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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. Objectives: To collect outcomes reported in studies assessing treatment interventions in pregnant women with PGDM. Search strategy: CENTRAL, Web of Science, Medline, CINAHL, Embase and ClinicalTrials.gov from their inception until 27 January 2020. Selection criteria: Any randomised controlled trial assessing treatment interventions in pregnant women with PGDM reported in English. Data collection and analysis: Two independent reviewers assessed the suitability of articles and retrieved the data. Outcomes extracted from the literature were broadly categorised into maternal, fetal/infant or other outcomes by the study advisory group. Main results: Sixty‐seven of the 1475 studies identified fulfilled the inclusion criteria. The median number of outcomes reported per study was 15 (range 1–46). The majority of studies were from North America and Europe. Insulin and metformin were the most commonly investigated pharmacological interventions. Glucose monitoring was the most assessed technological intervention. In all, 131 unique outcomes were extracted: maternal (n = 69), fetal/infant (n = 61) and other (n = 1). Conclusions: Outcome reporting in treatment interventions trials of pregnant women with PGDM is varied, making it difficult to synthesise evidence, especially for rare outcomes. Systems are needed to standardise outcome reporting in future clinical trials and so facilitate evidence synthesis in this area of maternal diabetes. Registration: The systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549). Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy. Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy. [ABSTRACT FROM AUTHOR]

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., (© 2024 The Author(s). International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Background: Neonatal encephalopathy (NE) is a multi-organ condition potentially leading to death or long-term neurodisability. Therapeutic hypothermia is the standard treatment for NE; however, long-term impairments remain common. Studies of new treatments for NE often measure and report different outcomes. Core outcome sets (COSs), a minimum set of outcomes to be measured and reported in all studies for a condition, address this problem. This paper aimed to identify outcomes reported (primary, secondary, adverse events and other reported outcomes) in (1) randomised trials and (2) systematic reviews of randomised trials of interventions for the treatment of NE in the process of developing a COS for interventions for the treatment of NE., Methods: We completed a systematic search for outcomes used to evaluate treatments for NE using MEDLINE, Embase, Cochrane CENTRAL, the Cochrane Database of Systematic Reviews and the WHO International Clinical Trials Registry Platform. Two reviewers screened all included articles independently. Outcomes were extracted verbatim, similar outcomes were grouped and outcome domains were developed., Results: 386 outcomes were reported in 116 papers, from 85 studies. Outcomes were categorised into 18 domains. No outcome was reported by all studies, a single study reported 11 outcomes and it was not explicitly stated that outcomes had input from parents., Discussion: Heterogeneity in reported outcomes means that synthesis of studies evaluating new treatments for NE remains difficult. A COS, that includes parental/family input, is needed to ensure consistency in measuring and reporting outcomes, and to enable comparison of randomised trials., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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., (© 2023. The Author(s).)

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., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Taneri et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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., Competing Interests: Declaration of Competing Interest The authors declare that they have no known personal relationships or any known competing financial interests that could appear to have influenced this qualitative research paper. A local Research and Education Foundation seed grant of €615 was used to pay for the interviews to be transcribed. No other funding or outside support was used to undertake this study., (Copyright © 2023 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.)

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. We investigated the outcomes prioritised in each survey and the 'feedback', 'iteration', and 'initial condition' effects to identify differences between the two survey methods., Results: In the RTD, n = 92 participants (83%) fully completed the survey. In the MRD, n = 60 participants (54%) completed all three rounds. Of the 92 outcomes presented, 26 (28%) were prioritised differently between the RTD and MRD. Significantly fewer participants amended their scores when shown stakeholder responses in the RTD compared to the MRD ('feedback effect'). The 'iteration effect' analysis found most experts appeared satisfied with their initial ratings in the RTD and did not amend their scores following stakeholder response feedback. Where they did amend their scores, ratings were amended substantially, suggesting greater convergence. Variance in scores reduced with subsequent rounds of the MRD ('iteration effect'). Whilst most participants did not change their initial scores in the RTD, of those that did, later recruits tended to align their final score more closely to the group mean final score than earlier recruits (an 'initial condition' effect)., Conclusion: The feedback effect differed between the two Delphi methods but the magnitude of this difference was small and likely due to the large number of observations rather than because of a meaningfully large difference. It did not appear to be advantageous to require participants to engage in three rounds of a survey due to the low change in scores. Larger drop-out through successive rounds in the MRD, together with a lesser convergence of scores and longer time to completion, indicate considerable benefits of the RTD approach., Trial Registration: NCT04471103. Registered on 14 July 2020., (© 2023. The Author(s).)

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., (© 2023. The Author(s).)

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2023 McCarthy M et al.)

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. talking about trials with potential participants, distributing trial information) they may not ordinarily do outside of the trial. Most trial recruitment interventions do not provide any theoretical basis for the potential effect (on behaviour) or describe if stakeholders were involved during development. The study aim was to use behavioural theory in a co-design process to develop an intervention for MHCPs tasked with approaching all eligible potential participants and inviting them to join a maternity trial and to assess the acceptability and feasibility of such an intervention., Methods: This study applied a step-wise sequential mixed-methods approach. Key stages were informed by the Theoretical Domains Framework and Behaviour Change Techniques (BCT) Taxonomy to map the accounts of MHCPs, with regard to challenges to trial recruitment, to theoretically informed behaviour change strategies. Our recruitment intervention was co-designed during workshops with MHCPs and maternity service users. Acceptability and feasibility of our intervention was assessed using an online questionnaire based on the Theoretical Framework of Acceptability (TFA) and involved a range of trial stakeholders., Results: Two co-design workshops, with a total of nine participants (n = 7 MHCP, n = 2 maternity service users), discussed thirteen BCTs as potential solutions. Ten BCTs, broadly covering Consequences and Reframing, progressed to intervention development. Forty-five trial stakeholders (clinical midwives, research midwives/nurses, doctors, allied health professionals and trial team members) participated in the online TFA questionnaire. The intervention was perceived effective, coherent, and not burdensome to engage with. Core areas for future refinement included Anticipated opportunity and Self-efficacy., Conclusion: We developed a behaviour change recruitment intervention which is based on the accounts of MHCP trial recruiters and developed in a co-design process. Overall, the intervention was deemed acceptable. Future evaluation of the intervention will establish its effectiveness in enabling MHCPs to invite all eligible people to participate in a maternity care trial, and determine whether this translates into an increase in maternity trial recruitment rates., (© 2022. The Author(s).)

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., Findings: Parents identified 54 outcomes overall, which mapped to 16 outcome domains. The domains identified were neurological outcomes, respiratory outcomes, gastrointestinal outcomes, cardiovascular outcomes, motor development, cognitive development, development (psychosocial), development (special senses), cognitive development, development (speech and social), other organ outcomes, survival/living outcomes, long-term disability, hospitalisation, parent-reported outcomes and adverse events., Conclusions: This study provides insight into the outcomes that parents of infants diagnosed with neonatal encephalopathy have identified as the most important, to be considered in the process of developing a COS for the treatment of neonatal encephalopathy. We also provide description of the processes employed to ensure the inclusion of participants from LMiCs as well as HiCs., Competing Interests: Competing interests: No, there are no competing interests., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Results: Twenty-two recruiters including midwives, nurses, allied health professionals and doctors were interviewed online or by telephone phone. Thematic analysis generated four global themes; Availability and accessibility of resources, Navigating the recruitment pathway, Prioritising clinical responsibilities over research responsibilities and The influence of colleagues and peers. Themes were mapped to the TDF, identifying 13 domains relevant to the behaviour., Conclusion: This paper identifies the factors enabling or inhibiting maternity HCP recruiters to invite all eligible women to participate in a maternity care trial. The findings provide guidance for researchers designing trials for this population and the essential first step in developing a recruiter-focused behaviour change intervention to support recruitment to trials in maternity care., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

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. The People's Trial aims to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims by actively involving them in all aspects of trial design. This was done by involving the public in the design, conduct, and dissemination of a randomised trial., Methods: Using a reflexive approach, we describe the processes of development, conduct, and dissemination of The People's Trial., Results: Over 3000 members of the public, from 72 countries, participated in The People's Trial. Through a series of online surveys, the public designed a trial called The Reading Trial. They chose the question the trial would try to answer and decided the components of the trial question. In December 2019, 991 participants were recruited to a trial to answer the question identified and prioritised by the public, i.e. 'Does reading a book in bed make a difference to sleep in comparison with not reading a book in bed?' We report the processes of The People's Trial in seven phases, paralleling the steps of a randomised trial, i.e. question identification and prioritisation, recruitment, randomisation, trial conduct, data analysis, and sharing of findings. We describe the decisions we made, the processes we used, the challenges we encountered, and the lessons we learned., Conclusion: The People's Trial involved the public successfully in the design, conduct, and dissemination of a randomised trial demonstrating the potential for such initiatives to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims., Trial Registration: ClinicalTrials.gov NCT04185818 . Registered on 4 December 2019., (© 2022. The Author(s).)

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. This means any differences found can be put down to the treatment received rather than other things, such as where people live, or health conditions they might have. The People's Trial aimed to help the public better understand randomised trials by inviting them to design and carry out a trial. The question chosen by the public for The People's Trial was: 'Does reading a book in bed make a difference to sleep, in comparison to not reading a book in bed?' This paper describes that trial, called 'The Reading Trial'., Methods: The Reading Trial was an online, randomised trial. Members of the public were invited to take part through social media campaigns. People were asked to either read a book in bed before going to sleep (intervention group) or not read a book in bed before going to sleep (control group). We asked everyone to do this for 7 days, after which they measured their sleep quality., Results: During December 2019, a total of 991 people took part in The Reading Trial, half (496 (50%)) in the intervention group and half (495 (50%)) in the control group. Not everyone finished the trial: 127 (25.6%) people in the intervention group and 90 (18.18%) people in the control group. Of those providing data, 156/369 (42%) people in the intervention group felt their sleep improved, compared to 112/405 (28%) of those in the control group, a difference of 14%. When we consider how certain we are of this finding, we estimate that, in The Reading Trial, sleep improved for between 8 and 22% more people in the intervention group compared to the control group., Conclusions: Reading a book in bed before going to sleep improved sleep quality, compared to not reading a book in bed., Trial Registration: ClinicalTrials.gov NCT04185818. Registered on 4 December 2019., (© 2021. The Author(s).)

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). In studies that do include PROs, PRO reporting is often of poor quality., Methods: We will conduct this systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Using a combination of medical subject headings and keywords (combined using Boolean operators), we will search web-based databases (PubMed, Cochrane and EMBASE) for RCTs published in English between 2013 and 2021. Two reviewers will review titles and abstracts. We will review the full texts of any relevant abstracts and extract the following data: date of publication or recruitment period, journal of publication, country of study, multicentre or single centre, population and number of participants, type of intervention, frequency of PRO assessment and type of PRO (or PRO measurement) used. We will also record if the PRO was a primary, secondary or exploratory outcome. We will exclude reviews, observational studies, unpublished data for example, conference abstracts and trial protocols. Any published RCT that includes data on a PRO as a primary or secondary outcome will then be compared against the Consolidated Standards of Reporting Trials-Patient-Reported Outcome extension checklist, a structured and approved framework for the publication of results of PROs., Ethics and Dissemination: Ethical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 24 March 2021 (CA 2592). We aim to publish our findings in a peer-reviewed journal and present our findings at national and international conferences., Systematic Review Registration: This systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number CRD42021234917., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Objectives: To collect outcomes reported in studies assessing treatment interventions in pregnant women with PGDM., Search Strategy: CENTRAL, Web of Science, Medline, CINAHL, Embase and ClinicalTrials.gov from their inception until 27 January 2020., Selection Criteria: Any randomised controlled trial assessing treatment interventions in pregnant women with PGDM reported in English., Data Collection and Analysis: Two independent reviewers assessed the suitability of articles and retrieved the data. Outcomes extracted from the literature were broadly categorised into maternal, fetal/infant or other outcomes by the study advisory group., Main Results: Sixty-seven of the 1475 studies identified fulfilled the inclusion criteria. The median number of outcomes reported per study was 15 (range 1-46). The majority of studies were from North America and Europe. Insulin and metformin were the most commonly investigated pharmacological interventions. Glucose monitoring was the most assessed technological intervention. In all, 131 unique outcomes were extracted: maternal (n = 69), fetal/infant (n = 61) and other (n = 1)., Conclusions: Outcome reporting in treatment interventions trials of pregnant women with PGDM is varied, making it difficult to synthesise evidence, especially for rare outcomes. Systems are needed to standardise outcome reporting in future clinical trials and so facilitate evidence synthesis in this area of maternal diabetes., Registration: The systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549)., Tweetable Abstract: Outcome reporting is heterogeneous in intervention trials of pregnant women with diabetes existing before pregnancy., (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

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., Population: Two hundred and five stakeholders completed the first round., Methods: The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS., Main Outcome Measures: All outcomes were extracted from the literature., Results: We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death., Conclusions: This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM., Tweetable Abstract: 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy., (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Background : 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. Qualitative data including videos, interviews, and observations are often more readily identifiable than quantitative data. Existing guidance from UK Economic and Social Research Council applies to sharing qualitative data but does not address the additional challenges related to sharing qualitative data collected within trials, including the need to incorporate the necessary information and consent into already complex recruitment processes, with the additional sensitive nature of health-related data. Methods: Work package 1 will involve separate focus group interviews with members of each stakeholder group: trial managers, clinical trialists, qualitative researchers, members of research funding bodies and trial participants who have been involved in qualitative research. Data will be analysed using thematic analysis and managed within QSR NVivo to enhance transparency. Work package 2 will involve a documentary analysis of current consent procedures for qualitative data collected as part of the conduct of clinical trials. We will include documents such as participant information leaflets and consent forms for the qualitative components in trials. We will extract data such as whether specific clauses for data sharing are included in the consent form. Content analysis will be used to analyse whether and how consent is being obtained for qualitative data sharing. Conclusions: This study will provide insight into the existing practice of sharing of qualitative data in clinical trials and the current issues and opportunities, to help shape future research and development of guidance to encourage maximum learning to be gained from this valuable data., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Houghton C et al.)

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. For this reason, the Delphi method is popular as a consensus building approach in developing core outcome sets (COS), i.e. the minimum agreed set of standardised outcomes that should be measured and reported in studies on a specific health condition. In a COS setting, participants prioritise the importance of outcomes for inclusion in a COS. This usually involves participating in multiple rounds of a survey that can span several weeks or months. Challenges with participant retention have been highlighted in previous COS. We will compare a three-round with a Real-Time Delphi approach on prioritised outcomes. This trial is embedded within the COHESION study which is developing a COS for interventions treating neonatal encephalopathy., Methods: One hundred and eighty stakeholders (parents/caregivers of infants diagnosed and treated with neonatal encephalopathy, healthcare providers and researchers) will be randomised using stratified randomisation to take part in either the Multi-Round or Real-Time Delphi. Stakeholders will rate the importance of the same set of outcomes in both arms. We will compare the prioritised outcomes at the end of both surveys as well as other parameters such as feedback, initial condition and iteration effects., Discussion: This trial will provide evidence to inform decisions on the use of Multi-Round compared to Real-Time Delphi survey methods., Trial Registration: NCT04471103 . Registered on 14 July 2020.

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. Treatment options for neonatal encephalopathy are limited mainly to therapeutic hypothermia, although other potential treatments are emerging. However, evaluations of the effectiveness of treatments are challenging because of heterogeneity and inconsistency in outcomes measured and reported between trials. In this paper, we detail how we will develop a core outcome set to standardise outcomes measured and reported upon for interventions for the treatment of neonatal encephalopathy., Methods: We will systematically review the literature to identify outcomes reported previously in randomised trials and systematic reviews of randomised trials. We will identify outcomes important to parents or caregivers of infants diagnosed with and who have received treatment for neonatal encephalopathy. We will do this by conducting in person or by video teleconferencing interviews with parents or caregivers in high-income and low- to middle-income countries. Stakeholders with expertise in neonatal encephalopathy (parents/caregivers, healthcare providers and researchers) will rate the importance of identified outcomes in an online Delphi survey using either a three-round Delphi survey or a "Real-Time" Delphi survey to which stakeholders will be allocated at random. Consensus meetings will take place by video conference to allow for an international group of stakeholder representatives to discuss and vote on the outcomes to include in the final core outcome set (COS)., Discussion: More research is needed on treatments for neonatal encephalopathy. Standardising outcomes measured and reported in evaluations of the effectiveness of interventions for the treatment of neonatal encephalopathy will improve evidence synthesis and improve results reported in systematic reviews and meta-analysis in this area. Overall, this COS will allow for improved treatments to be identified, heterogeneity in research to be reduced, and overall patient care to be enhanced., Trial Registration: This study is registered in the Core Outcome Measures for Effectiveness (COMET) database http://www.comet-initiative.org/Studies/Details/1270 .

Background: Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency. The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews)., Methods/design: Multicentre, pragmatic, parallel-group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton foetus ≥ 38 weeks gestation; cephalic presentation; longitudinal lie; intact membranes; English speaking and ≥ 18 years of age will be randomised in a 2:1 ratio to membrane sweep versus no membrane sweep. Women allocated randomly to a sweep will then be randomised further (factorial component) to early (from 39 weeks) versus late (from 40 weeks) sweep commencement and a single versus weekly sweep. The proposed feasibility study consists of four work packages, i.e. (1) a multicentre, pilot randomised trial; (2) a health economic analysis; (3) a qualitative study; and (4) a study within the host trial (a SWAT). Outcomes to be collected include recruitment and retention rates, compliance with protocol, randomisation and allocation processes, attrition rates and cost-effectiveness. Focus groups will be held with women and clinicians to explore the acceptability and feasibility of the proposed intervention, study procedures and perceived barriers and enablers to recruitment., Discussion: The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. Results will inform whether and how the design of the definitive trial as originally envisaged should be delivered or adapted., Trial Registration: ClinicalTrials.gov NCT04307199 . Registered on 12 March 2020.

Background: Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes including increased rates of caesarean section birth, macrosomia, congenital malformation, prematurity, admission to the neonatal intensive care unit and stillbirth. As a result, there has been an increase in interventions to improve outcomes in both mother and infant. To date, meaningful comparisons between these studies are limited due to heterogeneity in outcome selection and reporting. The aim of this study is to develop a core outcome set (COS) for randomised controlled trials evaluating the effectiveness of interventions for the treatment of pregnant women with PGDM., Methods: The study consists of three steps. The first step is a systematic review of the literature to assess outcomes reported in randomised controlled trials assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. The second step is a three round, online Delphi survey to prioritise these outcomes. In this step, stakeholders (including women with PGDM, healthcare workers, researchers and policymakers) will be asked to rank the importance of outcomes for inclusion in the COS using a 9-point Likert type scale. Outcomes that meet the inclusion criteria after completion of the Delphi surveys will be brought to the consensus meeting. The consensus meeting will be the third and final step, where the COS will be finalised. The consensus meeting will include members from each stakeholder group., Discussion: This paper describes the process used to develop a COS for the reporting of studies evaluating the effectiveness of interventions in pregnant women with PGDM. The COS will enable greater comparison between and information synthesis across RCTs in the treatment of PGDM. In addition, this COS will also help improve trial reporting and minimise research waste by prioritising the collection and reporting of outcomes that matter to all relevant stakeholder groups., Trial Registration: This COS has been registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative ( http://www.comet-initiative.org/studies/details/1425 ) on the 4th of November 2019. The systematic review component of this study has also been registered with the International Prospective Register of Systematic Reviews (PROSPERO) ( https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020173549 ).

Core Outcome Sets (COS) contain an agreed minimum set of outcomes to be measured and reported in all studies in a specific area, with the objective of standardizing outcome reporting. COS may minimize research waste by identifying outcomes important to key stakeholders, allowing for improved evidence synthesis, and facilitating translation of research findings to clinical practice. Over the past 5 years, there has been significant progress in developing COS relevant to studies of diabetes in pregnancy. This review summarizes work in this area, reviews the role of patient and public involvement in COS development, and suggests areas for future research., (© 2020 by the American Diabetes Association.)

Background: The COVID-19 pandemic has created a sense of urgency in the research community in their bid to contribute to the evidence required for healthcare policy decisions. With such urgency, researchers experience methodological challenges to maintain the rigour and transparency of their work. With this in mind, we offer reflections on our recent experience of undertaking a rapid Cochrane qualitative evidence synthesis (QES)., Methods: This process paper, using a reflexive approach, describes a rapid QES prepared during, and in response to, the COVID-19 pandemic., Findings: This paper reports the methodological decisions we made and the process we undertook. We place our decisions in the context of guidance offered in relation to rapid reviews and previously conducted QESs. We highlight some of the challenges we encountered in finding the balance between the time needed for thoughtfulness and comprehensiveness whilst providing a rapid response to an urgent request for evidence., Conclusion: The need for more guidance on rapid QES remains, but such guidance needs to be based on actual worked examples and case studies. This paper and the reflections offered may provide a useful framework for others to use and further develop.

Introduction: Research on research is key to enhancing efficacy in trial methodology. Clinical trials involving women during pregnancy and childbirth are limited, with a paucity of data guiding evidence-based practice. Following a prioritisation exercise that highlighted the top-ten unanswered recruitment questions, this qualitative evidence synthesis was designed specifically to focus on the barriers and enablers for clinicians/healthcare professionals in helping conduct randomised trials within the context of recruitment during pregnancy and childbirth., Methods: The synthesis was undertaken using Thomas and Harden's three stage thematic synthesis method and reported following the ENTREQ guidelines. Using a pre-determined SPIDER strategy, we conducted a comprehensive search of databases; Pubmed, CINAHL, PsycINFO, EMBASE, and grey searches for records until January 2019. We included all reports of qualitative data on recruiter's experiences, perceptions, views of recruiting women during pregnancy and childbirth to clinical trials. Altogether 13,401 records were screened, resulting in 31 full-text reviews, of which five were eligible for inclusion. Quality was appraised using CASP. Data were extracted onto a specifically defined form. We used thematic synthesis to identify descriptive and analytical themes, and to interpret and generate theory. Confidence was assessed using GRADE-CERQual. The review protocol is publicly available (OSF https://osf.io/g4dt9/)., Results: Five papers (representing four individual studies) from two different countries were included. All studies focused on the experiences of trial recruiters in the maternity setting. We identified four analytical themes; Recruitment through a clinician's lens, Recruiters judgement on acceptability, From protocol to recruiters lived experience, Framing recruitment in context. These were linked by an overarching theme combining beliefs and power., Conclusion: The overarching theme combining beliefs and power links the experiences and perceptions of recruiters. This synthesis shows a gap between the trial design study protocol and the recruiter's lived experience. Strategies such as collaborative trial design, mitigating gatekeeping behaviours, and training may support recruiters in their endeavour., Competing Interests: The authors have declared that no competing interests exist.

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. The study reported in this paper sought to explore children and teachers perceptions and experiences of the START initiative., Methods: We conducted eight, one-to one interviews with teachers and eight focus groups with 61 children who took part in the 2018 START initiative. Interviews and focus groups were recorded and transcribed and the data analysed using template analysis., Results: The findings of this study highlight the benefits of participating in START and the areas of the initiative that required further attention. Teachers and children recalled the benefits of experiential learning associated with START and learning by doing encouraged a fun way of engaging with trial processes. By recalling all aspects of planning, conducting and reporting their trial, the children in this study demonstrated their awareness of the trial processes. The teachers suggested that START provides a valuable framework to contribute to key aspects of the primary school curriculum in Ireland. The experiences of these participants also provided recommendation for improving the programme for future START participants., Conclusions: Increasing public awareness and understanding of randomised trials can help increase public engagement in trials. By educating children about the importance of trials and supporting them to 'learn by doing' by carrying out their own trial, the START initiative can contribute substantially to children's awareness and understanding of trial processes. Given that children are the public, the patients and the researchers of the future, initiatives such as START deserve attention.

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., (© 2019 John Wiley & Sons Ltd.)

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.

Background: One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is little evidence supporting methods to improve retention. This paper reports the PRioRiTy II project, a Priority Setting Partnership (PSP) that identified and prioritised unanswered questions and uncertainties around trial retention in collaboration with key stakeholders., Methods: This PSP was conducted in collaboration with the James Lind Alliance, a non-profit making initiative, to support key stakeholders (researchers, patients, and the public) in jointly identifying and agreeing on priority research questions. There were three stages. (1) First an initial online survey was conducted consisting of six open-ended questions about retention in randomised trials. Responses were coded into thematic groups to create a longlist of questions. The longlist of questions was checked against existing evidence to ensure that they had not been answered by existing research. (2) An interim stage involved a further online survey where stakeholders were asked to select questions of key importance from the longlist. (3) A face-to-face consensus meeting was held, where key stakeholder representatives agreed on an ordered list of 21 unanswered research questions for methods of improving retention in randomised trials., Results: A total of 456 respondents yielded 2431 answers to six open-ended questions, from which 372 questions specifically about retention were identified. Further analysis included thematically grouping all data items within answers and merging questions in consultation with the Steering Group. This produced 27 questions for further rating during the interim survey. The top 21 questions from the interim online survey were brought to a face-to-face consensus meeting in which key stakeholder representatives prioritised the order. The 'Top 10' of these are reported in this paper. The number one ranked question was 'What motivates a participant's decision to complete a clinical trial?' The entire list will be available at www.priorityresearch.ie ., Conclusion: The Top 10 list can inform the direction of future research on trial methods and be used by funders to guide projects aiming to address and improve retention in randomised trials.

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.

Problem Identification: Adherence to oral chemotherapy is influenced by many factors. This qualitative evidence synthesis aimed to contribute to an interpretive understanding of the factors that act as facilitators or barriers to adherence among people with cancer taking lifelong, noncurative oral chemotherapy., Literature Search: A systematic search strategy was developed, and searching was undertaken across several electronic databases (CINAHL®, Cochrane Library, EMBASE, EThOS, ProQuest, PsycINFO®, PubMed, Scopus, Web of Science including MEDLINE®)., Data Evaluation: 12 reports on 10 qualitative studies were included in the synthesis. A total of 206 patients were included, with 109 taking an oral tyrosine kinase inhibitor, along with a total of 57 healthcare professionals., Synthesis: Two principal analytic themes (driving adherence and disabling adherence) and seven subthemes were identified., Implications for Practice: A trusting relationship between healthcare professionals and patients is important to adherence. Open discussions concerning treatment side effects and patients' perceived quality of life should occur at each visit.

Background: Systematic reviews of randomised trials guide policy and healthcare decisions. Yet, we observed that some reviews judge randomised trials as high or unclear risk of bias (ROB) for sequence generation, potentially introducing bias. However, to date, the extent of this issue has not been well examined. We evaluated the consistency in the ROB assessment for sequence generation of randomised trials in Cochrane and non-Cochrane reviews, and explored the reviewers' judgement of the quality of evidence for the related outcomes., Methods: Cochrane intervention reviews (01/01/2017-31/03/2017) were retrieved from the Cochrane Database of Systematic Reviews. We also searched for systematic reviews in ten general medical journals with highest impact factors (01/01/2016-31/03/2017). We examined the proportion of reviews that rated the sequence generation domain as high, low or unclear risk of selection bias. For reviews that had rated any randomised trials as high or unclear risk of bias, we examined the proportion that had assessed the quality of evidence., Results: Overall, 100 systematic reviews were included in our analysis. We evaluated 64 Cochrane reviews which comprised of 984 randomised trials; 0.8% (n = 8) and 52.2% (n = 514) were rated as high and unclear ROB for sequence generation respectively. We further evaluated 36 non-Cochrane reviews which comprised of 1376 trials; 5.8% (n = 80) and 39.6% (n = 545) were rated as high and unclear ROB respectively. Ninety percent (n = 10) of non-Cochrane reviews which rated randomised trials as high ROB for sequence generation did not report an underlying reason. All Cochrane reviews assessed the quality of evidence (GRADE). For the non-Cochrane reviews, only just over half had assessed the quality of evidence., Conclusion: Systematic reviews of interventions frequently rate randomised trials as high or unclear ROB for sequence generation. In general, Cochrane reviews were more transparent than non-Cochrane reviews in ROB and quality of evidence assessment. The scientific community should more strongly promote consistent ROB assessment for sequence generation to minimise selection bias and support transparent quality of evidence assessment. Consistency ensures that appropriate conclusions are drawn from the data.

Background: Gestational diabetes (GDM) is associated with an increased lifetime risk for the development of glucose abnormalities, metabolic syndrome, cardiovascular disease, depression and tumours. Despite this high risk of additional comorbidities, there is no standardised approach to the long-term follow-up of women with a previous diagnosis of GDM. Also, there is no standardisation of outcome selection and reporting in studies involving this population. This increases the risk of reporting bias and reduces the possibility of meaningful comparisons between studies. The aim of this study is to develop a protocol for a core outcome set (COS) for the metabolic follow-up at 1 year and beyond of women with previous GDM treated with insulin and/or oral hypoglycaemic agents., Methods/design: This protocol will describe the steps that will be taken in order to develop the COS. The study will consist of three parts: (1) A systematic review of the literature of the outcomes reported in previous randomised controlled trials of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral hypoglycaemic agents; (2) A three-round, online Delphi survey with key stakeholders in order to prioritise these outcomes; and (3) A consensus meeting where the final COS will be decided., Discussion: The proposed protocol is the first step in developing a COS that will bring consistency and uniformity to outcome selection and reporting in GDM women treated with insulin and/or oral hypoglycaemic agents.

Background: The Objective Structured Clinical Examination (OSCE) has become widely accepted as a strategy for assessing clinical competence in nursing and midwifery education and training. There is a dearth of information, however, on the OSCE procedure from the perspective of midwifery students. In particular, there is an absence of an objective quantification of midwifery students' attitudes towards the OSCE., Objectives: The objective of this study is to report the conduct and findings of a survey of midwifery students' attitudes towards a Lactation and Infant Feeding OSCE and to consider these attitudes in the context of the international literature and the empirical evidence base., Methods: A descriptive survey design using an 18-item Likert (1 to 5 point) scale was used to capture the relevant data. Potential participants were 3rd year midwifery students who had undertaken a Lactation and Infant Feeding OSCE (n=35) in one School of Nursing & Midwifery in the Republic of Ireland. Survey responses were analysed using the Statistical Package for the Social Sciences Version 18., Results: Thirty-three students completed the survey providing a 94% response rate. Midwifery students' attitudes towards individual aspects of the OSCE varied. Overall, midwifery students were neutral/unsure of the OSCE as a strategy for assessing clinical competence (mean 3.3). Most agreed that the examiner made them feel at ease (mean 3.94). Contrastingly this does not appear to appease student nerves and stress as the majority agreed that the OSCE evokes nervousness (mean 4.27) and stress (mean 4.30). Midwifery students, overall, disagreed that the OSCE reflected real life clinical situations (mean 2.48). Midwifery students were neutral/unsure that the OSCE provided an opportunity to show their practical skills (mean 3.36)., Conclusion: The findings of this study identified that midwifery students were neutral/unsure of the OSCE as a strategy for assessing clinical competence. This has relevance for OSCE development at the authors' institution. The results suggest the need to explore further why students responded in this way. This will assist to develop this OSCE further to ensure that it becomes a positive assessment process for midwifery students and for student learning as they progress through their midwifery education and training., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

In Ireland, to register as a midwife, all student midwives must be deemed competent to practice with the assessment of competence an essential component of midwifery education. A variety of assessment strategies, including observed practice, clinical interviews, portfolios of reflection, the Objective Structured Clinical Examination (OSCE) and written examination papers, are utilised to assess midwifery students' clinical competence. In this paper, a critical review of the OSCE as a strategy for assessing clinical competence in one third level institution in Ireland is offered. Although utilised for assessing competence across a range of areas (e.g. obstetric emergencies and pharmacology/drug administration), the use of the OSCE for assessing midwifery students' competence in lactation and infant feeding practices, as an example for this paper, is described. The advantages, disadvantages, validity and reliability of the OSCE, as an assessment strategy, are critically explored. Recognising that no single assessment strategy can provide all the information required to assess something as complex as clinical performance, the OSCE, when viewed alongside other forms of assessment, and with relevance to the topic under examination, may be considered a valuable strategy for enhancing the assessment of students' clinical competence, and for embracing diversity within midwifery education and training., (Copyright © 2012 Elsevier Ltd. All rights reserved.)