specified).In the comparison of women at low risk of excessive bleeding, there were similar findings, except it was uncertain whether there was a difference identified between groups for severe primary PPH (average RR 0.31, 95% CI 0.05 to 2.17; 2 studies, 2941 women, I2 = 71%), maternal Hb less than 9 g/dL at 24 to 72 hours (average RR 0.17, 95% CI 0.02 to 1.47; 1 study, 193 women) or the need for neonatal admission (average RR 1.02, 95% CI 0.55 to 1.88; 1 study, 1512 women). In this group, active management may make little difference to the rate of neonatal jaundice requiring phototherapy (average RR 1.31, 95% CI 0.78 to 2.18; 1 study, 1447 women).Hypertension and interference with placental transfusion might be avoided by using modifications to the active management package, for example, omitting ergot and deferring cord clamping, but we have no direct evidence of this here. AUTHORS' CONCLUSIONS: Although the data appeared to show that active management reduced the risk of severe primary PPH greater than 1000 mL at the time of birth, we are uncertain of this finding because of the very low-quality evidence. Active management may reduce the incidence of maternal anaemia (Hb less than 9 g/dL) following birth, but harms such as postnatal hypertension, pain and return to hospital due to bleeding were identified.In women at low risk of excessive bleeding, it is uncertain whether there was a difference between active and expectant management for severe PPH or maternal Hb less than 9 g/dL (at 24 to 72 hours). Women could be given information on the benefits and harms of both methods to support informed choice. Given the concerns about early cord clamping and the potential adverse effects of some uterotonics, it is critical now to look at the individual components of third-stage management. Data are also required from low-income countries.It must be emphasised that this review includes only a small number of studies with relatively small numbers of participants, and the quality of evidence for primary outcomes is low or very low.

Identifying and prioritising midwifery care process metrics and indicators: a Delphi survey and stakeholder consensus process.

BACKGROUND: Measuring care processes is an important component of any effort to improve care quality, however knowing the appropriate metrics to measure is a challenge both in Ireland and other countries. Quality of midwifery care depends on the expert knowledge of the midwife and her/his contribution to women and their babies' safety in the healthcare environment. Therefore midwives need to be able to clearly articulate and measure what it is that they do, the dimensions of their professional practice frequently referred to as midwifery care processes. The objective of this paper is to report on the development and prioritisation of a national suite of Quality Care Metrics (QCM), and their associated indicators, for midwifery care processes in Ireland. METHODS: The study involved four discrete, yet complimentary, phases; i) a systematic literature review to identify midwifery care process metrics and their associated measurement indicators; ii) a two-round, online Delphi survey of midwives to develop consensus on the set of midwifery care process metrics to be measured; iii) a two-round online Delphi survey of midwives to develop consensus on the indicators that will be used to measure prioritised metrics; and iv) a face-to-face consensus meeting with midwives to review the findings and achieve consensus on the final suite of metrics and indicators. RESULTS: Following the consensus meeting, 18 metrics and 93 indicators were prioritised for inclusion in the suite of QCM Midwifery Metrics. These metrics span the pregnancy, birth and postpartum periods. CONCLUSION: The development of this suite of process metrics and indicators for midwifery care provides an opportunity for measuring the safety and quality of midwifery care in Ireland and for adapting internationally. This initial work should be followed by a rigorous evaluation of the impact of the new suite of metrics on midwifery care processes.

Critical care nurses' experiences of providing care for adults in a highly technological environment: A qualitative evidence synthesis.

AIMS AND OBJECTIVES: To synthesise the available body of qualitative evidence relating to nurses' perceptions and experiences of care provision in adult critical care environments. METHODS: The study adhered to ENTREQ (Confidence in Evidence of Reviews of Qualitative Research) guidelines. See Appendix S1. A systematic search of the literature in nine databases was undertaken: CINAHL, Web of Science, MEDLINE, EMBASE, PsycINFO, Campbell Collaboration, ProQuest A & I, DART and Lenus. Blind screening to select relevant studies was undertaken, and each selected study was assessed for quality using the Critical Appraisal Skills Programme framework. Guided by Thomas and Harden's three-stage approach to thematic analysis, line-by-line coding of participants' verbatim accounts and the researchers' interpretations in the selected studies' findings was undertaken and then organised into higher order analytical themes. Confidence in the findings was reviewed using GRADE-CERQual. RESULTS: Twelve studies reported in thirteen papers, including 122 nurses, were selected in the final sample for synthesis. Three analytical themes were identified: (a) sometimes machines get all the attention, (b) with experience the patient becomes the focus and (c) technology can't save everybody. CONCLUSIONS: Providing care for adult patients in a highly technological environment is challenging particularly for novice nurses, who face the potential of technology drawing all their attention. Experienced critical care nurses learn to keep technology in abeyance and deliver person-centred care within the bounds of a technological environment. RELEVANCE TO CLINICAL PRACTICE: The review supports Locsin's theory of technological competence and highlights that providing care in critical care requires nurses to actively balance attention for the person while managing machines. Experienced nurses achieve this balance and can offer support to novice nurses. Critical care nurse orientation programmes should be underpinned by a holistic approach which addresses the dualism of technology and care.

Planned birth at or near term for improving health outcomes for pregnant women with gestational diabetes and their infants.

BACKGROUND: Gestational diabetes is a type of diabetes that occurs during pregnancy. Women with gestational diabetes are more likely to experience adverse health outcomes such as pre-eclampsia or polyhydramnios (excess amniotic fluid). Their babies are also more likely to have health complications such as macrosomia (birthweight > 4000 g) and being large-for-gestational age (birthweight above the 90th percentile for gestational age). Current clinical guidelines support elective birth, at or near term in women with gestational diabetes to minimise perinatal complications, especially those related to macrosomia.This review replaces a review previously published in 2001 that included "diabetic pregnant women", which has now been split into two reviews. This current review focuses on pregnant women with gestational diabetes and a sister review focuses on women with pre-existing diabetes (Type 1 or Type 2). OBJECTIVES: To assess the effect of planned birth (either by induction of labour or caesarean birth), at or near term (37 to 40 weeks' gestation) compared with an expectant approach for improving health outcomes for women with gestational diabetes and their infants. The primary outcomes relate to maternal and perinatal mortality and morbidity. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 August 2017), and reference lists of retrieved studies. SELECTION CRITERIA: We included randomised trials comparing planned birth, at or near term (37 to 40 weeks' gestation), with an expectant approach, for women with gestational diabetes. Cluster-randomised and non-randomised trials (e.g. quasi-randomised trials using alternate allocation) were also eligible for inclusion but none were identified. DATA COLLECTION AND ANALYSIS: Two of the review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included study. The quality of the evidence was assessed using the GRADE approach. MAIN RESULTS: The findings of this review are based on a single trial involving 425 women with gestational diabetes. The trial compared induction of labour with expectant management (waiting for the spontaneous onset of labour in the absence of any maternal or fetal issues that may necessitate birth) in pregnant women with gestational diabetes at term. We assessed the overall risk of bias as being low for most domains, apart from performance, detection and attrition bias (for outcome perineum intact), which we assessed as being at high risk. It was an open-label trial, and women and healthcare professionals were not blinded.There were no clear differences between women randomised to induction of labour and women randomised to expectant management for maternal mortality or serious maternal morbidity (risk ratio (RR) 1.48, 95% confidence interval (CI) 0.25 to 8.76, one trial, 425 women); caesarean section (RR 1.06, 95% CI 0.64 to 1.77, one trial, 425 women); or instrumental vaginal birth (RR 0.81, 95% CI 0.45 to 1.46, one trial, 425 women). For the primary outcome of maternal mortality or serious maternal morbidity, there were no deaths in either group and serious maternal morbidity related to admissions to intensive care unit. The quality of the evidence contributing to these outcomes was assessed as very low, mainly due to the study having high risk of bias for some domains and because of the imprecision of effect estimates.In relation to primary neonatal outcomes, there were no perinatal deaths in either group. The quality of evidence for this outcome was judged as very low, mainly due to high risk of bias and imprecision of effect estimates. There were no clear differences in infant outcomes between women randomised to induction of labour and women randomised to expectant management: shoulder dystocia (RR 2.96, 95% CI 0.31 to 28.21, one trial, 425 infants, very low-quality evidence); large-for-gestational age (RR 0.53, 95% CI 0.28 to 1.02, one trial, 425 infants, low-quality evidence).There were no clear differences between women randomised to induction of labour and women randomised to expectant management for postpartum haemorrhage (RR 1.17, 95% CI 0.53 to 2.54, one trial, 425 women); admission to intensive care unit (RR 1.48, 95% CI 0.25 to 8.76, one trial, 425 women); and intact perineum (RR 1.02, 95% CI 0.73 to 1.43, one trial, 425 women). No infant experienced a birth trauma, therefore, we could not draw conclusions about the effect of the intervention on the outcomes of brachial plexus injury and bone fracture at birth. Infants of women in the induction-of-labour group had higher incidences of neonatal hyperbilirubinaemia (jaundice) when compared to infants of women in the expectant-management group (RR 2.46, 95% CI 1.11 to 5.46, one trial, 425 women).We found no data on the following prespecified outcomes of this review: postnatal depression, maternal satisfaction, length of postnatal stay (mother), acidaemia, intracranial haemorrhage, hypoxia ischaemic encephalopathy, small-for-gestational age, length of postnatal stay (baby) and cost.The authors of this trial acknowledge that it is underpowered for their primary outcome of caesarean section. The authors of the trial and of this review note that the CIs demonstrate a wide range, therefore making it inappropriate to draw definite conclusions. AUTHORS' CONCLUSIONS: There is limited evidence to inform implications for practice. The available data are not of high quality and lack power to detect possible important differences in either benefit or harm. There is an urgent need for high-quality trials evaluating the effectiveness of planned birth at or near term gestation for women with gestational diabetes compared with an expectant approach.

Planned birth at or near term for improving health outcomes for pregnant women with pre-existing diabetes and their infants.

BACKGROUND: Pregnant women with pre-existing diabetes (Type 1 or Type 2) have increased rates of adverse maternal and neonatal outcomes. Current clinical guidelines support elective birth, at or near term, because of increased perinatal mortality during the third trimester of pregnancy.This review replaces a review previously published in 2001 that included "diabetic pregnant women", which has now been split into two reviews. This current review focuses on pregnant women with pre-existing diabetes (Type 1 or Type 2) and a sister review focuses on women with gestational diabetes. OBJECTIVES: To assess the effect of planned birth (either by induction of labour or caesarean birth) at or near term gestation (37 to 40 weeks' gestation) compared with an expectant approach, for improving health outcomes for pregnant women with pre-existing diabetes and their infants. The primary outcomes relate to maternal and perinatal mortality and morbidity. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (15 August 2017), and reference lists of retrieved studies. SELECTION CRITERIA: We planned to include randomised trials (including those using a cluster-randomised design) and non-randomised trials (e.g. quasi-randomised trials using alternate allocation) which compared planned birth, at or near term, with an expectant approach for pregnant women with pre-existing diabetes. DATA COLLECTION AND ANALYSIS: Two of the review authors independently assessed study eligibility. In future updates of this review, at least two of the review authors will extract data and assess the risk of bias in included studies. We will also assess the quality of the evidence using the GRADE approach. MAIN RESULTS: We identified no eligible published trials for inclusion in this review.We did identify one randomised trial which examined whether expectant management reduced the incidence of caesarean birth in uncomplicated pregnancies of women with gestational diabetes (requiring insulin) and with pre-existing diabetes. However, published data from this trial does not differentiate between pre-existing and gestational diabetes, and therefore we excluded this trial. AUTHORS' CONCLUSIONS: In the absence of evidence, we are unable to reach any conclusions about the health outcomes associated with planned birth, at or near term, compared with an expectant approach for pregnant women with pre-existing diabetes.This review demonstrates the urgent need for high-quality trials evaluating the effectiveness of planned birth at or near term gestation for pregnant women with pre-existing (Type 1 or Type 2) diabetes compared with an expectant approach.

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. DESIGN: An integrative review of the literature. METHODS: Whittemore and Knafl's five-stage integrative review framework guided this review. A systematic literature search of the Medline, PsycINFO, Embase, CINAHL and ASSIA, Cochrane Library and ProQuest databases was conducted from inception to January 2023, with no language or geographical limiters set due to the paucity of research published in this subject area. Two researchers independently screened and reviewed each study's data extraction and methodological quality using the Joanna Briggs Institute and Mixed Method Appraisal Tool. Results were analysed and synthesised using narrative synthesis. RESULTS: A total of 21 studies met the inclusion criteria. From these, we identified nine types of psychosocial interventions for perinatal bereavement that can be delivered by midwives and nurses. The positive impacts of midwife/nurse-led psychosocial interventions on grief, anxiety, depression posttraumatic stress disorder and other psychosocial outcomes amongst parents experiencing perinatal loss have been demonstrated. In addition, we identified the useful components of these interventions and the experiences of midwives and nurses in delivering psychosocial interventions, thereby highlighting barriers such as lack of knowledge and skills, stressful working environments and inadequate emotional support. CONCLUSION: Our findings demonstrate that midwife/nurse-led psychosocial interventions have the potential to improve grief, anxiety, depression, posttraumatic stress disorder symptoms and other psychosocial outcomes for parents experiencing perinatal loss. Thus, future research should consider training, workload, time cost and emotional support for midwives/nurses when developing midwife/nurse-led psychosocial interventions for parents with perinatal loss. REGISTRATION NUMBER: CRD42022369032. TWEETABLE ABSTRACT: Midwife/nurse-led psychosocial interventions have the potential to improve mental health amongst 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 (n = 40) and providers (n = 30) of IPV routine enquiry as part of antenatal care policy in Ireland. Respondents supported IPV routine enquiry as part of usual antenatal care, and while immediate disclosure was recognized as important, it was not a primary expectation. Routine enquiry was seen as a woman's right and a providers' duty to provide holistic, empowered, women centered and safe care and where provision of information and education on IPV is as fundamental as the disclosure of abuse.

Outcomes of interventions in neonatal sepsis: A systematic review of qualitative research.

BACKGROUND: While a systematic review exists detailing neonatal sepsis outcomes from clinical trials, there remains an absence of a qualitative systematic review capturing the perspectives of key stakeholders. OBJECTIVES: Our aim is to identify outcomes from qualitative research on any intervention to prevent or improve the outcomes of neonatal sepsis that are important to parents, other family members, healthcare providers, policymakers, and researchers as a part of the development of a core outcome set (COS) for neonatal sepsis. SEARCH STRATEGY: A literature search was carried out using MEDLINE, EMBASE, CINAHL, and PsycInfo databases. SELECTION CRITERIA: Publications describing qualitative data relating to neonatal sepsis outcomes were included. DATA COLLECTION AND ANALYSIS: Drawing on the concepts of thematic synthesis, texts related to outcomes were coded and grouped. These outcomes were then mapped to the domain headings of an existing model. MAIN RESULTS: Out of 6777 records screened, six studies were included. Overall, 19 outcomes were extracted from the included studies. The most frequently reported outcomes were those in the domains related to parents, healthcare workers and individual organ systemas such as gastrointestinal system. The remaining outcomes were classified under the headings of general outcomes, miscellaneous outcomes, survival, and infection. CONCLUSIONS: The outcomes identified in this review are different from those reported in neonatal sepsis clinical trials, thus highlighting the importance of incorporating qualitative studies into COS development to encapsulate all relevant stakeholders' perspectives.

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. METHODS: Forty-four postnatal women with one previous CS who birthed between August 2021 and March 2022 were invited to participate in a qualitative study. Thirteen semi-structured interviews were undertaken in 2022. Thematic Analysis guided the analysis of the data and the findings are framed using the domains of the Socio-Ecological Model. FINDINGS: Decision making in relation to ERCS and VBAC is complex. Women want accurate VBAC information and time for discussions. Decisions are influenced by the woman's own confidence to birth naturally, family size, rite of passage to motherhood, control, previous birth experience, postnatal recovery and friends and family. DISCUSSION: Previous experience can influence but not predict the next mode of birth. However, there is no one script that healthcare professionals (HCP) can use for this decision making given the various factors that influence this. To meet women's individual needs, HCPs should discuss VBAC suitability postnatally, offer VBAC antenatal clinics and specific VBAC classes. CONCLUSION: Discussions about suitability for VBAC should occur following the primary CS. Continuity of care (COC), time for discussions and VBAC supportive HCP should be an option for all of this cohort.

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. research that aims to enhance the quality and rigour of research) is less clear. Using a qualitative case study, we explored public involvement in a research priority-setting partnership in rapid review methodology (Priority III) to give practical insights to inform public involvement in priority-setting for future methodological research. METHODS: Participant observation, documentary analysis, interviews and focus groups were used to explore the processes of Priority III and identify the views and experiences of the participants of a steering group (n = 26) regarding public involvement in Priority III. We used a case study research design and conducted two focus groups with five public partners; one focus group with four researchers; and seven one-to-one interviews with researchers and public partners. Nine episodes of participant observation of meetings were conducted. All data were analysed using template analysis. RESULTS: The findings of this case study present three themes and six subthemes: Theme 1 We all bring unique qualities to the table. Subtheme 1.1-Coming from different perspectives towards shared-decision making; Subtheme 1.2-Public partners bring pragmatism and grounding in reality; Theme 2 We need support and space at the table. Subtheme 2.1-Define and develop support needed for meaningful involvement; Subtheme 2.2-Creating safe space to listen, challenge and learn; Theme 3 We all benefit from working together. Subtheme 3.1-Reciprocity in mutual learning and capacity building; Subtheme 3.2-Relationships as partners in research, with a feeling of togetherness. Communication and trust, as inclusive ways of working, underpinned the partnership approach to involvement. CONCLUSIONS: This case study contributes to knowledge on public involvement in research by explaining the supportive strategies, spaces, attitudes and behaviours that enabled a productive working partnership to develop between a team of researchers and public partners in this research context.

Public and patient involvement is well known in research where patients share their lived experience for a health-related study. However, the role of public and patients in methodology research (research that aims to improve the quality of research) is not clear.A priority-setting partnership brings patients, carers, clinicians and other stakeholders together to jointly identify priorities for research. We looked at public involvement in a priority-setting partnership in how we plan, do, and share the results of rapid reviews­the Priority III project. We wanted to do this to better support public involvement in future research.We explored the processes of Priority III and asked the members of the Priority III steering group for their views and experiences of public involvement in the project. We found three themes:1: We all bring unique qualities to the table.2: We need support and space at the table.3: We all benefit from working together.Communication and trust were found to be important across all themes. Even though public partners felt outside of their comfort zones when starting the project, they significantly helped the project, brought unique views, ideas and practical solutions. Support and safe spaces were needed to help overcome challenges due to the complex methodological concepts. Researchers and public partners learned from one another, and developed relationships with a feeling of being "partners in research". Our findings offer insight into what helped public involvement in this research context. We give examples of practical actions and suggestions for future research.

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

Background: 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. Incorporating the necessary information about how qualitative data will be shared into already complex trial recruitment and consent processes proves challenging. The aim of this study was to explore whether and how trial teams share qualitative data collected as part of the design, conduct, analysis, or delivery of clinical trials. Methods: Phase 1 involved semi-structured, in-depth qualitative interviews and focus groups with key trial stakeholder groups including trial managers and clinical trialists (n=3), qualitative researchers in trials (n=9), members of research funding bodies (n=2) and trial participants (n=1). Data were analysed using thematic analysis. In Phase 2, we conducted a content analysis of 16 participant information leaflets (PIL) and consent forms (CF) for trials that collected qualitative data. Results: Three key themes were identified from our Phase 1 findings: ' Understanding and experiences of the potential benefits of sharing qualitative data from trials', 'Concerns about qualitative data sharing', and ' Future guidance and funding'. In phase 2, the PILs and CFs received revealed that the benefits of data sharing for participants were only explained in two of the study documents. Conclusions: The value of sharing qualitative data was acknowledged, but there are many uncertainties as to how, when, and where to share this data. In addition, there were ethical concerns in relation to the consent process required for qualitative data sharing in trials. This study provides insight into the existing practice of qualitative data sharing in trials.

Protocol for the development of a core outcome set for neonatal sepsis (NESCOS).

Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis. Since a systematic review of key outcomes from randomised trials of therapeutic interventions in neonatal sepsis was published recently, we will complement this with a qualitative systematic review of the key outcomes of neonatal sepsis identified by parents, other family members, parent representatives, healthcare providers, policymakers, and researchers. We will interpret the outcomes of both studies using a previously established framework. Stakeholders across three different groups i.e., (1) researchers, (2) healthcare providers, and (3) patients' parents/family members and parent representatives will rate the importance of the outcomes in an online Real-Time Delphi Survey. Afterwards, consensus meetings will be held to agree on the final COS through online discussions with key stakeholders. This COS is expected to minimize outcome heterogeneity in measurements and publications, improve comparability and synthesis, and decrease research waste.